chrisvoncsefalvay/vaers-outcomes huggingface dataset:
missed dose; This spontaneous case was reported by an other and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (Scheduled knee surgery due to bad previous surgery.) since 2018.    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 PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment information was reported.
2/14/2023 I had a constant cough. I took an at home COVID test which was negative. I called my doctor, and he prescribed promethazine syrup for my cough. I took another at home COVID test on 2/15/23 and it was positive. I called your doctor back and he prescribed PAXLOVID. I began taking the PAXLOVID that day. Eventually the cough subsided. This was a very mild case of COVID. The only symptom I had was a consistent cough.
Stored beyond use date. Moderna analysis requested. Full vaccine efficacy not shown. Recommended that patient receive an additional vaccine.
1 week after ProQuad administration, patient developed erythematous raised area at injection site and several vesicles on trunk.
Got GB, permanently crippled; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Got GB, permanently crippled) (serious criteria disability and GSK medically significant). The outcome of the guillain barre syndrome was not reported.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.   It was unknown if the company considered the guillain barre syndrome to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter asked that were you going to get the shingles shot after your shingles healed. The reporter had shingles right now and was considering the vaccine since this new one was more successful at preventing it.  The reporter was concerned about guillian barre from it though.  The reporter knew patient who got GB (guillian barre) after shingles shot and were permanently crippled now. The case had been linked to US2023AMR040477, reported by the same reporter, for a different patient. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR040477:Same reporter
COVID-19 positive; Influenza B positive; dry cough; congestion; tiredness; "major" cold symptoms; bedridden; warmth at injection site; tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warmth at injection site), NASOPHARYNGITIS ("major" cold symptoms), COVID-19 (COVID-19 positive), INFLUENZA (Influenza B positive) and COUGH (dry cough) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ADALIMUMAB (HUMIRA) and METHOTREXATE for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced INJECTION SITE WARMTH (warmth at injection site) and INJECTION SITE PAIN (tenderness at injection site). On 20-Feb-2021, the patient experienced NASOPHARYNGITIS ("major" cold symptoms) and BEDRIDDEN (bedridden). On 22-Feb-2021, the patient experienced COVID-19 (COVID-19 positive), INFLUENZA (Influenza B positive), COUGH (dry cough), NASAL CONGESTION (congestion) and FATIGUE (tiredness). The patient was treated with OSELTAMIVIR PHOSPHATE (TAMIFLU) for Adverse event, at a dose of UNK dosage form. On 22-Feb-2021, BEDRIDDEN (bedridden) had resolved. At the time of the report, INJECTION SITE WARMTH (warmth at injection site), NASOPHARYNGITIS ("major" cold symptoms), COVID-19 (COVID-19 positive), INFLUENZA (Influenza B positive), COUGH (dry cough), NASAL CONGESTION (congestion), FATIGUE (tiredness) and INJECTION SITE PAIN (tenderness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, COVID-19: Positive. On 22-Feb-2021, Influenza B virus test: Positive. On 22-Feb-2021, Oxygen saturation: 96-97 percent normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Administered booster dose of Moderna (blue top).  Person should have received Moderna Bivalent booster (blue top).  No adverse event occurred.
Pt died in hospital on 3/28/22. Pt was admitted with pneumonia/respiratory failure, pneumothorax and sepsis. She was not able to wean from vent, required pressors for hypotension and became unresponsive. Pt condition was futile and family made patient comfort care. She died 2 hours later.
Chronic spontaneous urticaria - hives all over my body in splotches that go away then reappear then disappear and reappear - hasn?t stopped
On 12/18/21 woke up with no voice that resulted 12/19/21.
High fever  102F - 103.4 F for three days following vaccine. Muscle pain, headaches for 5 days following shot. Lymphadenopathy for a week after shot administered.
Vaccine Administration Error - Pain received whole bottle of Grey Top Pfizer (6 doses; 1.8mL) instead of 1 dose (0.3mL).  Nursing management and ordering provider were notified.  Pt was called as soon as error was realized (about 3 1/2 hours later).  Pt was informed of situation, and reported she 'felt fine'.  ED  precautions were provided, and a f/u appt was scheduled for the next day. Also called Pfizer to report incident Follow up call to pt made at the end of the day as well; pt reports she still felt OK.  Pt spoke w/ provider following day, on 5/03/22.  Labs were ordered, ED precautions again provided.
Caller c/o headaches & dizziness since receiving the vaccine on 3/08/2021. Spoke with PCP who prescribed her meclizine, however she is still symptomatic.Spoke with caller who states that she is feeling much better, symptoms resolved as of yesterday.
This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age ethnicity and gender received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date a year before this report (in 2015) for immunisation. The patient medical history was and concomitant medications were not reported.   On an unspecified date the patient experienced there was a lot of bleeding after the injection The consumer was concerned that perhaps that injection was given into a vein by mistake rather than into the muscle. The outcome was unknown.
he was in bed for a day after all 3 COVID-19 vaccines; her son felt like his body was on fire; thousand needles sticking in him; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 44-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single, manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (dose 2, single, manufacturer unknown), for Covid-19 immunisation. The following information was reported: BEDRIDDEN (non-serious), outcome "unknown", described as "he was in bed for a day after all 3 COVID-19 vaccines"; FEELING HOT (non-serious), outcome "unknown", described as "her son felt like his body was on fire"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "thousand needles sticking in him".  Additional information:She states after her son's COVID vaccine, her son felt like his body was on fire and a thousand needles sticking in him. Caller states her son is 44-year-old and he was in bed for a day after all 3 COVID-19 vaccines. Caller states her son lives in withheld and she is in withheld and her husband won't take time with doing the report. Caller declined to complete report on her son and husband at this time. Full details unable to be obtained. Caller asks if Pfizer Drug Safety can help her or can she be transferred so she can find out if she can stop taking Paxlovid or should she continue taking Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient developed itching approximately one hour after receiving the flu vaccine at the fire house. He took some Benadryl. Approximately 12 hours later the sx recurred and were accompanied by some hives on the upper left arm.  He does not know which flu vaccine he received.
Pain, redness worse over 2 days extending 10 x 20 cm around injection site with right deltoid pain.
MODERNA COVID VACCINE DOSE #3 GIVEN 11/3/21, LOT #077C21B; Pt admitted to hospital from home; had a positive COVID test on 9/1/22; checked for COVID in hospital and was positive for COVID; dx with COVID, multifocal pneumonia, severe sepsis; pt passed away in the hospital
Vaccine may have been involved in a temperature excursion and it is unknown if it was a viable dose.  No adverse reactions noted in patient.
Kinrix vaccine was involved in a temperature excursion, not deemed viable by manufacturer and vaccine will need to be repeated.
Admitted with chest pain and elevated troponin. Cath lab for PCI that showed no vessel disease and impella insertion. Severe myocarditis with new severe cardiomyopathy (ejection fraction < 20 %). On mechanical respirator in cardiogenic shock with impella device on high dose norepinephrine, epinephrine, and vasopressin.
muscle spasms, chills Narrative: Wife reported that on 2/1/2021 patient had a fever of 100.3 with the following associated symptoms, tiredness, chills, muscle pains, uncontrollable shaking, increased confusion. Fever was treated with acetaminophen 650mg once and patient slept On2/2/2021, no ADEs reported.
exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number 5AR2D, expiry date 31-DEC-2025) for prophylaxis.   In JUN-2023, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023). The outcome of the incorrect storage of drug 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 Information: GSK receipt date: 3-AUG-2023 Nurse reported Bexsero vaccines was exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023.  Reporter did not have specific date of administration for each patient.  At the time of reporting, the dose has not been repeated. The Vaccine Administration Facility is the same as Primary Reporter. Consented to follow up. This is 1 of the 4 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023105930:same reporter US-GSK-US2023105935:same reporter US-GSK-US2023105936:same reporter
accidentally was given PROQUAD instead of the Varicella and MMR 11; for varicella virus vaccine live (oka/merck)(manufacturer unknown) vaccine but she accidentally was given measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S021619, expiry date: 09-JAN-2021; dose and route were not; accidentally was given PROQUAD instead of the Varicella and MMR 11; This spontaneous report was received from a physician concerning 14 years old female patient. No information regarding her concurrent condition, medical history or concomitant therapy was reported.      On 06-OCT-2020, the patient came in for her first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and also for varicella virus vaccine live (oka/merck)(manufacturer unknown) vaccine but she accidentally was given measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S021619, expiry date: 09-JAN-2021; dose and route were not reported) instead of the varicella virus vaccine live (oka/merck)(manufacturer unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route and lot# were not reported) (product administered to patient of inappropriate age, inappropriate schedule of product administration and wrong product administered). The patient was observed for five minutes after the vaccines were administered and she then said she felt fine and left. She was not given a separate varicella virus vaccine live (oka/merck)( manufacturer unknown). The accidental measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) administration was discovered after the patient had gone home. As of 06-OCT-2020, the patient was fine after receiving both products. The vials were discarded.
First dose was administered on 08-Jul-22 and Second dose was administered on 13-Jul-22; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 08-Jul-22 and Second dose was administered on 13-Jul-22) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Jul-2022 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .2 milliliter. On 13-Jul-2022 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 08-Jul-22 and Second dose was administered on 13-Jul-22). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 08-Jul-22 and Second dose was administered on 13-Jul-22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was not diagnosed or tested positive with Covid-19. No concomitant medications were reported. No treatment medications were reported. No adverse event were at that time.   This case was linked to MOD-2022-609975 (Patient Link).
Moderna COVID-19 Vaccine EUA Ache in upper half of arm receiving the shot, especially when using it and its muscles
Complete loss of hearing in right ear; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via unspecified route of administration on an unspecified date (at the age of 63-year-old) in the hospital as single dose for COVID-19 immunisation. Patient had no relevant medical history, concurrent conditions or any known allergies. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since, the vaccination patient has not been the patient been tested for COVID-19. Patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. On 04May2021, at 10:00, patient experienced complete loss of hearing in right ear and visited doctor or other healthcare professional office/clinic visit. Reporter considered the events as non-serious. Therapeutic measures in response to the event included treatment with steroid injections in ear and oral steroids. Outcome of the event was recovered with lasting effects (resolved with sequalae) on an unspecified date in 2021.  Information on the lot/batch number has been requested.
30-35mm swelling of injection site, (left deltoid upper arm), warm to touch, darkened color, itching Treatment:  Ice, Ibuprofen
Fainting - true full syncope on day 5 after FLUBLOK. Had 3 day myalgia, fever prodrome. Low WBC in ER.
her blood pressure also dropped; broke out in sweat; real hot flush again; the room turned a certain color, yellow, she was pale and white, and she could tell that she was going to pass out; the room turned a certain color, yellow, she was pale and white, and she could tell that she was going to pass out; she was pale and white; This is a spontaneous report from a contactable nurse (patient's mother). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; dose 1) via an unspecified route of administration on an unspecified date "3 weeks ago" as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Fifteen minutes after the vaccination, the patient "broke out in sweat," sat down on a table where she laid her head, and felt better after drinking "coke." Two and a half hours later, the patient felt a real hot flush again, the room turned a certain color, yellow, she was pale and white, and she could tell that she was going to pass out. The patient's blood pressure also dropped. The patient was placed in a ventilated room on an inclined chair for an hour. The patient's mother wanted to know if the patient could receive the second dose of the vaccine given her reaction to the first dose. The outcomes of broke out in sweat, hot flush, the room turned a certain color, she was pale and white, she could tell that she was going to pass out, and blood pressure also dropped were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Starting on 1-28-2022, I lost hearing in my right ear, and I felt as the ear was clogged with ringing and dizziness. I saw Dr. a couple of days later. He performed a Audiology Test and I was diagnosed with Acute Sensorial Hearing Loss. He gave me a course of steroids and the condition started to improve. I saw him again 1 week later and he repeated the test and said the hearing had returned to normal. I have no other follow up with him unless it comes back.
felt like they had stuck Covid in him; head pain; pain all over body; diarrhea; nose stopped up; nose running; sick; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 15Feb2021 (Lot number: EL3249) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 27Mar2020, stop date: 20Apr2020, notes: he had been in the hospital for Covid prior to the first dose. The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 15Feb2021, outcome "unknown", described as "felt like they had stuck Covid in him"; HEADACHE (medically significant) with onset 15Feb2021, outcome "recovered" (Feb2021), described as "head pain"; PAIN (non-serious) with onset 15Feb2021, outcome "recovered" (Feb2021), described as "pain all over body"; DIARRHOEA (non-serious) with onset 15Feb2021, outcome "recovered" (Feb2021), described as "diarrhea"; NASAL CONGESTION (non-serious) with onset 15Feb2021, outcome "recovered" (19Feb2021), described as "nose stopped up"; RHINORRHOEA (non-serious) with onset 15Feb2021, outcome "recovered" (Feb2021), described as "nose running"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore throat"; ILLNESS (non-serious) with onset 15Feb2021, outcome "unknown", described as "sick". The events "pain all over body", "diarrhea", "nose stopped up" and "nose running" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of headache, pain, nasal congestion, rhinorrhoea. He had on Covid 27Mar2020 and was cleared on 20Apr2020 prior to the shot. He stated that he knew what Covid felt like. When he got the shot on 15Feb2021 that he immediately got sick. He was well before with no problems, no symptoms. He was stated that the minute he got the shot that his body reacted really bad, and it took 4 days to recovered and he got back to his old self. He was recovered in 6-7 days from his head pain completely. Later clarified that he was not admitted to the hospital but in the emergency room on 16Feb2021 for 6 hours. He received antibiotics and was recovered from that pain all over his body from the first dose 5 days later completely. He recovered completely from diarrhoea from first dose in 3-4 days and was also recovered completely from nose stopped up from first dose in four days and his nose running from the first dose took about four days to recover completely. He recovered completely from real bad headache from the second dose in about three days. The fever from the second dose lasted for about two days and he recovered completely. He took Aleve for the fever about two days to recover completely from chills from second dose. He recovered completely from real bad body aches on third day.   Follow-up attempts are completed. No further information is expected.
SkinRash & Rash  Narrative:  Received second dose of COVID-19 2/9/2021 and within 24 hours developed swelling, pain, and rash at injection site. Rash has spread and right  deltoid area indurated and painful. Rash 15 cm x 11 cm macular, pruritic and  painful. This is similar reaction that employee had with first vaccination.  Other Relevant History:
Information has been received from a registered nurse concerning a 42 (also reported as 32) year old female patient "with a history of poor health" on 25-OCT-2007 was vaccinated IM into the right deltoid, into her right arm with a first 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot# 657038/0860U). Concomitant therapy given into left arm included a first dose of FLUZONE. Other concomitant therapy included PROZAC, WELLBUTRIN XL "300," ("TRAZADONE") "100," TOPMAX "25" AND ZOVIRAX 400 mg. It was reported that initially there was no reaction. On 25-OCT-2007, 12 hours post vaccination, the patient developed pain, expanding redness consistent with right shoulder cellulitis. The patient was treated for 7 days with dicloxacillin and doxycycline. The nurse did not feel that this was an inflammatory reaction. At the time of this report, the patient was recovering. No product quality complaint was involved. Right shoulder cellulitis was considered to be another important medical event. This is an amended report. Concomitant therapy FLUZONE is not a suspect medication. Additional information has been requested.
My shoulder was swollen about and 3/4 inch out and 3 inches in diameter.  It itched like crazy and was extremely sore.  The swelling went down after a day but was still sore 3 days afterward.
WITHIN 15 MINUTES OF RECEIVING VACCINE PT COMPLAINED OF SEVERE LOWER BACK PAIN.