chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness; Smells gasoline; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), DIZZINESS (dizziness) and PAROSMIA (Smells gasoline) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for Hypertension, MULTIVITAMINS, VITAMIN B COMPLEX, VITAMIN E NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) and CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE VIT) for Supplementation therapy, LEVOTHYROXINE for Thyroid activity decreased.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 27-Feb-2021, the patient experienced DIZZINESS (dizziness) and PAROSMIA (Smells gasoline). On 25-Feb-2021, PAIN IN EXTREMITY (arm soreness) had resolved. At the time of the report, DIZZINESS (dizziness) and PAROSMIA (Smells gasoline) had resolved.            No treatment was provided. The patient informed that had the symptoms from first vaccination as stated in the report. They only lasted for a few hours and then subsided. The patient did not have any symptoms (other than sore arms after both shots) after second Moderna vaccination   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Additional information  received on 29 Apr-2021 contains updated event outcome. On 13-Jul-2021: Follow up information received on 13 Jul-2021 contains updated event outcome.
Immediately afterward throat swelled and had burning sensation  Also had extreme muscle aches Mild fatigue Headache  Site injection pain
Starting 2 weeks after second covid moderna dose patient started with eczema on neck and it spread to her entire body.  Still unchanged , covering entire body, 4 months later
This spontaneous report was received from the registered nurse regarding female patient who on 10-JUN-2014 at 10:46 A.M was vaccinated with improperly store first dose of RECOMBIVAX HB (Thimerosal Free) (lot # J012520, expiration date 30-JAN-2016) intramuscularly. The reporter stated that, on unspecified dates (between May 14 and July 21, vaccine storage temperature dropped to 0-1 degree in 18 different episodes, and that according to minimum and maximum, all recorded temperatures were supposed to be between 2-8. The patient did not seek medical attention. Additional information is not expected because all follow up information was received.
Per parent's report (both=MD's) hive-like/circular rash at LUE ( approx 1-1 1/2 weeks post vaccination) followed by mibarin type rash at neck, chest, upper back. Treated with Zyrtec only.
Client states he felt dizzy and fell off chair.  He had head cradled in hands but did not hit his head.  Incident was witnessed by staff.  He regained consciousness within 10 seconds.  Laid him on back and feet elevated.  BP 138/82, P92, RR24. EMS on site.  He was able to stand with minimal assist to walk to gurney.  No distress.  A&Ox3.  Transported via ambulance to Medical Center at 2:37pm.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 79-year-old male patient who received SHINGRIX (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis. On 22nd June 2018, the patient received the 1st dose of SHINGRIX. On 24th June 2018, 2 days after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The healthcare professional reported that the patient experienced injection site reactions that radiated down to his elbow. For tolerance to 2nd dose refer linked case US2018GSK159189 for the same patient.
14JUN94 pt recvd vax 815AM; 17JUN94 began low grade temp no other sx; 20JUN94 t103-took to MD & unable to find cause of fever; pt lethargic 26JUN94;  27JUN94 pt irritable; dx osteomyelitis-viral; refused to bear weight, ambulate;
Child laid down for a few minutes in the morning. She then began to shake and say she was cold. She then proceeded to vomit 2 times. After this she was cold and laid down for approximately 5 minutes. She was then okay for the rest of the day.
Received the Moderna COVID-19 Vaccine and all had the same problems and that one of them died last week; All had the same problems; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Received the Moderna COVID-19 Vaccine and all had the same problems and that one of them died last week) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Received the Moderna COVID-19 Vaccine and all had the same problems and that one of them died last week) (seriousness criteria death and medically significant) and VACCINATION COMPLICATION (All had the same problems). The patient died in October 2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, VACCINATION COMPLICATION (All had the same problems) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious event of Death (unknown cause). The event occurred an unknown number of days after tan unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious event of Death (unknown cause). The event occurred an unknown number of days after tan unspecified dose of mRNA-1273 vaccine.The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
PT RECEIVED 1ST PFIZER COVID VACCINE ON 5/5/21 (LOT ER8736), ACCIDENTALLY RECEIVED 2ND PFIZER COVID VACCINE EARLY TODAY 5/19/21 (LOT EW0179).  DISCOVERED EARLY 2ND DOSE 5 MINUTES AFTER GIVEN. PT IS FEELING FINE.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 72-year-old female patient who received SHINGRIX (batch number MG42F, expiry date 29th May 2021) for prophylaxis. On 14th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In January 2019, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site induration, injection site discoloration, injection site warmth, injection site pain and injection site erythema. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the injection site induration, injection site discoloration, injection site warmth, injection site pain and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, injection site induration, injection site discoloration, injection site warmth, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The batch number was updated from NG42F to MG42F as per sales data sheet. The pharmacist reports that the patient got her 2nd dose of SHINGRIX on Monday and She had flu like symptoms for a day or so, but those have resolved. The patient currently has a hard area on her arm where she got the vaccine that was red, except for being purple in the middle, and hot to the touch. The patient arm was also sore.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored VAQTA (lo#, expiration date, dose and route were unknown). No adverse effects was reported. This is one of several reports from the same reporter. Additional information has been requested.
Starting that night post vaccine - discomfort in upper right quadrant of abdomen.  This continued and worsened in the coming days. Pain also in my back/shoulder blades but mainly abdomen. Pain and discomfit seemed to have subsided about 2 weeks later but then reoccurred.
Acute febrile illness, following vaccination, acute diarrhoea and vomiting requiring admission for rehydration (4/7/16-4/10/16). Hematochezia on 4/15.16. Admitted to PICU (4/7/16-4/9/16), Discharged home on 4/10/16.
Right eye turned blood red; the eye ball itself was swollen; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (a family friend) that: A 59-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8730,) via an unspecified route of administration, in left arm on an unspecified date in Apr2021 12:30 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization at Public Health Clinic. The patient medical history included prediabetic from an unknown date. The patient was not pregnant at the time of vaccination. The patient concomitants were included berberine (BERBERINE), cinnamon (CINNAMOMUM VERUM), ascorbic acid, zinc (ZINC C) and ascorbic acid (VITAMIN C ACID) all were taken for unknown indication, start and stop were unspecified date. The patient had previously received TETRACYCLIN and TERRAMYCIN after both drugs experienced allergy. The patient did not receive any vaccine within four weeks. The patient did not suffer from covid prior vaccination and did not underwent any covid test post vaccination. On Apr2021 12:00 AM the patient had experienced Right eye turned blood red and the eye-ball itself was swollen. It was reported that, Right eye turned blood red, no pain though. Next day the eye-ball itself was swollen, especially at the interior corner of eye. Still no pain. No discharge. Eye doctor could find no indication of anything in eye. Not allergies. Left eye was fine. This occurred 2 weeks past 1st vaccine. Doctor finally put me on Prednisone which helped. Both my father, a family friend and another patient at same doctor office all experienced same thing. We would not have attributed it to the vaccine if we had not been talking and realized we all had same symptoms, same time frame past vaccine for symptoms to show up and Pfizer vaccine. The patient received Fluorometholone and then Prednisone as treatment for the adverse events. The clinical outcome of the events was reported as unknown.  No follow-up attempts are needed. No further information is expected.
Patient got BEXSERO instead of MENACTRA; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB57AA, expiry date 31st August 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th December 2021, the patient received Bexsero (intramuscular) .5 ml and Bexsero Pre-Filled Syringe Device. On 14th December 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: Health care professional reported that, the patient was accidentally given Bexsero instead of Menactra, which led to wrong vaccine administered. The reporter consented to follow-up.
there was broken glass and she was punctured by a sliver of glass in her right index and middle finger; Accidental exposure to product; circumstance or information capable of leading to medication error; now has a Bump on her right middle finger.; Caller had rambled, pressured during call; Caller had rambled, pressured during call; there was broken glass and she was punctured by a sliver of glass in her right index and middle finger/ PQC Present?: Yes; This spontaneous report was received from a female patient of unknown age, referring to herself. The patient was not pregnant. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies.  In approximately 04-NOV-2021 (reported as on 04-NOV-2021 or 05-NOV-2021), the patient found vials of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # U019905, expiration date reported as 21-JUN-2023, but upon internal validation established as 24-JUN-2023), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot# T034380, expiration date reported as 08-OCT-2022, but upon internal validation established as 08-JAN-2022) and sterile diluent (MERCK STERILE DILUENT) (all suspects strength, dose detail were not reported, indication for vaccines was captured as prophylaxis) in a dumpster while looking through the dumpster and there was broken glass (product container issue). She was not looking for the vial and found them by accident. The patient was punctured by a sliver of glass in her right index and middle finger (accidental exposure to product and circumstance or information capable of leading to medication error). On an unknown date in November 2021, she had a bump on her right middle finger. The patient had rambled, pressured speech during call (onset date unspecified, captured as unknown dates in November 2021). No treatment was given to the patient. The patient didn't seek medical attention. The patient was suggested to take vials to closest pharmacy and request them to dispose of vials. It was reported that the products were unable to return. The outcome of the events was unknown. The causality assessment was not reported.
I was forced to get the Vaccine for my job but what I am looking that I keep feeling some weird palpitation is going on in my heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "I was forced to get the Vaccine for my job but what I am looking that I keep feeling some weird palpitation is going on in my heart".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
experiencing some weakness/ but feel kind of weak; Not feeling well; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (experiencing some weakness/ but feel kind of weak), MALAISE (Not feeling well) and CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-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 ASTHENIA (experiencing some weakness/ but feel kind of weak), MALAISE (Not feeling well) and CHILLS (chills). At the time of the report, ASTHENIA (experiencing some weakness/ but feel kind of weak), MALAISE (Not feeling well) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.  No Concomitant medication was reported.  No lab data was provided.
"15-20 minuets after receiving the vaccine my chest hurt, felt like something opened up."; " Felt wired and couldn't sleep at all."; " I was wheezing and I thought something is wrong or different than normal."; "My allergies are apposite from normal, Bronchial."; "I got chills"; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN ("15-20 minuets after receiving the vaccine my chest hurt, felt like something opened up."), SLEEP DISORDER (" Felt wired and couldn't sleep at all."), WHEEZING (" I was wheezing and I thought something is wrong or different than normal."), ASTHMA ("My allergies are apposite from normal, Bronchial.") and CHILLS ("I got chills") in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy (states that her seasonal allergies are normally nasal and sinus related. After receiving the vaccine "My allergies are apposite from normal, Bronchial.). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 08-Apr-2021, the patient experienced CHEST PAIN ("15-20 minuets after receiving the vaccine my chest hurt, felt like something opened up."), SLEEP DISORDER (" Felt wired and couldn't sleep at all."), WHEEZING (" I was wheezing and I thought something is wrong or different than normal."), ASTHMA ("My allergies are apposite from normal, Bronchial."), CHILLS ("I got chills") and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE (KENALOG 40) at an unspecified dose and frequency. On 08-Apr-2021, CHEST PAIN ("15-20 minuets after receiving the vaccine my chest hurt, felt like something opened up.") had resolved. On 14-Apr-2021, SLEEP DISORDER (" Felt wired and couldn't sleep at all."), WHEEZING (" I was wheezing and I thought something is wrong or different than normal."), CHILLS ("I got chills") and PYREXIA (fever) had resolved. At the time of the report, ASTHMA ("My allergies are apposite from normal, Bronchial.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient became lightheaded & not able to think clearly; BP elevated to 150/84 mmHg.  Patient given benadryl 50mg IM at 845am.  Skin noted to be clammy and warm.  Patient seen by MD and given epipen injection at 913am.  Patient reported that her head cleared and was able to think better after epipen injection.  BP noted to be 140/80 mmHg and HR 75 beats/min.  O2 sat stable at 97-99%. Patient transported to ER.  No further interventions needed.
after the 1st dose I could barely bare weight, stand up and walk for over a week; chills; sweats; headaches; fever; tingling throughout body; tiredness; muscle weakness; Delayed & inconsistent menstrual cycles; Forgetfulness; migraines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Feb2021 (Lot number: EL3246) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Shellfish" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSSTASIA (non-serious) with onset Feb2021, outcome "not recovered", described as "after the 1st dose I could barely bare weight, stand up and walk for over a week"; CHILLS (non-serious) with onset Feb2021, outcome "not recovered", described as "chills"; HYPERHIDROSIS (non-serious) with onset Feb2021, outcome "not recovered", described as "sweats"; HEADACHE (non-serious) with onset Feb2021, outcome "not recovered", described as "headaches"; PYREXIA (non-serious) with onset Feb2021, outcome "not recovered", described as "fever"; PARAESTHESIA (non-serious) with onset Feb2021, outcome "not recovered", described as "tingling throughout body"; FATIGUE (non-serious) with onset Feb2021, outcome "not recovered", described as "tiredness"; MUSCULAR WEAKNESS (non-serious) with onset Feb2021, outcome "not recovered", described as "muscle weakness"; MENSTRUAL DISORDER (non-serious) with onset Feb2021, outcome "not recovered", described as "Delayed & inconsistent menstrual cycles"; MEMORY IMPAIRMENT (non-serious) with onset Feb2021, outcome "not recovered", described as "Forgetfulness"; MIGRAINE (non-serious) with onset Feb2021, outcome "not recovered", described as "migraines". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysstasia, chills, hyperhidrosis, headache, pyrexia, paraesthesia, fatigue, muscular weakness, menstrual disorder, memory impairment, migraine. Additional information: If other vaccine in four weeks: No. Adverse event: Numbness and tingling in my legs from the waist done. Daily headaches/migraines. Forgetfulness. Delayed & inconsistent menstrual cycles. with both the 1st & 2nd dose within 10 mins of it being administered I had chills, sweats, headaches, fever, tingling throughout body, tiredness, muscle weakness, - these lasted over a week for both doses. after the 1st dose I could barely bare weight, stand up and walk for over a week. Adverse events start time: 03:15PM. No covid prior vaccination. If covid was tested post vaccination. Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200130355 similar report from same reporter
Area left thigh adjacent to shot site pink, swollen and warm, but not tender. Has full range of motion.
Patient had fever spike of 99.1 degrees to 105 degrees within 25 minutes.
43 year old patient received Shingrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 43-year-old female patient who received Herpes zoster (Shingrix) (batch number 94B7F, expiry date 25th May 2022) for prophylaxis.   On 3rd August 2021, the patient received the 1st dose of Shingrix. On 3rd August 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The nurse reported that 43 year old patient received Shingrix and confirmed that the patient did not present any risk of zoster due to immunodeficiency or inmunosupression caused by known disease or therapy, which led to inappropriate age at vaccine administration. The reporter consented to follow up.