chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe flu like symptoms; fatigue; muscle and joint pains; muscle and joint pains; headache; fever and chills; This is a spontaneous report from a contactable physician (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number LTM 2), via an unspecified route of administration (arm right) on 04Feb2021 00:00 (12 AM) at SINGLE DOSE for covid-19 immunisation, at 79 years old. Medical history included prostate cancer from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. No allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced severe flu like symptoms; fatigue; muscle and joint pains; headache; and fever and chills on 04Feb2021. Treatment was not received for the adverse events. Outcome of the events was recovering. The events were reported as non-serious.
Fever of 103.7 for a day, severe sweats and chills followed by weakness. Knee pain also felt
Vaccine vial was diluted with 1.8ml's of sterile water instead of what it should have been: 1.8ml's of 0.9% sodium chloride.  The correct 0.3ml was still given, but the dilution material was incorrect.  Mom updated and stated patient wasn't having any side effects.  Per Pfizer, Pfizer said that they could not clarify validity or stability because they have not run any tests regarding diluting with sterile water. Basically to review it with the medical director of the clinic and revaccinate 1st dose as this dose is considered invalid.
Moderna  COVID-19 Vaccine EUA Rash -"hives and blister" Treatment - Cortizone-10 , Benadryl and Zyrtec
Dizziness nauseated headache weakness sweating cold elevated heart rate and 101 temp. Bad enough that I thought I might have gotten covid before getting the shot. Went to a clinic and in order to get seen by doctor had to get covid tested. The test also tested for flu a and flu b. All came back negative. Doctor said I was experiencing effects from the vaccination and that it would pass in a couple days. She was right.
4 or 5 blisters ranging from 3 mm to 1 cm on the right leg.
Vaccines given above by mistake. Original TDaP and MCV4 given on 4/5/07. Patient had no adverse reactions/symptoms from above.
I have slight chest pain on the left-side. I'm assuming as a symptom of COVID-19, but reporting this in case in it's related to the vaccine. The pressure came on at some point, possibly the 10/31/2021 but fever came that day as well. It has remained some what constant but not significant enough to report to a doctor. I'm assuming it will go away on its own.
Rash and redness in arm at injection site in circular pattern with onset 8 days after vaccination, pruritic, tender, and warm to the touch, consistent with "Moderna arm".
Tinnitus in both ears noticed on 2am of the night after the shot was administered. Never experienced tinnitus before. Consistent ringing in both ears that has not changed, on top of it more pitches that appear randomly and loudly. gets worse with stress. adds stress anxiety and interrupts sleep and work.  Visit to ENT concluded no hearing loss and ears look normal. Acupuncture and jaw massages help calm and relieve symptoms but still persisting.  Full journal:  Scale (1 - non existent, 10 - very bad)  01/04/2021 02:00am - white noise and pressure in ears : 2 9:00am - headache: 3, ears: 2, intermittent ticking on right ear (heard once or twice in the morning) 10:00am - + nausea :2 2pm - ear pressure and ringing more noticeable with headphones: 3  02/04/2021 2am - ear pressure went down, ringing on right ear high B: 3 4pm - ringing on right ear not noticeable unless i focus hard on it.  03/04/2021 9pm - ringing on right ear high Cish - not noticeable unless it is quiet : 3, pressure in both ears - 3  04/04/2021 12pm - ringing on right ear  \- 3 pressure in right ear - 3 trying to put focus away all day. tried 10min ear exercises  04/05/2021 9am - did 10 min ear exercises 10am - pressure plus ringing in both ears - 1.5-2  6pm- acupuncture  04/07/2021 5-6pm - walk in city, still more sensitive to traffic and street noise, need to cover my ear frequently, friend noticed. 11pm - stressful conversation with partner, resolved 12am - ringing in right ear phased in louder volume (5/10) for 2 seconds and stopped. 7am - ringing in left ear phased in louder volume (7/10) for a second and resumed to normal volume, new pitch - high A  - left ear - 3 (intermittent), right ear - 2  04/08/2021 2am - left ear high A 5/10 goes up and down in volume mainly 4-5. took a long bike ride yesterday (90 mins), walked in the cold for 30 mins in the evening - was not dressed enough. EST visit - washed left ear to take out wax. no hearing loss - hearing looks high normal. no more info on 2nd shot.  6pm - acupuncture  04/09/2021 5am - no high A anymore. left ear- 1.5, notice only when block my ear, right ear 2-3.5 (phasing in and out) high F# and maybe C too  04/10/2021 8am - left ear - 2-3 only high Bb, right ear - 2-3 no high f#, only high C , white noise in both - 2  4pm -  stressful conversation with partner, resolved 5/10  04/11/2021 morning - barely noticeable 7pm - after being out all day and a little cold - high F# appeared again 3/10. no pressure in ear anymore  04/12/2021 9am - high C added to both again 3/10 10am - work virtual meeting - high C goes 5/10  9pm - after acupuncture feeling better overall, high F# again 2-3/10, no high C  04/13/2021 2:56am, 3am, 7am - woke up from bad new pitch - G 7/10. massaging jaw at 7am helped relief.
Fever. Extreme all over muscle pain and soreness. Debilitating. Could not move or get out of bed for 24 hours. Headache still lingering.
After about 6-weeks post 2nd vax, I started having odd tongue sensations. Over time I have lost a good percentage of my taste ability (50%+). Tastes are uneven, like the food wasn't mixed well. Tongue also feels less sensitive and somewhat numb.
6"x6" area of swelling and induration - central on site of varicella injection - tx - Aleve, Benadryl, Prednisone 60mg x 2 days.
Havrix vaccine was administered IM in left deltoid (after IPOL vaccine was administered IM in left deltoid). As soon as vaccine was administered, patient reported feeling pain. Her arm remained "very painful" for 2-3 days afterwards and then improved to a "dull soreness" which was not bothersome and sometimes not even noticeable. Patient called us to report this on 4/19/2012 after she had started lifting weights and noticed her left arm was more sensitive and reminiscent of the pain she felt after her Havrix vaccination. We encouraged the patient to see her primary care provider about this and also apply heat/take ibuprofen for the pain. She was mostly concerned there was something wrong with the vaccine itself. We searched for recall notices and none were found concerning that vaccine. She was also slightly concerned that if a nerve was hit during vaccination--how long would that feeling last? I encouraged her to see her primary doctor and we would be happy to share this report with him/her. Overall, she is not experiencing a severe reaction.
first dose was administrated on 2018/The patient did not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive nd dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. The reporter consented to follow up.
A throbbing pain started the same day, it kept on day after day sometimes radiating down to the wrist. It is very painful,not getting better at all. Patient was prescribed a Medrol dosepack to ease the pain on June 12th. Patient has to constantly take medication to ease the pain, and mostly dont help. Patient also sees a Chiropractor.
very achy as if I had a kidney infection; Alot of pain in bladder; if I had a bladder infection; Lower back pain above posterior; pain in the area of the kidneys; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 56 years old) via an unspecified route of administration, administered in Arm Right on Sep2021 09:30 AM (Batch/Lot Number: FC3183) as dose 1, single for covid-19 immunisation. Medical history included high blood pressure and 2 skin cancers (basal cells). The patient has no COVID-19 prior vaccination. Concomitant medication included hydrochlorothiazide, losartan potassium (LOSARTAN HCT). The patient previously took avelox for vertigo and allergies. The patient has no other vaccine in four weeks. On 18Sep2021 at 05:00, the patient experienced a lot of pain in bladder as if she had a bladder infection, lower back pain above posterior and pain in the area of the kidneys which was very achy as if she had a kidney infection. No other symptoms than those. The patient was not tested for COVID-19 post vaccination. The events were not treated. The outcome of the events was recovered on an unspecified date.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Fever, SkinRash & SWOLLEN KNOT PREDNISONE 20 MG BID 20MG PO BID
According to mother, the right forearm has swelling, redness, warm to touch, and pain.  We advised cold compresses.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; Covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "autoimmune disorders" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was received Paxlovid for treatment of Covid-19 from 03Aug2022 to 07Aug2022. The patient did not receive any other medication in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax; had a fever on & off all week end;noticed red dot on cheek;in the am,all over face,ears,neck,chest,back,stomach,groin area,buttock,legs & feet; prescribed hydroclyne;
high fever; severe chills; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 30Sep2022 as unk, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 01Oct2022, outcome "unknown", described as "high fever"; MYALGIA (non-serious) with onset 01Oct2022, outcome "unknown", described as "muscle aches"; CHILLS (non-serious) with onset 01Oct2022, outcome "unknown", described as "severe chills".  Additional information: Day before reporting patient received both the new Pfizer Bivalent and the Flu shot and had a violent reaction. High fever, severe chills and muscle aches and frankly patient thought he/ she was dying. It was irresponsible, deadly and assinine of Pfizer to tell the PUBLIC that was okay.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient got up to get water after feeling lightheaded and dizzy. Tunnel vision. Patient ended up passing out and falling over and had a seizure. Patient recovered shortly after with no long lasting effects.
I did not have an adverse reaction to the vaccine. On 05/23/2022 is when I got sick. My symptoms: chest congestion, headache, exhaustion, sore throat, and coughed up disgusted phlegm. I took four home test for COVID-19 and they all where negative. On 05/26/2022 at an urgent care center I was test and it was negative and diagnosis was upper respiratory infection. I returned to the urgent care center on 05/31 and the diagnosis was viral illness. They prescribed a cough syrup which did not help. I never tested positive for COVID-19 and I was negative for the flu.
Patient presented with wife 6/18/2021. Patient requested Janssen covid-19 vaccine. The immunization was administered at 6:55pm. After 7 minutes of sitting in waiting room, patient started to complain of dizziness, "spinning in head", heavy breathing, and sweating. Patient was very sweaty, pale, and uneasy. Patient then fell to the ground with wife next to him, and lost consciousness briefly. 911 was immediately contacted. Patient did not hit his head or other body parts. Patient was able to be picked up and brought back into his seat. He did lose consciousness again in his seat very briefly but was able to speak to me and answer questions as I spoke with 911. He was very pale and sweaty, but answered questions to check for mental status. 911 police and ambulance arrived and checked his pulse, blood pressure, and asked several questions to examine his mental status. Patient declined going to hospital. Patient did walk out with wife, more color apparent on face, and able to answer questions. Patient and wife were advised to stay home and relax post-vaccination and call 911 if symptoms arise.
extreme dizziness, vertigo. Tried to maintain vertical head position. Any bend at the neck would cause vertigo.
I did go to the emergency room Friday 10/5/18, I had a small reaction. The bottom half of my face (mouth/lips/tongue) did swell a medium amount so I was given stuff to reduce the swelling. I was given Benadryl and Prednisone, so I didn't need anything more. The swelling is almost gone today 10/8/18, but my mouth is still recovering (more tight and sore now).
patient developed fever, headache and fast heart rate.  She thought possibly the heart rate increased due to anxiety.  Side effects lasted for 1-2 days and went away
I experienced low grade fever, muscle aches and pains in November 2022. I did not have a cough but was very fatigued and tired. I took a COVID-19 test and a Flu test which was positive.  My symptoms lasted one week. After 3-4 days I got better. On the 5th day my COVID-19 test was negative.
This spontaneous report as received from a immunization official refers to an unknown number of patients of unknown age and gender. Medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL injection (lot# not provided) route, dosage and frequency were not reported. Concomitant therapy was not reported. The reporter informed that on an unknown date the patients may have received GARDASIL that was improperly stored from 11-JUN-2013 to 22-APR-2014. No adverse effects were reported. This is one of several reports received from the same reporter MARRS case #1405USA003763, #1405USA004444 and #1405USA004445. Additional information has been requested.
Within 12 hours of Tdap and MENACTRA vaccine patient developed red rash on both arms. The right (Tdap) measured 14cm by 10cm and the left (MENACTRA) measured 4cm by 3cm. The Arthus reaction is usually self limited. Antihistamines and steroid creams was given. A Tdap and MENACTRA booster will not be given again for at least 10 years.
Rash (appeared as though I had a sunburn all over my legs and feed) with Hives all over my body, Sore arm at injection site, swelling of feet and legs, headache, lethargy, nausea.  Received Pfizer Covid 19 Vaccination at 3pm, March 19th, 2021, injection in the left arm.  Waited 15 minutes at vaccination site.  No issues and was released.  Approximately 4 hours later, side effects began (listed above).   My sister in law is a registered nurse and she said, do not to take benedryl as the pharmacist told me to do, on Sunday,  March 21, 2021.  She said, if it got worse to call my physician.  The rash went away but the hives are still there and I itch.  I'm still exhausted.
I have normally periods due to birth control but have experienced very clotted blood in my period cycle compared to normal since the vaccine as well as heavier bleeding.
Information has been received from a registered nurse who in approximately 2008, about one year ago, was vaccinated with the second dose of PNEUMOVAX. The patient experienced severe cellulitis like reaction after receiving the second dose of PNEUMOVAX. Subsequently, the patient recovered from severe cellulitis like reaction. The patient sought unspecified medical attention. Additional information has been requested.
High fever 104 degrees. Severe arm/back pain. 48 hours of lethargy/malaise.
Within the first 24 hours his heart rate increased. When I took his pulse it was about 93 beats per minutes. He was not "ill", but said he did not feel very well. He has had each of the three shots given (listed below) with no adverse reactions when each was given separately in the past.
Pt reported experiencing hives as well as a flu-like syndrome (aches and pains). The flu-like syndrome is normal for her but the hives were a new adverse event.
This spontaneous report received from a medical assistant referred to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Medical assistant reported that on an unknown dates, multiple unspecified patients received improperly stored doses of VARIVAX (dose, frequency not reported) (Lot: M041513, expiry date: 11-OCT-2018) reconstituted with sterile water diluent (unknown lot number and expiration date). No adverse effects reported. Temperature and Time frame: -14°C to -10°C for 9 hours 43 minutes, -14°C to -10°C for 15 hours 46 minutes, -14°C to -10°C for 12 hours 31 minutes. Previous temperature excursion was -14°C to -10°C for 6 hours 26 minutes. The call was because of data logger. This is one of the two reports received from the same reporter. Additional information has been requested.
Significant back pain occurred approximately 48 hours after the vaccination. It subsided after two days, but re-occurred two weeks later (on the evening of 1/16/21). Forty-eight hours later I phoned NP and requested help. She prescribed Prednisone, 20mg, twice daily for 5 days, which I began taking on the evening on 1/18/21.  The pain slowly subsided and after 3 days I was feeling better.
mom states p/vax rt upper thigh turned purplish now has discolored spot w/sl rawed bumpy area @ inject site;
COVID-19; This spontaneous report received from a patient via other company manufacturer (Pfizer) concerned a 35 year old male and unspecified ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. 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 additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, Route and batch number was not reported, expiry: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate.  On 24-May-2022, the patient started non-company treatment drug Paxlovid for treatment of COVID-19. Paxlovid was discontinued on 29-May-2022. On 02-JUN-2022 at 09:00 hours, the patient experienced covid-19 and had rebound (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious.
My cousin now has Myocarditis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "My cousin now has Myocarditis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case is linked with case 2018SA302120 (same reporter). This case involves a four-year-old female patient who was vaccinated with a 0.5 ml dose of vaccine IPOL (lot P1A251M, expiration date 02-May-2020) via intramuscular route in the right thigh on 27-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included FLUZONE QIV for Immunisation on 27-Oct-2018; DTAP for Immunisation on 27-Oct-2018; MMR for Immunisation on 27-Oct-2018; and VARICELLA VACCINE for Immunisation on 27-Oct-2018. It was a case of actual medication error due to deteriorated drug administered and incorrect product storage. It was reported that the vaccines exposed to a temperature excursion twice on 22-sep-2018 with temp up to 8.29 C for 1 hour and on 19-Oct-2018, at 8.33 C for 1 hour (opened vial). It was reported that they had an open vial of IPOL and 4 patients received it after it should of been discarded. The patient didn't experience any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow up report received from other health care professional on 31-Oct-2018. The reporter has information about the other 3 patients. No information has been reported about the patient in this case. List of documents held by sender: none.