chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer / BioNTech: Dose#1,2,3,4; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Dose#1,2,3,4; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2020 at 09:00 as dose 1, single (Lot number: EH9899), in left arm, on 19Jan2021 at 09:00 as dose 2, single (Lot number: EL3302), in left arm, on 23Sep2021 at 14:00 as dose 3 (booster), single (Lot number: FC3181), in left arm and on 29Mar2022 at 17:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing); "microscopic colitis" (unspecified if ongoing), notes: microscopic colitis (no meds since May2022). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech: Dose#1,2,3,4; Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: Patient did not receive other medications in 2 weeks. Patient took paxlovid as COVID-19 treatment from 29May2022 to 03Jun2022 via orally. Adverse event reported as rebound symptoms onset 2-3 days after, sore throat, fever, headache (faint positive antigen test); then 7 days later fever/chills, congestion, malaise, positive antigen test on 06Jun2022 at 07:00 and patient was not taken any treatment for adverse events and events were not recovered. Known allergies reported as none known.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccinationfailure (LOE) and covid 19  cannot be ruled out.
I had the FLUZONE HD PF 15-16 INJ vaccine (RX #7859429) on 10/31/15. Within 2 to 3 hours I had a large swelling in my throat and also felt swelling in my upper lip. I could also feel something on both sides of my tongue. Next, I developed a severe headache, began to shake violently, felt feverish, and vomited. I did not go to the ER but thought I might need to. It was obviously a reaction to the flu vaccine and I thought I should report it. I was told they were mixing a stronger dose because of my age. I probably will never have another one but wanted someone to know about it.
pt recv vax 6/7/99 10:30Am & before leaving area pt arm checked no redness or swelling;mom called next day 6/8/99 930AM & stated lt arm was red & swollen 3cm wide 2cm in length;6/9/99 inj area pink dec duration, dec swelling;warm;induration
Given Tdap in left buttocks LUOQ and next day developed lump at injection site but then noticed swelling left groin 7/30/07
Starting 5 min after injection, my chest started hurting. Figured it must be anxiety and breathed through, but it didn?t change. The next several nights it was intense enough to keep me awake, HR only slightly elevated (5-10 beats) and oxygen 96-98% instead of my normal 98-100%. Mostly constant with further pressure/pain in the chest with activity. Short of breath with exertion. Very fatigued. No headache, no body ache, no nausea, minimal arm pain. Started ibuprofen and after several days of that, it was more intermittent. It feels like a raw pressure in the chest. It seems like it is improving but was still very present today without ibuprofen. It feels similar to the deep sensation from when I had radiation for hodgkins in 2012. My doctor and I feel it is likely radiation recall syndrome.
Information has been received on 15-FEB-2019 regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2009, the patient was administered the ZOSTAVAX by a pharmacist. On an unspecified date, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Pt present about 30 mins after exposure to latex and about 45 mins after getting flu mist. Symptoms began with local itch on chin and progressed to itching all over. No dyspnea/ dizzy.
1 day after vaccine, pt was noted to be very pale "face white", all day & slept more and vomited twice. He was alert when awake but stayed pale x 24 hrs. then returned to normal. ? fever also noted with pallor.
Redness, warmth, swelling at site of injection 1 day after injection. 3 days after inj had 4cm area of erythema and 1/2cm central area of firmness and tenderness. Tx: Keflex 500mg 1 tid x 7 days.
Within one minute of receiving the vaccine I experienced a very brief "fluttering" of my heart, resolved quickly. No other reactions during the 15 minute monitoring period. Within approx 25 minutes of receiving the vaccine, I experienced tingling and slight numbness of my lips. This progressed to numbness and tingling of both cheeks.  No swelling. No progression or worsening of described symptoms. This numbness/tingling continued for approximately 40 minutes then self-resolved.
Generalized body and face rash; This case was reported by a nurse via sales rep and described the occurrence of rash in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 3R774, expiry date unknown) for prophylaxis.   On 16th January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   The reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had Generalized body and face rash.  The reporter consented to follow up.
a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever.; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick; taste problems; I thought maybe I had this COVID because I was sick; feeling a little chilly; This is a spontaneous report from a contactable other health care professional. A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6198) at the vaccination age of 79-year via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunization. Patient historical vaccine includes first dose of  BNT162B2; LOT number: EL9269 ,which was administered on 12Feb2021 for COVID-19 immunization. Medical history included neuropathy peripheral and hypertension. Concomitant medications included, lisinopril taken for hypertension, gabapentin taken for neuropathy peripheral, levothyroxine and dicyclomine. On an unspecified date, the patient experienced I thought maybe I had this covid because I was sick; I had the taste problems and the doctor lately did a test on me to see if I still have the antibodies and I did not. so, he said no, it does not look like you had it; a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick and taste problems. On 05Mar2021 09:00 PM patient was feeling a little chilly. On an unspecified date the patient underwent lab tests and procedures which included blood thyroid stimulating hormone: unknown results, sars-cov-2 test: negative. The seriousness of all the event was reported as non-serious. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information expected.
2" by 4" red knot and severe itching/burning at injection site.  On 11/25/13 red spots, facial burning and swelling all over face that last for four days.
The week after the 2nd dose of Moderna Covid shot I had my period for 10 days.  The longest I have ever had a normal period was about 5 days.  Since then I am getting my period every 2-3 weeks.  Its not for as long but for a few days each time.  In the 33 years of having my period I was like clockwork at every 4 to 4.5 weeks of getting my cycle.
Hotness, hardness, soreness at injection site. Onset 3/9/13. Still present 3/14/13. Improving slightly. Unable to sleep on left side.
Tachycardia, chest pain/tightness, afib reported x 2 on home ecg device. HR up to 160
A couple hours after the flu shot, I felt pain at the site of the shot as well as a burning sensation in my fingers, upper and lower arm. This was accompanied a few days later by loss of motion and soreness. About 12 weeks later I was diagnosed with rotator cuff tendinitis. It has been treated with Aleve then with a cortisone shot.
shingles; couldn't stand; couldn't sit and had to be on my left side; stomach hurts; numbness in stomach; not much back pain; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced shingles, difficulty in standing, mobility decreased, stomach pain, numbness and back pain. On an unknown date, the outcome of the shingles, difficulty in standing, mobility decreased, stomach pain, numbness and back pain were unknown.   It was unknown if the reporter considered the shingles, difficulty in standing, mobility decreased, stomach pain, numbness and back pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported The patient had 2nd dose of the shingles vaccine then 3 weeks later the patient had the shingles.  The patient could not stand or sit and had to be on left side. Now the right side of stomach was completely numb and hurts. The back not so much. This stuff was bad.
Patient was given two diluents (for a total of 1 mL),  rather than one Shingrix and one diluent for a total amount of 0.5 mL.
Patient developed Guillan Bare syndrome, 4 days after the vaccination.  4/22/09 MR received for DOS 10/29-11/17/2008 with D/C DX:  Guillain-Barre Syndrome.  Non-Hodgkin's Lymphoma controlled with chemotherapy and radiation.  Pancytopenia r/t tx for Hodgkin's Lymphoma.  Pt initially presented to PCP on 10/13/08 with c/o L arm weakness x 8 days. Pt had recently been treated with radiation to the L axilla. Initially thought to be a radiation plexitis. Some improvement in pain level with steroids, none in weakness. Returned 10/28/08 with c/o profound lower and upper extremity weakness.  By 10/29/08 unable to stand or walk.  Admitted after (+) EMG/NCS in office. PE (+) for weakness in upper and lower extremities, areflexia, and brisk knee jerks. Tx with plasmapheresis w/o improvement. Developed bladder retention with Foley cath insertion. Unable to use IVIG due to low IgA level. Some improvement by d/c to rehab on 11/17/08.  4/28/09 Received Neuro consult of 10/13/08-2/19/09. FINAL DX: acute demyelinating inflammatory polyneuropathy, slowly resolving Records reveal patient experienced abrupt onset profound weakness of left arm x 1 wk prior to initial eval & beginning approx 2 days s/p radiation tx.  Tx w/steroids & referred for MRI.  Developed weakness of all 4 extremities within about 2 wks.  Subsequently hospitalized as above for GBS & inpatient rehab.  Returned to Neuro 2/19/09.  Remained areflexic & profoundly weak LUE & LLE.
A report has been received from a Health Professional concerning a 13 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. The reporter reported for 17 patients who had inadvertently administered expired FLUMIST. FLUMIST QUADRIVALENT (Intranasal) started on 27-Jan-2014. It was reported that the patient was inadvertently administered expired FLUMIST which started on 27-Jan-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.
Case number PHEH2016US018551 is an initial spontaneous report received from consumer on 13 Jul 2016. This report refers to 67 year old male patient. Medical history included allergic reaction to flu shots and concomitant medication were not reported. The patient was vaccinated with influenza vaccine (manufacturer: unknown, batch number: not reported) on an unknown date. On an unspecified date, the patient had drug reactions/allergies. Patient had allergic reaction to flu shots in the past and now refuses to get them. It was not reported which flu shot was administered in the past. The outcome of event was not reported. The causality of event was not reported. The seriousness of the event was reported as non serious. No further follow-up attempts were required.
Fever at 102; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever at 102) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever at 102). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and ACETYLSALICYLIC ACID (BABY ASPIRIN) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever at 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: 175/110 (High) 175/110 and 161/99 161/99. In February 2021, Heart rate: 157 bpm (High) 157 bpm. In February 2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant medication was not provided.
pneumonia; Initial information received on 09-Dec-2020 regarding an unsolicited valid serious case received from a consumer.  This case involves female patient of an unknown age who experienced pneumonia, while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  It was also reported that patient developed pneumonia and never recovered from it, she passed away.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  Date of death was not reported. It was unknown at the time of reporting if an autopsy was done and the cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: This was a poorly documented case  involves a female patient of an unknown age who died due to pneumonia, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. However, patient's medical condition at the time of vaccination, concomitant therapy, previous vaccination and tolerance, allergic history, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Pneumonia
As soon as vaccine given, patient felt pain in neck on (L) side - same side as vaccine admin. Then saw "blackout lines", felt very warm, couldn't feel left side of arm, neck and had trouble breathing. All lasted about 45 seconds and everything became back to normal except left with pain and (L) neck weakness in area, no tingling in arms.
No other AE; Vaccine excursion occurred on 06-AUG-2021 and was administered on 07-AUG-2021.; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, pertinent medical history, concomitant therapies and drug and/or allergies reactions was not provided.  On 06-AUG-2021, a temperature excursion was called for a varicella virus vaccine live (oka/merck) (VARIVAX) vaccine, at a temperature of 8.0 degrees Fahrenheit for a time frame of 45 minutes.  On 07-AUG-2021, the patient was inadvertently administered with improperly stored  varicella virus vaccine live (oka/merck)(VARIVAX) (dose reported as "1 time dose") (strength, vaccination scheme, route and anatomical location of administration were not provided, with lot number T032319 verified as valid and upon internal review expiration date established as 22-SEP-2022) for prophylaxis.  No previous temperature excursions were reported, no information was provided about the use of a data logger. No additional adverse event was reported.
Rash appeared Nov. of 2015 and lasted until Nov. 2016. It would be so intense, I'd itch until I had spots that bled. It appeared from my neck to my knees and would welt up when itched. Pravastatin sodium-quit taking these for a month as Dr. recommended-Latanoprost for eyes, used every night. Losartan used up until 9-22-2015 then tried Amlodipine for a month-made me dizzy then put on Lisinopril-made me cough continually-went back on Losartan 1-6-17 rash went away in Nov. 2016-I was advised to not get flu shot  in Fall.
Per mom, -whole Right arm felt paralyzed, fever and in bed for 2 days- symptoms resolved after tylenol and advil
any reports of weight gain after receiving 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 WEIGHT INCREASED (any reports of weight gain after receiving the Moderna vaccine) 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. On an unknown date, the patient experienced WEIGHT INCREASED (any reports of weight gain after receiving the Moderna vaccine). At the time of the report, WEIGHT INCREASED (any reports of weight gain after receiving the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The night after my first vaccine, I awoke at about 3:45AM with extreme aches and pains all over my body for about 4 hours, then I was okay.  Twelve days later, I tried to go for a short walk with my wife and the pain in my left leg was horrible at times.  The calf muscle was swollen and pink and very warm to the touch.  Also my toes were kind of purple and my ankles were badly swollen.  I thought the toes and ankles might be related to my Bradycardia, but the calf muscle sent us to the ER to be checked for a blood clot.  They did check the major arteries, as those are the dangerous ones, but did not check the calf as they said if one was there it wouldn't throw to the lungs or heart.  I was discharged.  The swelling went down in the calf.  Still some aches in the back of both legs now when I walk very far - but really not bad.  Having the purple toes and a possible blood clot... my daughter who is a nurse encouraged me to submit this information.  Thank you.
This case was reported by a consumer via interactive digital media and described the occurrence of mental retardation in a child male patient who received Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential MENVEO)) for prophylaxis. On an unknown date, the patient received Meningococcal ACWY Vaccine (potential MENVEO) at an unknown dose. On an unknown date, unknown after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced mental retardation (serious criteria GSK medically significant), epilepsy (serious criteria GSK medically significant), ear disorder and hearing impaired. On an unknown date, the outcome of the mental retardation, epilepsy, ear disorder and hearing impaired were not recovered/not resolved. It was unknown if the reporter considered the mental retardation, epilepsy, ear disorder and hearing impaired to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional detail were provided as follows: The age at vaccination was not reported. Immediately after this vaccine (Meningitis ACWY), the patient experienced epilepsy and severe ear problems, with severe hearing impairment. The patient received this vaccine as a travel vaccine, it was not yet (at the time of reporting) included in the schedule. At the moment the patient was fortunately better, but unfortunately the mental retardation that the patient had left due to these years of problems was still there. These symptoms were also likely to occurred after experiencing the disease. So the patient only got them immediately after the vaccine. The reporter asked that what reactions the patient received.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 03-SEP-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -0.55 Celsius Degrees for 32 hours, 1.11 Celsius Degrees for 208 hours, 0 Celsius Degrees for 152 hours and 0.55 Celsius Degrees for 200 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
10-Jan:  Sore arm. 11-Jan:  Sore arm and sore throat. 12-Jan:  All the above plus painful under arm and back (not as bad as under arm.  Raising arm hurts.
First dose of the vaccine, just there was little swelling on the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm, administration date 07Mar2021 (Lot number: EN6203, Expiration Date: 30Jun2021) at the age of 58 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "First dose of the vaccine, just there was little swelling on the arm".  No follow-up attempts are possible. No further information is expected.
Flushed cheeks, raise in temperature, (temp is approx. 100 degrees F) change in behavior, patient is more tired, sleeping often
received 2-6-2021. on 2-10-2021 patient states red itchy rash on both feet and ankles. no swelling.no chest pain .no shortness of breath, no other body rash