chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Swollen lymph nodes; tired all day; did not feel like herself-like she had the flu; soreness; This is a spontaneous report from a contactable nurse, the patient.  A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246), intramuscular in the right arm on 02Jan2021 at 11:45 as a single dose for COVID-19 immunization.  Medical history included polycystic ovarian syndrome, prehypertension, prediabetic, and vitamin D deficiency. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN), erythromycin (MANUFACTURER UNKNOWN), and ciprofloxacin (CIPRO); all for unspecified indications from unknown dates to unknown dates and experienced drug allergy. On 02Jan2021 at 18:00, the patient started having soreness. On 03Jan2021 at 16:45, the patient had nausea. On 03Jan2021, she also had swollen lymph nodes,  was tired all day, and "she just did not feel like herself-like she had the flu". The patient was not given any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcomes of the soreness, nausea, swollen lymph nodes, tiredness, and "she did not feel like herself-like she had the flu" were recovering.
Information has been received from a receptionist and a physician's assistant, concerning a female who was vaccinated with the first dose of GARDASIL. After the first dose, the patient's body was achy and wasn't generally feeling well. Approximately 3 hours after the second dose of GARDASIL, she had difficulty with breathing. She also experienced, lethargy, aches and headaches. The patient sought unspecified medical attention. The patient outcome was not reported. Additional information has been requested.
Patient given 2 vaccines in different arms, rxn was swelling/redness dx as "severe rxn to vaccinations". Pt fully recovered.
Fuzziness, fatigue, headache lasting more than 24 hours, fever between 100-101 C
Adult dose of Hepatitis A vaccine was given instead of the Pediatric dose of Hepatitis A.
The patient states that he didn't eat at all; Had very bad stomach pains; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (Had very bad stomach pains) and FEEDING DISORDER (The patient states that he didn't eat at all) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced ABDOMINAL PAIN UPPER (Had very bad stomach pains). On an unknown date, the patient experienced FEEDING DISORDER (The patient states that he didn't eat at all). The patient was treated with LICORICE [GLYCYRRHIZA GLABRA] at an unspecified dose and frequency; BISMUTH SUBSALICYLATE (BISMUTH SALICYLATE) at an unspecified dose and frequency and SIMETICONE (SIMETHICONE) at a dose of 125 milligram, pills. In January 2023, ABDOMINAL PAIN UPPER (Had very bad stomach pains) had resolved. At the time of the report, FEEDING DISORDER (The patient states that he didn't eat at all) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient received Moderna 1st dose on 02-Apr-2021 with batch number 026B21A, 2nd dose on 30-Apr-2021 with batch number 004C21A, third dose on 10-Nov-2021 with batch number 039905 and fourth dose on 22-Jun-2022 with batch number 014B22A. Patient never had any bad reactions to previous shots. It was like he got placebo shot for all of them, except the last one. He had no reaction at all to them. The last one, he did have a bad reaction to it. The only relief was chewing and swallowing natural licorice to help ease the pain. Patient had tried a Pepto Bismol (bismuth salicylate) tablet and Gas-X (simethicone 125mg) pills also. Patient was not experiencing stomach pains anymore. Stomach pains started late fall of 2022 to early January 2023. It was for a few days. Patient didn't have rash, weakness, myocarditis, pericarditis, or nausea.
PATIENT RECEIVED 0.25ML FOR SECOND DOSE. PATIENT INFORMED AND WILL RETURN AS SOON AS HE CAN FOR CORRECT DOSE
Red Rash on day 4 or day 5.  Both Arms & both upper legs.  Around ankles.; This is a spontaneous report received from contactable consumer, the patient. A 50-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on 12Mar2021 at 11:45 (at the age of 50-years-old), as single dose for COVID-19 immunisation. Medical history included patient was asthmatic. The patient was not allergic to medications, food and other products. Concomitant medication included ventolin(MANUFACTURER UNKNOWN) from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. On 16Mar2021, the patient experienced delayed reaction, red rash on day 4 or day 5, both arms & both upper legs and around ankles. On day 12 still had rash when body heats up shower or working out. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of red rash was not resolved at the time of report.   No follow-up attempts are possible. No further information is expected.
My pre-existing mild tinnitus got much more severe within a week of receiving the J&J COVID vaccine.
Within 6 minutes heart rate was elevated and blood pressure was high with ringing in ears.  Lips and tongue were numb, tightness in throat.  Hives developed on ears and back of neck.  Had difficulty concentrating and confusion.  Felt like passing out.  Pharmacist did not react or call for ambulance because I was still breathing.   My husband had to drive me home.  I have a doctor as a neighbor who was home when I got home still having reaction 30 min after the shot and took blood pressure that was extremely elevated (top number in 200) and heat rate still over 100bpm.  Took 50mg Benadryl and symptoms started decreasing within an hour and blood pressure was decreasing but still higher than normal.  By 7pm, blood pressure was back to normal and heart rate back to 70bpm.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient had a syncopal episode after the needlestick but prior to administration of vaccine solution.
Patient reports that about 3-4 days after receiving the first dose, she started experiencing difficulty in chewing and drooling out of the left side of her face. She then noticed a mild facial droop. On March 7th, 2021 she was evaluated in the Emergency room and  diagnosed with Bells' Palsy. Shewas discharged home the same day and was prescribed Valtrex and Prednisone. On March 9th, 2021 she consulted with a neurologist. She came in for consultation with us (infectious disease) on March 10th, 2021.
Employee received .2 cc of Pfizer instead of .3 cc which was inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our  Task Force, after speaking with proper channels, decided to offer the employee an additional COVID-19 vaccine dose.  Thanks.
Pfizer-BioNTech covid-19 pediatric 5-11 vaccine was administered after expiration of vaccine. Recall of vaccine issued on 10/12/2022 while vaccine was given on 10/01/22
Only shingrix diluent used; diluent only administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 27-Jul-2022 Reporter's comment: A pharmacist reported that a patient had received the Shingrix diluent only. The reporter did not had exact date of administration. The reporter consented to follow-up. This case is for 2 of 2 patients. Additional supportive information: The patient received the Shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022111740:Same reporter. Patient 1
PATIENT RECEIVED A DOSE OF PFIZER BIVALENT BOOSTER DOSE WAS PAST BUD, SPOKE TO PATIENT AND SHE STATED HAS NOT EXPERIENCING ANY ADVERSE EVENTS. PATIENT WILL SCHEDULE TO BE RE-VACCINATED.
received 2 consecutive doses of fluarix; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 15-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 54C23, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX QUADRIVALENT).   On 29th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 29th September 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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 provided as follows: The clinical manager reported that a patient had received two consecutive doses of Fluarix quadrivalent vaccine, which led to overdose. The reporter consent to follow up.
Pt reports having history of vagal response following any needle injections. After patient received vaccine he started yawning, became diaphoretic, pale  we lowered him to ground and elevated feet. He said he heard humming in his ears and blacked out.  His wife was present. She reported his hx of doing this previously. She said he is an avid runner and his resting heart rate is typically in the 40s. His heart rate was 37-40 when palpated radially. His Bp stayed about 90/50 which she said was also his baseline. I called the patient around 11AM 2 hours after the event and he reported he felt much better and had recovered.
Began having stabbing pain with reaching and moving right arm. The arm eventually became stiff over time and became a little limp and somewhat spastic movements. Limited range of motion causing decreased ability to perform ADL (putting on coats and grooming). Was eventually diagnosed with frozen shoulder.
I woke up and my whole face and lips were severely swollen, and an abscess popped up on the roof of my mouth with infection.
mom report high pitched screaming, staring, lethargy 14 & 15NOV92; had cold sx;
Swelling, redness and discomfort at injection site where Kinrix vaccine was given. Patient also had a low grade fever for 1 day.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, pertinent medical history, drug reactions, allergies or concomitant medications was reported. On 16-MAY-2017, the patient was vaccinated with one pediatric dose of RECOMBIVAX HB injection (dose number, route, anatomical location, lot # and expiration date were not reported) instead of two doses. No adverse effects were reported.
Area of erythema about 4 cm in diameter , blanching, tender raised on (Rt) arm at site of Varicella vaccine administration. Given Ibuprofen PRN pain.
After approximately ten hours after the vaccine shot, I felt tired, weak, and uncomfortable. I began to shiver and had a terrible headache. My body felt very heavy and my joints and muscles ached terribly. As I shivered, I also felt feverish. I went to bed and covered myself with blankets but continued to feel these symptoms during the night. After 24 hours, I felt better. Thankfully, I had no redness nor swelling around site of the injection. I would like to know if it is safe for me to have the second vaccine in two months.
This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A patient of unspecified age and gender receive PREVNAR 13, via an unspecified route of administration from an unspecified date AT single dose for immunisation. The patient's medical history and concomitant medications were not reported. The doctor reported that he does hear about pain and fever more often after he administered PREVNAR 13. Outcome of the events was unknown. Information on the batch number has been requested.
post nasal drip and irritation, kept falling asleep , slept all day on day 5
Recieved flu vaccine in Right Deltoid.  Reported swelling and tenderness under R arm in armpit area.  Resoved with in 5 days with out medical intevention.
This is a 95y.o. male with significant past medical history of HTN, Afib, CHF, CAD, and colon cancer that presented to the hospital with chief complaint of cough. Patient reported received his flu vaccine on 10/27/21. He states today upon walking he had a fever, chills, and felt shaky and fatigued. The patient's daughter performed a home COVID test which resulted as positive; subsequently he was brought to the ED for evaluation. He denies any headache, lightheadedness, dizziness, chest pain, palpitations, abdominal pain, nausea, vomiting, diarrhea, constipation, or urinary symptoms.    In the ED, patient normotensive, afebrile, stable SPO2 on room air. COVID swab positive. Troponin 0.10. CXR with mild CHF changes. Patient has been admitted for further evaluation and management with cardiology consultation.
Two hours after vaccine, I felt abdominal pain and felt like I was going to get diarrhea and I got really flushed; shaky; face red. They put ice on back of neck. Arm started to hurt. Took Tylenol and sat down. And felt better 15 minutes later. Intervention was ice on back of neck so I wouldn't faint and rest. Overnight, first night - chills. Woke up with a headache. Took ibuprofen and Tylenol and had body ache and joint pain, too. Five days consistently (positionally) - when I laid down I would get it for five days. I had the vertigo which started 2 days after vaccine. Had a migraine 7 days after vaccine and I had to miss work because it was so severe. Had a typical migraine. Had an aura and it was so bad I couldn't see to drive to work. I don't ever get vertigo with my migraines and so this was different. After 7 days all symptoms were resolved. I am currently breastfeeding.
No adverse effects were reported; dose of improperly stored ROTATEQ was administered on 22 Jun 2022; This spontaneous report was received from health care professional referring to unspecified age and gender patient whose medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.   On 22-JUN-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (lot number: 1837116 which was verified to be valid with expiration date: 24-MAR-2023, strength, dose, and vaccination scheme frequency were not provided) (product storage error).  The dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored in a temperature above 47 degrees Fahrenheit (F) (48.7F) for 0 hours, 11 minutes, 0 seconds. No previous temperature excursion was reported. No adverse events were reported.  This is one of two reports received from the same reporter.
During Occupational Therapy Session at Babysitter's house, the child suddenly stiffened, eyes rolled up slightly, mouth remained opened and became completely non-responsive to his surroundings for approximately 15-20 seconds. Both his baby sitter and therapist attempted to rouse him by clapping hands loudly near him, making noises and calling his name. He finally roused himself and returned to his normal state as if nothing had happened.  A second incident occurred on 02/15/13 at 9:35am but only lasted for 5-10 seconds.  Child was not ill, not running a fever, has not had any falls or trauma to head and has not had a history of similar types of "absence seizures" in past.
child found dead in bed 14Jan90.  Had full check up 12Jan90 with immunizations DPT/HIB/Oral Polio
On my right arm here got the second shot, I noticed there is a scar; I was keep scratching my arm and that was where I got the vaccine shot then it irritate; On my right arm here got the second shot, I noticed there is a scar; I was keep scratching my arm and that was where I got the vaccine shot then it irritate/ then feels itchiness and scratching; On my right arm here got the second shot, I noticed there is a scar; I was keep scratching my arm and that was where I got the vaccine shot then it irritate; Yes, my arm is sore/ then I noticed it's going to sore on their/ Outcome of event: Consumer stated, "It's getting worsened because it's scratching in arm, it's getting sore."; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0165 and expiration date: 31Aug2021), second dose via an unspecified route of administration, administered in right arm on 25May2021 at 08:30 (at the age of 60-yeasr-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing, no investigation assessment was reported. Concomitant medications included adalimumab (HUMIRA); gabapentin (GABAPENTIN); celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported. Historical vaccine given to patient previously was dose 1 received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EW0165 and expiration date: 31Aug2021), via an unspecified route of administration, administered in left arm on 04May2021 at 08:30, as a single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. It was reported that, on 25May2021, her right arm here got the second shot. The patient stated the first one was fine, and this was her second one. she put the bandage on it and then she thought it was okay and then took it off and then feels itchiness and scratching and look at and noticed there was a scar on it. The patient noticed there was a scar for the second time and for first time when she saw it, it was like five days after, and she was keep scratching her arm and that was where she got the vaccine shot then it irritates then no then she felt it again and then she noticed it's going to score on their and she wondered she want to know what she should supposed to do. The patient stated it was getting worsened because she was scratching in arm and it was getting sore. The patient just wants to know, what can she do with her arm. Should she go to the hospital or should she do anything. Treatment of the event, consumer stated no she did not want to take. The outcome of the events was unknown.  Information on batch/Lot number was obtained. Further information has been requested.
In April of 2022 I had contracted COVID-19. I had cold like symptoms it was a runny nose and a little cough. I wasn?t very sick. It wasn?t until days later I lost my taste and smell for four days. I think I was ill for about 11 days maybe. I was traveling and walking and noticed a little shortness of breath. I figured it was a cold and under the weather. It never has gotten better from when I was first sick. I recently went to my regular check and notified my doctor about this shortness of breath. She referred me to pulmonologist and ordered a chest Xray and Echocardiogram. The Pulmonologist will do the echocardiogram.  As of today, If I try to walk at a normal pace, I am winded and if i just walk up my stairs I am very winded. I really can't do everything I used to do. I am constantly having to pace myself. Nothing is as before.
Fever under 100 degrees following administration of shot.  Over the next few days my daughter became wheezy, hoarse, had difficulty breathing and a fever.  Symptoms did not fade, so she was brought back to the doctor at around 1:00 p.m. on 11/5/04.  Doctor said to monitor, give a decongestant and give albuteral via nebulizer.  Conditions seemed to worsen over the weekend.  Brought her to the doctor again on Monday, 11/8/04 at 9:50 a.m. and was told she had pnemonia - unknown whether bacterial or viral.  The doctor decided to treat for bacterial and she prescribed Augmentin. Medical Records received on 1/3/2005 states pt experienced cough, rhinitis, and anorexia.
G40.909 EPILEPSY, UNSPECIFIED 4/11/2022 ACUTE EXACERBATION OF COPD G40.909 EPILEPSY, UNSPECIFIED 4/11/2022 VITAMIN D DEFICIENCY G40.909 EPILEPSY, UNSPECIFIED 4/11/2022 ASTHMA, UNSPECIFIED
Sore lymph node under left armpit and left collar bone. Rash on left arm. Fatigue lasting a week. Lymph nodes better after 6 days. Rash appeared 7 days after shot and has not gone away.
first dose on 7/24/2019, 2nd dose 10/6/2021; This case was reported by a consumer and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th July 2019).   On 6th October 2021, the patient received the 2nd dose of Shingrix. On 6th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient did not get his/her second dose of Shingrix until 6th October 2021, which led to lengthening of vaccination schedule. The reporter also asked would he/she need a 3rd dose. No contact details were available.
Redness and swelling at injection site, no fever, no arm movement restriction. Slight pain. Patient was recommended to take Tylenol/Ibuprofen for swelling and pain, continue to monitor and contact oncologist for extra monitoring. Patient will also contact pharmacy if any new symptoms occur
Subject in pneumococcal vaccine trial, with severe COPD was hospitalized for pneumonia. Vaccination took place on 10/13/2008. According to the physician the relationship is 'Unlikely'. We would be happy to forward Study's SAE reporting form upon request.
From correspondence received at manufacturer on 12/5/01 it was reported that a 33 year old female patient received a Fluzone SV 2001-2002 vaccination administered on 12/5/01. Patient developed a local reaction 2 hours after vaccination--3.5cm red swollen area.