chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm became hot and red; Arm became hot and red; This spontaneous case was received on 27-Sep-2021 from other health professional via Med Communications (reference number: SEQW21-02839) and concerned a female patient, of an unreported age.   The patient's relevant medical history and concomitant medications were not reported.   On 20-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration and anatomical location: not reported) as prevention of seasonal influenza. The batch number reported was 312852 and expiry date: 17-Jun-2022.    On the same day, after receiving Fluad Quadrivalent, the patient experienced an adverse site reaction as her arm became hot and red.  The outcome of the events was unknown.   The reporter assessed the events as related to Fluad Quadrivalent.   The case is linked to cases 202103210 and 202103212 (same reporter).  Company comment: A patient of an unknown age received Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient's arm became hot and red. Causal role of the suspect vaccine is assessed as possibly related.; Reporter's Comments: The reporter assessed the events as related to Fluad Quadrivalent as it was stated that the patient experienced advirse site reaction.; Sender's Comments: A patient of an unknown age received Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient's arm became hot and red. Causal role of the suspect vaccine is assessed as possibly related.
This spontaneous report as received from a registered nurse, refers to an adult patient of unknown gender. On 12-NOV-2015 the patient was inadvertently vaccinated with a pediatric dose of RECOMBIVAX HB (5 microgram/0.5 ml). No adverse effect reported. Additional information has been requested.
This spontaneous report was received from a consumer who refers to unspecified number of patients of unknown age and gender. The patients' concurrent condition included service. The patients' medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 injections (dose, route of administration, lot# and expiration date were not reported). The reported stated that he recalled how sick the shot made all of them when they got them (date unspecified). The outcome of the event was not reported. The reported considered the event to be related to PNEUMOVAX 23. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent to follow-up. Sender's Comments: US-009507513-1701USA003557.
I started to experience skin tenderness, joint pain and congestion around 22h after my second dose of Covid-19 vaccine. Symptoms improved after taking 650mg of Acetaminophen one time. Experienced light headache starting around 26h post vaccination, it has not gone away with Acetaminophen. Developed chills and skin tenderness accompanied by joint pain again around 34h after vaccination and developed a fever of 37.6 degrees C around 36h after vaccination. I also feel my neck ganglia swollen and it pains me.
About a week after the first Pfizer vaccine (COVID-19), I started to get Psoriasis on my fingertips, ears, and groin area. I visited a dermatologists and was prescribed ointments and lotions. The treatments have not been relatively successful in the long term. I have an appointment scheduled with another dermatologists for a second opinion. Nothing had changed in  my healthcare routine except for the COVID vaccine.
Patient went to pharmacy for shingles vaccine. On Saturday morning woke up with swelling around injection site. Swelling continued to get larger and tender therefore she came in for an appt. for evaluation. Pt. was treated with prednisone and cephalexin.
Patient experienced chills & weakness following the vaccine. Patient died the following day. No gross anatomical findings of anaphylaxis at autopsy. Tryptase study pending.
Patient came in for a Moderna Vaccine. He had no DUR's. I gave him the vaccine at 9:25am. He waited the 15min. He walked over to the blood pressure machine and took his blood pressure. He then said He was starting to feel funny. Pharmacist took his blood pressure. Initially it was156/94 pulse 114. She gave him a water. She checked on him again a few minutes later and it was 166/76 pulse 103. I check on him. He said he felt tingly and his throat was still scratchy. But he was not having any problem breathing. He said he thought he was having a panic attack. I recommended Benadryl. I gave him 50mg Benadryl orally at 10:15. He was still feeling funny after and we called a manager to get paramedics ( he wanted paramedics called). He was a little shaky and still felt bad. Paramedics arrived a little after 10:30. They ran some tests and also said they thought it was a panic attack. They did not administer any meds to him that I saw, but did take his BG, BP, and check his heart. They went ahead and wheeled him to the ER. Patient apologized, I think he felt embarrassed.
Itchy palms , belly, and underarms on MAY 25.  May 26- itchy backs of hands and not palms, and itchy underarms still. May 27- nauseated and diarrhea.
Arm soreness; Headache; This is a spontaneous report from a non-contactable consumer. A 24-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution or injection, Lot Number: EL3247), dose 1 via an unspecified route of administration in right arm on an unspecified date (at the age of 24-years-old) as single for COVID-19 immunization. Medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID 19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 11Feb2021, the patient experienced arm soreness and headache. Advil was received as treatment for the events. The reporter classified the events as non-serious. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Redness, swelling, hard knot in center - Hydrocortisone cream TID
Patient  inadvertently scheduled  for a Second dose of Pfizer/BioNTech on 01/31/22 after receiving first dose Moderna on 12/29/22. Patient was administered Pfizer/BioNTech 0.3 ml IM in Left Deltoid on 01/31/2022.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information concerning the patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose, route of administration were not reported; lot # M033583, expiration date 14-APR-2019), for prophylaxis. The vaccine underwent a temperature excursion with 31 degrees Fahrenheit or colder (25.2 degrees Fahrenheit) for 16 hours and 48 minutes, for two cycles. No previous temperature excursions were reported. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA013861: US-009507513-1705USA013862:
Breakthrough case admission after 2 vaccines Moderna 1/11/21 lot# 032H20A;  Moderna 2/8/21 lot# 032H20A
chills; cough; shortness of breath; body aching; loss of taste; lots of nasal congestion and mucus; lots of nasal congestion and mucus; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route of administration on 14May2021, as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 18May2021, 4 days after receiving the vaccine, patient experienced chills, cough, shortness of breath, body aching, loss of taste, lots of nasal congestion and mucus, did not have a fever. Therapeutic measure taken for the events included unspecified antibiotics. The patient underwent lab test and procedure on 24May2021 which included for COVID-19 virus test and tested negative. Patient wanted to know if she could receive the second dose of the vaccine on Friday if they are still taking antibiotics. It was reported that no contraindications for patients with infections taking antibiotics. The patient stated that she prefers to make a written report and accepted to get contacted back. The patient was referred to her physician for treatment recommendations. The outcome of the events was unknown.   Information about Lot Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021651028 Same reporter/drug/event, different patient.;US-PFIZER INC-2021651029 Same reporter/drug/event, different patient.
This spontaneous report as received from a program manager (healthcare worker) refers to unspecified number of patients of unknown age. Program manager reported that patients might have been administered M-M-R II (injection, therapy type, strength, lot#, dose/frequency, route and duration were unspecified) that had been exposed to unspecified temperatures out of range for an unspecified length of time since an unspecified date in September 2012. No adverse effects reported. Outcome was unknown. Additional information has been requested.
This initial non-serious spontaneous case, was received on 26-Nov-2017, from the other health care professional concerning an elderly female patient (reported as older than 65). On an unspecified date (reported as more than 20 years ago), patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported), at work place. On an unspecified date, after vaccination the patient had cough, chills, fever and muscle aches. The reporter assessed the events as related to the vaccine.
Shoulder Inflamation - severe pain and reduced ROM treated with oral steroids , NSAIDS, resting/reduce use of injured arm and at home stretching
A month later, I started to feel increased anxiety and depression. I started to have general uncharacteristic behavior. I sought care from a counselor and have been prescribed anti-anxiety and anti-depressant medication. Also, random instances of pain in the arm where I received the 'shot'. It also messed with my asthma.
After the pt had left yesterday, 10/10/23 it was found that an error had taken place with the pts COVID vaccine administration. This CMA did not note that the vaccine vial was a multidose vial that needed to be diluted prior to administration. The pt received 0.3ml of the COVID vaccine without dilution. The lead clinic nurse along with our pharmacist here at the facility were contacted. Per pharmacy the pt should not have any long term effects from this error. The pt may experience an increase in the typical side effects from any COVID vaccine. The pts mother was notified. A safe qual event will be completed. This will also be reported to vaers.hhs.gov. Safe guards have been put in place to ensure this does not happen again. This standard procedure was discussed during our nursing huddle this morning, will be reported via email in the nursing huddle minutes and a note was placed in the injection room.    Mother states the pt is doing well today other than having a slight blotchy rash on her face.   Pts mother had inquired to see if the pt needed to get the additional 2 doses. Per pharmacy it was stated the pt should receive the 2nd and 3rd doses as recommended. The reason being to prolong protection from COVID.     Pfizer-BioTech COVID-19 vaccine. Lot # HH3252 EXP: 07/2024
Pt had bumps on lower back (6). 6 months later pt had 2nd flu vaccine at doctor's office: Dr., no reaction.  Pt had shingrix vaccines: pharmacy, last one 11/15/2020. Pt had painful bump on vagina. Pt used cortisone cream.   No medical attention for any AE.
Information has been received from a registered nurse concerning an elementary school aged child who on 02-MAY-2001 was vaccinated with a dose of varicella virus vaccine live. On approximately 28-FEB-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
9:00 PM - Sudden extreme chills (whole body shaking) with no fever - covered up with 4-5 blankets. 11:00 PM - Chills gone, fever of 103.4 degrees - administered 600mg Tylenol and cool wet compresses. Fever reduced to 101.2 by 7:00 AM next morning and gone by evening.
Information has been received from a physician concerning a 73 year old female who on  an unspecified date was vaccinated with a first dose of PNEUMOVAX 23 (lot# unknown). On 31-JUL-2007 the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot# 657143/0380U) in the right deltoid. On 01-AUG-2007 the patient developed redness, swelling and the arm was very painful. The doctor recommended BENADRYL every 6 hours when needed and ice. Medical attention was sought. On 03-AUG-2007 the reaction was spreading 6 inches down the arm and 3 inches wide from the injection site. Patient scheduled by the physician to be seen on 04-AUG-2007. Additional information is not expected.
Small fibre neuropathy positive skin biopsy; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 22-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Feb2021 09:15 (Lot number: EN5319) as dose 2, single and intramuscular, administered in arm left, administration date 17Jan2021 09:00 (Lot number: EL0142) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Percocet, reaction(s): "Known allergies: Percocet". The following information was reported: SMALL FIBRE NEUROPATHY (disability), outcome "not recovered", described as "Small fibre neuropathy positive skin biopsy". The event "small fibre neuropathy positive skin biopsy" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: biopsy skin: (unspecified date) positive, notes: Small -Fiber Neuropathy; COVID test: (Jan2022) negative, notes: Nasal Swab. Treatment received for the adverse event included Lyrica, Gabapentin, Cymbalta. Not diagnosed with COVID-19 prior to vaccination.; Sender's Comments: As there is limited information in the case provided, the causal association between the event small fibre neuropathy  and the suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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
immediately developed inflammation in his whole body; Immediately developed inflammation in his whole body but knee is worse; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFLAMMATION (immediately developed inflammation in his whole body) and ARTHRITIS (Immediately developed inflammation in his whole body but knee is worse) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (immediately developed inflammation in his whole body) and ARTHRITIS (Immediately developed inflammation in his whole body but knee is worse). At the time of the report, INFLAMMATION (immediately developed inflammation in his whole body) and ARTHRITIS (Immediately developed inflammation in his whole body but knee is worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that the patient had good health.  The patient's daughter stated that, her father listened to medical experts and took the Moderna vaccines and immediately developed inflammation in his whole body, but knee was worse. He had been battling this for a year and a half. The reporter didn't know when he received doses. She stated, when it first came out and people were directed to the health Department and sites to have them done. That was when he had his first vaccine and she think it was a few months later he got one booster.  No treatment medications were reported.  Company comment: This spontaneous case report concerns a male patient of an unspecified age with no previous medical history and underlying conditions, who developed non serious unexpected events of Arthritis (AESI) and Inflammation. Reportedly, after the patient had received mRNA-1273 vaccine (dose of the vaccine was not specified), he immediately developed inflammation in his whole body but it was stated that inflammation in the knee was the worst and the patient was having symptoms for a year and a half. At the time of this report, the events were still ongoing and no additional details regarding clinical course of the events were disclosed. No further details were available for medical assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-712478 (Patient Link).
Palm of left hand red, Extremely sore, lump. Redness has dissipated, soreness and lump still present.
nauseas and Queasy; body aches; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseas and Queasy), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced NAUSEA (nauseas and Queasy), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (fever). At the time of the report, NAUSEA (nauseas and Queasy), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to an unspecified group of patients of unknown age and gender. Patients' medical histories were not provided. On an unknown date, the patients were vaccinated with doses of RECOMBIVAX HB (doses, frequencies and lot numbers were not provided, intramuscularly) which were improperly exposed to 9.7 Celsius degree (C) for 1.25 hours on 09-DEC-2014. Concomitant medications were not reported. No adverse effects were known. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
sore throat began 12MAR-worse on 14MAR; rash appeared 15MAR over most of body-worst on trunk back & tops of legs;
After vaccine I had a sore arm and on 3/17 I ended up in the ER because I had a seizure.  Both me and my wife had the same reaction, a month ago both have had seizures and have never had seizures in our lives. We've seen the neurosurgeon and neurologist .  I am on seizure medication now, Keppra 500mg bid.
A report has been received from a health professional concerning a 12 year old, male subject, who had been receiving nasal FLUMIST QUADRIVALENT. The patient's medical history, concurrent diseases and concomitant medications were not reported. FLUMIST QUADRIVALENT started on 19-Dec-2013. The patient experienced expired FLUMIST QUADRIVALENT administered (preferred term: expired drug administered) on 19-Dec-2013. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious.
2 days after my vaccine, I developed a rash a couple inches below the injection site.  It was warm to the touch, and itchy.   I used a topical cream to treat it.  It is now Day 4  and the rash is nearly gone.
Slight headache, and mild stomach upset, my face had an extreme burning sensation - particularly on the L ear. The skin felt warmer than normal. Headache and stomach upset lasted about an hour or until I took some ibuprofen, the burning sensation to gradually increased in intensity for about 1 hour and than slowly dissipated during the next half hour. The burning sensation returned the following morning at approximately 7:00 am for about 40 minutes.
vaccine was administered to a patient from a vial that was refrigerated; No adverse event; Expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient), PRODUCT STORAGE ERROR (vaccine was administered to a patient from a vial that was refrigerated) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was administered to a patient from a vial that was refrigerated) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient), PRODUCT STORAGE ERROR (vaccine was administered to a patient from a vial that was refrigerated) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and PRODUCT STORAGE ERROR (vaccine was administered to a patient from a vial that was refrigerated).    The vial size was 2.5 mL and was an individual vial. The vial did not undergo any temperature excursions. No concomitant medications were reported. No treatment medications were reported.
I had hives, swollen in my throat and left side lymph nodes from my neck to my breast. I got COVID arm 9 days after (softball size lump and swollen at the injection site). Had to visit urgent care.