chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old male patient who received SHINGRIX. Concurrent medical conditions included chronic obstructive pulmonary disease (was taking BREO to treat). Concomitant products included Atorvastatin, fluticasone furoate, BREO ELLIPTA, ALEVE and trazodone. On 7th May 2018, the patient received the 1st dose of SHINGRIX. On 7th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and influenza-like symptoms. On an unknown date, the outcome of the injection site pain and influenza-like symptoms were recovered/resolved. The reporter considered the injection site pain and influenza-like symptoms to be probably related to SHINGRIX. Additional details were provided as follows: The patient was the caller's husband. The patient experienced injection site pain immediately after the vaccination and developed flu like symptoms. The patient was fine at the time of reporting.
Fever (102), chills, body aches, headache, nausea, sore arm that is red, swollen, hard and scaly
Initial report was received from a health care professional on 24 October 2011. A 37-year-old female patient received an intramuscular injection of FLUZONE in left deltoid, lot number UH442AB on 27 September 2011. On the same day of the injection, the patient experienced tenderness at the injection site. At the time of the vaccination the patient was lactating, after the vaccination the patient had "difficulty" lactating. No further information was available at the time of the report. The patient outcome was not recovered/not resolved. Follow-up information was received from a healthcare professional on 01 February 2012. The patient had no illness but was nursing at the time of vaccination. Concomitant medication was reported as unknown. No additional information was provided at the time of the report. The patient outcome was not reported. Documents held by sender: none.
My tongue is white with sores. I have an odd metallic taste and the tip of my tongue is sore.
Red inflamed area on face. both cheeks; Red inflamed area on face. both cheeks; This is a spontaneous report received from a non-contactable consumer (Patient). A 58-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Lot number: EP7534 and expiration date was not reported) via an unspecified route of administration on an unknown date as unknown single dose for COVID-19 immunisation. The patient was allergic to sulphur drugs and erythromycin. Concomitant therapies were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On unspecified date the patient experienced red inflamed area on face on both cheeks. No therapeutic measures were reported for the events red inflamed area on face. The clinical outcome of red face and skin inflammation was unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Patient's Initial captured in First name. 2. Dose Number leave blank. 3.  For relevant med history#1, the verbatim was updated as Known_allergies: Sulphur drugs; For relevant med history#2, the verbatim was updated as Known_allergies: sulphur drugs, erythromycin; 4. Narrative updated from "This is a spontaneous report received from a contactable consumer" to "This is a spontaneous report received from a non-contactable consumer".
This spontaneous report as received from a non health care professional (office manager) refers to an unknown number of unspecified patients of unknown demographics. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9 of lot # M040412 with an expiry date of 30-JUN-2019, (Strength, dose, frequency, route, anatomical location, were not reported) for prophylaxis. There were no concomitant therapies reported. The vaccines were exposed to 47 to 77 Fahrenheit degree (F) for 9 hours; 32 to 35 Fahrenheit degree (F) for 168 hours and 31 or colder (30) Fahrenheit degree (F) for 96 hours. There was no previous temperature excursion. Digital data logger was not involved. There were no adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1707USA013353: US-009507513-1708USA002330:
After pt left, started feeling cold. Arm was red and started swelling. Next day arm was really hot and didn't feel well. Pt missed work due to not feeling well. Then from then on it has been sore and tender. Today  (11/9) pt returned to work. we observed her arm and it is real red and swollen.
she was pregnant sometime after; No further adverse event reported; This spontaneous prospective pregnancy report was received from the patient's family member referring to a 32 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 13-JUN-2020 the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route, lot# and expiration date were not reported) for prophylaxis.   The patient was found out she was pregnant sometime after (exposure during pregnancy). The patient's  last period (LMP) was 15-JUN-2020. Date of conception was assumed as 29-JUN-2020 and the estimated due date (EDD) was 22-MAR-2021. Pregnancy outcome was pending. No further adverse event reported and no product complaint.
This case was reported by a other health professional via sales rep and described the occurrence of dizziness in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced dizziness and fever. On an unknown date, the outcome of the dizziness and fever were unknown. The reporter considered the dizziness to be related to SHINGRIX. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced dizziness and a low-grade fever. The reporter checked the vaccine information sheet (VIS) sheet which mentioned dizziness falls under severe allergic reaction. She thought the reaction was due to the vaccine. The reporter agreed for follow up.
Rash - Near Injection Site; Redness - Near Injection Site; Arm Pain; Itchy Sensation - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PAIN (Arm Pain), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PAIN (Arm Pain), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). At the time of the report, VACCINATION SITE RASH (Rash - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PAIN (Arm Pain), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment details included Benadryl (diphenhydramine HCL) - Advised by their HCP to try to alleviate the symptoms as well as Cortizone-10.
5-6 days post vax, the pt experienced severe pain and aching in left arm extending to fingers. Pt developed numbness of thumb and fore finger with tingling sensation. After 4 months, the pt still experiences numbness after almost 3 months of physical therapy. Pt is being treated with ????? and Vioxx daily and has used codeine for pain.
Pt received pediatric dose of Pfizer for first and second doses despite being aged 12.
Info has been received from a health professional concerning a 5 year old female with no known medical history or allergies who on 3/15/01, was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live. There was no concomitant medication. On approximately, 4/12/05, the pt developed breakthrough chickenpox with lesions that lasted 24 hours on her back. On 4/12/05, the pt was seen in the office. Treatment included calamine lotion and Benadryl. On 4/18/05, the pt was seen in the office, her lesions had resolved. There was no product quality complaint involved. Additional info has been requested.
Symptoms began Monday, March 29th (day after vaccine received) and included a fever of 100.4, fatigue, and body soreness. Fever decreased and body temperature was only slightly elevated on Tuesday, March 30th and Wednesday, March 31st, but fatigue and body soreness persisted. On Thursday, April 1st, I noticed a lump in my left armpit that persisted for about ~5 days.
Swollen lymph node in underarm area; This is a spontaneous report from a contactable consumer, the  patient. A 34-years-old-male patient received  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown,) via an unspecified route of administration in left arm on 14Mar2021 at 12:45  (at the age of 34-years-old)  as a single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient had no allergy to medications, food, or other products. The patient had not received any vaccine within four weeks prior to the COVID-19 vaccine. Prior to vaccination and since the vaccination the patient had not been diagnosed with COVID-19.  On 15Mar2021 at 18:00, the patient experienced swollen lymph node in underarm area.  The patient had not received any therapeutic measure or treatment taken for the resulted adverse event. The clinical outcome of  swollen lymph node was resolving.  Information about lot/batch number cannot be obtained. No further information is expected.
Approx 10-15 minutes after administrating 2 month old vaccines PEDIARIX (Hep B, DTAP, IPV), HIB, PCV-13, ROTAVIRUS child broke out in rash on forehead, face/neck and buttocks. Rash resolved in approx 30 min. No resp. distress.
Arm and shoulder pain, tenderness began within an hour and resolved over 3 days. Fever, headache, malaise began approximately 12-14 hours after injections, resolved within 24 hours.
Reaction to DTaP on left arm intramuscular site. Red, warm. Slight induration, pain and itching. Pt advised to use cold compress and Benedryl. Pt was also seen in clinic on 05/29/03.
Sore at injection site; This is a spontaneous report received from a non contactable consumer, the patient. A 45-year-old male patient received of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown), via an unspecified route of administration on 18Mar2021 at 09:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patients medical history includes Hypertension from unknown date. Concomitant medications includes Losartan for unknown indication from unknown date. The Patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient experienced Sore at injection site on 18Mar2021 at 15:00. The patient did not receive treatment for the reported event. The clinical outcome of the vaccination site pain was not recovered.   Information about lot/batch number cannot be obtained. No further information expected.
Generalized hives, lungs clear, no difficult breathing, no discomfort. Child has epipen at home for peanut allergy. School nurse called doctor's office, sent home child with mom, has doctor's appointment on 2/16/18.
Morning of 08/17 patient presented with right anterior thigh with erythema, warm to touch and slightly indurated area measuring approx. 8cm x 4cm. No discharge from area, patient able to ambulate. Prescribed Keflex.
Recieved Moderna booster at the family care practice where I work as a Provider in the morning. Saw patients of my own after the shot , then had lunch , ( soup) was catching up on documentation when I began to have pounding heart and dizinnes, and some nauseau. I reported this to my nurse manager, who then directed me to our NP who quicky took my heart rate and it was up to 139 and my blood pressure was also elevated. She discussed my presentation with our nurse manager and they sent me to our Emergency Department for a potential adverse response to the vaccine.  At the Ed I was triaged ny a nurse who took my blood pressure and it had increased to 169/122 ( or something close to that) and my heart rate continued to be above 90. I then sat in the waiting room for over two hours waiting to see a doctor. I was placed in a room alone then the doctor arrived with a person who had a computer and a badge identifying them as a contractor and took notes. The doctord did not introdyuce the other person. He asked me some questions, and then told me " I cant say if this is an adverse reaction to the vaccine" He stood up and began to physcially axamine me with out even telling me he was going to and began pushing on my abdomen then listened to my heart. My heart rate had come down some but I still felt tight in the chest and a bit dizzy. He did not take my blood pressure again. In stead he had me walk the hallway, and told me to take two ibuprofen and some tylenol and that I woudl be fine. When I questioned that he said " Do you want me to run millions of dollars worth of tests.?"  And he also said" I cant take the vaccine out of you", And " I cant give you a beta blocker becasue that drop in blood pressure coudl cause a stroke" After this. I was frustrated, he saw my frustration and acknowledged it out loud. I admitted to being frustrated . He then said " i have discharged some one with a bloood rpessure of 250 over 120, a spike in blood pressure is managable for a few days if there are not other health issues and your heart sounds fine. "  he asked if I ahd any more questions, and I asked who the person taking notes wa,s and he said that all ED visits are transcribed.  Well I was in the ED with my son the week before for asthma  and there was no transcriber. He write " dizinnes" on my discharge paperork and did not put down the tachycardia or the very increased  blood pressure.
Day of vax pt cried inconsolable, color very pale & around lips & nails. Nails dull color. When falls asleep awakes screaming.
Received COVID booster yesterday, causing sudden onset (L) shoulder joint pain; suspect vaccine may have been given intra-articularly.
Covid-19; Covid-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient. Regulatory number: 22K-163-4292770-00 (AbbVie).  A 24 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Nov2021 (Batch/Lot number: unknown) at the age of 24 years as dose 3 (booster), single, intramuscular, administration date 10Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 25Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at cf for crohn's disease. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "recovered" (2022) and all described as "Covid-19". The action taken for adalimumab was unknown.  Causality for HUMIRA (ADALIMUMAB)  The reporter's causality for the event(s) of COVID with HUMIRA (ADALIMUMAB) was no reasonable possibility.  Causality for COVID-19 (COVID-19) Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, De challenge: N/A  The reporter's assessment of the causal relationship of the (drug ineffective, Suspected covid-19) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
No adverse event; Expired Vaccine Used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used).    No concomitant medication information was provided.  The vial was initially stored in refrigerator on 7-Jun-2022.  The vial did not undergo any temperature excursions.  It was reported that a total of 35 doses were given from 4 vials for approximately 40 patients.  The dates of administration of the vaccines was reported as 1-Apr-2022, 5-Apr-2022, 6-Apr2-022, 8-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 9-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022.  The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses.  No treatment medication information was provided.
I was knocked out; I was not able to get out of bed for two days; I was sore all over; Sore in arm where I got the injection; A spontaneous report was received from a consumer concerning a 68 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced was knocked out/loss of consciousness,  was not able to get out of the bed for two days/movement disorder, sore in arm where got the injection/injection site pain and was sore all over/pain.  The patient's medical history included Covid-19 about a year ago.  Concomitant product use was not provided by the reporter.  On 01 Mar 2021, the patient received the first of two planned doses of mRNA-1273 (Batch number: 029A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unspecified date, approximately 12 hours after the vaccination patient experienced soreness all over and pain in arm where she got the vaccination. Later patient lost her consciousness and was not able to get out of bed for two days. Patient expressed these side effects are far worse than when getting the disease (Covid-19). Treated with Ibuprofen and it didn't help. No relevant laboratory details were included.  Action taken with the drug in response to the events were not reported.  The outcomes of the events, was knocked out/loss of consciousness,  was not able to get out of the bed for two days/movement disorder and was sore all over/pain were considered as unknown. The outcome of the event, sore in arm where got the injection/injection site pain was considered as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
This registered nurse, a 45-year-old female, received hepatitis b vaccine recombinant. One hour post vax, the pt developed hives and itching. It was reported that the hives were visible to the registered nurse. No concomitant medications were given. The hives have resolved but the itching persists. The pt was treated with oral and topical diphenhydramine HCl (Benadryl). Additional information has been requested.
Injection site warm to the touch, swollen, painful. Patient also experienced body aches and sensations of being hot, then cold.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced mild breakthrough chickenpox.
I took tylenol before I went in to get my vaccine. Around 4 pm I started get fatigued. At 9pm I started get chills, low grade fever, joint pain. I self medicated with tylenol for 14 hours around 6 pm the next day I felt better.
Low grade fever, irritable, (chicken pox like) rash on stomach, leg and back
marked erythema visible even 1 wk p/inj w/small hematoma; ran fever, irritable & c/o arm pain for several days p/inj; DTP in past w/o adverse rxn;
expired Havrix was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st June 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 21st June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 Information: GSK Receipt Date: 22-Jun-2022 Reporters comment: The healthcare professional reported that an expired Havrix was administered to a patient. No reactions reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up by email. Additional Supportive Information: The patient received expired dose of Havrix which led to expired vaccine used.