chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Pyrexia
Clinical narrative: feels lightheaded; fever; chills; headache; stomach upset; could not eat; diarrhea; aches all over; weak; This is spontaneous report from contactable consumer. This consumer (patient) reported that a 78-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot Number: EW0170), (at the age of 78-years-old) via an unspecified route of administration on 28Apr2021 at 15:00 (Wednesday afternoon) on right arm as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that after received shot she had been sick ever since. She has been taking two Tylenol every six hours. On 28Apr2021, the patient feels lightheaded when she gets up, fever and chills at night, headache, stomach upset, could not eat up until today and stated that she ate jello, diarrhea, stated that she did not known if she can drive or not that she was weak, aches all over and that the other day when she had the headache that Tylenol would not take it away. Stated that she was okay when she got it and it took 4 hours to get sick. Stated that she could not even drive. Stated that she had Covid on 28Jan2021 and waited 90 days to get the shot. The patient treated herself by using cold packs. The outcome of adverse events feels lightheaded, stomach upset, diarrhea, weak and aches all over was not recovered. On 29Apr2021, fever, chills were recovered. On 30Apr2021, headache was recovered. The outcome of adverse event could not eat was unknown.    No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dyspnoea, Hypoaesthesia, Paraesthesia
Clinical narrative: Shortness of breath; Severe numbness and tingling in all limbs, both arms and legs, hands and feet.; Severe numbness and tingling in all limbs, both arms and legs, hands and feet.; Very sore armpit on same side as injection site; This is a spontaneous report from a non-contactable consumer or other non hcp. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 12:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history included Raynaud's phenomenon from an unknown date and unknown if ongoing, menopause from an unknown date and unknown if ongoing and Historical Vaccine BNT162B2 (Dose number: 1) for COVID-19 immunization in on an unspecified date in Apr2021. The patient's concomitant medications were not reported. The patient experienced shortness of breath, severe numbness and tingling in all limbs, both arms and legs, hands and feet, very sore armpit on same side as injection site on an unspecified date. There were no other vaccines in four weeks. There was no treatment received. Patient did not have Covid prior vaccination. Patient was not Covid tested post vaccination. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. And there were not any other medications the patient received within 2 weeks of vaccination. The outcome of events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Vaginal disorder
Clinical narrative: urinary tract infection; She also asks if there are any side effects known that include vaginal symptoms or female issues; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the dose 1 of bnt162b2 for COVID-19 immunization. On an unspecified date, the patient experienced urinary tract infection and "she also asks if there are any side effects known that include vaginal symptoms or female issues". The patient received her second vaccine dose on previous Thursday and was now having some symptoms of a urinary tract infection. She reported that she will be taking Amoxicillin and asked if there was a contraindication or interaction between the vaccine and an antibiotic and asked if there was any information indicating vaginal symptoms as a side effect of the vaccine. She wanted to know if she starts an antibiotic like Ampillicin would that effect the COVID shot she already had. The outcome of the events was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear infection, Hypersensitivity, Sinusitis
Clinical narrative: She thinks she has a sinus or allergy related ear infection; She thinks she has a sinus or allergy related ear infection; She thinks she has a sinus or allergy related ear infection; Ear feels plugged up; This is a spontaneous initial report from a Pfizer sponsored program . This consumer (patient) reported for herself that. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8734), dose 1 via an unspecified route of administration on 13Apr2021 09:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing hypertension (She was probably diagnosed 40 years ago with high blood pressure), ongoing thyroid disorder (She was probably diagnosed 45 years ago or longer with her thyroid issue), ongoing hip surgery (She had hip surgery two months ago). There were no concomitant medications. No Investigation Assessment. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks. No Patients Medical History including any illness at time of vaccination. Family Medical History Relevant to AE(s): NO whole family has allergies. No Relevant Tests. The patient experienced she thinks she has a sinus or allergy related ear infection, and ear feels plugged up on 03May2021. It was reported that the caller is scheduled to get the second dose of the vaccine on 07May2021. She thinks she has a sinus or allergy related ear infection, but she is not sure. She was taking Coricidin, a cough and cold medication with high blood pressure. She stated she has high blood pressure. She took this yesterday morning at 9:30 AM and she did not take any more because she thought it might affect the shot. She stated she won't restart it until after the shot. She stated she is feeling better but does not know if this medication will affect the vaccine. It was reported that She was calling to see if she needed to stop this medication before getting her second dose. Confirmed caller has already stopped the medication. It was reported that she has had the ear infection for last four or 5 days, and she did not get it right after she had the shot. It was reported that she guesses it won't bother her, but it might bother him regarding contacting her physician. She never went to the doctor, or that she doesn't know if it is an ear infection or sinus drainage. She states her ear just feel plugged up. It was reported that it is not as bad as it was. She states she took 4 of those pills (Coricidine) and she got better but she still has the ear infection. She had to stop the pills because they could interfere with, COVID vaccine, and could not read the information on the box without glasses nor could she locate the NDC number on the box. Reporter seriousness for events: Unspecified. Patient was not visited Emergency Room or Physician Office for events. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthropathy, Vaccination site erythema
Clinical narrative: Red ring around injection site; Felt it in joints; This is a spontaneous report received from a contactable consumer or other non-Health Care Professional. A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration, on 28Apr2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 28Apr2021(Wednesday), the patient had experienced quite the immune response, red ring around injection site, felt it in joints. The outcome of events was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Hands Hurt; Swollen Hands/Arms itching, swollen, and red; hives are under his chest, groin, and all over now, but not on his face; itching on his hands like crazy, like he wanted to take his skin off; Arms itching, swollen, and red; This is a spontaneous report from a contactable consumer. A 51-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number and expiry date was not reported) via an unspecified route of administration on 23Apr2021 as a single dose for covid-19 immunisation. Medical history included ongoing splenectomy which was continuing. The patient's concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection) on 02APR2021 for covid-19 immunisation. On 29Apr2021 20:00 patient experienced swollen hands with, hives are under his chest, groin, and all over now, but not on his face, itching on his hands like crazy, like he wanted to take his skin off, hands hurt, arms itching, swollen, and red, arms itching, swollen, and red, arms itching, swollen, and red. Therapeutic measures were taken(Benadryl three times a day) as a result of swollen hands, hives are under his chest, groin, and all over now, but not on his face, itching on his hands like crazy, like he wanted to take his skin off, hands hurt, arms itching, swollen, and red, arms itching, swollen, and red , arms itching, swollen, and red. Patient did not visited emergency room/physician office due to events. Outcome of the events was recovering.    Information on the lot/batch number has been requested.   Follow-up (21Jun2021): Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Rash macular
Clinical narrative: Spotty Rashes on both arms and legs. Benedril helped rash to calm down for a few hours but rashes came back for 3 days.; Palms and Feet are tingling and itchy; Palms and Feet are tingling and itchy.; This is a spontaneous report from a contactable consumer. A 23-year-old male consumer (patient) reported for himself that he received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0170, Expiry Date: Unknown), via an unspecified route of administration, administered in Arm Left on 18Apr2021 at 15:30 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medication included Benefiber (DEXTRIN) taken in two weeks. No known allergies reported. No other vaccine was taken in four weeks. No COVID prior to vaccination. No COVID tested post vaccination. The patient experienced spotty rashes on both arms and legs on 29Apr2021 at 8:00PM. Benedril helped rash to calm down for a few hours but rashes came back for 3 days. Palms and feet were tingling and itchy. No treatment received for "palms and feet were tingling and itchy". Outcome of rash macular was Recovered/Resolved with Sequel. The outcome of other events was not recovered.   Follow-up attempts are needed. Further information is requested.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer. This consumer reported similar event for mother in law and 3 other people. This report is for 1 of those 3 people.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration, on an unspecified date as dose number unknown, single for Covid-19 immunisation. Patient's medical history and concomitant medications were not reported. After vaccination, the patient experienced shingles on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021513947 Same reporter, product, event/ different patient;US-PFIZER INC-2021513968 Same reporter, product, event/ different patient
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer. This consumer reported similar event for mother in law and 3 other people.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration, on an unspecified date as dose number unknown, single for Covid-19 immunization. Patient's medical history and concomitant medications were not reported. After vaccination, the patient experienced shingles on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Gastrooesophageal reflux disease, Joint swelling, Pruritus, Rash
Clinical narrative: Red/burning/itching patches on skin; Red/burning/itching patches on skin; Red/burning/itching patches on skin; Red/burning/itching patches on skin; Swelling joints in hands; Acid reflux; This is a spontaneous report from a Pfizer-sponsored Program (reported for himself). A contactable consumer, other health care professional and a physician reported that a 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunization. Patient received another suspect drug tofacitinib citrate (XELJANZ 5mg daily formulation: tablet) via oral on Apr2021 to an unspecified date in 2021 and on 04May2021 and ongoing as 5 mg daily for Rheumatoid arthritis. Patient decision to hold XELJANZ for two weeks and on 04May2021 restarted 5mg daily. Patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) COVID-19 immunization. Patient reported acid reflux while taking xeljanz 5mg twice daily, his decision to hold xeljanz for two weeks, restarted 5mg daily 04May2021 acid reflux improved. Patient reported with red/burning/itching patches on skin on an unspecified date in 2021, second dose COVID-19 vaccine few days prior to rash-visited urgent care 03May2021- anti-histamine prescribed. held xeljanz for first vaccine, did not stop xeljanz for second due to swelling joints in hands. Physician was unaware. Encouraged to discuss with physician. Outcome of event (Acid reflux) was recovering and unknown for other events.  Information about batch/ lot number has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: Red/burning/itching patches on skin; Red/burning/itching patches on skin; Red/burning/itching patches on skin; Red/burning/itching patches on skin; Swelling joints in hands; Acid reflux; This is a spontaneous report from a Pfizer-sponsored Program (reported for himself). A contactable consumer, other health care professional and a physician reported that a 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunization. Patient received another suspect drug tofacitinib citrate (XELJANZ 5mg daily formulation: tablet) via oral on Apr2021 to an unspecified date in 2021 and on 04May2021 and ongoing as 5 mg daily for Rheumatoid arthritis. Patient decision to hold XELJANZ for two weeks and on 04May2021 restarted 5mg daily. Patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) COVID-19 immunization. Patient reported acid reflux while taking xeljanz 5mg twice daily, his decision to hold xeljanz for two weeks, restarted 5mg daily 04May2021 acid reflux improved. Patient reported with red/burning/itching patches on skin on an unspecified date in 2021, second dose COVID-19 vaccine few days prior to rash-visited urgent care 03May2021- anti-histamine prescribed. held xeljanz for first vaccine, did not stop xeljanz for second due to swelling joints in hands. Physician was unaware. Encouraged to discuss with physician. Outcome of event (Acid reflux) was recovering and unknown for other events.  Information about batch/ lot number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Herpes zoster
Clinical narrative: Shingles; Severe fatigue; Weakness; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8734, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 15Apr2021 at 10:00 (at the age of 67-year-old) as dose 1, single for COVID-19 immunisation in pharmacy. The patient was retired registered nurse, no other medical history and concomitant medications were reported. Family medical history was none. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks) or any other vaccinations was given within four weeks prior to the first administration date of the suspect vaccine. On an unspecified date, the patient experienced shingles. On 15Apr2021, the patient experienced severe fatigue and weakness. The event shingles required a visit to physician office. The clinical course of the events was reported as the patient was a retired registered nurse, stated got the Pfizer Covid vaccine on 15Apr2021 and one week later she developed shingles, states she just wanted to report this, knew it had been a topic of concern. Patient stated she spoke with her doctor on 23Apr2021, symptoms had started prior to that, about 7 days after the first dose of the vaccine, exact date unknown. The doctor put her on Valtrex first, could not tolerate this medication, did not have product information at this time, no further details provided. She then started Acyclovir, 800mg five times a day by mouth, finished this medication yesterday 03May2021. Patient stated she was terrified to get next dose, scheduled for Thursday (as reported). Stated her doctors assured her that it was okay. No relevant tests were reported. The seriousness and causality assessment were not provided. The outcome of the event shingles was not resolved and recovering from the other events.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 18-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006463:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 17-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 17-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 16-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 15-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 15-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 15-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Sex: U
Vaccine: HEP
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: tingling/ felt in one arm/ then moved to the other; burning sensation/ felt in one arm/ then moved to the other; This case was reported by a consumer via other manufacturer and described the occurrence of tingling in a patient who received HBV (Engerix B) for prophylaxis.   On 1st February 2013, the patient received Engerix B. On an unknown date, several days after receiving Engerix B, the patient experienced tingling and burning sensation. On an unknown date, the outcome of the tingling and burning sensation were unknown.   It was unknown if the reporter considered the tingling and burning sensation to be related to Engerix B.  Additional details were provided as follows: Age at vaccination was not reported. The patient received Engerix B and several days after the injection experienced a tingling and burning sensation that was felt in one arm then moved to the other. No additional information and adverse event were provided. No product quality complaint was reported.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult Havrix given to 5 patients under age 19; Adult Havrix given to 5 patients under age 19; This case was reported by a other health professional via sales rep and described the occurrence of adult product administered to child in a patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional information was provided as follow: The patient was under 19 years of age and received Havrix adult, which led to adult product administered to child and overdose. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR137653:Same reporter  (pt 3/5) US-GLAXOSMITHKLINE-US2021AMR137655:Same reporter  (pt 5/5) US-GLAXOSMITHKLINE-US2021AMR137652:Same reporter (pt 2/5) US-GLAXOSMITHKLINE-US2021AMR137654:Same reporter  (pt 4/5)
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot, still got shingles/suspected vaccination failure; got shingles; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter stated that he/she had the shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Vaccination failure
Clinical narrative: She had the shot and got the disease a year after / Shot doesn't work!; She had the shot and got the disease a year after; Was in more pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in twenties).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, had more pain after the shot and got disease a year after. The reporter stated that, the shot did not work. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles and laboratory confirmation for shingles were not provided. This case was linked with case US2021AMR092424, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR092424:Same reporter.
Age: 1.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: received a dose of Pediarix/  intended vaccine was DTAP; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 14-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977P, expiry date 15th September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st June 2021, the patient received Pediarix (intramuscular) and Pediarix Pre-Filled Syringe Device. On 21st June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were reported as follows: A nurse reported that the patient received a dose of pediarix  in left thigh intended vaccine was DTAP, which led to wrong vaccine administered. The reported batch number was 4977P and as per sales data it was Infanrix Penta (DTPa HBV IPV) 4977T.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Disability, Gait disturbance, Limb discomfort, Myalgia
Clinical narrative: mild leg muscle pain; difficult to walk; legs feel heavy; stability problems; couldn't walk; leg pain has gotten worse over time; became a disability; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISABILITY (became a disability) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (The patient underwent 2 knee replacements.).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (leg pain has gotten worse over time). 04-Mar-2021, the patient experienced DISABILITY (became a disability) (seriousness criterion medically significant). On 06-Mar-2021, the patient experienced WALKING DISABILITY (couldn't walk). On 08-Mar-2021, the patient experienced GAIT DISTURBANCE (difficult to walk), LIMB DISCOMFORT (legs feel heavy) and BALANCE DISORDER (stability problems). On an unknown date, the patient experienced MYALGIA (mild leg muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (leg pain has gotten worse over time), WALKING DISABILITY (couldn't walk), GAIT DISTURBANCE (difficult to walk), LIMB DISCOMFORT (legs feel heavy), BALANCE DISORDER (stability problems), DISABILITY (became a disability) and MYALGIA (mild leg muscle pain) outcome was unknown.            No concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Walking disability
Clinical narrative: mild leg muscle pain; difficult to walk; legs feel heavy; stability problems; couldn't walk; leg pain has gotten worse over time; became a disability; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISABILITY (became a disability) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (The patient underwent 2 knee replacements.).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (leg pain has gotten worse over time). 04-Mar-2021, the patient experienced DISABILITY (became a disability) (seriousness criterion medically significant). On 06-Mar-2021, the patient experienced WALKING DISABILITY (couldn't walk). On 08-Mar-2021, the patient experienced GAIT DISTURBANCE (difficult to walk), LIMB DISCOMFORT (legs feel heavy) and BALANCE DISORDER (stability problems). On an unknown date, the patient experienced MYALGIA (mild leg muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (leg pain has gotten worse over time), WALKING DISABILITY (couldn't walk), GAIT DISTURBANCE (difficult to walk), LIMB DISCOMFORT (legs feel heavy), BALANCE DISORDER (stability problems), DISABILITY (became a disability) and MYALGIA (mild leg muscle pain) outcome was unknown.            No concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia, Periarthritis
Clinical narrative: Shoulder tensed and locked up after getting the second dose; nerve pain down the arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PERIARTHRITIS (Shoulder tensed and locked up after getting the second dose) and NEURALGIA (nerve pain down the arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIARTHRITIS (Shoulder tensed and locked up after getting the second dose) and NEURALGIA (nerve pain down the arm). The patient was treated with PARACETAMOL (TYLENOL) for Nerve pain, at a dose of 1 dosage form. At the time of the report, PERIARTHRITIS (Shoulder tensed and locked up after getting the second dose) and NEURALGIA (nerve pain down the arm) outcome was unknown.            No concomitant medications was reported    This case was linked to MOD-2021-225968 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Herpes zoster, Pruritus, Rash, Skin burning sensation
Clinical narrative: I know of someone else who suddenly got shingles some time after getting vaccinated; I developed a rash with small blisters on my back, on the left shoulder blade close to the spine.; I developed a rash with small blisters on my back, on the left shoulder blade close to the spine.; It's itchy and has a slight burning sensation.; It's itchy and has a slight burning sensation.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 38-years-old female patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine, solution for injection, Batch/Lot Number: EP0161), (at the age of 38-years-old) via an unspecified route of administration on 08Apr2021 14:45 left arm as single dose for COVID-19 immunisation. The patient's medical history had chicken pox as a child. She had no known allergies and no other medical history. Concomitant medications were not reported. Patient neither receive any other vaccines within 4 weeks prior to the COVID vaccine nor any other medications within 2 weeks of vaccination. The patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration on 18Mar2021 13:00 as historical vaccination on left arm as single dose for COVID-19 immunisation. On 30Apr2021, about a week ago (late Apr), the patient developed a rash with small blisters on my back, on the left shoulder blade close to the spine. It's itchy and has a slight burning sensation. From an online search I believe it's shingles. I'm 38 and never had shingles before. Now it seems that it started to dry out. If needed, I can provide photos of the rash from different stages. Of course, don't know if it is related to the vaccine, but I know of someone else who suddenly got shingles sometime after getting vaccinated, so I thought I'd report it just in case. The patient did not receive any treatment for adverse events. The patient did not test COVID prior to vaccination and post vaccination. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.