chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; fatigue; body aches; This is a spontaneous report from a contactable consumer (patient himself) via COVAES. A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in arm left on 17Feb2021 13:00 as dose 2, single for COVID-19 immunisation (at the age of 60-year-old). Medical history included stage 0 CLL. Concomitant medications included vitamin d [vitamin d nos], ubidecarenone (COQ10 [UBIDECARENONE]), cyanocobalamin (VIT B12), atorvastatin (LIPITOR [ATORVASTATIN]), diclofenac, minerals nos and vitamins nos (CENTRUM [MINERALS NOS; VITAMINS NOS]). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in arm left on 27Jan2021 13:015 as dose 1, single for COVID-19 immunisation. The patient previously also took doxycycline, tetracycline and experienced known allergies. The patient did not take any other vaccine in four weeks. The patient did not have COVID prior vaccination and not tested for COVID post vaccination. On 18Feb2021 04:30, the patient experienced headache, fatigue and body aches. Timeframe between vaccination and starting of symptoms was 15 hrs 30 min. The patient did not receive any treatment for adverse events. The outcome of the events was not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Contracting pneumonia; bacteria they found was the ''Achromobacter xylosidans sub specie''; Can't hardly breathe; 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 female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (hospitalization), outcome "unknown", described as "Contracting pneumonia"; ACHROMOBACTER INFECTION (hospitalization), outcome "unknown", described as "bacteria they found was the ''Achromobacter xylosidans sub specie''"; DYSPNOEA (non-serious), outcome "unknown", described as "Can't hardly breathe".  Clinical course: Caller said that she got Prevnar 13 and Prevnar 20 but still end up contracting pneumonia twice and they found a rare bacterium. Caller said that the bacteria they found was the ''Achromobacter xylosidans sub specie'' which is a blood resistant, and usually cause cystic fibrosis. Caller stated that she got pneumonia 1 year and 4 months ago, and was hospitalized for 9 and a half days, year later she contracted pneumonia again, they found that on her both Pneumonia the causative agent was the ''Achromobacter xylosidans''. Caller said that she is now considered as ''colonizer'', no cystic fibrosis, can't hardly breathe. Caller asked the reason why she got contracted pneumonia even though she got the Prevnar 13 and Prevnar 20.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300159856 same patient/AE, different drug;
Itchy red rash about the size of a silver dollar (started as small bumps and grew in size over the past few hour hours at the injection site
This spontaneous report was received from a nurse and refers to a 10-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 02-OCT-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection, intramuscularly (exact dose was not reported), lot # N009173 with expiration date on 20-NOV-2019, concomitantly with influenza virus vaccine (manufacturer unknown) (exact dose, route of administration, lot# and expiration date were not reported). Both vaccines were administered in the left deltoid for prophylaxis. On 16-OCT-2017 (reported as '2 weeks later'), the patient developed viral warts on the right forearm. Patient returned to physician's office and was referred to the dermatologist. Patient was seen by the dermatologist on an unspecified date and had the warts burned off. The outcome of the event was reported as recovered on an unspecified date. The relatedness between the event and GARDASIL 9 and influenza virus vaccine (manufacturer unknown) was not reported.
Pt reported red, swollen, painful, hot area around injection site 6 days after receiving shingrix vaccine.  Pt was advised to see PCP to rule out infection.  MD determined it was an vaccine reaction and ruled out infection, pt was prescribed steroid cream.
Just a gradual increase in blood pressure over time. Don't feel bad, still exercise and have always had low blood pressure. But it started going up and now... 2 more Moderna COVID vaccine doses later (last was 10/9/2022) the BP went up over 180. So on three meds that are not working to bring down the BP (Losartan 100mg, Amlodipine 5mg, and Bystolic 20mg). Take BP 2x a day and it's still in the 150/95 range.  I don't know that this is all related to the vaccine but these symptoms did start after taking the 2nd booster in March 2021.
This spontaneous report was received from a Registered Nurse via company representative and refers to a female patient of 7 years old. Patient's pertinent medical history include sulfonamide allergy. The patient had no other pertinent medical history. On an unknown date in 2006, the patient was vaccinated with a first dose of PNEUMOVAX 23 (dose, lot number and route were not reported). On 25-JAN-2016, the patient was vaccinated with a second dose PNEUMOVAX 23 intramuscular (dose, frequency, lot # and expiry date were unspecified by the reporter). Concomitant medication included ibuprofen. On an unspecified date in January 2016 (reported as 24 hours after vaccination) the patient experienced fever, chills, shaking and flu like symptoms. The reporter also stated that the patient sought medical attention on 28-JAN-2016, her body temperature was 103 F. It was reported that the patient had been sent to Doctor's office, for blood cultures to be drawn. In addition, on an unspecified date in January 2016, the patient experienced arm pain, swelling and redness at the injection site. At the time of this report, outcome of the events was not recovered. Additional information has been requested.
30 MINUTES AFTER RECEIVING IMMUNIZATION, PATIENT REPORTED DIZZINESS, SWEATING, HOT/FEVERISH, AND ELEVATED HR/BP. PATIENT RETURNED BACK TO IMMUNIZATION ROOM AND SAT FOR 30 MINUTES. PATIENT DRANK FLUIDS AND ATE FOOD. AFTER THAT 30 MINUTES PATIENT STATED THEY FELT BETTER. PATIENT'S WORKPLACE SUPERVISOR ADVISED THEY WOULD HAVE PATIENT PERFORM ONLY LIGHT WORK AFTER TAKING ANOTHER 1 HR BREAK. NO PARAMEDICS CALLED.
9:30 Headache at first and slight nausea. By noon I was light headed and sick to my stomach. Continued to feel bad. By 9pm- small hives at injection site; throwing up; fever, and sore arm. 2am- woke up with chills and fever and uncontrollable muscle spasms over my body. Sick to stomach and pain all over my body. Chest pain. Can?t move my left arm as it?s swollen and shoulder blade swollen. 8am next day- Lightheaded and can?t stand for more than a minute. Dizzy, high fever, vomiting, hives at injection site, headache, body pain all over. Can?t lift left arm up to dress or do anything.  Chest pain.
1:40 pt fel faint lowered self to floor;1:45 BP 92/62, P72, R20 skin cool clammy alert awake; 1:55 BP 118/62, P84, R16 juice given @ pts request walk to chair; 2:10 BP 118/62, P72;2:25 BP 100/78 walked around mall;2:40 BP 118/80;2:45 feelse
Patient developed bleeding, but stopped after a few minutes.  He also reported swollen arm which got much better today.  He mentioned it never happened to him before
12/15/2021 Scalp started itching 12/16/2021 Rash appeared on scalp, neck, face, groin, armpits, chest 12/17/2021 Face and scalp started swelling and this lasted for 3 more days of swelling before it started to recede.
Client's left arm swelled from shoulder to bend of elbow, red, with heat. Was going to go have doctor look at it.
No adverse event; a dose of the Moderna COVID-19 vaccine was given to one patient possibly on 6JAN2023 after the 30 day refrigeration period.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 vaccine was given to one patient possibly on 6JAN2023 after the 30 day refrigeration period.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 06-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 vaccine was given to one patient possibly on 6JAN2023 after the 30 day refrigeration period.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 vaccine was given to one patient possibly on 6JAN2023 after the 30 day refrigeration period.) 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 EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 vaccine was given to one patient possibly on 6JAN2023 after the 30 day refrigeration period.).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.
Approximately, two weeks after the vaccine, my lymph nodes on the side of my head under my sideburn, next to my ears, started to swell. They were painful to touch, I sought care at the clinic. The doctor looked at them and took a blood sample to determine if it was related to something else. My results were normal, and was told to allow it time to disappear. The swelling went down and I have not had a problem with them since June 2021.
on day of vaccination experienced "heavy duty shaking , HA, sore muscles, fever 101  - similar to symptoms of previous COVID+ event  S/S lasted 1 day -  Most concerning to patient  is the   insomnia and hallucinations he experienced  the night of the vaccine, none since
This spontaneous report as received from a nurse refers to unspecified number of patients. Their pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot# L042846, expiration date 15-SEP-2017 and lot# M033334, expiration date 11-AUG-2018 (dose and route of administration were not reported). Vaccines were stored at the temperature of 8.5 Celsius degrees for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 17-year-old patient of unknown gender. On 28-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N023828 (expiration date 25-JUN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Shaking like a leaf; Chills; Vomited; Diarrhea, it was so bad,; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea, it was so bad,), TREMOR (Shaking like a leaf), VOMITING (Vomited) and CHILLS (Chills) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia (had pneumonia several years ago), Memory impairment (medication for memory), Torticollis (torticollis medicine.) and Blood disorder (blood thinner medicine). Concurrent medical conditions included Hypertension (Blood pressure medicine,).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DIARRHOEA (Diarrhea, it was so bad,). On 20-Feb-2021, the patient experienced VOMITING (Vomited). On an unknown date, the patient experienced TREMOR (Shaking like a leaf) and CHILLS (Chills). At the time of the report, DIARRHOEA (Diarrhea, it was so bad,), TREMOR (Shaking like a leaf), VOMITING (Vomited) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines included medcines for  blood pressure, blood thinner, memory and torticollis. No treatment information reported.
lethargic; redness expanded; sore to touch; low-grade fever; pain in the arm; tender and sore to touch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), TENDERNESS (tender and sore to touch), LETHARGY (lethargic), ERYTHEMA (redness expanded) and INJECTION SITE PAIN (sore to touch) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event and Reaction to previous exposure to any vaccine (mild reaction to flu shot). Concurrent medical conditions included Drug allergy (Codein). Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) from 01-Jan-2015 to an unknown date for Insomnia, IBUPROFEN (ADVIL [IBUPROFEN]) and VITAMINS NOS for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), TENDERNESS (tender and sore to touch), ERYTHEMA (redness expanded), INJECTION SITE PAIN (sore to touch) and PYREXIA (low-grade fever). On 01-Feb-2021, the patient experienced LETHARGY (lethargic). On 06-Feb-2021, PAIN IN EXTREMITY (pain in the arm), TENDERNESS (tender and sore to touch), LETHARGY (lethargic), ERYTHEMA (redness expanded), INJECTION SITE PAIN (sore to touch) and PYREXIA (low-grade fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included Benadryl, ibuprofen for fever reducer, applied topical cortisone and Benadryl cream, hydroxyzine on prescription.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Added patient demographics, concomitant drug information added, updated event(s) onset date and stop date and updated outcome rom unknown to recovered, added 2nd dose information
IT MADE HAPPIER AND DANCE AROUND; This spontaneous report received from a patient concerned a female of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported for covid-19 prophylaxis. 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 it made happier and dance around (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of it made happier and dance around was not reported. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Colon cancer" (unspecified if ongoing); "known allergies: penicillian" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19; treatment with PAXLOVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2nd reaction- numb and tingling on right upper arm fingers, toes, foot, tongue and upper lip.  Moved to left side hand and foot with numbness, tingling. Today this still continues with hands and feet of numbness and feet
In the next morning pain in both eyes, inflammation in eyelids of both eyes, watery eyes, headache and pain to the touch.
woke up with mild vertigo for four days in a row had problems remembering words, which was obvious and not typical felt generalized confusion and foggy in the brain
Sore arm started early morning of the 17th, and fever started early afternoon on the 17th
The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 17Feb2016, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer on behalf of the patient. This contactable consumer reported similar events for three different patients. This is the second of three reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13 on 15Dec2015, at 0.5 ml single, in left shoulder. The patient medical history was not reported. Concomitant medication included vitamin b complex injection. The patient experienced thrush in mouth and nose in Jan2016 with outcome of not recovered (mouth and nose remain raw and red), chest pains on 16Dec2015 with outcome of not recovered, stomach pain on 16Dec2015 with outcome of not recovered, vomiting in Jan2016 with outcome of not recovered, was weak all the time and tired on an unspecified date with outcome of unknown, high blood pressure on unspecified date with outcome of unknown, lost 10 pounds on an unspecified date with outcome of unknown, nausea on an unspecified date with outcome of unknown, did not feel well on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of chest pains, stomach pain, vomiting, thrush in mouth and nose, nausea. No admission to hospital was involved.
warmness; Hardness; Redness; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmness), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PRURITUS (Itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L202) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warmness), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PRURITUS (Itchy). On 28-Jan-2021, VACCINATION SITE WARMTH (warmness), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included Ice packs.
PATIENT REPORTED HIVES, ITCHING, RELIEVED BY BENADRYL.
chills, t106, unable to breathe, leg & hip swollen, unable to walk; went to ER in Pm;
No additional AE; HCP reports that VARIVAX was administered to patient  with temperature excursion; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-FEB-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #w008712, expiration date: 14-MAR-2024, administered for prophylaxis (strength, dose number, and route of administration were not provided) (product storage error).  Administered dose of vaccine experienced the temperature excursion of 15.7 degrees Fahrenheit for 20 minutes.  No adverse event was reported.