chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heavy menstruation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 09Feb2022 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "recovering", described as "heavy menstruation". Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional Information: It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient reported onset of heavy menstruation shortly after receiving vaccine. Patient reported she has an IUD and does not menstruate regularly. Patient reported this occurred with the first and second doses as well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had gone to the Pharmacy to get a flu shot for 2021. However, by mistake they administered a Covid-19 Pfizer vaccine shot #3.  Earlier on March 10, 2021 I had received second Moderna Covid-19 vaccine shot. Therefore I had two Moderna shots by March 10, 2021 and now a third Pfizer Covid-19 vaccine shot on 8/16/2021.  Pharmacy called it a "Booster shot" when they realized their mistake. However, Booster shot was not approved by CDC/FDA at that time for people like me without any Immune compromise condition. What precautions and actions should I take before taking any more covid-19 shots including any future Booster shots ? Thank you......
Painful left arm, particularly when lying down; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8733), via an unspecified route of administration in the left arm on 15Apr2021 at 11:30 (at the age of 59-year-old), dose 2, single for COVID-19 immunisation. Medical history included tongue cancer in Aug2017 (successfully treated with surgery), hypertension, high cholesterol, arthritis, known allergy/sensitive to NSAIDs (cannot take them). Concomitant medications included fluoxetine; chlorthalidone; pravastatin; esomeprazole sodium (NEXIUM). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206) administered via an unspecified route of administration in the left arm on 18Mar2021 at 11:15 (at the age of 59-year-old), dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 15Apr2021 at 20:00, the patient had painful left arm, particularly when lying down. No apparent bruising, no muscle strain. The event started after second dose in Apr2021 and has lasted through 12Sep2021. The patient took Tylenol for the event. The patient had not been tested for COVID-19 since vaccination. The outcome of the event was not recovered.
Pt recvd vax & 5 days p/vax had nausea & vomiting that lasted 2 wks & then went away;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Jun2022 at 17:00 as dose 4 (booster), single (Lot number: FN2908), in left arm and on 17Sep2022 at 10:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 at 10:00 as dose 1, single (Lot number: EL9265), in left arm, on 23Feb2021 at 10:00 as dose 2, single (Lot number: EN6198), in left arm and on 13Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FF8841), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "sulfa drugs" (unspecified if ongoing), notes: sulfa drugs; "penicillin" (unspecified if ongoing), notes: penicillin; "latex" (unspecified if ongoing), notes: latex. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Chills, shivering violently, freezing cold, body and muscle aches, horrible headache-severe reaction, almost went to ER. Too sick to go. I thought I was dying. Told my dogs goodbye. This was an awful experience. I was sick for two days following the injection. It really scared me. I thought I was dying. I was too ill to drive myself to the emergency room. I told my dogs good-bye (I live alone). I thought I was actually dying. I would never recommend this vaccine to anyone.
Pt recvd 3 doses of Engerix-B & 3-5months p/3rd dose titer result was neg;
Information has been received from a consumer concerning her 13 year old daughter with no past medical history and no allergies who in June 2010, was vaccinated with the first dose of GARDASIL and on 30-AUG-2010 with the second dose of the vaccine. There was no concomitant medication. The mother reported that the patient developed a rash on her neck, face, torso, chest, arms, thighs and upper back a few days after received her second dose of GARDASIL. The rash was red, raised circle. The mother stated "it looked almost like ringworm if there was not so many of them". The rash had persisted. The patient was seen by the physician and her mother insisted on some type of topical treatment. A cream was prescribed (name unknown) but the patient had not begun treatment at the time of the report. The first dose of GARDASIL was given at the end of June 2010 and no reaction was noted. No lab tests or studies had been performed. The mother was not sure if she will allow her daughter to receive the third injection. Follow up information was received from a consumer which reported that the patient received the second dose of GARDASIL (Lot # 666163/0664Z) intramuscularly into her left arm on 31-AUG-2010 (previously reported as 30-AUG-2010), at 17:20. It was reported that the patient developed hives 3 days after immunization. The mother contacted office and requested Lot number. At the time of the report the outcome of the patient was not reported. The patient did not require an emergency room/doctor visit due to the hives. Additional information has been requested.
pain, swelling in lymph nodes in right armpit and above breast on the same side as the  injection. It's been  over 72 hours since the first dose of Pfizer
Strong arm pain where shot was administered throught day March 30.. Headache March 30th and 31st. Fever began around 4am at 100.1F. Currently 7:47 am, fever stays at 100 and above.
7 days after my shot I work up with a very sore arm and it was itchy. I saw a large oval reddish flat rash, approximately 3 by 4 inches at site where I got my Covid shot. It remained sore and itchy for about two days. The rash went from red to pink and took 13 days before it went away, actually I can still see the outline of it as I go into my 14 th day. I treated the early symptoms with ice and an antihistamine cream for the first three days.
I woke-up on 4/7 with an itchy throat and hives were starting to form on my stomach.  As the day went on, the hives were all over my torso and went up to my neck as well.  When I have hives on my neck, they usually start to bother my asthma/breathing, and this happened on 4/7 as well.  My allergist said to up the dosage of Allegra 24 hours from 2 tablets a day to 4.  I also took my Albuterol inhaler to control the wheezing.  My doctor also gave me a prescription for Prednisone in case I needed it over the weekend, and recommended I go to the ER if my symptoms got worse.  Luckily, the extra Allegra and asthma inhaler calmed by symptoms down.   Things calmed down over the weekend and by 4/14, the hives were completely gone and I was not longer experiencing any side effects.  I did not need to do any in-person doctor's visits; I just talked to my doctor on the phone.  Please note that I also had the 'flu-like' symptoms after the shot as well.  I felt great after the shot and even exercised on my elliptical around 7:45 that night.  At around 9:00, I had extreme chills, where my body was shaking, as well as sweating.  I also had extreme fatigue, a headache, and some body aches as well.  I slept for 16 hours that night and felt somewhat better when I got up.  By that late that night, all the flu-like symptoms were gone.   I took some Tylenol for the headache.
Patient received vaccine on 9/19/08. Patient had fever, body aches, ha and fatigue on 9/20/08.  Lasted for 2 days.  Ha still present today: temp: 99.  L deltoid: 5 x 5cm area of urticaria.
Dose administered greater than 12 hours on pre-draw syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours on pre-draw syringe) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours on pre-draw syringe). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours on pre-draw syringe) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   The pre-drawn syringe was given 1hour and 45minutes beyond the recommended 12hour period to a patient, only one dose was given. Patient was given today dose at around 11:17am and the dose in syringe expired at 09:30am.  Treatment information was not provided.
Patient stated she became very lethargic and sweaty. Her arm had swollen. What scared her most was she felt like her heart was racing. Symptoms started the day after her shot, 7/30/2022. She went to the ER.
14OCT97 pt noticed redness, swelling @ site size of a saucer that evening while dressing;stated was a hard area in center;applied warm compress x 3 days;area still pink but hard area almost gone p/6th day post vax
SWEATING; PAIN IN LEFT LEG; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sweating and pain in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sweating and pain in left leg was not reported. This report was non-serious.
she currently has shingles although she was vaccinated only last year; she currently has shingles although she was vaccinated only last year; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. In July 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received Shingrix both doses and currently had shingles although was vaccinated only last year.  The reporter consented for contact with HCP, but did not know any other information other that HCP name.  The patient called back to requested to retract consent and permission for follow up with her HCP.
On 6/11/99, the pt received an injection of Engerix-B; it was not known if he had received prior injections of Engerix-B. "Soon after the injection", the pt became immunosuppressed. The event persisted as of 10/16/01.
vaccine was kept in refrigerator on 29 Oct 2021 and administered on 02 Nov 2021; 606 doses were given after expiration date / vaccine was kept in refrigerator on 29 Oct 2021 and expired on 13 Oct 2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date / vaccine was kept in refrigerator on 29 Oct 2021 and expired on 13 Oct 2021) and PRODUCT STORAGE ERROR (vaccine was kept in refrigerator on 29 Oct 2021 and administered on 02 Nov 2021) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date / vaccine was kept in refrigerator on 29 Oct 2021 and expired on 13 Oct 2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was kept in refrigerator on 29 Oct 2021 and administered on 02 Nov 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date / vaccine was kept in refrigerator on 29 Oct 2021 and expired on 13 Oct 2021) and PRODUCT STORAGE ERROR (vaccine was kept in refrigerator on 29 Oct 2021 and administered on 02 Nov 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided. No temperature excursion of the product reported. No adverse event experienced by the patient.
Contracted COVID 19 in May2022; Contracted COVID 19 in May2022; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and in Jun2021 as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Contracted COVID 19 in May2022".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200108580 Same patient/vaccine; different dose and event.
sudden death after taking the vaccine; myocarditis; real vaccine-related injuries that caused people to have heart complications; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional). Other Case identifier(s): 2080958 (Case number).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "sudden death after taking the vaccine"; MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "real vaccine-related injuries that caused people to have heart complications". The patient date of death was unknown. The reported cause of death was "sudden death after taking the vaccine". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: sudden death after taking the vaccine
Patient seen in the ED on 12/23/22 for left sided chest pain that began approximately 5 days ago. He was previously diagnosed with pneumonia and has been taking antibiotics but reports worsening pain. Additionally, he reports fever, shortness of breath, and hemoptysis. CT scan showed pulmonary embolism. Additionally, a COVID-19 PCR test performed in the ED also resulted positive. Patient was admitted to the hospital 12/23/22 - 12/29/22, with discharge diagnoses including acute submassive pulmonary embolism to left lung with pulmonary infarction, acute hypoxemic respiratory failure due to above, and mild to moderate COVID-19, among other diagnoses. Of note, the provider states "In the absence of any other risk factors, the patient's pulmonary embolism considered to be provoked from COVID-19. " Patient has received the primary COVID-19 vaccine series.
Began vomiting and having diarrhea at 11:30 pm which lasted until 5pm on 10/30/2010. Running a fever, had the chills and etc. Had a family wedding to attend on 10/30 out of state and could barely board the plane. Was sick in car on the way to airport, at airport, on plane and once landed. It did not stop until 5pm and was AWFUL.
SEVERE chills, sweating, stomach cramps, diarrhea and nausea.  Still having diarrhea and stomach problems on June 15th (today)
Patient had mild reaction 10 days after the varicella vaccine was given on left arm, mild fever and swelling, rash of hard bumps that lasted 1 week then it went away and it came back 2 weeks later stayed for 2 weeks and extended to torso, arms and legs per mom.
pt recvd vax 9-915AM & @ 1030AM devel labored breathing & rt eye was swollen almost shut; pt was seen by MD & was to report back if worse a/630PM: pt was calming & swelling improved-next day swelling was down & gone; mass rt neck;
Patient called us on 1/30/21,  and said she may have had a reaction to Moderna COVID-19 shot on 1/18/21.  She said after ~3 days (1/21/21), her right arm become hot, red, swollen down to above her elbow.  She went to Urgent Caremon 1/30/21, and they told her it appeared to be cellulitis (staph infection) and would treat it accordingly.  She got an antibiotic shot and a steroid shot and was to pick up some other meds at her other pharmacy.
Rash below site 4"x3" approx 2 days later, left arm slightly below deltoid.
Patient had, hives within 15 mins, an itchy throat, chest tightness and diaphoresis
After receiving vaccine (within 30 minutes), pt presented with diaphoresis and palpitations. Rapid response was called and pt was sent to emergency room for further workup.
Patient had a fever of 103.7 and developed  a rash of red, slightly raised bumps on the front and back of  his torso, neck and face that lasted two days.  It started exactly one week from receiving the vaccines.
Weakness in both arms, especially the left arm with lack of control over left hand on occasion.  Shortness of breath and overall drowsiness.
pt recvd vax;soreness at site by next am;devel redness/induration starting 12jan95 & progressively inc;approx 3cm in diam;mild n, no emesis on am of 12jan95;
injection site infection; injection site swelling measuring 8 inches by 4 inches; injection site hardness; injection site redness; injection site heat; This case was reported by a pharmacist and described the occurrence of injection site infection in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 53X42, expiry date 9th September 2022) for prophylaxis.   On 11th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 15th December 2020, 4 days after receiving Shingrix, the patient experienced injection site infection, extensive swelling of vaccinated limb, injection site induration, injection site erythema and injection site warmth. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the injection site infection, extensive swelling of vaccinated limb, injection site induration, injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site infection, extensive swelling of vaccinated limb, injection site induration, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in the left deltoid and developed injection site redness, heat, hardness, and swelling measuring 8 inches by 4 inches (extensive swelling of vaccinated limb). The patient was examined by her health care provider and diagnosed the patient with an injection site infection and was prescribed Bactrim as treatment. Till the time of reporting, the events were reported as ongoing. The reporter consented to follow-up. This case had been linked with US2020AMR251357, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR251357:Same reporter
extremely lethargic; sore all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LETHARGY (non-serious), outcome "unknown", described as "extremely lethargic"; PAIN (non-serious), outcome "unknown", described as "sore all over".  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-2021282786 Same reporter and drug, similar events, different patient.
Case number PHEH2015US019390, is an initial spontaneous report received from a pharmacist on 30 Sep 2015. This report refers to a 58 year old female patient. Medical history and concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 151570) 0.1 ml intramuscular on 30 Sep 2015. No adverse event was reported following the overdose. No further information was provided.
Fever and chills from Friday all day till Saturday afternoon (for 1.5 days).
delayed reaction 8 days after receiving vaccine. Local erythema, swelling and itching without signs of infection. Pt has not taken any medications at this time, but we are going to have her take benadryl to see if helps. no systemic symptoms.