chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in the injection site for a day; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177), via an unspecified route of administration in the left arm on 15May2021 (at the age of 38-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 four weeks prior to the vaccination. On 15May2021, the patient experienced pain in the injection site for a day and on evening headache. Headache was not continuous, however prolonged for a long duration even though the patient took ibuprofen. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events and included treatment with ibuprofen. The clinical outcome of the events pain in the injection site for a day was recovering and headache was recovering.  No follow-up attempts are needed. No further information is expected.
covid vaccine was placed in refrigerator and was expired past 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (covid vaccine was placed in refrigerator and was expired past 30 days) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (covid vaccine was placed in refrigerator and was expired past 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (covid vaccine was placed in refrigerator and was expired past 30 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported . No treatment information provided .
A vaccine was given to a long-term care patient by a pharmacist, who was informed (incorrectly) by a nurse that the patient had not received a dose yet. No adverse events were reported, however this resulted in a second dose being given earlier than its due date, which was discovered when billing the shot afterwards - an insurance rejection indicated that an initial dose was actually given on 2/4/21. The facility was informed and a quality event was reported.
I received my  2nd dose of the Covid vaccine on 5/8/21. I had a positive pregnancy test on 5/14/21, I had an ultrasound performed at 7 weeks and baby was growing appropriately and a heart beat was detected. My HCG levels were monitored periodically until 9 weeks and were within normal limits. I went in for an ultrasound at 13 weeks and was told I had a missed miscarriage and the baby stopped growing at 8 weeks. My due date was supposed to be 1/21/22.
Extremely sore arm, swollen upper left arm that turned red and hot to touch, lasted from 1-6-1; starting to clear up by 1-14-16.
2/12/04 Received DTaP, MMR, IPV. 3/14/04-3/15/04 (31days) Developed symptoms of Bell's Palsy. 3/16/04 Diagnosed with Bell's Palsy by fly physician.
(Per mom) Fever 104.3 24 hrs after vaccinations, local reaction -> redness, edema, warm to touch. (L) lat. thigh. Hosp ER report: T 98.6, cellulitis, KEFLEX.
Immunizations given on 4-5-10. Swelling on Tuesday 4-6-10, went down on 4-7-10 and is holding steady. 4-7-10 noticed warm and red, slightly improved 4-8-10. Itching and slight pain, hot, hard, red swollen. No discharged, skin sluft, fever or decrease in activity. ABX, Ibuprofen, BENADRYL.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history was unknown. On 21-NOV-2014, a dose of VARIVAX (Merck) (subcutaneous, dose and lot# was unknown), which underwent a supported temperature excursion, was administered to the patient. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
MUSCLE SPASMS; STIFF NECK; TIGHTNESS IN THROAT; MUSCLE TWITCHES; HEAVINESS IN LIMBS; LOW GRADE FEVER; ARM PAIN; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old female. 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm pain. On 07-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced stiff neck. On 08-APR-2021, the subject experienced tightness in throat. On 08-APR-2021, the subject experienced muscle twitches. On 08-APR-2021, the subject experienced heaviness in limbs. On 08-APR-2021, the subject experienced low grade fever. On 12-APR-2021, the subject experienced muscle spasms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiff neck, and heaviness in limbs on 10-APR-2021, had not recovered from low grade fever, injection site pain, muscle spasms, arm pain, and muscle twitches, and the outcome of tightness in throat was not reported. This report was non-serious.
pain in the right arm then moved to the right side of back; pain in the right arm, right shoulder and upper right side of my back; pain in the right arm, right shoulder and upper right side of my back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the right arm then moved to the right side of back), BACK PAIN (pain in the right arm, right shoulder and upper right side of my back) and ARTHRALGIA (pain in the right arm, right shoulder and upper right side of my back) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form once. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, the patient experienced PAIN IN EXTREMITY (pain in the right arm then moved to the right side of back), BACK PAIN (pain in the right arm, right shoulder and upper right side of my back) and ARTHRALGIA (pain in the right arm, right shoulder and upper right side of my back). At the time of the report, PAIN IN EXTREMITY (pain in the right arm then moved to the right side of back), BACK PAIN (pain in the right arm, right shoulder and upper right side of my back) and ARTHRALGIA (pain in the right arm, right shoulder and upper right side of my back) had not resolved.            Concurrent condition of the patient was unknown. Concomitant medications were not reported. It was unknown if the patient was treated for the events.   Reporter did not allow further contact
COVID vaccine breakthrough case. Moderna 2/24/21 010A21A, 3/24/21 047A21A and boosted 11/23/21 012H21B
Pt recvd vax on MAY92 w/no adverse reaction; JUN92 pt was vaxed w/the 2nd dose & devel burning sensation upon inject as well as soreness & or an aching sensation in the arm; sensation persisted assoc w/feeling of heaviness in the arm;
Covid infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concomitant products included DUPILUMAB (DUPIXENT) for an unknown indication.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid infection). At the time of the report, COVID-19 (Covid infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported by reporter. It was reported that patient got covid infection during Dupixent therapy. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 occurred on an unknown date in the context of receiving a dose of mRNA-1273 vaccine. Onset latency could not be determined as event onset date was not provided. Clinical course, laboratory, and treatment details were not reported. The outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 occurred on an unknown date in the context of receiving a dose of mRNA-1273 vaccine. Onset latency could not be determined as event onset date was not provided. Clinical course, laboratory, and treatment details were not reported. The outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient waited for 15 minutes, did not have symptoms. Drove home, started having symptoms of fainting and dizziness. Parent reported that the child barely made it home without passing out. Had a difficult time getting out of the vehicle. Parent report that the child was feeling better later in the day.
she bad a really bad reaction/ Reaction was intimidate; The patient had heard that it fights against Covid/ that patient requested it after her daughter told her it would help fight against COVID; This spontaneous report has been received from a nurse, referring to a 57 years old female patient. The patient's pertinent medical history included palpitations and anxiety disorder. The patient's drug reactions or allergies included lidocaine, latex (some redness), tramadol, sertraline hydrochloride (ZOLOFT), acetaminophen (+) hydrocodone bitartrate (VICODIN) and tropicamide. The patient's concomitant medication was unknown by reporter.  On 20-AUG-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S031483 with expiration date: 07-OCT-2021; 0.5 milliliter, strength unknown), subcutaneously for prophylaxis (reported as fight against corona virus disease 2019 (COVID)) (product use in unapproved indication).        On the same day, the patient had a really bad reaction and went to the emergency room (ER). Reaction was intimidate. The patient left the emergency department after waiting and before being treated. The patient was given treatment with oxygen for this event. It was unknown if lab diagnostics or studies performed or not. The outcome of bad reaction was unknown (also reported as present status: stable). The causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and bad reaction was related.   The reporter considered the bad reaction to be serious for the following reason: significant disability or incapacity.
Red circular blotch about 3 inches in diameter around injection site. Slightly itchy. Not painful. Not hot to the touch.
vertigo; arm soreness; really bad and pretty severe headaches/her head felt that was going to explode; started menstruating again; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (started menstruating again), VERTIGO (vertigo), PAIN IN EXTREMITY (arm soreness) and HEADACHE (really bad and pretty severe headaches/her head felt that was going to explode) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a21b) for COVID-19 vaccination.     The patient's past medical history included Vertigo. Concomitant products included VITAMINS NOS for an unknown indication.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced MENSTRUAL DISORDER (started menstruating again), PAIN IN EXTREMITY (arm soreness) and HEADACHE (really bad and pretty severe headaches/her head felt that was going to explode). On an unknown date, the patient experienced VERTIGO (vertigo). At the time of the report, MENSTRUAL DISORDER (started menstruating again), VERTIGO (vertigo), PAIN IN EXTREMITY (arm soreness) and HEADACHE (really bad and pretty severe headaches/her head felt that was going to explode) outcome was unknown.            Patient was also taking supplements. It was reported that the patient had stopped having her period and the last time she had her period before receiving the vaccine and she didn't remember when was that. It was reported that the patient started to experience the events after 24hours later. No treatment medication was reported.   This case was linked to MOD-2021-407032, MOD-2021-407149 (Patient Link).
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Dec2021 14:00 (Lot number: FH8027) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose brand unknown: False,, Prev dose lot number: EL3247,, Prev dose lot unknown: False,, Prev dose administrator route: Intramuscular,, Prev dose administration date: 19Feb2021,, Prev dose administration time: 02:00 PM, Prev dose dose number: 2,, Prev dose vaccine location: Left arm,), administration date: 19Feb2021, when the patient was 50 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Previous dose details: , Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose brand unknown: False,, Prev dose lot number: EL3247,, Prev dose lot unknown: False,, Prev dose administrator route: Intramuscular , Prev dose administration date: 29Jan2021,, Prev dose administration time: 12:45PM, Prev dose dose number: 1,, Prev dose vaccine location: Left arm), administration date: 29Jan2021, when the patient was 50 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 14:00, outcome "recovered" (2021), described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 20Dec2021 17:00, outcome "recovered" (2021), described as "Sore arm - 72 hours"; MYALGIA (non-serious) with onset 20Dec2021 17:00, outcome "recovered" (2021), described as "muscle aches - 48 hours"; HEADACHE (non-serious) with onset 20Dec2021 17:00, outcome "recovered" (2021), described as "intense headache - 24 hours/mild headache - 54 hours"; FATIGUE (non-serious) with onset 20Dec2021 17:00, outcome "recovered" (2021), described as "fatigue - 54 hours". Therapeutic measures were not taken as a result of immunisation, pain in extremity, myalgia, headache, fatigue. No follow-up attempts are possible. No further information is expected.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case included information of patient 9th out of 100 patients.  No concomitant medication was provided by reporter. Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11 Jan 2023, lot numbers unknown to the HCP.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
A few days later after vaccine about 9:30 I got the chills. When I woke up around 4p. i had a headache nauseous. Very fatigued till around 10pm. i woke up the next day and I was fine.
Patient was given a Bivalent booster dose instead of a primary dose of Pfizer.
Employee stated she felt her heart racing and felt "off." Appeared to RN to be diaphoretic and pale but remained alert, oriented, speaking full sentences no shortness of breath, scratchy throat or rash. 50mg Benadryl PO at 06:25am. Highly encouraged patient to stay for additional 15 minutes. Patient refused to stay stating she didn't have childcare beyond 7am. Instructions given to patient re: symptoms to monitor for and to seek medical assistance if symptoms worsened or persisted. Additionallyasked patient to contact employee health.
About 10 or 11 days after the vaccine, my arm got a red blotch on it near the vaccine injection site   It hurt a little when touched.  It seems to be lighter in color but is still present.  Headaches in the morning and some fatigue.
soreness at the site of injection.; This is a spontaneous report from a contactable consumer, the patient.  A 54 year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EK5730 via an unspecified route of administration on 18Dec2020 at 10:45 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included loratadine (CLARITIN) from an unknown date and unknown if ongoing, or an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 18Dec2020 at 12:00, the patient experienced soreness at the site of injection. The patient did not receive any treatment for the event. The clinical outcome of the soreness at the site of injection was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Fatigue, nausea, vomiting, soreness at injection site/ inability to raise injected arm, headache.
This case was reported by a pharmacist via call center representative and described the occurrence of herpes zoster in a 52-year-old adult female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Co-suspect products included BENLYSTA unknown for product used for unknown indication. On 5th February 2018, the patient received SHINGRIX. In February 2018, the patient started BENLYSTA at an unknown dose and frequency. On an unknown date, less than a month after receiving SHINGRIX and 14 days after starting BENLYSTA, the patient experienced herpes zoster and rash. The action taken with BENLYSTA was unknown (Dechallenge was unknown). Rechallenge with BENLYSTA was unknown. On an unknown date, the outcome of the herpes zoster and rash were recovered/resolved. It was unknown if the reporter considered the herpes zoster and rash to be related to SHINGRIX and BENLYSTA. Additional details were reported as follows: The age at vaccination was not reported. Roughly 2 weeks after receiving SHINGRIX, the patient received BENLYSTA. The patient then experienced a mild case of herpes zoster that began during the 2 weeks after receiving BENLYSTA. The rash was resolved and the healthcare provider was unsure if there was any correlation. The healthcare professional was not sure about the exact date of BENLYSTA or Herpes zoster episode, but did occur within 1 month after the 1st dose of SHINGRIX. The patient stated that, the shingles rash was very mild and resolved with no complications. The reported lot number (L24KL) for SHINGRIX did not exist and was updated to 3Z4KL, according to sales database.