chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 at 16:45 as dose 1, single (Lot number: EN6198), in left arm, on 06Mar2021 at 17:00 as dose 2, single (Lot number: EN6206), in left arm and on 12Nov2021 at 13:15 as dose 3 (booster), single (Lot number: FH8020) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes. Concomitant medication(s) included: METFORMIN, start date: 01Jun2019; RYBELSUS, start date: 01Mar2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: I tested positive 5 days later; (Jun2022) Negative, notes: tested negative on Day 9. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Tested negative on Day 9, but then covid rebounded and She tested positive 5 days later. Her symptoms are milder now but she was stuck isolating again for 5 days. Patient received Paxlovid for 5 days as a treatment for the adverse event.  No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200813655 Same patient, same drug, different event, different dose;
Patient was given half dose of Moderna Bivalent Booster. Wrong dose was given.
pt reports that her arm was a little more painful than she expected immediately after the vaccination. She had pain but normal ROM for the first 4-5 days, but then has been getting progressively more painful, and abduction of the left shoulder is now intensely painful 13 days after the vaccination. No other injury. She has tried ice, topicals. I gave her oral steriods. She pointed to the site of the injection and it was a little closer to the acromion process than ideal, less than 2 fingers away.
Injection site painful w/itching, redness and swelling, headache & congestion, muscle & joint aches, chills & sweating, fever to 101.0, fatigues, malaise
Mother reported that soon after his vaccine he was "lethargic".  She states that we did not respond as usual for several hours.  He did eat normally.  He has acted normally since that time.
Xerelto daily and continue to monitor, will repeat diagnostics in 6 weeks from intial visit
Infant received PEDIARIX in (L) upper thigh on 7-15-08.  Mother states within 2 hours - he developed raised red rash on all of (L) upper thigh & face with white whelps - denies any fever, respiratory symptoms.  To Dr. - she Tx with steroids and hydroxine - Dr. requests next dose that components be given separately to determine cause.
Progressively inflamed upper arm, warm, red, painful swollen, limited movement, (nausea, vomiting started 5-2-11).
Thursday afternoon some months after the Covid vaccine, I had what I suspected at the time to be an allergic reaction to something; eyes watering and upper lip numb.  The watering reduced and was only in my left eye the next day, but I noticed I felt like the left side of my face was anaesthetized.  I was marginally improved the following day so we went to get a CT scan at the hospital.
Severe myalgias, headache and fatigue two days after the second dose of the vaccine. On day 3 the acute symptoms were gone. However, I started to have numbness and tingling in my hands, feet and legs that persisted for about 4 months post-vaccine. The symptoms of paresthesias were at their worst at 6-8 weeks post-vaccine. Additionally, I had rapid and irregular heart rhythms at random times after the second dose of the vaccine.
This spontaneous report as received from a pharmacist refers to patients of unknown age. On an unknown date the patients were vaccinated with a dose of ZOSTAVAX (lot/batch#, dose and route unknown). The pharmacist reported that between two and four patients have returned to the pharmacy with active cases of shingles. The reporter stated that the onset date had been anywhere from 2 days to two weeks. The reporter stated that these patients have sought treatment from their physicians. At the time of reporting, the outcome of adverse event was unknown. Additional information has been requested.
Right after receiving influenza vaccine spent the night having body aches, upper respiratory and upper and lower gastric trouble. Symptoms persisted for 6 hours along with a fever, and then were all gone.
Seeing new sleep doctor to improve this; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non Health Care Professional). An adult patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "believe POTS amongst others" (unspecified if ongoing), notes: believe POTS amongst others. The patient's concomitant medications were not reported. The following information was reported: SLEEP DISORDER (non-serious), outcome "unknown", described as "Seeing new sleep doctor to improve this".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional information: Pfizer colleague was speaking with someone who had to quit job because standing too long was impacting their health, this person also seeing new sleep doctor to improve this. Vaccination time frame reported as probably early-mid 2020 (not 100% sure which vaccine and vaccination time frame) for full vaccination. Patient has several health issues: believe may have POTS (Postural orthostatic tachycardia syndrome) along with other disorders. Likely the above is related to already ongoing disorders. Unsure when exactly quit job and started seeing new doctor, but probably recent. On 12Jan2022 it was reported that individual was fully vaccinated likely around early-mid 2021 (Not 2020). On 27Jan2022 a consumer reported in response to Non-HCP letter sent via email follow up activity reporter mobile number and Institution.
Approximately 6 hours following the second dose in the two-dose Pfizer COVID-19 vaccination series, I began experiencing nausea, vomiting, moderate body aches, and headaches. I have been unable to keep down liquids (including water, gatorade, and soup broth) and solids. At this time, I have continuous vomiting, with each following the intake of food and/or beverages. Physical exam is negative for redness, swelling or rash at the injection site. Additionally, I have not appreciated any fever or signs of anaphylaxis.   Following my first dose in the two-dose series, I did not experience any side effects other than the expected sore arm for 24-48 hours.
Vaginal bleeding after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding after 2nd dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination.     No medical history for patient was reported.  Concomitant products included TRAZODONE from 01-Jan-2019 to an unknown date for Insomnia.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding after 2nd dose). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding after 2nd dose) had resolved.            No treatment medication was reported.   This case was linked to MOD-2021-386812 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up received contains event outcome updated.
administered 0.3mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (administered 0.3mL) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced ACCIDENTAL UNDERDOSE (administered 0.3mL). At the time of the report, ACCIDENTAL UNDERDOSE (administered 0.3mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment given and no symptoms reported. Pharmacist would like to know if there is any course of action to be taken. Consent for the follow up given
horrible reaction to the second shot but not the first; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (horrible reaction to the second shot but not the first) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first 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 COMPLICATION (horrible reaction to the second shot but not the first). At the time of the report, VACCINATION COMPLICATION (horrible reaction to the second shot but not the first) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Fever, chills, myalgias, fatigue, generalized weakness , starting 12 hours after the vaccination and lasting approximately 24 hours, except fatigue lasting 2-3 days
Leg swollen, fever of 102F; pt not seen by MD; 3 prior DTP w/ no problem; No hx of convuls in pt or parents or siblings;
Patient turned stopped breathing and blue, 4:30 am at 1 1/2 days old. Taken to nursery to be watched 7:30am turned stopped breathing and turned blue again, taken to nursery to be watched. Took a while to get his O2 up again. 12:30 pm stopped breathing and turned blue, called code blue for nurses and sent him to NICU. After that, he stopped breathing and turned blue and needed help via AMBU bag or Oxygen 13+ times in his first week and a half life.
dizziness; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051B22A, 031(M or H)21A, 003B21A and 031A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) had not resolved.            It was reported that patient is not on any medications for any health conditions and patient has not taken any medication for the dizziness. It was reported that they have been feeling like this for the past 2 days.   This case was linked to MOD-2022-609216, MOD-2022-609219 (Patient Link).
12/01/2020 Pfizer Covid vaccine Lot # EH9899 01/18/2021 Pfizer Covid vaccine Lot #El3246 3/30/2021 Asymptomatic, LTC POC Antigen positive covid 04/10/2021 returned to work
On arrival, he is in atrial fibrillation with RVR, with rates 110-136. On cardiac monitor, his QRS pattern varies between a wide QRS and narrow QRS, with underlying irregular rhythm consistent with atrial fibrillation   Initial EKG was obtained, personally reviewed interpreted, shows atrial fibrillation with RVR, rate 136, with left bundle-branch pattern on the EKG.  He denies any chest pain. Did obtain a repeat EKG with narrow QRS pattern on cardiac monitor, and this shows atrial fibrillation, rate of 99, no acute ischemic changes.  Positive for COVID-19.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Given after being punctured 25 hours before) and EXPIRED PRODUCT ADMINISTERED (Adult received a vaccine from a Moderna vial that had been stored in the refrigerator for 25 hours after the initial puncture) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.  Previously administered products included for Product used for unknown indication: pfizer (Lot number-EN6199) on 04-Mar-2021 and pfizer (Lot number-EP7533) on 25-Mar-2021. Past adverse reactions to the above products included No adverse event with pfizer and pfizer. On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 11-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Given after being punctured 25 hours before) and EXPIRED PRODUCT ADMINISTERED (Adult received a vaccine from a Moderna vial that had been stored in the refrigerator for 25 hours after the initial puncture). On 11-Nov-2021, PRODUCT STORAGE ERROR (Given after being punctured 25 hours before) and EXPIRED PRODUCT ADMINISTERED (Adult received a vaccine from a Moderna vial that had been stored in the refrigerator for 25 hours after the initial puncture) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No concomitant medication details was reported.No treatment medication details was reported.Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow up document was received and contains no new information.
I had a metallic taste of everything I ate and smelled for about 4 months until it  Is went away once in a while I still have it happen. I have severe pressure Behind my eyes It has slowly gotten worse. I just flew on a plane and I was in a higher altitude zone and now that I am home it has doubled the problem it is almost unbearable. It is actually worrying me now.
6 cm raised hard welt at site of injection noted day after vaccination. Welt was itchy and employee went to emergency department of her local hospital for evaluation. She reported being given oral Benedryl for treatment. Welt resolved slowly over the next several days.
This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. Information on medical history, past drugs, concurrent conditions and concomitant medications were not reported. The nurse reported that on 16-AUG-2017, the patient was vaccinated with PROQUAD (Lot # L047305, Expiry date: 23-MAY-2017), (dose, frequency were not provided) for prophylaxis which was expired on 23-MAY-2017 (Expired product administered). Nurse stated that the PROQUAD did not have any temperature excursions prior to administration. No adverse symptoms were reported. No further information was provided. No product quality complaint (PQC) was found. Outcome of events was unknown.
12 hours after I received the vaccine I had, and continue to have, severe itching which results in red splotches all over body. Itching is all over body including  face, stomach, breasts, neck, ankles. There is no itching at the injection site or mark around the injection site.  Reaction may be onset with consumption of food (and more severe with the consumption of dairy) with no previous allergies.  Currently taking benadryl which helps for an hour or so, and apply hydrocortisone to the itchy areas, which does not at all.  Currently 11 weeks, no complications. estimated due date 5/13.
I had a severe reaction to the first shot.  I had Covid in Dec 2019 before it was suppose to be here.  Last summer I developed a bad reaction to bee stings.  After the first Covid shot I felt my whole body tingling after about ten minutes.  I gave myself epicenter shot when I got to my truck.  The next morning after breakfast I threw up and slept for about 6 hours.  The severe tingling in hands, feet, and necklace and face woke me up.  I gave myself a second epipen shot within 30 hours.    I called my doctor to have epipens refilled.  He told me I should have gone to hospital the next day for fluids.  My doctor told me not to take the second shot for the possibility of three days in hospital for fluids, chance of lung or brain injury or the most drastic reaction could be I would have a fatal anaphalegic reaction.  For these reasons I called to cancel my second appointment
heart palpitations; insomnia; flu-like symptoms; some parts of the body feeling tired; shot of energy; numbness on left side of face; numbness of the front of tongue and lips; numbness of the front of tongue and lips; fingers feeling a little numb on the right side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 11May2022 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: HYPOAESTHESIA (non-serious) with onset May2022, outcome "unknown", described as "fingers feeling a little numb on the right side"; INFLUENZA LIKE ILLNESS (non-serious) with onset May2022, outcome "unknown", described as "flu-like symptoms"; INSOMNIA (non-serious) with onset May2022, outcome "unknown"; HYPOAESTHESIA ORAL (non-serious), HYPOAESTHESIA ORAL (non-serious) all with onset May2022, outcome "unknown" and all described as "numbness of the front of tongue and lips"; HYPOAESTHESIA (non-serious) with onset May2022, outcome "unknown", described as "numbness on left side of face"; ASTHENIA (non-serious) with onset May2022, outcome "unknown", described as "shot of energy"; FATIGUE (non-serious) with onset May2022, outcome "unknown", described as "some parts of the body feeling tired"; PALPITATIONS (non-serious) with onset 25May2022, outcome "unknown", described as "heart palpitations".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Developed Varicella Disease. Had Varicella vaccine on 09/14/1998
Information has been received from a registered nurse referring to multiple unspecified patients. Information about concurrent condition, medical history and drug reactions/allergies was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration were unknown, lot # L033343, expiration date 12-SEP-2017). These vaccines were exposed to 0.4 degree centigrade for 6 hours 30 min (incorrect product storage). A data logger was used to log temperatures and there were no prior excursion. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Approximately 10 hours after the injection (about 2 weeks prior to this ER visit) the patient started experience paresthesias of the right arm and face. Evaluation in the ER on today's date did not show objective findings of the paresthesias, nor identified cause, including evaluation for stroke.
palpitations; irregular heartbeat; light headed; Upon receiving at first I felt weird; felt like my heart was skipping beats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (palpitations) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Contrast media allergy and Drug allergy. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), ROPINIROLE, ALENDRONATE SODIUM (ALENDRONATE), ATORVASTATIN CALCIUM (ATORVASTIN), FAMOTIDINE, LORATADINE and PANTOPRAZOLE MAGNESIUM (PANTOPRAX) for an unknown indication.    On 04-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PALPITATIONS (palpitations) (seriousness criterion hospitalization), DIZZINESS (light headed), FEELING ABNORMAL (Upon receiving at first I felt weird) and EXTRASYSTOLES (felt like my heart was skipping beats). On 13-Feb-2021, the patient experienced HEART RATE IRREGULAR (irregular heartbeat). The patient was hospitalized on 19-Feb-2021 due to PALPITATIONS. At the time of the report, PALPITATIONS (palpitations), HEART RATE IRREGULAR (irregular heartbeat), FEELING ABNORMAL (Upon receiving at first I felt weird) and EXTRASYSTOLES (felt like my heart was skipping beats) outcome was unknown and DIZZINESS (light headed) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Electrocardiogram: unknown (Inconclusive) Unknown. On 13-Feb-2021, Heart rate: irregular (abnormal) Irregular.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       About 9 days later she experienced irregular heartbeat. She was seen by a physician and treated with Metoprolol. Upon receiving at first she felt weird, light headed and that night she starting heart palpitations. It felt like her heart was skipping beats. She called doctor and had an electrocardiogram (EKG), and then she went home. The heart palpitations continued to get worse and she went back to doctor and was admitted in the hospital on 19-Feb-2021. She was continually working with her doctor.  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.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: added patient contact details (address, email ID, phone number), patient demographics (height, weight, race), added patient's allergies, concomitant drugs and events (palpitation, weird feeling, dizziness, heartbeats skipped); 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.
Report 20010267651 describes hives in an approx. 12 year old female who received hep B vaccine (Engerix-B). The vaccinee received no concurrent immunizations on 11/08/2001. Her concurrent conditions and medical history were not specified. Medical history included an unspecified "skin reaction." On 11/08/2001, the vaccinee received her first intramuscular dose of Engerix-B. "Soon" after receiving the vaccine, the vaccinee developed hives. The hives were treated with oral Benadryl. The hives lasted for approx. 12 hours and then resolved. The vaccinee was "fine" and was attending school again on 11/09/2001. Mother stated that she remembered "a skin reaction like this before" but did not remember if it occurred with a vaccine or some other type of medication. As of 11/09/2001, the adverse event had resolved.