chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.; No adverse event; Two doses were administered on 05-JUN-2023 after the excursion happened; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.), POOR QUALITY PRODUCT ADMINISTERED (Two doses were administered on 05-JUN-2023 after the excursion happened) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Two doses were administered on 05-JUN-2023 after the excursion happened). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.), POOR QUALITY PRODUCT ADMINISTERED (Two doses were administered on 05-JUN-2023 after the excursion happened) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.) and POOR QUALITY PRODUCT ADMINISTERED (Two doses were administered on 05-JUN-2023 after the excursion happened).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Concomitant medication details not reported by the reporter. Maximum temperature reached was 57A°F. This was the first and only excursion. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727790 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727790:patient 1 of 2
severe h/a, t101-102, swollen deltoid extremely tender arm, n/v w/temp elevated, swollen axillary lymph nodes;
Patient did not receive full second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient did not receive full second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient did not receive full second dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient did not receive full second dose) had resolved. Not Provided      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.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Information has been received from a physician concerning 5 females (age not reported) who on unspecified dates was vaccinated with a dose of Gardasil (lot# unknown). On unspecified dates the patients fainted. The patients all recovered within half an hour. No further information was provided. Additional information has been requested.
Reports rash approx 10 days post vax; rash red, pimple-like, on back of neck, head, in hair, a few on arms, very itchy; Also reports cold-like sx 3-7 days following immun, congestion-nasal, ear plugged, feeling of congestion;
fever, chills, fatigue, aches - 3/10/21 itchiness & rash over both arms - 3/14/21 evening
pt describes getting pimply rash all over that itched; pt had a sl h/a; pt basically ignored the sx & was well the next day;
Patient blacked out from syncope or seizure falling off exam table and breaking front teeth, lacerations to tongue, and inside mouth. Cuts and bumps to forehead, under nose and neck.
"NO significant PMH. No Allergies. S/p COVID Infection Oct 2020 - not hospitalized. NO Current medications. 3hrs post vaccination, pt went to the ED c/o dizziness, nausea, rapid HR, chest pain.  Pt was administered epi in the ED, was observed overnight, then discharged home.  The reaction was severe enough to warrant avoiding future doses of Pfizer.  Pt opted to get Janssen to complete the series."
Information has been received from a consumer concerning her 16 year old granddaughter who 1 and 1/2 years ago, was vaccinated with a series of GARDASIL.  Last month, the patient's Pap test was abnormal.  It was not reported whether the patient sought medical attention.  No further information is available.
No additional AEs or PQC reported; expired dose of MMR II was administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, and drug reactions or allergies were not reported.  On 02-JUN-2022, an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, was administered, lot #T018635 with expiration date: 29-MAY-2022, administered subcutaneously for prophylaxis (strength was not provided). No other information provided. No additional adverse events (AEs) or product quality complaint (PQC) reported.
Rash on torso; This spontaneous case was reported by a health care professional and describes the occurrence of RASH (Rash on torso) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced RASH (Rash on torso). The patient was treated with STEROIDS at an unspecified dose and frequency. At the time of the report, RASH (Rash on torso) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included IV Steroids for three days. No concomitant medications reported by investigator   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up received including No New Information.
Caller received the first Moderna shot on 03Jan2023; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Caller received the first Moderna shot on 03Jan2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.  On 03-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Caller received the first Moderna shot on 03Jan2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Caller received the first Moderna shot on 03Jan2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Caller received the first Moderna shot on 03Jan2023).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  No treatment medications were reported.  Reporter did not allow further contact
Developed a lump at site of injection left thigh no fever. lump is tender. She has 4 erythematous papules over the site of the lump.
Injection site reaction at the site characterized by more redness and swelling than usual. Concomitant therapy included revacort. This is 1 of 2 pts from this facility who experienced event following receipt of vax.
Headache, Myalgia, chills, injection site pain Narrative:  Other Relevant History:
Patient reported a rash on 4-29-21,  that appeared a few days after the vaccine and stayed for 2 weeks, growing outward with an itchy border.  I observed the rash which took up a large oval area on the arm.  Patient was not overly concerned, but wanted to know if it was serious.  I said that others had reported rashes, but that was one of the largest I had seen.  I directed her to Benadryl 2% topical for itching and told her to contact her PCP if it got worse.  I let her know that I would report it.  I reported it to our QRE reporting  at Publix immediately, and gave the patient a VAERS flyer.
Hives appeared on left upper arm  from 9/14-9/11/2020. Occasional hives show on arm 9/12 - to current date.  On 9/23/20, hives appeared on both legs above ankle.  Each incident was treated with an ice pack. Took 1 antihistamine capsule on 9/13/20. On 9/23/2020, took 1 antihistamine tablet.
no interest in work; Hypersensitive; No appetite; Put me in bed; Passed out, thought I was gone; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out, thought I was gone) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included DEXTROAMPHETAMINE [DEXAMFETAMINE], CLONAZEPAM (CLONAPIN), TEMAZEPAM and OMEPRAZOLE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LOSS OF CONSCIOUSNESS (Passed out, thought I was gone) (seriousness criterion medically significant). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (no interest in work), HYPERSENSITIVITY (Hypersensitive), DECREASED APPETITE (No appetite) and BEDRIDDEN (Put me in bed). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at a dose of UNK dosage form. On 02-Apr-2021 at 3:15 AM, LOSS OF CONSCIOUSNESS (Passed out, thought I was gone) had resolved. At the time of the report, IMPAIRED WORK ABILITY (no interest in work), HYPERSENSITIVITY (Hypersensitive), DECREASED APPETITE (No appetite) and BEDRIDDEN (Put me in bed) outcome was unknown.            It was reported that after the 2nd dose, within 75 min, the patient passed out after going home until 3:15AM the next morning (02Apr2021). The patient reported that the nurse at the vaccinating facility, after checking with the Doctor gave the 2nd dose in spite of the patient's concern (he was feeling sick on that day) if he needs to wait for the 2nd shot. The patient stated he made a terrible mistake getting the 2nd shot while still sick from the 1st shot. He is going for lab tests the next Monday (14 Jun 2021).              Other treatment information include more amount water.  company comment:Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-218564 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Very severe fever blisters that have been continuous since the shot. My son also had the same reaction when he got his H1N1 vaccine. He has had continuous severe fever blisters as well.
Pt states that her arm hurts a lot. It is bruised, red and bumpy at the site of vaccine.
Severe pain, redness, swelling (soft-ball size) Numbness left-side of body (persistent in left arm) Swollen throat  Fever (101 max- lowered by tylenol) Malaise
Information has been received from a 63 year old female consumer with a history of hives who on 12-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck). In approximately July 2007 "a month after receiving vaccine", the patient experienced itching in her right arm. The consumer reported that itching started 2 inches from wrist and is 3 inches from the injection site. The consumer sought unspecified medical attention. The consumer reported that she had been rubbing hydrocortisone to help relieve the itching. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. 12/21/2007 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a 63 year old female with osteopenia, hyperglycemia, hyperlipidaemia, hypertension and a history of hives who on 12-JUN-2007 at 15:30 PM was vaccinated with a first dose of ZOSTAVAX (Oka/Merck) (Lot # 656395/0290U). There was no illness at the time of vaccination. In approximately July 2007 "a month after receiving vaccine", the patient experienced itching in her right arm. The consumer reported that itching started 2 inches from wrist and is 3 inches from the injection site. The consumer sought unspecified medical attention. The consumer reported that she had been rubbing hydrocortisone to help relieve the itching. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been received from the physician who stated that the patient developed itchy rash on right arm starting at injection site. The patient applied CORTAID. The patient recovered after 6 to 8 weeks. No further information is expected.
Patient presented with an itchy rash on chest and shoulders about 2 weeks post vaccinations (booster dose). The skin at the rash appears raised. Rash has traveled access his body affecting his ankles, calves, neck, forearms, buttocks, shoulders and chest. The rash has not subsided to date. Antihistamines temporarily alleviate itching.
Pt recv vax on 5/26/98; on the same dy pt exp itching, warmth, &swelling at site to elbow. Pt tx=Benadryl.  As of 7/17/98 pt imp.
Starting the night of the vaccine 3/23/21, I had fatigue, fever, body aches, chills, and migraine every night for 25+ days. Developed Covid Arm 1 week later on 3/30/21.  Note: I had Shingles shot 3 weeks prior on 3/1/21. I was advised to wait 2 weeks to get Covid shot  and I waited 3 weeks. I think the vaccines were too close together.
Headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache on 08Feb2021. It was reported that, patient took vaccine on Saturday and started having a headache yesterday and still had it. Patient wanted to know if there was anything for her to be concerned about. The outcome of the event was not recovered.  Information about Lot/Batch number is requested.  Follow-up attempts are completed. No further information is expected.
Pt developed a red rash/reaction after getting her MENVEO vaccine. Site was the Lt upper arm, area was red, swollen, patient said it itches and burns.
48 hrs /p immun. mother noted excessive irritability, high pitched cry, difficult to settle, afebrile
Arm was more sore right now than in her first shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was more sore right now than in her first shot".  Additional information: Question: Caller had the second shot of the Pfizer COVID-19 vaccine yesterday and she wanted to know why she is reacting differently than when she had her first shot. Caller said her arm was more sore right now than in her first shot. Caller disconnected while I was asking for a call-back number. I was unable to ask first and last name due to the disconnect.   No follow-up attempts are possible. No further information is expected.
Patient vaccinated at 1215. Reaction began at 1250.  Pt was told she would be observed for 30 minutes due to previous history of a reaction to the typhoid vaccine.  After 30 minute observation patient stated she was light headed, dizzy, warm, and nauseous.  Nausea subsided at 1325. Stated she was still dizzy at 1335 and stated her throat started to feel scratchy and difficult to swallow.  Rapid Response called and patient evaluated. Patient transported to ED for further evaluation.
chills, followed by redness, pain, warmth, swelling of injection site. Self-treating w/ice, ibuprofen
Fever; This is a spontaneous report from a non-contactable consumer (patient) by a Pfizer sponsored program COVAX US Support.    A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 30Jul2021 (Batch/Lot number was not reported) as single dose, for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced fever in 2021; patient wondering how long it will take before she can take Tylenol.  The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND) 4/20/2023 DIASTOLIC HEART FAILURE, UNSPECIFIED ACUITY
Caller's husband experienced arm swelling after the vaccine.; This is a spontaneous report from a Pfizer-sponsored program via contactable consumer (patient wife). A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot Number and expiry date was unknown), via an unspecified route administration on an unspecified date as a single dose COVID-19 immunisation. Medical history and concomitant drugs were not reported. On an unspecified date, patient experienced arm swelling after the vaccine. The outcome of the event was unknown.  Information about lot and batch number was requested.  Follow-up attempts are completed. No further information is expected.
Skin breaking out; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Skin breaking out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced RASH (Skin breaking out). At the time of the report, RASH (Skin breaking out) was resolving.            No concomitant medication information was reported.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
After about 8 hours my left side of my face began twitching and my left ear hurt in and behind it. Happened again the morning. Went away later in the morning. Next day, I had pain on both of my ears and they felt full. Now, I have tinnitus in both of my ears.
Left leg swelling, redness, warm to the touch, diagnosis of edema and thrombophlebitis
Started to having pounding heart and rapid heart rate around 8/9p following 2nd dose of Moderna. Continued for 3+ hours before falling asleep (took ibuprofen and Unisom HCI).  Also had moderate lump/swelling at injection site and pain.
Approx. 10 minutes after receiving the vaccine, patient started having SOB and chest tightness. Patient has a h/o asthma when she was a child. Patient said that it felt the same as when she was a little girl when she was having an asthma attack. Dr.  was brought into the room to assess the patient. Patient was given 2 puffs of a VentolinHFA with improvement.
1AUG95 that PM arm was swelling; next day arm sore; p/soreness started going away, 4AUG95 arm started itching & redness started spreading; never ran fever; hot to touch; 4cm knot noted @ inj site; firm to touch
No adverse event noted as of 07/09/2015.  HPV vaccine administered in error, was supposed to get PCV13.