chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is an initial spontaneous report by a contactable Physician. This Pfizer Sales Representative reported on behalf of a Physician. A 29-month-old male patient received a dose of PREVNAR 13 on 10Aug2010 (lot number E60220) (age 12-months). The patient had previously received 3 doses of PREVNAR 7 on 22Sep2009 (lot number D48927/first dose at age 2-months), 08Dec2009 (lot number D59304/second dose at age 4-months) and 09Feb2010 (lot number D59304/third dose at 6-months). Past vaccine history included 3 doses of Hepatitis B vaccine on 24Jul2009, 24Sep2009 and 09Feb2010; 3 doses of PENTACEL on 22Sep2009, 08Dec2009 and 09Feb2010 and 2 doses of ROTARIX on 22Sep2009 and 08Dec2009. Relevant medical history and relevant concomitant medications were unknown. Vaccines given on the same day (10Aug2010) included Hepatitis A vaccine, MMR and Varicella virus vaccine. Concomitant vaccines included 3 doses of FLUZONE administered on 26Oct2010, 14Dec2010 and 13Oct2011, a 2nd dose of Hepatitis A vaccine on 15Feb2011 and a 4th dose of PENTACEL on 26Oct2010. Vaccines taken within the last four weeks were unknown. On 12Jan2012, following vaccine administration, the patient experienced pneumococcal sepsis. Relevant laboratory data was unknown. Treatment included unspecified intravenous antibiotics. On 14Jan2012, the patient recovered from the event. The reporter commented: Causal Relationship: PREVNAR 7 and PREVNAR 13 did not prevent infection. Follow up (19Mar2012): New information reported from a contactable physician includes: Patient details (updated age), product details, concomitant vaccines and past vaccine history, event details including onset and recovery dates, treatment modalities, recovery status, and reporter comment.
Diarrhea; Left arm pain; Nausea; This is a spontaneous report received from a contactable consumer (patient). This 60-Year-old female consumer reported for herself. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW2245) via an unspecified route of administration in arm left on 09Feb2021 10:00 AM as dose 1, single (age at vaccination: 60 years) for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. Historical vaccine includes flu shot from an unspecified date Sep2020 to an unspecified date Sep2020. History of all previous immunisation with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunisations if dates of birth or immunisations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations within 4 weeks was none. On 09Feb2021, the patient experienced left arm pain, nausea. On 10Feb2021, had diarrhoea. It was stated that she was having a little bit of a side effect after receiving the COVID-19 Vaccine, her arm feels better, but she was nauseated and had diarrhoea. She knows she should go to her doctor if the side effects keep up and if there was anything else, she can really do for her COVID-19 Vaccine side effects, and will she go through the same side effects again with her second COVID-19 Vaccine dose in a couple weeks. Reported her roommate called to an emergency room to ask questions about her side effects, but the emergency room staff said they could not give her any information over the phone. Her left arm pain started at around 8:00PM last night, diarrhoea started this morning, and her last episode of diarrhoea was about an hour ago at 10:00AM. Treatment received was for the pain in her left arm she took aspirin and pain medicine. She said she put a warm water bottle on her left arm last night and left the warm water bottle on her arm all night. This really helped with her left arm pain. She took 2 Medline Ibuprofen 200mg (brown) tablets (NDC: Unknown Lot: WJO7688 Expiration: Mar2022) and gericare Aspirin 325mg as needed for pain (UPC: 5789690101 Lot: P120438 Exp: May2022) and had previously taken the Gericare Aspirin 325mg, as needed, for pain. Reported she goes to a clinic, and sees whatever doctor was available, so she does not have a set doctor. The adverse event did not require a visit to emergency room, physician Office. The clinical outcome of the event diarrhoea was not resolved and rest of the events was resolving.  Follow-up attempts completed. No further information expected.
Swelling in shoulder, supraclavicular area around neck. Painful shoulder developed over few days. Pain persistent in shoulder at injection site and in subacromial area.
This case was reported by a healthcare professional and described the occurrence of nausea in a 22-year-old female subject who was vaccinated with TWINRIX, (GlaxoSmithKline).  Concurrent vaccination included MMR vaccine (Merck) administered on 30 November 2007, subcutaneously, in the right arm.  Previous vaccination included ADACEL (TDAP) given on 26 November 2007 in the left arm.  The subject experienced chills and fever one day following vaccination with ADACEL.  These events were said to have resolved.  On 30 November 2007 the subject received 1st dose of TWINRIX at 1.0 ml, intramuscularly in the right arm.  On 30 November 2007 (at 19:30), about 3 to 4 hours after vaccination with TWINRIX (and MMR vaccine), the subject experienced nausea, vomiting and fever.  The events reportedly resolved by 02 December 2007.
fatigued; feeling pain; headache; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued), MYALGIA (feeling pain), HEADACHE (headache) and CHILLS (chills) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Shellfish allergy and Drug allergy (codeine and lipitor). Concomitant products included FENOFIBRATE, OXYBUTYNIN, AMILORIDE, AMLODIPINE, POTASSIUM CHLORIDE, LOSARTAN, OLOPATADINE, CALCIUM CITRATE, IRON, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), FLUTICASONE PROPIONATE (FLUTICASONE [FLUTICASONE PROPIONATE]) and NITROGLYCERIN for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigued), MYALGIA (feeling pain), HEADACHE (headache) and CHILLS (chills). At the time of the report, FATIGUE (fatigued), MYALGIA (feeling pain), HEADACHE (headache) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also included "Nitro SR".  Patient reported that she drank water, diet coke, and cranberry juice. She wanted to know if she could take Tylenol to relieve her symptoms or not. Patient was scheduled for the second dose on 08-Apr-2021. Treatment details were not provided.
83 yo c/o dizziness and blurred vision 15 minutes after receiving his 2nd dose of the Pfizer vaccine. Patient stated to staff member that after he stood up he felt like passing out. Patient was escorted to the triage area where he was evaluated by on-site EMS and NP.  Vital signs and EKG initiated . BP elevated. Patient states he has not taken morning BP meds which may be causing the elevation.  Patient has a PMH of HTN. Allergic to Pollens and Perfumes. After about 15 minutes, BP decreases and patient states he's feeling better. Patient agreed to leave and have daughter drive him home.
Pericardial effusion 11-20-09 --> present. Night temperature, sweating, pain in rib cage.
Starting around April 15 I began developing right ankle pain and then in moves into knee pain and the knee pain and joint pain over time it  got worse where I can barely go up or down stairs straighten my legs or ankles or even walk and it moved into my wrist my jaw my lower back and at night it?s the worst where I can barely move in bed and if I do I?m in awful pain all over my body in order to work and sleep I need to take over the counter pain killers.  I?m also very fatigued all the time and it?s making my job as a city firefighter almost impossible.
Patient received second dose of Covid vaccine while bedded as inpatient on 5/6/21. The first dose received was Moderna at outside facility on 4/7/21 Lot 044A21A  but the second dose received while bedded as inpatient was Pfizer. Lot EW0158.
Redness, Swelling, stiffness in hands and wrist then noticed thigh about 30m minutes later as well as itching at that time and bumps/swelling on forear,.
Patient felt warmth in his arm and became faint. He had his eyes open and remained sitting, but became pale and not responding appropriately. He was reclined with his feet up, cold cloth and returned to normal rather quickly.  His vitals were withing normal limits, drank water, was observed x 30 minutes. His mother, who was present the entire episode, stated he has had a sililar reaction to a previous routine vaccine. Instructed to contact Primary Care MD to discuss further immunizations. Patient walked out with his mother feeling fine.
Severe chills followed by sweating the next day; headache; fatigue; nausea; feeling faint; large red, warm blotch near injection site
1. I had Covid Arm, rash around injection site- still there. - No Treatment  2. Pain under my arm in my armpit area on the same arm as injection.- No treatment 3. right side of my neck i had an enlargement of my lymphoid, 3x2 cm- saw my Dr and was proscribed Bactrim and has ultrasound done.
Patient received their 1st Moderna Covid vaccine on 8/30/2021. Patient received their second Moderna Covid vaccine on 9/20/2021. The vaccine was given out of interval. It was administered 21 days apart rather than 28 days apart. No adverse reactions were noted.  Patient was informed of event.
a heart attack after warming up; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional (hcp).  This case involves a 40-year-old patient (unknown gender) who experienced a heart attack after warming up while receiving vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation: unknown) (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on the batch number was requested.  On an unknown date the patient developed a serious event of, heart attack after warming up (myocardial infarction) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (a heart attack after warming up).  At time of reporting, the outcome was Unknown for the event a heart attack after warming up.; Sender's Comments: Sanofi company comment dated 07-Feb-2022: This case concerns a 40-year-old adult patient who experienced a heart attack after warming up, after vaccination with Influenza Vaccine. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed
pt recvd vax; 11aug95 broke out on rash of approx 40 lesions;
10 days after vaccine administration, fever with rash started. Faint erythematous papules on chest, left thigh with vesicular lesion
Acute onset (within 26 hours of booster shot) RIGHT supraclavicular lymphadenopathy, with one single palpable lymph node of ~5-7mm, tender to palpation and mobile (i.e not fixed).
heart attack; Short breaths; My left side of my chest was being stabbed; My left breast I wanted to rip out; pain; the patient received third dose; This is a spontaneous report from a contactable consumer (patient). A 38-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: 32030BD), via an unspecified route of administration, administered in arm left on 11Nov2021 at 18:00 (at the age of 38-years-old) as dose 3 (booster), single for covid-19 immunization.  Medical history included allergy to mango and generic depo, endometriosis and autoimmune thyroiditis from an unknown date and unknown if ongoing. The patient previously received other vaccine in four weeks which included flu shot on 28Oct2021. Concomitant medications included unspecified other medications in two weeks. Prior to vaccination, the patient was not diagnosed with covid-19. The patient historical vaccines included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number Er8729), via an unspecified route of administration, administered in arm left on 18Mar2021 as dose 1, single for covid-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number Er8729), via an unspecified route of administration, administered in arm left on 08Apr2021 as dose 2, single for covid-19 immunization. On 11Nov2021 at 18:00, the patient received third dose of vaccine (coded to booster). On 11Nov2021 at 22:00, the patient thought she was having a heart attack, her left side of chest was being stabbed. She wanted to rip out her left breast. She had short breaths. Next day she could not say full sentences and was still in pain, but better. The patient underwent lab test and procedures which included sars-cov-2 test (nasal swab): negative on 05Sep2021. The patient did not receive any treatment. Device date was reported as 13Nov2021. The outcome of the event pain was recovering and for all other events was unknown.  Follow-up attempts are completed. No further information is expected.
inflammation of my left, behind my boob; had a 1.1 centimeter lymphadenopathy; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF2593, Expiry date: unknown) via an unspecified route of administration on 20Oct2021 as dose 3 (booster), single for COVID-19 immunization. Medical history included pulmonary embolism from an unknown date and unknown if ongoing, patient is a cardiac patient from an unknown date and unknown if ongoing. Patient previously took first dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient's concomitant medications were not reported. On unspecified date of Oct2021 the patient experienced inflammation of my left, behind my boob and had a 1.1-centimetre lymphadenopathy and on 20Oct2021 the patient had his booster dose and off-label use. Patient just got home from a visit to emergency room and one of the things that was going on and patient had these things in list as possible side effect. Patient read about it around the injection site, surrounding the injection site, maybe the arm but this in patient's boob. The outcome of events was unknown.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; ALLERGIC REACTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with additional information on 17-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, premature ventricular contractions, arrhythmia, several food allergy, and seasonal allergies. The patient was previously received two doses of Pfizer (tozinameran) (Dose number in series: 1) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on 16-JAN-2021 12:00 on left arm and second dose on 19-FEB-2021 10:00 on left arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with two doses of Pfizer (tozinameran) (Dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 16-NOV-2021 11:00 on left arm for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection and had suspected clinical vaccination failure (Dose number in series: 2). Patient took Paxlovid (Ritonavir/nirmatrelvir) (batch number: FY6859) for covid-19 treatment first dose on 06-MAY-2022 and second dose on 07-MAY-2022. After 16 hours of first dose of Paxlovid which was on 07-MAY-2022, the patient experienced asthma like breathing problems, itching in throat, swelling in throat, itching in mouth, and swelling in mouth (allergic reaction) (Dose number in series: 2). It was stopped after taking 2 doses of Paxlovid. Treatment medications (dates unspecified) included: Benadryl (diphenhydramine hydrochloride), Zyrtec (cetirizine hydrochloride), PepsideAC (Peptides) and Albuterol (salbutamol). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from allergic reaction on 08-MAY-2022, and the outcome of suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220526451.; Sender's Comments: V0- 20220530409 -COVID-19 VACCINE Ad26.COV2.S- Suspected Clinical Vaccination failure- The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
sinus is completely stuffed and; Doesn't feel good; Body Aches; Aches; feels like he has covid; Diarrhea; (sinus) flutters; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus is completely stuffed and), FEELING ABNORMAL (Doesn't feel good), PAIN (Body Aches), PAIN (Aches) and COVID-19 (feels like he has covid) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 026A2114) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE, SUCRALFATE and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-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 SINUSITIS (sinus is completely stuffed and), FEELING ABNORMAL (Doesn't feel good), PAIN (Body Aches), PAIN (Aches), COVID-19 (feels like he has covid), DIARRHOEA (Diarrhea) and SINUSITIS ((sinus) flutters). At the time of the report, SINUSITIS (sinus is completely stuffed and), FEELING ABNORMAL (Doesn't feel good), PAIN (Body Aches), PAIN (Aches), COVID-19 (feels like he has covid), DIARRHOEA (Diarrhea) and SINUSITIS ((sinus) flutters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information  provided
This spontaneous case reported by a consumer, describes the occurrence of unexpected therapeutic response (now she has no gouty arthritis pain) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's medical history included gouty arthritis. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient had an unexpected therapeutic response (now she has no gouty arthritis pain). At the time of the report, unexpected therapeutic response (now she has no gouty arthritis pain) outcome unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Information has been received from a certified medical assistant concerning a patient who on 03-MAY-2010, was vaccinated inadvertently with a 0.5 ml SC dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). The Medical Assistant stated that this was staff error and not product confusion. No adverse effect was reported. It was unknown if the patient sought medical attention. Follow up information has been received which reported that there was no adverse event to report. Additional information is not expected.
c/o body aches, rash, vomiting and diarrhea - was prescribed prednisone by mouth x 5 days
SIDE EFFECTS; This spontaneous report received from a patient via company representative concerned a patient of unspecified age, sex, race and ethnicity. 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 (Dose number series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced very minimal side effects (Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s, was not applicable. On an unspecified date, the patient received additional non-company suspect vaccine Tozinameran shot (Pfizer) (Dose number in series 2) (form of admin, route of administration, batch number and expiry were not reported) dose was not reported, administered for prophylactic vaccination.  On an unspecified date, following vaccination with Tozinameran shot, the patient experienced bad side effects (Dose number in series 2). The action taken with tozinameran was not applicable. The outcome of side effects was not reported. This report was non-serious.
Tested positive for COVID-19 (routine test) for placement at inpatient rehab 8/18/2022 PCR (asymptomatic).
There was no reactions report from parent. Mistake was caught by staff here while reviewing records and inventory.