chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician received via a Pfizer sales representative. This physician reported similar events for two patients. This is the second of two reports. A 71-year-old female patient of an unspecified ethnicity received a single dose of PREVNAR 13 (Lot Number: J67643), via an unspecified route of administration on 08Dec2014. No other vaccinations were given at this time. The patient's medical history and concomitant medications were not reported. On an unknown date in Dec2014 within 24 hours after receiving the vaccination, the patient started to experience intense pain, then progressed to arm numbness radiating down the arm and through fingertips, and intense pain radiating up the neck, into the jawbone and cheek. The patient went to the emergency room and it was unknown if the patient was admitted. Lab tests were unknown. Therapeutic measures were taken in response to the events and included treatment with steroids. The clinical outcome for the events was unknown. It was reported the events were improved within a week from the time of initiating steroid therapy.
inject site muscle was still somewhat reddish & firm approx 2 wks p/inject; no fever noted by dad; described as somewhat fussy for a couple days;
This spontaneous report as received from other health professional (registered nurse) refers to a patient of unknown age, gender and ethnicity. On 23-JAN-2014, an expired dose PNEUMOVAX23, lot # J005071, expiration date: 19-JAN-2015 (dose, route of administration and indication not reported) was administered to the patient. No adverse effects were reported. No further information was provided. Additional information has been requested.
Redness and warmth around injection site. Painful to touch. Most symptoms started 3/4/16. Pt c/o soreness same day as injection. Pt advised to use warm compresses and TYLENOL as needed. to call if not improving.
Pt developed within 24 hrs erythematous rash, with pruritus no tender no fever.
started with body aches, progressed to severe headache, severe nausea ,diarrhea, for the next 36 hours
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in an 86-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021).The location of the vaccination site were Mixmed pharmacy. It was reported that the vaccines was stored in freezer, they took out one to two vials and place in fridge each day as needed.  No concomitant medications were reported.  No treatment medications were reported.
Acute onset of severe headache, confusion, aphasia, muscular weakness, nausea, and vomiting
Information has been received from a registered nurse concerning a patient who was vaccinated with the first 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (no lot number available). The patient developed breakthrough after the first dose. It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Within a minute after MMR2 pt had 3 wheals of 0.4cm around the injection which developed into on wheal of 2cmx1cm with pruritus and surrounding redness. Benadryl given and observed for 45 min.
I contracted COVID-19 on 06/23/2022 with symptoms of sore throat, headache, congestion, runny nose, slight cough, shortness of breathe, and fatigue. I was prescribed Methyl Prednisone and Azithromycin on 06/28/2022. My symptoms have begun to improve but I am not recovered as of yet.
Patient had hives, rash, wheals. Patient took Benadryl PO 50mg on 8/19/2014. Patient came into the clinic 8/20/2014, patient was given Zyrtec 10mg Po and Prednisone 60mg PO. Observed for 30 minutes and sent home with Zyrtec 10 mg PO daily x 3 days.
On 7/5/08, patient was admitted with weakness and hypotension. He received fluids intravenously and his blood pressure responded initially. In the evening of 7/5/08, he was assessed by the registered nurse per the Executive Committee of the Medical Staff approved "Pneumococcal Opt-out Protocol" and the vaccine was administered. On 7/7/08, upon examination it was noted that the patient's left upper arm (deltoid) was warm, reddened and tender to touch. The patient developed a temperature with an elevated WBC of 12. Infectious Disease was consulted and an MRI of the left arm was obtained. The MRI revealed inflammation of fascia. A surgical consult was obtained and the patient underwent a fasciotomy on 7/7/08. The fascia and muscle appeared healthy with a couple of purulent pockets. The site was debrided and cleaned. The patient was started on broad spectrum antibiotics. The wound culture was negative for bacterial growth. On 7/11/08, the patient was discharged to the rehabilitation center in stable condition. On 7/23/08, the rehabilitation facility stated that the wound was healing well. 8/6/08-records received for DOS 7/5-7/11/08-DC DX: fasciitis. Four days prior to admission episode of vomiting, on day of admission diet refusal, became withdrawn, diaphoretic and systolic blood pressure in 70s. Day 2 of admission C/O pain in left shoulder area, re-evaluated evidence of infection with erythema, induration. ID revealed fascitis.
Shoulder inflamed pain radiating under armpit, hot to the touch, very sleepy, loss of appetite.
nerve pain in hand, face and feet; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (nerve pain in hand, face and feet) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEURALGIA (nerve pain in hand, face and feet). At the time of the report, NEURALGIA (nerve pain in hand, face and feet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported No treatment information was provided
On 10/4, patient had a seizure and went unresponsive. She had elevated blood pressure. +Irregular breathing
This is a spontaneous report from a contactable consumer for a female patient (daughter). A female patient of an unspecified age received TRUMENBA, via an unspecified route of administration on 01Jun2018 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. In the past, 1-2 years ago, the patient previously took HPV vaccine for immunisation and experienced golf ball lymph nodes under her arms. The patient experienced swollen lymph nodes and upset stomach on unspecified date in Jun2018 with outcome of unknown. Per reporter: When her Dr. pressed on the golf ball sized lymph nodes my daughter almost passed out. The lymph nodes were really tender. Do you have any links between HPV vaccine and meningococcal group b rlp2086?
Received the two doses of the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Received the two doses of the vaccine while pregnant) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 043L20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 9:20 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 09-Sep-2021. On 15-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Received the two doses of the vaccine while pregnant). On 25-Feb-2021, EXPOSURE DURING PREGNANCY (Received the two doses of the vaccine while pregnant) had resolved. Not Provided; Reporter's Comments: This case concerns a 33 year-old, female patient, who is pregnant and experienced an event of exposure during pregnancy after receiving her first and then the second dose of mRNA-1273 vaccine on the 11th week of pregnancy. No adverse events were reported.
classic right sided Bell's palsy with right sided weakness; This is a spontaneous report from a contactable Physician reporting for a patient (reporter's son.) A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in the left arm on 04Apr2021 14:45 (Lot Number: ER8732) as a single dose (at the age of 46-years-old) for COVID-19 immunisation.  Medical history included ongoing gout (controlled), and Bell's palsy from an unknown date (patient had Bell's palsy 13 years before). Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication included allopurinol (300 mg) at 300 mg from an unknown date for gout.  The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 12Apr2021 the patient experienced Bell's palsy.  The patient started symptoms on 12Apr2021 and progressed to facial paralysis on 23Apr2021 which was finally diagnosed as Bell's Palsy. The Bell's Palsy is stable and has not improved much yet. Clinical course is as follows: on Monday, 12Apr2021 one and a half weeks after the vaccine the patient's symptoms began, he had minimal symptoms on 10Apr2021 and on 23Apr2021 he had facial paralysis and on that day he started treatment. On Friday (date not specified) the patient had facial weakness. The reporter considered the event non-serious. The reporter would like to know the post-marketing incidence of Bell's palsy and the reporter was trying to decide whether the patient (reporter's son) gets second dose of Pfizer Covid BioNTech Vaccine or forgoes it. Therapeutic measures were taken as a result Bell's palsy included treatment with high-dose prednisone and valicyclovir (VALTREX). The clinical outcome of the Bell's palsy was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The reporter stated that this (Bell's palsy) may be a random event or a related event.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event Bell's Palsy and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a RN concerning a 15 year old female pt who on 03/05/93 was vaccinated SC with a second 0.5mL dose of MMRII (Lot # not reported). On 04/18/89 she was vaccinated with a first dose of MMRII (Lot # not reported). On 01/23/04 the pt had titers drawn and they were negative for rubella. Unspecified medical attention was sought. Additional information has been requested.
Fever 100.1, hard to concentrate, discomfort where injected, strong headache. Slept fitfully, fever broke 4am, returned 11am 100.0, with crusted eyes, bloodshot, rash all over, mild eye swelling, mild itch at injection site, legs rubbery, flu-like pains in body, arms very tired, feeling of exhaustion. Vaccine was 17 hours ago. Zostavax shingles vaccine.
Vaccine given past expiry date of 09/30/2022 and past stability date of 10/19/2022
Rash spreading on thigh; Rash near injection site on thigh; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), RASH (Rash spreading on thigh) and VACCINATION SITE RASH (Rash near injection site on thigh) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PRURITUS (Itchiness) and VACCINATION SITE RASH (Rash near injection site on thigh). On 05-Mar-2021, the patient experienced RASH (Rash spreading on thigh). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of 1 dosage form and CORTISONE at a dose of 1 dosage form. At the time of the report, PRURITUS (Itchiness), RASH (Rash spreading on thigh) and VACCINATION SITE RASH (Rash near injection site on thigh) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.
Fever of 101 F. Gave Infants Motrin at 1200AM 28 Sept. Woke up at 0230 still feeling warm. Gave Infants Tylenol. Woke up at 0430 with no fever. Gave Motrin at 0630. Daycare called at 11AM to pick up child because of 100.8F fever and irritability. They also noted a wrash on his butt.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). In 2021, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. In 2021, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported. Expiration dates are unknown, they only have the 30 day mark which was on 16May2021.
3 inch raised, red, warm, itchy area located approximately 2 inches below injection site.  Symptoms showed up one day post vaccine, although itchiness resolved same day.
My cycle has become irregular; This is a spontaneous report from a contactable consumer (patient). A female patient received second dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: Unknown, expiry date: unknown), via an unknown route of administration on an unknown date as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced 'my cycle has become irregular'. It happened right after taking the 2nd vaccine. When paraphrased, consumer stated, "Irregular, it is no longer the same. It is irregular." The outcome of the event was unknown.  Information about lot/batch number has been requested.
sore; red itchy reaction around the injection site; red patch; Itchy; Mild sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild sore arm), VACCINATION SITE ERYTHEMA (red itchy reaction around the injection site; red patch), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE PAIN (sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (Mild sore arm). On 25-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red itchy reaction around the injection site; red patch) and VACCINATION SITE PRURITUS (Itchy). On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore). At the time of the report, VACCINATION SITE PAIN (Mild sore arm), VACCINATION SITE ERYTHEMA (red itchy reaction around the injection site; red patch), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE PAIN (sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
booster; blurred vision; she couldn't read; she couldn't drive to work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Dec2021 05:15 (Lot number: SJ8757) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LITHIUM (ongoing); ZYPREXA (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, lot number CR8731), administration date: 15Apr2021, when the patient was 41 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, lot number EW0182), administration date: 06May2021, when the patient was 41 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Dec2021, outcome "unknown", described as "booster "; VISION BLURRED (non-serious) with onset 11Dec2021, outcome "not recovered", described as "blurred vision"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Dec2021, outcome "unknown", described as "she couldn't read"; IMPAIRED DRIVING ABILITY (non-serious) with onset Dec2021, outcome "unknown", described as "she couldn't drive to work ". Therapeutic measures were taken as a result of vision blurred.  Additional information: The reporter indicates that she developed blurred vision immediately after getting the booster shot of the pfizer covid 19 vaccine. On 11Dec2021 (Saturday), she could not read, she was better on 13Dec2021 (reported as today). She cannot see without her glasses which is not common on her. She got the booster dose on 11Dec2021 at 5:15pm. The blurred vision happened as soon as he jabbed her. It was instant. She sat down for 15 minutes, and when she got up to walk out, she realized she couldn't read the lettering on the signs and she usually can with her glasses. She went ahead and drove home because she only lives 2 blocks away. She was wondering if it was a side effect. She had to work from home today because she couldn't drive to work this morning. The blurred vision was really bad on 11Dec2021 (Saturday) and 12Dec2021 (Sunday). On 13Dec2021 (Today), she still needs to wear glasses as long as she was awake. Usually at home, she can take them off and see fine. Now she has to wear her glasses at all times. That was unusual for her. She tried making an eye doctor appointment, but they had no openings. She was hoping they could give her drops or something. She has been using Refresh tears for the blurred vision, and It wasn't 100% helping, but it was helping some. It has lot number T0156. The patient received her booster vaccine in a   No follow-up attempts are possible. No further information is expected.
Patient got the Moderna vaccine during the day and then by 330am she got a fever, chills and body aches.  At 10am her left foot was throbbing and it "killed her to put pressure on it."  The top outer side of her foot was "on fire" and there was a lump there.  Her blood pressure was "through the roof."  She said it was way higher than normal for her.  Her doctor said it looks like she broke her foot so they did an x-ray but it showed that her foot was fine.  She reports that by the next day her foot was fine.
I have contracted  Covid 19 while visiting family.  Arrived on June 30th and became symptomatic on July 7, 2021.
Patient received Pfizer COVID vaccine on 6/9/21 and 7/20/21. On 3/13/22, patient admitted to our inpatient CCU after being intubated on the field s/p asystolic cardiac arrest. His other indications for admission include severe hyponatremia, seizure, acute respiratory failure, acute metabolic encephalopathy, and positive COVID status (chest xray without any signs of pneumonia). Patient was in CCU intubated from 3/13/22 to 3/16/22, then transferred to med/surg. As of today (3/17/22), patient is still admitted in the med/surg  unit.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer-sponsored program Support. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed symptoms of the COVID virus on an unspecified date after getting the first dose. She developed fatigue, body ache, headache, and she was getting worried about the loss of smell. The patient tested positive for the COVID rapid test, on an unspecified date. Right now, they were waiting for the COVID PCR (polymerase chain reaction) exam results. The outcome of positive COVID-19 test with symptoms was unknown.  Information on the lot/batch number has been requested.
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and unknown gender. On an unspecified date, the unspecified number of patients were vaccinated with doses of improperly stored PROQUAD (Merck) (lot # K014799, expiry date: 12-MAR-2016 and lot L010142, expiry date: 24-SEP-2016). No adverse effects were reported. Additional information has been requested.
NO ADVERSE EVENT REPORTED - PATIENT WAS NOT CORRECT AGE AT TIME OF VACCINATION