chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in to receive his 3rd dose of Pfizer Covid-19 vaccine.  He said he qualified as immunocompromised.  The pharmacist on duty stated that he appeared to be in good health as far as she could tell.  Team member claimed he was disoriented upon checking out for his purchase, they helped him to his car.  He crumpled to the ground and team members helped him sit up in his car and waited with him for EMS.  After a few minutes we were told that he became incoherent and this continued when EMS arrived.  EMS medic came to the pharmacy around 12:30pm to let the pharmacist know the patient was despondent.  Upon later information from the family, the patient had passed away at the hospital due to a brain bleed.
Symptoms:  fatigue/exhaustion, insomnia, dizziness, confusion, weight loss, urinary frequency, heart palpitations, brain fog, tingling hands and feet, numbness in hands and feet, inability to sweat, burning in arms, nausea, loss of appetite, electric sensations, crawling sensations on skin, internal vibrations, trembling in hands, sensory overload (sound and vision), memory loss, lack of concentration, muscle weakness, muscle twitching, muscle cramps, shaking /vibrating sensation in head
Almost like cellulitis; Had significant pain and swelling in arm; Had significant pain and swelling in arm; This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for 3 patients. This is the 3rd of 3 reports.   A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced almost like cellulitis, had significant pain and swelling in arm all on an unspecified date with outcome of unknown.  The information on the lot number has been requested.; Sender's Comments: Based on the information currently available, it cannot be fully excluded that the vaccination with PREVNAR 13 might have played a contributory role towards the occurrence of cellulitis like having significant pain and swelling in arm.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2019267621 same reporter/drug/event, different patient;US-PFIZER INC-2019267626 same reporter/drug/event, different patient
Roughly 20 to 25 minutes after receiving the vaccine I felt my entire jaw swell  which for me is an allergic reaction to the the shot I have a long list of allergies and when beginning allergy shots to help deal with those allergies and finding the correct dose to begin with the swelling of the jaw and tightness was an allergic reaction for me I recognized it right away and took OTC generic Benadryl when I got home with a low dose-400mg ibuprofen for site pain. Continued OTC generic Benadryl roughly every 5 hrs. Did this for roughly 24 hrs Jaw still feels slightly swollen-most likely the lymph nodes around the jaw but am not taking extra meds at this point  This leads me to acknowledge that for the next dose, which usu has more of an affect on the body, that I will possibly need my epipen that I carry with me
Report 2000035164-1 describes an injection site lump in a 22 year-old female who received an injection  of hepatitis b vaccine (Engerix-B).  The vaccinee had no concurrent medical conditions and was taking no concurrent medications. She received her first injection of Engerix-B  on 17 may 2000; she had no adverse experience following receipt of this dose. She received her second dose of Engerix-B on 08 June 2000. She also received injections of tetanus toxoid (brand name unknown) and hepatitis A vaccine (brand name unknown) on 08 June 2000. Six hours post-immunization, she developed redness, itching, and swelling at the site of Engerix-B administration. The redness, itching, and swelling resolved after one week.  The vaccinee gradually developed a "marble-sized lump" at the Engerix-B injection site. The lump resolved after one month
Patient said she was feeling okay, however, patient then passed out. Shortly after passing out and losing consciousness, the patient started to have seizure like activity (extreme muscle rigidity in a spasm like way), with some vocal sounds. This continued for maybe around 1.5-2 minutes, and then patient regained consciousness. She wet her pants. Came to and felt extremely tingly everywhere. Looked extremely pale.  Provided water, patient mentioned she hadn't eaten. Grabbed her a bar to snack on. EMS then arrived on the scene and took over care.
A non-serious spontaneous report of product left at room temperature for 20 days was received from a Consumer or other non health professional concerning a 6 year-old. The father had purchased FLUMIST over the counter and was not advised or counseled to refrigerate. The father did not read to packaging and stored at room temperature. The FLUMIST was left at room temperature for 20 days and then administered on 10-Jan-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Rash and large swelling around injection site. went to ER as a pre-caution.
Parent describes that approx. 3 hours, post vax, right leg had reddened area the size of a tennis ball. Parent applied cold compresses and administered Tylenol as advised. Area has now decreased in size (golf ball sized) reddened area. No hardness; not warm to touch. Child in no distress.
10 x 15 cm red/warm (L) deltoid, fever/chills.
pt received covid vaccines.  later diagnosed with covid on 02/07/2022, and passed on 02/17/2022
Pt with no significant medical history, received dose 1 Moderna during unknown pregnancy. Her second dose of Moderna was on 1/21/21, she began experiencing vaginal bleeding at midnight on 1/22/21. Her estimated delivery date was 9/21/2020. She experienced a full spontaneous abortion. Pt is now presenting to ED pregnant for the second time at 5 weeks with vaginal bleeding x2 days with abdominal cramping. Pt diagnosed with threatened miscarriage, pregnancy viability status to be determined with further monitoring.
Fever and elevated heart rate. MD made aware with an order to do stat CBC, BMP, UA/CS, CXR- 2 views. Ferritin, procalcitonin, D-Dimer, CRP, Vit. D level on 1/28/21 and check vitals Q 4 hours.
Started with sore arm where the shot was injected.  Then the next day had sore throat, productive cough, low grade fever, body aches, malaise, sore arm, headache.  Weakness and tiredness and head congestion.
Reaction to booster shots the next morning, symptoms red, whelp and rash at site, warm to touch.
This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a 76-year-old female patient who received SHINGRIX for prophylaxis.  On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was in bed with flu like symptoms for 4 days. This case has been linked with US2019GSK022777 and US2019GSK022778, reported by same reporter.
profound sore arm difficulty in lifting by 8pm after shot, Fever and chills by 12 midnight with temp running 101.9, muscle joints ache had these symptoms until 6:30pm on Saturday 13th
experienced metallic taste in mouth; sore arm at injection site; This is a spontaneous report from non-contactable consumer via Pfizer Sales Representative. This 57-year-old female consumer reported for herself that:  Reporter Name: (name-withheld) Reported by: Consumer Reporter Contact Information: Dont know Patient Name: (name-withheld)  Description of Event: 57 yo F, experienced metallic taste in mouth that went away quickly and sore arm at injection site that went away next day  Optional Information: Event took place shortly after 1st dose Synthroid  Name of Product: COVID Vaccine Awareness Date: 30Mar2021 Country of Occurrence:  Event took place after use of product.  Follow-up(23May2021): This is a follow-up spontaneous report from non-contactable consumer via Pfizer Sales Representative. This consumer reported for herself that:  Reporter Name: Consumer Reported by: Consumer Reporter Contact Information: Dont know Patient Name: (name-withheld) Description of Event: 56 yo female about 5ft 2 in  Pt experienced big yellow circle mark at injection site following 2nd dose and now has various bruising on arms/forearms which she says she did not have before vaccine 2nd dose in April  Optional Information: Hypothyroidism on synthroid, diabetes  Name of Product: COVID vaccine Awareness Date: 23May2021 Country of Occurrence:  Event took place after use of product.  No follow up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected. This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism. The following information was reported: DYSGEUSIA (non-serious) with onset 30Mar2021, outcome "unknown", described as "experienced metallic taste in mouth"; VACCINATION SITE PAIN (non-serious) with onset 30Mar2021, outcome "unknown", described as "sore arm at injection site". This is a spontaneous report received from non-contactable reporter (Consumer) from a sales representative. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication included: SYNTHROID taken for hypothyroidism. The following information was reported: DYSGEUSIA (non-serious) with onset 30Mar2021, outcome "unknown", described as "experienced metallic taste in mouth"; VACCINATION SITE PAIN (non-serious) with onset 30Mar2021, outcome "unknown", described as "sore arm at injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine given on the posterior side of the left deltoid. The location of the injection seemed high to the parent and the patient had severe pain immediately after the injection was given. The shoulder was especially painful with abduction. There was some improvement in the range of motion and level of pain after about one week. Then, the patient operated a combine for 2 days during harvest. The repetitive movement resulted in increased sharp, stabbing pain in the shoulder and decreased range of motion. Patient rates the pain at 9-10 on a 0-10 scale. Again, the pain is worst when the arm is abducted, and at the end of the day, the shoulder is achy. Patient has tried over the counter pain medications (ibuprofen and acetaminophen), ice, and rest of the joint, with little improvement.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 4:01 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 4:01 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 55.13.  Concomitant products were not provided.  On 27-Oct-2021, the six vials were moved to clinic. On the same day between 09 AM to 10 AM, vials underwent temperature excursion with temperature 29- and 32-degrees Fahrenheit respectively. On 29-Oct-2021, the vaccines were moved to fridge. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 29-Oct-2021 and 04-Nov-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was stored in cooler 1, on 27-Oct-2021, temperature excursion at 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 PM: 43, 1PM: 43, 2 PM: 43, 3 PM: 46 and 4 PM: 46.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
CLAIMANT ALLEGES THAT HE RECEIVED HIS COVID-19 VACCINATION  J&J (JANSSEN ) WHEN HE HAD AN ALLERGIC REACTION. THE CLAIMANT FELL ON THE FLOOR AND PASSED  OUT FOR ABOUT 30 SECONDS AND CAME BACK . THE CLAIMANT WAS CHECK OUT AT THE STORE BY E.M.S
Possible blood clot in left leg; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 22Mar2021 14:00 (Lot Number: EP7534) as 2nd dose single dose at the age of 62-year-old for covid-19 immunisation. Historic vaccine included bnt162b2 dose 1 via an unspecified route of administration, administered in left arm on 01Mar2021 14:00 (Lot Number: EN6203) as 1st dose single dose at the age of 62-year-old for covid-19 immunisation. Medical history included heart, diabetes, gastrooesophageal reflux disease(gerd), arthritis, high blood pressure (HBP) from an unknown date. Past drug event included diltiazem (CARDIZEM) and experienced known allergies to diltiazem. Concomitant medications included clopidogrel bisulfate (PLAVIX), acetylsalicylic acid (ASPIRIN), metformin, metoprolol, and semaglutide (OZEMPIC), all taken for an unspecified indication, within 2 weeks of vaccination. The patient experienced possible blood clot in left leg on 19May2021 05:00. The adverse event result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No other vaccine in four weeks. The outcome of event was not recovered.
Bell?s Palsy - facial paralysis on left side  Prednisone and valacyclovir Has improved but not fully recovered. Still paralyzed. Have been told will take up to six months to heal.
Just so tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Just so tired) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00M20A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FATIGUE (Just so tired). At the time of the report, FATIGUE (Just so tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.     Reporter did not allow further contact
signs of heavy cold-sore throat, running nose, dry cough, some chest congestion;
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.
tested positive for COVID19.; tested positive for COVID19.; caller developed several kidney stones; This is a spontaneous report from a contactable consumer (patient). A 62 years old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Mar2021 (at age of 62 years old) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. However post-vaccination, caller developed several kidney stones and tested positive for COVID19. Following his intent to travel internationally, he would like to know if he can still get his 2nd dose or does he have to re-do it given that it was over 70 days (79 days) from his first dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Adult dose given to a 6-month-old; Adult dose given to a 6-month-old; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 6-month-old female patient who received HBV (Engerix B adult) (batch number 39TZ2, expiry date 07-SEP-2023) for prophylaxis.   On 24-MAR-2023, the patient received the 3rd dose of Engerix B adult. On 24-MAR-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: Adult dose given to a 6-month-old) and adult product administered to child (Verbatim: Adult dose given to a 6-month-old). The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-MAR-2023 The nurse Leader/RN states that a patient was getting the 3rd dose of Engerix-B and the adult dose was administered instead of the pediatric dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. 6 month old patient was administered an adult dose of Engerix-B instead of the pediatric dose, which led to overdose and adult product administered to child.
Information was received on 28-AUG-2017 from a nurse who was reporting on a 63 year old male patient. No concomitant medications or medical history was reported. On 18-AUG-2017, the patient received a dose of VARIVAX (lot N001530, expires 13-JAN-2019) 0.5 ml subcutaneously (injection site not reported), instead of a dose of ZOSTAVAX. Lot number and expiration of sterile diluent was not reported. No adverse effects reported. The nurse stated that she thought that their pharmacy had reported the event to VAERS (no number available). No further information was provided. Additional information has been requested.
pt had a positive COVID test in her assisted living home (name of facility unknown), and brought to ED; had a positive COVID test in ED and also found to have a UTI; pt treated with dexamethasone, heparin SQ, and ABX for UTI; pt had a sudden decline and transferred to ICU; family decided on hospice for pt and to withdraw all life saving treatments; pt died in the hospital
Patient received booster dose of Moderna 10/27/21 (unclear exactly when patient got 1st two doses due to not having information available). Patient became weak, tired, coughing and positive for COVID which led to admission 11/22/21. Patient is still admitted
Delayed adverse reaction "Covid Arm". treated with hydrocortisone and Benadryl.  Less redness but still a large rash.
"knot" on arm at site of injection, rash on arms and both legs, nausea, dizziness and light-headed.
red spot about silver dollar size on arms w/swelling itching, hot to touch x 3 days; lt thumb & index finger joints throb; lt arm feels weak;
Triggered autoimmune disease symptoms which were sore joints,  fatigue, constipation, bloating, severe abdominal pain, nausea,  and vomiting.
1.) Soreness, aching, hot, redness & swelling. 2.) Cold compressors, lots of liquids & MOTRIN.
nausea started about  hours later, then uncontrollable chills about 8 hours later, along with body aches, headache, joint pain. Body aches & flu like symptoms still occurring now 30 hours later
Entire upper left arm aches(hurts) pain at time radiates into shoulder.  Loss of motion in left arm.  Unable to lift left arm above my head, general limited motion.  Constant ache at times pain.  Unable to put a coat on in a usual manner, etc.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 05-MAY-2016 the patient was vaccinated with an improperly stored dose of VAQTA 50 U/1 ml (lot # L042838, expiration date: 26-MAY-2017; dose, frequency and route unspecified). No adverse effects were reported. The storage criteria was refrigerator (R). The total cumulative excursion time was 88 hours with the lowest recorded temperature 32 (Fahrenheit degree/Celsius) and the type of excursion (R/F) was 0 and R. This is one of several reports received from the same source. Additional information has been requested.