chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I tested positive for COVID; I tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Lot number: EK4776), in left arm, on 27Jan2021 as dose 2, single (Lot number: EL9261), in left arm and on 12Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 03Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 03Jun2022, outcome "not recovered" and all described as "I tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) Positive; (13Jun2022) Negative; (19Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid, indication for use in the case: treatment of COVID-19, date of start of drug: 04Jun2022, date of last administration: 09Jun2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
This spontaneous report was received from a licensed practical nurse (L.P.N.)) referring to unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with doses of GARDASIL 9 (dose and route of administration were not reported) (Lot# K026246, expiration date: 02-JAN-2017; Lot# K026246, expiration date: 28-JAN-2017; Lot# L000610, expiration date: 31-JAN-2017; Lot# L007560, expiration date: 15-JUN-2017), which were exposed to temperatures outside of the recommended range. No adverse experiences have been reported. There was no product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
flushed face and sweating and bp was 150/100 , dizzy and muscle pain in neckand central back area
Patient had fever, headache, body aches on 4/20/2021 by 4/21/2021 she had bloody urine, upon arriving in our office on 4/22/2021 she had 3+ blood in her urine analysis.
unspecified side effects; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot Number: Unknown, Route of administration: Unknown), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 28Apr2021 05:00, outcome "unknown", described as "Chills"; ADVERSE DRUG REACTION (non-serious), outcome "unknown", described as "unspecified side effects".  Additional information: The caller called in regards to the Pfizer COVID vaccine that she received at the (Name with held). She has received both vaccines. She received the second vaccine on 18Mar2021. She had some side effects; she took that Friday off and was fine by Saturday. She has been doing everything that she is supposed to masking, sanitizing, she sanitizes the carts when she goes to the supermarket. However, she woke up at 5AM this morning with chills. She had no headache, no temperature. Caller wanted to know can there be a side effect this late after receiving the vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Constant ringing in left ear, no treatment available. Started after a couple of weeks after first dose.
Pt fainted in the observation area by the pharmacy.  He was pale and trembling.  We called 911 and the paramedics checked his BP, Blood sugar, and heart function.  Everything was normal and paramedics  let his wife pick him up and take him home.  I spoke to pt around 8:15pm on 6/24 and he said he was feeling fine
On 11/8/19 patient/employee came to work at approx 1745 and was found to have red, warm inflammation to left arm/deltoid around site of injection (11/5/19) as noticed by charge nurse and HR rep.  Contacted RN, Employee Health Nurse who was told by employee that her Lupus MD advised her to go to ED instead of work.  She decided instead to report to work.  She was complaining of feeling generally bad, feverish and had pain, warmth and redness to left arm that started about 24 hours after injection.     Employee immediately released from work and sent to ED.  Followed up with employee in ED who was seen by ED physician at approx 2000.  Released from ED on Bactrim.  Followed up with Lupus MD next day.  Was treated with steroids and told to return to work Sunday.  Followed up with employee Sunday 11/10/19 and was told she had fever of 102 but arm had improved greatly.  She notified her MD of this and was told by MD not to return to work until fever is below 99.  Employee excused from work, told to stay home until fevers under control per MD orders.  She stated that she has appt to follow up with Lupus MD on 11/11/19 and that this event was being treated as a Lupus flair that she has experienced prior, but never as the result of an immunization.
Right shoulder pain with decreased range of motion Pain was better 1/25/21 but it hits intensely with posterior rotation and adduction.  This is new for this shoulder and interferes with work.
This 23 year old male was vaccinated with Vivotif (Ty21a oral typhoid vaccine: batch no. 3000297) on 05/08/2004 at 9:30 A.M.. One day later, on 05/09/2004 at 3:00 he woke up with chills, shaking, and maybe. At 7:00 A.M. he experienced headache, nausea, and sweats. He took ibuprofen and felt better by 12:00 A.M.. By 05/10/2004 the symptoms had completely resolved. One day before the vaccination with Vivotif he received Hepatitis A immunization with Havrix, Hepatitis B immunization with Engerix and Yellow Fever vaccine. From the patients history an allergy to pollen and animal dander are known but the patient does'nt remember if the doctor examined these allergies. Pharmacovigilance Comments: This case is considered non-serious and the reactions except for hyperhydrosis as expected.  Causality is assessed as possible.
On 7/26/2004, pt. received DTaP#4 IM,23g 1"needle, Rt. upper thigh, Varicella #1 SQ25g 5/8" needle given on thr Rt. lower thigh, and Hep B#3 IM 23gauge, 1" neddle to the Lt. thigh.  Pt. also received PPd (Mantoux) 0.1cc to Lt. fore-arm, pt. returned on 7/28/04 for PPd reading, and also presented with Rt. thigh swelling, redness, area warm to touch, VS= 96.6 F, HR-107,RR-22,B/P-92/58, pt. was examined by doctor and was discharged on cephalexin PO qid x 10 days, pt. was given a f/u phone call was made on 7/29/04 and mother states swelling of Rt. thigh is better and redness has decreased, mother instructed to continue antibiotics and pt. has a f/u appt. 8/2/04, pt. mother instructed to keep appt.
COVID Vaccine Breakthrough  Pfizer Dose 1 3/29/21 (EN6205) Pfizer Dose 2 4/16/21 (EM9809) COVID Positive 11/21/21 Hospitalized 11/21/21-11/28/2 Discharged 11/28/21  11/21/21: 87-year-old male with past medical history of diabetes mellitus, hypertension, hyperlipidemia, BPH presents with worsening shortness of breath.  Patient had noticed his pulse ox is to be 82% at home; he had been feeling weak and having dry cough for the last week. Patient has been vaccinated for COVID.  Before coming to the hospital the patient also endorsed a fever of 101 °. In the ED patient had saturation of 84% and was placed on oxygen; patient's saturations were not adequate and the patient required to be placed on BiPAP.  Patient has tested positive for COVID  11/25/21: . Respiratory failure, acute  Admitted  to  ICU   for   treatment of   COVID  hypoxic respiratory failure. treated   per  standard  care set including Remdesivir, Decadron,  Vitamin D/zinc.   Weaned off   BIPAP.   Dr. on consult 2. COVID-19, COVID-19, Pneumonia due to COVID-19 virus, Pneumonia due to COVID-19 virus as  above .  Also  treated  with  antibiotics empirically. Home  walk  test   shows  pt's  O2 sats  dropping  with ambulation.  he   requires  5 L   O2 with ambulation 3. Hypoxia, Hypoxia  Remained  stable  on   medical   floor.  needs   1-2 Liters  O2 with  rest.   5  Liters  with ambulation Discharge  12/1/21: Readmitted. 87-year-old male with past medical history of diabetes mellitus, hypertension, hyperlipidemia, BPH presents with worsening shortness of breath.  Patient had noticed his pulse ox is to be 67% at home; patient recently hospitalized for management of COVID pneumonia. Pt was discharged on home oxygen; 5L with activity 1L at rest; he was using at the time of desat. In the ED the patient was initially requiring 15L; CT chest showed bilateral pulmonary emboli  12/6/21: B/l pulmonary emboli, Acute on chronic respiratory failure, HTN, DMII, Anemia, Lung nodules. Current with VNA; will follow at discharge.
Transverse Myelitis- temporary paralysis, intense pain, muscle spasms, bladder retention, 4 UTIs in 3 months, physical therapy to regain mobility which is still limited. Doctors indicated recovery will take 6-12 months.
Pain/numbness in left arm that started in the deltoid region that migrated up to the left side of the neck and scapula. Those symptoms continued for 3 days and after that, the pain/numbness traveled down arm to 3rd and 4th fingers.
Vtach resulting in loss of consciousness. Then 7 more Vtach episodes  from March 12-May 1, 2022.
This spontaneous report as received from a registered nurse refers to a 2 year old male patient. On 14-JAN-2014, the patient was vaccinated with the first 0.5ml dose of VAQTA (lot # not reported) intramuscularly and on 19-JUN-2014, the patient received the second 0.5 ml dose of VAQTA (lot # not reported) intramuscularly. No adverse effects were reported. Additional information has been requested.
Pt recv vax on 8/28/98; on 8/29/98 pt exp chickenpox of 750 spots in mouth, back,legs; pt went to E.R.
Numbness, tingling mouth and lips, mild itching over body approx 4 hours after injection
After the vaccine I felt flu like, achy and my joints ached for about 30 hours.  The symptoms began about 12 hours after the booster.    I started having a runny nose and congestion on July 18th.  I took PCR that was positive.  I continued to have nasal congestion and began to have a cough and runny.  Paxlovid wasn't recommended because it had been several days and my symptoms were beginning to resolve.  I felt good for a few days but then I still tested positive as of July 29th.  As of today I do not have lingering symptoms.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date).    Concomitant products were not reported.  It was reported that 30 day beyond use date of lot 053c21a was 01-Jul-2021.  Treatment medications were not reported.
Hives began on (L) deltoid, became all over body by afternoon. Took antihistamine.
11/26/02 on visit for #3 shot left arm. Symptoms itching in local area and some numbness within 24 hours. Itching started midmorning, swelling and red, blotchy mid afternoon today. Patient states tightening of abdomen for 3-4 minutes after shot was given. No medicines given. Recommended by doctor to follow up in morning 11/27/02 or to come into ER if started having fever or swelling gets worse. No meds given. Patient states during short series #2 had a out ring then a bruise around injection point. Went to ER 10/21/02. No meds but mouth swab done, results unknown.
right side of body went numb on 21st - then again on 24th - resulting in hospitalization for a week.  Still have numbness and tingling on right side of body - from head to toe.  Additionally, found a severe infection in the lower back while in the hospital that required 6 weeks of intravenous antibiotics.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines which underwent a temperature excursion in the freezer), POOR QUALITY PRODUCT ADMINISTERED (patients received vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.       Concomitant medications were not reported.   Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. Just found out about the excursion today in an audit and No adverse event reported.  Treatment medications were not reported.
Beginning the night after the immunizations, she began to experience headache, neck soreness, swollen and red upper arms, severe nausea, muscle weakness/ataxia, and incontinence. These were severe from Friday night to Sunday night. Beginning Monday morning they began to decrease in severity.
None noted. Pt was not seen in our office after vaccine administration. Death was reported to our practice on Tuesday AM 5/26/09.  7/10/09 Autopsy report states COD as idiopathic epilepsy. Report also states pt had history of cardiac pacemaker & seizure disorder.  Admitted to hospital on 5/23/09 for local reaction w/swelling at injection site, had seizure & cardiac arrest on 5/24/09.
I started having migraines two days after. They got worse until the light and noise were making it worse. I  needed IV Pain killers and was discharged after 8 hours. I had a swollen lymph node on neck on the left side which I needed prescription for antibiotics.  My lymph nodes swelled up with second dose also and I needed antibiotics again. No Migraines with second dose. My Migraines have returned to their normal rate after a week . The lymph node on the left side of my neck is still swollen since second dose on 02/05/2021.
Client after 5 minutes of administration of the vaccine, she reported a feeling of initial dizziness and nausea. Then, she reported a tingling sensation throughout her body.  I call 911. An EMS Unit arrived 10 minutes after. The lead responder with another team member. Client's vitals were: BP 128/84, HR 82, Glucose level 79 mg/dl, Oxygenation rate of 100%. She ate pizza at 1:15pm, her weight was 170 lbs 4 months post gravidarum. The EMS team asked her to stand without assistance. She did without any trouble. She was not dizzy then . The team asked her if she wanted to go to  the hospital. The client refused and was against medical advice. I asked her if needed to go to the hospital. She declined also. The EMS team asked her to stand up again. She did without feeling dizzy or faint. She wanted to have her sister escort her to her house. The EMS team and I asked again if her wanted to go to the hospital, she refused again. She was able to stand and walk without assistance. The EMS team asked when will her sister arrive. She said that she will arrive in 10 minutes. Then, they left. Her sister, arrived in 10 minutes, to take her home.  She had no trouble standing or walking. I escorted the client and her sister to the door of the store.  The client was contacted twice at 8:30pm, and at 9:11pm. She reported that she was a lot better.
10 minutes into 15 minute observation period patient complained of generalized itching and hives noted across his back; administered 10mg of cetirizine.
hypersensitivity reaction; This spontaneous report was received from a physician, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) as prophylaxis (dose, frequency, route of administration, lot # and expiration date were not reported).  On an unknown date, the patient experienced a severe hypersensitivity reaction. The outcome of hypersensitivity was unknown.  The reporter considered hypersensitivity to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown).  This is a non-valid case due to lack of patient identifiers.  Follow-up information has been received on 01-APR-2022 from a physician. The patient was established to be female. The reporter stated that the event was remote and since that time, the patient was boosted again.
This spontaneous report as received from a licensed nurse practitioner and a healthcare worker refers to an unspecified amount of patients. Concomitant medication and pertinent medical history were not provided. The healthcare worker reported that on unknown dates, unspecified amount of patients were vaccinated with GARDASIL (lot number, dose, route and frequency were not provided) which were improperly stored. The GARDASIL were exposed to a lowest temperature of 32F for a total of 136 hours over 17 days occurring since 01-JAN-2014. The nurse practitioner reported that she was unsure if the GARDASIL had undergone excursions since 01-JAN-2014. She reported that "some" might have undergone multiple excursions and "others" might have undergone no excursions but she was not exactly sure of which ones. No adverse effect reported. On an unknown date an unspecified amount of patients were vaccinated with GARDASIL which were improperly stored. No adverse effect reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine. Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had an allergic reaction to his/her 1st Shingles vaccine. The follow-up would not possible as no contact details were available.
Initial report received from a healthcare professional on 12 December 2012. An 18-month old female patient had received subcutaneous fourth dose of PENTACEL vaccine (lot number C4371AA) on left thigh on 04 December 2012. The patient had no illness at the time of vaccination and no concomitant medications. The patient's medical history was unknown. On 04 December 2012, the patient was administered received subcutaneous dose of PENTACEL vaccine on left thigh. On the same day after vaccination, the patient presented erythema and induration inferior to injection site. Laboratory data and corrective medications were not reported. At the time of this report, the patient had not recovered from the events. List of documents held by sender: None.
Patient went temporarily unconscious and pulse ox went down to 74. Nurses triaged and pharmacy manager called Ems
Chest pain. Hospital found my heart enzymes were at the level of a massive heart attack. The muscle surrounding my heart was enlarged. The levels went back to normal after 24hrs.
Macular rash abdomen and neck. (+) pruritic given BENADRYL 50mg Q 6 prn.
During administration, shot leaked out of hub of syringe.  Administering pharmacy technician decided hardly any was actually injected. A repeat vaccination of flucelvax was given.
got 1st dose then feels sick, sore and swollen arm.; got 1st dose then feels sick, sore and swollen arm; got 1st dose then feels sick, sore and swollen arm; Now has fever; tiredness; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (got 1st dose then feels sick, sore and swollen arm.), PAIN IN EXTREMITY (got 1st dose then feels sick, sore and swollen arm), SWELLING (got 1st dose then feels sick, sore and swollen arm), PYREXIA (Now has fever) and FATIGUE (tiredness) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced FEELING ABNORMAL (got 1st dose then feels sick, sore and swollen arm.), PAIN IN EXTREMITY (got 1st dose then feels sick, sore and swollen arm), SWELLING (got 1st dose then feels sick, sore and swollen arm), PYREXIA (Now has fever) and FATIGUE (tiredness). At the time of the report, FEELING ABNORMAL (got 1st dose then feels sick, sore and swollen arm.), PAIN IN EXTREMITY (got 1st dose then feels sick, sore and swollen arm), SWELLING (got 1st dose then feels sick, sore and swollen arm), PYREXIA (Now has fever) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications taken by the patient was not provided.  Treatment information was  not provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Itchy and reddened skin all over, lumps developed on skin. Welts on neck, coughing.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (dose, route of administration and frequency were unspecified). The improperly doses of VARIVAX corresponded to the following lot number: K021487, expiration date: 03-NOV-2016; L030158, expiration date: 11-AUG-2017 and M010482 (lot# reported as), expiration date: 01-MAR-2018, which were exposed to a temperature of 8.8 Fahrenheit degrees for a time frame of 40 minutes due to a digital data logger, then the vaccines were put back in range. No adverse effects were reported. This is one of several reports from the same reporter (linked case: 1608USA014330). Additional information has been requested.