chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
developed symptoms on 25Sep2021 and became sero positive for COVID-19 on an unspecified date; developed symptoms on 25Sep2021 and became sero positive for COVID-19 on an unspecified date; This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients (uncle and aunty). This is the 2nd (aunty) of 2 reports. An elderly female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Sep2021 (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunization. Non-pregnant at time of vaccination. The patient medical history and concomitant medications were not reported. No Covid prior vaccination. No other vaccine in four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient received the Pfizer BioNTech vaccine booster (completing the series of 3) and developed symptoms on 25Sep2021 and became sero positive for COVID-19 on an unspecified date, thus qualifying as a lack of efficacy AE (adverse event). The events did not result in emergency room visit or physician office visit. The patient underwent lab tests and procedures which included COVID-19: positive on an unspecified date. Therapeutic measures were taken as a result of the events included regeneron monoclonal antibodies. The outcome of the events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events vaccination failure and COVID-19 cannot be totally excluded.,Linked Report(s) : US-PFIZER INC-202101325477 same reporter/drug/event, different patient
Patient was  seen in the ED on 03/30/2021 with weakness that started 6 days after receiving first dose of COVID-19 vaccine. She was further admitted for rule out Guillain-Barre Syndrome. CPK was normal. Lumbar puncture was unremarkable. She was discharged home without definitive diagnosis of etiology of her weakness following the COVID-19 vaccine - although they assume very mild GBS. Patient readmitted 10/2021 with worsening GBS and treated with IVIG.
This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, expiry date and route of administration were not reported) (lot # N000508) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
It all started with my toes being discolored, swollen and numb. It last at least a month. The skin on my toes started to peel and looking discussing. I couldn't get my toes to go down. So I called my doctor and we did a Teladoc over the phone. I sent her pictures of my toes. She called it Chilblains Toes. It took two months to clear up. Now at times I notice that my toes will get discolored if i get cold. Which has never happen before.
Developed COVID symptom sand tested positive for COVID via RT-PCR on 3/19/21 and notified the employer.
Pain, redness, swelling from inject site to fingers. Unable to raise arm. Friday evening started, by Monday was quite improved.
It started out on 12/12/2022 with just a tiny bit of scratchy throat. That night I just filled with a massive amount of mucus. When I woke up on 12/13/2022 I had a horrible headache and I was exhausted. That lasted for two days and I tried taking Advil and Tylenol but that didn't help. The next day I took two Aspirin when I woke up and it immediately made me feel a lot better. I spoke with a doctor on 12/15/2022 who said I was eligible to get on Paxlovid but we decided since I was already feeling better I should wait until the next day to see how I feel.
Patient woke up with a rash on the spot of the vaccine on her right leg on 06/16. It progressively got worse and raised the next few days until 6/20 she has a few spots on her head, Parent thought they were bug bites until the next afternoon she had broken out everywhere in chicken pox.
Seen in ER on 10/14/2019 for two days of weakness, slurred speech,  difficulty swallowing, and numbness and tingling to extremities bilaterally. Back in ER on 10/19/2019 progressive weakness, trouble swallowing, arm weakness and feels as though it is progressing to legs, and SOB. Client was intubated. 20G of IVIG was administered 10/19/2019. Client was transferred from Regional to  Hospital. Currently in-patient. Client was weaned off ventilator on 10/20/2019.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient. A 57 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 15Jul2021 (Lot number: ER8736) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Right back basal cell carcinoma", stop date: 07Jan2016, notes: Illness/AE: Right back basal cell carcinoma, Stop date: 07Jan2016, Pertinent details:excision. Concomitant medication(s) included: IMIQUIMOD taken for precancerous condition, start date: 01Apr2021, stop date: 19May2021. Vaccination history included: Bnt162b2 (Dose:1, Date and Time: 13Mar2021, Anatomical site of Injection: Left deltoid, Route of Administration: Intramuscular, Batch/Lot number: ER6166), administration date: 13Mar2021, when the patient was 56 years old, for COVID-19 immunisation; Bnt162b2 (Dose:2, Date and Time: 01Apr2021 , Anatomical site of Injection: Left deltoid, Route of Administration: Intramuscular, Batch/Lot number: ER0866), administration date: 01Apr2021, when the patient was 56 years old, for COVID-19 immunisation. The following information was reported: VITAMIN D DECREASED (non-serious), outcome "unknown", described as "low vitamin D"; VITAMIN B12 DECREASED (non-serious), outcome "unknown", described as "low vit B12"; GLOBULINS DECREASED (non-serious), outcome "unknown", described as "low globulin"; RED BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "RBC low"; HAEMATOCRIT DECREASED (non-serious), outcome "unknown", described as "HCT low"; MEAN CELL HAEMOGLOBIN CONCENTRATION INCREASED (non-serious), outcome "unknown", described as "MCHC high"; IMMUNISATION (non-serious) with onset 15Jul2021, outcome "unknown", described as "Booster". Relevant laboratory tests and procedures are available in the appropriate section. Additional information- Laboratory results (02Oct2021) abnormal results found Hx of low vit D (25 oh vit D total) at 19.3mg/ml (30-100 mg/ml) 2021 labs check up show low vit B 12 at 157 pg/ml (211-911). Low globulin at 2.13 gm/dl (2.5-3.4) (may used to produce IgG covid-19). CBC: total RBC 4.34 millions/cu.mm (4.5-5.5) (may cause by low vit B 12). HCT (pcv) 39.2 percent (40-50) (may cause by low vit B 12). MCHC 35.5 g/dl (31.5-34.5) (may cause by low vit B 12). No follow-up attempts are possible. No further information is expected.
On Wednesday, March 31st in the evening I started to hear ringing in my ears. By last night, Thursday, April 1 it was rather severe. Sounds like high pitched running water all the time. Very distracting. Am also a bit dizzy today.
I administered FLUARIX QUAD 2016-17 IM, RA. THE INJECTION SITE SWELLS UP AFTER ABOUT 2 TO 3 MINUTES OF INJECTION. I APPLIED COLD PACKS TO THE SITE FOR ABOUT ONE HOUR. SWELLING WENT DOWN TO ABOUT HALF OF WHAT IT HAD STARTED OUT WITH.
Throbbing pain at injection site.  Muscle aches, fever of 101.7,  headache, fatigue, chills.
Hives on left arm, left side of neck, some on left side of chest - Began 2/18/2021 at about 6:30 AM Swelling at injection site - Began 2/17/2021 at midday  Regularly prescribed Zyrtec taken at 7:10 AM, Benadryl taken at 7:45 AM, Atarax taken at 10:10 AM  Both currently occurring (2/18/2021 at 10:30 AM)
No adverse reaction reported by patient but received first dose of Astra Zeneca on April 6, 2021.  Administered COVID19  vaccine per guidelines and completing VAERS report per CDC.
I gave patient a Flu shot, she got up and went to stand by her dad outside of the booth. I gave mom her vaccinations. Then mom went out to stand with the little girl. Then I started to give dad his vaccination when I noticed that the daughter had fallen down. This was probably 5 minutes after vaccination.  I went out immediately to check on her and she was just opening her eyes and said she didn't know what happened. She asked for a drink of water and so I gave her a drink of water and called for assistance from store management. She said her head hurt (I think she hit it when she fell) and I asked if she would like an ice pack, she said yes, so I gave her an ice pack and she sat for probably another 15 - 20 minutes and then she said she was feeling better and so they left. Store management also collected information from mom and dad for their report.
pain @ site lt arm-inc pain over 3 days w/axillary, shoulder & neck pain over following wk called PMD 20NOV97;employee states flu shot acted as catalyst for pain
Contracted Covid 19; Contracted Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 11:15 as dose 5 (booster), single (Lot number: GJ6742) at the age of 60 years intramuscular, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Mar2021 at 09:00 as dose 1, single (Lot number: EL3247), in left arm, on 01Apr2021 at 09:00 as dose 2, single (Lot number: EP6955), in left arm, on 03Dec2021 at 09:45 as dose 3 (booster), single (Lot number: FH8027), in left arm and on 04May2022 at 11:15 as dose 4 (booster), single (Lot number: FL3197), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]; ESOMEPRAZOLE MAGNESIUM; ESCITALOPRAM. Past drug history included: Ceftin, reaction(s): "Known allergies: ceftin". The following information was reported: VACCINATION FAILURE (medically significant) with onset 21Nov2022, outcome "unknown", COVID-19 (medically significant) with onset 21Nov2022, outcome "recovering" and all described as "Contracted Covid 19". The event "contracted covid 19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Nov2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200672278 Same reporter/patient, same drug/different dose, different AE;US-PFIZER INC-202200672278 Same reporter/patient, same drug/different dose, different AE;
06/18/2019 Went to bed with an itchy bump on left arm. Arm was sore. 06/19/2019 Woke up with a welt larger than a quarter, tired and ill feeling. Arm was even more sore. At night, welt was larger, still ill feeling, and itchy all over. Nausea and headache. Arm really hurt. Called doctor. Told to give Benadryl and ibuprofen. 06/20/2019 Woke up, the welt had grown larger still. Still felt very ill. Itchy on back of neck and left harm. Felt as though it was hard to breathe. Pain in arm. Took Benadryl and ibuprofen through the day. 06/21/2019 The welt started going down. All symptoms were beginning to lessen. Continued to take ibuprofen. 06/23/2019 All symptoms had resolved.
Pt came in on 12/10/08 at 1:20 PM to have her TB test read. She showed me her right upper arm. She had a 3" red circle around injection area. It is tender to touch. She will follow-up tomorrow if no improvement.
This case was reported by a consumer via call center representative and described the occurrence of feeling hot in a adult male patient who received SHINGRIX. Concomitant products included ALOQUIN. In February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, less than a week after receiving SHINGRIX, the patient experienced feeling hot, injection site pain and sleeplessness. On an unknown date, the patient experienced lethargy and feeling unwell. On an unknown date, the outcome of the feeling hot, injection site pain, sleeplessness and feeling unwell were recovered/resolved and the outcome of the lethargy was unknown. The reporter considered the feeling hot, injection site pain, lethargy, sleeplessness and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Three months before the date of reporting, the patient received SHINGRIX in the right arm. The patient felt ill for 48 hours following vaccination and then it resolved. The patient described it as feeling feverish but did not have a fever, lethargic, didn't sleep well and pain at the injection site. This case was linked with US2018GSK097942, reported by the same reporter. The patient refused to provide his details and rushed off the phone.
This spontaneous report as received from a consumer refers to a 72 years old female patient with penicillin allergy. Pertinent medical history included: "thyroid, cholesterol and estrogent". The patient was vaccinated with ZOSTAVAX (lot# unspecified) subcutaneously on 24-SEP-2012. No other co-suspects were reported. Concomitant medications included levothyroxine sodium, simvastatin, estradiol, and XANAX. On 24-SEP-2012 the patient started with itching along her right side by her little finger on right side. Then it moved to right arm, to her back, and on her knee. She described it as a bug bite, about the size of a dime. She would consult her physician. No treatment was given. The outcome of itching was unknown. No lab test was performed. Additional information has been requested.
8 hours later , I had 101 fever , shivers , nausea and full on body aches . Since feeling so bad , next day I had a thc gummy to help with pain . That night , I could not move my legs ... a paralysis feeling went from feet to face . Half of my fave was crooked and I could barely talk .
Information has been received from a registered nurse concerning a geriatric female patient who on Jan 04 2005 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). There were no other concomitant vaccinations reported. On Jan 05 2005 the patient experienced swelling, redness, warmth and pain in the injection site arm. It was reported that the patient was treated with prednisone. It was reported that on other female geriatric patient had a similar adverse experience following administration of pneumococcal 23v polysaccharide vaccine (lot 649692/0371P) (WAES0502USA00097). Additional information has been requested.
Increased systemic muscle aches, myalgia, chills to the point of missed work. Fishbowl headache. No nausea, no vomiting. No irritation at the injection sites.
15FEB93 mom noted rash like area & rough around inject site; 17FEB93 noted blotchy red rash on palms & c/o them itchy; 18FEB93 99.6 ax; 20FEB93 n&v several times between 3PM 12PM; 25FEB93 cough, irritable, bright red rash;
Syncope, hospitalization for GI bleed for 4 days. probable diagnosis diverticulosis bleed
Within 2 hours of receiving the vaccination I was unable to use my left arm.  The pain was excruciating.  I had to lie down and stay immobile for more then 24 hours.  When I did have to get up, for bio breaks, I became light headed.   The pain continued for three days after the vaccination, disrupting my sleep.  Each day it was a little less, however one week later I am still not able to use my arm to it's fullest extent, my shoulder joint not having full motion. I do feel the shot was administered high on my shoulder rather than in the usual site.  That being lower than the shoulder in the upper arm muscles.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022).    No concomitant product use was reported.  Reportedly, Patient received half dose.  Date the vial was initially stored in the refrigerator was 04-Jun-2022.    Vial did not undergone any temperature excursions.  No treatment information was provided.
Approximately 6 months after first dose, I started experiencing extreme swelling of my lower lip.  This has continued roughly monthly each month since .  Swelling seems to respond to Benadryl and my lip returns to normal after approximately 24-30 hours.
Patient was observed for 15 minutes and then returned to her department.  About an hour later she began experiencing respiratory distress.  Was brought back to the vaccine clinic where her VS were:  98.6, 161/90, 94, 12, with 02 sats of 100%.  Patient was anxious and sounded breathless when speaking.  Reports history of similar problems requiring nebulizer treatments and trips to the ED.  Rapid response team was called and patient was transferred to the ED.  Requested to use a wheelchair rather than a stretcher.
Parent reports 40 mins post injection of 1st Gardasil immunization, pt developed swelling of face and eyelids.  Parent reports administering Benadryl with effectiveness.
Legs numbness and tingling, unable to walk, back pains, left arm, left armpit & left breast swollen, left shoulder in pain and swollen, unable to lift left arm above chest and very light headed.
Nausea, Vomiting, Arm pain, Headache x 1 day.
On May 14, patient developed fatigue and weakness. He took 2 tablets of acetaminophen 500mg and after a couple of hours he felt better. Three days later on May 17, at 5 am patient developed chest pain. He visited a local health clinic patient presented high troponin levels 2533.4. At 6:58 pm he was transferred to the Emergency Department. Patient was admitted to the Pediatric Intensive Care Unit (PICU) at 8:00pm. The date of the event patient received Motrin 400mg, Toradol 30mg, Aspirin 81mg, Brilinta 180mg and Tridil 250mg/50ml (at 3 ml/hr). An acute myocardial event was rule out with a negative result of the catheterization procedure. Patient was diagnosed with myopericarditis. He still hospitalized, his troponins levels are decreasing and chest pain has been resolved.
It was reported that an 18 year old female pt received a Menomune vaccination (UA413AA) administered SC in the left arm on 8/28/01. Reportedly that same day the pt experienced pain at the injection site, "feels tender and hurts, six on a scale of 1-10" per pt. Feels slightly warm to touch. Does not appear red or swollen. Ice pack applied. Pt states will take Tylenol. Campus physician examined pt and states, "not a problem."
No symptoms reported. No further AE; HCP called to report an expired dose of VARIVAX was administered to Multiple patients.; Date of excursion: 3/2/2023; This spontaneous report as received from a pharmacist refers to a 12-month-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.   On 14-JUN-2023 the patient was vaccinated with expired and improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # W0252273 (not valid for varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter for prophylaxis (dose number and route and site of administration were not provided) (expired product administered and product storage error and no adverse event).
Information has been received from a registered nurse referring to five unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, between 28-JUN-2016 and 05-JUL-2016, the patients were vaccinated with improperly stored M-M-R II (recombinant human albumin (rHA); lot # L028273 with expiry date 28-JUL-2017; dose and frequency were not reported) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe sciatica pain on my left leg starting at the hip and radiating downwards. It started two days after I got the Pfizer booster shot and it is worse when I try to get up in the morning. My husband who got his booster shot a few days earlier (same place, same batch) also experienced severe back and sciatica pain and he is taking steroids, prescribed by his doctor,  to alleviate the pain . At the time we didn't think this had to do anything with the booster shot but the fact that I got similar symptoms makes us think there may be a correlation.