chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt said day after couldn't get out of bed, couldn't breathe, got ambulance went to hospital.
Day 5 after first injection my injection shit is red, swollen, hot and extremely sore and itchy.     These symptoms are now on day 4
Pt given vaccines at 11:15 and 5 minutes later, pt broke out with hives on both feet. Treated with 1 tsp Benadryl at 11:30.
rash around the shoulder area spread a little ways down towards belly and down the back; lot number FP7135; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 2-year-old female patient received BNT162b2 (BNT162B2), on 06Jul2022 at 14:30 as dose 1, single (Lot number: FP7135) at the age of 2 years, in left leg for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 06Jul2022 at 13:30, outcome "unknown", described as "lot number FP7135"; RASH (non-serious) with onset 06Jul2022 at 13:45, outcome "recovering", described as "rash around the shoulder area spread a little ways down towards belly and down the back". The events "rash around the shoulder area spread a little ways down towards belly and down the back" required emergency room visit. Therapeutic measures were taken as a result of rash.  Additional information: No other vaccine received in four weeks and no other medications in two weeks. Patient was not received covid prior vaccination and not tested covid post vaccination. It was reported that patient had a rash that wasn't a severe reaction couple of mins after the shot. Was around the shoulder area and under the neck both front and back and rash spread a little ways down towards belly and down the back. AE resulted in Emergency room/department or urgent care. Doctor checked and gave Benadryl.  No follow-up attempts are possible. No further information is expected.
Administration error: Patient received the wrong vaccine. She had registered for a Johnson & Johnson vaccine and wanted to receive this one, but was inadvertently injected with a Pfizer vaccine. The patient was observed for 30 minutes following her vaccine and then informed of the error 1 hour after her appointment time when the error was discovered. She did not appear to have any adverse effects of the Pfizer vaccine and did not have any contraindications to the vaccine.
The patient reported normal pain the day after her 2nd dose on 4/29, the same kind of pain as from her first dose. The pain continued then went away. Pain symptoms returned severely on 5/7 at 2:00pm. She reported severe left upper shoulder pain, back pain and chest pain. She began taking three (3) tablets of Ibuprofen 200mg over-the-counter for pain every 6 hours. Upon speaking to the patient on 5/13 at 11:00am, the pain is still present with slight improvement. She continues taking Ibuprofen scheduled every 6 hours for the current pain.  The patient stated she had COVID in early January and was hospitalized for 2 days because her oxygen was low and she received medications which were continued at home.
Redness and induration and pain; x 2 weeks; treated w/ BENADRYL and ibuprofen.
Delayed/missed menstrual cycle. Menstrual cycle was 24 days late.
Pain in and around right eye, worsens over time, almost blind by02/09/14.  Patient went to ER. Diagnosed with optic neuritis. Was given infusion of Solumedrol  for 3 days, then started on prednisone and tapered over 2 weeks.  03/10/14 optic neuritis in left eye. Repeat therapy with prednisone taper over 4 weeks. 04/08/14 symptoms reappear in left eye.  Solumedrol given for 5 days, then prednisone taper.  Blood test and spinal tap indicate Neuromyelitis Optica. Diagnosed 04/23/14.  Since then, repeated bouts of optic neuritis and treatment with Rituximab, Cell Cept and prednisone.
emailed with the following complaint: "Great shot no problems maybe a little stomach upset. About 28 hrs post shot dev extreme upper respiratory response. Sneezing bad headache fatigue not too much joint pain but real allergic reaction. Over in a day and used sinus tabs that helped as well as opening some windows a little   Then next day very sore arm. But now better with nsaids. I am 73. Didn?t expect this reaction. Will it be worse with second shot on Jan 30?"  Have attempted to contact her numerous times but unable to speak with her. She did leave a message that she completed the Covid vaccine series, subsequently had a Shingrix injection which was "much worse" and the issues are now resolved; did not get medical follow up.
Severe, explosive diarrhea for four days; weight loss of over one pound a day and ultimately 5 pounds lost; severe nausea for four days. Fatigue and arm pain for one day.
pt says the next day after getting the vax she was completely fatigued.  She had to lay flat on her back from 3/26/21 to 4/3/2021.  She had a sore in her mouth She had her second chemo infusion on 4/7/21 and started her chemo pills again. On 4/9/21 she was completely fatigued. She feels like she had just taken the vax again.  She has a strange taste in her mouth, like a coating in her mouth.  She has nausea, loss of appetite, very weak and has SOB.  she had to cancel her appt for her 2nd covid vax dose.  She has another infusion coming up on 4/27/21 so she is really concerned about getting another dose with the side affects she is having.  She is very frail feeling and scared since she did well after taking the chemo infusion until getting the covid vax.  Now she says she feels disabled and cant do anything anymore.  She called her oncologist clinic coordinator to let them know her symptoms.
Patient was given GARDASIL #3 and Hep A #2 no hx reactions in past. She felt faint,, diaphoresis, dizzy, nausea, pulse was slow 50 bpm. Increased resp. rate given water, cool compresses, oxygen.
swelling under her left arm/swelling progressed to include the area under her left ear down to the collarbone/swelling of the left side of neck; Fever; swelling around the area of injection (left arm); Redness around the area of injection (left arm); Swelling hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Swelling hurts), SWELLING (swelling under her left arm/swelling progressed to include the area under her left ear down to the collarbone/swelling of the left side of neck), PYREXIA (Fever), VACCINATION SITE SWELLING (swelling around the area of injection (left arm)) and VACCINATION SITE ERYTHEMA (Redness around the area of injection (left arm)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose, lot number - 8735) on 31-Mar-2021, Pfizer (2nd dose and lot number - 8731) on 23-Apr-2021. Past adverse reactions to the above products included Fever with Pfizer and Pfizer.    On 24-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced PAIN (Swelling hurts), VACCINATION SITE SWELLING (swelling around the area of injection (left arm)) and VACCINATION SITE ERYTHEMA (Redness around the area of injection (left arm)). On 24-Apr-2022, the patient experienced PYREXIA (Fever). On 26-Apr-2022, the patient experienced SWELLING (swelling under her left arm/swelling progressed to include the area under her left ear down to the collarbone/swelling of the left side of neck). On 26-Apr-2022, PYREXIA (Fever) had resolved. At the time of the report, PAIN (Swelling hurts), SWELLING (swelling under her left arm/swelling progressed to include the area under her left ear down to the collarbone/swelling of the left side of neck), VACCINATION SITE SWELLING (swelling around the area of injection (left arm)) and VACCINATION SITE ERYTHEMA (Redness around the area of injection (left arm)) outcome was unknown.            The patient had no history of allergies to medications, food and other products. Patient denied any COVID-19 diagnosis pre or post vaccination with COVID-19 vaccines. The patient did not have any concomitant medical conditions nor was she taking any medication except for vitamins. Patient received first booster dose on 24-Apr-2022. No treatment medications were reported.
Temperature reported of 105 approximately 12 hours after vaccine. Significant pain in arm - (R) >> (L).
Ten days after vaccination I experienced extremely high blood pressure,  nausea, vomiting, weight loss, body rash. Over the next three months, my internist and then with a referral to a Nephrologist were able to reduce my blood pressure by introducing three new anti hypertensives. I was then started on Celcept and Prednisone which I am currently taking.
Began with fever, then noted diarrhea, dyspepsia. Symptoms onset after vaccine and persisted today. Seen and labs sent for evaluation.
Patient died 2 weeks following the 2nd dose of Moderna vaccine, Pt died of upper G.I bleed and multi system organ failure in ER at Hospital on feb 19. .   Ist day following vaccine, pt experienced fever of 101, shaking chills, feeling like the "flu". Over the next several days, pt c/o lethargy, "No energy", GI distress, esophageal and stomach " burning".  He had decreased appetite, and took tums daily. He complained that his 60yr old smallpox and polio site in arm was "itching."  He had an outbreak of a cold sore on mouth.  ( not experience for over 15 years).    Pt on Feb 19 was not feeling well, felt dizzy, became cold, clammy before calling ambulance. He was not able to walk to bathroom, he fell and had dark colored stools when medics arrived.  He was awake and oriented.
The pt experienced generalized urticaria eruption approximately 6 hours post vax. The rash resolved over the next 12 hours. No fever, dyspnea or joint swelling. Benadryl was given by mouth for relief of pruritus.
Ischemic stroke on 11/13/2016 at 4 AM resulting in right hemiparesis (dominant side). Now can only walk with a cane for limited distance, balance problems, swallowing/speaking problems. No longer employed, had to give up most all normal activities (tennis, ballroom dancing, etc.).
Patients guardian falsified DOB when registering for vaccination, stating the minor's DOB. Guardian, consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB.  Which made the vaccine a contraindication.  No known adverse reactions noted.
Right upper extremity swelling, itching, redness and warm/hot to touch after injection. Patient was seen at acute care and treated with antibiotic.
This spontaneous report was received from a Certified Medical Assistant (C.M.A) referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of PROQUAD (Merck) rHA (strength, dose and route of administration were not provided) (lot # L030592 expiry date 12-FEB-2017, L034931 expiry date 03-MAR-2017, L041628 expiry date 20-APR-2017 and reported lot number L044058 expiry date 02-MAY-2017). The Certified Medical Assistant (C.M.A) stated that PROQUAD (Merck) was exposed to the following temperature conditions: -14 degree C for 93 hours. There was not a previous temperature excursion. No adverse event was reported and no product quality issue was involved. Additional information has been requested. This is one of several reports received from the same reporter.
cold like allergy; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration on 03May2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated on an unspecified date she had a cold like allergy as she also mentioned too but she objected that it was a reaction from the first dose of the vaccine. Reporter called to reschedule her second dose schedule for the covid-19 vaccine which was supposed to be on 23May2021 at 4:10 and would like to go on the next day on 24May2021 since they had a walk-in process and because the distance was far, and she would like to have a doctor's appointment on 24May2021. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
The patient received the H1N1 flu vaccine on 11/09/09. On 11/112/09 the patient had severe pain in both legs. The patient experience numbness in legs that would not allow her to walk. The patient was taken to the emergency room where she was monitored and 3 hours later the patient recovered.
On 4/2/08 pt came back to health center to have her arm checked.  There was a 2 inch red raised wheal on arm at site of YF vaccine given 3-28-08.  She states bump started on 4-1-08 around noon & was very itchy.  On 4-2-08 she states the bump is the same size as 4-1-08 & less itchy.  Denies itchiness elsewhere on body, difficulty breathing, swollen throat or other allergy sx.
pt reported dizziness and nausea after 15 mins at 12:20pm getting his 2nd dose of pfizer covid vaccine. Pt had similar episode of nausea/dizziness when getting his 1st shot 3 weeks ago. Pt was instructed to lay down and drink some Gatorade. Pharmacist on duty started measuring his BP every 5 mins with reading as below 99/60, HR:63  (12;20pm), 100/63, HR 59 (12:25pm), 101/62 Hr 71(12:30am). Pt 's nausea and dizziness was gone after 10 mins laying down at 12:20pm. Pt recovered completely without other complication and left the pharmacy at 12:40pm
Case number PHEH2011US01835 is an initial consumer report received on 17 Aug 2011. This report refers to 2 patients who were vaccinated with only Men CYW-135 liquid conjugate of MENVEO (batch number: unknown) intramuscularly, without reconstituting with Men A lyophilized powder component.
Flushing/sweating, shortness of breath. BP 150/83 (pulse 89), 99% O2 sat.
nurse was administering a Fluzone Quadrivalent to a 30 months old boy, he grabbed vaccine during administration and threw it across the room, approximately half of it may have been received/No AE; Initial information received on 09-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 30 months old male patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number UJ430AB, expiration date: 30-Jun-2021) via intramuscular route in the left thigh as prophylactic vaccination on 09-Sep-2020.  It was reported that while administering a Fluzone Quadrivalent to a two and a half year-old boy, he grabbed the vaccine during administration and threw it across the room and the nurse was not sure about how much of the vaccine was administered, approximately half of it may have been received (PT: underdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any concomitant medication.   It was a case of vaccine underdose (same day latency).  No adverse event reported at the time of reporting.  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.
Patient states extreme pain in arm, warmth and swelling stated the night she received the vaccination. Her whole arm and into her neck were extremely painful. Patient states the Advil helped.
HAD A SLIGHT FEVER OF 99.0 AND WAS RESOLVED ON THE SAME DAY
24 hours post vax, the pt was plagued by extreme achiness, headache, very upset stomach, no fever for a duration of 48 hours.
Pt had fever evening 20NOV91 devel rash, fretful, crying given APAP w/no fever reduction; Pt taken to MD 21NOV91 w/ t103-104, rash, high-pitched cry; was told by MD that this was a reaction "to the "P" in DTP" & that pt would get over it;
Dose 1: rash at injection and sore throat day 5. Narrative: Dose 1: rash at injection site and sore throat day 5.   Other Relevant History:
I got sick; chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I got sick), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 013L20A and 058H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced ILLNESS (I got sick), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. In February 2021, ILLNESS (I got sick), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) had resolved.            Concomitant given as Compound hormone therapy in a capsule form , Medication to control bladder leakage.   This case was linked to MOD-2021-404993 (Patient Link).
Was at work on September 30, 2021, and felt dizzy and fatigued.  Medical staff at work took blood pressure and read 151/121 and 146/119.  Immediately went to Urgent Care, blood pressure went down however started feeling the onsets body aches all over and extreme fatigue.  Went home and bed rest.  Symptoms worsened to October 1, 2021, with headache, body ache, fatigue, and cold sweat chills.  No arm pain from injection site.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid as treatment of COVID-19. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
headache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 29-year-old female patient (Non pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 16Mar2021 12:30 (Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included migraine headaches. The patient did not have COVID prior vaccination. No Known allergies. No COVID tested post vaccination. Concomitant medications included propranolol and rimegepant (NURTEC ODT) for migraine. No other vaccine received in four weeks. The consumer reported that headache was not an adverse event of the 1st dose of vaccine. She had woken up the morning of 05Apr with a headache. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Event headache is likely an intercurrent condition and unrelated to BNT162B2.
Four hours following the vaccination the patient developed Numbness; Tingling of the back of her neck with extension to the back of her head; Headache; Dizziness; Fatigue; Arm pain; Rash at the injection site; Blurry vision for one day.  All symptoms except the rash and the blurry vision were still present after one week when seen in the Medical Centers ER.
This case was reported by a physician and described the occurrence of anaphylactic reaction in a female subject of unspecified age (a child) who was vaccinated with DTaP, manufacturer unspecified for prophylaxis. On an unspecified date the subject received unspecified dose of DTaP (unknown). At an unspecified time after vaccination with DTaP, the subject experienced an anaphylactic reaction. This event was considered to be medically serious by GSK. At the time of reporting the event was reported as resolved.
Pt came in on 02/20/2002 for questionable ear infection. Pt was given DTaP, IPV, Hib. Pt tolerated these fine up until 02/21/2002 she developed temp of 104 deg. F. She had a seizure. She was evaluated at the office on 02/22/2002.
Patient hospitalized on 1/28/21 for fetal tachycardia. She was also admitted to the hospital on 2/12/21 for induction of labor. Estimated date of delivery was 2/13/21. Patient had cesarean section on 2/12/21. Birth weight was not available.
Round 5:30 P.m.  I started becoming nauseas, I had a terrible headache , OTC Ibuprofen did not help, nasal congestion ,, Only slept 2 Hours Wednesday night.. the next day 7am  stayed in bed all day , headaches, congestion was worse. Could not sleep. Feeling better today but I am super tired     10/02/2020 Was tested for COVID-19 . The test was confirmed positive the next day.
Muscle pain in extremities, headache, chills, sweats,fatigue, loss of appetite within 8 hours of injection. Overall malaise for following 3 days
pregnant; A spontaneous report was received from a Consumer concerning a female pregnant patient who received Moderna's COVID-19 vaccine (mRNA-1273) and want to be registered for pregnancy registry of Moderna.  The patient's medical history was not provided.  No relevant concomitant medications were reported.     On 25 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 25 Jan 2021 date, The patient liked to get register for pregnancy registry of Moderna.  No Laboratory details was provided.   No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event is Reported
Started off slowly with tenderness at injection site, progressed to severe pain when arm was placed in certian positions, especially behind center line of body. Pain raising left arm, putting it behind the back, trouble relaxing arm especially at night. Two months later I wasn't using left arm for normal tasks like taking off or putting on clothes.
Headache, Myalgia, NauseaVomiting,  Fatigue, Chills Narrative:
Presented to ED via EMS c/o fever and chills; COVID-19+ finding but asymptomatic
She reported having chills and fever. When she arrived to clinic she had no fever. Area was swollen, red, and warm to touch. Cold pack placed on arm and was given off 3 days off work.
6 month old male received PENTACEL, PREVNAR and ROTA (had received and done well with same vaccines at 2 and 4 months of age) child with eczema and allergy to egg, milk, peanut. Child went home and within hour after vaccines started with cough, wheezing, increased work of breathing.