chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 09Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 07Feb2022 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 17Sep2023, outcome "unknown", COVID-19 (medically significant) with onset 17Sep2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 17Sep2023 to 21Sep2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312383 same patient/drug and different dose and event;
Patient's are swelled and had pain. She had a 102 fever which lasted 2 days. She experienced fatigue, nausea, body aches and headache.
Reports: feeling flushed and anxious, "didn't hydrate enough prior to vaccine" vitals obtained / stable, po hydration, rest, monitor x 30 minutes symptoms improve/ subside released from facility to home
Narrative: Patient reported that 24 hours after receiving his 3rd dose of vaccine he developed diarrhea, fever, chills, vomiting, and trouble breathing. He states he almost went to the ER but decided not to and all the symptoms resolved on their own with no intervention.
Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; This is a spontaneous report from contactable consumer 83-year-old female (patient) reported for herself. An 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in arm left on an unspecified date as 2nd dose, single for COVID-19 immunization (at the age of 83-year-old). Medical history included ongoing gout, ongoing High blood pressure and ongoing pain. Concomitant medications included allopurinol taken for gout, aspirin (ACETYLSALICYLIC ACID), losartan taken for high blood pressure, felodipine for high blood pressure, diclofenac sodium taken for pain. The patient administered BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown), first dose via an unspecified route of administration, administered in arm left on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient did not receive any other vaccine prior to COVID-19 Vaccine. On an unspecified date, the patient experienced Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine. The patient stated she wanted to go to the Urgent Care, but it was crowded. She feels stressed out, because she was waiting for her daughter to take her to the hospital. She cannot figure out why she hurts so bad. The patient stated she was a lady who can get around and take care of herself and stated several examples of how she was independent, and she exercises. The patient stated her daughter was going to take her to the hospital, because she feels there was something serious going on that day. Outcome of the events were reported as unknown.   Information about lot/batch number is requested.
Not serious--just would have liked to have known it was a possibility.  Felt like I'd taken a diuretic.  Had to pee large amounts frequently starting the day after the shot, and continuing through the evening.
None. Pt needed MMR and varicella. Nurse found MMRV together and gave pt. MMRV (PROQUAD) is licensed for 12 year old and under. Next time will have separate injections. No symptoms occurred.
Within 4 months of receiving the J and J vaccine, I developed a kidney infection. I have never had any sort of infection in my life. I'm a healthy 37 year old. I don't smoke or do drugs. I drink alcohol very minimally on occasion. I'm reporting this because I know my body. The only change I've had recently is the fact that I got the shot. I believe it is something to look into: If these vaccines are linked to kidney or other infections in individuals. I have no proof the vaccination caused my infection but it is highly suspicious. Also, I'm on antibiotics again for an infection in my right breast. So why all of a sudden is my body not fighting infection? Please look into this!
This case was reported by a other health professional and described the occurrence of injection site swelling in a 34-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 5ZT94 ?, expiry date 30th June 2014). Co-suspect products included MEDICATION UNKNOWN (VACCINE). Previously administered products included influenza vaccine with an associated reaction of pain in extremity and influenza vaccine with an associated reaction of nausea. On 6th November 2014, the patient received FLULAVAL QUADRIVALENT and VACCINE. On 6th November 2014, 0 min after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site swelling (serious criteria disability), injection site hardness, injection site warmth and musculoskeletal stiffness. On 7th November 2014, the patient experienced vomiting, chills, stomach upset, diarrhea and low grade temperature. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site swelling, injection site hardness, injection site warmth and musculoskeletal stiffness were recovering/resolving and the outcome of the vomiting, chills, stomach upset, diarrhea and low grade temperature were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site hardness, injection site warmth, musculoskeletal stiffness, vomiting, chills, stomach upset, diarrhea and low grade temperature to be related to FLULAVAL QUADRIVALENT. The reporter considered the injection site swelling, injection site hardness, injection site warmth, musculoskeletal stiffness, vomiting, chills, stomach upset, diarrhea and low grade temperature to be not reported if related to FLULAVAL QUADRIVALENT. Additional information: The reporter (patient) was a physical therapy assistant. The patient had no known allergies. There was no concomitant medication. Injection site reaction occurred in the evening of 6 November 2014, neck and back stiffness during the night. On 7 November 2014, within 24 hours of vaccination, the patient experienced stomach upset with vomiting and diarrhea, chills and low grade temperature. As of the day she was recovered about 75% but she could not keep anything in her stomach. She could not do anything all day and took ibuprofen to get some sleep. Stomach upset with vomiting and diarrhea, chills and low grade temperature all lasted for 72 hours. She did not contact a health care professional. Refer to case US2014GSK023616 for tolerance to previous vaccination.
pt recv vax 13OCT95 & 14OCT95 pt exp moderate edema of the lt upper extremity & erythema & tenderness of dorsal/medial elbow;ROM was intact but w/pain;radial pulse was "2/4" & motor was intact;to MD or ER;tx w/med & ice, elevation;
This is a  11 Years  old  Female  accompanied with mother complaining of skin rash for 2 days. Patients mother said that she is having left arm pain where she got the shot and a rash appeared on her upper back that was itchy. She was given benydral to help with the allergic reaction. Better with nothing, worse with nothing.  Patient complains of rash to the upper back.     Patient states that the rash is stable.   Rash is described as moderate in nature and is itchy.      Patient has no history of the same.   The potential cause of the rash is Tdap shot.
Member came in today to provide feedback on her SHINGRIX vaccine that she received on 04/02/2019. She indicated that she had soreness, redness, swelling and pain around injection site.  She also mentioned that she had low grade fever with the temperature about 100 for couple of days. She felt fine after 2 to 3 days.
1328 - Father stated daughter didn't feel well - walked to stretcher and fainted.  1330  - Patient awake, VS taken, on stretcher, color improved, talking. BP = 98/53, HR = 74, RR = 22, O2 Sat = 100% 1335 - Patient sitting up. 1340 - Patient talking, drinking soda. BP = 117/76, HR = 80, RR = 22, O2 Sat = 100% 1350 - Patient's color pink, in no apparent distress. BP = 129/71, Hr = 83, RR = 16, O2 Sat = 98% 1351 - Patient ambulated out of clinic with father.
Constant ringing in the ears since obtaining the Moderna vaccine; 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   in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was given.  No treatment medication was given.  Company Comment: This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the unexpected event of tinnitus. The event tinnitus exact occurrence unknown but stated that the event occurred since the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable. 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 relevant medical history, who experienced the unexpected event of tinnitus. The event tinnitus exact occurrence unknown but stated that the event occurred since the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient reported sudden onset of severe pain in left shoulder where vaccine was administered. Patient still has pain in left shoulder with shoulder abduction approx. 6 weeks later.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications were reported. no treatment drugs were reported.
10 days after the injection I developed a high fever and chills and aches. The fever became low grade and continued for 10 days. I was then diagnosed with reactivated Epstein bar virus. So it was an active virus but I had also previously been exposed to EBV
This spontaneous report received from a consumer concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On NOV-2021, the patient experienced legs and hand twitching. On NOV-2021, the patient experienced eye twitching. On NOV-2021, the patient experienced more than flu like symptoms. On NOV-2021, the patient experienced cramps of extremities. On NOV-2021, the patient experienced headache. On an unspecified date, the patient experienced lesions on scalp, and skin rashes.The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported.The outcome of the lesions on scalp, legs and hand twitching, eye twitching, headache, skin rashes, more than flu like symptoms and cramps of extremities was not reported.This report was non-serious.
Pt. came in for physical exam on 9/27/12. Dr ordered the Flu vaccine for patient. Nurse gave Flu vaccine. Patient was instructed to take TYLENOL Q4hr PRN. Mother of patient had another appt. for herself while waiting for her appt. patient developed a fever and had a seizure.
This spontaneous report was received from a Doctor of pharmacy refers to an approximately 54 year old female patient. On 11-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX. Concomitant medications were not reported. On unknown date the patient was diagnosed with HIV. At the time the patient received ZOSTAVAX she did not know that she was positive for HIV. On an unknown date, the patient experienced "cold symptoms" of sweating, coughing, and lethargy. The reporter was unaware when these symptoms started or if the patient had communicated her receipt of ZOSTAVAX or her current symptoms to her primary physician. No treatment was reported. The patient sought medical attention (consulted pharmacist). At the time of this report the events were reported as not recovered. Additional information has been requested.
pt recvd vax & exp arthritis-like sx in hands,shoulders,& legs;29JUN94 recvd 2nd dose of vax;sx cont intermittently & are being treated by a rheumatologist;
patient developed localized hives on left deltoid at injection site, hives spread to face. no respiratory distress. Benadryl 25mg given. No other sequelae
On 03/16/2021,  the night of the vaccine at 8:00 or 9:00 pm I had  soreness and cramps, like a true achy pain in my legs, and then my arm the burning at the injection site stayed for a couple of months. The achiness and discomfort of my arms and legs, severe flu like reactions, headache, could not get warm even with blankets. By the middle of the night my fever was 103. It took me 20 minutes for me to get up and get Tylenol because I was not feeling well. I called in to work because I wasn't feeling functional. The only reason I was able to go to work the 2nd day, I was working virtual, and I was able to leave early. If we working in person, I would not have been able to go to work. For 4 to 5 months after my vaccine, to say I was thirsty was an understatement. The thirst was uncontrollable. I dreamt about drinking water. I started to have heart palpitations, I was having headaches that were almost daily. Wake up with a headache and it would go away in the early afternoon and come back in the evening, like clockwork. I also lost my  appetite for about 2 months after the vaccine. I could go the whole day and not remember that I had not eaten. August of 2020 - I was having extra periods in a month and heavy bleeding, I had the cyst on my left ovary I was seeing Dr.  She prescribed the birth control, but I stopped taking the pill in November 2020. I started my period on the day of my vaccine. And I have not had a period since. I would randomly start getting sweats throughout the day, I felt like I was breathing heavily, and I'm tired all the time. A cardiologist put a heart monitor to check my heart palpitations from 07/16/2021 until 07/23/2021.  On May 24, 2021, she prescribed to take Tylenol as needed for my headaches.  I have not recovered from the AEs:  I still have headaches, I still haven't slept through the night, even on the days I don't have a headache, and I am passed exhaustion, but I can't sleep through the night, I still don't have a period. I don't feel like I am as fit as I was prior to my vaccine.  I am out of breath while doing me job, and normally was not out of breath. (I transfer children from wheelchairs.)
Woke up with severe chills, shaking hard all over and my teeth chattering uncontrollably.  My husband got blankets and a heating pad.  Realized I had fever and took a reading, 101.5. Normal temperature is somewhat below 98.6 usually. Took some Tylenol and after about 45 minutes my fever came down and the chills subsided.  Continued taking Tylenol through the night every 4 hours, and all the next day until about 5:00 when the fever didn't seem to creep back up any longer.
Pt died in hospital on 12/24/21. Pt developed hypotension requiring pressors.  Patient coded twice with successful resuscitation. Family changed code status to DNR and patient expired a short time later.
This patient had a fever, body muscle aches, headache, general symptoms of the flu, mild to moderate.
93 year old vaccinated male resident was admitted for Covid-19 pneumonia and UTI. He also was in encephalopathy on admission. Mental status improved back to baseline with treatments. Urine culture was (-). He finished 5 days of Remdesivir therapy. Beta blocker was stopped and heart rate improved. He will be transferred back to NH today.
Localized skin allergic reaction on deltoid muscle, lasting about 2 weeks, itching, rash. Starts in the morning and progressively worsens throughout the day.
I had two days of either myocarditis or pericarditis; I had two days of either myocarditis or pericarditis; stabbing pains in my chest; had stabbing pains in my chest and left temple area; lymphadenopathy; This is a spontaneous report from a contactable consumer(patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: fc3180 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 21Aug2021 11:15 (at the age 51-years-old) at dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient received other medications within 2 weeks of vaccination included cholesterol medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at Pharmacy or drug Store. The patient had two days of either myocarditis or pericarditis on 28Aug2021, also had stabbing pains in chest and left temple area and lymphadenopathy on 28Aug2021. The adverse event was resulted in any of the following at Doctor or other healthcare professional office/clinic visit. No treatment was given for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (patient received expired Moderna COVID-19 vaccine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 028A21A) for COVID-19 immunization. No medical history reported. On Jun 10, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 10, 2021, patient administered expired product (patient received expired Moderna COVID-19 vaccine). At the time of the report, administered expired product (patient received expired Moderna COVID-19 vaccine) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments.
Started with tingling lips, then lips swelled to twice the normal size. Blister, cracks, and burning. That lasted3 day and then swelling started to go down. Now have severe raw, dryness around the entire mouth, what looks like a deflated blister on L bottom lip,  severe cuts to both corners of my mouth, and red spots (now 10 of them) around my jawline and neck. I can barely open my mouth to eat (only having jello) or drink. I have also had a sore throat on and off, but a runny nose every day.
Fine for 10+ hours. That evening, L arm really ached, really painful to lift above shoulder height. Noticeably sore at injection spot. Joints started aching, tired, noticeably sore up through neck on L side. Was driving at night- distance vision was blurry (could have been dry eyes, not sure related to vaccine). Slept 14 hours. Woke with muscles still achy, not quite as much as day before. Neck still sore. Injection site only sore to touch. Still very tired, could have slept more. Woke up today, feel pretty normal. A bit tired.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with worsened coronary artery disease. Vaccination took place on 3/19/2009. According to the physician, the relationship is none. We would be happy to fax you the studys SAE report.
tingling tongue, tachycardia, flushing  Tx: Vital signs, monitored for 90 min  1/25/ allergy evaluation -> Recommended hydration administer 2ND dose in reclined position observe for 60 min  1/27 2nd dose c adverse reaction
Large area of redness, hardness and pain covering entire upper arm up to shoulder and down to elbow.
Nausea, vomiting, increased heart rate (217bpm at time of paramedics arrival), crushing chest pain, massive headache, and fever.  Hospital gave me fluids, took blood test, EKG, and x-rays then sent me home. Increased heart rate lasted approximately one week. Headache lasted two weeks.
On May 7, 2023, I had endless sneezing, up to 50 or 60 times a day and a clear runny nose.  The next day I had a fever of 103 and terrible body aches.  I tested positive for COVID-19 May 8, 2023. I had a telehealth visit and was prescribed on this day.  After several days I started to feel better.  But the horrible taste of Paxlovid made me not hungry and I lost 10 pounds.  Sunday the 14th I tested negative.  As of today, I still feel exhausted and weak.
lose her hair; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (lose her hair) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (lose her hair). At the time of the report, ALOPECIA (lose her hair) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.