chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient. On 19-OCT-2013 at 11:00, the patient was administered with M-M-R II (lot number H018184, expiry date 05-OCT-2014) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date M-M-R II was exposed approximately for 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17: 14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13:26 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7 degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Warmth at the site of injection in left arm 1 week after the vaccination; Swelling at the site of injection in left arm 1 week after the vaccination; tching at the site of injection in left arm 1 week after the vaccination; Redness at the site of injection in left arm 1 week after the vaccination; Pain at the site of injection in left arm 1 week after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmth at the site of injection in left arm 1 week after the vaccination), VACCINATION SITE SWELLING (Swelling at the site of injection in left arm 1 week after the vaccination), VACCINATION SITE PRURITUS (tching at the site of injection in left arm 1 week after the vaccination), VACCINATION SITE ERYTHEMA (Redness at the site of injection in left arm 1 week after the vaccination) and VACCINATION SITE PAIN (Pain at the site of injection in left arm 1 week after the vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warmth at the site of injection in left arm 1 week after the vaccination), VACCINATION SITE SWELLING (Swelling at the site of injection in left arm 1 week after the vaccination), VACCINATION SITE PRURITUS (tching at the site of injection in left arm 1 week after the vaccination), VACCINATION SITE ERYTHEMA (Redness at the site of injection in left arm 1 week after the vaccination) and VACCINATION SITE PAIN (Pain at the site of injection in left arm 1 week after the vaccination). At the time of the report, VACCINATION SITE WARMTH (Warmth at the site of injection in left arm 1 week after the vaccination), VACCINATION SITE SWELLING (Swelling at the site of injection in left arm 1 week after the vaccination), VACCINATION SITE PRURITUS (tching at the site of injection in left arm 1 week after the vaccination), VACCINATION SITE ERYTHEMA (Redness at the site of injection in left arm 1 week after the vaccination) and VACCINATION SITE PAIN (Pain at the site of injection in left arm 1 week after the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: TCR follow up. Pt declined to provide email and said is better.
Pt. received Hep A #2 at visit on 02-18-16. Developed fever (99 degrees-104.3 degrees max) and (Lt) leg limp on 03/02/16. No other s/s illness. TX = X-ray (Bi) Hip, AP Pelvic and (Lt) knee; hip U.S. (all normal). Labs - mildly elevated. To tx fever with OTC; recheck if s/s worsen or progress.
After 3-5 minutes of receiving the vaccine. patient indicated she was not feeling well. symptoms were dizziness and nauseous and she wanted to lay down and could not stand straight.  We checked blood pressure and it was  107/72 and no hives or swelling was noticed. patient did not feel swelling or itchiness or difficulty breathing. we laid the patient on the floor and put a cold pack on her forehead, her body was sweating and clammy, we called 911. EMS came in and they stated that they do not believe that she needs hospitalization and that they will monitor her for a while and then discharge her home. she was discharged from pharmacy care to the EMS  and the patient was walking with EMS with the help of her husband.
2 hours after vaccine I started to see blood in my urine (urine is bright red color).
2nd shot administered 4/21 and a couple of days later (4/23-4/24) I experienced headache, nausea, chills and feeling hot (but no fever) fatigue and vomiting. I could not eat much (basically soup). The vomiting went went away but the other symptoms lasted 2 days, then I was okay.  A week later (4/29-4/30) I experienced severe traveling pain. It was an immediate onset of  pain that started ~2:00PM with a headache, then it radiated to the back of my neck, then back of both of my shoulders, then my back, while pain extended from my shoulders down my arms (primarily my left arm) down to my fingertips, then down both my legs to my feet and toes. It was very severe pain and it was so sudden and intense. I took 15mg Meloxicam for the pain (1 every 2 hours, then about every 4 hours) for the rest of the day and throughout the evening. I experienced chills and I was very hot but my temperature was only 98.1.  The pain gradually went away and I have not experienced that level of pain since.  I could only think that this was a side affect of the vaccine. I reported it to my Primary Care Physician this morning during our scheduled visit and she encouraged me to report this to site. She acknowledges that it may not be related to the Moderna vaccine, but that it was important that it be reported in case other people experience the same thing and it will allow trending analysis to occur.
Arm pain in right shoulder after 24 hours with no improvement, has been > 1 month since pain onset.
Decline in kidney funtion.  Ultra sound to be complete on 10/7/2021
tested positive agaiin for Covid. Mild Covid syptoms; tested positive agaiin for Covid. Mild Covid syptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "Polymyalgia" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: Oct2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive agaiin for Covid. Mild Covid syptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive agaiin for Covid; (16Jul2022) positive, notes: tested positive agaiin for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from  06Jul2022 to 10 Jul2022 for the treatment of Covid- 19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dr. received his flu shot on 12/20/2022 in his R deltoid. Last evening he reports visible swelling to his bicep with pain 7/10. Cramping pain which radiates to shoulder & elbow and impacted his sleep. He has not applied heat/ice & has not taken any meds.
received vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050e21a) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Concomitant medication was not provided.
3 children were accidently given the adult COVID vaccine; 3 children were accidently given the adult COVID vaccine; The children have been pretty ill this week; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team.  A patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ACCIDENTAL OVERDOSE (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown" and all described as "3 kids were accidently given the adult COVID vaccine"; ILLNESS (non-serious), outcome "unknown", described as "The kids have been pretty ill this week".  Additional information: It was reported that 3 kids were accidently given the adult COVID vaccine. The kids have been pretty ill that week as a result. The reporter wanted to know if there might be some information available.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201150442 Same reporter/product/dose/different patients;
a little soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Cholesterol" (ongoing), notes: she takes a cholesterol pill; "High Blood pressure" (ongoing), notes: High blood pressure medication. Concomitant medication(s) included: WIXELA INHUB taken for chronic obstructive pulmonary disease. Vaccination history included: BNT162b2 (Dose 1, lot EN53190), administration date: 25Jan2021, when the patient was 76-year-old, for COVID-19 immunization, reaction(s): "a little soreness"; BNT162b2 (Dose 2, lot looks like EL9266), administration date: 15Feb2021, when the patient was 76-year-old, for COVID-19 immunization, reaction(s): "a little soreness". The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "a little soreness".  Additional information: Phone-in 3:26 pm from reporter (consumer/patient) in response to phone-out 10:16 am to clarify whether the statement, "initial shot part" that is reported in Initial (13Oct2022) is referring to the first dose of the Pfizer COVID-19 vaccine (Dose 1) or the primary series of vaccination (Dose 1 and Dose 2). Reporter stated that she was referring to Dose 1, Dose 2, Dose 3 and Dose 4 of the Pfizer COVID-19 Vaccine. Reporter stated that with Dose 1, Dose 2, Dose 3 and Dose 4, that she did not experience any adverse events, that she just experienced a little soreness when she initially received those 4 shots and added that it was nothing and the soreness went away right away and that she does not consider "a little soreness" an adverse event. Concomitant Medication was states she takes a cholesterol pill and as of recently she had to start a high blood pressure medication, it's not that high but they want to make sure.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hyperthyroidism, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 17-Aug-2020 and the estimated date of delivery was 24-May-2021. On 09-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 09-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported had history of full term , live child birth currently 2 yrs old.  No Treatment medications was provided by the reporter.
This spontaneous report refers to a 70 year old female patient who wished to remain anonymous. On 04-NOV-2013 the patient was vaccinated with ZOSTAVAX in the left arm for preventions of shingles. Dose, route, lot and expiry date were not reported. Concomitant medications were none. The patient received the vaccine and had tenderness in her arm. She was injected on the left arm and it was swollen and itchy. The outcome of events was unknown. Additional information has been requested.
Pfizer 4/13/21, 5/11/21, 10/7/21. Positive on 2/7/22
I had a sore arm for over six weeks to the point I could not lift my arm very much on the right side. I saw NP for it and was referred to PT, which I did for six to ten weeks along with massage to try and keep it from becoming frozen shoulder. I did not have this reaction to the first shot or the booster.
Affected heartbeat (the next morning).; Swollen throat--not too much; Difficulty breathing--not gasping for air,; Unable to sleep; Headache; Joint pain; Nausea; Muscle pain; Fever of 101.3; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Affected heartbeat (the next morning).), PHARYNGEAL SWELLING (Swollen throat--not too much), DYSPNOEA (Difficulty breathing--not gasping for air,), INSOMNIA (Unable to sleep) and HEADACHE (Headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (December 2020). Concurrent medical conditions included Lung scarring (Due to COVID-19 in December2020). Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), LATANOPROST, DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (BENADRYL ALLERGY & COLD) and DORZOLAMIDE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PHARYNGEAL SWELLING (Swollen throat--not too much), DYSPNOEA (Difficulty breathing--not gasping for air,), INSOMNIA (Unable to sleep), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), MYALGIA (Muscle pain), PYREXIA (Fever of 101.3) and CHILLS (Chills). On 28-Feb-2021, the patient experienced HEART RATE IRREGULAR (Affected heartbeat (the next morning).). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, HEART RATE IRREGULAR (Affected heartbeat (the next morning).), PHARYNGEAL SWELLING (Swollen throat--not too much), DYSPNOEA (Difficulty breathing--not gasping for air,), INSOMNIA (Unable to sleep), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), MYALGIA (Muscle pain), PYREXIA (Fever of 101.3) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 (High) Units not reported, Fever confirmed.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient was very warm, then cold. Slept all evening. Arm was red & warm. Patient said she had same reaction last year to flu shot.
Stomach rash, hive like rash on lower left stomach area. Has lasted at least the last 6 or so days, got slightly worse lately but hydrocortisone cream helps with the itch.
Left upper arm - Slight erythema w/some inner area,  1-2cm erythematous area no prox streaking.
EAR RINGING NOISE SINCE 4/5 2am , very stressful and disabling.  Requested for ENT appointment
pt recvd vax;hhives 18-24 hrs p/ 2nd in post exposure series;27jan94 tx w/ DPH;resolved in 25 mins;tx w/ DPH & prednisone prior to 4 & 5; no further rxns;
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8/10/02 pt Rt arm was swollen from shoulder to elbow. Rash noted. Grandmother c/o child itching. Pt  taken to hospital. Pt given Keflex and Beandryl. Child is better still slightly swollen.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable nurse (patient).  A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient is a nurse anesthetist that got Covid vaccine on 17Dec2020 and tested positive for COVID-19 after the vaccine on 26Dec2020. The patient was wondering if have seen this. Stated that she was signed up for the booster scheduled for 05Jan2021 and wanted to know if they had any information about taking this. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug bnt162b2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
after his 2nd dose of the vaccine the lump got even larger; after his 2nd dose of the vaccine the lump got even larger; states that after the 2nd dose, he had a second lump; This is a spontaneous report from a contactable consumer. This consumer (parent) reported for a 25-year-old male son (Patient).  A 25-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration, administered in left arm on 19Apr2021 15:30 (at the age of 25-years-old) as dose 2, single for COVID-19 immunisation. Reason for no lot number: of Pfizer COVID Vaccine: Other: Caller states Reporter has no lot numbers, expiry dates or NDC numbers to provide as her son is not there and he has his patient card for the Pfizer COVID vaccine. Medical history included gene mutation (they have a weird gene mutation called SCN5A). The patient concomitant medications were not reported. The patient has not had any vaccines since Dec2020 when his mother made him get a flu shot and has had no others prior to that for a year. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number was not reported) via an unspecified route of administration, administered in Arm left on 29Mar2021 11:45 as dose 1, single for COVID-19 immunisation and experienced lump on neck. No Investigation Assessment reported. The reporter stated she was calling about the Pfizer COVID vaccine and was calling regarding her 25-year-old son and he got the two different Pfizer COVID vaccine doses. Reporter stated after his second dose of the vaccine the lump on his neck got even larger and was probably the size of a large grape and has also gotten firmer. Reporter further stated that after the 2nd dose, patient had a second lump, and it was probably the size of like between a raisin or a small green olive. Reporter stated the second lump happened the same day as the 2nd dose of the Pfizer COVID Vaccine on 19Apr2021. Reporter wanted to know if that was normal or if it was something they need to be concerned about and at what point do they see the HCP. Reporter stated the patient has not yet had any treatment for the reported events. Adverse events did not require a visit to ER or MD office. Reporter seriousness for the events was reported as unspecified. The outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 62-year-old female patient who received ENGERIX B adult (batch number UNKNOWN, expiry date unknown). Co-suspect products included ENGERIX B adult. Previously administered products TWINRIX (dose 1). On an unknown date, the patient received the 2nd dose of ENGERIX B adult and the 3rd dose of ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult and ENGERIX B adult, the patient experienced wrong vaccine administered and underdose. On an unknown date, the outcome of the wrong vaccine administered and underdose were unknown. Additional information: a patient was started on TWINRIX series (received 1 dose) but completed her HepB portion with ENGERIX-B for the last 2 doses.
The patient stated that he needed his second vaccine and at first said the thought he first received the Pfizer injextion.  I spoke to him and told him we have all 3 vaccines but the only 2 vaccines that required 2 shots was the Pfizer and then Moderna.  I told him he needed to get the same vaccine for both and he then stated Moderna.  I asked him if her was sure and he said yes.  He didn't have his card upon the initial visit.  We vaccinated him with Moderna and when he returned with his card it indicated he received the Pfizer for the first vaccine.  We observed his for the 15 minutes without any adverse reactions.