chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash, UrticariaPruritus & URTICARIA; PRURITUS; RASH
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: & Erythema; Swelling of arm
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got shingles
Age: 62.0
Sex: F
Vaccine: VARZOS, HEPAB, UNK, VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Groin pain, Influenza like illness
Clinical narrative: severe pain in right side rib cage area of back and side -pain like a broken rib feels, pain in hips and groin area, ache in both legs, very sore arm and neck on the right side of my body. redness around shot the 4th day. sore throat and swollen glands on both sides of upper neck. chills, dizziness, flu like symptoms mostly the 2nd third and fourth days. felt feverish but no fever. shot area still feels tender 6 days after injection. I had a tender spot on my right side of forehead running down the right side of my nasal area felt like i had hit my head on something. My rib soreness was the worst part of the symptoms, this along with the leg and hip pain kept me awake for 2 nights. I felt intermitted  nausea for about 3 days.
Age: 62.0
Sex: F
Vaccine: VARZOS, HEPAB, UNK, VARZOS
Symptoms: Injection site erythema, Injection site pain, Lymphadenopathy, Musculoskeletal chest pain, Nausea
Clinical narrative: severe pain in right side rib cage area of back and side -pain like a broken rib feels, pain in hips and groin area, ache in both legs, very sore arm and neck on the right side of my body. redness around shot the 4th day. sore throat and swollen glands on both sides of upper neck. chills, dizziness, flu like symptoms mostly the 2nd third and fourth days. felt feverish but no fever. shot area still feels tender 6 days after injection. I had a tender spot on my right side of forehead running down the right side of my nasal area felt like i had hit my head on something. My rib soreness was the worst part of the symptoms, this along with the leg and hip pain kept me awake for 2 nights. I felt intermitted  nausea for about 3 days.
Age: 62.0
Sex: F
Vaccine: VARZOS, HEPAB, UNK, VARZOS
Symptoms: Neck pain, Oropharyngeal pain, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: severe pain in right side rib cage area of back and side -pain like a broken rib feels, pain in hips and groin area, ache in both legs, very sore arm and neck on the right side of my body. redness around shot the 4th day. sore throat and swollen glands on both sides of upper neck. chills, dizziness, flu like symptoms mostly the 2nd third and fourth days. felt feverish but no fever. shot area still feels tender 6 days after injection. I had a tender spot on my right side of forehead running down the right side of my nasal area felt like i had hit my head on something. My rib soreness was the worst part of the symptoms, this along with the leg and hip pain kept me awake for 2 nights. I felt intermitted  nausea for about 3 days.
Age: 62.0
Sex: F
Vaccine: VARZOS, HEPAB, UNK, VARZOS
Symptoms: Back pain, Chills, Dizziness, Injection site erythema, Injection site pain
Clinical narrative: severe pain in right side rib cage area of back and side -pain like a broken rib feels, pain in hips and groin area, ache in both legs, very sore arm and neck on the right side of my body. redness around shot the 4th day. sore throat and swollen glands on both sides of upper neck. chills, dizziness, flu like symptoms mostly the 2nd third and fourth days. felt feverish but no fever. shot area still feels tender 6 days after injection. I had a tender spot on my right side of forehead running down the right side of my nasal area felt like i had hit my head on something. My rib soreness was the worst part of the symptoms, this along with the leg and hip pain kept me awake for 2 nights. I felt intermitted  nausea for about 3 days.
Age: 62.0
Sex: F
Vaccine: VARZOS, HEPAB, UNK, VARZOS
Symptoms: Musculoskeletal chest pain, Musculoskeletal stiffness, Nausea, Neck pain, Oropharyngeal pain
Clinical narrative: severe pain in right side rib cage area of back and side -pain like a broken rib feels, pain in hips and groin area, ache in both legs, very sore arm and neck on the right side of my body. redness around shot the 4th day. sore throat and swollen glands on both sides of upper neck. chills, dizziness, flu like symptoms mostly the 2nd third and fourth days. felt feverish but no fever. shot area still feels tender 6 days after injection. I had a tender spot on my right side of forehead running down the right side of my nasal area felt like i had hit my head on something. My rib soreness was the worst part of the symptoms, this along with the leg and hip pain kept me awake for 2 nights. I felt intermitted  nausea for about 3 days.
Age: 62.0
Sex: F
Vaccine: VARZOS, HEPAB, UNK, VARZOS
Symptoms: Pain, Pain in extremity, Pharyngeal swelling, Pyrexia
Clinical narrative: severe pain in right side rib cage area of back and side -pain like a broken rib feels, pain in hips and groin area, ache in both legs, very sore arm and neck on the right side of my body. redness around shot the 4th day. sore throat and swollen glands on both sides of upper neck. chills, dizziness, flu like symptoms mostly the 2nd third and fourth days. felt feverish but no fever. shot area still feels tender 6 days after injection. I had a tender spot on my right side of forehead running down the right side of my nasal area felt like i had hit my head on something. My rib soreness was the worst part of the symptoms, this along with the leg and hip pain kept me awake for 2 nights. I felt intermitted  nausea for about 3 days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Client has red itchy rash to her thighs and feet
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Temp to  100.5 evening  that immunizations given
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Incomplete course of vaccination, Nervous system disorder, Pain
Clinical narrative: did not have second dose; contracted shingles; pain is minimal; itching cab be very distracting; the problem is in the nerves; numbness; can be too itchy to sleep through; This case was reported by a consumer via other manufacturer and described the occurrence of shingles in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In March 2020, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, pain, pruritus, nervous system disorder, numbness and sleep disturbance. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles, pain, pruritus, nervous system disorder, numbness, sleep disturbance and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles, pain, pruritus, nervous system disorder, numbness and sleep disturbance to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Contracted shingles March 2020. These six weeks of shingles had taught me at least one thing.  You could wear a pair of pants amazingly low, even with the top button undone, without them falling down.  The shingles extended down patients left hip, so this was a very practical effect.  The patient still had the shingles, but the pain was minimal at this point.  It was clearly going away, but slowly. My shingles seem to have stalled at almost healed.  The pain was negligible, but the itchiness could be very distracting.  At this point, itching was not painful, either, but itching did not work because the problem was in the nerves.  According to patient's physician the virus had been gone for at least a month.  Tomorrow was 8 weeks.  The last two weeks had been easily bearable.  Very little pain two weeks ago and pretty much none now.  The patient had a little numbness and my side could be too itchy to sleep through.  Showers help, so might be Ipatient need to take two a day, one in the morning for the day, and one in the evening for the night. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Sleep disorder
Clinical narrative: did not have second dose; contracted shingles; pain is minimal; itching cab be very distracting; the problem is in the nerves; numbness; can be too itchy to sleep through; This case was reported by a consumer via other manufacturer and described the occurrence of shingles in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In March 2020, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, pain, pruritus, nervous system disorder, numbness and sleep disturbance. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles, pain, pruritus, nervous system disorder, numbness, sleep disturbance and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles, pain, pruritus, nervous system disorder, numbness and sleep disturbance to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Contracted shingles March 2020. These six weeks of shingles had taught me at least one thing.  You could wear a pair of pants amazingly low, even with the top button undone, without them falling down.  The shingles extended down patients left hip, so this was a very practical effect.  The patient still had the shingles, but the pain was minimal at this point.  It was clearly going away, but slowly. My shingles seem to have stalled at almost healed.  The pain was negligible, but the itchiness could be very distracting.  At this point, itching was not painful, either, but itching did not work because the problem was in the nerves.  According to patient's physician the virus had been gone for at least a month.  Tomorrow was 8 weeks.  The last two weeks had been easily bearable.  Very little pain two weeks ago and pretty much none now.  The patient had a little numbness and my side could be too itchy to sleep through.  Showers help, so might be Ipatient need to take two a day, one in the morning for the day, and one in the evening for the night. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: Muscle soreness at injection site; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site muscle pain and tiredness. On an unknown date, the outcome of the injection site muscle pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the injection site muscle pain and tiredness to be related to Shingrix.  Additional details were provided as follows: After getting the first dose of Shingrix vaccine, the patient experienced muscle soreness at injection site and tiredness.  This lasted for a week then he recovered.  For tolerance after 2nd dose refer case US2020087455. This case is 1 out of 3 cases reported by the same reporter
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaemia, Condition aggravated, Transfusion
Clinical narrative: Not know if the medical condition got worse; This case was reported by a pharmacist via call center representative and described the occurrence of anemia aggravated in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included anemia.   On 9th March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced anemia aggravated. On an unknown date, the outcome of the anemia aggravated was unknown.   It was unknown if the reporter considered the anemia aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a blood transfusion on March 2020, and before the blood transfusion, the patient received 1st dose. The patient did not know if the medical condition got worse because of the first dose of Shingrix. The patient wanted to receive 2nd dose of Shingrix. The reporter did not consent to follow up.
Age: 2.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site pain, Injection site pustule, Injection site rash, Injection site swelling
Clinical narrative: Day 10 after vaccine administered, developed 2 pox like lesions (non-weeping) at the injection site.  Injection site then swelled to about 1.5in in diameter, round and smooth. Gave ibuprofen and swelling went down. Day 11, area is still swollen but now in an uneven, bumpy pattern, and pox are now visible at the area again. Area is painful, but child does not have a fever.
Age: 2.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Injection site bruising, Injection site reaction, Injection site swelling, Rash vesicular
Clinical narrative: Day 10 after vaccine administered, developed 2 pox like lesions (non-weeping) at the injection site.  Injection site then swelled to about 1.5in in diameter, round and smooth. Gave ibuprofen and swelling went down. Day 11, area is still swollen but now in an uneven, bumpy pattern, and pox are now visible at the area again. Area is painful, but child does not have a fever.
Age: 26.0
Sex: F
Vaccine: YF
Symptoms: Cough, Laryngitis
Clinical narrative: She reports the day following vaccination she woke up with cough. This progressed to laryngitis and she was seen at local urgent care facility. She advised me she was given a prescription for accuneb inhaler for use. She advised me no lab testing of x-rays taken.
Age: 54.0
Sex: M
Vaccine: HEPA, MMR, YF
Symptoms: Body temperature increased, Chills, Full blood count, Headache, Mean cell haemoglobin increased
Clinical narrative: On 10-30-19 reports generalized body aches, slight headache, Slight chills. Denies fever. Called back on 11-1-19 he reports temp 99.2 contact his primary care provider who ordered lab work.
Age: 54.0
Sex: M
Vaccine: HEPA, MMR, YF
Symptoms: Mean cell volume increased, Pain, Platelet count decreased, Red blood cell count decreased, White blood cell count decreased
Clinical narrative: On 10-30-19 reports generalized body aches, slight headache, Slight chills. Denies fever. Called back on 11-1-19 he reports temp 99.2 contact his primary care provider who ordered lab work.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported; Nurse called reporting improperly stored VARIV AX was administered to patient on 01-MAY-2020; This spontaneous report was received from a registered nurse refering to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 01-MAY-2020 the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot number S012036 , which has been verified to be valid, expiration date reported and validated as 17-APR-2021) (strength, dosage schedule, route of administration and anatomical location were not reported) for prophylaxis (Product storage error).  It was reported that on an unspecified date, the vaccine was exposed to a temperature of 48.2 (no units reported) for 4 hours as recorded by the data logger. There were no previous tempeture excursions. There was no adverse effect reported.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; on 5/28/2020 a 2 month old patient was administered a properly stored but expired ROTATEQ; This spontaneous report was received from a medical assistant and refers to a 2-month-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 28-MAY-2020, the patient was vaccinated with properly stored but expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R022221, expiration date 23-MAY-2020 (exact dose, dose number, dose site and route of administration were not provided) for prophylaxis. No additional adverse events were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pyrexia
Clinical narrative: flu like symptoms; fever; chills; headache; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills and headache. On an unknown date, the outcome of the influenza-like symptoms, fever, chills and headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills and headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Blood pressure increased, Insomnia, Panic attack
Clinical narrative: have insomnia; Panic attacks; had anxiety; Blood pressure elevated and hard to control; This case was reported by a consumer via call center representative and described the occurrence of insomnia in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included losartan potassium (Losartin), nebivolol hydrochloride (Bystolic) and amlodipine.   On 27th February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced insomnia, panic attack, anxiety attack and increased blood pressure. On an unknown date, the outcome of the insomnia, panic attack, anxiety attack and increased blood pressure were not recovered/not resolved.   It was unknown if the reporter considered the insomnia, panic attack, anxiety attack and increased blood pressure to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's blood pressure elevated and hard to control after receiving Shingrix. She also had anxiety, panic attacks and insomnia. The reporter statd her blood pressure was better controlled since she was started on blood pressure medications and that these might be why the patient was having insomnia.
Sex: F
Vaccine: PNC13
Symptoms: Vaccination complication
Clinical narrative: Kept her in the bed for a week; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (lot number: AG8347) on unspecified date in 2019 at single dose for immunisation. Medical history and concomitant medications were not reported. She wanted to know this and where the ingredients come from since she had a bad reaction to the drug, she described it as "out of the charts" reaction that kept her in the bed for a week. This all happened back in Oct2019. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: MMR, YF
Symptoms: Abdominal pain, Computerised tomogram, Diarrhoea, Differential white blood cell count, Full blood count
Clinical narrative: Notified on 3-3-20 that patient was seen and evaluated in the emergency room for Abdominal pain with nausea and diarrhea.
Age: 48.0
Sex: F
Vaccine: MMR, YF
Symptoms: Influenza virus test, Lipase, Metabolic function test, Nausea, Urine analysis
Clinical narrative: Notified on 3-3-20 that patient was seen and evaluated in the emergency room for Abdominal pain with nausea and diarrhea.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Pain, Pruritus, Swelling
Clinical narrative: sore, swollen, hard and itching
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Patchy red histamine reaction type rash over cheeks, forehead, bilateral arms and bilateral legs, also on R chest wall, otherwise sparing torso.  Rash responded to benadryl, has not occurred before or since.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Skin warm
Clinical narrative: On Saturday (2 days after receiving vaccine) patient noticed a rash on her arm. The rash was itchy and continued to spread across her entire upper arm until she reported to the pharmacy on Monday morning. The rash was warm to the touch.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Fatigue, Myalgia, Pyrexia
Clinical narrative: Low grade fever, fatigue & muscle + joint pain - symptoms started the day after he received the vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: reports one patient received one dose of improperly stored VARIVAX; No additional adverse effects reported; Information has been received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided.  On 24-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot number S022756 and expiration date of 22-JUL-2021 and lot number R020654 and expiration date of 18-JUL-2020 (route of administration, dose and anatomical location were unknown) for prophylaxis; the sterile diluent used to reconstitute the varicella virus vaccine live (oka/merck)(VARIVAX) was properly stored (lot number and expiration date were not provided). The vaccine was exposed to a temperature excursion of 5.7°F with a time frame of 18 minutes. The previous temperature excursion was -13.3 °C for 18 minutes; -13.2 °C for 18 minutes. A "data logger" was involved. No additional adverse effects reported.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Concussion, Head injury, Injection site pruritus, Injection site swelling, Loss of consciousness
Clinical narrative: The injection site (upper arm) was swollen and itchy the next day, and I ran a fever of 100 (not unexpected, per the drug information I was given).  Two days later, without any warning , I passed out, hit my head on a doorway and got a mild concussion.  The only other time in my life I have passed out was in the 1970's when I was getting the flu, so I am not prone to syncopal episodes.  It took several weeks before I felt normal again.  I did report the episode to my Dr..
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: The injection site (upper arm) was swollen and itchy the next day, and I ran a fever of 100 (not unexpected, per the drug information I was given).  Two days later, without any warning , I passed out, hit my head on a doorway and got a mild concussion.  The only other time in my life I have passed out was in the 1970's when I was getting the flu, so I am not prone to syncopal episodes.  It took several weeks before I felt normal again.  I did report the episode to my Dr..
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient was given pediatric dose of Hepatitis B
Age: 23.0
Sex: M
Vaccine: FLU4, HEP, MNQ, TDAP
Symptoms: Pruritus
Clinical narrative: Patient received immunizations and bicillin shot IM. While sitting for observation began to complain of itching.  Taken to med asses department for evaluation.  Observed for 1 hr.  Treated with Zyrtec. Itching resolved. Allergy  consult requested by  providers.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Faeces discoloured, Injection site rash, Pyrexia
Clinical narrative: Mother states child started having the very next day green stool, rash (on left thigh), and fever of 101F. She spoke to her Pediatrician and advised to hold of on future doses of Rotateq. Mother and Pediatrician both believe it may have been Rotateq.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Myalgia, Pain
Clinical narrative: Shivers Fever Headache Muscle Aches Redness, warmth and pain below injection site
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Shivers Fever Headache Muscle Aches Redness, warmth and pain below injection site
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Hives and rash beginning under arms and in groin, advancing to back, chest, arms, legs and face over 12 hours.  Took Zyrtec for 4 days, which slowly reduced rash and hives until gone.  Checked with primary care doctor by telephone on morning after event first occurred.  He concurred in continuing to take Zyrtec.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Contusion, Erythema, Induration, Nodule
Clinical narrative: REDNESS IN PATCHES, SORE ARM, HARD SWOLLEN KNOT, BRUISE7 ON THE INSIDE OF UPPER ARM, WHOLE ARM WAS VERY SORE, SORENESS AROUND ARMPIT AREA
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Swelling
Clinical narrative: REDNESS IN PATCHES, SORE ARM, HARD SWOLLEN KNOT, BRUISE7 ON THE INSIDE OF UPPER ARM, WHOLE ARM WAS VERY SORE, SORENESS AROUND ARMPIT AREA
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash
Clinical narrative: PATIENT PRESENTED TWO DAYS AFTER VACCINATION WITH RASH ON ABDOMEN WITHIN A DAY OF IMMUNIZATION; NO RASH AT INJECTION SITE (A LITTLE REDNESS). DID NOT REPORT ANY ITCHING. STATED THAT THIS HAPPENED BEFORE AFTER THE LAST VACCINE. RECOMMENDED BENADRYL AND, IF IT BECAME ITCHY, HYDROCORTISONE. PATIENT WAS TO REPORT TO THE DOCTOR OR EMERGENCY ROOM IF SHE PRESENTED WITH DIFFICULTY BREATHING/SWELLING.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: patient received vaccination at 1:00 pm patient called into pharmacy stating he was starting to have hives with 4 present. No respiratory difficulty. Patient was advised to go directly to the Emergency Department. Phone call to Emergency Department to notify them of patient's need to be seen at their facility.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Diffuse erythema around injection site, Warm to touch, non tender, and no induration. Caregiver told to place a cold compress for 20 minutes, to injection site every 1-2 hours for 24-48 hours. May also give oral Tylenol for pain. Patient was assessed by Dr., and she concluded patient was experiencing a local reaction to the vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Myalgia
Clinical narrative: muscle pain, tiredness, headache, shivering, and upset stomach
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Immunizations were dropped off over the weekend to a storage facility. When medical employee picked the immunizations up on Monday 01JUN2020 it was noticed that the freezer vaccinations were stored in the fridge. The vaccinations were bagged with a note that said do not use the immunizations. A medical employee went into the freezer, and drew up a dose of the varicella. The vaccination was given to the patient.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Muscle twitching
Clinical narrative: muscle twitching the day after vaccines were given that are brief (3 seconds) and stopped when mother held the extremity.  Also was a rightward twitch of the head.  No additional seizure descriptions per history.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warm, red, swollen area around injection site starting 3 days post injection - stable/slowly worsening over time - patient contacted pharmacy 6/1/20 and presented to urgent care 6/1/20 for a dx of celluitis. Treated with abx
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: headache, muscle aches and pain over most of the body, weak to stand and fever of 101 for the day (Saturday, May 30, 2020
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Pain, Rash erythematous, Rash macular
Clinical narrative: Patient tucked on her shorts recently and noticed discomfort. There's a rash that's red and dark splotches that look as if they were popped. Pain upon touch.
Age: 1.08
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Diet refusal, Eye movement disorder, Hypophagia, Irritability
Clinical narrative: The following day after vaccination, my daughter would cry and whimper from when she had woken up until she had fallen asleep.  With minimal periods through out the day where she would calm down. She refused to eat all day, only drink fluids. The second day post vaccination, still fussy through out the day however a bit easier to calm. Not much eaten. Odd eye movements and neck arching throughout the day. Times where she would just "blank out", for almost a minute. Awaking multiple times throughout the night. Third day, she is doing better with being put down and playing, though still having small, random bursts of fussiness. Doing better with eating but not like she was. Still doing the same odd eye movements and neck arching throughout the day and the periods of blanking out.
Age: 1.08
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Loss of consciousness, Posture abnormal
Clinical narrative: The following day after vaccination, my daughter would cry and whimper from when she had woken up until she had fallen asleep.  With minimal periods through out the day where she would calm down. She refused to eat all day, only drink fluids. The second day post vaccination, still fussy through out the day however a bit easier to calm. Not much eaten. Odd eye movements and neck arching throughout the day. Times where she would just "blank out", for almost a minute. Awaking multiple times throughout the night. Third day, she is doing better with being put down and playing, though still having small, random bursts of fussiness. Doing better with eating but not like she was. Still doing the same odd eye movements and neck arching throughout the day and the periods of blanking out.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Dermatitis allergic, Rash, Rash pruritic, Urticaria
Clinical narrative: Approx. 5 days post Shingrix injection I developed an intensely itchy rash (Hives) on decollate, right side, followed by back top left shoulder, back right shoulder, mid back, thighs, addomen, scalp, nape of neck. Rash continued to spread. Saw Derm NP on 3/11/20, who Rx'd Tramcinolone 0.1% cream. Did not abate itch or spread. Saw MD, derm w/ interest in autoimmune skin disorders who took a biopsy. She diagnosed HIVES/dermal hypersensitivity due to either a spider bit or drug reaction. Vaccine is highly suspect as Hives initiated so shortly after vaccination. I've never had HIVES before. Zyrtec 40mg/day did not help. Elect not to use immunosuppressive therapy recommended by Dr. Hives continue.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Cellulitis, Concussion, Gait inability, Loss of personal independence in daily activities
Clinical narrative: (L) arm cellulitis/swelling, syncope, muscle weakness (generalized) unable to ambulate & complete ADLs, severe back pain, concussion from syncopal episode Patient has gained mobility back and able to complete ADLs. Patient was unable to complete these for 2 wks after the vaccine was given. She continues to have minimal muscle weakness & continue to have severe back pain and moderate (L) arm pain & swelling. Patient declined a work up in the Emergency dept and/or our office for the reaction to the vaccine. Patient verbalized all symptoms including concussion from syncopal episode that occurred that night - 12/13/19.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Muscular weakness, Pain in extremity, Peripheral swelling, Syncope
Clinical narrative: (L) arm cellulitis/swelling, syncope, muscle weakness (generalized) unable to ambulate & complete ADLs, severe back pain, concussion from syncopal episode Patient has gained mobility back and able to complete ADLs. Patient was unable to complete these for 2 wks after the vaccine was given. She continues to have minimal muscle weakness & continue to have severe back pain and moderate (L) arm pain & swelling. Patient declined a work up in the Emergency dept and/or our office for the reaction to the vaccine. Patient verbalized all symptoms including concussion from syncopal episode that occurred that night - 12/13/19.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, IPV, MMRV, VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: (L) arm Hot/swelling/itchy
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness on right upper thigh, somewhat indurated
Age: 1.25
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Tdap was given instead of DTAP.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Nausea, Pain, Peripheral swelling
Clinical narrative: That evening chills, sweating, vomiting   Injection site warm to touch- ice applied. Next morning, injection site red above elbow and swollen- ice applied- Dr. notified. Instructed to continue ice and call back in three days. Thursday morning- right arm more swollen -red below elbow (cellulitis). Dr. notified appointment made for that day. Keflex 500mg twice a day for 7 days prescribed. Symptoms cleared after 7 days
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pruritus, Skin warm
Clinical narrative: That evening chills, sweating, vomiting   Injection site warm to touch- ice applied. Next morning, injection site red above elbow and swollen- ice applied- Dr. notified. Instructed to continue ice and call back in three days. Thursday morning- right arm more swollen -red below elbow (cellulitis). Dr. notified appointment made for that day. Keflex 500mg twice a day for 7 days prescribed. Symptoms cleared after 7 days
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Erythema, Hyperhidrosis, Injection site erythema
Clinical narrative: That evening chills, sweating, vomiting   Injection site warm to touch- ice applied. Next morning, injection site red above elbow and swollen- ice applied- Dr. notified. Instructed to continue ice and call back in three days. Thursday morning- right arm more swollen -red below elbow (cellulitis). Dr. notified appointment made for that day. Keflex 500mg twice a day for 7 days prescribed. Symptoms cleared after 7 days
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Injection site warmth, Peripheral swelling, Vomiting
Clinical narrative: That evening chills, sweating, vomiting   Injection site warm to touch- ice applied. Next morning, injection site red above elbow and swollen- ice applied- Dr. notified. Instructed to continue ice and call back in three days. Thursday morning- right arm more swollen -red below elbow (cellulitis). Dr. notified appointment made for that day. Keflex 500mg twice a day for 7 days prescribed. Symptoms cleared after 7 days
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: the patient was administered an expired dose of MMR II; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 27-MAY-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R014690, expiration date: 23-MAY-2020 for prophylaxis (strength, dosing schedule and route of administration were not reported). The sterile diluent used for reconstitution was not expired (lot# S016521, expiration date: 09-APR-2022). No temperature excursion was noted for both. No additional adverse event information provided.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient was administered an expired dose of MMR II; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 27-MAY-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R014690, expiration date: 23-MAY-2020 for prophylaxis (strength, dosing schedule and route of administration were not reported). The sterile diluent used for reconstitution was not expired (lot# S016521, expiration date: 09-APR-2022). No temperature excursion was noted for both. No additional adverse event information provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; on 5/19/2020 patient was administered a dose of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions, or allergies were not provided.  On 19-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number S028771, which has been verified to be valid, expiration date reported and validated as 09-APR-2021), administered orally as prophylaxis (vaccination scheme was not reported) (product storage error). The administered dose of the vaccine underwent a temperature excursion below 36 degrees Fahrenheit (F) (34.9F) for 16 hours, as recorded by data logger. There was no previous temperature excursion. No additional adverse effect reported.; Sender's Comments:  US-009507513-2005USA008524:
Age: 1.0
Sex: U
Vaccine: HEPA, HEPA, HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects reported.; the patient was "inadvertently administered 3 doses of VAQTA instead of the recommended 2 doses."; the patient was "inadvertently administered 3 doses of VAQTA instead of the recommended 2 doses."; This spontaneous report has been received from a medical assistant referring to a 5 years old patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      The patient was inadvertently administered 3 doses of hepatitis a vaccine, inactivated (VAQTA) instead of the recommended 2 doses. On 11-NOV-2016, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (lot #: L030442, expiration date: 19-DEC-2016; route and dose details were unknown) for prophylaxis. On 24-MAY-2017, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) (lot #: M039202, expiration date: 11-MAR-2018; route and dose details were unknown). On 22-MAY-2020, the patient was vaccinated with the third dose of hepatitis a vaccine, inactivated (VAQTA) (lot #: S032055, expiration date: 09-NOV-2020; route and dose details were unknown) (incorrect dose administered and extra dose administered). No adverse effects reported.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: L030442; expirationdate: 19-DEC-2016; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: bell´s palsy; This initial spontaneous report was received from a lawyer on 27-MAY-220, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On or around 12-MAY-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for routine health maintenance and its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), on an unspecified date, the patient suffered Bell's palsy. As a direct and proximate result of vaccination, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of their condition. The patient sustained severe and permanent personal injuries. Further as a tragic consequence of vaccination, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; Nurse reported the patient was administered an improperly stored dose of ROTATEQ on 5/21/2020.; This spontaneous report was received from a registered nurse referring to patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, concomitant therapy, previous drug reaction, and allergies was not provided.  On 21-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, administered by oral route as prophylaxis (information regarding dose, route of administration, vaccination scheme frequency and anatomical site of administration was not reported; lot number 1660941, which has been verified to be a valid lot number, expiration date reported and validated as 12-FEB-2021).  The administered dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored in a temperature of 12.1 degrees Celsius (C) for a timeframe of 16 hours and 11 minutes, as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse events were reported.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of VAQTA on 5/19/2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.          On 19-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) (lot # S032055, expiration date 09-NOV-2020, dosage detail, route and strength were not provided) for prophylaxis (product storage error). Administered doses of vaccine experienced temperature excursion of 12.1 degrees Celsius (C) for 16 hours and 11 minutes. There was no previous temperature excursion. Digital data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032055; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No symptoms or adverse effects reported; Nurse reports 8 patients received unspecified dose of PROQUAD that was improperly stored; This spontaneous report was received from a registered nurse, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided.  On 10-FEB-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number S012530 and expiration date 20-OCT-2020) as prophylaxis. The sterile diluent (manufacturer unknown) used was properly stored.  According to the reporter, the temperature excursion was -12.8 degrees Celsius for a time frame of two hours and 38 minutes on an unspecified date (product storage error), with multiple previous temperature excursion of, the worst temperature/ was -9.8 degrees Celsius for about 112 minutes; which was detected by a digital data logger.  This is one of eight reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000425: US-009507513-2006USA000426: US-009507513-2006USA000427: US-009507513-2006USA000424: US-009507513-2006USA000428: US-009507513-2006USA000422: US-009507513-2006USA000423:
Sex: U
Vaccine: HPV9, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported; Improper storage of vaccine; This spontaneous report was received from a certified medical assistant (CMA) referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 26-MAY-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (therapy type: Digital Data Logger) (GARDASIL 9) (lot # 1621931, expiration date reported as 26-JAN-2022, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to a temperature of 30.2 Fahrenheit (F) for 1 hour as recorded by a data logger. The vaccine had no previous temperature excursion. No adverse effects reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity:; manufacturerstate: ; manufacturercountry: ; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability