chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart rate dropped to below 50 ppm; finger tips heavily tingled the morning after the injection.; This is a spontaneous report received from a contactable consumer (patient). A 64-years-old male patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 64-years-old ,via an unspecified route of administration, administered in Arm Left on 29Mar2021 12:30 (Lot Number: ER8730) as single dose for Covid-19 immunisation. Medical history included cardiac failure, diabetes 2, obese. No Allergies to medications, food, or other products The patient's concomitant medications were not reported. The patient experienced heart rate dropped to below 50 ppm on 30Mar2021 10:00 with outcome of recovered, finger tips heavily tingled the morning after the injection on 30Mar2021 10:00 with outcome of recovered. No treatment received for adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Severe headache, nausea, chills, fever, and throwing up. For 48 hours.   Also, next menstrual period after 2nd dose was extremely painful and long.
No adverse event; patient was administered a lower than authorized dose volume of the Moderna COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (patient was administered a lower than authorized dose volume of the Moderna COVID-19) and NO ADVERSE EVENT (No adverse event) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (Booster dose). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 Vaccine.   On 02-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 02-Nov-2022, the patient experienced UNDERDOSE (patient was administered a lower than authorized dose volume of the Moderna COVID-19). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient was administered a lower than authorized dose volume of the Moderna COVID-19) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (patient was administered a lower than authorized dose volume of the Moderna COVID-19).    Patient takes multiple regular medications. No treatment medication details was reported. It was reported that bivalent dose was given after receiving 2 primary series doses and a booster dose of the Pfizer COVID-19 vaccines.
Difficulty breathing starting ~24 hours after, lasted around 24 hours; Nausea starting ~16 hours after, still happening  Diarrhea starting ~24 hours after, still happening; Fatigue and malaise ~12 hours after, still happening; Unable to drink/eat more than Gatorade and Electrolites without vomiting.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-APR-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2016, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
PARTIAL PARALYSIS OF NECK AND ARM; LOSS OF MUSCLE; DIFFICULTY SWALLOWING FOOD; DOUBLE VISION; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 71 year old male of an unspecified race and ethnic origin. The patient's weight was 70 kilograms, and height was 182.88 centimeters. The patient's concurrent conditions included: non-alcohol user, and smoker (Two or three cigars a day), and other pre-existing medical conditions included: Patient had no history of drug abuse, no any other medical history or relevant preexisting conditions, patient was not on any medication at the time of adverse event started, no illness at the time of vaccination, no past history of similar event , no adverse event after any previous vaccination, no history of allergy to vaccine, drug, or food, no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, with cause, no family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 4381507, expiry: Unknown) dose was not reported, 1 total administered to right upper arm on 03-DEC-2021 for covid-19 prophylaxis. Age at time of vaccination 70 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced fatigue, double vision, shortness of breath, partial paralysis of neck and arm, loss of muscle, and difficulty swallowing food. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from double vision, had not recovered from partial paralysis of neck and arm, and the outcome of loss of muscle, difficulty swallowing food and shortness of breath was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20220829713.; Sender's Comments: V0: 20221034082-covid-19 vaccine ad26.cov2.s-partial paralysis of neck and arm. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Local reaction: red, swollen, itchy, painful. Area of inflammation approx. 2-2 1/2 inches across.
1215PM pt recv vax on 5AUG96 & 1220 pt fainted on chair & pt told to put head down between legs;pt was better then-pt told to lie down BP 90/60, 9:25 BP 94/70;no injuries noted mom accompanied pt out;
reaction/faint grey dot (still present); This case was reported by a nurse via sales rep and described the occurrence of skin discoloration in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 95552X, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Hib (Hiberix) (batch number 242A7, expiry date unknown) for prophylaxis, HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (ACTHIB) (batch number 242A7, expiry date unknown) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) (batch number FX0078, expiry date unknown) for prophylaxis.   Previously administered products included Pediarix (received first dose on 10th June 2022, for tolerance case refer US2022AMR148962), Pediarix (received second dose on 17th August 2022 for tolerance case refer US2022AMR149551), Hiberix (received first dose on 10th June 2022, for tolerance case refer US2022AMR148962) and Hiberix (received second dose on 17th August 2022 for tolerance case refer US2022AMR149551).   On 1st November 2022, the patient received the 3rd dose of Pediarix (intramuscular), Pediarix Pre-Filled Syringe Device, the 3rd dose of Hiberix, the 3rd dose of ACTHIB (intramuscular) and the 3rd dose of PREVNAR. On an unknown date, less than 3 weeks after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. Rechallenge with Pediarix was positive. Rechallenge with Hiberix was positive. Rechallenge with ACTHIB was positive. Rechallenge with PREVNAR was positive. On an unknown date, the outcome of the skin discoloration was not recovered/not resolved.   The reporter considered the skin discoloration to be probably related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR148962, US2022AMR149551   Additional Information: GSK Receipt Date: 16-Nov-2022 Reporter's comment: The patient had reaction/faint grey dot which was still present. The reporter considered the skin discoloration to be probably related to Acthib and Prevnar. The consent to follow-up was granted.; Sender's Comments:  US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171056:Same reporter
Woke up at 5am with Fever; Deep sweat; Feeling groggy; Slight chills; About 30 mins nausea; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 09Apr2021 at 12:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included uric acid high, elevated blood pressure (bp) and penicillin allergy. Concomitant medications included colchicine (MANUFACTURER UNKNOWN), febuxostat (MANUFACTURER UNKNOWN), indometacin (MANUFACTURER UNKNOWN) and ascorbic acid, betacarotene, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine, tin, tocopheryl acetate, vanadium, vitamin k nos, zinc (CENTRUM MEN) all from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 12Mar2021 at 16:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient previously took Daypro on an unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 13:00 about 30 mins, the patient experienced nausea, at 13:15 followed by feeling groggy then slight chills. Woke up at 5am on 10Apr2021 with fever, nausea and chills. Woke up in a deep sweat, but patient was feeling much better. Still a little nausea after lunch, but not too bad. Therapeutic measures were taken as a result of adverse events with Tylenol and Advil. The clinical outcome of the event nausea at 13:00, followed by feeling groggy then slight chills at 13:15. Woke up at 5am on 10Apr2021 with Fever, nausea and Chills. Woke up in a deep sweat, but patient was feeling much better. Still a little nausea after lunch were resolving.  No follow-up attempts are needed. No further information is expected.
Information has been received from a consumer concerning her 14 year old daughter with no drug reaction or allergies and no pertinent medical history who on 11-OCT-2010 around 5pm, was vaccinated with a dose of GARDASIL. Concomitant therapy included nasal flu vaccine and growth hormones. The mother stated that her daughter called her from school and told her that on 12-OCT-2010, at 12:30 pm her hands had turned a sort of light gray/bluish color. Her hands had also gone somewhat numb. They went to the doctor, where they were told to come back on 13-OCT-2010 if the symptoms hadn't subsided. It was reported the adverse events improved, but the tingliness in her hands came and went, the overall syndrome were still there. The patient was about to go back to the doctor's office. The patient had blood work every couple of months because of growth hormones (results not reported). At the time of reporting, the patient had not recovered. Additional information has been requested.
1st Event of 4/23/21 - Woke in night with heart pounding out of my chest, extremely painful, could not speak or move, lasted upwards of 11 minutes. I thought I was dying of a heart attack or stroke. I did not consider any relation to vaccine at time, did not report.   2nd Event Approx. July 20th - Woke in night to same as above, though this time it resolved within 2 minutes.  3rd Event Approx. August 7th - Same as above. 4th Event August 10th - Same as above, though it resolved faster, within 1 1/2 minutes of waking. 5th Event August 12th - Same as above.  6th Event August 15th - Same as above. 7th Event August 20th - Same as above.
pt experienced red rash & itching, applied Bendadryl topical spray & contacted MD, rash was 5 X5 , but has decreased to 2x 2 today 9/13
Extreme lymph pain under arm put on side of vaccine. Left. And breast area. For 24 hours.
Severe migraine , full body joint /bone pain, extreme fatigue,  Chills so severe resembled causing  strong shivering. Chills followed by severe sweating . Unable to sleep due to these symptoms . Had intermittent episodes of lightheaded ness .  Loose stooling . No appetite . These symptoms went on for 3days starting morning of day after vaccine . The left arm was  also very painful for 5 days . Temperature at highest point 100.8. Pre-treated prior to vaccine with Claritin took 2 hrs prior because of history with reaction to flu vaccine years ago from multi vial .  Treated chills with Tylenol 325mg as needed. Took Ibuprofen prn for joint pain.  Treated migraine with 1dose of Excedrin  which did not take the headache away.
Initial information received on 21-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves female patient who experienced flu like symptoms and severe sore arm, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious flu like symptoms and severe sore arm for several days (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included no lab data.) Final diagnosis was severe sore arm and flu like symptoms. It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown all the event. List of documents held by sender: none.
pt exp mild swelling & discomfort @ inj site later that same day sx gradually inc over the next 3 days & by 4th day could not move arm w/o  pain;throbbing sensation & edema & erythema of lt shoulder;firm mass;cult grew A radiobacter;
Patient received first and second dose of shingrix on 1/14/2019 and 03/25/2019.  Mistakenly patient received third dose on 2/9/2022
The patient answered "yes" on the immunization screening consent form for the question: Have you ever had a serious reaction or fainted after receiving a vaccination? She reported that she had fainted after a flu shot a long time ago, but was willing to proceed with the flu shot when she asked. She was counseled to remain in the vaccination room for a few minutes after the immunization was administered. She was moved to the lobby to continue waiting the remaining 15 to 20 minutes. Shortly after she returned to the counter to report that her tongue and throat were swelling. She reported at this time that she had experienced an anaphylactic reaction to some allergy shots when she was younger, and this "feels the same." We immediately called for emergency assistance and brought her into our vaccination room. As per protocol, she was given 1 dose 0.3 mg of epinephrine by IM administration and her blood pressure and heart rate were checked. She confirmed the absence of any hives or itching so we did not administer diphenhydramine.  Emergency assistance arrived and after speaking with the patient and listening to our report,  she was transported to the emergency room for further evaluation and continued monitoring.
Was given Adacel Tdap at age 5 when should not have been given until age 8.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021 at 1:24 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.78. Concomitant products were not provided. On 27-Feb-2021, excursion time was 9 AM, 11AM,12AM,1PM,2PM,3PM,4PM,5PM, with temperature as 33, 35, 35, 35, 35, 35,34, 34 and 35 respectively. Total doses given for the day was 199 for 9AM vials. Condition of vaccine prior to administration was not frozen. 9AM vaccine was moved to fridge on 24-Feb-2021 and 9 AM. 20 Vial was moved to clinic on 27-feb-2021 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021 for 9 AM respectively. On 27-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 35, 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34, 4 PM: 34 and 5 PM: 35. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
fever 104 R; cried most of noc; nl in AM; fever 104.0, cranky, lethargic;
This spontaneous case reported by a nurse, describes the occurrence of product temperature excursion issue (there was an excursion from the freezer) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 939901) for COVID-19 immunization. No medical history reported. On Oct 25, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine, unknown route; 1 dosage form. On Oct 25, 2021, patient experienced product temperature excursion issue (there was an excursion from the freezer). On Oct 25, 2021, product temperature excursion issue (there was an excursion from the freezer) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, there was excursion from the freezer on Oct 1, 2021. Storage condition at the time of the excursion: frozen. Maximum and minimum temperatures reached: Minimum: 4.2 degrees F; maximum 5.7 degrees F. Excursion duration-6 minutes. This case linked to MOD-2021-383410 (patient link). Most recent follow-up information incorporated: On Nov 15, 2021: Significant follow-up: Patient demographics, vaccine start date and dose number of the vaccine added.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. 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: MENSTRUAL DISORDER (medically significant), outcome "unknown", described as "blood clots"; VAGINAL HAEMORRHAGE (medically significant), outcome "not recovered", described as "vagina/been bleeding 60 days"; IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "I can't go back to work". Clinical course: Ever since the patient got the first dose of Pfizer COVID vaccine on 09Jan (as reported) 3 weeks proceeded of blood clots coming out of her vagina with only a 1 week pause then another 2 weeks of blood clots coming out of her vagina with a 2 week pause and then another 14 days. It was later stated that she could not go back to work with blood clots coming out of her vagina for 2 weeks at a time, and the longest she has been able to get it to stop was 2 weeks. Further stated that going into the month of Apr (as reported) and she has been bleeding 60 days since 09Jan (as reported). The lot number for bnt162b2 was not provided and will be requested during follow up.
Red, swollen, warm to touch, sore and tender. Mom watched area if it was getting bigger, it did not. Cool cloth applied, TYLENOL for discomfort. Lasted 2 days.
Pt. received hep. B and Typhoid vaccines at a drill weekend.  Became nauseous, and started vomiting about 1 1/2 hours after immunizations.  Also had a fever and headache.  He laid down at event and rested for a couple of hours.  No problem since and back to baseline.