chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited social media report received from a non-healthcare professional via other company Pfizer (under the manufacturer control number: 2017142378) on 10-Apr-2017. This case involves patient (unknown age and gender), who was vaccinated with INFLUENZA VACCINE (Flushot) (Batch number, expiration date, dose, route dose in series and site of administration were not reported) on an unspecified date. Patient's medical history and cncomittant medication was not reported. On an unknown date, following the vaccination the patient had influenza A. This was a case of suspected vaccination failure as no information regarding confirmatory tests (PCR/serology) was reported). Patient's laboratory data and corrective treatment were not reported. Outcome of the event was not reported. Upon internal review the company considered the event as serious because of important medical event influenza. Documents held by sender: none; Sender's Comments: A patient experienced influenza a after receiving flu shot (MFR UNK). This was a case of suspected vaccination failure as the information regarding confirmatory test (PCR and serology) were not reported). Time to onset was not reported and information regarding patients medical history, tolerance to previous vaccinations, ongoing medical condition and dose number of flu vaccine was also not reported. Additional information regarding PCR/serological tests would be required to further assess the case. Based upon available information the role of the vaccine can not be assessed.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient 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 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    No concomitant medication was provided by reporter. Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients were involved and date of administration was 11-Jan-2023, lot numbers were unknown to the HCP. No treatment medication was provided by reporter. This case is for 51 patient out of 100 male patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Allergic reaction for 10 days; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. The patient was treated with allergy medication {nos} (Allergy Pill). On an unknown date, the outcome of the allergic reaction was recovered/resolved.   The reporter considered the allergic reaction to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The husband reported that his wife  patient had an allergic reaction to the shingrix vaccine, gone on for ten days. The reporter asked for information on what to do about a bad reaction that had gone on for twelve days now. Allergy pills had been helping. The call center representative provided all the relevant information to the reporter.
Information has been received from the registered nurse concerning to an approximately 67 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 17-MAR-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (lot number: K005402 with unknown expiration date) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with PNEUMOVAX 23 was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Fatigue, 99.5 fever, uncontrollable shaking, chills, nausea, shortness of breath while moving,  after COVID vaccine
Muscle aches, headache, chills, between 12:00 am until 4:30 am, took Ibuprofen for some relief
She got her vaccine and it was so high up that it hit a nerve in her joint.  She did not have any symptoms after the injection.  Went to bed, and woke up and her arm is swollen, it's like she has a frozen shoulder, is pounding pain, extremely tight, difficult to move, can't move it, and very constricted which prevents her from using it.   The pain goes all the way down to her elbow.  She cannot use the left hand, and when she tries to move her arm at the elbow has excruciating pain.   She took 2 Tylenol which helped, but the pain comes back when it's time for more Tylenol and is also taking Ibuprofen but the symptoms are still there.  Just to lift her arm up to put on the arms of a chair is painful with no mobility in the arm.
feeling really fatigue; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of FATIGUE (feeling really fatigue) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced FATIGUE (feeling really fatigue). At the time of the report, FATIGUE (feeling really fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 59 years, in left arm for COVID-19 immunization; 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 immunization. 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient received COVID-19 treatment with Paxlovid start date: 08Jan2023 and stop date: 13Jan2023.  No follow-up attempts are possible. No further information is expected.
2x3 inch red spot that sometimes itches, just to the left of injection site, began almost immediately and still there 9 days later
Two days after vaccine booster, I developed a blood clot in my left calf. I assumed this was a pulled muscle, but 5 days later I went to the hospital and learned the clots had spread to my lungs. This caused pain in the chest when I breathed.
3 hrs p/vax was administered in thigh, leg became hot & red w/swelling, hives w/splotchy areas appeared on leg shortly p/; no APAP administered; walked on leg & reaction dissapated by 2 days;
Fever 104-105 degrees - brief (less than 1 minute) generalized seizure.
This is a spontaneous report from a Non-contactable consumer (patient). A male patient of an unknown age reported that he had received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) via unknown route on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient historical vaccine included of BNT162B2 (at single dose for COVID-19 immunization. The patient had experienced diarrhoea and dizziness on an unspecified date. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a medical assistant and a nurse refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot# M004330, expiration date 26-JAN-2018; lot# M009766, expiration date 23-FEB-2018; lot# M044349, expiration date 04-NOV-2018; lot# M049126, expiration date 15-DEC-2018; lot# M019641, expiration date 20-APR-2018; lot# M041513, expiration date 11-OCT-2018 and reported as lot# N012488, expiration date 20-APR-2018 (requires lot# verification) (doses and routes of administration were not reported for all) reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -14 Celsius degrees to -10 Celsius degrees for 16 hours. Data logger was not involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA009797.
lt arm deltoid area swollen, red; c/o 20AUG93 chest pain; 21AUG-23AUG93 felt sick, fever 102.5, cold sweats; 24AUG93 no fever, area hot to touch, red going down arm;
had classic flu like symptoms 12 hours later after shot; tired; achy; This is a spontaneous report from a contactable other hcp (patient himself). A 60-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL3247), via an unspecified route of administration, administered in right arm on 17Feb2021 13:30 (Age at vaccination: 60 years) as DOSE 2, SINGLE for covid-19 immunisation in the workplace clinic. The patient's medical history included high blood pressure, gout, fatty liver, hepatic steatosis. Concomitant medication(s) included losartan 100mg; allopurinol 300mg. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3247) via an unspecified route of administration, administered in right arm on 27Jan2021 13:30 as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. The patient had no known allergies. On 18Feb2021 01:30, the patient had classic flu like symptoms 12 hours later after shot, tired, achy. Then lasted 24 hour later achy and tired. Then less on second day after taking Tylenol 500mg. By 19Feb2021 (Friday night), all was normal again. The patient did not receive any treatment for the adverse events. The patient was not diagnosed with covid prior to vaccination nor was tested for covid since vaccination. The outcome of the events was recovered on 19Feb2021 13:30.   Follow-up attempts completed. No further information expected.
On October 26th, about 12 hours following the booster, I experienced a severe migraine with no relief.  On October 27th, the migraine head pain was so severe that I went to my Primary Care doctor for relief.  He checked me to ensure there was nothing outside of the vaccine that was causing my migraine.  I have continued to suffer from migraines every single day except one since the Moderna booster.  Additionally, I have had heart palpitations and can hear my blood thumping in my ears the onset of which occurred with the booster.  I have had extensive bloodwork, EKG and ultrasound of my carotid arteries to ensure there is not a condition unrelated to the booster.
She got her vaccine, she waited 15-20 minutes after the injection, went home and went about her daily activities with no problems, no wheezing or anything.  About 8-8:30 last night she began with wheezing that became more severe and then had bronchospasm.  Because she is asthmatic she keeps a pulse ox and peak flow meter and it was trending down, lowest 85.  She gave her 3 nebulizer treatments and took 30 mg of Prednisone.  Basically tried to stay calm and everything reversed when her Sp02 came back to 95 or so and this took about 12 hours to normalize.  She was able to fall asleep on 3 pillows, and this morning her voice is hoarse and has a little bit of wheezing left.  She contacted her pulmonologist and he has put her on a course of Prednisone and to use her nebulizer every 4-6 hours as necessary.    She has not had an asthma attack like this in over 15 years.  She has the things to treat it at home, but was within 15-20 minutes of considering going to the hospital but it began turning around.    The vaccine was the only thing that was different that day.
Severe involuntary "shaking" of whole body as if was "chilled". Episode lasted 1 hour and no other associated signs and symptoms other than extremities felt cold like as if you have a fever or poor circulation. Temperature was taken and noted to  be 98.8. Mental feeling of "something is not right" but could have been from anxiety due to the situation.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 02-FEB-2015, the patient was vaccinated VARIVAX dose 1, (dose, lot # K007982, expiry date unknown). On 06-APR-2015, patient received improperly stored VARIVAX dose 2, from (lot # K007985 expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Fever 100.7 started within 24 hours of shot lasted for 10 hours felt like had the flu- also had muscle weakness in legs and felt like she could not walk as far or stand as long-- this is still ongoing.
This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients received doses of improperly stored PROQUAD (dose and route of administration were not reported) for prophylaxis. Data Logger was involved. No adverse effects reported. A product quality complaint was not involved. The following lot numbers and temperature were reported: M014301 expiration date 09/22/17 -13.9C for 15 minutes -14.9C for 15 minutes -14.8C for 15 minutes M022400 expiration date 11/01/17 -14.6C for 15 minutes -14.9C for 15 minutes -14.3C for 05 minutes -14.7C for 05 minutes -14.7C for 05 minutes -14.6C for 05 minutes -14.6C for 05 minutes -14.7C for 15 minutes -14.8C for 15 minutes -14.9C for 15 minutes -14.1C for 15 minutes -14.8C for 15 minutes -10.7C for 10 minutes - 9.4C for 01 minutes Lot number report as M224001 expiration date 11/01/17 -14.8C for 15 minutes -14.9C for 15 minutes -14.1C for 07 minutes -14.5C for 15 minutes -14.8C for 15 minutes -10.7C for 10 minutes - 9.4C for 01 minute -14.5C for 15 minutes - 9.4C for 11 minutes -10.3C for 03 minutes -14.8C for 15 minutes - 9.6C for 01 minute -13.0C for 14 minutes -14.9C for 05 minutes -14.6C for 05 minutes M032496 expiration date 01/02/18 - 9.4C for 01 minute -10.7C for 10 minutes -14.5C for 15 minutes - 9.4C for 11 minutes -10.3C for 03 minutes -14.8C for 15 minutes - 9.6C for 01 minute -13.0C for 14 minutes -14.9C for 05 minutes M035690 (RHA) expiration date 02/06/18 -14.6C for 05 minutes This is one of the two cases reported for the same contact. Additional information has been requested; Sender's Comments:  US-009507513-1612USA005779: Original Case : 1612USA005638
Sore arm. 8 days.  Mild nausea. 1 day.  Mild headache. 1 day.  Feeling tired. 2 days.  Very hungry. 2 days.
Localized redness and edema surrounding (R) thigh injection site 5 min after receiving vaccines. 4-5 small raised wheals around injection site. No tenderness. No facial swelling or SOB. No vomiting.
Rash on stomach then moved to cheek and seems to be spreading to other side of face; This spontaneous case from the United States was received on 14-Oct-2021 from other health professional (nurse) via agency (reference number: SEQW21-03946) and concerned a 11-year-old patient of unspecified gender.  The patient's concurrent conditions were not reported. The patient's historical condition included cold the week prior vaccination.  The patient's concomitant medications were not reported.  On 11-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (Influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration, indication and anatomical: not reported). The batch number was not reported.  On the same day, Monday evening, the patient started experiencing rash on stomach then moved to cheek and seemed to be spreading to other side of face. The rash was not itchy.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 11-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same day, after receiving vaccine, the patient developed rash. Temporal relationship is plausible. Causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: A 11-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same day, after receiving vaccine, the patient developed rash. Temporal relationship is plausible. Causal role of the suspect vaccine is assessed as possibly related.
Patient reported injection site pain erythema starting approximately 2 hrs post injection. She then developed burning sensation at the site that radiate down to radial wrist. Burning with pain have persisted.
red blotches on both of my forearms; my skin looked blotchy and inflamed; had random itchy spots on my body including my scalp, legs, palms, nose and chest; This is a spontaneous report from a non-contactable consumer reporting for herself. A 33-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Aug2021 18:15 (lot number: FC3180) at the age of 33 years old on the left arm as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was at Pharmacy or Drug Store. Medical history included congenital spinal fusion in C1 and C2, Ovary and breast cysts, wasp/hornet allergy. Concomitant medication included norethisterone acetate (NORETHINDRONE). The patient stated "About 15 minutes after receiving the vaccine (10Aug2021 18:30), I started noticing red blotches on both of my forearms. There were no hives but my skin looked blotchy and inflamed. I also had random itchy spots on my body including my scalp, legs, palms, nose and chest." Treatment received for the events included Benadryl. The outcome of the events were resolved in Aug2021.
Mother states that L arm became red & swollen, skin very tight ?? ??, she applied ice to arm, states that swelling has decreased today. In clinic arm is L deltoid reddened and swollen 2"x2".
16 years old received 1st dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old received 1st dose of the vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old received 1st dose of the vaccine). On 03-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old received 1st dose of the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number 012M20A) with no associated AEs reported.
Tongue swelling, shortness of breath began about 1-2 hours after administration of Zostavax and Fluvirin. Patient took Benadryl and was told to call 911 and go to ER.  In ER was given Benadryl and steroids.
Rigors, temp of 104.7, chills, teeth chattering, weakness, unable to get out of bed
Vasovagal syncope w/in 2 minutes of GARDASIL administration.