chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; Severe headache; This is a spontaneous report from a non-contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 03Apr2021 at 11:15 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included metformin (MANUFACTURER UNKNOWN) glibenclamide (GLYBURIDE) losartan (MANUFACTURER UNKNOWN) amlodipine (MANUFACTURER UNKNOWN) and escitalopram oxalate (CITALO) all were from unknown date and for unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient had reported no known allergies. Prior to the vaccination, the patient was 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 four weeks prior to the vaccination. On 04Apr2021, the patient experienced severe headache and nausea. The adverse event resulted in doctor or other healthcare professional office/clinic visit and in emergency room/department or urgent care. The patient underwent CT scan of head, blood work, on an unknown date and the results of the test were not reported. Therapeutic measures were taken as a result of adverse events and included treatment with reglan, benadryl and morphine. The clinical outcome of the events severe headache and nausea was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Receiving a 0.25ml dose as a first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Receiving a 0.25ml dose as a first dose) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 21-Nov-2021, the patient experienced UNDERDOSE (Receiving a 0.25ml dose as a first dose). On 21-Nov-2021, UNDERDOSE (Receiving a 0.25ml dose as a first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment medicines were reported.   This case was linked to MOD-2022-440136 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2022: Followup document received contains no new information.
**I WAS GIVEN A SUB Q INJECTION; NOT AN IM INJECTION.  I NEED SOMEONE TO CONTACT THE SITE TO FIND OUT WHO  THE NURSE WAS SO THIS DOES NOT HAPPEN TO OTHER PEOPLE.
Information has been received from a clinical director/ registered nurse, concerning a 25 year old female patient, who on 11-JUN-2007 was vaccinated with the first dose of GARDASIL 0.5mL IM, the second dose of GARDASIL (Lot #658094/0524U) on 13-AUG-2007 and the third dose of GARDASIL (Lot #659439/1267U) on 02-JAN-2008. The patient experienced facial paralysis and numbness and tingling of the hands and feet one and a half months (approximately in July 2007) after get the first dose of GARDASIL. The patient had been seen by the primary care physician and a neurologist for the symptoms. All laboratories and diagnostic studies came back negative (computed tomography scan, spinal tap and magnetic resonance imaging) for cause and GARDASIL is now the primary suspect. At the time of reporting the patient did not recovered. There was no product quality complaint. Additional information has been requested.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with doses of improperly stored PROQUAD (dose and route not reported, lot # L010141 with expiration date 24-SEP-2016). Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Patient was given booster on 8/5/2022 with vaccine that had been in the fridge for 10 weeks on 7/30/2022.  CDC was contacted and recommended revaccination.  Patient was notified.
Fully vaccinated with J&J, not boosted.   COVID infection breakthrough and admit to inpatient ICU.  Chronic trach.
Patient is pregnant with a due date of 12/3/21.  I am reporting as this is my second patient who has tested positive for Covid-19 after vaccination during pregnancy.  (I understand that this is well within the effectiveness range, but wanted to report in case this is happening more frequently with others in pregnancy. ) She began having symptoms on 7/4/21 with runny nose , congestion and headache.  She then had loss of taste and smell and got tested.  Her Covid-19 swab was positive on 7/10/21.  She is currently 19 weeks pregnant.  As her symptoms have remained mild, I do not expect any complications for pregnancy.
Vaccination site warmth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-318263, MOD-2021-318424 (Patient Link).
DECREASED PLATELET COUNT; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: liver transplant, and concurrent conditions included: chemotherapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced decreased platelet count. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) Decreased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of decreased platelet count was not reported. This report was non-serious. This case, from the same reporter is linked to 20211011824.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Patient's doctor recommended and approved her to receive the Janssen vaccine following an adverse reaction to the moderna vaccine (1st dose).  Patient reported she experienced hives and mild throat irritation from her first dose of moderna and successfully took benadryl to relieve the symptoms. The patient was asked to stay for 30 minutes following Janssen vaccine for monitoring. Within 10 minutes, the patient reported eye and body itching. The patient refused epinephrine and took benadryl. Within 15 minutes, the patient said she felt better.
breakthrough COVID 19 infection - only symptom was fatigue and generalized weakness. no shortness of breath, no cough
Muscle Soreness, Tenderness, Decreased range of motion, Sharp Pain when arm is above 90 Degrees.
a sore in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 91-year-old female patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 2, single (Lot number: FM9810) at the age of 89 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EL9262, She read from the vaccine card: MSB1-NZ), administration date: 23Jan2021, when the patient was 89-year-old, for COVID-19 Immunization, reaction(s): "sore in her arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a sore in her arm".  Additional Information: PQC Details: Request Name: REQ, Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than =12 years - 15/15 mcg per dos. Question: Transfer in from DSU: (Name withheld): Report: E-transmit, possible duplicate/additional information gathered. Per DSU, caller "had her 5th dose of the Pfizer Covid vaccine, and called it the 'new updated one'". Caller is a consumer (91-year-old female) who confirms that she's had "diarrhea since that 5th dose" and that it started "within 2 hours" of having that dose and was "severe the 4th day and getting less severe, still a watery stool." Caller states her pharmacist told her to take imodium to treat this side effect and wants to know if that's correct. She'd like to know how long to expect diarrhea to last, and if having a side effect will affect the efficacy of the vaccine. Caller also expressed concern regarding the handling of the vaccine prior to administration stating, "the person giving it was carrying it around in a jug. I was a little surprised." Please see REQ for handling. Per attached Cons doc, no information about duration of diarrhea, many side effects only lasted 1-2 days on average. Directed back to HCP for treatment recommendations.She brought up concerns about the handling of the vaccination, stating, "the vaccination was given to me in the whole general area, the person giving it was carrying it ar ound in a jug. I was little surprised." She asked, isn't it supposed to be refrigerated.Caller is a consumer reporting an AE to the Bivalent PFizer-Covid19 vaccine. She asks, "could I be allergic to something in this new formulation".She is calling to report about a negative effect when she got new Pfizer covid vaccine from (Name withheld). Asks if she really needs to go through this, she just wants to report the effect.  No follow-up attempts are needed. No further information is expected.
I received injections of Fluzone HD PF 20-21 and also Pneumovax 23 25 in the same arm. By the evening my arm was extremely sore so that I could not lift it above shoulder level. I am 68 years old, an endurance cyclist, and very fit so this is not just being a wimp. I went to bed at my normal time and awoke in the middle of the night with chills and also sweating profusely. I got up and took Acetaminophen and went back to bed. I did not measure my temperature. Chills and sweating remained into the night. I usually get up by 7:00am but I felt so fatigued that I slept until 10:00. When I awoke the chills and sweating were gone. My arm is still a bit sore but I have full range of motion.
Potential seizure about 34 hours after injection. Woke up about 3 am on 5 December 2021 with a very sore left arm/under-arm lymph node. Didn't fully wake up before losing consciousness; spouse said I went stiff, was making noises (like air escaping lungs), and was unresponsive for ~15 seconds. Became responsive for ~ 1 minute and then passed out (went limp, eyes rolled back) for another ~15 seconds. Regained consciousness after passing out.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 29-Jul-2022; No adverse event; Administered the vaccine to patient after the 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 29-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 29-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 29-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 29-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 29-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 29-Jul-2022).    Concomitant product use was not provided by the reporter.  Patient received full dose.  On 04-Jun-2022 the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  Treatment information was not provided.
rash, vomiting, nausea, hives, migraines, tremors, facial swelling
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of improperly stored of VARIVAX (Merck) (lot # L018002 and expiration date on 19-MAY-2017, dose and route unknown) (Incorrect product storage). The stored temperature was 12 Fahrenheit and time frame was 96 hours. No previous temperature excursion was reported. No adverse effects were reported. Additional information has been requested.
Rash, inflammation, pruritis at site of immunization and spreading down toward the elbow.
Adverse Effects began next morning after vaccination for patient, She began feeling weak, feverish, increased arthritic pain, nervous.  She stated symptoms lasted for 3-4 days until feeling better.
Patient came in 4/11/21 to receive 2nd dose of Shingrix vaccine, but insurance rejected the claim stating he had already received 2 doses. Pharmacist on duty called insurance company and insurance representative stated that the billing of the second dose was a mistake and patient only received one dose. Insurance rep also stated in order to get override for second dose to go through the pharmacist would need to call the PA department which was now closed. Pharmacist gave patient dose of Shingrix and left note to call insurance 4/12/21. On 4/12/21 pharmacist on duty called insurance PA department to get override for second dose. A different insurance representative informed the pharmacist that the patient had already received both doses of Shingrix - first on 1/8/2020 at Pharmacy and second on 12/28/2020 at Vaccine clinic This was checked on the WIR and confirmed, so patient received 3rd Shingrix vaccine on 4/11/2021. No adverse effects were reported.
1st dose COVID-19 vaccine 10ug dose administered to child < 5 years of age.
severe rash/ burns to neck, chest, abdomen, back, legs- started approximately 12 hours after 2nd vaccine administration, lasted approximately 3 weeks. Severe fatigue lasting months
Nervous; chills little bit for about half of day/chills and all but I did not have a fever; felt really tired and I felt really tired the day this two days feeling very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 20Mar2021 (Lot number: ER8729) at the age of 63 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Anxiety disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NERVOUSNESS (non-serious) with onset 22Mar2021, outcome "unknown", described as "Nervous"; CHILLS (non-serious) with onset 21Mar2021, outcome "recovered" (Mar2021), described as "chills little bit for about half of day/chills and all but I did not have a fever"; FATIGUE (non-serious) with onset 21Mar2021, outcome "not recovered", described as "felt really tired and I felt really tired the day this two days feeling very tired". Therapeutic measures were taken as a result of chills.  Additional information: The patient received Tylenol for chills.  No follow-up attempts are possible. No further information is expected.
102.2 temperature for 2 days chills headache arm very sore, more sore than most injections
Injected with ZOSTAVAX and months later broke out with shingles. This happened in 10-1-12 and to date I still have them 1-7-13. I have two friends who have had same experience. Merck should go back and review their research,
This spontaneous report as received from a licensed nurse practitioner refers to multiple unspecified patients of unknown age and gender. On 01-OCT-2014 the patients were vaccinated with GARDASIL (dosing details unknown). The reporter stated that she had a supported temperature excursion that affected GARDASIL. Reporter stated that she presumed she had administered to multiple unspecified patients since the first excursion date, on 01-OCT-2014, but had no patient or product specific information to offer. No adverse effects were noted. Outcome of the temperature excursion of GARDASIL was unknown. No product quality complaint was involved. Telephone call follow up was received on 08-DEC-2014, the physician was not available at the time of the call. A voice message was left requesting a returned phone call. Follow up information has been received from the Nurse Practitioner on 22-DEC-2014. Lot number of GARDASIL was reported as: J014875 (invalid lot number). Vaccination date was reported as: 07-NOV-2014 (previously reported as 01-OCT-2014). Also the reporting Nurse stated that the vaccines removed from the office would be returned to the vaccine program as directed. This is one of the several cases received from the same reporter. Additional information is not expected because all follow up information required to complete the case was already received.
Lip swelling, Tongue swelling, disorientation, confusion, nausea, body aches
Pt Admitted: 10/13/2021:  Chief Complaint: pt tested covid + today. c/o cough for 1 wk with weakness. fever and SOB over the last day. cancer pt with HOG. History of Present Illness: patient is a 59 y/o female with hx of CAD, HTN, DMII, CKD 3, HLD, melanoma currently receiving chemotherapy through HOG who presented to the ED with cough and SOB. Patient reports she has felt unwell for a week with cough. She reports over the past day she has had SOB as well as low grade temperature to 99.8. She reports chest pressure associated with the SOB today. She reports myalgias and loss of taste. She reports nausea but denies diarrhea or vomiting. She denies sick contacts. She has received both doses of COVID-19 vaccination.  She reports chronic LEE which has been worse recently. She denies any history of CHF, orthopnea. She reports she has had intermittent DOE over the past several months. She has an upcoming appointment with her Cardiologist due to this complaint. Today her symptoms worsened with increased weakness and so she presented to the ED.   Discharge date: 10/17/2021
MUSCLE SORENESS IN DELTOID/SURROUNDING OF ARM OF ADMINISTRATION LASTING 3 WEEKS
Pt presents with cough, fever.  Diagnosed with pneumonia w/ groundglass opacities.
Crohn's disease aggravated; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's disease aggravated) and ILLNESS (Sickness) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's disease aggravated) (seriousness criteria hospitalization prolonged and medically significant) and ILLNESS (Sickness) (seriousness criterion hospitalization prolonged). At the time of the report, CROHN'S DISEASE (Crohn's disease aggravated) was resolving and ILLNESS (Sickness) had resolved.            Concomitant medications were not reported. Treatment information was not provided.  The patient experienced really bad crohn's disease bowel flare ups which included nonstop diarrhea that landed them in the hospital. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Company Comment:  This spontaneous case concerns an adult male patient, with a relevant history of Crohn's disease on adalimumab, who experienced the unexpected, serious (hospitalization, medically significant) adverse event of Crohn's disease aggravated, the serious (hospitalization) event Sickness, which occurred unknown days after the second dose of mRNA-1273 vaccine administration. It was reported that the patient experienced really bad Crohn's disease bowel flare ups which included nonstop diarrhea which led the patient to be hospitalized. Underlying  history of Crohn's disease on adalimumab could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient, with a relevant history of Crohn's disease on adalimumab, who experienced the unexpected, serious (hospitalization, medically significant) adverse event of Crohn's disease aggravated, the serious (hospitalization) event Sickness, which occurred unknown days after the second dose of mRNA-1273 vaccine administration. It was reported that the patient experienced really bad Crohn's disease bowel flare ups which included nonstop diarrhea which led the patient to be hospitalized. Underlying  history of Crohn's disease on adalimumab could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Vertigo developed after my 2nd shot of Pfizer vaccine: Within three hours of shot: fatigue and arm pain at site; 12 hours after shot: chills and bone pain all over lasting about 12 hours, and started feeling dizzy. By 48 hours after: Lingering dizziness turned into ongoing vertigo. Vertigo made worse by visual stimulation (reading printed material or anything on a screen; bright lights). It interfered with my ability to work (could not read on a computer). Caused fatigued and I had to lay down in dark room and wait for it to subside, but it was ongoing. Previous to this, I have never experienced dizziness like this. I went to my ENT doctor (I was an established patient). They ruled out benign positional vertigo, t