chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT CALLED AROUND 515PM TODAY. STATED SHE RECEIVED HER MODERNA VACCINE ON 8/2. DUE TO SEVERE PAIN LIMITED MOTION AND USE OF THE ARM WHERE SHE RECEIVED THE VACCINE SHE WENT TO URGENT CARE FRIDAY 8/6/21 TO HAVE IT LOOKED AT. THE DR AT THE URGENT CARE STATED THE VACCINE HAD BEEN GIVEN IN THE WRONG LOCATION, IN THE SHOULDER AND SHOULD HAVE BEEN GIVEN THREE FINGERS AWAY FROM THE SHOULDER. SHE SATES THE DR COULD SEE WHERE IT WAS GIVEN IN THE SHOULDER AND NOT THE MUSCLE. THE PT THEN STATED THAT WHEN SHE RECEIVED THE VACCINE SHE HOLLERED OUT BECAUSE IT HURT SO BAD, AND THAT IT THEN BUBBLED UP IN THE AREA OF THE VACCINE.
Syncope 20 hrs after vaccine. Swollen glands 32 hrs after vaccine.  Rash on right upper arm 48 hrs after vaccine.
Headache, progressed to fever of over 101 for 4 days, then turned to cough, low energy, paleness, complaints of not feeling good, decreased appetite.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. In April 2018, the patient received SHINGRIX. In April 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient received SHINGRIX in an unknown arm. At the time of reporting, as of 3 months after vaccination, the patient still had arm pain at the injection site. The pharmacist had limited information at the time of reporting.
Initial unsolicited report received from a consumer (patient's parent) on 4 August 2015.  A male (age not reported) patient, whose medical history and concomitant medication were not reported, had received a second dose of meningococcal vaccine (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. On an unspecified date post-vaccination, the patient was very sick. The patient could not breathe and turned red. It was reported that, the patient had to wait at the clinic till he got better. Laboratory investigation and corrective treatment were not reported. At the time of this report, the patient was recovering from sickness and outcome of the events could not breathe, turned red was not reported. List of documents held by sender: none.
(R) leg swollen, red, itchy after shots 2 days ago. On exam noted macular rash swelling at (R) injection site warm to touch. No systemic reaction. No fever no systemic pain. Denied SOB. Abscess, cellulitis. Triamcinolone 0.1% cream apply to effected area, BACTROBAN oint apply to effected abscess. ZYRTEC 1mg/1ml 5 ml PO QD.
Severe joint pain in injected shoulder which developed during past week such that I can barely move arm.
myalgia; fatigue; dizz/dizziness; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 14 year-old female patient received bnt162b2 (COMIRNATY), administration date 09Jan2022 15:30 (Batch/Lot number: unknown) at the age of 14 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 09Jan2022 21:00, outcome "unknown", described as "dizz/dizziness"; MYALGIA (non-serious) with onset 10Jan2022 07:00, outcome "unknown", described as "myalgia"; FATIGUE (non-serious) with onset 10Jan2022 07:00, outcome "unknown", described as "fatigue". Additional information Description of Event: 14 year old healthy female. Received costed at 03:30pm on 09Jan.  Felt dizzy by 9pm. Awoke at 7am 10Jan with myalgia, fatigue, dizziness Optional Information: NKDA. No significant PMH. No medications  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient got COVID; Patient got COVID; This is a spontaneous report received from contactable reporter (consumer). Other Case identifier: 2022NVX-US-000002649.  A patient in their 70's received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Patient got COVID".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Injection site pain .  More painful than with 1st dose.    On 4/30 still sore but not as significant as on 4/28-4/29.   Quite painful to move arm or touch injection site area.
Vaccine expired on 09-Nov-2021 and stored in freezer before administration and administered on 19-Jan-2022; doses administered past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine expired on 09-Nov-2021 and stored in freezer before administration and administered on 19-Jan-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 09-Nov-2021 and stored in freezer before administration and administered on 19-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine expired on 09-Nov-2021 and stored in freezer before administration and administered on 19-Jan-2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  Treatment medications were not reported.
This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (increased blood pressure), PRURITUS (itchy) and VACCINATION SITE PAIN (soreness in arm at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LOSARTAN, AMLODIPINE and HYDROCHLOROTHIAZIDE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (increased blood pressure), PRURITUS (itchy) and VACCINATION SITE PAIN (soreness in arm at injection site). At the time of the report, BLOOD PRESSURE INCREASED (increased blood pressure), PRURITUS (itchy) and VACCINATION SITE PAIN (soreness in arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pallor, fainting episode, eye rolling movement to right, brief jerking movement upper limbs 5 secs. Patient placed supine with knees flexed and recovered in 2 minutes.
7-month-old was administered an extra dose of HIB; Initial information received on 25-Mar-2021 regarding an unsolicited valid non-serious case from a other health professional (Inquiry number: 00535159).  It was reported that an extra dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ359AAA).(Suspension For Injection) was administered to a 7-month-old patient, on 25-Mar-2021 via an unknown route for prophylactic vaccination (extra dose administered).  It was a case of actual medication error due to extra dose administered.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Over period of 3 days c/o "scratchy" throat -> chest tightness -> chest pain - seen in ED 10/26/12 - obs x 24 hrs.
Light headed, felt like vomiting, stomach blotted, sweating a little (had dry heaves), Took 1 dose pepto bismal and was ok 1/2 hour later and felt fine the rest of the day.
Fatigue the day of vaccination, severe arthritis pain in neck, back, hips & knees for several days after vaccination so used Gabapentin and Voltaren, swollen lymph nodes in neck 2 days after vaccination prescribed Azithromycin 250mg dose pk and methylprednisolone 4mg dosepk but did not take latter due to prednisone interaction with Moderna
pt recv vax 27NOV95 & 16FEB98 pt devel about 40 skin lesion that were not pruritic;
Patient staff member became flushed, nauseated, and dizzy approximately 1 hour after immunization administration. Saw facility's medical director and received injection of epinephrine with cessation of symptoms.
Onset of pain in the arm of injection mostly around shoulder and the  part of arm below the shoulder. Pain started about 2 weeks after 2nd shot. Concern is that this may be a side effect from the vaccine.
Body aches, headache, fever 101-102.2, weakness, shortness of air, severe chest pain
Site pain; Low grade fever; Body aches; Fatigue; Loss of appetite; Joint pain; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced site pain, low grade fever, body aches, fatigue, loss of appetite, and joint pain following 2nd dose of covid vaccine on an unspecified date. Outcome of events were unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician refers to his wife, a 65 year old female patient. The patient's medical history included peripheral neuropathy and fibromyalgia, also she allergy to tetracycline and RECOMBIVAX HB. On APRIL 2008 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. Concomitant therapies included prednisone. On 09-APR-2013 the patient experienced chest tightness, a "rash suggestive of shingles" and dysesthesia. The patient spent one night in hospital in MAY 2013 for chest tightness. The reporter reported that the patient has an allergy to RECOMBIVAX HB in the form of pain and fatigue that lasted 6 months (MARRS#1306USA007772). The patient did the Electromyogram test, and it showed peripheral neuropathy in arms and legs. The patient also did Brain MRI and the routine labs, the tests were normal. The outcome of shingles was reported as recovered but the patient was still left with dysesthesia. The outcome of the chest tightness was unknown. Additional information has been requested.
having pain in the injection side  for a  week after both doses; felling a bit tired after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (having pain in the injection side  for a  week after both doses) and FATIGUE (felling a bit tired after the second dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PREGABALIN (LYRICA), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), PARACETAMOL (TYLENOL) and LORATADINE for an unknown indication.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (having pain in the injection side  for a  week after both doses) and FATIGUE (felling a bit tired after the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (having pain in the injection side  for a  week after both doses) and FATIGUE (felling a bit tired after the second dose) outcome was unknown.            Other concomitant medications include powder for stomach pain, Blood pressure medications.   This case was linked to MOD-2021-332031 (Patient Link).
A report has been received from a Health Professional concerning  a patient, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 21-Jan-2014. The patient received inadvertently expired FLUMIST which started on 21-Jan-2014. The outcome of the event of EXPIRED FLUMIST ADMINISTERED is unknown. The report was considered to be non-serious by the reporter.
Soft ball sized in diameter reaction with a red streak running down arm that was hot to the touch. Cough for 12 hours started and ended abruptly, overwhelming fatigue for 1.5 days.
vaccine expired by 8 hours was administered; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine expired by 8 hours was administered) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine expired by 8 hours was administered) and NO ADVERSE EVENT (No adverse event). On 28-Apr-2021, EXPIRED PRODUCT ADMINISTERED (vaccine expired by 8 hours was administered) and NO ADVERSE EVENT (No adverse event) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Patient stated that she did not experience any adverse events after administration of expired vaccine. Patient date of birth was reported as 02-AUG-1974.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: This follow-up was received on 03-JUN-2021 which updated patient demographics, initials, age, route of administration was corrected and facility information was also updated.
Pain in my left arm where I had received vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in Arm right, administration date 08Mar2021 11:15 (Lot number: EL3247) at the age of 36 years as dose 1,single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: INJECTION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered", described as "Pain in my left arm where I had received vaccination".  Additional information: Therapeutic measures were not taken as a result of injection site pain.   No follow-up attempts are possible. No further information is expected.
Full body ache beginning in the middle of the night following injection and lasting through the following day (09/10/19). On 09/11/19, body ache resolved and injection site reaction appeared - red, slightly raised, and approx. 2 inch in diameter. Injection site was painful, with pain moving up to the ear.
At 6 days after the vaccine, I developed some itching and mild swelling at the injection site. The next 2 days it became progressively more itchy, and I noticed progressive redness, warmth, and swelling to about 6-7 inches in diameter around the injection site despite using topical hydrocortisone. I was seen by virtual urgent care 8 days after the vaccine, and the doctor recommended around the clock ibuprofen for what he thought was a delayed hypersensitivity response, which helped. It resolved after 4-5 days of intermittent ibuprofen (400mg about twice a day) and topical hydrocortisone. I never had fever or other systemic symptoms.
This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a nurse practitioner concerning a 21 year old female Radiologist Aide, with no pertinent medical history, who on an 16-MAR-2007 was vaccinated IM in right deltoid with a first dose of Gardasil. Subsequently, on an unspecified date, the patient developed a rash on her leg. The patient's rash never fully went away. On an unspecified date, the patient was vaccinated IM with a second dose of Gardasil. Subsequently, on an unspecified date, the patient's rash on her leg was "more prominent and longer" then the rash received after her first dose. The nurse practitioner reported that the patient was referred to a dermatologist for an evaluation. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Rapid swelling, redness, itching, and warmth developed in the exact location of the injection. Swelling was egg-shaped, approximately 3 cm x 4.5 cm.  Subsided over the course of three days
Sore arm after which was worse after 12 hours, much worse than first dose. Began to get aches in entire body around 18 hours after second shot. Around 24 hours after, aches persisted with events of extreme cold chills then hot flashes almost flu like. Around 36 hours side effects have subsided and just tired body. No alcohol was consumed, with plenty of water and healthy foods.
he had a bit of runny nose; a bit allergy after; This is a spontaneous report from a Pfizer Regulatory Authority. a contactable consumer or other non-hcp (Patient) reported for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 08Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. As reported patient was stating that he got the 1st dose of the vaccine on 08Mar2021 and mentioned that he had a bit of runny nose and a bit allergy after and then he was asking if he can take antihistamine. On an unspecified date in 2021 the patient experienced he had a bit of runny nose, a bit allergy after. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
A report has been received from a Health Professional concerning a 12 year old, male patient who had been receiving FLUMIST (intranasal). FLUMIST (intranasal) started on an unknown date. The patient experienced fever, runny nose and tired. The patient recovered from the event of fever, runny nose and tired on an unspecified date. The report was considered to be non-serious by the company physician.
Presented in ER on 12/21. COVID- symptoms began a few days ago which included: fever, cough, sob, n/v, diarrhea, body aches, and fatigue. In the ED, the patient was afebrile and saturating at 94% on room air, but desaturated down to 86% and placed on 3L O2. Admitted and started on azithromycin, ceftriaxone, remdesivir, and dexamethasone,  Patient continued to be stable throughout her hospital stay. Patient had an elevated D-dimer and CTA was performed to r/o PE demonstrating    Due to patient requiring oxygen, a 6 minute walk was performed, which indicated that home supplemental oxygen would not be needed. Discharged on 12/23/21
Covid 19; Covid 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 22Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "Known allergies:Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), administration date: 21Apr2023, when the patient was 70-year-old, for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Covid 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid as COVID 19 Treatment from 13Oct2023 till 18Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
hives on face; facial flushing; swelling of lips, tongue and throat; swelling of lips, tongue and throat; swelling of lips, tongue and throat; known allergy clearly the Pfizer Covid vaccine; This is a spontaneous report from a contactable consumer.  A 62-year-old female consumer reported that she received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318) intramuscular into the left arm on 01Apr2021 at 09:00 am (at the age of 62-year-old) at single dose for COVID-19 immunization. Concomitant drugs included vitamins only. Known allergies included all shellfish, Percocet, adhesives on bandages. On 01Apr2021 at 09:15 am the patient experienced facial flushing, hives on face, swelling of lips, tongue and throat. As per reporter the AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient was treated with IV with epi, solu-medrol, prednisone and Benadryl. The patient reported as known allergy 'clearly the Pfizer Covid vaccine'. The patient recovered from the events on an unknown date.
ill; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unwell. On an unknown date, the outcome of the unwell was unknown.   It was unknown if the reporter considered the unwell to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the reporter whom he/she knew. The age at vaccination was not reported. The reporter stated that shot could make you feel like you were dying. The reporter stated that he/she knew patient who got Shingles vaccine and got extremely ill. The case was linked with US2021AMR186613 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186613:same reporter