chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Joint Pain; Nausea; Severe headache; Tender arm; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRALGIA (Joint Pain), MYALGIA (Tender arm), NAUSEA (Nausea) and HEADACHE (Severe headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced MYALGIA (Tender arm). On 22-Mar-2021, the patient experienced ARTHRALGIA (Joint Pain), NAUSEA (Nausea) and HEADACHE (Severe headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (Joint Pain), MYALGIA (Tender arm), NAUSEA (Nausea) and HEADACHE (Severe headache) outcome was unknown. 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 medication was provided.
This spontaneous report as received from a nurse refers to a female patient of unknown age. On 29-JUN-2017 the patient was vaccinated with VAQTA lot # M040421 exp 26-MAY-2017. The patient received expired product. The patient did not experience an adverse event. The reporter refused follow-up contact. Additional information is not expected.
Swollen lips 22 hours after injection. Had lip filler approximately 6 months ago.  One month later, lips have started to spontaneously swell again
Came down with shingles. Sores in my mouth and tongue and in my right nostril
L shoulder pain at site of injection w/o signs of erythema/edema/warmth/induration and unable to flex L elbow
Stroke; Lost sight in one eye; Double vision; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and BLINDNESS UNILATERAL (Lost sight in one eye) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced BLINDNESS UNILATERAL (Lost sight in one eye) (seriousness criterion medically significant) and DIPLOPIA (Double vision). On 16-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 16-May-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), BLINDNESS UNILATERAL (Lost sight in one eye) and DIPLOPIA (Double vision) outcome was unknown.            Concomitant product use was not provided.  It was reported that the patient is planning to go to rehab center from Hospital.  Treatment information was unknown.  Very limited information regarding these events has been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested
Patient reported her arm is still sore after 2 months of getting her 2nd covid-19 vaccine
pain/ swelling of fingers, hands (knuckles), wrists bilateral beginning 10-10-2020, still continuing
A little more than 24 hours I noticed a rash that started near her injection site on her thigh, on her buttocks, near the back of her neck on her back and on both arms starting at the biceps and continuing up towards the deltoids.  The rash was not raised.  No sign of irritation or discomfort.  Called on-call nurse and was told to give Benedryl and bring to clinic in morning.  Did not give Benedryl and checked rash in the morning and it was gone.
Chest pain 05/23/2021, 1 hour duration Arm pain, 05/23-05/24/2021 (not yet resolved) Aches/chills/headache 05/24/2021 (not yet resolved)
Covid Bivalent vaccine was administered to the patient from a vial that was first punctured on 4/21/23. No treatment required at this time. No signs and symptoms at this time. Patient informed and instructed by physician to monitor for side effects of the vaccine and report any issues to Dr.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 28-JUN-2011, patient received improperly stored VARIVAX dose 2, from batch/lot # 669223/1564Z (expiry date, dose units, route and anatomical location were not specified). Concomitant medication were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 3:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 3:14 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 75.10 for dose administered on 03-Nov-2021. No concomitant medications were reported. Batch number 035C21A underwent temperature excursion on 03-Nov-2021 with 35 degrees Fahrenheit from 10:00 AM. Batch number 035C21A has also undergone temperature excursion on 27-Oct -2021 and 22-Oct-2021. These vials were moved to fridge on 05-Oct-2021 and beyond use date for the vials was reported 05-Nov-2021.Product moved to clinic on 03-Nov-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported
Tiredness. Severe (barely lasted through my work day and was very unproductive) Headache. Mild. On and off throughout the day. Muscle pain. Severe throughout the day.  Chills. Mild. A few times a day. Fever. Up to 102°F  I was taking 400mg Ibuprofen as directed on the bottle throughout the day.
Chest pain; difficulty breathing/having challenges breathing; have fluid around his heart; This is a spontaneous report from a non-contactable physician via Pfizer sales representative. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced chest pain and difficulty breathing/having challenges breathing in Mar2021. He was hospitalized on an unspecified date. The doctor attributed the events to the vaccine and he was advised not to get a second shot. Patient was released from the hospital and upon-follow up with a cardiologist, he was found to have fluid around his heart on an unspecified date. The patient is currently getting more testing. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the limited information provided, the reported events are likely intercurrent medical conditions and unrelated to BNT162B2. Of note, medical history, patient's age and concomitant medications were not provided to determine pre-existing risk factors or conditions that may have led to the events. Case will be reassess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
patient received one dose of GARDASIL in 2011, followed by three doses of GARDASIL 9 within the past year; No adverse effects were reported; patient received one dose of GARDASIL in 2011, followed by three doses of GARDASIL 9 within the past year; This spontaneous report was received from a registered nurse and refers to a 20 year old female patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On an unknown date in 2011, the patient was vaccinated with one dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), 1 dosage form (strength, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. Subsequently, approximately since 2018, reported as "within the past year", the patient started being vaccinated with three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, frequency, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 12-JUN-2019, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). No adverse effects were reported.
It was mild after first dose, I was just weak and tired. The 2nd dose I felt flu like symptoms had a slight fever. Then I broke up with rash, hives called angioedema. I think it was Chinese food that triggered it. Now I'm having all kinds of outbreaks. I have to carry an EpiPen now.
Post vax, pt felt dizzy and nauseous. BP 120/80, pulse 60 beats per minute.
No additional adverse events reported; patient received M-M-R II and V ARlV AX vaccines on 7/13/2021 and again on 7/20/2021; Varivax administered intamuscularly; varivax administered intamuscularly; This spontaneous report was received from a physician's office referring to a 37- year- old patient of unknown gender.  Information regarding the patient's pertinent medical history, drug allergies, reactions or concomitant medications was not provided.  On 13-JUL-2021, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliters (ml) intramuscular (anatomical location, lot number and expiration date were not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (ml) intramuscular (incorrect route of product administration)(anatomical location, lot number and expiration date were not reported) for prophylaxis.  On 20-JUL-2021, the patient was vaccinated again with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA (recombinant human albumin))(M-M-R II) 0.5 milliliters (ml) intramuscular, reported lot number: S036662 and expiration date: 14-NOV-2021 (anatomical location was not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (ml) intramuscular (incorrect route of product administration) reported lot number: T000340 and expiration date 05-JAN-2022 (anatomical location, was not reported) for prophylaxis (inappropriate schedule of product administration).
Swelling, redness and warmth to left arm. Patient was seen in the ER the evening of injection and was prescribed Zantac and Benadryl and to use ice.
1 1/2 teaspoons of Ibuprofen were given to child at 6:00 pm due to complaints of pain from the injection by his mother.  Child went to bed and woke up at 6:00 am on 8/27/2010.  His right upper arm is warm to the touch, swollen hard, and itching.  There is a 2.5 inch red area around the injection site.  Child has vomited.
I got a headache on the right side and shooting pain down my neck and arm. I also got pink eye
45 hours after receiving the vaccine, my son had a lung collapse while sitting in class. He was sent by ambulance to hospital where he was diagnosed with a spontaneous pneumothorax. He had a chest tube inserted. After 7 days, without healing, he was sent to another hospital.  5/11/09-Medical records received for DOS 11/3/08 to 11/7/09. FINAL DIAGNOSIS: Resolved Pneumothorax Transferred to this hospital, after stepping on chest tube, for definitive management of persistant pneumothorax.  Air leak. Decreased breath sounds on right, chest pain. Fever, tachycardia.
Nausea, fever of 103 by days end with Motrin and Tylenol in her system, joint pain spreading to several joints - resulted in ER visit and referral to rheumatologist. She's still in pain and cause remains unknown.
Had redness and swelling at injection site (Lt deltoid) immediately after injection was given.  Also has slight dizziness.  B/P-140/90, pulse 64.  Re-checked patient at 9:30AM B/P-144/92, pulse-66.  There was less redness and swelling at injection site.  Patient feeling good except for slight dizziness.  Checked again at 11:00AM B/P-138/88, pulse 72.  Feeling good.  No pain or redness at injection site.  Still very slight dizziness.  Instructed to see MD if dizziness continues or has any other symptoms.
expired dose of Shingrix was administered today; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 252JX, expiry date 14-SEP-2023) for prophylaxis.   On 03-OCT-2023, the patient received the 1st dose of Shingrix. On 03-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: expired dose of Shingrix was administered today).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 3-Oct-2023 The case was received from the medical assistant. Initials were not provided during call. The reporter consented to follow-up via email. The patient received an expired dose of Shingrix, which led to expired vaccine used.
FELT ACHY DUE TO BOOSTER; TIRED DUE TO BOOSTER COVID VACCINE; FEVER DUE TO BOOSTER COVID VACCINE; This spontaneous case was reported by a patient and describes the occurrence of PAIN (FELT ACHY DUE TO BOOSTER), FATIGUE (TIRED DUE TO BOOSTER COVID VACCINE) and PYREXIA (FEVER DUE TO BOOSTER COVID VACCINE) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    The patient's past medical history included Bronchitis and Hysterectomy in March 2021. Concurrent medical conditions included Crohn's disease.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Solution for injection in pre-filled pen. In August 2021, the patient experienced PAIN (FELT ACHY DUE TO BOOSTER), FATIGUE (TIRED DUE TO BOOSTER COVID VACCINE) and PYREXIA (FEVER DUE TO BOOSTER COVID VACCINE). At the time of the report, PAIN (FELT ACHY DUE TO BOOSTER), FATIGUE (TIRED DUE TO BOOSTER COVID VACCINE) and PYREXIA (FEVER DUE TO BOOSTER COVID VACCINE) had resolved.            Concomitant drugs were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the events of  TIRED DUE TO BOOSTER COVID VACCINE, FEVER DUE TO BOOSTER COVID VACCINE and FELT ACHY DUE TO BOOSTER COVID VACCINE with HUMIRA was no reasonable possibility.  Treatment details were not given.  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   This case was linked to US-MODERNATX, INC.-MOD-2021-621585 (E2B Linked Report). This case was linked to MOD-2021-621585 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-621585:Dose 1
Patient is a 30 year old female whom is 27 weeks 4 days pregnant.  Patient was inadvertently given a DTAP vaccination instead of the TDAP vaccination at her prenatal appointment.  No adverse reactions. Last TDAP was on 01/21/2020.
Administered the Moderna COVID-19 vaccine to a patient under the age limit according to the EUA. Minimum age reported by EUA is 18 years-old and the patient was 17 years-old when the vaccine was administered. Patient is a healthcare provider (medical intern) and had a letter from Dr.   who works at her clinic with a note authorizing vaccination.
This case was reported by a pharmacist and described the occurrence of injection site rash in a 51-year-old female patient who received FLUARIX quadrivalent (batch number 7329G, expiry date 30th June 2015). Previously administered products included flu vaccine with an associated reaction of no adverse event. Concomitant products included PNEUMOVAX. On 1st November 2014, the patient received FLUARIX quadrivalent (injection). On 2nd November 2014, 1 day after receiving FLUARIX quadrivalent, the patient experienced injection site rash, fever, chills and pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site rash, fever, chills and pain were recovering/resolving. The reporter considered the injection site rash, fever, chills and pain to be probably related to FLUARIX quadrivalent. Additional information received: RPh called to report that their patient received the FLUARIX QIV on 11/1/2014 and less than 24 hours later developed fever, chills, body ache, and "apple" sized rash at the injection site. The patient received FLUARIX QIV on the right arm and the rash is also at that injection site on the right arm. The patient also received PNEUMOVAX on that day as well this was given in the left arm. After the onset of symptoms the patient took ibuprofen and the symptoms have improved but has not completely resolved.
11/23/2022 I started vomiting and had a low grade fever. I tested positive for COVID-19 and reached out to urgent care they gave me a prescription of PAXLOVID. And was feeling better within 48 hours. About 20 days later I started having vomiting and vertigo and I couldn't hold anything down. I went to urgent care and they prescribed ZOFRAN. Vertigo and vomiting ended about 24 hours later and was feeling much better. It may have been a rebound COVID-19 case, I heard that it may have been a rebound case of COVID-19 that happens after taking PAXLOVID.
BODY FEELS LIKE ASS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination (series 1). The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced body feels like ass. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of body feels like ass was not reported. This report was non-serious.
General malaise, fatigue, achy joints, headache, symptoms increasing through day. Not serious but enough to cause the patient to go to bed and sleep. Though mild reactions, the symptoms seemed worth mentioning. This patient generally has a reaction to flu vaccine each year.
Beginning 10PM (11 hours post vaccine) I experienced severe body pains and was unable to sleep.  Called out sick from work.  Took 800 mg OTC   Ibruprophin every four hours, which only reduced pain for  an hour.  Temperature went up to 102.1 morning of 02-09-21.  Severe body aches and fever continued until 2:00am on 02-10-21, when the fever broke the body pain subsided as well.  Overslept morning of 02-10-21, but was able to report to work an hour late.  No side effects at this time, except for dull pain in  site of injection.
Period has been erratic and heavy; I was on my period at the time of the booster and have had it two more times in the past month and a half, two weeks each time. A week of brown blood followed by a full period. My mental health has also been extremely bad; my depression has worsened to become almost unmanageable, although it is now improving. I didn't think to link this to the vaccine until I spoke with some other female friends, and four of them have had similar symptoms.
Several hours after the vaccine my upper arm began to swell. The injection site had a rash, my entire upper arm looked like a giant hive.  It was very painful.  I called the on call physician.  He advised me to take an antihistimine and apply ice.  At that point the swelling stopped.  Over 24 hours later the arm is still very sore and very swollen.