chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He has developed muscle aches and pains; This is a spontaneous report from a contactable consumer (wife). A 89-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration in 2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, patient has developed muscle aches and pains. His second dose is scheduled for 13Feb2021. The outcome of event was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Fatigue started a few hours after shot and was moderate intensity for that day, low intensity starting day 2, but low intensity fatigue continues to be present 2 weeks later. Napping almost daily; was not a regular nap-taker previously.
Information was received on 22-FEB-2019 from a lawyer regarding a case in litigation involving a female patient, history not provided. In 2014, at 65 years of age, the patient was prescribed ZOSTAVAX and it was administered by a pharmacist at a pharmacy for the long term prevention of shingles and zoster related conditions. The patient was treated by a physician at a hospital for the following injuries resulting from ZOSTAVAX use: shingles. Outcome of shingles was not reported.   Additional information has been requested.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No past medical history was reported.  The patient's past medical history included No adverse event (no medical history).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant product was reported patient has diarrhea on 11,feb-2021
Tested positive for COVID-19, developed fatigue, scratch through (as reported) on 04Oct.; Tested positive for COVID-19, developed fatigue, scratch through (as reported) on 04Oct.; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: AH9702) at the age of 57 years intramuscular, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 12Apr2021 as dose 2, single (Lot number: EP6955), in left arm and on 29Oct2021 as dose 3 (booster), single (Lot number: Ft2590), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 033K212A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Oct2022 at 21:00, outcome "not recovered" and all described as "Tested positive for COVID-19, developed fatigue, scratch through (as reported) on 04Oct.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (05Oct2022) Positive; (05Oct2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information:  Tested positive for COVID-19, developed fatigue, scratch through (as reported) on 04Oct. On 05Oct, development more cold & Flu-like symptoms and took COVID-19 home test and tested positive. Report of test result to me (name withheld) on 05Oct. [Note: Patient believes to have been exposed to Covid at a school reunion on 01Oct2022. Reportedly, so far, 9 of 13 attendees at the dinner table that night have tested positive for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201210241 same patient, different drug/event;
It now goes up to her neck, her back, down her arm and her hand; It now goes up to her neck, her back, down her arm and her hand; immense pain travel down her entire left arm into her hand; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 03Apr2021 at 13:45 as a single dose for COVID-19 immunization.  Medical history included migraine and unspecified known allergies both from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. Concomitant medications included topiramate (manufacturer unknown); sumatriptan (manufacturer unknown); eszopiclone (LUNESTA) and promethazine (manufacturer unknown) all taken for an unspecified indication, start and stop date were not reported. The patient did not have other vaccines in four weeks prior to the COVID vaccine. The patient was not tested for COVID post vaccination. On 03Apr2021, it was reported that within two minutes of receiving the injection, the patient had immense pain travel down her entire left arm into her hand. She knew it wasn't normal. The patient called the paramedics over because the pain got so intense she couldn't even touch her arm nor her hand. The paramedic said this was not a normal reaction and maybe they hit a nerve but he's not sure what's going on. It's been two weeks since her vaccine injection. The pain comes and goes just as bad as that bad. It now goes up to her neck, her back, down her arm and her hand. She can't use it nor touch it. The events result in a doctor or other healthcare professional office visit and was reported to have caused disability/permanent damage. The patient had not recovered from the events.   Information about lot/batch number has been requested.
No adverse effects; Caller is an office manager who reports administration of vaccine following temperature excursion. No adverse effects of administration. No further information provided. No other AE/no PQC.         ?    Names of vaccines involved (including lot/exp; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 21-APR-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) 0.5 milliliter, lot number U013036, expiration date 23-APR-2023 for prophylaxis (route of administration not reported) (product storage error). The vaccine was reconstituted with sterile diluent that did not experienced any temperature excursion.   no adverse event was reported.  The vaccine underwent a temperature excursion of 14.5 degrees Celsius for 10 hours. No previous temperature excursions were detected.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Body temperature: 99 (High) 99 degrees Fahrenheit..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Upon an internal review on 21 May 2021, the age was corrected to an unknown age.
Aplastic anemia = Bone marrow exhaustion  eventually death.  She found out when she tried to donate plasma.  She's always donated plasma but after her booster this showed up.  She failed a Coombs test when she went to give plasma.  She had to go to the cancer center and failed the test again.  As far as she knows there is no treatment and she will eventually die.
mom states that w/in 48 hrs of receiving vax pt began to cry a high pitched cry that lasted on & off for a long time (1-2hrs); mom did not want pt to receive shot again; mom brought note from MD stating pt probably should not get DTP;
Hives and rash all over the body except face and stomach. Itchy and painful and feels like Shingles. Dr prescribed Prednisone, Benadryl, Zyrtec, and Pepcid but symptoms are unresolved. Any contact with the skin creates more of a rash including taking a shower, wearing gloves, wearing a coat, wearing underwear or socks.
Information has been received from a physician concerning an 18 week old male, with no medical history and no allergies, who on 13-JAN-2007 was vaccinated with a second 2ml oral dose of Rotateq (lot #655175/0849F). there was no concomitant medication. On 17-JAN-2007 the patient developed diarrhea. The patient's mother called the physician on 21-JAN-2007 to say that the child still had watery stools. The patient was admitted to the hospital on the evening of 21-JAN-2007 and was given intravenous fluids to prevent dehydration. At the time of the report the patient was recovering but was still in the hospital. The patient's diarrhea was also considered to be an other important medical event by the reporter as he had to receive intravenous fluids. Additional information has been requested.
By 5 p.m., had chest tightness and left arm numbness. By 10 p.m., numbness in left hand and fingers, heart palpitations (sensation of someone blowing bubbles under water but in my heart). By 2 p.m., heart palpitations continued with burning sensation on bottoms of both lungs. Still having some chest tightness and some palpitations, with left arm occasionally tingling.  Some tightness in lungs still present now when running.
positive for COVID-19; exposed to COVID; This is a spontaneous report from a contactable consumer (patient's mother). A 22-year-old female patient (reporter's daughter) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 12Mar2021, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter (patient's mother) reported that she, her husband, and her daughter all received the first dose of the Pfizer COVID-19 vaccine last Friday, 12Mar2021. She stated that her daughter was exposed to COVID-19 the next day on 13Mar2021, started having symptoms on Wednesday and was tested for COVID-19. She received her results today and her daughter was positive for COVID-19 on 17Mar2021. All three of them were scheduled to receive their second dose of the Pfizer COVID-19 vaccine on 02Apr2021 and the reporter would like to know what her daughter should did about receiving her second dose. The reporter would also like information on what her and her husband should do regarding their second doses scheduled on 02Apr2021 since they were now considered exposed to COVID-19 because the daughter lives with them in their household. The daughter has been quarantined and isolated away from the rest of the family. The reporter would like to know if her daughter has to reschedule her second dose of the Pfizer COVID-19 vaccine due to her having COVID-19 would she have to restart the vaccination series and also would like to know if receiving the first dose of the Pfizer COVID-19 vaccine might help decrease symptoms of COVID-19 or make it less severe should her and her husband become positive. The reporter wanted to know if her and her husband will be "any worse off" since they received the first dose of the Pfizer COVID-19 vaccine if they did end up testing positive for COVID-19. Clarified with reporter and wanted to verify that the vaccine would make an infection stronger due to the way the vaccine works. The reporter stated that she was on hold for an hour and a half and then she was transferred to a Pharmacy in another department then that pharmacist said, "I'm not sure why you were transferred to this department." 3 family were vaccinated last week Friday. The patient's (daughter's) boyfriend tested positive for COVID-19. The patient underwent lab tests and procedures which included that she was tested positive on Wednesday,17Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
getting dizzy; nauseous; chills; weren't as bad; Headache is what gets me. Headache is at my temple and behind it, real severe; feeling horrible; neck ache; her temperature went up slightly; felt real crappy; Headache; had chills; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck ache), DIZZINESS (getting dizzy), BODY TEMPERATURE INCREASED (her temperature went up slightly), FEELING ABNORMAL (felt real crappy) and FEELING ABNORMAL (feeling horrible) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), RIVAROXABAN (XARELTO), TOPIRAMATE (TOPAMAX), MULTIVITAMIN [VITAMINS NOS], VITAMIN B NOS and MAGNESIUM for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced NECK PAIN (neck ache), BODY TEMPERATURE INCREASED (her temperature went up slightly), FEELING ABNORMAL (felt real crappy), HEADACHE (Headache) and CHILLS (had chills). On 27-Apr-2021, the patient experienced FEELING ABNORMAL (feeling horrible) and HEADACHE (Headache is what gets me. Headache is at my temple and behind it, real severe). On 28-Apr-2021, the patient experienced DIZZINESS (getting dizzy), NAUSEA (nauseous) and CHILLS (chills; weren't as bad). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 15-Apr-2021, NECK PAIN (neck ache), BODY TEMPERATURE INCREASED (her temperature went up slightly), FEELING ABNORMAL (felt real crappy), HEADACHE (Headache) and CHILLS (had chills) had resolved. At the time of the report, DIZZINESS (getting dizzy), FEELING ABNORMAL (feeling horrible), NAUSEA (nauseous), HEADACHE (Headache is what gets me. Headache is at my temple and behind it, real severe) and CHILLS (chills; weren't as bad) outcome was unknown.            Concomitant medication also included blood thinners.   This case was linked to MOD-2021-060943 (Patient Link).
Severe arm pain where shot was administered. Difficulty moving my arm due to pain. Entire upper arm in pain. Sick with flu-like systems for two days. Fever as high as 100.8, muscle aches, headache, fatigue, difficulty sleeping, etc. I feel like I have the flu. I've been down for two days because of this vaccine. It ruined all of my plans for the Memorial Day weekend.
TOOK A DOSE OF VIVOTIF THAT WAS LEFT IN THE CAR FOR ABOUT AN HOUR; This spontaneous case report (PVX2019-1772) was received from a pharmacist on 10-Jul-2019. It describes a male consumer who "took a dose of Vivotif that was left in the car for about an hour", while being on Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 09-Jul-2019, which was unrefrigerated in a car over 77-degree Fahrenheit for about an hour.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took a dose of Vivotif that was left in the car for about an hour" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took a dose of Vivotif that was left in the car for about an hour" was considered as not applicable.
An "itchy" sensation in her upper respiratory tract; Earache; Headache; Feels "tired all the time"; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 67-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 24Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced an "itchy" sensation in her upper respiratory tract, earache, headache, feels "tired all the time" on an unknown date. She did not have fever. Consumer asked if the 2nd dose should be administered (scheduled for 23Mar2021) after experiencing same symptoms. The outcome of the events was reported as unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Hives all over middle area of back and stomach, left front are, lower right thigh; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 at 10:15 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, rheumatoid arthritis, penicillin allergy, latex allergy and allergic reaction to bee stings. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received diazepam (VALIUM) for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER7534) via an unspecified route of administration in the left arm on 24Mar2021 at 10:15 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 10:30, the patient experienced hives all over middle area of back and stomach, left front area and lower right thigh. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with prednisone (MANUFACTURER UNKNOWN) and shot. The clinical outcome of the event hives all over middle area of back and stomach, left front area and lower right thigh was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
flacid, glassy eyed, mild sz-like activity w/& during t104;temp responded to advil;
Moderna COVID-19 Vaccine EUA Fever, chills, body aches, headache
20 patients received Adacel vaccine that had experienced delayed transit time, 11 hours over the recommended transit time, the shipment should have been received on 06-Jun-2019 but it was received on 07-Jun-2019 at 11:52 am; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves 20 patients who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine that had experienced delayed transit time, 11 hours over the recommended transit time, the shipment should have been received on 06-Jun-2019 but it was received on 07-Jun-2019 at 11:52 am lot number and expiry date not reported via unknown route in unknown administration site On an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.  Information on the batch number was requested.  List of documents held by sender: none.
menstrual cycle irregularities after receiving the COVID-19 vaccine and the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series complete, she is experiencing menstrual cycle irregularities after receiving the COVID-19 vaccine and the booster.), for COVID-19 immunization, reaction(s): "Menstrual cycle abnormal". The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "menstrual cycle irregularities after receiving the COVID-19 vaccine and the booster".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I'll start at the first dose because it's all related, however the events from the 2nd dose have been more profound.   1st dose 3.27.21 Pfizer Left arm- within 30 seconds a metallic taste in my mouth lasting about 5 hours. Arm soreness that is it.  2nd dose:  4.17.21 Same arm for injection.  within 30 seconds metallic taste in my mouth lasting 24 hours about an hour later my tongue felt like I had eaten 10 ghost peppers - this lasted another 24 hours, reappearing off and on for a few days -by Wednesday 4/21/21 the burning subsided.    On 4/22/21, I started to feel off, but was able to work.  At approximately 4:00pm, I turned away from a coworker to grab a pen - nothing unusual, no swift moves,  when the world started spinning and the floor felt unstable, I grabbed the counter but that felt like it was moving.  My coworker sat me down, within an hour I was  better.  I have had many dizzy spells since but nothing as epic as today where I was sent home.  My session is running out so that's about all I can say.
Patient described of an elevated Heart Rate of 103-110 BPM for a few days post vaccination.
Syringe used for vaccine administration (at end of administration needle) hub broke off from syringe. All vaccine went in. Needle and hub removed from patients arm. No adverse effect