chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 21-NOV-2015, the patient was vaccinated with improperly stored ROTATEQ oral liquid, lot # L008574, expiration date 22-NOV-2016, (dose and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 19-NOV-2015, the patient was vaccinated with improperly stored ROTATEQ oral liquid, lot # L008574, expiration date 22-NOV-2016, (dose and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 23-NOV-2015, the patient was vaccinated with improperly stored ROTATEQ oral liquid, lot # K022995, expiration date 22-JUL-2016, (dose and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 21-NOV-2015, the patient was vaccinated with improperly stored ROTATEQ oral liquid, lot # K022995, expiration date 22-JUL-2016, (dose and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 20-NOV-2015, the patient was vaccinated with improperly stored GARDASIL, lot # K011562, expiration date 08-APR-2017, (dose, dose number, route and anatomical location were unspecified). No averse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 20-NOV-2015, the patient was vaccinated with improperly stored GARDASIL, lot # K011562, expiration date 08-APR-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 19-NOV-2015, the patient was vaccinated with improperly stored GARDASIL, lot # K00120, expiration date 22-JAN-2016, (dose, dose number, route and anatomical location were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 23-NOV-2015, the patient was vaccinated with improperly stored GARDASIL, lot # K011562, expiration date 08-APR-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 24-NOV-2015, the patient was vaccinated with improperly stored GARDASIL, lot # K011215, expiration date 05-MAY-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 23-NOV-2015, the patient was vaccinated with improperly stored GARDASIL, lot # K011215, expiration date 05-MAY-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 25-NOV-2015, the patient was vaccinated with improperly stored GARDASIL, lot # K011215, expiration date 05-MAY-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 19-NOV-2015 the patient was vaccinated with improperly stored GARDASIL, lot # K011215, expiration date 05-MAY-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Presyncope
Clinical narrative: This spontaneous report has been received from a nurse practitioner via a company representative concerning a male patient of unknown age. The patient's concurrent conditions and pertinent medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (Lot #, exp. date, strength, route of administration and dose were not provided). There was no concomitant medication reported. On an unknown date, the patient experienced dizziness and almost fainting after receiving GARDASIL 9. The patient sought medical attention in the office only and received an ice pack and water to recover at the office before leaving. However, the outcome of dizziness and almost fainting was not reported. The causal assessment of dizziness and almost fainting to GARDASIL 9 was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were inadvertently vaccinated with improperly stored doses of PROQUAD (Merck), lot # K008870, expiration date: 19-DEC-2015, (dosage and route were not reported). No adverse effects were reported. Concomitant therapy was not reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected because there is not permission to contact physician.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 25-NOV-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (Lot # K024036, expiration date 26-NOV-2016) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report has been received from a nurse practitioner via a company representative concerning a female patient of unknown age. The patient's concurrent conditions and pertinent medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (Lot #, exp. date, strength, route of administration and dose were not provided). There was no concomitant medication reported. On an unknown date, the patient experienced dizziness and almost fainting after receiving GARDASIL 9. The patient sought medical attention in the office only and received an ice pack and water to recover at the office before leaving. However, the outcome of dizziness and almost fainting was not reported. The causal assessment of dizziness and almost fainting to GARDASIL 9 was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an epidemiologist and refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 30-NOV-2015, the patient was vaccinated with a dose of an improperly stored VARIVAX (Merck), lot number reported as 1024255, expiration date 01-JUL-2017, (dose, route and anatomical location were not reported). No adverse effects were reported. There was no concomitant medication reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 17-NOV-2015, the patient was vaccinated with ZOSTAVAX. In November 2015, the patient experienced herpes virus infection referred as "herpes outbreak". On 22-NOV-2015, the patient stated taking VALTREX for the "herpes outbreak". Pharmacist reported that patient just stated that it was "herpes outbreak" and pharmacist did not clarify with patient if "herpes outbreak" was herpes simplex (cold sores), herpes zoster (shingles) or genital herpes. VZVIP was mentioned to pharmacist since shingles could not be ruled out but pharmacist was adamant about not receiving VZVIP packet because he was not sure if patient was having shingles or other types of herpes outbreak. The outcome of herpes virus infection was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On an unspecified dates, from 12-NOV-2015 thru 30-NOV-2015, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L016428 and expiration date 30-JUN-2017, (dose, route of administration and anatomical location were not provided). There were no concomitant medications provided. No adverse effects were reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to 3 unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On 09-DEC-2015, the patient was vaccinated with PROQUAD (Merck) (lot # L039269, dose 1, subcutaneous, dose not provided) and VARIVAX (Merck) (lot # L005299, dose 1, dose and route not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Vaccination complication
Clinical narrative: This spontaneous report as received from a medical assistant at the physician's office refers to approximately 16 year old male patient. The patient drug allergies were none. On 24-NOV-2015, the patient was vaccinated with third dose of GARDASIL (lot #K016966 and expiry date: 10-MAY-2017) intramuscularly. Concomitant medication were none. On 24-NOV-2015, the patient experienced dizzy and lightheaded. The patient did not sought medical attention. The patient was treated with water and cold compresses. On an unknown date, the patient experienced slight reaction to second dose of GARDASIL. The outcome of dizzy and lightheaded was recovering/resolving (reported as patient was doing fine on 25-NOV-2015 during the check). The outcome of slight reaction was unknown. The reporter considered slight reaction to be related to GARDASIL and causality of dizzy and lightheaded was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported, On 03-JUN-2015 the patient was vaccinated with the first dose of VAQTA (dose, route, lot# and expiration date were not reported). The second dose (dose, route, lot# and expiration date were not reported) was administered on 07-JUL-2015 for the same indication . No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist referring to multiple unspecified pharmacists of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these pharmacists developed shingles an unspecified amount of time after they administered ZOSTAVAX (vaccination dates, doses, frequencies, lot # and expiration dates were unknown) to unspecified patients. The reporting pharmacist stated that one of these pharmacist had ever received ZOSTAVAX and the reporting pharmacist wondered if this could be potential transmission from the vaccines. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 24-NOV_2015, the patient was vaccinated with improperly stored ROTATEQ oral liquid, lot # L008574, expiration date 22-NOV-2016, (dose and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Per pt he developed rash starting in left arm and spread to both hands. Rash moves to head, face and neck but not to lower extremities, pt has been taking BENADRYL 50mg daily for 3 days.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Per pt he developed rash starting in left arm and spread to both hands. Rash moves to head, face and neck but not to lower extremities, pt has been taking BENADRYL 50mg daily for 3 days.
Age: 19.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Pharyngeal oedema
Clinical narrative: Swelling of throat making breathing difficult. Two doses of Benadryl with no effect. Administration of EpiPen.
Age: 19.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Throat tightness
Clinical narrative: Swelling of throat making breathing difficult. Two doses of Benadryl with no effect. Administration of EpiPen.
Age: 19.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Pharyngeal oedema
Clinical narrative: Mild tightness in throat, persistent, not worsening over time.
Age: 19.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Throat tightness
Clinical narrative: Mild tightness in throat, persistent, not worsening over time.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Vertigo
Clinical narrative: Woke up in the evening with vertigo.  This has persisted throughout the morning.  No previous history of vertigo in my lifetime.  Vertigo is listed as a side-effect on the insert.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Pyrexia, Tinnitus
Clinical narrative: Ringing in Ears which has continued and is ongoing as of today's date 12/13/2015.  Fever and flu like symptoms occurred and last for 48 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling at the injection site. Patient stated it swelled to the size of an egg and was itchy. She did take oral Benadryl to help with the itching and said that helped. The swelling had gone away by 12/13/2015, but was still slightly itchy. She is continuing to use oral Benadryl to help with itching.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Rash, Skin warm
Clinical narrative: Patient noticed arm soreness late at night on 12/12/15. Upon waking in the morning on 12/13/15 could not lift arm. A circular rash with swelling, redness, and warmth occurred on the arm vaccine was given but not at the injection site. The reaction became larger throughout the morning but stayed local.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Patient noticed arm soreness late at night on 12/12/15. Upon waking in the morning on 12/13/15 could not lift arm. A circular rash with swelling, redness, and warmth occurred on the arm vaccine was given but not at the injection site. The reaction became larger throughout the morning but stayed local.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had redness, swelling and itching at the injection site.
Age: 13.0
Sex: F
Vaccine: HEPA, HPVX
Symptoms: Abdominal pain upper, Amnesia, Arthralgia, Asthenia, Confusional state
Clinical narrative: Instantly couldn't move arm and felt weak went home and took a 14hour nap within weeks couldn't stay on feet for to long had extreme fatigue than started experiencing stomach aches and joint pain with body spasms than she would have moments of total confusion soon after the second round in April 2014 her fatigue got worse she experienced horrible nausea and reflex than irregular periods. Than would start to have headaches soreness than in August 2015 she started having blackout episodes that turned in to simple complex seizures she now has lost over 20 pounds and can't put it back on and experiences daily dizziness and nausea and stomach pains and indigestion with short term memory loss, slurred speech and headaches she also can't solve simple problems like 25=25 she has her zone out episodes all the time where she is awake but has a hard time responding and grasping what's around her.
Age: 13.0
Sex: F
Vaccine: HEPA, HPVX
Symptoms: Dizziness, Dysarthria, Dyspepsia, Fatigue, Headache
Clinical narrative: Instantly couldn't move arm and felt weak went home and took a 14hour nap within weeks couldn't stay on feet for to long had extreme fatigue than started experiencing stomach aches and joint pain with body spasms than she would have moments of total confusion soon after the second round in April 2014 her fatigue got worse she experienced horrible nausea and reflex than irregular periods. Than would start to have headaches soreness than in August 2015 she started having blackout episodes that turned in to simple complex seizures she now has lost over 20 pounds and can't put it back on and experiences daily dizziness and nausea and stomach pains and indigestion with short term memory loss, slurred speech and headaches she also can't solve simple problems like 25=25 she has her zone out episodes all the time where she is awake but has a hard time responding and grasping what's around her.
Age: 13.0
Sex: F
Vaccine: HEPA, HPVX
Symptoms: Loss of consciousness, Menstruation irregular, Mobility decreased, Muscle spasms, Nausea
Clinical narrative: Instantly couldn't move arm and felt weak went home and took a 14hour nap within weeks couldn't stay on feet for to long had extreme fatigue than started experiencing stomach aches and joint pain with body spasms than she would have moments of total confusion soon after the second round in April 2014 her fatigue got worse she experienced horrible nausea and reflex than irregular periods. Than would start to have headaches soreness than in August 2015 she started having blackout episodes that turned in to simple complex seizures she now has lost over 20 pounds and can't put it back on and experiences daily dizziness and nausea and stomach pains and indigestion with short term memory loss, slurred speech and headaches she also can't solve simple problems like 25=25 she has her zone out episodes all the time where she is awake but has a hard time responding and grasping what's around her.
Age: 13.0
Sex: F
Vaccine: HEPA, HPVX
Symptoms: Pain, Seizure, Slow response to stimuli, Thinking abnormal, Weight decreased
Clinical narrative: Instantly couldn't move arm and felt weak went home and took a 14hour nap within weeks couldn't stay on feet for to long had extreme fatigue than started experiencing stomach aches and joint pain with body spasms than she would have moments of total confusion soon after the second round in April 2014 her fatigue got worse she experienced horrible nausea and reflex than irregular periods. Than would start to have headaches soreness than in August 2015 she started having blackout episodes that turned in to simple complex seizures she now has lost over 20 pounds and can't put it back on and experiences daily dizziness and nausea and stomach pains and indigestion with short term memory loss, slurred speech and headaches she also can't solve simple problems like 25=25 she has her zone out episodes all the time where she is awake but has a hard time responding and grasping what's around her.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Erythema, warmth, pain at injection site.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Pain/Discomfort in Shoulder over first 24 hours. Over the next 24 hours shoulder exhibited approximately four quarter sized red/inflammed areas on skin. These areas were exhibiting warmth and inflammation.  Patient arrived at pharmacy on 12/12/15 and allowed pharmacy to see shoulder.  Pt. said area felt better and seemed to be getting better.  Pharmacist on duty recommended oral Benadryl as well as ibuprofen over next 24-48 hours to help alleviate reaction.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness, Nasopharyngitis
Clinical narrative: I came down with cold symptoms on 10/17/2015. It worsened to flu like symptoms the next day on 10/18/2015. When little improvement after taking over the counter, I went to the doctor on 10/22/2015.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: The patient reportrf having swelling on her arm where the shot was injected and developed a welt.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Patient went to Dr. because he developed a rash on his face near and in his righ eye. His Dr. said that he had shingles.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain in extremity, Sleep disorder
Clinical narrative: Persistent upper arm and shoulder pain since the shot. I can't sleep on that side or the pain becomes unbearable.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pain
Clinical narrative: Severe arm pain, with lump currently very hot and tender to touch. Body aches, slight headache, diaherra, nausa, very tired.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Skin warm, Tenderness, Upper extremity mass
Clinical narrative: Severe arm pain, with lump currently very hot and tender to touch. Body aches, slight headache, diaherra, nausa, very tired.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: PATENT CAME IN ON 12/12/2015 SAID HIS ARM HURTS EVER SINCE THE SHOT BUT ONLY WHEN HE LIFTS THE ARM.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Paraesthesia, Peripheral swelling, Vaccination complication
Clinical narrative: I had an adverse reaction to the Gardasil vaccination when I received the second and third vaccines in the series. My hands and feet tingled and swelled, building up slowly over the course of several days until I woke up one morning and was unable to close my hand because it was so swollen, and it hurt to walk on my feet. I painstakingly made it to the clinic and was given numerous medications and a large shot of Benadryl. It was not until I started to feel the tingling feeling again a day or so after my third vaccination that the connection was made between the vaccine and my reaction.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site rash, Injection site swelling, Swollen tongue
Clinical narrative: Rash at injection site, large lump under skin at injection site, swelling of left upper arm, and swelling of tongue.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Patient's arm was swollen and itchy at site of injection. She also developed a fever.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Injection site swelling, Peripheral swelling, Rash, Skin warm
Clinical narrative: Left arm swollen around injection site of ZOSTAVAX. She reported rash at different part of body the day after getting the vaccine. The upper arm was red, swollen and warm to touch on 12/12/15. Patient said the swelling has been going down steadily. She is using BENADRYL.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager (health professional) referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VAQTA (lot # L028666, expiration date 04-NOV-2016, strength, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager (health professional) referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot # L004014, expiration date 04-MAR-2017, strength, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager (health professional) referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot # K011947, expiration date 07-JUN-2016, strength and dose were unknown) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager (health professional) referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K021444, expiration date 17-SEP-2016, strength, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager (health professional) referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored M-M-R II (lot # was reported as L00458, expiration date 03-APR-2017, strength, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information received from a nurse referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 01-DEC-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L023589, expiration date was 26-JUN-2017, strength, dose and route were unknown). No adverse effects were reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: Information has been received from a pharmacist referring to a 66 year old female patient. The patient had none pertinent medical history or drug reactions. On 19-NOV-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # L028283, expiration ate 28-OCT-2015, 0.65 ml) subcutaneously in the back of an unspecified arm. The patient had none concomitant therapies. On 22-NOV-2015, the back of her arm was itchy around the injection site and there was a small bump underneath the skin. "Clarified with the pharmacist that the "lump" was not a rash, but an "injection site reaction.". No treatment was given for the adverse events. None lab diagnostics studies were performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. From 23-NOV-2015 to 09-DEC-2015, these patients were vaccinated with oral, ROTATEQ (lot# reported as L008050, expiration date 09-NOV-2016; lot#K023537, expiration date 22-JUN-2016; lot# L000569, expiration date 13-JUL-2016; dose and route not reported) immunization series that were improperly stored. No adverse effects were reported. Additional information has been requested.
Age: 0.21
Sex: M
Vaccine: RV5
Symptoms: Culture stool positive, Haematochezia, Milk allergy
Clinical narrative: This spontaneous report as received from a consumer refers to her 11 week old son. The patient's pertinent medical history was none. On 14-AUG-2015, the patient was vaccinated with first dose of ROTATEQ via oral route. Concomitant medications were none. On 15-AUG-2015, the patient experienced bloody stools. On 30-SEP-2015, the patient was vaccinated with second dose of ROTATEQ. The patient had bloody stools on 30-SEP-2015 and continued to have bloody stools each day until 05-OCT-2015 (unknown if recovered). The patient's mother had the stools tested and the results indicated that the patient had a dairy protein allergy. The patient sought medical attention with the physician and no treatment was provided for the events. The outcome of the events was unknown. The relatedness of the events with ROTATEQ was not reported. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent condition were not provided. On unspecified dates ("sometime") in October 2015 and November 2015, the patients might have been received possibly improperly stored PROQUAD (Merck) injection (lot number L031602, expired date 18-FEB-2017, dosage, strength and route were not reported). No symptoms were reported. The nurse also inquired for the temperature stability data. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Rash, fever intermittent, fussy.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU4, FLU3
Symptoms: Insomnia, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Most pain in life. Lasted 3 months. Wiggled needle around. Never had pain like this. Had 7 operations all cancer. Lost kidney.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU4, FLU3
Symptoms: Crying, Insomnia, Mobility decreased, Musculoskeletal pain, Paralysis
Clinical narrative: Most pain in life. Lasted 3 months. Wiggled needle around. Never had pain like this. Had 7 operations all cancer. Lost kidney.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU4, FLU3
Symptoms: Cancer surgery, Insomnia, Pain, Renal failure, Vaccination error
Clinical narrative: Most pain in life. Lasted 3 months. Wiggled needle around. Never had pain like this. Had 7 operations all cancer. Lost kidney.
Age: 93.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Asthenia, Cellulitis, Culture, Skin infection, X-ray
Clinical narrative: Patient states redness occurred at injection site 2 days after vaccine, and worsened daily after that, was seen in clinic was seen on 10/18/15 by MD Right upper arm: about half dollar size bruising surround withabout 8 cm blanchable redness. Mild tenderness to palpation but does not appear cellulitic. Skin intact, dry.  10/20/2015 return to clinic for worsening of redness, was given ABX rocephin x 1 and keflex oral   10/22/2015 was evaluted and noted to have rash spreading despite oral ABX was transferred to ER then admitted due to failed ABX oral treatment
Age: 93.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Blood lactic acid normal, Cellulitis, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Patient states redness occurred at injection site 2 days after vaccine, and worsened daily after that, was seen in clinic was seen on 10/18/15 by MD Right upper arm: about half dollar size bruising surround withabout 8 cm blanchable redness. Mild tenderness to palpation but does not appear cellulitic. Skin intact, dry.  10/20/2015 return to clinic for worsening of redness, was given ABX rocephin x 1 and keflex oral   10/22/2015 was evaluted and noted to have rash spreading despite oral ABX was transferred to ER then admitted due to failed ABX oral treatment
Age: 93.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Leukocytosis, Rash
Clinical narrative: Patient states redness occurred at injection site 2 days after vaccine, and worsened daily after that, was seen in clinic was seen on 10/18/15 by MD Right upper arm: about half dollar size bruising surround withabout 8 cm blanchable redness. Mild tenderness to palpation but does not appear cellulitic. Skin intact, dry.  10/20/2015 return to clinic for worsening of redness, was given ABX rocephin x 1 and keflex oral   10/22/2015 was evaluted and noted to have rash spreading despite oral ABX was transferred to ER then admitted due to failed ABX oral treatment
Age: 93.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Cellulitis
Clinical narrative: Patient states redness occurred at injection site 2 days after vaccine, and worsened daily after that, was seen in clinic was seen on 10/18/15 by MD Right upper arm: about half dollar size bruising surround withabout 8 cm blanchable redness. Mild tenderness to palpation but does not appear cellulitic. Skin intact, dry.  10/20/2015 return to clinic for worsening of redness, was given ABX rocephin x 1 and keflex oral   10/22/2015 was evaluted and noted to have rash spreading despite oral ABX was transferred to ER then admitted due to failed ABX oral treatment
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a 52 year old female patient. Concurrent conditions and medical history of the patient were not reported. On 16-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX (Lot#, expiration date, route and dose were unspecified). Other suspect and concomitant therapies were not reported. On 17-NOV-2015, the patient had developed "swelling, an unspecified rash", and had injection site "tenderness". The patient sought medical attention and the pharmacist recommended that the patient take BENADRYL. The outcome of the events was unknown. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a 52 year old female patient. Concurrent conditions and medical history of the patient were not reported. On 16-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX (Lot#, expiration date, route and dose were unspecified). Other suspect and concomitant therapies were not reported. On 17-NOV-2015, the patient had developed "swelling, an unspecified rash", and had injection site "tenderness". The patient sought medical attention and the pharmacist recommended that the patient take BENADRYL. The outcome of the events was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse referring to a non-pregnant 11 year old female patient without pertinent medical history. The patient had drug allergies or reactions to penicillin, ZITHROMAX and CEFZIL. On 07-DEC-2015, the patient was vaccinated with a 0.5 ml dose of GARDASIL 9 (lot # K06247, expiration date: 29-JAN-2017, intramuscularly in the left deltoid region). On the same date, the patient also received a dose of MENACTRA in the left deltoid region (dose, lot#, indication and route unknown). The patient's mother called the office to seek medical attention. It was reported that the patient developed "hives all over her chest area" on 07-DEC-2015. The patient was advised to take an unspecified dose of BENADRYL for treatment on 07-DEC-2015. No lab diagnostics studies were performed. The outcome of the event was unknown. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Dyspepsia, Injection site erythema, Pruritus
Clinical narrative: Note, because of some acid indigestion I took a Walzan-75 prior to bed time 11 PM 12/12/2015. At 1:00AM or 2:00AM itchiness noted near site of vaccine. Scratched it. In the morning took a look and there was a red patch next to the bandaid 3 inches long, 2 inches wide. Still a little itch at time of writing this. Same amount of redness.
Age: 47.0
Sex: F
Vaccine: FLUN4
Symptoms: Coma
Clinical narrative: Coma.
Age: 37.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Headache, Oropharyngeal pain, Sneezing
Clinical narrative: Headache, coughing, sneezing, sore throat.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Headache, Oropharyngeal pain, Sneezing
Clinical narrative: Headache, coughing, sneezing, sore throat.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Headache, Oropharyngeal pain, Sneezing
Clinical narrative: Headache, coughing, sneezing, sore throat.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: Gave vaccine 12/9/15, and a red, quarter-size area developed 12/10/15. As of today, 12/12/15, the area involved is much larger with one small whelp, but she says it is improving.
Age: 36.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Erythema - raised area left upper deltoid at injection site - local reaction advised routine NSAIDS. Ice pack applied.
Age: 36.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Headache, Oropharyngeal pain, Respiratory tract congestion, Sneezing
Clinical narrative: Headache, coughing, sneezing, sore throat, congestion, grogginess.
Age: 36.0
Sex: M
Vaccine: FLUN4
Symptoms: Somnolence
Clinical narrative: Headache, coughing, sneezing, sore throat, congestion, grogginess.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient states that she has an itchy rash from the injection site all the way down her arm to the elbow.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: PATIENT SELF DESCRIBED OVER PHONE A WARM, 7 INCH, RED REACTION AFTER RECEIVING ZOSTER VACCINE. SHE MARKED THE ARM TO MAKE SURE THAT THE SITE IS NOT GETTING WORSE. PATIENT ALSO TOOK DIPHENHYDRAMINE.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site scab, Injection site swelling, Injection site warmth
Clinical narrative: R deltoid swelling at injection site; erythema, warm to touch; swelling from R deltoid to elbow; seen in ED - dx cellulitis; crusting at injection site; PO Keflex rx by ED for 10 days; per father, has resolved as of 12/14/15.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Adult Hep A dose given to pediatric patient.
Age: 0.62
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Injection site rash
Clinical narrative: Rash developed on thighs that evening, previous rxn same at 4months vaccines.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Insomnia, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Significant  shoulder pain and restricted range of motion in shoulder and arm.  Pain radiated down through arm to thumb.  Resulted in lack of sleep due to pain at night.  Naproxen taken for pain with no result.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient states she started to get arm pain the day after injection (12/3/15). On 12/10/15 patient noticed redness, warmth at injection site. Noted on 12/11/15 an area of erythema, redness and swelling that measures about 5cm x 4cm in size.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Patient experienced pain on left shoulder after receiving flu shot. She reported that this pain intensified that evening to a pain level of 9/10 and diminished over the course of the next 24 hours but never went away. On 12/5/15, she reported a continuous dull pain at level of 3/10. It hurt when raising arm or with pulling motion. She went to see orthopedic doctor on 12/1/15 who recommended MRI if no improvement in 1-2 weeks.
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB, IPV, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: Pt was given PENTACEL (DTaP, IPV, HIB) and by mistake also given IPV. Parents where given explanation of what happened and given ER warnings pt's mother stated understanding.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Chills, Erythema, Hyperhidrosis, Malaise
Clinical narrative: Pt started feeling ill the night of the day she received vaccine. Chills, sweats, arm red and warm. Came to clinic on 12/11/15. VS-129/79 P-99 T-100.5. PPD placed same day. Assessed by physician in clinic.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Pt started feeling ill the night of the day she received vaccine. Chills, sweats, arm red and warm. Came to clinic on 12/11/15. VS-129/79 P-99 T-100.5. PPD placed same day. Assessed by physician in clinic.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Unsure whether it was the flu shot or a new lotion, but patient broke out with red bumps 3 days after shot.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Numbness to (R) hand - started approximately 1 day after vaccine and lasted around 2 wks.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: Sore arm - 3 days. Redness on appx 2/3 of arm. Slight fever - 1 day. Redness lasted appx 2 weeks.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient says the day following her immunization the injection site was raised and red but there was no bruising. The area is better now.
Age: 87.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Blood test, Dizziness, Urine analysis
Clinical narrative: I got the shot at 8:00 A.M. at 8:45 after I arrived home, I got dizzy and felt very weak. I went to the E.R. They tested my blood and urine. Nothing showed up. The dizziness gradually went away. However I felt lightheaded the rest of the day.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Chest pain, Dyspnoea, Myalgia
Clinical narrative: On 19 September 2014 he received his second dose of Anthrax and the following day (20 September) he noted onset of myalgias and developed chest pain and shortness of breath while running. He denies rhinoconjunctival, lip/tongue/oral/laryngeal, cutaneous and GI symptoms. He denies any adverse vaccine reactions prior to or since this episode. He has not received further doses of Anthrax.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Disorientation, Headache, Malaise, Peripheral swelling, Pruritus
Clinical narrative: Headache, Malaise, Disoriented, Swelling and Rash on administered arm "Look like Australia".  Itchiness, and swollen.