chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient CALLED AND ASKED IF WE HAD J&J VACCINE IN STOCK. WE SAID YES AND SHE CAME BY TO GET THE SHOT. SHE FILLED OUT THE PAPERWORK. WE ASKED IF THIS WAS HER FIRST SHOT AND SHE SAID YES "IT WAS GOING TO BE HER FIRST J&J SHOT". WE CHECKED Database AND IT DIDNT SHOW THAT SHE HAD RECIEVED ANY COVID VACCINES. WE GAVE HER THE SHOT AND VACCINE CARD.  AFTER SHE RECEIVED HER VACCINE CARD SHE CONFESSED THAT SHE HAD GONE TO another facility FOR A J&J SHOT THAT MORNING BUT THEY GAVE HER PFIZER INSTEAD. SHE WAS TOLD TO COME BACK IN 21 DAYS AND SHE SAID SHE COULD NOT BECAUSE SHE NEEDED TO BE FULLY VACINATED.  SO SHE CAME TO OUR STORE TO GET THE J&J VACCINE. WE CALLED AND CHECKED ON HER LATER THAT AFTERNOON AND SHE SAID SHE HAD A HEADACHE. WE RECOMMENDED TYLENOL AND THAT SHE TAKE IT EASY FOR THE NEXT DAY OR SO AND TO NOTIFY US OR HER DOCTOR IF SHE HAD ANY OTHER SYMPTOMS.
At 11:19 am Client was extremely anxious prior to vaccination. After vaccination client had a syncope episode in the chair, head lowered feet elevated. VS taken, after a few seconds client was responsive juice and food provided. Client did not eat or drink for the day. VS monitored until completely oriented. escorted to waiting area with parents. Left at approximately 1pm  in good health.
general Malaise all day on Sunday; sore arm; nausea; Initial information was received on 07-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-Healthcare professional via Medical Information (Reference number-00757082).  This case involves a 11-year-old male patient who experienced sore arm (pain in extremity), nausea, general malaise (malaise), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 04-Sep-2021, the patient received a dose of 0.5 mL suspect INFLUENZA QUADRIVAL A-B VACCINE (suspension for injection, lot UJ685AA and expiry date was not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 04-SEP-2021 the patient developed non-serious nausea and sore arm (pain in extremity) (same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 05-SEP-2021, the patient developed non-serious general malaise all day on Sunday (malaise) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported " Caller reporting an adverse event that her son experienced after receiving a Fluzone Quadrivalent injection on Saturday. "Why did he experience a reaction this time and he has never had a reaction in the previous years? What is different? What can I do about his sore arm? Do it have anything to do with him receiving the vaccine at the clinic and not the pediatrician office? Are the flu shots the same? This is the first time ever he had such a reaction. He experienced nausea and next morning the nausea was gone. Plus his arm has been sore since Saturday and it is getting better now. He also experienced general Malaise all day on Sunday. Caller states that she used children's Tylenol Saturday and part of Sunday."  Details of laboratory data were not reported.  The patient received children's Tylenol for the events.  On 05-Sep-2021, the patient was recovered for the event nausea.  At time of reporting, the patient was recovering for the event sore arm, the outcome was unknown for the event general malaise.
This spontaneous report was received from a pharmacist via a company representative refers to a patient of unknown demographics. No relevant medical history of the patient was reported. On 28-AUG-2014, the patient was vaccinated with PNEUMOVAX23 (lot # J014399, expiry date: 20-NOV-2014) (strength, dose and route of administration were not reported). Other suspect  therapies included FLUZONE (strength, dose and route of administration, lot number and expiry date were not reported), administered on the same day. Concomitant medications were not reported. On an unknown date in 2014 the patient experienced flu like symptoms and could not sleep on his or her side because of the discomfort in the arm in which they received the PNEUMOVAX23. The patient came to the pharmacy on 02-SEP-2014, and the reporting pharmacist diagnosed the patients injection site reaction as cellulitis. It was unspecified whether the patient had received any treatment for the events. There was no product quality complaint involved. The outcome of flu like symptoms, injection site reaction cellulitis and could not sleep on his or her side because of the discomfort in the arm in which they received the PNEUMOVAX23 was unknown. The causality of the events was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
COMPLAINED OF SEVERE MACULOPAPULAR  RASH ON LEGS, DOWN ARM AND ALL OVER BODY;
Lethargy significant enough to require CT head, spinal tap, lab, etc. - 1/5/06 Review of 21-page medical record indicates initial assessment of lethargy and urinary tract infection treated with Rocephin. Low grade fever and sl. red left TM were also noted in while in hospital.
Event woke her up; feeling really bad; kind of sick at her stomach; fatigue, tired; really nauseous; Really, really sick; This is a spontaneous report received from a contactable consumer (patient). This contactable 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6198) via an unspecified route of administration in the right upper arm on 06Mar2021 at 13:30, reported as about 13:30 to 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes mellitus from 2001 and ongoing, high blood pressure from 2001 and ongoing, and chronic obstructive pulmonary disease from 2001 and ongoing. Concomitant medications were not reported; the patient stated she'd been taking them for years and they were not relevant to these events. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of BNT162B2 on 06Mar2021 around 13:30-14:00. She reported being really, really sick later that day on 06Mar2021 and called to inquire if this event could be related to the vaccine and asked if she had to get the same type of COVID-19 vaccine for both doses, or if she could get a different manufacturer's COVID-19 vaccine for the second dose. She reported really, really sick initially onset around 19:00-20:00 on 06Mar2021 and continued for 2 days, until around 08Mar2021 then she felt better. Starting 09Mar2021 around 19:00-20:00 she started feeling really, really sick again like she was on 06Mar2021. She was feeling really bad, kind of sick at her stomach, really nauseous, fatigued, and tired. The event woke her up around 06:30 on 11Mar2021. She further reported the ongoing event is about the same as initial onset, persistent. Regarding bloodwork performed about a month or so before being administered BNT162B2, approximately Feb2021, she reported that they had corrected her low iron and low B12. The events did not require hospitalization. The clinical outcomes of really, really sick, feeling really bad, kind of sick at her stomach, fatigue, tired, nauseous and event woke her up were not recovered.   Follow-up attempts are completed. No further information is expected.
pt recv vax 25FEB98 & 28FEB98 pt devel diarrhea, h/a, chills;
Small redness at site for 2 days, then all gone. Then 2/19/2021 Redness and swelling came back and is worsening daily
It was the needle it was "intravenous" (not clarified) I don't know when they bring it in; Left arm is swelled up like a big knot; Developed hives; developed rash  in my left arm where I took the vaccine; huge inflamed lump in my left arm where I took the vaccine; This is a spontaneous report from a contactable consumer. This 69-year-old female consumer(patient) reported for herself.  A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0180, Expiration date: unknown) in left arm on 07Jul2021 at 11:30 am (at the age of 69-year-old) as dose 1, single for COVID-19 immunisation. Medical history of the patient included high Blood Pressure and acid Reflux Disease. Concomitant medication included Bisoprolol for High Blood Pressure and Omeprazole for unspecified indication. On an unspecified date in Jul2021, the patient experienced Left arm is swelled up like a big knot and developed some tube rash, hives and it itches hardly bad, small amount of rash was inside the vaccination area; when broke up with hives it was like broken out on hand and in arm and then huge inflamed lump in my left arm where took the vaccine. Patient reported that" it was the needle it was "intravenous" (not clarified) I don't know when they bring it in" and "I had first dose on 7th July but Pharmacy says they have batches that went bad and have to get new batches of vaccine; I am scheduled to take second vaccine in August on coming Monday".  Patient was concerned if there was any reason for her not to take the vaccine or still it is safe to take the vaccine. It was reported that "Last year I had an extreme itching and adding at the hive make "popular" (not clarified) but it wasn't severe rash and I also use Isopropyl and the antiseptic I put it on that". Treatment was taken as benadryl  and Tylenol then warm compress on arm and used warm compress the arm and it was best thing happened and it helped a lot. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
extra dose administered; very weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (very weak) and EXTRA DOSE ADMINISTERED (extra dose administered) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery on 19-Feb-2021. Concurrent medical conditions included Colon cancer since 13-Feb-2021.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (very weak). On 18-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (extra dose administered). On 18-Mar-2021, EXTRA DOSE ADMINISTERED (extra dose administered) had resolved. At the time of the report, ASTHENIA (very weak) outcome was unknown.            On 18MAR2021, the rehab facility made a mistake to give her a third dose claiming that the 2nd dose she received was not documented.  Concomitant product use was not provided by the reporter. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.  Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, 8 doses of improperly stored ROTATEQ, orally (dose and lot number were not reported) had been administered to an unspecified number of patients. The temperature excursions were found to be supported excursions with in-house stability data. No adverse symptoms were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Tachycardia 5 minutes after injection... symptom lasted  for about 5 minutes and resolved. 35 minutes after injection, I developed mild tingling in my upper lip and I developed rhinorrhea... these 2 symptoms lasted about 5 minutes and resolved without further incidence. Pain at injection site ... was moderate pain for the  first few days and now just slightly tender 1 week after injection.
tingling a few hours after administration of vaccine and that the symptom has not resolved/from her elbow to her hand was tingling like she hit her funny bone; This is a spontaneous report from a contactable physician (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 28Dec2020, the patient experienced tingling a few hours after administration of vaccine and that the symptom has not resolved. She got her vaccine, and a few hours later, from her elbow to her hand was tingling like she hit her funny bone, and she was wondering if this was a known side effect of the vaccine. Clinical outcome of the event was not recovered.  Information on Lot/Batch has been requested.
rashes after the second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (rashes after the second shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rashes after the second shot). At the time of the report, RASH (rashes after the second shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
The adverse event took place at night after a normal day. I had dinner with my family and had done my usual activities that day. I was resting watching tv suddenly I had an accelerated heart rate, and I went took my Blood Pressure which was alarming. My Blood Pressure was 178/115. I called 911. I went to the Emergency Room and was there until 1am the morning. They ran tests and gave me medication to bring my Blood Pressure down. They gave me Norvasc 5 mg. Shortly after that event I had another event on July 11th that led me back to the Emergency Room. I followed up with a Cardiologist. I also had tennis elbow after my vaccine, and a rash on my back and one close to my armpit. Not as concerned as with the abnormal Blood Pressure.
stopped walking; had a high fever; rash; joint swelling; stopped forming speech for about 1 month; hypersensitivity reaction to MMR-II; This spontaneous report was received from a consumer and refers to a male.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On unknown date, the patient gad a hypersensitivity reaction to the vaccine after receiving first dose. The reporter stated that the patient stopped walking, had high fever, rash, joint swelling and stopped forming speech for about 1 month after receiving that first dose on unknown date. At the time of reporting, the outcome of the events were not known.  The reporter considered hypersensitivity reaction to MMR-II to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The causal relationship between the rest of adverse events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
The pt's right deltoid was swollen, hot, red and extremely painful lasting 2-3 days.
aches; Sore right arm; slight headache; fatigue; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 16:45 (Lot number: FH8028) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing), notes: seasonal/indoor allergies; "indoor allergies" (unspecified if ongoing), notes: seasonal/indoor allergies. Concomitant medication(s) included: IUD NOS; NEXIUM MUPS [ESOMEPRAZOLE MAGNESIUM]; PROBIOTICS NOS; ALLEGRA; B12 [CYANOCOBALAMIN]; FISH OIL; TURMERIC [CURCUMA LONGA RHIZOME]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 30Mar2021, when the patient was 44 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 09Mar2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 16:45, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 16Dec2021 07:30, outcome "not recovered", described as "aches"; PAIN IN EXTREMITY (non-serious) with onset 16Dec2021 07:30, outcome "not recovered", described as "Sore right arm"; HEADACHE (non-serious) with onset 16Dec2021 07:30, outcome "not recovered", described as "slight headache"; FATIGUE (non-serious) with onset 16Dec2021 07:30, outcome "not recovered", described as "fatigue". Therapeutic measures were not taken as a result of pain, pain in extremity, headache, fatigue. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, was not diagnosed, Prior to vaccination and has the patient not been test, Since the vaccination for COVID-19. known allergies: No  Follow-Up (21Dec2021): Follow-up attempts are completed. No further information is expected.
within a few minutes, i started having extreme burning at the site of the injection.  there was no swelling or redness, however.  they administered liquid benadryl and gave me tylenol.    i iced the injection site at home and continued benadryl for about the next twelve hours.  the site became exceptionally sore over the course of the next day.  by the next evening, there was a swelling about the size of a goose egg at the site, and redness and heat were present.  i did not have to seek any additional treatment, however, and continued using ice and tylenol.  over the next few days the swelling, heat, and tenderness went away.  4/12/2021, extreme tenderness and soreness at injection site has returned.  no swelling, redness, or heat.
A non-serious spontaneous report of administration of FLUMIST to a female greater that 49 years old was received from a licensed practical nurse concerning a 69-year-old female. Relevant medical history and concomitant medications were not reported. On 11-Sep-2009, the patient received FLUMIST. There were no adverse events associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved. Follow-up obtained on 0-Oct-2009 verified no adverse events occurred.
Work up at 12:30 a.m. very hot and nauseous.   When I tried to stand up I fainted.  When I came to I crawled to the bathroom and vomited several times.  Continued to run fever for about an hour or so.  Then headache began.  As of 7:00 I still feel nauseous and have a slight headache.
Very intense all over body aches, severe headache, nausea, weakness, very painful left arm, lasting 4 days
pt recvd flu vax on 12OCT92; that noc felt sl sick; 37 pts seen @ dialysis center recvd vax from this lot; 32 had no adverse events; 2 pts had minor reactions the day of vax; 2 others exp problems during dialysis sessions;
Feeling Sick; COVID-19 diagnosis/received the positive result of the test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 diagnosis/received the positive result of the test) and MALAISE (Feeling Sick) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced COVID-19 (COVID-19 diagnosis/received the positive result of the test). On an unknown date, the patient experienced MALAISE (Feeling Sick). At the time of the report, COVID-19 (COVID-19 diagnosis/received the positive result of the test) and MALAISE (Feeling Sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.         The patient went to get moderna booster dose and also received the positive result of the COVID 19 test.  No concomitant medications were reported.  No treatment information was provided This case concerns a 29 year-old male patient with no reported medical history who experienced the unexpected adverse event of special interest of COVID-19. The event occurred approximately on an unknown date relative to vaccination with the third dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 29 year-old male patient with no reported medical history who experienced the unexpected adverse event of special interest of COVID-19. The event occurred approximately on an unknown date relative to vaccination with the third dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
This child had a fever of 103F, complaining of severe jaw pain, no redness, or swelling.
Vaccination Date 12-4-19. Pt presented to ER 2 days later. 6 days prior to vacs he had fever.
Tender arm; Menstrual bleeding for 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Tender arm) and OLIGOMENORRHOEA (Menstrual bleeding for 3 weeks) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Tender arm) and OLIGOMENORRHOEA (Menstrual bleeding for 3 weeks). In September 2021, OLIGOMENORRHOEA (Menstrual bleeding for 3 weeks) had resolved. At the time of the report, PAIN IN EXTREMITY (Tender arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant details was not provided.  No treatment information was provided.   This case was linked to MOD-2021-348591 (Patient Link).
Aching, soreness, stiffness in right thigh and hip so that it was and is difficult to walk--as though I've run a marathon.  In addition, there is continued pain and aching in my right shoulder and neck where the vaccine was administered.
Fever, Sever Chills, fatigue, body wide joint pains, diaphragm pain, small red welts over entire back which started on 11/06/19,  redness and swelling at injection sight.
Felt miserable, collapsed, blacked out for unknown length of time, diarrhea, sweating, hot flashes.