chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's palsy; numbness in their face and in their arms and finger tips; This is a spontaneous report from contactable consumer.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: not reported, Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced Bell's palsy and numbness in their face and in their arms and fingertips. Reporter also stated, I was given this number so that I can speak with a medical, somebody that is familiar with the adverse side effects that are not the normal side effects from the Pfizer Covid-19 vaccine. We have a patient that has had their first shot and had an adverse reaction of what appear to be the Bell's palsy where they experienced the numbness in their face and in their arms and fingertips and so for.  Outcome for events was unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Received the vaccine Thursday afternoon. Friday night, patient noted a nickel sized red area at the injection site. By Saturday, the area had grown in size to approximately 5x4 inches and was red, hot, and slightly itchy. As of today (Sunday), the patient said the area seems to be fading and at the very least not getting bigger.
Expired dose of MENACTRA being administered to a patient with no reported adverse events; Initial information received on 22-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] being administered to a patient with no reported adverse events.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Jun-2022, the patient received expired dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine, solution for injection (lot number not reported and expiry date 09-Jun-2022 was administered to a patient with no reported adverse events (expired product administered).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of menactra being administered to a patient with no reprted adverse events.   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 the 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.
Progressively more uncomfortable with severe myalgias,fever,chills, shaking with severe pain. Incontinent of diarrhea stool and urine, significant numbness and tingling above the tops of her knees. Patient fell trying to go to bathroom. 11/20/09 Medical records received for dates 11/16/09 to 11/17/09. DX: transverse myelitis, possible adverse reaction to H1N1 vax. Pt states received H1N1 vax on 11/5 and steroid inj. for plantar fasciitis 11/6. Pt states since that time have become increasingly uncomfortable w/ myalgias, severe pain. One day ago pt. states became incontinent of urine and stool and fell down while attempting to move to the bathroom. Pt states feel sig. tingling/numbness over top of bi-lat knees. Pt had neuro consult while in hosp. w/ DX peripheral neuropathy, presumptive GBS.
Vaccine administered came from vial that was kept in fridge longer than manufacturer recommended storage date. The manufacturer informed us via written statement the vaccine "maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration." Revaccination not advised. We called the patient to inform them of the situation and the information we received from the manufacturer. No adverse reactions reported by the patient.
102 Degrees Fahrenheit Fever day after injection. As I complete this report it is 8 days since I received the vaccine and i still have a red rash from the vaccine site to below my elbow.
Information has been received from a RN concerning a 95 year old female at a skilled nursing facility with an allergy to PCN and a previous vaccination with an unspecified influenza virus vaccine on 16-DEC-2004 with no reported adverse effect. It was reported that the pt had lab work for albumin and pre-albumin levels ordered for hospice continued care (laboratory values were not provided). On 04-JAN-2005 the pt was vaccinated with Pneumovax 23. There were no illnesses reported at the time of vaccination. On 05-JAN-2005 at 9:20 AM the pt developed left arm pain. It was reported that the pt treated with Tylenol. On 06-JAN-2005 the pt developed arm redness and was swollen. It was reported that the pt's left arm continued to be red and was "painful to touch" thru 13-JAN-2005. It was reported that the pt remained afebrile the entire course. At the time of this report the outcome of the events were unknown. Additional information has been requested.
Pt vaccinated with DTP/HIB developed generalized tonic clonic seizure lasting about 5 min, 12 hrs post injection. Also, fever to 102. No treatment given.
Right away, the tip of my tongue and lips were numb. That symptom continues to this day. I got the classic Covid arm rash around the injection site. It was about 3 inches across, red, and mildly itchy. This resolved in 3 days. I was very tired right away and needed to sleep. Fatigue has somewhat resolved gradually, but I still have some mild fatigue.
soreness of the arm; Indigestion; Upset stomach/indigestion; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness of the arm), DYSPEPSIA (Indigestion) and ABDOMINAL DISCOMFORT (Upset stomach/indigestion) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness of the arm), DYSPEPSIA (Indigestion) and ABDOMINAL DISCOMFORT (Upset stomach/indigestion). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE PAIN (soreness of the arm), DYSPEPSIA (Indigestion) and ABDOMINAL DISCOMFORT (Upset stomach/indigestion) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Patient's e-mail address updated.
This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ILL-DEFINED DISORDER (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ASTHENIA (felt weak), CHILLS (chills) and PYREXIA (low grade fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced GAIT DISTURBANCE (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ILL-DEFINED DISORDER (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), CHILLS (chills), PYREXIA (low grade fever) and VOMITING (throwing up dark yellow and it tasted terrible). On 28-Feb-2021, the patient experienced ASTHENIA (felt weak) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ILL-DEFINED DISORDER (felt in a Ping-Pong machine, could not walk very well, she was bouncing back and forth), ASTHENIA (felt weak), CHILLS (chills), PYREXIA (low grade fever), VOMITING (throwing up dark yellow and it tasted terrible) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient was administered the vaccine and was talking to the pharmacist asking about the nationality etc. and all of a sudden he stopped talking for 3 to 4 seconds and was feeling uncomfortable and was not able to communicate properly.  Asked if he was able to breathe,  he said he is not having any difficulty breathing but was complaining of pain down the spine in his back .  Called 911 and the EMT arrived quickly, patient  got up and walked with them. Later he was checked for his vitals, not admitted to hospital.  I spoke with the patient  over phone after 2 and 1/2 hours post incident. Patient said he was resting and I advised him to see a Doctor as soon as possible as a follow-up.
experienced redness swelling and warmth to touch; experienced redness swelling and warmth to touch; experienced redness swelling and warmth to touch; experiencing ongoing limitation of arm movement, with pain when trying to raise her arm above the head; experiencing ongoing limitation of arm movement, with pain when trying to raise her arm above the head; This is a spontaneous report from a contactable nurse.  A female patient of an unspecified age received the pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (reported as: on 09Dec) at a single dose for immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: experienced redness swelling and warmth to touch, experiencing ongoing limitation of arm movement, with pain when trying to raise her arm above the head. The clinical outcome of the event, experienced redness swelling and warmth to touch, was recovered on an unspecified date. The clinical outcome of the event, experiencing ongoing limitation of arm movement, with pain when trying to raise her arm above the head, was not recovered.  The batch/lot numbers for the vaccine, pneumococcal 13-val conj vac (dipht crm197 protein), were not provided and will be requested during follow up.
This spontaneous case, initially received from the other health care professional on 09-Feb-2018, concerns 36-year-old adult, female patient. The patient's medical history and concomitant medications not reported. On 08-Feb-2018, the patient was administered with partial dose of FLUCELVAX QIV (dose: less than 0.5ml as reported, intramuscular, anatomical location: arm, route of administration, batch number and expiry date: not reported), as the needle was not placed on syringe correctly. While administration half of vaccine leaked onto patient's arm. The reporter assessed this as non-serious. Follow-up received from the reporter on 26-Mar-2018: Follow-up for this case was not being sought as response was not available. Non-significant case correction received with IRD 26-Mar-2018: Typo error (follow was changed to follow-up). Case comment was changed. Non-significant case correction received with IRD 09-Feb-2018: Dose: less than 0.5ml as reported, so deleted from dose field and mentioned in the narrative.
Patient complained of pain, redness and swelling at injection site a few hours after receiving the vaccine. States she had chills overnight. Patient came back into the office the next day to be evaluated. Use ice, elevation, Benadryl and naprosyn. Call if symptoms worsen.
administered to a 14 year old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th November 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 9th November 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-NOV-2022 Reporter's comments: The health care professional reported that the 14 years old patient received a dose of Twinrix. At the time of reporting, lot number and expiry date were not available. The reporter consented to follow up by postal. Additional supportive information: The 14 years old patient received a dose of Twinrix, which led to inappropriate age at vaccine administration.
Member is feeling like her tongue is swelling up.  No visible swelling.  Observed while in gurney.  Vital signs taken while laying down and when sitting up.  Water provided.  Monitored from time after vaccination to 5pm. Member felt swelling was going down and was fine to go home.
Shoulder pain at sight of injection at first - then spread to entire shoulder joint.  Pain started night of injection and caused limited mobility as well. This was very intense for the first four days. After that, it started to improve - day by day- for the next six days or so. However, at that point (about 10 days post injection) the pain in the shoulder started increasing - day by day- and now is very painful again.  Ice the first day, then switched to heat after that. Not much improvement or relief.  Also took Tylenol but it barely helps at all.  The intensity of the shoulder pain is causing related pain in my neck and jaw because I find myself clenching my teeth in pain - which causes jaw/face pain and now headaches. They are tension type headaches because of the grinding/clenching.
has caused continuous periorbital edema and put me in ER today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: PERIORBITAL OEDEMA (non-serious), 1 day after the suspect product(s) administration, outcome "not recovered", described as "has caused continuous periorbital edema and put me in ER today". The events "has caused continuous periorbital edema and put me in er today" required emergency room visit.  Additional information: Patient had Pfizer #1& #2 dose of covid vaccine. Then patient had "3 booster and after #4 newest, the latest has caused continuous periorbital edema and put me in ER today after almost 4 months.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
- Stomachache, high grade proteinuria, hypoalbuminemia and edema of sudden onset  in July 2021 - Diagnosed as Minimal Change Disease (Nephrotic Syndrome) in August 2021 following kidney biopsy - Steroid dependent remissions and relapses Sept-Jan 2022 until he received two rounds of rituximab IV - Still being monitored as of Jan 20, 2022
Initial information received on 16-Oct-2018 regarding an unsolicited non-valid and non-serious case received from a other health professional. This case involves an seven patient who were vaccines with TYPHIM VI, MENACTRA, TENIVAC and ADACEL and TUBERSOL that were stored outside the recommended temperature range. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to incorrect product storage. It was reported that the vaccines reached min temp of 29.0 F and max was temp of 50 F for 11 hours 30 min and in second reading temp excursion temp min was 32.0 F and temp max was 50 F for 11 hours 20 min. It was not reported whether the patients had any adverse event. 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. List of documents held by sender: none. Follow up received from other health professional on 16-Oct-2018. Case becomes valid as number of patient reported.
Patient  received bivalent formulation for second shot of primary series. Intended formulation was the monovalent. First shot on 12/12/2022, Second shot on 1/12/2023.
injection sight (left arm) started out with just a little red spot (about the size of a quarter). A few days later it started to get bigger (about the size of a silver dollar) and the skin was hot and itchy. It started to get bigger (size of soft ball) and then slowly started to go down. Then on the 18th, it increased double in size and is very itchy and hot to the touch. There is what appears to be a bruise in the middle area.
Arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis flare up) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arthritis and Hysterectomy (Patient had hysterectomy's surgery) in April 2021. Previously administered products included for Drug use for unknown indication: Humira. Past adverse reactions to the above products included No adverse event with Humira.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced ARTHRITIS (Arthritis flare up). At the time of the report, ARTHRITIS (Arthritis flare up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient had hysterectomy's surgery in April 2021, one week after her birthday and that was recovered, stopped humira for 3 weeks prior to and after surgery. She took Moderna injection and 3 days after shot her arthritis had serious flareup. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. 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 40-year-old female patient with relevant medical history of arthritis, who experienced the unexpected, non-serious  adverse event of special interest Arthritis (reported as Arthritis flare up) 3  days after receiving the first dose of mRNA-1273 vaccine.  Outcome of the event was reported as unknown. No information on any other doses of COVID-19 vaccination was provided. The relevant medical history of arthritis remains a confounder as arthritis is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 40-year-old female patient with relevant medical history of arthritis, who experienced the unexpected, non-serious  adverse event of special interest Arthritis (reported as Arthritis flare up) 3  days after receiving the first dose of mRNA-1273 vaccine.  Outcome of the event was reported as unknown. No information on any other doses of COVID-19 vaccination was provided. The relevant medical history of arthritis remains a confounder as arthritis is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
No wheal formed with 1st attempt so 2nd dose given; wheal formed on 2nd attempt
This case was reported by a nurse and described the occurrence of chest pain in a 48 year old male who received hepatitis B vaccine recombinant for prophylaxis. Concurrent medications included Erythropoietin and Simplet. The indications for these concurrent medications were not provided. On 9/14/05, at 3:30 PM, the subject received the first dose of Engerix B (lot AHVBVB077BA). At an unspecified period of time following the first dose of Engerix B, on 9/14/05, the subject experienced chest pain, back pain and nausea. The subject was hospitalized. The immunization series with Engerix B was discontinued. The outcome of the events was not provided. The nurse considered the events to possibly be related to vaccination with Engerix B. Information received on 9/16/05 indicated that the patient's history was significant for Type 1 Diabetes, hypertension, chronic hepatitis C infection, and chronic renal failure secondary to diabetic nephropathy. He underwent a cardiac stress test three or four months ago that reportedly did not reveal significant ischemia or arrhythmia's. On the day of the events, the patient began hemodialysis at 12 noon. He received recombinant human erythropoietin 10,000 units, Venofer, 100mg, IV and Zemplar 2.5mcg IV. Engerix B 40mcg was administered at 3:30 PM. Ten minutes later, the subject complained of nausea and chest pain; his vital signs were stable. An additional 15 minutes later (25 minutes after injection), the chest pain worsened and back pain was reported. Dialysis was terminated and the subject was transported to a local Emergency Department. He was subsequently admitted to the hospital. Information regarding his in-hospital course are not available. The patient was discharged the following day.
Diagnosis of Type 1 Diabetes, onset of symptoms of Type 1 Diabetes began 1 year after vaccination. Diagnosis of Type 1 Diabetes was on 1/20/2015 with a A1C of 12.1, which means I had Type 1 Diabetes undiagnosed for 3 months if not longer.
12/28/ 2021 fever, body aches and body pain and fever , running nose and congestion. 12/30/2021Cough presented and continued with the running nose and fever. 12/30/2021 Went to get tested for COVID  and was diagnosed.    Fever presented after 02:00 PM daily.  Voice is still changed, slight cough and some congestion.