chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given 10/14. She saw me on 10/18 & reported that very soon after the injection, she noted redness & itching at the inj. site. On 10/15 - increasing soreness. By 10/18, she had great difficulty moving her shoulder & had pain in deltoid - radiating to upper back & neck. No redness, no swelling not at office visit. No fever.
STARTED WITH ACUTE LEFT ARM PAIN WITH DIFFULTY RAISING LIMB, PAIN EXTENDED TO LEFT SHOULDER AND ELBOW, FEVER, GENERALIZED JOINT PAIN,  FATIGUE. TOOK PERCOGESIC AND ACETAMINOPHEN
administered a dose of Adacel post temperature excursion due to a refrigerator malfunction, low temperature reached negative 2.1 celsius from 07-mar-2022 until 31-mar-2022 not due to a human error with no adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid non-serious case received from health professional.  This case involves a 55-year-old female patient who was administered a dose of diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] post temperature excursion due to a refrigerator malfunction, low temperature reached negative 2.1 celsius from 07-mar-2022 until 31-mar-2022 not due to a human error with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine rge (cho) (Shingrix) for Immunisation.  On 31-Mar-2022, the patient received a dose of 0.5 ml total Frequency: once of suspect diphtheria-2/tetanus/5 ac pertussis vaccine lot C5963AA expiry date: 18-Jan-2024 via intramuscular route in right deltoid for immunization.  On 31-Mar-2022 the patient was administered a dose post temperature excursion (product storage error) (Latency: same day) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken was not applicable.  Outcome was Unknown.    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.; Sender's Comments:  01068650: 01068813: 01068814: 01068816: 01068817: 01068825: 01068827: 01068828: 01068830: 01068831: 01068832: 01068835: 01068838:
Febrile response within 36 hrs of 105.6 F and then next two days up to 104 F.
The patient was administered the pediatric formulation of the Pfizer-BioNTech despite being 12 years old and indicated for the adult formulation.
FEVER; VOMITING; DIZZY; RINGING IN EARS; BLOOD PRESSURE HIGH; This spontaneous report received from a patient concerned a 74 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 09-APR-2021, the subject experienced vomiting. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced ringing in ears. On 09-APR-2021, the subject experienced blood pressure high. On 10-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 150/75 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, blood pressure high, and fever, and had not recovered from dizzy, and ringing in ears. This report was non-serious.
Dizziness; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd February 2022, the patient received Shingrix. On 23rd February 2022, less than a day after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix vaccine and experienced dizziness. No further information reported. The follow-up would not possible as no contact details were available.
Pt has had tinnitus for decades, he's used to it. Directly after shot, it became approx 4 times louder - noticeably much louder. This was reported on V-Safe, but V-Safe has d/c requesting reports after day 8. Tinnitus continues about 2x louder now 9 days later, and has been that loud since subsiding from 4x over the initial few days.
Felt a little dizzy off balance time 3 days, emesis thus Ave without diarrhea or fever. Slight increase in Blood Pressure. No increase confusion, no tinnitus.
Information has been received from a physician's assistant concerning a 28 year old female  (67inches, 227lbs.) with hypothyroidism, drug hypersensitivity to morphine sulfate, DEMEROL and ZITHROMAX who on 11-APR-2007 was vaccinated with the first dose of Gardasil (Lot#657617/0384U) intramuscularly in the left deltoid. Concomitant therapy included paroxetine, LEVOXYL and MIRCETE. Within 24 hours, on 12-APR-2007, the patient experienced significant swelling at injection site, swelling/swollen nodular area over left clavicle, significant malaise/lethargy and low grade fever. As of 20-APR-2007 the patient was significantly improved and considered recovered. The patient declined an appointment. Additional information has been requested.
Pfizer 3/17/21, 4/7/21, 11/22/21. Positive on 8/11/22
Raised red rash over trunk, arms and legs. Itching and hives. Began Wednesday evening, still red and itching a week later, but is getting less.
patient is 70 years old female with past medical history of hyperlipidemia and hypothyroidism sent to the emergency room with episode of altered mental status. At home she was noted to have facial droop but in emergency room it was not appreciated. She tested positive for COVID-19 infection emergency room, chest x-ray came unremarkable and CT scan of the head showed no acute abnormalities. No history of fever or chills, patient is very poor historian and confused.
6 weeks after getting my second shot I began having severe tachycardia with elevated BP and  cardia arrhythmia which sent me to the ER 4 xs. No previous cardia issues other than mild hypertension which was controlled. Presently have been out of work with this issue ongoing. I have seen cardiology with stress test completed, halter monitor and ECHO done. Significant change in medication has occurred. Have f/u with doctors for results. Also seeing a nephrologist and endocrinologist
Approx 1 hr p/vax pt began to swell & hives developed; DPH given w/good results but p/effect of DPH wore off, arm swelled again; swelling lasted x 2-3 days;
Patient came in for her PNEUMOVAX 23 vaccine. The next day the husband came in with a Rx for 2 medications for the patient from the emergency room and stated that during the night she starting having a bad reaction on her arm in the same area as where the vaccine was given. He said the arm was very swollen almost down to the elbow.
Warmth at the injection site; Redness at the injection site; Little bit swelling at the injection site; Itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE SWELLING (Little bit swelling at the injection site), INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE WARMTH (Warmth at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE SWELLING (Little bit swelling at the injection site), INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE WARMTH (Warmth at the injection site). At the time of the report, INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE SWELLING (Little bit swelling at the injection site), INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE WARMTH (Warmth at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Patient complains of headache after 1 hour of Hep A shot, muscle cramps on the left arm, tingling of the left fingers.
Shortly after dose on way home had lip, tongue swelling. Have had intermittent issues of this in past with unknown etiology. Ignored as symptoms didn't get worse. 11/1 started on new BP med. After 2 doses woke up with SOB, shakiness, fast heart rate - 100. 11/3 told to stop med. Saw md - told to restart. Episode again 11/5 = went to ER. Lab normal. Told to stop med. Episode 11/6 as before also  feeling of difficulty swallowing - went to ER. Started on prednisone x 5 days. 11/7 - saw md with ongoing symptoms of lip, tongue, roof of mouth swelling. Started on antihistamine & to see allergist. Not sure if the vaccine started all of my issues, but since still having symptoms, & the original swelling started with vaccine this time, thought needed to report.
Left deltoid area has approximately 2" diameter are of redness around injection site and also in areas where band-aid applied with 1/2" area of skin breakdown approximately 2.5" away from injection site (on right side) which appears to have been from band-aid. Oozing a little, afebrile.
Had TDAP 8/25/10- 2 days after started feeling bad, headache, slightly sore arm, hoarseness, fatigued went to PMD- was give antibiotics & a steroid pack for sinus infection. Still felt bad- went back to PMD & ordered a CT scan of sinuses- results- sinus clear. Had light run down throat for c/o hoarseness- vocal cords ok. Client still felt run down low grade temp.
chronic tinnitus; This is a spontaneous report received from a contactable reporter consumer or other non HCP. The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Sep2021 as dose 2, single (Lot number: FF2588) for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Doxycycline, reaction(s): "Known allergies", notes: known allergies: docxycycline. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: fa7485), administration date: 06Aug2021, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "chronic tinnitus". The event "chronic tinnitus" required physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: No other vaccine in four weeks and No other medications in two weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101144990 same reporter/patient/product, different dose/AEs;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 at 09:00 as dose number unknown, single (Lot number: FJ9943) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient did not receive other medication in 2weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (28Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received covid-19 treatment from 16Jun2022 to 20Jun2022.  On 28Jun2022, a rebound infection occurred including sore throat, dry cough and fatigue. Positive Covid test.
Pt recvd Hep B vax on 18MAY92 & approx 24 hrs p/vax devel fatigue which lasted approx 1 wk then resolved; 18JUN92 recvd 2nd dose of vax & w/in 24 hrs devel severe fatigue, vertigo, vomiting, fullness in throat, chest tightness & anxiety;
Pt received third Hepatuitis B vaccine and reported swelling of lips.  No other symptoms reported - pt took antihistamine with reduction of symptoms.
This case was reported by a consumer via call center representative and described the occurrence of tremor in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced tremor, heartbeats increased and fever. On an unknown date, the outcome of the tremor, heartbeats increased and fever were unknown. It was unknown if the reporter considered the tremor, heartbeats increased and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe effects of the SHINGRIX included tremors, rapid heartbeat and slight fever.
Within 12 hrs of receiving injection, trouble breathing, intense burning and itching over entire body with various body parts swelling. This resulted in 48 hours of symptoms - unrelieved by medication.
Hives, both elbows, knuckles both hands, left foot. both knees
Complications from Anthrax vaccine (unevaluable reaction). Subject, age 24, reportedly died 9/2/06 from complications resulting from an Anthrax vaccine he received while serving in military.
Got more migraines went from 10-15 days to 28+ days and 2-5 a day. My heart is beating faster, brain fog, loss of work. Loss of consentration
Pt developed hives on face & trunk BENADRYL given & pt placed on a monitor. Pt observed for 1 - 1 1/2 hr - hives resolved. BENADRYL Rx given x 3 days - called patient next day - pt doing well.
NO ADVERSE REACTION AT TIME OF VACCINE.   EVENT IS THAT THE PATIENT IS UNDER THE RECOMMENDED AGE FOR ADMINISTRATION OF MODERNA.
Patient had pain at injection site shortly after injection and then pain from shoulder down arm later in the day.  Over the next few weeks and months she had decreased range of motion and then a frozen shoulder.  This was brought to attention of the pharmacy in July of 2020 when asked if she wanted a flu vaccine this year.  At the time she told the pharmacist she did not want one as she was having shoulder issues.  The pharmacist asked her if it was related to the vaccine the previous year and if she wanted us to report an adverse event and she did not at this time.
Had vaccine#2 at noon on the 4th.  Woke up with 101 temp and body aches at 4:30 the next morning.  Temp is down with tylonol but back, neck, eyes... Especially back are extremely sure and achy.  Slept at day with no energy
Mother described a rash the size of a baseball on pt's left thigh which was red, swollen and warm.  Provider suggested Benadryl and rash resolved after a few days. *another pt had same vaccinations- same reaction DTap (common)
partial paralysis of the right side of my face/Bells Palsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01Mar2021 (Lot number: EN6200) at the age of 22 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1; lot EL9265), administration date: 08Feb2021, when the patient was 22 years old, for COVID-19 immunization. The following information was reported: BELL'S PALSY (disability) with onset 01Mar2021, outcome "recovered with sequelae", described as "partial paralysis of the right side of my face/Bells Palsy". The event "partial paralysis of the right side of my face/bells palsy" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of bell's palsy included doxycycline, and methylprednisolone.  Additional information: It was reported that the patient had no covid prior vaccination and was not covid tested post vaccination. Patient had no known allergies. It was reported that after her second dose, she had partial paralysis of the right side of her face. The day after she got the second dose, she called her dermatologist and they told her to go to the ER. Once she arrived, the stroke team ruled out having a stroke. She was diagnosed with having Bells Palsy and the doctors believed it was caused by the Pfizer vaccine. The patient had no other vaccine in 4 weeks and no other medications in 2 weeks. The patient received 3rd dose of Pfizer vaccine on 28Dec2021 (lot FJ1611).  No follow-up attempts are possible. No further information is expected.
Narrative:  Unknown when vaccination occurred given patient did not receive at our clinic. Unknown apart from patient report of ADE what treatment was given. Per patient report, ADE is as follows, "I had flu vaccine and I developed a reaction and lost part of the myelin sheath in my left forearm and have numbness to 3 of my fingers."
Strong flu-like symptoms:  Extreme fatigue, headache, chills, slight fever of 99.1  soreness at injection site
12 hours after injection I had chills, body aches, fever, headache, nausea, vomited, diarrhea. Temperature was in the 101.5 range for more than 24 hours, About 30 hours with a fever.
Burning in deltoid, arm pain/soreness, some numbness and tingling in hands and feet. Doctor's office reports that the patient has often had numbness and tingling in extremeties prior to the vaccine, but patient is reporting that she feels it is related to the vaccine.
Mom reports that patient had subjective Fever, then fever to 101.9. Gave Tylenol. Patient woke up at 330 on 8/21 Hot & Fussy. Tylenol given. Patient screaming at 0830, patient then started aggressively shaking x 15 sec, then unresponsive x 45 sec. Then tired. Went to ER. Dx febrile seizure. Patient taking scheduled antipyretic medications and doing well since. Playful.
Extreme fatigue; decreased energy; needed to sleep most of the day; difficulty maintaining balance; heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, lot number: EN6200), via an unspecified route of administration, administered in Arm Left on 09Mar2021 12:00 (received at the age of 73-years-old)  as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to receiving bnt162b2. Medical history included asthenia and known allergies to Sulfa drugs, NSAIDS. The patient was not pregnant. She did not have covid prior vaccination. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; and vitamins.  The patient experienced extreme fatigue (fatigue) (disability, life threatening), decreased energy (asthenia) (disability, life threatening), needed to sleep most of the day (hypersomnia) (disability, life threatening), difficulty maintaining balance (balance disorder) (disability, life threatening), heart palpitations (palpitations) (disability, life threatening), all on 11Mar2021 04:00. These conditions started 2-3 days after the first vaccine (as reported). The adverse events resulted in Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient did not receive any treatment for the adverse events. Outcome of the events was recovered on an unspecified date in 2021. The patient was not tested for covid post vaccination.
This case was reported by a consumer and described the occurrence of hair loss in a male patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 2nd dose of SHINGRIX. On 15th December 2018, 7 days after receiving SHINGRIX, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was not recovered/not resolved. It was unknown if the reporter considered the hair loss to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The week after SHINGRIX vaccination, the patient noticed significant hair loss. This was never an issue for the patient in the past. The patient's hair had always grown very fast and rarely noticed any hair fall. This could be purely coincidental and the vaccine was a protein derivative, but it was a condition none the less. The patient realized this was likely entirely coincidental, but he had always been exceptionally healthy.
After I got the booster, I had a headache and fatigue but that went away the next day. Months later, I started having tingling in my lips and facial paralysis. I went to the doctor for examination; the doctor believed I had shingles since I've had it in the past. For treatment, the doctor prescribed me prednisone and BELTRAX for about a week as well as physical therapy sessions. I was diagnosed with Bells palsy that corrected itself within 4 days or so of treatment. No medical testing was done, but now I'm doing great and much better.
Rotavirus vaccine given out of recommended guidelines (First rotavirus given >12 weeks of age).
Headache for a couple of days Muscle and bad joint pain for about 3 weeks Fatigue continues and has not gone away
Itching & redness on both arms and face; Beet red face & arms; Itching redness on palms & backs of hands; Itching redness on palms & backs of hands; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching redness on palms & backs of hands), ERYTHEMA (Itching redness on palms & backs of hands), PRURITUS (Itching & redness on both arms and face) and ERYTHEMA (Beet red face & arms) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Previously administered products included for historical  Vaccine: Pneumovax. Past adverse reactions to the above products included Influenza with Pneumovax. Concurrent medical conditions included Penicillin allergy, Drug allergy and Asthma chronic.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PRURITUS (Itching redness on palms & backs of hands) and ERYTHEMA (Itching redness on palms & backs of hands). On 07-Mar-2021, the patient experienced PRURITUS (Itching & redness on both arms and face) and ERYTHEMA (Beet red face & arms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and OMALIZUMAB (XOLAIR) at an unspecified dose and frequency. On 03-Mar-2021, PRURITUS (Itching redness on palms & backs of hands) and ERYTHEMA (Itching redness on palms & backs of hands) had resolved. On 07-Mar-2021, PRURITUS (Itching & redness on both arms and face) and ERYTHEMA (Beet red face & arms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment medication was provided.