chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of recurrent cancer in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX (batch number N9CA2, expiry date 2nd July 2021) for prophylaxis.  The patient's past medical history included cancer. On 28th May 2018, the patient received the 1st dose of SHINGRIX. On 6th March 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced recurrent cancer (serious criteria GSK medically significant) and drug dose administration interval too long. On an unknown date, the outcome of the recurrent cancer and drug dose administration interval too long were unknown. It was unknown if the reporter considered the recurrent cancer to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was a cancer survivor. The patient received 2nd dose of SHINGRIX 10 months apart from a 1st dose of SHINGRIX, which led to the lengthening of the vaccination interval. The patient's cancer returned sometime after1st dose of SHINGRIX. The reporter did not know the exact date of cancer returned. The reporter declined to provide patients initials or date of birth.
Information has been received from a physician concerning a patient (age and gender unknown) who on 19-FEB-2007 was vaccinated with Gardasil (Lot number 654540/0800F). On 16-FEB-2007 the patient the received vaccine in the bottom. No further information is available.
Pt received 2nd dose of Moderna on 7/23/2021. Experience flu-like symptoms over the weekend but said those have mostly resolved as of today but noticed red, splotchy areas on his arm that resemble a rash but do not itch and that it just appeared today as far as he knows. Pt stated it is not at the injection site but near it and also on his bicep. Advised pt to have a physician examine him to ensure there are no complications and to follow-up with us as well.
patient received the first moderna shot after having already received the full dose of the pfizer vaccine 3 weeks ago
Patient c/o redness, pain and swelling in left arm persisting 3 days after Pneumovax & influenza vaccines (unknown if one/both vaccinations were  given in left arm).
This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 26-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis. The lot of M-M-R II were reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
No adverse event(s) reported by the patient, but the wrong vaccine was administered. Patient had the Moderna vaccine first, then received the Pfizer vaccine today. Lot: EY0584 Exp: 10/31/21
Patient called on Monday August 30th 2021 around 11 am and complain that she has muscle pain, bone ache, not feeling hungry and feeling tired. No SOB, rashes or hives. Recommended patient to contact PCP immediately.
hives, itching, short of breath - Benadryl, epi pen, tapering dose of prednisone
Few days after the first shot I observed it was slightly swollen.  I started putting some heat compression over it. But now I am observing slight bump in that area and it?s getting hard  and the pain is not going away
fatigue; chills; malaise; began to experience symptoms consistent with a sinus infection (nasal congestion, headache, runny nose, cough, sore throat); ears filled with fluid; ear is still feeling clogged; hearing in the left ear is impaired; ear infection in the left ear; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EW0182), via an unspecified route of administration, administered in the right arm on May2021 (also reported as '18Apr2021'), dose 2, single for COVID-19 immunization.  Medical history included allergy to sulfa antibiotics and asthma from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number: EW0170, expiry date unknown) on 18Apr2021 (at 35-years-old) at 14:30 in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not have COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. On 10May2021 at 08:00, approximately 18 hours after the second shot, the patient began to experience fatigue, chills and malaise lasting for approximately 8 hours.  Following those 8 hours, the patient's initial symptoms eased and were gone within 36 hours after the shot on an unspecified date in May2021.  However, around the same point, on an unknown date in May2021, the patient began to experience symptoms consistent with a sinus infection (nasal congestion, headache, runny nose, cough, sore throat). The symptoms persisted for approximately 1 week.  Around day 8/9, following a trip to higher altitude, the patient's ears filled with fluid and within 12 hours she had developed an ear infection in the left ear. This was treated with steroids and a course of antibiotics (amoxicillin). A week later, approximately 18 days after the shot, the infection has cleared but her ear is still feeling clogged and her hearing in the left ear is impaired. The events resulted to a clinic visit and an emergency room or urgent care visit. The patient received antibiotics, steroids and OTC medications as treatment for the events.  The outcome of the event fatigue, chills and malaise recovered in May2021. The outcome of the events ear infection in the left ear and began to experience symptoms consistent with a sinus infection (nasal congestion, headache, runny nose, cough, sore throat) recovered with sequel in May2021. The outcome of the events ears filled with fluid, ear is still feeling clogged and hearing in the left ear is impaired recovered with sequel on an unknown date.
Approximately 1 week prior to admission patient developed increased bruising and a few minor episodes of epistaxis.  She also experienced 1 day of diarrhea which was followed by 4 days of significant fatigue with subsequent improvement. Labs performed by PCP 5/21/2021 showed platelet count of 2000 and when labs resulted on 5/22/2021 patient was instructed to present to the emergency department where her count was repeated and was less than 2000. Patient is receiving 4-day course of IV immune globulin 20 g and prednisone 1 mg/kg (60 mg) daily for 2-3 weeks Patient received 1 unit platelet transfusion in emergency department on 5/22/2021 COVID-19 vaccination could have precipitated relapse of ITP
Reduced immune response; This non-serious case was reported by a physician via sales rep and described the occurrence of therapeutic response decreased in an unspecified numbers of patients who received Hepatitis B vaccine for prophylaxis.   Concurrent medical conditions included hiv infection.   On an unknown date, the patients received Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patients experienced therapeutic response decreased (Verbatim: Reduced immune response). The outcome of the therapeutic response decreased was unknown.   Additional Information: GSK receipt date: 15-Sep-2023 The reporter reported that they were double vaccinating HIV patients with the HBV vaccine due to observed reduced immune response in the patient's population. The reporter did not agreed to follow up. The patients had reduced immune response after Hepatitis B vaccination, which led to therapeutic response decreased.
Crying started 630PM on 30JAN91-mom gave tylenol q 4 hrs p/immun; Called FMD & was advised to cont giving tylenol; child screamed for 2.5 hrs to 3 hrs continuously; P/this time went to sleep & no more problems;
This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 65-year-old female patient received PREVNAR 13; (batch number unknown), via an unspecified route of administration on 06Dec2018 at 0.5 ml, single for immunization. The patient's medical history and concomitant medications were not reported. The patient's arm was really warm to touch and she had fever, and patient was still not feeling well in Dec2018. The outcome of the events arm was really warm to touch and had fever was unknown while patient was still not feeling well was not recovered. Information on the batch number has been requested.
This spontaneous report as received from a registered nurse, also reported as a physician, via a company representative refers to a 15 month old male patient with no drug reactions/allergies. The patient's medical history included chicken pox at the age of 7 months. On 07-JUN-2013 the patient was vaccinated with VARIVAX (Merck). The dose number, strength, lot number and expiry date were not reported. The patient did not take concomitant medications. On 14-JUN-2013 the patient experienced chicken pox. The patient saw a doctor at the office and was treated with an unspecified dose of BENADRYL and Calamine lotion (dose and manufacturer not specified). No lab diagnostic tests were performed. The outcome of chicken pox and causality were not reported. Additional information has been requested.
Pt went to the gym and died from a heart attack/stroke?? within 24hrs of obtaining H1N1 injection.  12/22/09 ED records received. Service dates 11/23/09 to 11/24/09. Assessment: Cardiac arrest. EMS called because of chest pain, arrested on route to ED. Intubation. Resusitation.  Ventricular Fibrillation. Patient presents in cardiac arrest. Radial pulses absent. Pupils fixed and dilated. Skin mottled, clammy, temperature is cool. Pronounced expired
PT woke up with a headache and vertigo.  By 11:30 AM vertigo was so bad she couldn't walk (feet wouldn't move in the right directions).  Pediatrician tested and got negative results for COVID, flu, and strep and sent us on to ER.  PT developed knee pain in both knees and also hand tremors while at the pediatrician.  At the ER continued to have symptoms and also had slight blurriness in left eye peripheral at one point.  All bloodwork normal except for slightly low White blood cell and MPV.  MRI without contrast performed and determined to be normal.  PT continued to have symptoms and was admitted for overnight observation.  Neuro consult the next day concluded she'd had a migraine which lead to the vertigo, but also gave her a diagnosis of functional neurological disorder.  She had also developed a rash on her left arm 2 days after the second dose which went away after 2 days and wasn't present when the more serious symptoms started.  Over the course of this week PT has started experiencing panic attacks lasting up to 2 hours in length, with as many as 4 per day. She had no anxiety attacks or other issues prior to the shots.
Patient received monovalent vaccine as a booster shot when bivalent vaccine was on the market. Clinic was not up to date on most recent bivalent vaccine recommendations, so monovalent was being given as booster.
Herpes Zoster; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. The concurrent conditions, medical history and concomitant medications were not reported. On or about 06-JUN-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided) as prescribed and/or administered by a healthcare provider in a clinic, for the long-term prevention of shingles and zoster-related conditions. Subsequent to vaccination, the patient was treated by a healthcare provider at a clinic for herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for those injuries; significant medical and related expenses as a result of those injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Information has been received from a certified medical assistant concerning a less than 18 month old male who on 05-OCT-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine instead of PREVNAR. There was no adverse event report. No product quality complaint was involved. Additional information has been requested.
Swelling; This case was reported by a nurse via call center representative and described the occurrence of swelling in a adult patient who received Herpes zoster (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 swelling. On an unknown date, the outcome of the swelling was unknown.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional details were provided as follows: This case was reported via chat. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter asked, if Shingrix was a live vaccine. The reporter stated, her friend was swelling as she reported and they just went to the emergency room. After being provided information that the vaccine was not live, reporter ended chat. No further information was provided.
Patient was sitting in Observation Area after her 1st Moderna COVID Vaccine and began to cough and itch, with rash appearing on neckline. Patient was given 2 puffs of her own albuterol and then her own does .3 mg of Epi. Patient was transported to Care Center where she was treated and released same day.
Patient received an extra dose of the FLUZONE QUADRIVALENT PF shot (3 doses in total). I reviewed their immunization card and it showed that they only had one influenza vaccine and needed second dose. I did not review medical records because I assumed that the immunization card was accurate and I followed the orders of the RN. After the patient left I reviewed medical records and noticed that he already 2 doses of influenza vaccine and had given them a third dose. I spoke to Dr. regarding my mistake and she reassured me that there is no harm to the patient.
This case was reported by a nurse via call center representative and described the occurrence of stiffness in a adult male patient who received DTaP vaccine for prophylaxis. On an unknown date, the patient received the 1st dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced stiffness, swelling, fever and crying. On an unknown date, the outcome of the stiffness, swelling, fever and crying were recovered/resolved. It was unknown if the reporter considered the stiffness, swelling, fever and crying to be related to DTaP vaccine. Additional details were provided as follows: The age at the vaccination was not reported, however at the time of the event the patient's age group was infant. The healthcare professional stated, the patient's mother reported that when patient was infant and received dose of DTaP vaccine, the patient experienced lot of stiffness, swelling, high fever, inconsolable crying for couple days after the vaccination. The healthcare professional did not have vaccine information or if it was a GlaxoSmithKline vaccine. This case was linked to the case US2018137399, reported by the same reporter for the same patient for 2nd dose with same adverse events.
Missed dose; This case was reported by a consumer via call center representative and described the occurrence of rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. The patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.   Follow up information received from consumer on 2nd October 2019: The reporter authorized to contact physician.
Approximately 4 hours after my injection I began presenting with a fever, which is abnormal for me given my long-term steroid use. I also had a headache and dizziness. The fever continued to grow over the next 48 hours. By Thursday morning, my fever was over 101. I took Tylenol and Advil but it did not reduce the fever. I also had severe muscle pain and my heart rate was 120. After 4 hours with no significant change, I called my PCP and my pain management clinic. I relayed questions for doctor or NP. Both offices phoned back that afternoon and told me that this was within expected side effects for the vaccine. The higher heart rate being unusual but potentially caused by the fever and pain increase.
her arm is aching; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her arm is aching on an unspecified date. The outcome of the event pain in extremity was unknown.  Follow-up attempts are completed. No further information is expected.
Very red face; Broke out in rash that eventually covered my whole body; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: El3248), via an unspecified route of administration from 29Jan2021 11:00 to an unspecified date at single dose for covid-19 immunization. Medical history included 2 knee replacement, diabetic, high blood pressure, anemic and allergies to penicillin. Concomitant medication included insulin, paracetamol (TYLENOL) and metformin. The patient previously took Benadryl and experienced drug hypersensitivity. The patient experienced very red face and broke out in rash that eventually covered my whole body on 29Jan2021 at 18:15. The outcome of the event was not recovered.
This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 19-MAY-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 with unspecified Lot No. and expiration date: 19-MAR-2016 (dose and route of administration were not reported). No concomitant therapy was provided. No adverse effect was reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
PPD and TD administered at office. Pt presented to ER in late PM with rash and tenderness at DT injection site, chills, fever, headache and stomach ache.
This spontaneous report received from a patient via a company representative via a social media concerned a patient of unspecified age, sex, race and ethnicity 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, expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced myasthenia gravis and patient will visit neurologist in coming weeks. Dose number in series-1. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myasthenia gravis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211162414-COVID-19 VACCINE AD26.COV2.S-myasthenia gravis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)
This spontaneous report was received from a pharmacist, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 13-FEB-2018, the patient was vaccinated with an expired dose of ZOSTAVAX, subcutaneously, in the left arm, (lot # M041085 with an expiration date in 03-JAN-2018), for prophylaxis, (dose and frequency were not provided). No adverse effects reported.
I got a flu shot on Saturday afternoon (9/23/23) and shortly after noticed a red rash that was warm. Sunday, the rash expanded, the rash was still warm to the touch, and a blister appeared on my skin. Monday, I went to the doctor. I had a white blood cell test performed (it's fine) and received a series of antibiotics - a shot in the urgent care office and an oral prescription for 7 days. I've had to mark my arm to monitor the growth of the rash and blister.
Patient received only the diluent portion of the Menveo; Patient received only the diluent portion of the Menveo; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA712A, expiry date 31st May 2023) for prophylaxis.   On 20th August 2022, the patient received Menveo. On 20th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date:22-AUG-2022 Reporters comment: The patient received only the diluent portion of the Menveo. No reactions reported.  Call Notes:Follow up email The reporter given consent to follow-up. Additional Supportive information: Till the time of reporting the patient received only the diluent portion of the Menveo which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered
I received the vaccine on Tues. Nov 18, 2014. Later that evening I began to experience a sore throat. The next day I experienced a sore throat and nasal congestion of left nare. On Thurs I had intermittent nonproductive cough. Friday and Saturday green nasal discharge. Sunday lethargic, sore throat, nausea, nasal congestion.