chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore Scalp; eye twitching, eye spasms; pain behind her eye.; Hives; left marks on her skin.; Side pain; having pain in her back and down her sides; pain in her big left toe and pain in both thumbs; itchy patch on her back; This case was reported by a consumer via call center representative and described the occurrence of scalp pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2021, the patient received the 1st dose of Shingrix (intramuscular). In June 2021, less than a month after receiving Shingrix, the patient experienced itching and pain in toe. In September 2021, the patient experienced back pain and pain localized. On an unknown date, the patient experienced scalp pain, blepharospasm, eye pain, hives and skin disorder. On an unknown date, the outcome of the scalp pain, blepharospasm, hives and skin disorder were unknown and the outcome of the eye pain, back pain and pain localized were not recovered/not resolved and the outcome of the itching and pain in toe were recovered/resolved.   It was unknown if the reporter considered the scalp pain, blepharospasm, eye pain, hives, itching, back pain, pain in toe, skin disorder and pain localized to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient for herself. The patient received the dose in her left arm. One to two weeks after the vaccine, she reported an itchy patch on her back.  A few weeks later at the end of June she started experiencing pain in her big left toe and pain in both thumbs which went away after a week or two.  After the ain in her toe and thumbs, she started experiencing symptoms in her eyes which included eye twitching, eye spasms, and pain behind her eye. The patient went to an eye doctor for this issue but at the time did not realize it could be vaccine related and the doctor was not sure why she was experiencing it either. The eye pain was still present at the time of reporting. A month before reporting, the caller reported that she started having pain in her back and down her sides which was also unresolved.  The patient also reported having hives 3 weeks after her Shingrix that left marks on her skin. She experienced another episode of hives around the first of August.  Patient was referred to her Health Care professional and was provided the phone number for MI for her doctor to call if there are furthe concerns. The reporter consented to follow up.
Pt with history of mild psoriasis to knees and elbows. One week after 2nd Moderna developed generalized psoriasis plaques to face; ear lobes, trunk, lower arms and legs.
Pain in arm & R/hand 1 wk after injection to date reported 11/23/99. Injection given 11/5/99. Also, noticed a knot at injection site, 7x7mm hard knot on R/upper arm, warm to touch.
8 Jun 2021 started with chills and fever at 1600hrs, Shortness of breath and elevated heart rate 2100hrs, arrived at Emergency Room approx 2145hrs. Heart rate @ 180bpm, Fever, prescribed antibody's, Antibiotics, Had a Chest CT scan. Kept overnight until heart rate was <100bpm. I then noticed shortness of breath and walking became an effort and had to pause to catch my breath. Scheduled appointment with Family Doctor at a local Clinic on 22 Jun 2021.
Inflamed rash around site all down arm pain all way down lymph nodes in armpit for 7 days.
Patient / received / first dose / on 28Nov2020 and / second on 24Apr2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) (batch number 57E3G, expiry date 20th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 28th November 2020).   On 24th April 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 24th April 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional information was provided as follows: The age at vaccination was not reported.  The reporter declined to provide patient data. The pharmacist reported that the patient received a late 2nd dose for Twinrix, which led to lengthening of vaccination schedule. The reporter consented to follow up.
5 hours after shot experienced severe chills. Several hours later started vomiting every hour for about 6 hours. 2nd day very fatigued all over body. Back to normal the next day.
Extreme soreness at injection site. Pain progressed to include shoulder and decreased range of motion. On 11/21/2014, ~4 weeks after vaccine, treatment sought. Physician diagnosed frozen shoulder & referred me to a shoulder surgeon to evaluate need for MRI and/or physical therapy. There is no history of shoulder problems prior to vaccine.
30 minutes after immunization given, pt returned with swelling of face/eyes but not lips, erythema of face. Had abdominal pain but no vomiting/diarrhea. Had wheezing on exam. Gave EPIPEN Jr (0.15mg) IM, albuterol nebulizer treatment inhaled, EMT's called and arrived in minutes and assumed care. Taken to ED.
Significant tinnitus in both ears; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 18:00 (Lot number: 33025bd) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergy: Sulfa" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0150, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 03May2021, when the patient was 34 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0164, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 12Apr2021, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: TINNITUS (disability) with onset 29Dec2021 15:00, outcome "not recovered", described as "Significant tinnitus in both ears"; IMMUNISATION (non-serious) with onset 23Dec2021 18:00, outcome "unknown", described as "Booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were not taken as a result of tinnitus.  No follow-up attempts are possible. No further information is expected.       Dose received: 3 Most recent dose details:  Product=COVID 19 Brand= Pfizer  Brand unknown=False Lot number= 33025bd Lot unknown=False Administration date= 23Dec2021 Administration time=06:00 PM Dose number=3 Vaccine location= Left arm  Previous dose details: Prev dose product=COVID 19 Prev dose brand=Pfizer Prev dose brand unknown=False Prev dose lot number= Ew0150 Prev dose lot unknown= False Prev dose administration date= 03May2021 Prev dose administration time=03:00 PM Prev dose dose number=2 Prev dose vaccine location=Left arm Prev dose product=COVID 19 Prev dose brand=Pfizer Prev dose brand unknown=False Prev dose lot number= Ew0164 Prev dose lot unknown= False Prev dose administration date= 12Apr2021 Prev dose administration time= 03:00 PM Prev dose dose number=1 Prev dose vaccine location=Left arm  Facility type Vaccine: Hospital If other vaccine in four weeks : No Other medications in two weeks: No  Adverse event: Significant tinnitus in both ears Adverse event start date: 29Dec2021 Adverse event start time: 03:00 PM Adverse event country:  AE resulted in: Disability or permanent damage If patient recovered: Not recovered If treatment ae: No  If Covid prior vaccination: No If Covid tested post vaccination: Yes Covid test post vaccination  Covid test type post vaccination=Nasal Swab Covid test result=Negative  Known allergies: Sulfa drug  Follow-Up (12Jan2022): Follow-up attempts are completed. No further information is expected.
lymph nodes left arm pit swollen and hard tender to touch.  Woke up from sleep.  Last at least 3 days has gone down but still tender.
On 2/26/01 (2 weeks after immunizations), pt started having a fever of 100.8F and later increased to 103F with no relief with Tylenol. Pt went to see PMD and was admitted to the hospital on 2/27/01. On 2/28/01, he was dx'd with H. Influenza infection. Pt was discharged home on 3/5/01 with Augmentin X 5 days. Follow-up on 3/9/01 with PMD.
Rapid pulse with little or no exercise/movement  Chills/aches Body temp varied from one side to other This occurred on 5/25/2021 morning throughout day and evening - rapid pulse.        Did not seek medical attention as I thought this was a normal side effect  - until seeing later it was not.   The heart is what concerns me
5-10 min after vaccination pt collapsed and c/o shortness of breath and impending door. Given Epi, O2, Benadryl and monitored until return to WNL conditions.
Arm got red, swollen, and painful. Went to doctor on 11/14/15 and received antibiotics and pain meds to treat diagnosis of cellulitis.
- Patient Believes it was administered caregiver to high in arm. Patient reports pain. Patient taking IBU & ice.
Patient called and reported redness at injection site that extended from the injection site down to close to the elbow. Patent reported it was a red band about 3 inches wide and possibly warm to the touch.
I caught it once from the flu shoot; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case from a patient via social media.  This case involves adult patient of an unknown gender who caught it once from the flu shot (influenza), while the patient received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medication was reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (with an unknown route, frequency, strength, lot number and expiry date) for prophylactic vaccination.  On an unknown date (latency unknown) after starting the suspect vaccine therapy, the patient reported that the caught it once from the flu shot (influenza), and stated that yes you do catch the flu by taking a flu shot, also if you took the covid 19 (coronavirus disease 2019) flu shot you would catch covid 19.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
I know 3 people that also had Moderna & they also are itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (I know 3 people that also had Moderna & they also are itching) in a  patient of an unknown age and 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (I know 3 people that also had Moderna & they also are itching). At the time of the report, PRURITUS (I know 3 people that also had Moderna & they also are itching) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided. This case is reported for patient 1 out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-724918, US-MODERNATX, INC.-MOD-2023-724915 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724918:(Patient 3) US-MODERNATX, INC.-MOD-2023-724915:(Patient 2)
Upper extremity DVT same side of vaccination Left upper arm pain, bruising, swelling  Symptoms started approximately 2 days after injection
This spontaneous report as received from a 60 years old female consumer refers to herself. The patient had none pertinent medical history. The patient had none drug allergies. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # not reported) on "Monday", 27-AUG-2012. Concomitant medications included: metoprolol tartrate. It was reported that then "the next night", on 28-AUG-2012 the patient had some itching. On the morning of 29-AUG-2012 the patient then noticed a hard lump on her arm about 3 to 4 inches in diameter. The patient was going to a medical clinic on 29-AUG-2012 to treat this adverse event and had no specific doctor that she saw. No treatment was given. No lab diagnostics studies was performed. The adverse event did not improve. The outcome was reported as not recovered. Additional information is not expected.
Injection site is a little bit warmer than other places; Redness around the injection site, that is a distant pinkish color; Pain at the injection site; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site is a little bit warmer than other places), INJECTION SITE SWELLING (Swelling at the injection site), INJECTION SITE ERYTHEMA (Redness around the injection site, that is a distant pinkish color) and INJECTION SITE PAIN (Pain at the injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PAIN (Pain at the injection site). On an unknown date, the patient experienced INJECTION SITE WARMTH (Injection site is a little bit warmer than other places) and INJECTION SITE ERYTHEMA (Redness around the injection site, that is a distant pinkish color). At the time of the report, INJECTION SITE WARMTH (Injection site is a little bit warmer than other places), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE ERYTHEMA (Redness around the injection site, that is a distant pinkish color) had not resolved and INJECTION SITE PAIN (Pain at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported  No treatment information was specified
6 days after vaccination had recurrence of lump and redness at injection site. Over the past week had continued spread of redness and new recurrence of pain at injection site.
rash on bottom of feet; swollen hands; blanching of legs; Information has been received from a nurse referring to a 22 years old female patient who was not pregnant. The patient's concomitant medications included birth control drugs. She had no medical history. The patient was allergic to acyclovir and sulfa.  On 08-JUL-2019, the patient received the second dose  of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot number: R011630; expiration date: 12-DEC-2020; strength was not reported), intramuscularly for human papillomavirus (HPV) prevention. On 09-JUL-2019, the nurse reported that the patient experienced rash on bottom of feet, swollen hands and blanching of legs after receiving the second dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The patient called the office to seek medical attention. There was no treatment given to the events. Lab diagnostics or studies were not performed. The outcome of the events was recovering. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was unknown.
One week and one day after I received the shot my right arm got a red, warm, sort of rash.  It was quite large and shaped like an arrowhead.   I did have a slight reaction for 48 hours after the shot with a fever and aches but no red, warm, rash.
pt recv vax 30JAN95 & 6FEB95 pt exp a blister-like rash around ankles, wrists, flank & thighs;exp has flared up every few months since inj;
she was very sick; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Oct2020 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She stated that she could taste it right away and within a few hours, she was very sick in Oct2020. She was told that she cannot take the second dose. She was wondering if she was protected at all with just having first dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
She states about 24 hours after she received the vaccination she broke out in hives. Hives are still present 01/10/21.
pt recvd flu vax 20NOV95 & 23NOV95 devel intense burning & itching of the ulnar surfaces of back hands lasting 4 days;denies use of chemicals, etc;
Conjunctivitis formed in my left eye suddenly (same side of the body where I got the shot). I only noticed when I got out of the shower and looked in the mirror. After that I noticed my eye was tearing and goopy. It was very red for an hour or two and then it started to improve. The redness went down considerably by 10:30pm, but my eye remained slightly goopy and irritated for 2 days. I was able to continue wearing the same pair of contacts. It just went away on its own.  I wore my contacts as a test to see if it were truly a bacterial or viral conjunctivitis I contracted by coincidence, but I knew it was not. I don't go anywhere. The fact that it went away on its own so quickly was confirmation that it was a side effect.   It is worth saying that I have also experienced pink eye from a virus in the past. Maybe my body is more susceptible.
She was feeling weak and she notice little rash at injection site left arm where ZOSTAVAX administered. After 2 days Dr. prescribed prednisone as treatment and she is ok now.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 29-OCT-2012 02:30, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Severe headache, low grade fever, hoarseness, congestion, pale, chills, weakness.
pt recvd vax;1 wk later,exp tinnitus & lightheadedness; outcome:unresolved
First dose: had a ticklish cough; kind of like squeeze in the chest; post nasal drip, it lasted 3 weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Aug2021 12:30 (Lot number: FC3183) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: allergic to Sulfur oxide; "allergic to wine" (unspecified if ongoing), notes: allergic to wine; "left ventricular wall leak", start date: Jun2020 (ongoing). There were no concomitant medications. The following information was reported: COUGH (non-serious) with onset 31Aug2021, outcome "recovering", described as "First dose: had a ticklish cough"; UPPER-AIRWAY COUGH SYNDROME (non-serious) with onset 2021, outcome "unknown", described as "post nasal drip, it lasted 3 weeks"; CHEST DISCOMFORT (non-serious) with onset 31Aug2021, outcome "recovering", described as "kind of like squeeze in the chest".  Additional Information: The patient had cough, kind of a ticklish cough, assumed it was the vaccine but had also post nasal drip, it lasted 3 weeks, that was why the patient delayed her second shot and waited to get better, she had still a little bit, that was a ticklish cough, kind of like squeeze in the chest, not really major. The patient confirmed it started two days after the shot. It felt like she ate something she was allergic to Sulfur oxide, that was in dried prunes, red wine, it has sulfates, usually the patient had that cough after consuming that.  She took communion, and every time she had that and drink red wine, had coughs. She was just allergic to wine. But she had when laying on the cough and felt like a squeezing ticklish cough. The patient had no prior Vaccinations (within 4 weeks) and no other vaccinations within four weeks prior to the first dose. The patient did not require emergency Room/physician Office for the events.  No follow-up attempts are possible. No further information is expected.
Fever for four days, highest recorded temp 100° Coughing Stuffy nose Sore throat General malaise Went to urgent care and was given an antibiotic and cough medicine which finally ended the fever. Did not feel back to normal for 2 weeks. Chest congestion and coughing persisted the longest.
12/06/2021  The patient presents with Medical clearance. Pt states she is coming from SNF due to having a positive COVID-19 test though she is only c/o cough and congestion. The pt notes she has multiple lung diseases and is regularly on 2L of o2. Denies any other symptoms or complaints.  The onset was just prior to arrival.  The course/duration of symptoms is constant.  The character of symptoms is COVID-19 symptoms.