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). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 28Dec2021 as dose 3 (booster), single (Lot number: 30336BD) at the age of 36 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: Yes. The patient previously receive a COVID-19 Vaccine. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.
Acyclovir 200/5- 1.5tsp po qid x 5 d. Less than 50 pox.
fever 103 for 48 hrs tx w/APAP also lethargic, incoherent, staring, glassy eyed, c/o pain in neck & @ site of inject; c/o neck pain, loss of energy & appetite, tires easily; 19SEP93 to ER Due to stiff neck & severe pain;
Red, swollen around injection site and now on 1-11-21 red ring around injection site.
Patient tested positive for COVID-19 by PCR on 4/20/21, >2 wks after 2nd COVID vaccine. Patient was asymptomatic and was only tested due to upcoming planned procedure at our facility.
On Monday the 5th day, I started getting chills, feet tingling burning sensation in my lips and face. I also had pressure in my head as well I went to the ER where they told me it was allergies or a thyroid issue. They told me to take Zyrtec but I continued taking Claritin D. I went back to the ER the next day because my head pressure was worse. they gave me a migraine cocktail, steroid and allergy meds. My feet tingling and burning sensation has increased since last Saturday. I went to the Dr. where they did bloodwork. That came back normal. I have been using heat and trying to stretch more, I also use ibuprofen.
Information has been received from a nurse concerning a female patient in her nineties who was vaccinated in the arm with a dose of Zostavax (Oka/Merck).  Two days after vaccination, the patient came back into the office and "her entire arm looked like cellulitis with fluid in it."  The injection was given in the back of the affected arm.  The patient was given BENADRYL and told to put ice on the arm area and was sent home.  A product quality complaint was not involved.  No further information is available.
1 day history of diffuse mildly pruritic macular eruption on trunk, arms and legs.
The Pt is a 30 year old female who presents with urticaria to the right neck 25 minutes following 1st dose Pfizer vaccination to the left deltoid. She has a Hx of seasonal allergies and childhood asthma but currently takes no medications. Pt endorses allergy to penicillin and notes similar skin rash as the reaction. Pt denies any Hx of severe allergic reactions. Currently the Pt denies any swelling of the face/lips/eye, difficulty swallowing, tightness of the throat, or itching of the skin. She also denies dizziness, diaphoresis, or vision changes.
he did have an allergic reaction with the vaccine/He had the allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (COMIRNATY), administration date 11Mar2021 (Lot number: EN6205) at the age of 67 years 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: ALLERGY TO VACCINE (non-serious) with onset 11Mar2021, outcome "unknown", described as "he did have an allergic reaction with the vaccine/He had the allergic reaction".  Additional information: Patient was asking how to find out which component of the Pfizer Biontech COVID19 vaccine he is allergic with. Patient said he did have an allergic reaction with the vaccine on 11Mar2021. Patient said his HCP told him to call Pfizer to know where can he get the allergy testing and he needs to know the location. Patient said the testing for the component is not common and does not exist in every state. Patient said he left a detailed message of his reaction on 12Mar2021 over a telephone message machine with CDC and explained that he do not use the internet. Patient mentioned that he had the allergic reaction (Event captured as per verbatim) with vaccine on 11Mar2021. Patient stated, his weight "About 170(not further clarified, hence not captured in tab)." Patient was not prescribed covid19 vaccine at doctor office / It was took it from facility where many, many people to come to in their car, I had it in my car. I think, that is all as true. Patient was stated, "I don't see expiration date."  No follow-up attempts are possible. No further information is expected.
I had vaccination on 04/25/2022. On 09/05/2022 I started to experience a runny nose sore throat body aches. I tested COVID-19 positive on 09/05/2022. I was prescribed PAXLOVID on 09/06/2022. It took almost to test COVID19 negative and had symptoms for about 3 weeks.
This case was considered medically important (OMIC). Information regarding Hib-Titer vaccine was received from a consumer regarding his now 5 year old son who experienced mercury poisoning. The patient received vaccine on unspecified dates. Relevant medical history was not provided. Indication for Hib-Titer Vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. The child's father believes that his son has developed mercury poisoning per the reporter. The child's father also stated that his child is not autistic. No additional information was available at the time of this report. The reporter indicated that his son received Hib-Titer vaccine, lot 570003A; however, this is not a valid lot number.
a Nurse mildly cut herself on the finger from the VAXNEUVANCE syringe; her thumb slipped and cut against the broken finger flange; Nurse mildly cut herself on the finger from the syringe; This spontaneous report was received from a office manager and refers to a 32-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.      On 14-JUL-2023, the nurse was performing vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # W026150 and expiration date 20-OCT-2024 for prophylaxis (exact dose, dose number, route and site of administration were not provided) and the syringe broke (syringe issue).       On 14-JUL-2023, the patient experienced skin laceration and injury associated with device. The outcome of skin laceration and injury associated with device was unknown. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the events was not applicable.  The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not provided.
Headaches, sweats, right upper quadrant pain/ultimately diagnosed with leukemia (AML).  Blood tests done during time of vaccination all normal.
Community partner reported that they found her unresponsive on the 17th (so she may have died on the 16th) from what they believe was a heart attack. The family has requested an autopsy.
Left upper arm with red warm tender itching induration approximately 5 cm diameter over pneumonia subcutaneous injection site.
This medically confirmed spontaneous report (initial receipt: 28-Sep-2012) concerns a female patient, who has a pertinent medical history of COPD (chronic obstructive pulmonary disease) and hypertension. She was allergic to codeine. Concomitant medications included tiotropium bromide, fluticasone propionate, metoprolol succinate and hydrochlorothiazide. The patient experienced swelling and soreness at the injection site, following multiple prior doses of influenza vaccine (manufacturer, brand name and batch number were not provided) administered on unspecified dates over many years. The event outcome was not reported.
Numbness on the left side of my body. From my mouth all the way down my left side to my foot.
Received vaccination on 3/28/03.  On 4/1/03 I had left arm pain with some pain that went across my chest for approximately 2-3 hours.  Also some shortness of breath noted during that time.  No symptoms since.
third time was after the first Shingrix shot; barely hurt at all; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles three times), blister (second time he//she only had a couple of blisters) and pain (the pain was even worse than the first time).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: third time was after the first Shingrix shot) and pain (Verbatim: barely hurt at all). The outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  It was unknown if the company considered the shingles and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shingles third time was after the first Shingrix shot, a breakthrough case.  The reporter stated that one barely hurt at all.  The first dose of the Shingrix shot must had helped.  The patient got the second dose of Shingrix and had not had shingles since (knock wood). The follow up would not possible as no contact details were available.
after 4 hours post vaccination, fatigue, sore arm, eyes burning Narrative:  reaction lasted until 1/29/2021
Reporting administration error as per Agency.  We contacted Pfizer for expiration dates, pfizer vaccine specialist advised that the expiration dates are deemed viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted  pfizer to obtain expirations dates directly from them.  No adverse reaction reported from the patient at the time of vaccination. No adverse reaction reported since the administration of vaccination.
Information has been received from a physician concerning an 8 year old female patient who on 20-AUG-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (LOT# 658056/0835U). On 22-AUG-2007, the patient experienced redness and swelling at the site. The patient's outcome was not reported. Additional information has been requested.
Red spot in axilla with significant swelling of lymph nodes throughout right breast tissue; extremely sensitive and sore for one week, resolved itself.
Patient received 2 vaccines in left arm on 11-2-15. On 11-4-15 mom noticed bruise and softball size lump under arm. Area was red and tender to touch. Denies fever, nausea, vomiting, open sore or drainage. Mom will give BENADRYL, ice pack and monitor.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a 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 14Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 09Feb2021 as dose 2, single (Lot number: EL8982), in left arm, on 15Sep2021 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: 33036BD), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic myeloid leukaemia" (unspecified if ongoing); "Known allergies: Gadalinium" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR; VIT D [VITAMIN D NOS]; METOPROLOL; ROSUVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Nov2022) Negative; (Nov2022) Negative; (Nov2022) Negative; (Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Cold like symptoms deep cough; Cold like symptoms deep cough; Other vaccine same date product=Flu; Other vaccine same date product=Flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Nov2022 at 13:00 as dose 4 (booster), single (Lot number: GJ6739) at the age of 65 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 13Nov2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 13Nov2022, outcome "unknown" and all described as "Other vaccine same date product=Flu"; NASOPHARYNGITIS (non-serious), COUGH (non-serious) all with onset 14Nov2022, outcome "recovering" and all described as "Cold like symptoms deep cough". Therapeutic measures were not taken as a result of nasopharyngitis, cough.  Additional information: The patient did not receive other vaccine in four weeks. Patient did not receive other medications in two weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19.  Patient had no known allergies.
J96.00 ACUTE RESPIRATORY FAILURE 4/29/2022 ASPIRATION PNEUMONIA R09.02 HYPOXIA 4/29/2022 ASPIRATION PNEUMONIA
Elevated heart rate; During one event I had to stop the workout to catch my breath; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a female patient (reporter's wife) that female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On an unknown date in 2021, the patient experienced elevated heart rate and during one event i had to stop the workout to catch my breath. Facility where the most recent COVID-19 vaccine was administered at doctor's office/urgent care. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient was not received any other medications within 2 weeks of vaccination. The clinical outcome of both events were unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021598382 same reporter/AE/SD, different patients.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergy were not reported. On 11-AUG-2017, the patient was given an expired dose of PNEUMOVAX23 (lot # L031459, expiration date 30-APR-2017, route not reported) for prophylaxis. No adverse effect was reported.
Expired PENTACEL was inadvertently administered with no reported AE; Initial information received on 15-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 months old female patient to whom diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Prophylactic vaccination; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination.  On 15-May-2023, the patient received a expired 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ668AAA, expiry date: 13-MAY-2023 with unknown strength) via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
pt. recvd vax M-M-R II& exp. "mumps-like synd" w/ "testicular involvement".
Injection +8 hours: strong headache, full body sensitivity, body fatigue, flush neck and face, full body chills, full body shivering. +9 hours: hands pale, thumb capillary refill L: no refill, R: 6 seconds. HR98 +10 hours: Temp: 101.4, thumb capillary refill L:2 R:2. Eyes bloodshot, headache over eyes/temples +11 hours: Temp 102.5, HR 109, SpO2 95 +12 hours: full body chills transition to full body slight flush/damp. Headache pulsing behind/above eyes and temples. +18 hours: Temp 100.2, HR 87, SpO2 99, headache continues.
Painful, it swelled up and turned blue/ It sting like a bee sting; Swelled up; Turned blue; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Painful, it swelled up and turned blue/ It sting like a bee sting), local swelling (Verbatim: Swelled up) and bruise (Verbatim: Turned blue). The patient was treated with malus spp vinegar extract (Apple Cider Vinegar). The outcome of the pain was resolved and the outcome of the local swelling and bruise were not reported.   It was unknown if the reporter considered the pain, local swelling and bruise to be related to Shingles vaccine.     It was unknown if the company considered the pain, local swelling and bruise to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient had both shots and the shot it's self was so painful, it swelled up and turned blue. It stung like a bee sting so patient put apple cider vinegar on it and it took out the sting and felt much better. The follow-up could not be possible as no contact details were available.
Client received a Pfizer 1st dose on 12/31 and J&J on 8/19/21.  No A/R reported to date.
Pruritus at the site on Injection , started a few minutes after the shot was given her vaccine , this is her 2nd shot, she had no reaction to the 1st  Moderna vaccine.  Pt was given Benadryl 50mg and Solu-medrol 125mg IM  Symptoms resolved
Patient had acute onset of headache that progressed over the next 2 days and was described as frontal, throbbing, and continuous.  He had a tactile temperature associated with the headache, but no vomiting or diarrhea. Patient went to ER on 04/15/2011 and then another ER on 4/16/2011, transferred to inpatient pediatrics floor 04/16/2011.  Still hospitalized as of 4/18/2011 for workup and treatment, patient appears clinically better at times, but at others has possible meningitic findings.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: also stated "could not hear"
convulsions; This case was reported by a pharmacist via call center representative and described the occurrence of convulsion in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 15th January 2020, 1 days after receiving Shingrix, the patient experienced convulsion (serious criteria GSK medically significant). On an unknown date, the outcome of the convulsion was unknown.   It was unknown if the reporter considered the convulsion to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in an unknown deltoid. At night, the patient started to have convulsions. The patient did not seek medical attention. Caller did not have full patient demographics or lot information at the time of the call.