chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: EW0164) at the age of 52 years intramuscular, in right thigh for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Crab, Lobster, sand fleas" (unspecified if ongoing), notes: Known allergies: Crab, Lobster, sand fleas; "smoker/former smoker: No" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot number EL0140, route of administration: Intramuscular, Anatomical location: Right leg thigh), administration date: 23Dec2020, when the patient was 52-year-old, for COVID-19 immunisation, reaction(s): "Vaccine administered at inappropriate site"; BNT162b2 (DOSE 2, SINGLE, lot number EL1283, route of administration: Intramuscular, Anatomical location: Right leg thigh), administration date: 09Jan2021, when the patient was 52-year-old, for COVID-19 immunisation, reaction(s): "Vaccine administered at inappropriate site", "Inappropriate schedule of vaccine administered". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 30Sep2021, outcome "unknown", described as "Location of injection: Leg Right thigh"; HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "HA"; FATIGUE (non-serious) with onset 2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient did not receive any other medications within 2 weeks of vaccination. This report was assessed as non serious. The patient received vaccination on the right leg thigh. The patient experienced fatigue and headache during the COVID-19 illness. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Follow-up (09Aug2022): This is a spontaneous follow-up report received from same contactable Nurse. This Nurse reported in response to HCP letter sent in cross reference case that included: New information: reporter information (contact information), patient contact information and age, historical vaccine details, lab data, vaccination details (start date, stop date, lot number, route of administration, anatomical location), concomitant drug, event details (additional event headache and fatigue, start date) and additional information was updated.
Diagnosed with COVID 12/28. Symptoms of cough, headache started 12/26. Husband with similar symptoms and positive 12/28. Son (11months) in daycare with cough and cold symptoms who tested negative, I am RN on COVID unit, unknown source of infection.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients might have received doses of ROTATEQ (dose and lot # not reported) orally that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Stiff neck, limited arm and neck movement without extreme pain. Problem has persisted since 11/22/2009. Pain has diminished and movement has been restored somewhat pain free. Application of heat to affected area. Taking of aspirin and lots of water. Immobilization of affected area with rest. Some pain and discomfort still persists but not nearly as intense as onset. Dr. has been informed.
One moment she was fine. The next moment she was completely pale, white as a sheet, even her lips were white. She had beads of sweat on her forehead. She said she didn't feel well, and she didn't want lunch. Then she went and vomited. We took her temperature, and it was normal. We talked to her, made sure she was oriented. She then had a bout of diarrhea in the bathroom. It took about an hour for her color to completely come back and for her to feel better. She called Pfizer and spoke to them to make a report. They told her they have not had reports like this a few days after the vaccine was given. We were not sure if she should have the 2nd round or not.
I noticed that I was unusually forgetful beginning about a week following my first dose of the vaccine. Forgetting when I was supposed to be somewhere, things people told me a day or two before etc.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: never unresponsive
The vial was punctured and left out at room temperature over night./patient received an invalid dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (The vial was punctured and left out at room temperature over night./patient received an invalid dose) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (The vial was punctured and left out at room temperature over night./patient received an invalid dose). At the time of the report, PRODUCT ADMINISTRATION ERROR (The vial was punctured and left out at room temperature over night./patient received an invalid dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Information has been received from a nurse concerning a 13 year old female with no known allergies or drug reactions who on 20-FEB-2008 was vaccinated with the first dose of GARDASIL (lot no. 657736/0389U) IM, into the right arm and the first dose of MENACTRA (lot no 42421AA) IM, into the left arm. On 21-APR-2008, the patient was administered the second dose of GARDASIL (lot no. 657736/0389U) IM, into the right arm. In August 2008, the patient experienced shooting pain, paresthesia in both thighs and legs. The problem went from head, now range of motion in both hips decreased, especially the abdomen. The patient was diagnosed with neuropathy and radiculopathy. The patient also had entire body pain. On 08-OCT-2008, a thoracic and lumbar magnetic resonance imaging were performed (results not reported). On 06-SEP-2008, a complete blood cell count, a complete metabolic panel, serum C-reactive protein test and serum antinuclear antibodies test were performed (results no reported). Additional information has been requested.  2/24/09 Received vaccine records & PCP medical records of 9/4/08-1/30/2009. FINAL DX:adjustment disorder Records reveal patient experienced general body pain, chest pain, right shoulder pain.  Neuro exam WNL.  Referred for MRI of shoulder & spine & labs.  RTC 9/18 & had not been able to get MRI or labs done due to family & homeless developments as well as depression w/suicidal ideation.  Psych hospital admit & dx w/adjustment disorder.  Developed insomnia, pes plana, pharyngitis as well as continued psych & behavioral issues.
10/1/21: Went to ED the day after 2nd Covid vaccine. Is nauseous, has a headache and is sensitive to light.
SHAKING; RASH; CRAZY CHILLS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case No concomitant medications were reported. On an unspecified date, the subject experienced shaking, rash, and crazy chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash, crazy chills and shaking was not reported. This report was non-serious.
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves patient of an unknown demographics who received vaccine FLUZONE QUADRIVALENT (batch number, expiry date, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to wrong injection technique. It was reported that received Flu shot FLUZONE QIV felt it was not injected properly into Deltoid muscle. (was injected into head of deltoid/ most proximal aspect). It was unknown if any adverse event was occurred. 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 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. Documents held by sender: none.
R knee precious surgery 15 years ago now has tenderness; R knee precious surgery 15 years ago now has tenderness and inflammation.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 28Mar2021 at 14:00 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included right knee surgery 15years ago, spontaneous coronary artery dissection (SCAD), fibromuscular dysplasia (FMD), hashimoto's disease and heart attack. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) of dose 88mcg, eplerenone (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and metoprolol (MANUFACTURER UNKNOWN), all from unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6204) via an unspecified route of administration in the right arm on 06Mar2021 at 11: 00 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. The patient previously received oxycodone acetaminophen (PERCOCET) on an unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Apr2021 at 08:00, the patient had right knee precious surgery 15 years ago and now has tenderness and inflammation. Feels like it did prior to surgery. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events tenderness in right knee tenderness and inflammation was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Acute diffuse abdominal pain and nausea/vomiting. These GI sx continued for 2 full weeks until she developed palpable purpura and petechiae to the lower extremities suggestive of HSP. Earlier in the illness (around illness day #8) she had several days of self-limited petechiae that did not recur until illness day #14. Presence of this skin lesions along with diffuse abdominal pain favors a dx of HSP.  Once HSP was diagnosed, she was treated with supportive care.
Tenderness, burning and hurtful left breast; Tenderness, burning and hurtful left breast.; Really run down and tired as expected.; This is a spontaneous report from a contactable consumer, the patient. This 54-year-old non-pregnant female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via unspecified route in the left arm on 23Mar2021 at 15:15 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included overweight. The patient had no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. 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. There were no concomitant medications. On 24Mar2021 at 12:00 AM, the patient experienced tenderness, burning and hurtful left breast, especially around the of the breast almost as if touching a splinter on the breast. The patient also reported she was really run down and tired as expected. There was no treatment received for tenderness, burning and hurtful left breast, run down and tired. The clinical outcomes of tenderness, burning and hurtful left breast, run down and tired was not recovered. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Began having extreme shortness of breath and palpitations Mid June, lasted about two weeks of daily (every hour or so) occurrence of heart quivering and shortness of breath. Subsided in July, returned in mid August
about 3 days after vaccine 1, hive like, extremely itchy burning rash on torso, around waist.  For 3 days, evenings strong, days lighter. Went away on its own.
Supperior Sagittead sinus thrombus, left transverse and sigmoid sinuses thrombosed. Left parietal parenchymal edema related the above , venous cva
Tired; Upset stomach; Dizzy spells; Threw up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Oct2021 13:00 (Lot number: FH82521) at the age of 79 years as dose 3, (booster) single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot-EM9810), administration date: 02Feb2021, when the patient was 78 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 2, Lot-ENG198), administration date: 23Feb2021, when the patient was 78 years old, for COVID-19 Immunization.  The following information was reported: DIZZINESS (non-serious) with onset 25Oct2021, outcome "recovered" (Oct2021), described as "Dizzy spells"; VOMITING (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Threw up"; FATIGUE (non-serious) with onset 27Oct2021, outcome "unknown", described as "Tired"; ABDOMINAL DISCOMFORT (non-serious) with onset 26Oct2021, outcome "unknown", described as "Upset stomach".  Additional information: Patient, reporting on the Pfizer Covid booster that she got on Monday and wanted to report an events after getting the product. It was explained that she waited for 15 minutes and then left, about 5-10 minutes after that she starting having dizzy spells. On Tuesday this was really bad. That night she threw up. The dizzy spells and throwing up are gone now but now she was tired. This started yesterday and today. She also had an upset stomach Tuesday night. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. No Relevant Tests.  No follow-up attempts are possible. No further information is expected.
Got both doses and has Shingles now/Suspected vaccination failure; Shingles; Blisters; This case was reported by a consumer via call center representative and described the occurrence of Suspected vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (She has a history of shingles, she has had multiple outbreaks before receiving the shingles vaccine).  On an unknown date, the patient received the 1st dose of Shingrix. In 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 9 months after receiving Shingrix and Shingrix and an unknown time after starting acyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blister. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure was recovered/resolved and the outcome of the shingles and blister were not recovered/not resolved.  It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient reported that she received both the doses of shingles vaccine on an unknown arm. The patient was not sure about year of vaccination, but may be this year (sometime in 2021). The patient had an outbreak of Shingles now, she has had it for approximately 2 weeks. The patient described as really bad and it looks weird and worse and it was on her butt, you sit on it, on the blisters, they keep spreading and they won't go away, the blisters are bigger than usual. The patient had not seen the doctor but he prescribed acyclovir cream. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation were not provided. The reporter consented to follow up. The reporter consented to follow up with her MD. This case is linked for first dose with US2021174384, for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021174384:Same reporter.
I contracted Covid19 on 04/30/2022 with symptoms of sore throat, runny nose, and congestion until I began Paxlovid. When I began taking Paxlovid on 05/02/2022 and I developed additional symptoms of low grade fever, chills, myalgia, and a cough. I was ill for 7 days, but then my symptoms returned on 05/13/2022. I am still experiencing mild symptoms, and I have a lingering cough.
With in ten hours broke in in hives was able to treat with Benadryl and Cetirizine, persisted for two weeks
Information has been received form a medical assistant referring to multiple patients of unknown age and gender. The unspecified multiple patients were vaccinated with PNEUMOVAX 23 lot # M005287, expiration date 08-OCT-2017, 0.5 ml, route and strength were unknown) and PMEUMOVAX 23 lot # M013156, expirations date 15-OCT-2017,  0.5 m, route and strength were unknown) on multiple unspecified dates (Extra dose administered). No adverse effect were reported. It was unspecified if the patients sought medical attention. Additional information has been requested.
The patient received the pneumococcal vaccine on 7/23/2015. The day after, the patient presented to the ER with febrile seizures.
Caller started Paxlovid 14Aug2023 and completed the treatment; Caller started Paxlovid 14Aug2023 and completed the treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster),single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, 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 Aug2023, outcome "unknown" and all described as "Caller started Paxlovid 14Aug2023 and completed the treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had started Paxlovid treatment on 14Aug2023. She has had all her shots and boosters for Covid 19 from Pfizer.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300287028 same patient, different drug/events;
Dizziness, lightheaded, blurry vision.  Reported not eating the morning of vaccine.  BP 144/71, HR 81.  Juice and crackers given.   Vials rechecked after 15 minutes.  BP 135/72.  BP 79.  Still lightheaded at 30 minutes.  After about 55 minutes, patient was standing adn walking. Felt better. BP 127/65, HR 75.  Felt okay to leave.  Offered EMS but refused.  Recommended that the patient eat prior to vaccine #2.
Pt vaccinated with DTP/OPV developed probable hypotonic, hyporesponsive rx to DTP, listless, staring, pale & several hrs by hx vomited.
Pt was discovered in parent's bed in the morning on his side with swollen eye, nasal bleeding, swollen tongue, perioral petechiae. He was taken via paramedics to Hospital and was unable to be resuscitated.
Because the patient had prior history of reaction to vaccines, the patient was pre treated with  with Benadryl 25mg oral.  The vaccine was administered around 1:20 PM on 9/12/2022.  At 9:pm in the evening and after eating few bites of cheese and crackers, she developed swollen lips and tongue and scratchy sensation.  The patient took 2 benadryl tablet.  She had difficulty swallowing due to swollen throat. The patient went to the ER, she was treated with steroids, pepcid, and benadryl and observed for 5 hours.  She was later released from the hospital.  The patient still has discomfort in the throat. The ER physician indicated that this might last for few days.  Each time the patient eats, the same symptoms come back
arm was still red since 1st dose; This is a spontaneous report from a contactable consumer (patient husband) via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot Number was not reported), via an unspecified route of administration on 19Jan2021 as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm was still red (at the time of report) since her 1st Pfizer COVID vaccine on 19Jan2021 (3 weeks ago). The outcome of the event was not resolved. Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from Registered Nurse regarding multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unspecified dates, multiple unspecified number of patients were vaccinated with improperly stored doses of M-M-R II (lot # L004656, expiry date 11-FEB-2017 and lot # K021151, expiry date 02-NOV-2016) dosage regimen and route unknown. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. This report is one of the several reported received from the same reporter.  Additional information has been requested.