chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I tested positive for COVID 19 via a home testing kit on 22May2022; I tested positive for COVID 19 via a home testing kit on 22May2022; Fever; Ache; cold symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient of unspecified age/gender received COVID-19 immunisation with the first dose of BNT162B2 (COMIRNATY, solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on an unspecified date; a second dose of BNT162B2 (COMIRNATY solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on an unspecified date; and a third (booster) dose of BNT162B2 (COMIRNATY, solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on 21Dec2021. There was no medical history or concomitant medications reported. The patient reported that he/she tested positive for COVID-19 via a home testing kit on 22May2022. The patient mentioned that he/she was certain that the caught in on an airline flight on 15May2022. The patient reported that the symptoms were minor and included fever and aches lasting approximately 12 hours, followed by cold symptoms that lasted three days. The patient reported that he maintained CDC guidelines on quarantining and masking. Treatment details, if any, were not reported. The outcome of the events Fever and Aches was recovered on an unspecified date in May2022 after approximately twelve hours. The outcome of the event cold symptoms was recovered on an unspecified date in May2022 after three days. The outcome of the events I tested positive for COVID 19 via a home testing kit on 22May2022 was unknown.   The information on the batch/lot number for [BNT162B2], has been requested and will be submitted if and when received.
Patient received a Moderna Booster (first two vaccines were Pfizer). Patient was in the observation area and approached the counter because she was feeling dizzy and lost her vision for 5-10 seconds which made her very upset. I met her in the vaccination room and asked her if she was having any difficulty breathing, she reported no. I asked if she had a reaction to her first two vaccines, she reported no. I asked if she had a history of anxiety or panic attack, she reported no. She stated that her vision was better but it was going black in and out. I told her I was going to contact the paramedics who would come and take her vitals, assess her situation and give a recommendation on how to proceed based on her vitals. By the time the paramedics arrived the patients vision was back but she was now complaining of headache (4/10 pain) and chills. The paramedics took her vitals and she was stable and they did not recommend transporting her to the hospital. Patient was released to go home with her Dad who came to pick her up.
Normal initial sweating  reported with the COVID19 vaccination shot but a sharp pain in my abdomenon the right side the following day.  Hoefully it will be better tomorrow.
Patient discovered down and unresponsive with immediate declaration of death.  Pronounced dead 4/6/2021 11:45 PM
Narrative: COVID infection following COVID vaccine series 01/22, Pfizer, dose #1 02/12, Pfizer, dose #2 09/30, Pfizer, dose #3 NON-FACILITY PHARM 08/23 COVID swab, result: not detected 09/04 pt cc: chills, cough, fatigue, headache, myalgias, rhinorrhea, sore throat exposure: unknown 09/08 COVID swab, result: detected 09/08 SARS-COV-2 Variant Sequencing result: pending
pt recv vax 5/5/99 mom called to school on morning of 5/6/99 because child c/o blurred vision, clammy, lt deltoid red & swollen;slept most of 5/6/99 w/fever & cont c/o blurred vision;
Had pneumonvax given on L deltoid area. Not painful during administration. Below shot area patient developed swelling and large indurated patch consistent with urticaria. No other systemic symptoms. No hard on forearm.   symptoms- treat with Benadryl and Zantac if not (hot/painful), Medrol dose pak
Upset stomach; Slight sore throat; This case was reported by a consumer via interactive digital media and described the occurrence of upset stomach in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2020, the patient received the 1st dose of Shingrix. On 16th September 2020, less than a day after receiving Shingrix, the patient experienced upset stomach and sore throat. On an unknown date, the outcome of the upset stomach and sore throat were unknown.   It was unknown if the reporter considered the upset stomach and sore throat to be related to Shingrix.  Additional details were provided as follows: The reporter who was a patient stated that Shingrix was received about 3 hours ago. The patient experienced upset stomach and slight sore throat. The patient drank iced coca cola and felt pretty good then. The reporter had also questioned if they should be concerned. The follow-up was not required.
This case was reported by a consumer via call center representative and described the occurrence of erythematous rash in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd April 2018, immediately after receiving SHINGRIX, the patient experienced erythematous rash. In April 2018, the outcome of the erythematous rash was recovered/resolved. It was unknown if the reporter considered the erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient did not have lot numbers or expiration dates. The patient experienced large rash that was super red about the diameter of a grapefruit after the first dose of the SHINGRIX series. The event lasted for 4 days. For tolerance effect after 2nd dose of SHINGRIX, refer linked case US2018GSK147866.
Got hives all over the legs and back during the night/every night new places develop on the body with hives/Got it on the face as well now; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Got hives all over the legs and back during the night/every night new places develop on the body with hives/Got it on the face as well now) 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 31-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced URTICARIA (Got hives all over the legs and back during the night/every night new places develop on the body with hives/Got it on the face as well now). The patient was treated with CETIRIZINE HYDROCHLORIDE (CETRIZINE) ongoing since an unknown date for Adverse event, at a dose of 10 milligram once a day. At the time of the report, URTICARIA (Got hives all over the legs and back during the night/every night new places develop on the body with hives/Got it on the face as well now) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was just at the start now with the hives.  No concomitant medication reported.   This case was linked to MOD-2022-462072 (Patient Link).
Facial swelling, warmth, and numbness affecting right side of face including around eye and inside ear; onset  was about 25-30 min after vaccination. Symptoms resolved within another 30 min after 50mg diphenhydramine
Patient received Moderna bivalent vaccine on 1/9/23.  Inadvertently, patient received another dose of the Pfizer bivalent vaccine on 1/25/23.  All of patients covid vaccines had been Pfizer.  He consented for the Pfizer Bivalent vaccine.  No ASE noted as of 1/26/23 at this time.
The patient complained of flu like symptoms; body aches and chilly feeling. The patient developed redness at the injection site in an 3 cm area. The redness, swelling and pain increased on 10/30/2001 with swelling to the elbow.
pt recvd vax & exp burning & swelling @ the inject site which required tx w/ice; w/in several hrs of vax sx subsided; The nurse then switched to a different lot# of vax & the sx did not recur; no further details were provided;
Within 15 minutes of recieving the vaccine my son couldn't even the leave the parking lot of the pediatrician's office, he was vomiting, dizzy, nauseas, reported feeling unusually cold, had the chills, had a headache with migraine floaters and described seeing blue and white balls (all of these are listed as adverse reactions in the Merck insert for the Varicella vaccine.) Beforehand  he was fine. He had to be monitored until after the doctor's office closed and was brought back inside.  We stayed until 6:15PM.
Next day on June 8, 1999 the pt developed symptoms of chickenpox (fever and lesions). On June 9, 1999 she had full-blown chickenpox with approximately 70 lesions. The reporter MD believed that there was no association between the patients sx and varicella.
This case was reported by a other health professional via sales rep and described the occurrence of swelling in a adult patient who received SHINGRIX for prophylaxis. On 15th January 2019, the patient received SHINGRIX (subcutaneous) .5 ml. In January 2019, less than a week after receiving SHINGRIX, the patient experienced swelling, erythema and rash. On 15th January 2019, the patient experienced intramuscular formulation administered by other route. The patient was treated with NOS BENADRYL. On an unknown date, the outcome of the swelling, erythema, rash and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the swelling, erythema and rash 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 SHINGRIX was administered via wrong route, given subcutaneously instead of intramuscularly, which led to inappropriate route of vaccination. On 17th January 2019, it was notified to office about the patient experiencing redness, swelling, and rash. The patient was told to take BENADRYL for rash. The reporter could not describe severity or quality of any of the events. The reporter stated that, she would call MSL back with additional information needed to complete report. The reporter did not have patient's chart at time of discussion and said she would call back with more information. The reporter did not agree to follow up from GSK. This case has been linked to the case US2019GSK009270, reported by same reporter.
The patient became very limp on 05/30/2000 hours after receiving the two vaccines. The patient stopped rolling over and lifting his head, which he had been doing. He now has hypotonia and delays in fine motor, gross motor and speech.
Painful swollen lump the size of a pea just above left collar bone (same side as vaccine shot in arm).
Received Moderna vaccine in R arm.  Approximately 2 days later, noted a quarter size nodule at injection site.  Warm to touch, reddened and raised.  A few days later, area of redness has spread, and a fine, slightly itchy rash developed around injection site.  A few days late, slightly raised red welts appeared approximately 4 inches from site, and encircling sight.  Welts were itchy.  Entire reaction remained for approximately 2 weeks after receiving initial injection, but now has cleared.  I felt fine otherwise.
Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves 72 years old female patient who was vaccinated with a 0.5 ml second dose of FLUZONE QUADRIVALENT (Batch number: UT6258MA, expiration date: 30-Jun-2019, route and site of administration was not reported) instead of FLUZONE HD on unknown date. The patients medical history and concomitant medications were not reported.It was an actual medication error due to wrong vaccine administered (patient received FLUZONE HIGH DOSE reports the lot number is for FLUZONE QUADRIVALENT). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Chest clear to auscultation oropharynx without edema. BP 119/94 mmHg, HR 82 BPM, 98% RA Around 10 mins after receiving vaccination, she reported sensation of lump in throat, chest tightness/dull pressure and hives on the back of her tongue, without facial/lip/tongue swelling, hoarseness, SOB, dysphagia or pruritic. Apart from the chest tightness, she reports similar reactions in the past to shellfish, corn, and iodine contrast, but resolved after receiving Benadryl 25 mg capsule with subsequent improvement in the lump sensation, but also reported the chest pressure was not going away. She and her husband were advised to go to the ED via EMS, but they declined and stated they would seek emergent evaluation if symptoms worsened or didn't improve fully/resolve, and husband said he is an EMT. They were again advised that we should call EMS and have her go to the ED, but they again declined
This spontaneous report was received from a registered nurse and refers to a 12 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-OCT-2016, the patient was vaccinated with an improperly stored PROQUAD lot # M022402 with expiration date of 01-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 8 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1705USA013888:
sore throat; nasal congestion; Tested Positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (nasal congestion) and COVID-19 (Tested Positive for COVID-19) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included CELECOXIB (CELEXA [CELECOXIB]), ATORVASTATIN CALCIUM (LIPITOR) and VITAMINS NOS (DAILY VITAMINS) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced COVID-19 (Tested Positive for COVID-19). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (nasal congestion). At the time of the report, OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (nasal congestion) and COVID-19 (Tested Positive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Racing heart 40 minutes after vaccination Large redness and itching where the vaccine was done on left arm  2.5 days after vaccination
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 20-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Pt was given Moderna vaccine on 4/29/21. Her appointment for her second dose was made for a Pfizer vaccine on 5/20/21, and it should have been for a Moderna vaccine on 5/27/21. She was given a Pfizer vaccine instead on 5/20/21. The error is that she received one dose of each vaccine 3 weeks apart, Moderna as first dose, Pfizer as second dose.
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Approximately in 2015 (over the last 90 days), the patients were vaccinated with ZOSTAVAX (unknown route and dose) for prevention of herpes zoster. Concomitant medications were not reported. The pharmacist stated that another pharmacist who works at another store had been receiving a "usually large" amount of complaints of injection site pain from patients who had ZOSTAVAX administered over the last 90 days. The outcome of the event was unknown. Causality assessment was not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to two patient of unknown age. On 28-AUG-2014 the patients were vaccinated expired doses of M-M-R II (lot # H014647, expiration date 03-AUG-2014) (dose, route unspecified). No symptoms reported. This is one of several reports received from same source.  Follow up information has been received. This spontaneous report refers to one of the two patients who were twins. On 21-AUG-2014 the patients were vaccinated with expired doses of M-M-R II (dose, route, therapy type unspecified). This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 16-SEP-2011, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 16-JAN-2014, the patient was treated by a physician for possible shingles outbreak. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Tested positive for COVID on rapid antigen test Treated with Paxlovid Symptoms:  cough, slight shortness of breath, runny nose, sneezing, headache, fatigue Symptoms lasted approximately 1.5 weeks
Burning upon injection. Numbness at injection site and entire left arm. 100.6 fever. Switch between chills and feverish and sweating. Intense pain under left breast radiating tru to left shoulder blade. 22 hours after injection, vomiting began and lasted the next 14 hours. Appetite is gone. 4th day post shot and all I've consumed is a banana and a yougurt. I has Covid 09/20 and the injection reaction was worse than Covid.
5 month old child was inadvertently administered vaccines. Child should have received Rotavirus, Hib, PREVNAR and Pdx (DTAP, Hep B, IPV). Child was also administered MMR, Varicella, Hep A in error. No adverse reaction reported to date.
Vaccine administered 2/6/2009 on february 19, 2009 rash covering trunk and face no fever otherwise normal . rash pruritic blanching raised papule on trunk face arms
Mom said pt's arm (L) was OK when he went to bed but when she woke up this AM about 1030, mom said pt's (L) arm was swollen. Swelling noted in (L) deltoid. Instructed mom to cont. giving pt Tylenol every 4-6 hr and today and tomorrow and apply cool cloths to (L) arm.
It was reported that a pt (1 of 4) received a Fluzone 2000-2001 vaccination, given IM on 10/19/2000. Reportedly the pt developed numbness and tingling in the arm and hand after the injection. No specifics were provided. Further information is being requested. From additional correspondence received on 03/16/2001, it was reported, mild, short duration relived with ice application.  Reportedly the pt recovered from this experience.
This case was reported by a consumer and described the occurrence of swelling arm in a female patient who received Meningococcal B vaccine for prophylaxis. In December 2018, the patient received Meningococcal B vaccine. In December 2018, less than a week after receiving Meningococcal B vaccine, the patient experienced swelling arm and pain in arm. The patient was treated with ethanol (Alcohol). On an unknown date, the outcome of the swelling arm and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the swelling arm and pain in arm to be related to Meningococcal B vaccine. Additional details were provided as follows: Age at vaccination was not reported. The patient was daughter of the reporter. 3 days ago the reporting, the patient received the Meningococcal B shot. The patient arm was swollen and want to know that what should be done. The reporter put alcohol on the patient's arm, but still the arm was swollen and hurting.