chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Could barely get out of bed; Minor sore arm; Was wiped out; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Could barely get out of bed), PAIN IN EXTREMITY (Minor sore arm) and FATIGUE (Was wiped out) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A, 029L20A and 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced ASTHENIA (Could barely get out of bed), PAIN IN EXTREMITY (Minor sore arm) and FATIGUE (Was wiped out). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 03-Sep-2021, ASTHENIA (Could barely get out of bed), PAIN IN EXTREMITY (Minor sore arm) and FATIGUE (Was wiped out) had resolved.            No concomitant medications were given by the reporter.   This case was linked to MOD-2021-308020, MOD-2021-307981 (Patient Link).
Inconsolable crying for 3 days after 2 month vaccinations (Pentacel, Prevnar, Hepatitis B #1 and Rotavirus). Also less interactive per parents.
Adverse reaction is to the Prizer booster number 301558A given on 10/02/2021 I had no reaction to the first two shots, only the booster
1/10/21 - Feeling of "pulling a muscle" in armpit in left upper extremity that limited movement. (around 8:00 am). New onset of hives, erythema, warmth, edema, pain, and itching experienced at injection site in left upper extremity (6:34 pm). Call was placed to NP, the provider on call at 6:46 pm. Under advisement of provider, application of hydrocortisone cream at injection site and X2 PO 25 mg benadryl self-administered (around 7:00 pm). Sensation of throat closing and hoarseness/change in voice surfaced (around 7:45 pm).  Presented to ED, with complaints as listed (around 8:15 pm). Condition/symptoms treated at ED with 60 mg prednisone and pepcid (8:31 pm) followed by direct observation until 10:08 pm.  Prescription for prednisone 20 mg X3/day for 5 days written by MD. 1/11/21 - Arm continued to appear slightly swollen with erythema and warmth at the site. Treatment included observation throughout the day. 1/12/21 - Follow-up appointment attended with provider at 2:10 pm. Told by provider that prednisone would only be necessary in  the case of resurfacing symptoms of a hypersensitivity reaction.  At this time the cause of said symptoms is undetermined. Tingling sensation experienced in face and direct observation of left-sided facial swelling noticed (5:59 pm).  Call placed to provider on call (6:08 pm) . Provider advised to take X2 25 mg benadryl and to take X3 20 mg prednisone stat. Benadryl taken at 6:15 pm and prednisone taken at 6:30 pm. Tingling sensation minimized by 7:30 pm, but left sided facial swelling remains as of 7:40 pm. Plans to follow-up with PCP later in the week and potential for re-visiting ED  if symptoms worsen or continue throughout the night.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included: asthma flares (everyone in immediate family had asthma). The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient received booster dose of non-company suspect vaccine Pfizer biontech covid-19 vaccine (tozinameran) (Dose number in series 2) (form of admin, route of admin, batch number were not reported and expiry: unknown) dose was not reported, administered on an unspecified date in NOV-2021 for prophylactic vaccination.  Around on 20-APR-2022, the patient experienced covid-19 (suspected covid-19 infection (Dose number in series 2) and suspected clinical vaccination failure (Dose number in series 1). The patient recovered at home and was not treated. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient recovered from suspected covid-19 infection on an unspecified date in 2022, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220542436. This report was associated with product quality complaint.; Sender's Comments: V0: 20220606884 -Covid-19 vaccine ad26.cov2.s -SUSPECTED CLINICAL VACCINATION FAILURE. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
CHILD'S DATE OF BIRTH WRITTEN (WITHOUT DAY) AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS FATHER.  CHILD IDENTIFIED IN SYSTEM AS HAVING DATE OF BIRTH OF A DIFFERENT DATE WHICH MAKES CHILD TOO YOUNG FOR VACCINE IN 8/2021.
Cold; Red bumps; Itching; a rash on her injection site arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red bumps), PRURITUS (Itching), NASOPHARYNGITIS (Cold) and INJECTION SITE RASH (a rash on her injection site arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced ERYTHEMA (Red bumps), PRURITUS (Itching) and NASOPHARYNGITIS (Cold). On an unknown date, the patient experienced INJECTION SITE RASH (a rash on her injection site arm). At the time of the report, ERYTHEMA (Red bumps) and PRURITUS (Itching) had not resolved and NASOPHARYNGITIS (Cold) and INJECTION SITE RASH (a rash on her injection site arm) had resolved.      No concomitant products were reported.  Treatment information provided included Ibuprofen, Benadryl, Calamine Lotion and vasline   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17-May-2021. New event added. Outcome of the event cold (nasopharyngitis) changed from not recovered/not resolved to recovered/resolved.
Localized reaction starting on Day 1 after shots, persisting through day 10. Redness, itching
Janssen COVID-19 Vaccine EUA Per EMT in First Aid area of Vaccine POD Chief Complaint: "I'm having trouble breathing" 11:08 AM B/P 130/88 Pulse 90 Respirations 18 Pulse oximetry 99 % on room air 11:18 AM B/P 128/88 Pulse 86 Respirations 18 Pulse oximetry 99 %  on room air Patient reported difficulty breathing, has history of asthma, seated in chair, upright, no tripoding, no accessory muscle usage, denies chest pain, appearing to breath normally, CAO X 4, patient states history of anxiety, presenting with anxiety symptoms, patient coached on breathing, instructed to listen to her heartbeat on pulse ox, cold pack to back of neck, patient declined EMS, counseled on normal COVID vaccine side effects, counseled on symptoms of anaphylaxis, MD present throughout assessment, patient felt better after assessment and left under own power,
This spontaneous report was received from a pharmacist via company representative regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were unknown. On an unknown date, the patient was vaccinated with M-M-R II injection (dosing details, lot# and expiry date unknown). The patient experienced "stinging" at the injection site during the time that the M-M-R II was being administered. The patient recovered as soon as the M-M-R II was finished being administered. Causality assessment was not provided. There was no Product Quality Complaint (PQC) involved. Additional information is not expected as the reporter denied consent to be contacted for further information.
Tongue, roof of mouth and throat felt prickly and sore (same as when you burn your mouth with hot coffee) that started 40 minutes after shot and lasted for 4 days. Exhaustion, chills, and body aches that began around 8pm on night of vaccine and lasted 2 days. Sore arm that began several hours after shot and lasted 2 days.
Broke out with hives; itching; Rashes, Rash occurred on 11/22/21 and continues to be a huge problem everyday for me; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out with hives), PRURITUS (itching) and RASH (Rashes, Rash occurred on 11/22/21 and continues to be a huge problem everyday for me) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .025 ml. On 22-Nov-2021, the patient experienced RASH (Rashes, Rash occurred on 11/22/21 and continues to be a huge problem everyday for me). On an unknown date, the patient experienced URTICARIA (Broke out with hives) and PRURITUS (itching). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Rash, at an unspecified dose and frequency. At the time of the report, URTICARIA (Broke out with hives) and PRURITUS (itching) outcome was unknown and RASH (Rashes, Rash occurred on 11/22/21 and continues to be a huge problem everyday for me) had not resolved.            No relevant concomitant medications were reported. Treatment information also included steroids to control the rash.
Client had runny nose, low grade temps and had been fussy since 1/22/2010.  Mother had been giving child Tylenol and Motrin for low grade fevers. Client had been fine all day, but became very fussy after dinnertime.  Mother had been giving child a bath when the child became very restless and stood up in the tub suddenly.  The mother took the child out of the bath and laid her on the floor after she began shaking.  Mother stated that she was having a seizure.  She states that her husband provided rescue breaths because the girl had stopped breathing.  Her pulse was faint as well, but the girl began breathing on her own.  Child was transported to ER by ambulance where she was evaluated, treated and released.  Her temperature was over 103 degrees and she was given Tylenol and an antibiotic.  Chest x-ray negative and they were unable to get a urine sample.  Mother noticed that child had a red circle the day before (1/22/2010) where the varicella had been given.  Child has made a full recovery and is working with MD on vaccinations.
My arm is really swollen and red and itching it has started to swell all across my arm nothing I'm taking seems to ease the pain. So not sure if I need to go see my doctor
Cellulitis left thigh. Keflex 250 mg TID for 10 days, warm soaks and Benadryl PO q 4-6 hours.
The patient, 5 minutes after administering the vaccine, told her mother hat he wanted to vomit. In the evaluation area she had two episodes of vomiting, Mom says that it happens frequently to her. She was evaluated and the Doctor was called, who gave instructions to observe for 30 minutes.
I received my first dose on 2/08. I started my period 10 days later. I have been in menopause for a year with only one very short period of bleeding. I did not stop bleeding despite treatment by my OBGYN. I received my second dose on 3/22 and the bleeding became more severe. I again did not stop bleeding despite treatment by my OBGYN. It is 4/12 and I have just stopped bleeding. All bleeding was accompanied by severe uterine cramps.
Bell's Palsy dx - with smile-droop left mouth/sag of left side of face. EOM intact - no other cranial nerve palsy identified.
3/1: About an hour after injection, numb face middle to right side, numbness in feet and right leg increased substantially, teeth aching. Numbness subsided after about 4 hours, settling into a level slightly above normal.  3/6: Felt eye strain, vision not as clear, severe headache in left temple/perioribital area, severe nausea, moderate chills, photsensitivity, sound and smell sensitivity, headache mostly gone by bedtime.  3/7: Woke up with headache and nausea, vision in left eye blurry most of afternoon, thick wavy bands of bluriness, overall blurriness, feeling of congestion/thickness/pressure on eye, jaw pain. Vision cleared after several hours, headache mild, left temple pain when coughing.   (cont.)
diagnosed with shingles; This is a spontaneous report from a contactable consumer. This consumer reported the same event for two patients. This is second of two reports.  A contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at an unknown dose number, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was diagnosed with shingles on an unspecified date. The outcome of the event was unknown.   Follow-up attempts not completed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021361731 same reporter/drug/event, different patient
kidneys are hurting very bad; his whole body is sore; This is a spontaneous report from report from a contactable consumer (patient) via Pfizer-sponsored program. A male patient of an unspecified age received first dose of  BNT162B2 ((PFIZER-BIONTECH COVID-19, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Aug2021, as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Aug2021, the patient reported that his kidneys were hurting very bad and his whole body was sore and he would also like to know if this happened to other people. The outcome of the events were not recovered.   Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.
Bell's palsy was on the right side of face; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes, hypertension, back pain and clubfoot (right club feet'). Concomitant products included lorazepam, diltiazem hydrochloride (Diltiazem), thyroxine sodium (Levothyroxine), lisinopril, glimepiride, metformin and hydrocodone bitartrate + paracetamol (Vicodin).   On 25th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 7th November 2019, 13 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was not recovered/not resolved.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient received Shingrix in his left arm. The patient had Bell's palsy on the right side of his face. The patient planned to continue follow-up with his physician on an unknown date. Emergency room visit was required. The patient consented to follow up.
The day after receiving Tdap vaccine, pt c/o soreness, pain, erythema, edema and arm warm to touch. Seen in clinic 2 days later with same symptoms. Was taking Tylenol with no relief. Referred to MD for evaluation.
Can no longer eat any type of meat. It tastes/smells disgusting.; Can no longer eat any type of meat. It tastes/smells disgusting.; Can no longer eat any type of meat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Lot number: FA7485) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Graves' disease" (unspecified if ongoing), notes: other medical history Hashitoxicosis Graves' disease; "Hashitoxicosis" (unspecified if ongoing), notes: other medical history Hashitoxicosis Graves' disease; "Covid" (unspecified if ongoing), notes: if covid prior vaccination Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=EW0196,, administration time=01:30 PM,, dose number=1,, vaccine location=Right arm), when the patient was 52 years old, for COVID-19 immunization. The following information was reported: PAROSMIA (non-serious), TASTE DISORDER (non-serious) all with onset 13Jul2021, outcome "not recovered" and all described as "Can no longer eat any type of meat. It tastes/smells disgusting."; EATING DISORDER SYMPTOM (non-serious) with onset 13Jul2021, outcome "not recovered", described as "Can no longer eat any type of meat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of parosmia, taste disorder, eating disorder symptom. No follow-up attempts are possible. No further information is expected.
Mom noticed on Saturday that patient had hives on her right thigh which is the leg where she received the vaccination Pediarix.  The hives were still on her leg on Sunday.
I had a bad cough, but I could not cough anything up.  I was really tired. I had no aplite.  I was confused as well.  I had a fever. When I did cough up something it was black and gray. I was SOB. I went the ER.  They did test me for Covid-19, which came back positive. They did a chest X-ray, and CT scan.  I was in the hospital for 8 days and on the ventilator.  Since then, my cough is off, and I have a funny tasted.  I am tired a lot more. And now I have to do a breathing treatment.
She had a sore throat, a runny nose, felt stuffy, tired, achy, headache, muscle aches, fatigue, and pain in arm. She  didn't have a fever. Her headache, fatigue, and muscle aches were moderate. She ended up leaving school early that day because she wasn't feeling well. Her arm stopped hurting on 1/20/2022. She still had a headache, muscle aches, fatigue, and a sore throat. Then she started throwing up mucus drainage. She said she was getting out of breath when walking up the stairs, but she had no tightness in her chest. Sunday she started to feel better. She just had a sore throat, headache, mucus, and runny nose. Friday we took her to get a covid test which came back as negative. She had a mild headache on Sunday. Since we found out that she does not have covid we think its just a cold she caught in coincidental timing of getting the vaccine.
dermatographia that has continued to the present day (about 3 months so far), taking Zyrtec once a day, also acid reflux that just happened to start within 24 hours of the dermatographia  (acute chest pain out of the blue, but has occurred only 8-10 times in the last 3 months, but never occurred prior to the onset of dermatographia), taking Pepcid twice a day for the reflux
32 yo M, no known chronic medical conditions, p/w FLS since getting the J&J vaccine yesterday. Sx are improving, but pt was feeling sick at work so his supervisor told him to come to ED for eval. Only sx pt currently has are severe fatigue, mild frontal HA, and mild nausea.
This spontaneous report as received from a Nurse Practitioner refers to an unknown number of patients were inadvertently vaccinated with GARDASIL, RECOMBIVAX HB, VAQTA and PEDVAXHIB had been improperly stored. No further information was provided. Additional information was received from Nurse practitioner, who reported that GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB went through multiple unsupported temperature excursions from 10/09/2013 to 10/17/2013. The Nurse practitioner reported GARDASIL (Lot# J003727, expiration date 11/07/2015) was administered to 2 unspecified patients on 10/10/13 (MARRS# 1310USA015162), 2 unspecified patients on 10/12/13 (MARRS # 1401USA000269), 1 unspecified patient on 10/14/13 (MARRS# 1410USA000273), 1 unspecified patient on 10/17/13 (MARRS# 1401USA000271) and 1 unspecified patient on 10/19/13 (MARRS# 1401USA000272). GARDASIL (Lot# J008423, expiration date 01/21/2016) was administered to 3 unspecified patients on 10/25/13 and 1 unspecified patient on 10/26/13 (MARRS# 1401USA00027). VAQTA (Lot# J008090, expiration date 08/23/2015) was administered to 1 unspecified patient on 10/17/2013 (MARRS# 1401USA000279) and 1 unspecified patient on 10/25/2013 (MARRS# 1401USA000278). RECOMBIVAX (Lot# H012250, expiration date 02/06/2015) was administered to 1 unspecified patient on 10/26/2013 (MARRS# 1401USA000277). PEDVAXHIB (Lot# J005670, expiration 12/17/2015) was administered to 1 unspecified patient on 10/15/2013 (MARRS# 1401USA000275), 1 unspecified patient on 10/25/2013 (MARRS# 1401USA000276) and 1 unspecified patient on 10/29/2013 (MARRS# 1401USA000280). No adverse effects reported. No further information was provided. Additional information has been requested.
Fever of 104.6F, given OTC Tylenol every 12 hrs.  Temp WNL on Monday, but is screaming and mumpling in sleep. Had seasonal vaccine approx 2 weeks prior.  Takes Zyrtec for allergies.
Narrative:  78 y.o. male Patient who received dose #1 of Moderna COVID vaccine (Lot #012L20A, exp 7/6/21) on 1/12/21 and dose #2 of Moderna COVID vaccine (Lot #013M20A, exp 7/31/21) on 2/9/21. Patient had a PMH of ESRD and had been on dialysis for the previous year. Patient elected to stop dialysis on 4/14/21 and was followed by hospice team. The Patient passed on 4/25/21. Reaction classified as severe as death occurred following vaccination.
Diagnosed with Shingles on April 18.  The rash first appeared on April  16. Not sure if any relation to the vaccine  but thought I should report. Note - I had not previously had the shingles vaccine. Started taking  ValACYclovir HCI. Expected to be a normal duration of shingles.
I experienced expected injection site tenderness in my arm and body aches, headache, and chills the following day (after administration of my 2nd dose) starting around 10 AM that tapered off by the following day. However, my concern has been for on-going, intermittent, continued pain and swelling of the lymph nodes near my left arm pit.  At times  it feels as if there is a hard lump in my armpit.  I?ve had 3-4 episodes of this since receiving my second dose of the vaccine.  Never in my life, prior to receiving the vaccine have I ever had this experience and I am currently in better health than I have been in years.  It is clear to me that o set was definitely after receiving the 2nd vaccine and would not be better explained by anything else in my daily routine.
On 9/30/13 the patient received influenza trivalent vaccine and HIB vaccine. Taken home, took a nap and awoke crying. When attempting to crawl, pt could not put weight on left arm or left knee. When attempting to sit would fall over. Low grade fever that night. On 10/1/13 was able to put more weight on (L) hand and (L) leg. Has slowly improved. As of 11/4/13 almost back to normal.