chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A 35-year-old (non pregnant) female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the vaccination age of 35, via an unspecified route of route of administration, in left arm, on Feb 23, 2021, at 18:30, single dose, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history not reported. Concomitant medications included Xanax (alprazolam) for an unspecified indication (start and stop date not reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. On Feb 23, 2021, at 19:00, patient felt lightheaded and dizzy. On Feb 23, 2021 (post vaccination), patient had a COVID-19 nasal swab test (results pending). The patient did not receive any treatment for the events. The outcome of the events: recovering. Information about batch/lot number cannot be obtained. Follow-up attempts completed. No further information expected.
p/vax pt devel laryngitis w/no other symptoms; laryngitis has persisted & has appointment for a ENT consultation
Screaming episode p/recvd DTP inject, temp 101 R, local reaction; called MD; pt is not to recvd Pertussis again;
She has nose bleed 15 mins after the vaccine, while she was leaving the vaccine clinic. It stopped after a few minutes as she went back to do more observation. Her blood pressure (BP) was measured high at the time. then from March 5-22 she had 5 nose bleeds, some can be stopped after a few minutes, some took a long time (one time it took 30 mins or more, and bled maybe 120ml and lastly on March 22 at 4am, the nose bleed can't be stopped, we called the ambulance). She's been self monitoring her BP at home since March 5, they were all normal, and just once a bit lower than usual. Besides the nose bleed, she also has been experiencing more mild headaches and fatigues. All of the 3 symptoms are rare for her, especially nose bleed. We already tried to use humidifier, be gentle when blowing nose, not eating spicy food.
Woke up next morning after shots & pts (L) arm is swollen from elbow to shoulder, has a red tent and keeps a fever.
Arm is swollen, hot, red, sore; Arm is swollen, hot, red, sore; Headache; Arm is swollen, hot, red, sore; Arm is swollen, hot, red, sore; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE SWELLING, VACCINATION SITE ERYTHEMA, HEADACHE, VACCINATION SITE WARMTH, and PAIN IN EXTREMITY in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE SWELLING, VACCINATION SITE ERYTHEMA, HEADACHE, VACCINATION SITE WARMTH, and PAIN IN EXTREMITY. At the time of the report, VACCINATION SITE SWELLING , VACCINATION SITE ERYTHEMA, HEADACHE, VACCINATION SITE WARMTH, and PAIN IN EXTREMITY outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Elevated temp. 102, flushed cheeks on 11/7/09 went to ER. Treated with TYELENOL and cough syrup. Temp. remained elevated on 11/7/09. On 11/8/09 temp. decreased to 99.2 with TYLENOL and MOTRIN. F/u with Dr. on 11/9/09 temp at 99, TAMIFLU given.
Information has been received from a registered nurse concerning a female pt who on 10/16/02 was vaccinated with pneumococcal vaccine 23 polyvalent (643783/0709M). On approximately 10/16/02 she developed pain, redness and a "swollen circumference around her arm." It was noted the registered nurse described it as an "extreme reaction." Unspecified medical attention was sought. The reporter expressed concern and is requesting a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Pfizer Covid shot - I had itching all over later in the evening after my shot.  I had a huge, sore lump in my arm at the shot site for a full 8 days after shot.
administration of ACTHIB that was reconstituted with a normal sterile diluent, not the ACTHIB diluent with no reported adverse event; Initial information received on 10-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 1 years old female patient who was administrated HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted with a normal sterile diluent, not the acthib diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR); and pneumococcal vaccine conj (Pneumococcal Conjugate Vaccine) [PCV-13] for Prophylactic vaccination.  On 06-Jul-2023, the patient received 0.5 mL dose 4 of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (Batch number: UJ756AAA; Expiry date: 12-Aug-2023) via intramuscular route in the left thigh for Immunization, reconstituted with a normal sterile diluent, not the acthib diluent with no reported adverse event (product preparation error) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administration of acthib that was reconstituted with a normal sterile diluent, not the acthib diluent with no reported 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 the guidelines. 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.
Patient with 2 syncope episodes 5 min after flu shot. Patient was transferred to ER by paramedics in stable condition for further evaluation and care.
Ringing in my ears started that night. Fever, aching, headache lasted the entire day after. After 2 days,.ringing in my ears has not yet gone away.
About 5 minutes after H1N1 injection, heart began beating rapidly and I felt as if I were going to pass out. I sat down and put my head on a table-reaction cleared in about 10 mins. (No prior problems with any vaccines, blood test, etc.).
indigestion; Can't eat; lost her appetite; Lower legs felt like burning,burning feels like fire; Stomach feels swollen like its already full; Nauseous; low grade fever; Injection site swollen; Injection site warm to the touch; Pink and kinda red; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (indigestion), FEEDING DISORDER (Can't eat), DECREASED APPETITE (lost her appetite), BURNING SENSATION (Lower legs felt like burning,burning feels like fire) and ABDOMINAL DISTENSION (Stomach feels swollen like its already full) in a 79-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 was provided by the reporter.  Concomitant products included WARFARIN, ROSUVASTATIN and AMLODIPINE for an unknown indication.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced ERYTHEMA (Pink and kinda red), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE WARMTH (Injection site warm to the touch). On 25-Apr-2021, the patient experienced DYSPEPSIA (indigestion), FEEDING DISORDER (Can't eat), DECREASED APPETITE (lost her appetite), BURNING SENSATION (Lower legs felt like burning,burning feels like fire), ABDOMINAL DISTENSION (Stomach feels swollen like its already full), NAUSEA (Nauseous) and PYREXIA (low grade fever). The patient was treated with PREGABALIN (LYRICA) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPEPSIA (indigestion), FEEDING DISORDER (Can't eat), DECREASED APPETITE (lost her appetite), BURNING SENSATION (Lower legs felt like burning,burning feels like fire), ABDOMINAL DISTENSION (Stomach feels swollen like its already full), ERYTHEMA (Pink and kinda red), NAUSEA (Nauseous), VACCINATION SITE SWELLING (Injection site swollen), VACCINATION SITE WARMTH (Injection site warm to the touch) and PYREXIA (low grade fever) outcome was unknown.            No concomitant medications were provided. No treatment information was provided.  Action taken with mRNA-1273 was not applicable
Client was apprehensive, c/o intense itching and difficulty breathing.  Epi Pen administered and EMS called.  Client was transported to Twin County Regional Hospital for evaluation. Follow up phone call 3/30:  client feels okay, was given  02 and Benedryl in ER and discharged home with a prescription for Benedryl.
Wicked lower back pain for two days. Moderated to a 10 in two more days. Still some twinges to this date. Never had such reaction to flu, shingles, pneumonia, vax.
The employee was hospitalized on 1/25/21 and is currently being treated for multiple reasons including IVIG therapy for Guillian Barre.
GBS about 6 wks after flu shot given; required plasma exchange x4; intubation; rehabilitation;
Employee developed muscle aches and pains, fever, extreme fatigue, called off work 4 days.  Continues to have moderate-severe leg pain as of 1/20/21.  Tylenol brings pain from moderate to mild.
Headache, nausea, and body aches. Could not move and had to go to sleep until the next day. Still until 11/10 I get headaches mid day that are unbearable and have to take ibuprofen.
Fever, started @ 2:30 a.m. - 1/15/00 ended at 5:00 pm 1/15/00.
Aches all over body; headache; 101 to 102 fever; stomach ache, constipation nausea
Began with itching, swelling of L arm.  By 8:00 am arm red and swollen and PAINFUL to touch from shoulder to elbow.  Next day swollen to almost wrist. Urgent care gave shot, took antihistamine and high dose NSAD for 4 days.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial and follow-up information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267227; 2019SA267226; 2019SA267229; 2019SA267228; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves a female patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left arm on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other concomitant vaccine was given.  It was a case of actual medication error due to incorrect product storage.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Documents held by sender: none.
I had been in menopause with no menstrual cycle in exactly 358 days (and only 2 cycles in the 6 months prior to that).  After receiving my second dose of the Moderna vaccine on April 13, 2021, my period returned on May 27, 2021.  I then had cycles for the following 5 months (May, June, July, August and September 2021).  I received my booster on December 9, 2021 and am waiting to see if my cycles return again.  As of January 11, 2022 they have not YET returned.  I also had a fever 24 hours after receiving the 2nd dose on April 13, 2021 and the booster on December 9, 2021 which reached 102 degrees and lasted for 12-18 hours.
Itching started the evening of Day 0 or early morning Day 1 after injection. A couple of bumps popped up and I thought they might be mosquito bites. Itching grew progressively worse on D1 and I was up most of the night. Morning of Day 2 I checked my skin in the mirror and there were hives on my hear, face, neck, torso, arms, and legs. Hives continue to pop up as D2 progresses. Took Benedryl 25mg with little to no relief. Took Prednisone 40 mg 2-3 hours after Benedryl and took 50mg of Benedryl 4 hours after initial does. At the time of writing this report it's been 2ish hours since taking the Prednisone and 30-45 minutes since taking Benedryl 50mg. I am having some relief from the itching.
p/vax pt exp a swollen lt arm from shoulder to just above elbow, a hot 4 inch red circle @ the inj site, & a recurrence of fatigue;pt took own antihistamines;lymerix discontinued;outcome not provided;
Severe arthritic pain in full body. Notably in left calf. Negative ultrasound for blood clot in leg.  Intermediate burning sensation is limbs.  Prednisone issued by Rheumatologist for 6 days beginning 4/27/21.
Fever 105.5 at night same day vaccine given. Limping right leg. Maculopapular blanching erythematous confluent rash, lesions round from 1mm-3mm.  Dx: mixed bacterial vaccination reaction.
Diarrohoea; Injection site rash; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of diarrhea in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included Proquad (batch number X018581, expiry date 01-MAY-2025) for prophylaxis.   On 27-OCT-2023, the patient received Kinrix and Proquad. On 27-OCT-2023, less than a day after receiving Kinrix, the patient experienced diarrhea (Verbatim: Diarrohoea) and injection site rash (Verbatim: Injection site rash). On 30-OCT-2023, the outcome of the diarrhea and injection site rash were resolved (duration 3 days).   It was unknown if the reporter considered the diarrhea and injection site rash to be related to Kinrix.     It was unknown if the company considered the diarrhea and injection site rash to be related to Kinrix.   Additional Information: GSK receipt date: 08-NOV-2023 Employee called on behalf of HCP to report potential adverse event. Reporter stated patient was administered with Proquad and Kinrix, then experienced diarrhea and a rash on injection site later that day (on the day of vaccination). Reporter stated patient experienced symptoms for 3 days. Patient went to HCP for follow up. HCP stated diarrhea may be caused by separate virus that was not known at the time and may not have been from Proquad. It was unknown if the reporter considered the injection site rash to be related to Proquad. The reporter consented to follow up.
The patient has reported night sweats, difficulty sleeping, and severe fatigue for the past 3 weeks.  Also, the patient reported numbness and tingling in the upper extremities.
Acute respiratory disease due to COVID-19 virus. He received remdesivir, dexamethasone and oxygen here.  He improved quickly.  On day of discharge he was not needing oxygen and felt well. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Information has been received from a medical technologist concerning a patient who on 05/02/2000 was vaccinated with one dose of varicella virus vaccine live. On 05/16/2000 the patient developed "watery blisters on his head and body and was aching". The patient sought unspecified medical attention. Additional information has been requested.
Arm swollen; Arm redness; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and 2 days after the vaccination experienced her left arm was swollen and red for a week.  The reporter stated that the redness and swelling occurred below the injection site closer to the elbow. The reporter was also inquiring how common this reaction was, why did it happen, and should she wait longer than two months to receive the second dose. No additional details were provided. Provided medical advice disclaimer. Spoke from PI (package insert) and content. The patient declined permission to contact her HCP (health care professional). The reporter did not consent to follow-up.
Pt developed abscess in (R) thigh after PROQUAD vaccine. Red area - nickel size appeared 10 days after vaccine. Pt placed on SEPTRA 200/40 mg /5 mL x 10 days. Had I and D at ER on 11-30-2013.
Red around the area itchy, raised area from the base and warm to touch, she had Td 10 years ago but no reaction.
Joint pain entire body, fever/chills, headache/migraine, nausea/vomiting, ear ringing
Patient was scheduled to receive the second dose in the covid-19 pfizer series.  Patient was given the pfizer bivalent instead of the second dose.
Employee states that adverse events started on the second day after vaccine( Feb. 9th) and they continue to persist as of today. She has following symptoms: Hives on the left arm (injection site), face is swollen, upper lip is swollen, mouth is really itchy, chills, sweats.
1820 on 9/4 N/V x1 advised of worse or not better to seek medical attention. 0914 on 9/5 injection site red/swollen 2cm, Abd pain, N and fever. Patient evaluated by Dr., discharged - possible allergic Rx to shot.
The staff inadvertently gave a dose of Moderna Covid 19 Bivalent to a patient from a vial that had been punctured the previous day. It had been 28 hours since the vial was punctured; Moderna Covid 19 Bivalent vaccine administred to a patient 28 hours post puncture; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The staff inadvertently gave a dose of Moderna Covid 19 Bivalent to a patient from a vial that had been punctured the previous day. It had been 28 hours since the vial was punctured), POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine administred to a patient 28 hours post puncture) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The staff inadvertently gave a dose of Moderna Covid 19 Bivalent to a patient from a vial that had been punctured the previous day. It had been 28 hours since the vial was punctured), POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine administred to a patient 28 hours post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The staff inadvertently gave a dose of Moderna Covid 19 Bivalent to a patient from a vial that had been punctured the previous day. It had been 28 hours since the vial was punctured), POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine administred to a patient 28 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The staff inadvertently gave a dose of Moderna Covid 19 Bivalent to a patient from a vial that had been punctured the previous day. It had been 28 hours since the vial was punctured) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine administred to a patient 28 hours post puncture).    No concomitant medication was reported.  No treatment information was reported.
Had headaches for 3 weeks after receiving second Covid Vaccine Dose.Went to Neurologist who cares for my Migraines.He informed me that other migraine suffers had a similar reaction to Covid Vaccines. At that point the daily headaches subsided.
On 12/25 woke up with chills,   body aches ,no appetite, mild nausea & extremely tired. Low grade fever 99.2. Only had orange juice to keep my blood sugar up. I have Type 1 Diabetes. Felt this way all day until I went to bed. Woke up today 12/26 feeling fine
Spotting two days before menese after second vaccine also had breast sensitivity. Pt is on OCP  typically has regular predictable menses so therefore these symptoms are abnormal for her.
pt recv vax 29OCT95 & devel muscle weakness,fatigue & gen itching;pt has not yet recovered as of reporting date
Patient had 2nd dose of COVID-19 vaccine on 1/10/2021.    On 4/27/2021 developed nasal congestion.  Positive for COVID.
This case was reported by a other health professional and described the occurrence of incorrect storage in a patient who received KINRIX. On an unknown date, the patient received KINRIX at an unknown dose. On an unknown date, an unknown time after receiving KINRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage was unknown. Additional information: CMA from clinic calling about 4 vaccines (This report is for KINRIX) that had a below temp excursion to 31 deg F last July of 2014 for KINRIX, HAVRIX, ENGERIX-B and RTX less 4 hours. Since then they have administered these vaccines to possibly multiple unknown patients of all ages. They do not have the lot numbers, expiration dates, or patient details at this time.
I had congestion, a cough and extreme fatigue. My coworker was COVID 19 positive, so I tested myself on Sunday June 26th and was positive. I took SUDAFED, MUCINEX and NYQUIL to treat my symptoms. My doctor prescribed PAXLOVID on that Monday. My symptoms did improve but I don't recall the time frame. I have since completely recovered with no residual effects.
Was just over 6 weeks pregnant at time of vaccination. Pregnancy confirmed via two home tests. Estimated delivery date was August 31, 2022. About 38 hours after receiving the vaccine booster, I began a spontaneous miscarriage. My physical reactions to the booster prior to miscarriage were mild and mirrored my reactions to the first two doses. I was fatigued and needed to rest several times during the day and limited my activity and productivity greatly. There may or may not be a correlation to the booster, but I wanted to report the event for future data and studies.