chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a female consumer regarding herself. Patient's historical condition included herpes virus. Patient's drug reactions/allergies included penicillin-developed a rash. Approximately in March 2014 (also reported as "last week") the patient was vaccinated with ZOSTAVAX, subcutaneous. Approximately in March 2014, the patient reported that "next day" a "2 inch line that was a 1/2 inch thick" developed at the injection site as well as itchiness, warm to touch and a "dark pink" appearance at the injection site. On unknown date, the patient received treatment for the adverse event and she was informed by the pharmacist to apply BENADRYL cream. No bad diagnostics studies were performed. The outcome of injection site warm to touch, "dark pink" appearance at the injection site, injection site as well as itchiness and "2 inch line that was a 1/2 inch thick" developed at the injection site was reported as not recovered/not resolved. This is one of two reports from the same source. Additional information has been requested.
Four months after getting vaccinated, I got a breakthrough covid illness. I had a horrible headache and really bad body aches and I was fatigued. Also had some congestion and runny nose. Fatigue lasted two weeks.
Flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms". Additional Information: Reporter was unwilling to complete the report. Hence, Limited information was available over the call.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Concomitant products included VITAMIN D NOS, CALCIUM and VALSARTAN for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DIARRHOEA (diarrhea), ASTHENIA (weakness), TREMOR (shaking), HEADACHE (headache), MYALGIA (muscle aches) and NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), ASTHENIA (weakness), TREMOR (shaking), HEADACHE (headache), MYALGIA (muscle aches) and NAUSEA (nausea) outcome was unknown.        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.   This case was linked to MOD21-022057 (Patient Link).
This spontaneous report as received from Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Since 17-OCT-2014 the patients were vaccinated with an improperly stored dose of VAQTA (strength, route of administration, dose and lot # were not reported). The vaccine was exposed to a supported temperature excursion on 17-OCT-2014. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Approx 10 hrs after shot, was nauseous, very dizzy.  When I stood up to go to bathroom, I passed out, then I got up to go to kitchen, passed out again.  Sweat then chills.   Went to bed.
passed out; woke up the next day, caller said she did not remember anything of what happened; hallo feeling in the top of my head/funny feeling; Ended up in the floor/ fall down on the floor and her roommate found her and put her into bed; like a short neckless, red round in the top right of my head, that symptom lasted the whole; Chills; sore left arm for 2 or 3 days; This case was received via an unknown source on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included TIZANIDINE, SERTRALINE, FUROSEMIDE, ATENOLOL, CLONIDINE, GABAPENTIN, COLESTIPOL and VALSARTAN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), MEMORY IMPAIRMENT (woke up the next day, caller said she did not remember anything of what happened), FEELING ABNORMAL (hallo feeling in the top of my head/funny feeling), FALL (Ended up in the floor/ fall down on the floor and her roommate found her and put her into bed), ERYTHEMA (like a short neckless, red round in the top right of my head, that symptom lasted the whole), CHILLS (Chills) and VACCINATION SITE PAIN (sore left arm for 2 or 3 days). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), MEMORY IMPAIRMENT (woke up the next day, caller said she did not remember anything of what happened), FALL (Ended up in the floor/ fall down on the floor and her roommate found her and put her into bed), ERYTHEMA (like a short neckless, red round in the top right of my head, that symptom lasted the whole), CHILLS (Chills) and VACCINATION SITE PAIN (sore left arm for 2 or 3 days) outcome was unknown and FEELING ABNORMAL (hallo feeling in the top of my head/funny feeling) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. 2nd dose scheduled  on 05Apr2021.  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. Patient's advanced age along with concomitant medications may have been contributory for the occurrence of the events.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: No specific follow-up information recorded.; 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. Patient's advanced age along with concomitant medications may have been contributory for the occurrence of the events.
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 25-NOV-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L011080, expiry date 01-OCT-2016, (dose, strength, route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case was reported by a patient and describes the occurrence of PAIN (different aches and pains in different parts of body, mainly in upper left side that sometimes goes to the front, and it seems to be above heart) and CHEST PAIN (different aches and pains in different parts of body, mainly in upper left side that sometimes goes to the front, and it seems to be above heart) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer (First booster dose) on 01-Oct-2021, Pfizer (Second primary dose) and Pfizer (First primary dose). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Sulfonamide allergy (Sulfamethazine), Allergy to antibiotic (Amoxicillin) and Allergy to antibiotic (Cefalexin). Concomitant products included HYDROCODONE for Pain, ASPIRIN [ACETYLSALICYLIC ACID] for Prophylaxis.    On 09-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2022, the patient experienced PAIN (different aches and pains in different parts of body, mainly in upper left side that sometimes goes to the front, and it seems to be above heart) and CHEST PAIN (different aches and pains in different parts of body, mainly in upper left side that sometimes goes to the front, and it seems to be above heart). At the time of the report, PAIN (different aches and pains in different parts of body, mainly in upper left side that sometimes goes to the front, and it seems to be above heart) and CHEST PAIN (different aches and pains in different parts of body, mainly in upper left side that sometimes goes to the front, and it seems to be above heart) had not resolved.            Patient height was reported as 5 feet 9 inches. It was reported that patient had been vaccinated with the primary doses, first booster dose from Pfizer and did not experienced any side effects.  Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient did not experienced similar event in the past. Patient had no COVID positive test or diagnosis. No treatment medications were provided.   Reporter did not allow further contact
I woke at 2:30 AM the day after my shot (so 7/18/21) with chills, a fever of 101.3, and body aches in my joints, teeth, and face. I was unable to sleep through it. Around 10AM, I took 400mg of ibuprofen and was able to sleep for a bit. I woke around noon feeling hot. I basically bounced from being too hot to being too cold all day, in and out of sleep, from here. At 8 PM, the left side of my upper chest started to hurt and I discovered a lump between my armpit and left breast. I determined this to be enlarged lymph nodes. It was very difficult to sleep that night due to this soreness (I can best describe that it felt like a bruised rib). The next morning, (so 7/19/21),
I have been dizzy and my head feels cloudy and I can't stand up well without falling over.
Heart problems; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2023US017600 (Novartis).  A 76-year-old female patient received BNT162b2 (BNT162B2 NOS), 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart problems".  Additional information: Product was COVID-19 Vaccine. Reporter stated she got the COVID-19 vaccine, and it caused heart problems.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About 10 days after the vaccine, I developed, over the course of 30 minutes, pain/pressure from my left distal forearm to my hand, with stiffness and vague weakness in the area. Over the next hour or so I noted swelling of the wrist; swelling and pain in the dorsal and radial aspects of the left wrist have persisted until the following day when I am submitting this report. I had done some activities with the wrist prior to the onset of symptoms (opened a difficult jar, sat on my hand to keep it warm while using the computer) but these didn't seem outside of my normal daily activities.
Left thigh swollen to knee 48 hrs after injection with redness. Eval'd per MD approx 72 hrs after injection. Decreased swelling, no limping, no pain.
The patient started to feel dizzy almost right away, we had her sit, she was sweating and pale and had black visions in front of her eyes.  We gave her water and after a few minutes she started feeling better but we called 911 anyway.  When they came her blood pressure was 80/54 and they gave her IV fluids right away and decided to take her to the ER for observation.
There is redness and pain at the injection site. (No anaphylactic reaction). Area around the injection appears a bit swollen. This started a few hours after the injection and so far, has lasted into the second day.
Redness, swelling and itching at injection site 7 days after vaccine was originally given.
BLOOD CLOT; TINGLING SENSATION IN HIS LEG; SHARP PAIN AND NUMBING SENSATION IN HIS RIGHT FOOT; This spontaneous report received from a parent concerned a 34 year old male. The patient's height, and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number, expiry were not reported) dose, start therapy date were not reported, dose number in series was 01, 01 in total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient developed blood clot. After the shot, he felt a tingling sensation in his leg and then sharp pains and numbing sensation in his right foot. He was rushed to an emergency room (ER) and then transferred to another facility that was better to equipped to handle the situation and underwent surgery (dose number in series was 01). On an unspecified date patient was hospitalized and discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot, and the outcome of tingling sensation in his leg, sharp pains and numbing sensation in his right foot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220156613 - covid-19 vaccine ad26.cov2.s - blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20220156613 -covid-19 vaccine ad26.cov2.s- tingling sensation in his leg, sharp pains and numbing sensation in his right foot. This event(s) is labeled per RA and is therefore considered potentially related.
she has tested positive for the Covid virus/she has had both Pfizer Covid 19 vaccines and the booster some months ago; she has tested positive for the Covid virus/she has had both Pfizer Covid 19 vaccines and the booster some months ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (172086). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she has tested positive for the Covid virus/she has had both Pfizer Covid 19 vaccines and the booster some months ago". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical information: On an unknown date, the patient also received Paxlovid (considered as co suspect). She wanted to know if it was FDA-approved. Action Taken with Paxlovid was Unknown. She presently was not taking Paxlovid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Ringing in the ears after 2nd dose/Tinnitus after 2nd dose; Can not sleep after 2nd dose; Feels Florescent light over his head after 2nd dose; Sore Arm after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS, SLEEP DISORDER, FEELING ABNORMAL, and VACCINATION SITE PAIN in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced TINNITUS, SLEEP DISORDER, FEELING ABNORMAL, and VACCINATION SITE PAIN. The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, TINNITUS, SLEEP DISORDER, FEELING ABNORMAL, and VACCINATION SITE PAIN outcome was unknown.            No Concomitant medications were reported.
Mom called 13 hours after vaccination - child woke with fever 103 - given oral Motrin with reduction in fever 75 minutes later - afebrile since then. This was child's 1st flu shot.
This spontaneous report was received from a physician regarding unspecified number of patients of unknown demographics. There was information about concurrent conditions and historical medication. On an unknown date, the patiens were vaccinated with unspecified doses of improperly stored oral, ROTATEQ lot # K008140, Expiration Date- 30-MAR-2016, (dose strength and route was unknown). No concomitant medication was reported. No adverse event reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a female patient who on approximately 18-OCT-2007 "this week", was vaccinated with a first 0.5ml dose of Gardasil. Subsequently, the patient fainted. Unspecified medical attention was sought. It was reported that the patient was monitored and recovered. No product quality complaint was involved. Additional information is not expected.
Pfizer #2/2 on 5/22/21  Developed Bell's Palsy 6/22/21, seen at ER and f/u with PCP in office on 6/24/21. Was started on Prednisone 60mg qd for 7 days on 6/24/21.
Bumps on legs and fore arms; This non-serious case was reported by a consumer via call center representative and described the occurrence of papule in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number XY22F) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingrix (injection, left arm). In FEB-2023, 1 week after receiving Shingrix, the patient experienced papule (Verbatim: Bumps on legs and fore arms). The outcome of the papule was unknown.   It was unknown if the reporter considered the papule to be related to Shingrix.     It was unknown if the company considered the papule to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAR-2023 The patient self-reported this case. The patient received Shingrix about 3 weeks ago from reporting, most likely in his left arm, (he was not sure), and about 1 week to 10 days after receiving the Shingrix vaccine, he got bumps on his legs and forearms that popped. The reporter did not consent to follow up.
This spontaneous report was received from a 55 year old female patient with latex, shellfish and mold allergies, who was reporting on herself. The patient's medical history was not reported. On 12-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX in the left arm (lot #, dose and route of administration were not reported). No concomitant therapies were reported. On the same date, the patient developed a very large welt and swelling from armpit to elbow. The patient also reported that she did not feel well since the day after the vaccine was administered. The outcome of the events was reported as not recovered. The patient sought unspecified medical attention. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Noticed swollen lymph node under left arm.; This is a spontaneous report from a contactable consumer, patient. A 57 years old non pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID 19 mRNA Vaccine; Lot number: EN6203) via unspecified route of administration in the left arm on 16Mar2021 at 9:45 am, as a single dose for COVID 19 immunisation. Medical history included mild asthma, only have one half of thyroid on unknown date. Patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID 19 mRNA Vaccvine; Lot number: EL3247), (age at vaccination was 57 years old) via unspecified route of administration in the left arm on 23FEB2021 at 9:00 am, as a single dose for COVID-19 immunisation. Patient was found to be allergic to honey. Concomitant medications reported were Synthroid tabs 50 mcg (UNKNOWN MANUFACTURE); QVAR RediHaler 80 mcg (UNKNOWN MANUFACTURE) for unknown indication from unknown date. Unknown, prior to vaccination the patient was not diagnosed with COVID 19. On 17Mar2021 10:00 am the patient experienced swollen lymph nodes. Since the vaccination, the patient had not been tested for COVID 19. The patient did not receive treatment for the reported events. The clinical outcome for swollen lymph nodes was recovering. No follow up attempts are possible. No further information is expected.
evening of day of vax: hives all over, eyes watering, nose running, no wheezing, no SOB, no facial lip swelling;tx DPH, inc cool, clear liquids, calamine lotion for itch;call back if sx worsen;
6 days post vaccine, arm felt a little itchy by  the next day area was red, erythematous, slightly warm
Severe Vomiting - Not able to keep fluids down - started @ 9:00 p.m. on 5/6/21 -  continued until 5/9/21;  tried to drink Pedilayte, water Chills, headache, low-grade fever, muscle aches, , mild diarrhea, tiredness -  started 9:00 p.m. on 5/6/21-  continued until 5/14/21;  treatment - Tylenol
Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient was concerned that her blood pressure was up. EMS checked her blood pressure and it was within normal limits. She was observed for 30 minutes. No other treatment given.
On 2/8/00, the pt presented to the physician's office with a "mild case" of chickenpox. It was noted that the pt had some malaise and swollen glands, but was afebrile. Additional information has been requested.
Rash @ inject site; Low-grade fever; Swelling @ site; Very irritable;
This is a spontaneous report from a contactable consumer via Pfizer sponsored program.  A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 13Mar2021, the patient had a positive covid test done. Laboratory tests included sars-cov-2 test positive. It was reported that on 31Mar2021, the patient was scheduled to get second dose and she was wondering as now when can she get the second dose. The Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.