chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-MAR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 11-NOV-2016, the patient was administered the ZOSTAVAX vaccine (lot # and route not specified) by a Physician Assistant. On an unspecified date, the patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant referring two unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not reported. On 23-OCT-2017, at 12 years, two unspecified patients were vaccinated with the first dose of with GARDASIL 9 (dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis, the medical assistant reported that on 14-NOV-2018, the two unspecified patient were vaccinated with the second dose of GARDASIL 9 (lot# 1586752 (expiration date:16-FEB-2021) and  lot# N009123 (expiration date was not reported)) (dose, frequency and route of administration were not reported) for prophylaxis. No adverse effects were reported. Lot number (N009123) is an invalid lot number for [hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 10-JAN-2012, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager via Pfizer regarding a 6-month-old female patient. It was reported that patient had no vaccinations in the previous 4 weeks. The patient's medical history including any illness at the time of vaccination were reported as none. The patient's concomitant medications and current conditions were unknown. On an unknown date, the patient was vaccinated with ROTATEQ (lot # R015607 and expiry date: 21-APR-2020) via oral route for prophylaxis. On an unknown date, the patient received vaccine which had undergone temperature excursion (product storage error) and no adverse events had been reported (no adverse event). The outcome of product storage error and no adverse event was unknown.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Full blood count, Loss of consciousness, Syncope
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a 14-year-old female patient. The patient's concurrent conditions included malignant neoplasm of adrenal gland and Gilbert's syndrome. The patient had no drug reaction or allergies. The patient's medical history was not reported and she was not taking any concomitant medications. On 11-MAR-2019, the patient received a dose of GARDASIL 9, intramuscularly (lot #: R023607, expiration date: 06-MAY-2021); dosage not reported. The next day, on 12-MAR-2019, the patient "passed out at school". On an unknown date, a complete blood count (CBC) was performed with unknown results. On an unknown date, the patient recovered from the event of syncope. No additional information was provided. The causal relationship between the event of syncope and GARDASIL 9 was unknown.
Age: 0.33
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Information has been received from a nurse referring to a 4-month-old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 14-MAR-2019, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (1 dosage form, lot# R024025, expiration date of 02-SEP-2020, strength and frequency were unknown) intramuscularly for prophylaxis (Wrong product administered). No adverse event was reported. No product quality compliant (PQC) was involved.
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Accidental exposure to product, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a 32 year old consumer regarding herself. The patient's current conditions included type 1 diabetes mellitus. The patient was on treatment with unspecified diabetes treatment. The patient did not had any drug allergies/reactions. Information on medical history was unknown. On 13-MAR-2019, from the physician's office, the patient was inadvertently vaccinated with GARDASIL 9 injection for prophylaxis (strength, dose, frequency, lot#, expiry date not reported). The patient became pregnant with last menstrual period (LMP) of 14-AUG-2018 and estimated date of delivery (EDD) of 21-MAY-2019. Initial exposure to GARDASIL 9 was at 30 week(s). The pregnancy outcome was unknown. On an unknown date, the patient sought medical attention by contacting the physician's office. The patient did not receive any treatment neither underwent any lab tests. The patient did not report about any ill effects experienced with GARDASIL 9. There was no product quality complaint associated with this report.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unspecified amount of unspecified patients of unknown age and gender. Concomitant medication included sterile diluent (lot number R028661 expiration date: 31-JAN-2020; N028747 expiration date: 28-MAR-2020). Information about pertinent medical history, concurrent conditions, and drug reactions/allergies was not provided. From 11-MAR-2019 to 14-MAR-2019, the patients were administered improperly stored doses of PROQUAD (lot #: R012416, expiration date: 28-OCT-2019; dose, strength, route and frequency were not reported) and VARIVAX (lot #: R023513, expiration date: 16-AUG-2020; dose, strength, route and frequency were not reported) for prophylaxis. Sterile diluent was stored properly. No adverse effects were reported. The vaccines were exposed to temperature of -14 Celsius degree to -10 Celsius degree (-13.8 Celsius degree) for 1 hour and 20 minutes and the data logger was involved. There was no previous excursions. This is a non-valid report with no patient identifiers.
Age: 26.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Cellulitis, Chills, Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from the mother of a 26 year old male patient with no drug allergies. There was no pertinent medical history and no concomitant medication. On 07-MAR-2019, the patient received the PNEUMOVAX 23 one shot, once, in the "shoulder" (lot number R024025, expiration date 02-SEP-2020) to "boost his cells because he was having problems with sinus infections." On 08-MAR-2019, the patient experienced chills. His arm became swollen and red and he iced it all day. By 10-MAR-2019, it was worse and the patient went to urgent care where he was told that there was nothing wrong. On 11-MAR-2019, the patient went to his physician who confirmed the patient had cellulitis. The patient underwent "blood tests for cellulitis" (results not provided). The physician said it was a "bad batch." The patient was taken to the hospital for the day and was given unspecified intravenous antibiotics and was prescribed ten days of unspecified antibiotics. The patient was reported to be recovering but still had another week of antibiotics to take. Upon internal review, cellulitis was determined to be medically significant. This is one of three cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1903USA007431: US-009507513-1903USA007424.
Age: 26.0
Sex: M
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age, Product use in unapproved indication
Clinical narrative: This spontaneous report was received from the mother of a 26 year old male patient with no drug allergies. There was no pertinent medical history and no concomitant medication. On 07-MAR-2019, the patient received the PNEUMOVAX 23 one shot, once, in the "shoulder" (lot number R024025, expiration date 02-SEP-2020) to "boost his cells because he was having problems with sinus infections." On 08-MAR-2019, the patient experienced chills. His arm became swollen and red and he iced it all day. By 10-MAR-2019, it was worse and the patient went to urgent care where he was told that there was nothing wrong. On 11-MAR-2019, the patient went to his physician who confirmed the patient had cellulitis. The patient underwent "blood tests for cellulitis" (results not provided). The physician said it was a "bad batch." The patient was taken to the hospital for the day and was given unspecified intravenous antibiotics and was prescribed ten days of unspecified antibiotics. The patient was reported to be recovering but still had another week of antibiotics to take. Upon internal review, cellulitis was determined to be medically significant. This is one of three cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1903USA007431: US-009507513-1903USA007424.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistance referring to an unknown age and gender patient. No information was provided regarding the patient's medical history, current conditions or drug reactions or allergies. On 15-MAR-2019, the patient was vaccinated with an expired dose of with ROTATEQ orally for prophylaxis, with lot number N021308 and expiration date on 05-MAR-2019 (strength, dose, dose number, route of administration and anatomical injection site were not reported). No adverse effects were reported in the patient.
Sex: U
Vaccine: RV1
Symptoms: Intussusception
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of intussusception in a infant patient who received ROTARIX for prophylaxis. On an unknown date, the patient received ROTARIX (oral). On an unknown date, less than a year after receiving ROTARIX, the patient experienced intussusception (serious criteria GSK medically significant). On an unknown date, the outcome of the intussusception was unknown. It was unknown if the reporter considered the intussusception to be related to ROTARIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter had seen patient that developed intesessuption after having received ROTARIX. No specific details were available. The reporter did not agree to follow up from GlaxoSmithKline. This case has been linked to the cases US2019GSK048422 and US2019GSK048421, reported by same reporter.
Sex: U
Vaccine: RV1
Symptoms: Intussusception
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of intussusception in a infant patient who received ROTARIX for prophylaxis. On an unknown date, the patient received ROTARIX (oral). On an unknown date, less than a year after receiving ROTARIX, the patient experienced intussusception (serious criteria GSK medically significant). On an unknown date, the outcome of the intussusception was unknown. It was unknown if the reporter considered the intussusception to be related to ROTARIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter had seen patient that developed intesessuption after having received ROTARIX. No specific details were available. The reporter did not agree to follow up from GlaxoSmithKline. This case has been linked to the cases US2019AMR047518 and US2019GSK048422, reported by same reporter.
Sex: U
Vaccine: RV1
Symptoms: Intussusception
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of intussusception in a infant patient who received ROTARIX for prophylaxis. On an unknown date, the patient received ROTARIX (oral). On an unknown date, less than a year after receiving ROTARIX,  the patient experienced intussusception (serious criteria GSK medically significant). On an unknown date, the outcome of the intussusception was unknown. It was unknown if the reporter considered the intussusception to be related to ROTARIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter had seen patient that developed intesessuption after having received ROTARIX. No specific details were available. The reporter did not agree to follow up from GlaxoSmithKline. This case has been linked to the cases US2019AMR047518 and US2019GSK048421, reported by same reporter.
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Hypotonia, Injection site pain, Insomnia, Muscular weakness, Pain
Clinical narrative: Left deltoid area is very tender to touch and painful to move arm in most any direction. Pain increases during night time hours and is painful to be slept on. Arm is also very weak and becomes more flaccid as the pain increases. Muscle strength in that arm is 1/2 if not less at certain times of the day then it was prior and today marks the 11th day since the vaccine was given. I have been taking ibuprofen at least once if not twice daily which is helpful for a few hours but doesn't eliminate the pain.
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity
Clinical narrative: Left deltoid area is very tender to touch and painful to move arm in most any direction. Pain increases during night time hours and is painful to be slept on. Arm is also very weak and becomes more flaccid as the pain increases. Muscle strength in that arm is 1/2 if not less at certain times of the day then it was prior and today marks the 11th day since the vaccine was given. I have been taking ibuprofen at least once if not twice daily which is helpful for a few hours but doesn't eliminate the pain.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Diet refusal, Discomfort, Flatulence, Immediate post-injection reaction
Clinical narrative: Patient immediately vomited following vaccine administration. After mom left the clinic, she called saying that the infant had been crying nonstop for more than 3 hours following vaccination, looking as if she was in pain and very uncomfortable. Patient continued vomiting several times following administration of vaccine. The mother reported stomach gurgling, gas, and refusing to breast feed. Pt had 1 soft stool following vaccine. Doctor advised to do probiotic, mylicon, and gripe water. Told to bring to ER if symptoms continue for 1-2 hours. That night, the baby finally started to calm down with the probiotics and gripe water. The next day the infant was eating again and seemed to have improved significantly.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pain, Vomiting
Clinical narrative: Patient immediately vomited following vaccine administration. After mom left the clinic, she called saying that the infant had been crying nonstop for more than 3 hours following vaccination, looking as if she was in pain and very uncomfortable. Patient continued vomiting several times following administration of vaccine. The mother reported stomach gurgling, gas, and refusing to breast feed. Pt had 1 soft stool following vaccine. Doctor advised to do probiotic, mylicon, and gripe water. Told to bring to ER if symptoms continue for 1-2 hours. That night, the baby finally started to calm down with the probiotics and gripe water. The next day the infant was eating again and seemed to have improved significantly.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site nodule, Peripheral swelling
Clinical narrative: Pt stated starting 3/15/3/16, her left arm started swelling and turning red. Pt states there was an oval shaped nodule under the injection site. Pt stated swelling lasted until 3/17, still some swelling today but mostly gone. There is still the oval shaped nodule around the injection site.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Ear pain, Erythema, Influenza virus test negative, Oropharyngeal pain, Pain
Clinical narrative: Arm pain, red, warm to touch 3/12/19 swelling ER given BENADRYL, ice on area 3/14/19 PCP visit sore throat, body aches, ear pain, congestion, fever - checked for flu (-) given prednisone, AUGMENTIN.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Respiratory tract congestion, Skin warm
Clinical narrative: Arm pain, red, warm to touch 3/12/19 swelling ER given BENADRYL, ice on area 3/14/19 PCP visit sore throat, body aches, ear pain, congestion, fever - checked for flu (-) given prednisone, AUGMENTIN.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Vaccine expired at time of injection. Patient notified to be revaccinated.
Age: 1.33
Sex: M
Vaccine: TDAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given the adult dose TDaP when he should have received the pediatric dose of DTaP. There are not any reported adverse reactions at this time.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 02-DEC-2015, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Off label use
Clinical narrative: This spontaneous report was received from the mother of a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In approximately 2017 (reported as "about two years ago"), the patient received a PNEUMOVAX 23 injection in the arm "to help her fight sinus infections" (lot number, dosage and specific route of injection not provided). There were no adverse reactions reported. No additional information was provided. This is one of three cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1903USA007431: US-009507513-1903USA007433.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. In March 2019, the patient received SHINGRIX. In March 2019, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received the vaccine 4 days before the date of reporting, almost exactly 96 hours, developed flu-like symptoms that evening, but the patient expected those to resolve by now. The patient still felt like he had influenza.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Viral test positive
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The batch number for SHINGRIX was not provided. The patient went to the office a week later and tested positive for shingles. The name and address of Pharmacy that administered the product were not provided. Lab Comments: on an unknown date serology test was performed.
Sex: F
Vaccine: HEPAB
Symptoms: Alopecia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of alopecia in a female patient who received TWINRIX (batch number 53AT5, expiry date 28th November 2020) for prophylaxis. Previously administered products included TWINRIX (1st dose received on an unknown date, with batch number: 3C422 and expiry date: 27th April 2021). On 7th December 2018, the patient received the 2nd dose of TWINRIX. On an unknown date, unknown after receiving TWINRIX, the patient experienced alopecia. On an unknown date, the outcome of the alopecia was unknown. It was unknown if the reporter considered the alopecia to be related to TWINRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced alopecia after receiving two doses of TWINRIX. The reporter did not want to provide any details further than what was reported at time of initial report. The suspect vaccine was changed from KINRIX to TWINRIX as per the batch number reported which were found to be of TWINRIX and not KINRIX as per sales data sheet.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Injection site pain, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 1st March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 1st March 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain and feeling unwell. On an unknown date, the patient experienced incomplete course of vaccination. On 3rd March 2018, the outcome of the injection site pain and feeling unwell were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the injection site pain and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the reporter for her accountant. The age at vaccination was not reported. Only limited information was provided by the reporter. The patient experienced pain at the injection site, and did not feel well (unknown symptoms). Also, the caller reported that till the time of reporting, the patient had not received his second dose of SHINGRIX, which led to incomplete course of vaccination.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Skin exfoliation
Clinical narrative: A blister formed at the site where the injection took place. The blister left her skin looking burnt and scaly. Patient went to the emergency room for care.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Erythema, Induration, Injection site swelling, Peripheral swelling, Skin warm
Clinical narrative: Extreme swelling, redness, warm to and hard to touch. swelling started around the site of the shot, but progressed all the way to the elbow and even below within 2-3 days. It also went around the back and above the injection site. The doctor put him on BENADRYL, which seems to be helping.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Dermatitis diaper, Diarrhoea, Discomfort, Immediate post-injection reaction
Clinical narrative: We (and the doctors/nurse where administered) believe it was a Reaction to the MMR. She screamed for hours immediately after and thru the night. Had a fever off and on for over a week. Developed a rash about a week later that lasted for almost 7 weeks suffering in severity. Had diarrhea, horrific diaper rash, swollen feet and ankles. Appeared to be uncomfortable and in pain off and on, not herself for almost 2 months. Spoke to Drs on 7/19/17, 8/12/17, 8/17/17 and multiple other times as well as contacted nurses line. Overall she.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Joint swelling, Pain, Peripheral swelling, Pyrexia, Rash
Clinical narrative: We (and the doctors/nurse where administered) believe it was a Reaction to the MMR. She screamed for hours immediately after and thru the night. Had a fever off and on for over a week. Developed a rash about a week later that lasted for almost 7 weeks suffering in severity. Had diarrhea, horrific diaper rash, swollen feet and ankles. Appeared to be uncomfortable and in pain off and on, not herself for almost 2 months. Spoke to Drs on 7/19/17, 8/12/17, 8/17/17 and multiple other times as well as contacted nurses line. Overall she.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Screaming
Clinical narrative: We (and the doctors/nurse where administered) believe it was a Reaction to the MMR. She screamed for hours immediately after and thru the night. Had a fever off and on for over a week. Developed a rash about a week later that lasted for almost 7 weeks suffering in severity. Had diarrhea, horrific diaper rash, swollen feet and ankles. Appeared to be uncomfortable and in pain off and on, not herself for almost 2 months. Spoke to Drs on 7/19/17, 8/12/17, 8/17/17 and multiple other times as well as contacted nurses line. Overall she.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: Mild flu-like symptoms - body aches and fatigue.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Decreased appetite, Fatigue, Rash, Varicella post vaccine
Clinical narrative: Loss of appetite and fatigue beginning on approximately 3/6 (reports maybe sooner) then began breaking out with a chicken pox rash on back and side of neck, torso, both thighs.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Feeling cold, Glassy eyes, Headache, Tremor
Clinical narrative: Sudden onset of intense headache. He came to me (his mother) cold, trembling, and glassy eyed. I thought he was going to collapse.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: About 26 hours after receiving vaccine could not feel legs and arms - numbness and tingling, extremely weak. Progressed to torso and weaker the next several weeks. Started to get better after about four weeks to this day I still have weakness in the arms and legs.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain
Clinical narrative: Body aches and joint pain.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus generalised
Clinical narrative: Patient reported itching all over body overnight. No rash/redness/warmth at injection site reported. No swelling or difficulty breathing. She has been taking oral diphenhydramine. Counseled to also take cimetidine to increase histamine blockage and to call her physician.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Since I had the shot my arm hurts. It was given to me 9/26/18 and 6 months later I still have pain. I wake up at night in pain. I have trouble lifting up my arm. And I am in very good shape, work out so this is very frustrating for me.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Headache, Injection site pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: Typical soreness at the injection site, 3-4 hours after injection. Following morning, muscle stiffness in  lower back. 19 hours later, slight headache, lower back pain, across the back. 22 hrs later slight neck stiffness, no headache, muscle soreness in lower right side/back.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site papule, Injection site rash
Clinical narrative: Per mother patient developed rash on left thigh where vaccines were administered the previous day. Mother denies any additional symptoms, no redness at site, only small white papules covering left thigh.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose given to pediatric patient. Hepatitis A (GlaxoSmithKline).
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Guillain-Barre syndrome, Lethargy, Muscular weakness, Neurological examination
Clinical narrative: Patient was given flu vaccine on or about January 31, 2018. Onset of Guillain-Barré Syndrome (GBS) on or around March 5th. Symptoms included lethargy, diarrhea, vomiting and extreme lower extremity weakness that lasted approximately 10 days. Pt was admitted to hospital and treated with fluids.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Pulmonary function test, Vomiting
Clinical narrative: Patient was given flu vaccine on or about January 31, 2018. Onset of Guillain-Barré Syndrome (GBS) on or around March 5th. Symptoms included lethargy, diarrhea, vomiting and extreme lower extremity weakness that lasted approximately 10 days. Pt was admitted to hospital and treated with fluids.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Gave expired vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm, Tenderness
Clinical narrative: Patient presented to the pharmacy with an oblong raised red "welt" approximately the size of a softball. The patient noticed the redness on her arm Sunday night into Monday morning. She was not sure if it was getting worse over time. It did not itch but was warm and painful to the touch. The location of the affected area was slightly below the deltoid and moving around the arm towards the armpit. Follow up on 03/19/19, patient indicates that after 1 dose of antibiotics, she has noticed some improvement in the tenderness and warmth from the area. She has not noticed a decrease in the size of the affected area.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Redness swelling, pain at injection site going up neck, muscle pain, a headache, shivering, fever, nausea, sharp stomach pain. Could not sleep all night.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Insomnia, Myalgia, Nausea, Pyrexia
Clinical narrative: Redness swelling, pain at injection site going up neck, muscle pain, a headache, shivering, fever, nausea, sharp stomach pain. Could not sleep all night.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-MAR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In September 2016, the patient was administered the ZOSTAVAX vaccine (lot # and route not specified) by a pharmacist. On an unspecified date, the patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from his use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In January 2017 the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 18-year-old patient of unknown gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported. On an unknown dates in 2015, the patient completed the vaccination schedule with three doses of GARDASIL 9 (exact dose, route of administration, injection site, lot# and expiration date were not provided), for prophylaxis. On 14-MAR-2019, the patient was vaccinated with fourth dose of GARDASIL 9 (lot# R020947, expiration date: 04-MAY-2019), (exact dose, route of administration and injection site were not reported), for prophylaxis. There were no adverse effects.
Age: 38.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and referred to a 38-year-old female patient. It was reported that the patient had no pertinent medical history, no concomitant medication and no known drug reactions and allergies. On 08-FEB-2019, the patient was vaccinated with the first dose of GARDASIL 9, intramuscularly (exact dose, lot number and expiration date were not provided) for prophylaxis. On 09-MAR-2019, the patient was vaccinated with the second dose of GARDASIL 9 injection, intramuscularly, lot number R000301, expiration date 29-AUG-2020 (exact dose was not provided) for prophylaxis. On 10-MAR-2019, the patient experienced severe arm pain near the injection site. The patient sought a medical attention by calling the pharmacist. No treatment was given. No laboratory diagnostics or studies were performed. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and GARDASIL 9 was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. In November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, pain in joint involving shoulder region and mobility decreased. On an unknown date, the outcome of the injection site pain, pain in joint involving shoulder region and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, pain in joint involving shoulder region and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving the SHINGRIX vaccine, the patient experienced  injection site pain which never went away. The pain moved up into the joint of the shoulder limiting the movement of the shoulder. The patient stated that, he was awakened by the ache from the shot In January 2019, the patient had the 2nd dose of SHINGRIX. The patient stated that nothing had changed between the 1st and 2nd injection. The patient stated that ached before the 2nd injection, and continued to ache at about the same amount after the 2nd injection.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on 31st December 2018 and experienced muscle aches, refer linked case US2019045242). Concurrent medical conditions included herpes virus infection. On 11th March 2019, the patient received the 2nd dose of SHINGRIX. On 11th March 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient had the SHINGRIX on the day before the reporting and so far all she had experienced was a sore arm, which began in evening of vaccination day and was worsen at the time of reporting. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 2nd November 2018, the patient received the 1st dose of SHINGRIX. On 2nd November 2018, less than a day after receiving SHINGRIX, the patient experienced fever, muscle pain, shivering, pain in arm and swelling arm. On 28th November 2018, the patient experienced shingles. On an unknown date, the outcome of the fever, muscle pain, shivering, pain in arm, swelling arm and shingles were recovered/resolved. It was unknown if the reporter considered the fever, muscle pain, shivering, pain in arm, swelling arm and shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the unknown arm. The patient experienced a sore and swollen arm where she received the injection, fever of 103, shivering and muscle aches on the day of vaccination. On 2nd November 2018, the patient's body temperature was recorded as 103 degree F. The symptoms were most severe the first 2 days but took approximately 5 days to resolve. The reporter gave consent to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 2nd November 2018, the patient received the 1st dose of SHINGRIX. On 2nd November 2018, less than a day after receiving SHINGRIX, the patient experienced fever, muscle pain, shivering, pain in arm and swelling arm. On 28th November 2018, the patient experienced shingles. On an unknown date, the outcome of the fever, muscle pain, shivering, pain in arm, swelling arm and shingles were recovered/resolved. It was unknown if the reporter considered the fever, muscle pain, shivering, pain in arm, swelling arm and shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the unknown arm. The patient experienced a sore and swollen arm where she received the injection, fever of 103, shivering and muscle aches on the day of vaccination. On 2nd November 2018, the patient's body temperature was recorded as 103 degree F. The symptoms were most severe the first 2 days but took approximately 5 days to resolve. The reporter gave consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 6th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th March 2019, less than a day after receiving SHINGRIX, the patient experienced fatigue, cold and shivering. On an unknown date, the outcome of the fatigue, cold and shivering were recovered/resolved. It was unknown if the reporter considered the fatigue, cold and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient reported that she experienced fatigue in the afternoon and that evening she had chills and shivering and was cold. The patient could not warm up even after taking TYLENOL and using a heating pad. These symptoms prevented her from doing her daily activities. She felt better the next morning and her symptoms lasted about two days and then everything was resolved. The reporter gave consent to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 57-year-old female patient who received SHINGRIX (batch number 32ZG4, expiry date 9th July 2021) for prophylaxis. On 6th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th March 2019, 1 days after receiving SHINGRIX, the patient experienced fever, injection site swelling, injection site warmth, injection site redness and injection site itching. On an unknown date, the outcome of the fever, injection site swelling and injection site warmth were recovered/resolved and the outcome of the injection site redness and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the fever, injection site swelling, injection site warmth, injection site redness and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported the patient's injection site reaction to first SHINGRIX vaccine dose. The patient had a fever, a warm, swollen, red and itchy injection site. In March 2019, the outcome of the fever, injection site swelling and injection site warmth were recovered/resolved. The pharmacist stated that all the events were resolved except for redness and itching at the site. The pharmacist provided the consent for follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a elderly female patient who received SHINGRIX for prophylaxis. On 5th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 78 or 79 years. The Healthcare professional reported that SHINGRIX dose was administered at a different facility. The lot and expiry date were unknown.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included herpes virus infection. On 31st December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, less than a day after receiving SHINGRIX, the patient experienced muscle pain. On an unknown date, the patient experienced fever. In January 2019, the outcome of the muscle pain was recovered/resolved. On an unknown date, the outcome of the fever was recovered/resolved. The reporter considered the fever and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The patient received the SHINGRIX on 31st December 2018 around 4:00 pm. In the middle of the night several hours after receiving SHINGRIX, she felt as if she had a fever. The next morning, her fever was over 101 and she was experiencing muscle aches. By the end of the day, her fever started to go down and by the 3rd day, all symptoms were resolved. For tolerance of 2nd dose refer linked case US2019GSK048458.
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received PREVNAR 13, (unknown lot number and expiration date), via an unspecified route of administration on 12Jan2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient got the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on 12Jan2019 and had some redness at the injection site which spread down his arm. He then had a rash on his arms, back, stomach, chest, legs, over 70 % of his body. He was given BENADRYL and fluocinolone cream and IV prednisone. It started getting better for a little while on the medication but it was back. They are going to see a dermatologist today. They wanted to know if there is an antidote. The patient had not recovered from the events. Information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's parent). A female patient of an unspecified age received the second dose of PREVNAR 13 via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. The patient previously took the first dose of PREVNAR 13 on an unspecified date. On an unspecified date, after the second dose of pneumococcal 13-val conj vac (dipht crm197 protein), the patient experienced fever of 102.5 Fahrenheit rectally. At the time of the report, the outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.