chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around 11 pm the night of the shot I started shivering and did so sometimes severely for about three hours until I got warmed up.  I slept almost all of the next day, ate very little to nothing, was fatigued and had poor balance when upright.  Day two morning I was able to get out of bed but was still fatigued, ate very little, and slept until late afternoon, when I felt better and strong enough to take the trash out, then I had to lay back down.  Day three I was essentially fine again.  I also periodically had a fever throughout day 1, for which I took Tylenol.
PATIENT WAS LIGHT HEADED AND DIZZY FOLLOWING VACCINATION AND BREIFLY FAINTED. NO INJURIES. FELT BETTER AFTER WATER, ICE PACKS AND CANDY. PATIENT DID NOT EAT LUNCH OR DINNER THAT DAY, ALSO HAS A HISTORY OF FAINTING AFTER A PREVIOUS VACCINATION AND WHILE DONATING BLOOD. REFUSED OFFER FOR AMBULANCE. LEFT PHARMACY APPROX 30 MIN AFTER VACCINATION. FOLLOW UP PHONE CALL WITH PATIENT 1.5 HRS LATER- PATIENT STATED HE FELT GOOD
she was diagnosed with COVID; A spontaneous report was received from a consumer concerning a 46-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events she was diagnosed with covid.  The patient's medical history was not provided. Concomitant medications reported were levothyroxine, albuterol Inhaler for drug use for unknown indication.  On 19 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 003B21A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Mar 2021, the patient experienced the evens she was diagnosed with covid.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, she was diagnosed with covid was unknown.
Severe vomiting & diarrhea, body aches, chills, headache, fatigue, beginning 12 hours after dosage.  Vomiting and diarrhea lasted approximately 6 hours.  Body aches, headache and extreme fatigue lasted throughout day 2 after shot was administered.  Felt some relief by the evening of the second day, but still had some body achiness, considerable fatigue and brain fog.  By day 3 felt much improved, but depleted from the ordeal.  By day four was pretty much back to normal but still felt slightly foggy and weakened.  Improvement continued.  I have had some recent intestinal issues in the past two weeks, in the form of bloating and gas, and will follow-up with my physician if they do not improve.
Patient received a Moderna booster and was not eligible for that particular shot due to age (younger than 18 years).
Came down with extreme  nausea, stomach issues 2 days after vax.  It?s been 8 months  and I still have severe nausea, no vomiting but increased constipation/ diarrhea .  Extensive lab work came back good, Ct of stomach, no blockage, no fluid but  evident constipation.   I take promethazine and zophran for nausea.  I take fiber 3 times daily, miralax 2  times daily., lomotil for diarrhea..
Approx. 1 minute, post vax of Prevnar, pt developed generalized redness with numerous hives all over.
Swelling lymph node under armpit in the same arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swelling lymph node under armpit in the same arm of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swelling lymph node under armpit in the same arm of the injection). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swelling lymph node under armpit in the same arm of the injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swelling lymph node under armpit in the same arm of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swelling lymph node under armpit in the same arm of the injection). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swelling lymph node under armpit in the same arm of the injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Heart palpitations; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 at 17:15 as dose 1, single (Lot number: HG4659) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medications included: LEVOTHYROXINE; OMEPRAZOLE. The following information was reported: PALPITATIONS (non-serious) with onset 15Oct2023 at 10:00, outcome "not recovered", described as "Heart palpitations". The event "heart palpitations" required physician office visit. It was unknown if therapeutic measures were taken as a result of palpitations. Additional information: The patient had no known drug allergies (NKDA). Aside from the Pfizer COVID-19 vaccine, the patient received other vaccines from Pfizer on the same date (14Oct2023): two dose number 1 and one dose number 2 of unspecified vaccines administered on the left deltoid. The vaccination facility was the pharmacy or drug store. There was no other vaccine in four weeks. The patient had no covid prior vaccination and was not tested for covid post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
COVID TEST POSITIVE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 23-JUL-2021, the subject experienced covid test positive. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000187245 The suspected product quality complaint has been confirmed to be voided (no PQC was identified within the time period when complaint was reported) based on the PQC evaluation/investigation performed.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case assessed non-serious
Initial report was received on 01 October 2012 from a health care professional. An unidentified patient had received FLUZONE, lot number UH731AA (route, site and date of administration not reported) and an unspecified amount of time later, developed flash pulmonary edema. The patient was hospitalized however, according to the reporter it was not known if the patient had been hospitalized "for another reason and then got the vaccination and the reaction." No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Pain; Burning; Aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain), BURNING SENSATION (Burning) and MYALGIA (Aches) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain), BURNING SENSATION (Burning) and MYALGIA (Aches). At the time of the report, PAIN IN EXTREMITY (Pain), BURNING SENSATION (Burning) and MYALGIA (Aches) outcome was unknown.            No concomitant medications were provided. No treatment information provided.
Following vaccination, began experiencing numbness and difficulty of grip in the left hand's ring and pinkie finger- difficulty to feel strong sensation
patient received the vaccine at the pharmacy, came into urgent care on 5/2 with ongoing hives/rash since time of vaccine.  No difficulty breathing or swelling. Rash is intermittent and urticarial and itchy
No adverse events. Patient accidentally vaccinated 16 days after 1st dose, 8 days earlier than minimum interval. Per CDC guidance, no further vaccinations needed. Patient advised of error.
pt recvd vax 1115 @ approx 105 & noticed pt was shaking & making gutteral sounds; mom stated episode lasted 1-2mins; t102.5 ax sl red ear;
Lingering soreness and pain in left arm and shoulder. Stiff neck and headache, neck better after  acupuncture and massage. But shoulder pain lasting for  3 weeks, now improved to 96%. Arm soreness and occasional pain even now after more than 4 weeks.
At 2:15 am on 4/17/21, I woke up with nausea and stomach pain. Experienced fainting (twice), vomiting and diarrhea (twice).
Diarrhea for 6 weeks now; Fatigue; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea for 6 weeks now) and FATIGUE (Fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea for 6 weeks now) and FATIGUE (Fatigue). The patient was treated with OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Adverse event, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea for 6 weeks now) and FATIGUE (Fatigue) had not resolved. Not Provided      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.   Concomitant product use was not provided by the reporter This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea for 6 weeks now) and FATIGUE (Fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea for 6 weeks now) and FATIGUE (Fatigue). The patient was treated with OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Adverse event, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea for 6 weeks now) and FATIGUE (Fatigue) had not resolved. Not Provided      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.   Concomitant product use was not provided by the reporter
pt recvd vax w/out side effect; on 23mar89, pt recvd 2nd dose of vax w/out adverse event;
Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). On 14-Mar-2021, VACCINATION SITE PAIN (Sore arm at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No Treatments were reported.   This case was linked to MOD-2021-045641 (E2B Linked Report).; Sender's Comments:  MOD-2021-045641:same reporter and two patients mentioned in source document. one case is processed in ICSR ID MOD-2021-045641
sick; Initial information received on 21-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media.  This case involves Adult of an unknown gender patient who experienced sick ,while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In October 2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (unknown dose, formulation, via unknown route in unknown administration site) as prophylactic vaccination.  In 2021,the patient developed a non-serious event "sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"I hot the flu shot last October and got sick a few days later."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Unknown for the event sick.
pt recv vax 6SEP96 & lab eval revealed a lack of seroconversion;
devel acute cerebellar ataxia, overt 9 days p/receiving vax; viral illness @ time of immun administration;
Spiked fever on 3-4-05 to 102.6 degrees - seized x 2, each one lasting 20-25 minutes.  Additional siezure on 3-6-05 lasting 5 minutes.  Seen in the ER each time - Tylenol and Motrin were given.
Patient experienced seizure aura, lost color, began to sweat, eyes rolled back, and was mildly unresponsive within 5 minutes of vaccine administration. Called 911. Placed patient on left side per direction of EMS dispatch. Patient stated the aura had decreased within a few moments of lying down on his left side. EMS assessed the patient's vitals which were normal on arrival. Patient declined transport to hospital and left in care of mother.
localized pain at injection site; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (localized pain at injection site) and PYREXIA (fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (localized pain at injection site) and PYREXIA (fever). At the time of the report, VACCINATION SITE PAIN (localized pain at injection site) outcome was unknown and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Body temperature: 98.5 (High) body temperature was recorded as 98.5 for around 15 hours. On 17-May-2021, Antibody test: negative (Negative) On 17-MAY-2021 results came that no antibodies are present.         No concomitant medications were reported.  No treatment details were reported.  Event outcome for injection site pain was not reported.
This spontaneous report was received from a pharmacist referring to a 66 year old female patient. The patient's medical history and concurrent conditions were not provided. It was reported no drug reactions or allergies. On 25-OCT-2017, the patient was vaccinated with one shot of PNEUMOVAX 23 (strength, dose, dose number and administration route were not reported) lot number M041686, expiration date 20-MAY-2018, according to Centers for Disease Control and Prevention (CDC) recommendations. Concomitant therapies included SYNTHROID 75 micrograms and CELEBREX 200 mg. Since 25-OCT-2017 (reported as "for around 5 days" and "later that day"), the patient had been experiencing nausea, chills, fever, pain in the back with deep breaths. The pharmacist also reported the patient had redness, warmth and swelling around injection site for around 5 days. Treatment was not given for the adverse events. The patient had not sought medical attention but she was scheduled to see her physician on 30-OCT-2017. At the reporting time, the outcome of back pain, pyrexia, chills, nausea, vaccination site warmth, vaccination site erythema, vaccination site swelling and hyperventilation was not resolved. The causality assessment between PNEUMOVAX 23 and the aforementioned events were not provided.
The pharmacist gave a painless shot. However, when the flu vaccine was injected, I immediately felt a sickening and burning feeling (I get flu shots every year but this was the Senior version) but the sensation passed as I walked out. However, within three hours, I could barely move my left arm without pain (especially if I raised my arm) which increased throughout the night. Finally took ALEVE about 4am which helped a bit. The pain was constant and only lessened three days later. I tried to play tennis (I usually play 2-3 times weekly) but it was still bad. Today (Wednesday) is my first "good day" with only a hint of muscular pain when I raise my arm.
Rash on face and legs after vaccination on 07/30/07 at 6:00 pm. Symptoms start on 7/30/07 at 11:00 pm Rx=Claritin 10 mg once qd x 10.
Redness, swelling, burning, fever over injection site, hard knot where injection site was
Fever started 12/24/2013 followed by head to toe red rash bumps blisters appearing on 12/27/2013.
On the day shot was given patient had: severe arm pain, headaches, severe chills at night. On the day after shot patient had: 101.6 fever, headaches, severe arm pain, chills, feelings of nausea. Went to see Dr who told her it should clear up by tommorrow and to take motrin. I am writing this on the night after shot was given. If symptoms do not improve I will need to seek doctor's advice.
a patient who is now 14 years-old received MMR II & VARIVAX at age 1 and has not received their second dose.; This spontaneous report was received from a medical assistant referring to a currently 14 years old patient of unknown gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reaction or allergy were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, batch/lot# and expiration date were unknown, strength and route were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, batch/lot# and expiration date were unknown, strength and route were not provided) for prophylaxis at 1 years old. The patient was now 14 years old and had not received their second dose (inappropriate schedule of vaccine administered).
receiving FLUZONE HIGH DOSE QUADRIVALENT when patient already received Fluad vaccine with no AE; had intended on getting the pneumonia vaccine, she already had a flu vaccine with no AE; Initial information received on 10-Dec-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 68 years old female patient who received fluzone high dose quadrivalent when patient already received fluad vaccine (extra dose administered) and had intended on getting the pneumonia vaccine, she already had a flu vaccine (wrong product administered), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], INFLUENZA VACCINE INACT SAG 3V [FLUAD] and PNEUMOCOCCAL VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medication was reported.  On 08-Oct-2020, the patient received suspect FLUAD (INFLUENZA VACCINE INACT SAG 3V) with an unknown dose, route, frequency, strength and formulation for prophylactic vaccination.  On 12-Oct-2020, the patient received 0.7 ml to 2 ml once a day dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE via intramuscular route in right arm (lot number: UJ540AA and expiry date: 30-Jun-2021) for prophylactic vaccination.  On an unknown date, the patient received PNEUMOCOCCAL VACCINE with an unknown dose, route, frequency, strength and formulation for prophylactic vaccination.  On an unknown date (latency unknown), the patient received FLUZONE HIGH DOSE QUADRIVALENT when the patient already received FLUAD vaccine (extra dose administered) and pharmacist stated that the patient came in to the pharmacy and requested a Flu vaccine. She filled out the consent form and checked the influenza vaccine box. Then, after she received it, she asked the pharmacist if that was the 23 that she had received. The patient had intended on getting the pneumonia vaccine, she already had a flu vaccine in October (year unknown) (wrong product administered).  This was an actual medication error due to extra dose administered and wrong vaccine administered.  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recv vax 17JUL98 & had general malaise 18JUL98 1 day post vax;fever 19JUL98, 20JUL98 & 21JUL98 highest T102.5 off & on relieved some w/APAP & Ibuprofen;22JUL98 MD noted pink blotchy rash on tops & inside of both arms & inside thigh;