chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose Number1: 02Feb2021, dose2: 25Mar2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 at 11:00 as dose 2, single (Lot number: EP6955) at the age of 19 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: No" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COVID-19 (DOSE 1, SINGLE at 17:00, Anatomical Location: Arm right), administration date: 02Feb2021, for COVID-19 Immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (hospitalization) with onset 25Mar2021 at 11:00, described as "Dose Number1: 02Feb2021, dose2: 25Mar2021". The patient was hospitalized for inappropriate schedule of product administration (hospitalization duration: 4 day(s)). The patient did not have covid prior to the vaccination. The patient was tested for covid post vaccination. The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (03May2022) Negative, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200733254 Same patient and drug, different event separated in time
Information has been received from a physician concerning a female patient who in August 2008, was vaccinated with a dose of GARDASIL (Lot not reported).  In approximately February 2009, the patient told her doctor she experienced seizure and headaches.  At the time of reporting the outcome of the patient was unknown.  Upon internal review, seizure was considered to be an Other Important Medical Event.  Additional information has been requested.
Patient fainted and vomited immediately after receiving  her school immunizations. Mother stated she only had coffee today.
Patient was administered Moderna vaccine and is under 18, advised parent and patient Moderna no approved for those 18 years of age, reviewed common side effects, advised of adverse reactions and to call 911, observed for 15 minutes at the POD clinic, advised to consult with PCP to determine if patient should get the secon Moderna vaccine or Pfizer. Gave patient contact information for any questions or concerns.
This spontaneous report as received from a nurse practitioner via a field representative refers to a 40-50 year old female patient. On 12-NOV-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, lot# and route not reported) 1 single shot. On approximately 29-OCT-2014 (reported as 2 weeks prior to receiving PNEUMOVAX 23), the patient received an unspecified influenza virus vaccine (manufacturer unknown). On 15-NOV-2014, 3 days after receiving PNEUMOVAX 23 the patient experienced swelling and pain near the injection site. The patient sought unspecified medical attention. Unspecified antibiotics was given for adverse event. No lab diagnostics studies were performed. The outcome of the event was unknown. Additional information has been requested.
severe body aches starting evening of vaccine (dose #1), along with worsening weakness. Vaccine given 1/26/2021. Pt with ED visit for body aches 2/8/21 (high ESR > 100). Then admitted for observation 2/9/21
Within three months of my second dose, I got the worst headache of my like. I actually have no memory of a two-and-a-half-week period while I had that headache ongoing. The headache never let up and my family had to help take care of me. I had extreme Nausea and I threw up even if I drank water. I went to the ER two times. I did not eat for eight days. I was discharged after each visit, and they just gave me. I went to a different hospital the third time and I was hospitalized for 3 days. My blood work and fever were elevated. I was diagnosed with possible Acute Metabolic Encephalopathy. It was months before I got a firm diagnosis after much testing.
Father states pt devel a red, swollen lt arm that was warm to touch on 13APR94 in the AM; The swelling started @ the inject site & radiated down past the eblow; pt was afebrile; father states they took the pt to the MD on 14APR93 in the afn
pt recvd vax & exp pain & stiffness of the rt neck, arm & shoulder; pt was not seen by MD; sx have not resolved;
foggy feeling; headaches; Tingling in hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "foggy feeling"; HEADACHE (non-serious), outcome "recovered", described as "headaches"; PARAESTHESIA (non-serious), outcome "recovered", described as "Tingling in hands".  Additional Information: Patient had tingling in hands, headaches, foggy feeling, since taking the booster, It has lasted over a month, Has this occurred before with the booster. Patient had no side effects after the first 2 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Booster; The patient contracted the Omicron variant of SARS-COV-2; The patient contracted the Omicron variant of SARS-COV-2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "The patient contracted the Omicron variant of SARS-COV-2". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive, notes: contracted the Omicron variant. The patient contracted the Omicron variant of SARS-COV-2 and had experienced mild symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200058699 same reporter/drug/event, different patient;US-PFIZER INC-202200058698 same reporter/drug/event, different patient;US-PFIZER INC-202200058700 same reporter/drug/event, different patient
After receiving PCV13 vaccine, left office. Became very drowsy and needed wife to finish driving car home. Slept approx one hour and began hallucinating. Awakened and called out to wife. Drank water and had an energy bar. Slept for three more hours.
PATIENT PREVIOUSLY RECIEVED JJ SHOT 4/26/21 AND WAS HERE FOR BOOSTER AND CHOSE MODERNA. AFTER GETTING SHOT, PT EXPERIENCED RASH, THROAT CLOSING, INCREASE IN BLOOD PRESSURE, AND BEGAN HAVING MUSCLE CONTRACTION (SHACKING OF BODY). WAS GIVEN 50MG DIPHENHYDRAMINE AND 1 SHOT OF 0.3MG EPI PEN.  PT WAS ALERT, AND RESPONSIVE. CALLED LOCAL EMT. FINDINGS WERE STABLE UPON ARIVALE. PT TAKING TO LOCAL ER.
Pain at injection site, swelling and large red blotch at injection site, muscle pains whole body, chills, confusion, blurred vision, confusion. Onset a few hours after, lasting 48 hours.
Client was given the influenza vaccine without requesting it. She had received the vaccine 5 months previous. She was told she would be unlikely to have adverse affects from the second dose and to let the health department  know if she felt any negative affects. Client was satisfied with the explanation.
large redness on arm of injection; swelling on arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (large redness on arm of injection) and VACCINATION SITE SWELLING (swelling on arm of injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (large redness on arm of injection) and VACCINATION SITE SWELLING (swelling on arm of injection). On 15-Feb-2021, VACCINATION SITE SWELLING (swelling on arm of injection) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (large redness on arm of injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment information included antihistamine, Tylenol, hot and cold compression.
After shot was given no pain - got home and few hours later, pt experiences pain on left shoudler, can't move thru out the night, still has pain, can't lift his arm or shoulder.
Pain; This case was reported by a physician via sales rep and described the occurrence of pain in an unspecified number of patients who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, less than a year after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that her patients experienced more pain with Fluarix Quadrivalent 2019-2020 season than Sanofi flu vaccine. The reporter consented to follow up.
Patient describes it as having tingling sensations all over body (brief zap like feeling). It is not continuous but happens here and there. Was improving, then got the second Moderna vaccination 4-12-21 (again in the left arm) and it worsened again. Pt did not feel it was going away at all after the second shot. She found it hard to sleep. She did some research online about two weeks after second shot since it wasn't improving and saw other people were having similar side effects. Notes she has a very low pain tolerance. People reported feeling better after taking vitamin B complex. She started taking Vitamin B complex over the counter and has found that has helped. She still has the tingling sensations occasionally but not as often. She is still taking the Vitamin B complex. She has not stopped the Vitamin B complex so does not know if it would worsen or not.
fever; aches and pains; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), MYALGIA (aches and pains) and VOMITING (Vomiting) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 027C21A) for COVID-19 vaccination.     Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (NIKKI) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PYREXIA (fever), CHILLS (chills), MYALGIA (aches and pains) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 08-May-2021, PYREXIA (fever), CHILLS (chills), MYALGIA (aches and pains) and VOMITING (Vomiting) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and MYALGIA (aches and pains) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 027C21A) for COVID-19 vaccination.     Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (NIKKI) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 07-May-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced PYREXIA (fever) and MYALGIA (aches and pains). On 08-May-2021, CHILLS (chills) outcome was unknown. At the time of the report, PYREXIA (fever) and MYALGIA (aches and pains) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Had a severe side effect to the Smallpox Vaccine... woke up on Day 9 following the vaccination with an extreme headache and nausea.  I have never had a headache to the magnitude/degree like this one.  It completely incapacitated me for the day.  I couldn't keep any food down.
Pt recv vax on 9/23/96; on 10/14/96 pt exp joint degeneration, toe pain, right elbow &hand pain; pt to neurologist; dx=joint erosions, positive rheum factor, positive ANA c/w Rt arm
Patient with h/o afib presented to ED on the next day with shortness of breath after having with full-body chills, associated diaphoresis, fever temp 100.6, HR 120 and palpitations after receiving the 1st dose of the Moderna Covid vaccine. Patient had Covid+ back on 12/21. Patient was given IV fluid bolus and Tylenol.  Discharged after reassuring labs and imaging. Fever has resolved.
Soreness in arm at the injection site; Chills; Fever; Sweating; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, chills, fever and sweating. On an unknown date, the outcome of the injection site pain, chills, fever and sweating were unknown.   It was unknown if the reporter considered the injection site pain, chills, fever and sweating to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. It was reported that the patient had soreness in her arm at the injection site for both the first and second vaccine. The patient had chills, fever, and sweating. The reporter did not consent to follow up. For tolerance after 2nd dose refer case US2020AMR004687.
When giving the second dose of Pfizer using the vanish point needle, a noise was heard like a pshing sound and the plunger would no longer push the rest of the dose into the patient. The patient also heard the noise. The dose remainder of the dose was retrieved and placed into another syringe and given but the .3 ml was given in the rt arm and .2 was given in the Lt. arm
pt recv flu vax lt arm pt c/o mild burning, area became red & raised;tx duricef;
pain and discomfort in and around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain and discomfort in and around the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 026D21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to Nitrofurantoin. Spike in A1C level.  Pain and cramps in tendons/ligaments of feet.) on 01-Jan-2017, Hypothyroidism since 01-Jan-2005 and High cholesterol since 01-Jan-2005. Concomitant products included SIMVASTATIN from 01-Jan-2005 to an unknown date for High cholesterol, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 01-Jan-2005 to an unknown date for Hypothyroidism.   On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-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 PAIN (pain and discomfort in and around the injection site). At the time of the report, VACCINATION SITE PAIN (pain and discomfort in and around the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medications were reported   This case was linked to MOD-2021-224090 (Patient Link).
Parsonage-turner syndrome, confirmed by neurologist and primary care provider. 5 days after 2nd dose, the patient developed severe pain around vaccination site and arm, followed by muscle atrophy, weakness and clinical signs consistent with acute brachial neuritis.
he was experiencing headaches that wouldn't go away since 1 month ago; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Sep2021, outcome "not recovered", described as "he was experiencing headaches that wouldn't go away since 1 month ago".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose and route unknown) (lot# reported as M037533 with expiration date 17-MAY-2018) for prophylaxis. The vaccine was exposed to temperature excursion of 35 Fahrenheit degree (F) for 6 hours. There was no previous temperature excursion. No data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005918: US-009507513-1701USA001893: US-009507513-1701USA001894.
Patient reported swelling and itching around the vaccination site approximately 36 hours post vaccination.  She tried topical and oral diphenhydramine which gave mild relief.  I instructed her to mark the area with a pen and monitor if it was increasing in size or decreasing.  She reported on 2/1/21 that the inflamed area was growing and I instructed her to see her doctor. At the time she was able to see her doctor it had spread up to her armpit and down to her elbow. Her doctor prescribed a steroid and over the counter oral and topical antihistamines.  The patient reported on 2/3/21 that the rash is now receding.
12/1/21 pt arrived by EMS s/p cardiac arrest (Per patient's wife, the patient developed decreased appetite, shortness of breath, and cough for the past several days tested positive for COVID-19) - Probable hypoxemic cardiopulmonary arrest, patient was intubated chest x-ray is abnormal, pt expired on 12/3/21
Vigorous bleeding from injection site in the arm and then a seizure lasting approximately 10 to 15 seconds and passed out unconscious for another 15 seconds. Taken to exam room, given apple juice, took temperature and blood pressure and stayed at the office 30 minutes to be sure there were no more adverse reactions.
numbness down her left side; This case was reported by a physician via sales rep and described the occurrence of numbness in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced numbness. On an unknown date, the outcome of the numbness was recovered/resolved.   It was unknown if the reporter considered the numbness to be related to Shingrix.  Additional details were provided as follows: The patient stated that getting the vaccine at a pharmacy in left deltoid and soon thereafter, experienced numbness down her left side.  It lasted a couple of weeks but then completely subsided.  She was hesitant to get the 2nd dose based on her reaction if even related to the 1st dose.
The vial was initially stored in the refrigerator on 07-Mar-2022, expired on 06-Apr-2022 and the dose was administered on 08-Apr-2022; Patient potentially administered with expired vaccine (beyond 30 days use by date)/Expired booster vaccine dose administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient potentially administered with expired vaccine (beyond 30 days use by date)/Expired booster vaccine dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Mar-2022, expired on 06-Apr-2022 and the dose was administered on 08-Apr-2022) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient potentially administered with expired vaccine (beyond 30 days use by date)/Expired booster vaccine dose administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Mar-2022, expired on 06-Apr-2022 and the dose was administered on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient potentially administered with expired vaccine (beyond 30 days use by date)/Expired booster vaccine dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Mar-2022, expired on 06-Apr-2022 and the dose was administered on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported by health care professional that there was an error in documentation that occurred in their facility. The 30 days use by date was written inadvertently as 16-Apr and they found out that it was supposed to be 06-Apr-2022. Some patients were potentially given these vaccines on 07-Apr-2022 to 08-Apr-2022. The vial was initially stored in the refrigerator on 07-Mar-2022. The vial had not undergone any temperature excursions. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2022: Follow up received includes significant information: suspect vaccine information was added. On 12-Apr-2022: Follow up received includes significant information: Live FU received, significant checkbox ticked because the case was valid in FU 2 version (received patient details). Added patient details and historical condition.
patient called in day after injection stating her arm ached from left shoulder to left elbow ( "felt like I had been slugged in my arm) 2 hours after receiving injection and that today she had a sore throat and fatigue. denies fever.
Whole body hives/rash about 12 hours after flu shot. 2 EDs visits for BENADRYL SOLU MEDROL. Place on 10 days worth of SOLU MEDROL and SINGULAR per PCP.