chrisvoncsefalvay/vaers-outcomes huggingface dataset:
on 8/31/19 developed a fever of 100.8 which lasted 24 hours.  Followed by a non pruritic rash on face, followed by trunk and then extremities .  Denies any  cough or sneezing.  c/o periorbital pain when moving eyes which resolved.
Chills, pressure on chest and some breathing discomfort since the day after the first shot, i.e., starting on March 17, 2021
HOSPITALIZED WITH COVID PNEUMONIA 8/19/2021, ICU AND INTUBATED 8/24/2021, DEATH 9/3/2021
RECEIVED LESS THAN 0.5ML (APPROXIMATELY AROUND 0.3ML) OF VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 35 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series was 1), 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, 1 total, administered (dose number in series was 2) at left arm on 01-DEC-2021 for prophylactic vaccination which was an off label use as patient received less than 0.5 ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine under dose) (both events dose number in series was 2). No concomitant medications were reported.  "As per the report, the health care professional (HCP) withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5 mL but the caller mentioned that the math (she arrived at that by dividing 2.5 mL by 5 doses) did prove that they received approximately around 0.3 mL." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml (approximately around 0.3ml) of vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211209976, 20211210160, 20211210588, 20211210159, 20211210610, 20211210409, 20211210733, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211209775, 20211212088, 20211212082, 20211210662, 20211209679, 20211209740, 20211210670, 20211210824, 20211210350, 20211209912, 20211210141, 20211210585, 20211210107, 20211210684, 20211210590, 20211210385, 20211210334, 20211210143, 20211210106, 20211210058, 20211210019, 20211209843, 20211209706, 20211209884, 20211209874, 20211209798, 20211210555, 20211210112, 20211210549 and 20211209921.
Hard Red area that itched and increased pain in the arm.  Red area increased in size on 01/08/2021
Mild and constant headache; Pain over injection site; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ELO140), via an unspecified route of administration in left arm on 17Mar2021 at 17:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included headache. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 18Mar2021, the patient experienced pain over injection site. On 20Mar2021 and 23Mar2021, the patient experienced mild and constant headache. The patient had headache several times a month even before the vaccination. It was reported that the real concern of the patient was when the pharmacist gave the injection, was that she noticed an intact pack of Pfizer vials (probably two dozen of them) left on the table. The patient did not complain and was not sure how the vaccine should be handled until afterwards she seriously doubted the vaccine vials were handled properly because there were fewer than 10 people waiting only, so there was no need to keep a pack of dozens on the table. The patient was concerned that the vaccine she had might have gotten compromised. The patient did not know how long the pack of those vaccines was left on the table. The patients friend who got her shot at another Walgreens said the same. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the pain over injection site and headache were resolved on unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Thyrotoxic storm, heart failure, atrial fibrillation, cardiopathy and Grave's disease. ICU for 7 days. Discharged with 7 prescriptions.
Suffered an acute massive pulmonary embolism.  Two-weeks prior to returning to campus, I immediately start with symptoms of shortage of breathe, dry coughing, and dizziness.   Hospitalized for six(6) days of which, I spent three days in ICU.  Dr. had to perform an emergency caterization to remove the massive blood clot from my lungs.  Additionally, they found other smallers clots that they used Heparin and other blood thinners to resolve the clots.  Currently I am on Eliquis twice a day and plan to be seen as a follow up with Hemologist.  Lot number  - First Vaccination was EW0186                            Second Vaccination lot number is EW0191
Moderna COVID-19 Vaccine EUA   -- Arm not sore at all on 3/1/2021.    Next morning 3/2/2021 right deltoid was sore, and got more sore as day went on. Nausea, fatigue and low fever 99.5 (normal temp 96.8-97.6 degrees) afternoon starting at noon .  Took Ibuprofen 400 mg and Tylenol 1000 mg at 3:30 p.m. and 200 mg Ibuprofen and 500 Tylenol at 9:00 p.m.  3/3/2021  - 7:30 am fatigue Body aches esp right hip.  Right deltoid Injection site much less sore on 3/3/21.  Took Ipubrofen 400 mg on 3/3/2021.   Symptoms were similar to a mild case of Covid 19 which I experienced in July 2020.  I had to stop work at 3:30 p.m. on 3/2/2021 and stayed home due to fatigue on 3/3/2021.  Symptoms improving on 3/3/2021 at the time of filling out this form.
received Moderna vaccine on 3/5/21, due to a scheduling error she was invited back to a Pfizer second dose clinic on 3/27/21 and received the Pfizer vaccine at that time. Patient was informed of error. No adverse effects reported at this time.
PT WAS GIVEN MODERNA AS THE 2ND DOSE IN HIS COVID VACCINE SERIES INSTEAD OF PFIZER (WHICH HE HAD RECEIVED FOR HIS FIRST DOSE)
after the 1st one that they all felt really bad like they all had flu after they had the vaccine; after the 1st one that they all felt really bad like they all had flu after they had the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (after the 1st one that they all felt really bad like they all had flu after they had the vaccine) and INFLUENZA LIKE ILLNESS (after the 1st one that they all felt really bad like they all had flu after they had the vaccine) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (after the 1st one that they all felt really bad like they all had flu after they had the vaccine) and INFLUENZA LIKE ILLNESS (after the 1st one that they all felt really bad like they all had flu after they had the vaccine). At the time of the report, FEELING ABNORMAL (after the 1st one that they all felt really bad like they all had flu after they had the vaccine) and INFLUENZA LIKE ILLNESS (after the 1st one that they all felt really bad like they all had flu after they had the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that after the first one they all felt really bad like they had the flu after they had the vaccine. Patient had flu like issues. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Shot was given 1-7-19 in the evening pt woke up at 5 am with aches, and chills had to stay in bed - then had high fever symptoms lasted about 24 hours.
Calling for his father. Father received 1st dose of Covid vaccine January 21st and then developed Covid; This is a spontaneous report from a contactable consumer (Son) received from a Pfizer Sponsored Program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Jan2021 as single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer calling for his father. father received 1st dose of covid vaccine january 21st and then developed covid on an unspecified date. They are wondering what his father should do about his 2nd dose. The action taken in response to the event(s) for BNT162B2 was not applicable. The outcome of event was unknown. Information on the Batch/Lot has been requested.
Felt tired, fatigue and weakness and all-over body aches. For at least a 24+ hour period
pt cold sxs-runny nose, cough, post nasal drip-tender (papular) lump behind jaw & ear, (papular) rash on face-upper arm, chest, back
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 11:14 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:14 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 62.11 for dose administered on 20-Mar-2021.  No concomitant medications were reported.  Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 37 degree Fahrenheit at 10:00 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Panic attacks including tachycardia, shortness of breath, shakiness, and gastrointestinal upset. Joint pain in areas including neck pain, hand pain, hip pain, and costochondritis. Swollen lymph nodes in neck.
Patient states that she was feeling fine the day of the vaccination and a little achy the day after. The night of 10/13/22, patient states that her long-time controlled fibromyalgia became excruciating. Patient had been on pregabalin TID before the incident and had been decreased due to sleepiness associated with it. Patient was directed to call MD to see about temporarily increasing dose of pregabalin to address pain. Patient states that she was not able to sleep due to the pain and it was the worst it has ever been in her life.
Headache, Muscle Pain, Chills, Fever, Nausea, Diarrhea, Tiredness
Patient presented on 12/5/2021  a week after 3rd covid vaccine 11/29/2021 (2 moderna then a pfizer) with 36 hours of dysarthria that resolved without treatment. Hospitalized for stroke work-up,  MRI did not show a stroke but did show non-enhancing lesions concerning for demyelinating lesions. LP done on 12/13/2021 showed oligoclonal bands and elevated IgG index and patient is now being evaluated for MS.
cough; congestion; potentially receiving the second dose of the vaccine more than 36 days after the first dose; This spontaneous case was reported by a patient and describes the occurrence of COUGH (cough), NASAL CONGESTION (congestion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (potentially receiving the second dose of the vaccine more than 36 days after the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (cough), NASAL CONGESTION (congestion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (potentially receiving the second dose of the vaccine more than 36 days after the first dose). At the time of the report, COUGH (cough) and NASAL CONGESTION (congestion) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (potentially receiving the second dose of the vaccine more than 36 days after the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
Had immunizations 7/15/03.  7/16 started blisters in mouth oral mucosa, and lips.  In health department  7/17/03, refered to private doc.
No additional AE's; a six month old patient received a third dose of PEDVAX HIB; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender whose concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 08-NOV-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, used as directed to prevent haemophilis influenza b infection (lot number: W002453, which was verified to be valid with an expiration date: 24-JUN-2024; strength and route of administration were not provided) (Inappropriate schedule of vaccine administered).  No additional adverse event (AE) was reported.
Pt had reaction to varicella vaccine. Redness and swelling at site of injection. Given left subcutaneous.
Pfizer COVID Vaccine: Formulation/Dosage Error Patient received Pfizer vaccines on 2/12/2022 and 3/5/2022. The product provided on 3/5/2022 was 0.3 ml of the adult formulation
Had screening mammogram 2 weeks after second modern (lot 010m20A, 02/12/21) which demonstrated prominent left axillary lymph nodes. I then had ultrasound done 3 months later 05/17/202 with few prominent axillary LN cortex up to 3.8mm.  I wanted to hold off on further testing figuring it was fro the vaccine.  But was strongly recommended I undergo a FNA.  I had to then have a FNA of LN June/9/2021. Final pathology:  lymphoncytes seen, no malignant cells
(1) Hives/redness/swelling in (L) arm (L) - tx: Claritin, calamine lotion (2) Headache/vomiting - Zofran, ibuprofen - (next morning/day)  (3) diffuse used rash all over upper torso/bilateral  arm - Benadryl, tac clean (next day)
3 days after getting FLUZONE she started with dystonic hand, arm, head shaking. 1 week later started with slowed/slurred speech. No resolution yet as of 11-13-12.
Vasovagal syncope, Pt resolved quickly, given a cold water and watched for an additional 30 minutes
Lump in the right arm but patient received vaccination in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (Lump in the right arm but patient received vaccination in the left arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced SKIN MASS (Lump in the right arm but patient received vaccination in the left arm). At the time of the report, SKIN MASS (Lump in the right arm but patient received vaccination in the left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Right after shot was given I felt itching on the site. Then in evening I felt pain, it was hot, then a red bump about the size of the inside of my palm.
Information has been received from a consumer concerning her 17 year old daughter with no pertinent medical history and no known drug allergies/drug reactions who "in August 2007" was vaccinated with the first dose of GARDASIL on the right arm. The patient received the second dose in December 2007. There was no concomitant medication reported. It was reported that "within the week of the first vaccination" the patient had been experiencing seizures and fainting after having first dose of GARDASIL. It was reported that the patient started to feel "electric shocks" on the right side of the body along with muscles spasms. She also had strange headaches and petit mal seizures. The patient saw a physician. An electroencephalogram (EEG) and magnetic resonance imaging (MRI) were performed (results not provided). It was reported that the patient had not recovered at the time of the report. Upon internal review, the events of seizures and petite mal seizures were determined to be other important medical events. Additional information has been requested.   9/15/09 Received PCP medical records. FINAL DX: atypical HA; possible seizures Records reveal patient experienced rash, mono, OM, migraine HA, URI, UTI, abdominal pain, fibula fracture from diving accident, .  Referred to dermatology & neuro.  Neuro eval of 10/08 revealed atypical HA, electric shock type pain, staring spells, mild speech difficulty, intermittent balance problams.  Tx w/meds & improved.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager, referring to a 13-year-old female patient. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 04-FEB-2023, the patient was vaccinated one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot numbers and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023, administered for prophylaxis (administration sites, and routes of administration were not provided).  The doses of vaccines experienced 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 min. Total time: 25 mins. Temperatures were reported as 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). Excursions were not noted until after the fact due to employee error of cleaning data logger more than once a day. There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Difficulty moving left arm with pain left neck shoulder and medial deltoid proximal 1/3rd left arm. Findings on examination do not raise any concern for vaccine administration concerns.   It is apparent patient may have been sensitive to medication causing an apparent irritation to the local muscles with underlying inflammatory conditions including arthritis per self-report vs. Neck spasms of unknown etiology.
Maybe 5 minutes after the shot I noticed a headache, then about 25 minutes after the shot, my face started to swell a bit around my mouth and I had some pain. My sinuses and breathing passages swelled. The swelling went down gradually within 24 hours or so, but since then my lips and the area surrounding them have remained numb and it hasn't gone away. Hurts a bit to smile. I kept waiting for it to end so I could report what happened as far as duration, but it hasn't ended. I'm slightly angry about this and also recognize it is what it is.  I regret getting this vaccine for sure though knowing it was a rushed process!  I called my doctor today and have an appointment next week to discuss my allergies and reactions in general.  Other reactions that happened but not sure if they are related -- intense, long lasting menstrual cramps post shot (just way more than usual) and blood for several days in my bowl movements. Those two items have subsided.
Severe left upper Virgin tooth PreMolar spontanous fracture & pain.  Awoke while sleeping.
On day 9 after my second  vaccination woke up feeling itchy, inflamed with severe joint pain in knuckles, hips, and feet and a hot scalp headache, extreme fatigue. On Saturday had the same pain/inflammation symptoms and began running a low grade fever (99.4-99.6) that was not responsive to ibuprofen. Ran a fever also on Sunday, 99.6, again not responsive to ibuprofen. Began taking Claritin in case this was a  serum sickness like reaction on Monday and that helped immensely, finally the ibuprofen was able to work and the fever went down. Today, Tuesday, I am still itchy all over, fatigued and with some pain but not as bad. I also took Claritin and ibuprofen on waking. While I have chronic health issues these reactions are totally new for me. I had four weeks of intense, relentless inflammation, headaches and extreme joint pain (my joints visibly red for weeks) (no fever after my first dose of the vaccine) but my doctors never mentioned SSLR. With the second dose I actually felt better for over a week, but then it all came back, was much worse and the delay was confusing. It was almost impossible to find information about delayed non-local reactions.  I am reporting it because other people need to know that SSLRs are possible with this vaccine and can be debilitating. Please let people know!