chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Potential AE due to doses administered from vials that may have been compromised; Administered vaccine from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported. The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021. Moderna date ordered was reported as 01-Nov-2021 and 15-Nov-2021. Reporter stated that, they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised. No treatment information was provided.
Acute substernal chest pain @ day 13, d-dimer levels high, ECG showed abnormal R-wave progression; fatigue @ day 14; SOB with minimal exertion, worsens with lying down and relieved with lying forward @ day 15; medical diagnosis (PA) indicates likely pericarditis. No recent hx of infection/illness or exposure (isolation due to high-risk).
Extreme diarrhea and stomach pain, at the point where the patient was not able to leave the house for fear of being stuck somewhere without access to a bathroom due to lack of notice and abrupt need.
After the vaccine, pt went shopping, but started to feel like she couldn't breathe. She stated she was dizzy when she stood up after getting the vaccine, but felt ok to walk around. She came back, sat down, and wanted emergency services because she said she felt like she couldn't breathe. I talked to her about other symptoms and she was flushed, so I got 2 ice packs to put on her neck and forehead since it was sounding more like an allergic reaction, even though she has had flu shots in the past. I went to call 911, but she said she was starting to feel better. I gave benadryl in case she was having an allergic reaction and she was able to swallow. She continued to feel better, but mentioned that she had a metallic taste in her mouth almost immediately after getting the vaccine. She gets her flu shot every year and we've carried the same one for several years.
Hard time swallowing within 2 minutes, tongue felty tingly and swollen within 2 minutes, headache within 20 minutes, felt like a baseball bat to the throat within 1 hour, lost voice and pain talking within 2 hours. Still in pain 6 days post shot- PCP ordered steroid pack which I started taking on 8/21- still in pain. Took benedryl Thursday, 8/19- did not help
VAERS reporting as required by law, death occurred on 01/30/2022. Pfizer COVID 19 vaccines completed on 2/3/2021 and 2/25/2021.
Positve for COVID; Redness near the injection site; Warm near the injection site; Swollen ear the injection site; Itch near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness near the injection site), INJECTION SITE WARMTH (Warm near the injection site), INJECTION SITE SWELLING (Swollen ear the injection site), INJECTION SITE PRURITUS (Itch near the injection site) and COVID-19 (Positve for COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness near the injection site), INJECTION SITE WARMTH (Warm near the injection site), INJECTION SITE SWELLING (Swollen ear the injection site) and INJECTION SITE PRURITUS (Itch near the injection site). On 22-Jan-2021, the patient experienced COVID-19 (Positve for COVID). At the time of the report, INJECTION SITE ERYTHEMA (Redness near the injection site), INJECTION SITE WARMTH (Warm near the injection site), INJECTION SITE SWELLING (Swollen ear the injection site), INJECTION SITE PRURITUS (Itch near the injection site) and COVID-19 (Positve for COVID) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
This spontaneous report as received from a 60 years old female consumer reporting on herself with no pertinent medical history or drug reactions/allergies who on 14-JAN-2013 was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. On 15-JAN-2013, a day later, the patient noticed that she had a red rash that was spreading down her right arm. The patient sought medical attention by going to her doctor's office; but her doctor told her that he was not familiar with injection site reactions for ZOSTAVAX. The patient did not receive treatment. The outcome of the event was unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information is not expected.
Very low energy upon waking on morning after the vaccine. Lasted all day. Felt feverish but no fever. Slept  most of day until late afternoon when I finally took 2 aspirin. Injection site tenderness.
PRODUCT QUANTITY PACKAGING ISSUE; UNDERDOSE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced product quantity packaging issue, and underdose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product quantity packaging issue and underdose was not reported. This report was non-serious.
rashes; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history concomitant medications were not reported. The patient reported that she was had rashes after getting the first dose on an unspecified date. She inquired since the first vaccine shot that she has had, she was having like rashes if is it possible for that to happened. The outcome of the event was unknown.  The following information on the batch/lot number has been requested.
Dizziness from day of injection. 2 weeks later nausea, chest heaviness and left arm pain, numbness/hallow feeling. Feeling like fainting or passing out. Feels like falling at times.  Started 2 weeks ago and was sporadic. Constant since Sunday, 10/10/21. Another dr appointment scheduled 10/13/21.
Patient receive first dose of Moderna vaccine on March 1st. On March 8th she woke with itchy eyes and a few welts dispersed throughout her body. March 9th she visited her primary care physician with full body welts and was prescribed prednisone. March 10 she called the pharmacy to inform of the situation
Mix up between DTaP and Tdap.  Several dosages were administered.  Pharmacy manager had asked pharmacy buyer to get DTaP for the employee health clinic.  Buyer ordered DTaP just the way she was asked to.  DTaP was received by pharmacy technician and placed in the refrigerator.  Employee clinic ordered the vaccine, it was dispensed by the pharmacist and administered by the RN to over 80 employees.  Adverse events were minor as reported earlier (only 2 ADR with swelling and pain at the injection site).  No other cases were reported.
Patient received Pfizer-BioNTech COVID19 Vaccine on 01/08/2021 at 1426.  Given the patient's medical history, the patient was required to stay for observation for 30 minutes.  Within the first 15 minutes, the patient began to experiencing itching.  Initially, there was concern that she was reacting to the bandaid (history of latex allergy).  The bandaid was removed and staff confirmed the bandaid was LATEX FREE.  Per protocol, the patient was administered diphenhydramine 25 mg po x 1 dose.  After 15 minutes, the patient's itching continued and she started to develop a skin rash on her chest.  Diphenhydramine 25 mg po x 1 dose was repeated and the decision was made to take the patient to the Emergency Department in a wheelchair.  Documentation from the Emergency Department Provider:  40 y/o F who comes in from the covid vaccine clinic for a possible allergic reaction. Initially thought to be to latex but then we found out she was not given a bandaid with latex so we assume it is the vaccine. pt had a rash and scratchy throat and initialy felt improved with the benadryl, pepcid and steroids but after about 2 hours had recurrence of her sx. She was then given IM epi. She has now been observed for four more hours and is still feeling well. Will d/c to home with steroids and an epi pen and epi traning. Given return precautions and f/uw ith PCP. .
Breasfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breasfeeding) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced EXPOSURE VIA BREAST MILK (Breasfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Breasfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
This case was reported by a other health professional via call center representative and described the occurrence of herpes ophthalmic in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced herpes ophthalmic (serious criteria GSK medically significant). On an unknown date, the outcome of the herpes ophthalmic was unknown. It was unknown if the reporter considered the herpes ophthalmic to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient developed ocular herpes sometime after receiving the dose of SHINGRIX. The episode was resolved and then flared back up. The reporter consented to follow up. The healthcare professional requested to contact her to get additional information at later time.
I went to the urgent care because I had unusual bowel movements with mucus.  I was having multiple bowel movements with tiny feces and mucus and cramps.  The symptoms began in the morning, but I couldn?t go to urgent care until that afternoon and just had a consultation.  They told me to take Metamucil.  This was a Friday.  Over the weekend the same symptoms occurred but unable to go to see anyone.  I saw my regular doctor on October 11, 2022.  I had several episodes of unusual bowel symptoms since then.  My doctor and I discussed my issues.  She wasn?t sure what it was but sounded like it was irritable bowel syndrome.  The other symptoms in total from the vaccine were a sore arm for about four days.  I just felt tired after the vaccine.  As of today I am not in any pain and there is not activity at all.
her arm was sore and there was redness and slight swelling; her arm was sore and there was redness and slight swelling; her arm was sore and there was redness and slight swelling/ redness underneath injection site; This is a spontaneous report from a contactable 74-year-old female consumer reported for herself that she received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunization. The medical history and concomitant medications were not reported. On an unknown date, the patient experienced arm was sore and there was redness and slight swelling and she had some discomfort and redness underneath injection site that lasted a few days and first day it was bad but then as the days went on the swelling got better and eventually resolved by the fourth or fifth day. The outcome of the events was unknown whereas the event Vaccination site swelling resolved on an unknown date.   Information about Lot/batch number is requested
Information has been received from a Medical Assistant concerning a 54 year old male patient with gastrooesophageal reflux disease, diabetes, hypertension, hyperlipidaemia and allergic rhinitis and no drug reactions/allergies, who on 01-NOV-2010 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # 665925/0932Z). Concomitant therapy included PRILOSEC, metformin, glipizide, aspirin, CRESTOR, COREG and ASTEPRO. The same night of vaccination, the patient developed redness, swelling and heat at injection site. He also had a fever. The patient was diagnosed with cellulitis. The patient was treated with BACTRIM. At the time of the report, the patient was recovering. No laboratory diagnostics studies were performed. This is one of several reports from the same source. The reported is requesting a lot check. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Research Center and was released. Follow-up information has been received from a certified medical assistant who stated that the patient who on 01-NOV-2010, was vaccinated IM in the left arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 665925/0932Z). Approximately 8 hours later the patient experienced redness, stiffness, heat, swelling and pain at injection site. The patient returned to the physician's office on 03-NOV-2010 and was evaluated and treated for cellulitis with BACTRIM DS. It was also reported that on 19-NOV-2010 (also reported duration 5 days) the patient recovered. Cellulitis was reported to be an other important medical event. No further information is available.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Batch/Lot number: unknown), on 21Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history included: "myogenic ptosis" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Known allergies: Cat dander" (unspecified if ongoing); "Known allergies: Dog dander" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2022) Positive, notes: COVID 19 Treatment, diagnosed with covid 19 on 13Sep2022 and took paxlovid 13Sep2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, the reported events Vaccination Failure and Covid-19 cannot be excluded for the suspect drug BNT162b2 .
10/15/09 2am vomit one felt cold. 5am vomited once legs itchy felt cold. Went to work with chills and body aches. Continued with chills once home. Skin warmer than usual per wife. Went to bed early. 10/16/09 5 am chills and body aches 9 am temp 101.1-1st time recorded. c/o hot and cold TYLENOL taken this morning around 9 a.m. attempting to see PMD. Patient came to work and was sent home due to the fact that he claimed to have a temperature of 100.3 and 100.4 on 10/17/09 and 10/18/09. Also had vommited on 10/18/09 after dinner. Patient saw his PMD on 10/19/09 , had lab work, chest x-ray all results were normal per patient. Placed on Zpac. Returned to work on 10/23/09. Last fever per patient was on 10/21/09. He has been back to work since 10/23/09 and feels better now. Patient also mentioned that one of his children was ill with viral symptoms just around the time patient took the flu vaccine.
I began to be tired and fatigue the day after the vaccine. I had to take the day off work. I returned back to work on 7/16 for the entire day. Unfortunately I came home and felt tired so slept. That evening I went out with my family for dinner and noticed I couldn?t taste the food. Then in the morning I woke up with severe body aches. I struggled to get out of bed and move around as my body would cramp.  I was able to move somewhat and tried to shake it off. Then the Sunday 7/18 towards afternoon I began a fever and slight cough. I stayed home and ended up sleeping. I woke up for work Monday and about half way through work day my body started to crash. I began vomiting at work, my fever temp spiked dramatically and I had to make my way home immediately. I went and taken a shower and tried to lay down and keep upright. I eventually got fatigued and slept. When I woke the cough/fever and body aches were bad. I decided to check myself into urgent care. They tested me for covid and I was positive. They asked me to quarantine and I did but the next 5 days were the hardest days I?ve had probably ever.  The 5th day I decided to either go back to urgent care and ER as my condition was severe. I went back to  urgent care. The doctor said my o2 level was very low and I had lost 23 lbs since the vaccine. I asked him for something strong and he gave me steroids and a very strong Cough suppression which I?ve been taking and has brought down the symptoms. Ive worked in hospitals pre covid. I never get sick, had not even a fever or Temp and then I get the first dose phifzee and end up almost going into the ER and testing positive with covid.
Pt recvd vax 14FEB94 & on 26FEB94 exp serum sickness, rash, fever, malaise & myalgia & was hospitalized; pt was treated w/Floxin, Rocephin & Doxycycline;
Information has been received from a male with hypertension and oesophageal acid reflux who on 01-MAR-2007 was vaccinated SQ with Zostavax (Oka/Merck).  Concomitant therapy included LIPITOR, NEXIUM and AVALIDE.  On approximately 09-APR-2007 the patient's ride side of his mouth and tongue were full of ulcers.  His mouth started out by feeling strange and progressed from soreness to the ulcers.  As of 02-JUL-2007 the patient's ulcers were improving but his mouth was still extremely hot and burned all the time.  Medical attention was sought and unspecified blood work, infectious test and an AIDS test were performed (results not reported).  Additional information has been requested.
Received Pfizer COVID-19 vaccine on the afternoon of 1/21/2021 at 2:12 pm. Patient was monitored for 15 minutes at Center and went home. A few hours after going home the individual started to experience edema and itching of the skin at  his inner left eye. The individual treated himself at home with hydrocortisone cream, Benadryl and ice. The individuals symptoms improved later on that day.
25 y/o female with past medical history of Atopic Dermatitis, who presents with dizziness and nausea post vaccination. Patient states that this is her 2nd dose in the two-dose series. Patient denies reaction to the first vaccination. Patient denies sore throat, difficulty breathing, shortness of breath or rash/itch. Patient states that she is newly pregnant and has been experiencing nausea prior to coming for her 2nd vaccination. Patient was placed in the wheelchair and taken to the partitioned area with the NP and Paramedics. Patient was placed on the cot in Trendelenburg position. Patient vitals remained within normal limits (111/75 BP, 85 HR, 99% RA, 12 Resp) (112/74 BP, 69 HR, 99% RA, 12 Resp). Patient provided with water and a mint as requested. Patient was observed for 30 mins with resolution of symptoms. Patient was able to ambulate without difficulty. Patient was cleared to go home by the NP. Patient is taking and Uber home.
Initially just a sore hot arm. By the next day, 2/17, I was dizzy severe headache sweats, could not get out of bed without falling down. Could barely move I was so weak. Could not eat or drink. Sore throat. Bad stomach pains. Ate two pieces of toast and yogurt anyway and threw up. Had diarrhea. Took two Tylenol, five hours apart three times.Didn?t help. Kept falling asleep and waking up every hour in a sweat. Very bad headache and blurry vision.
This spontaneous report as received from the consumers mother refers to a male patient of unknown age. Medical history and drug reactions allergies were not reported. On an unspecified date in 2011, the patient was vaccinated with GARDASIL, first dose (lot, dose and route not reported). In July 2012, the patient was vaccinated with GARDASIL, second dose (lot, dose and route not reported). Concomitant medication was not reported. No adverse effects reported. Additional information has been requested.