chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Licensed Vocational Nurse and refers to an unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored doses of VARIVAX lot # M003439 with an expiration date: 19-JAN-2017; lot# L000453 with an expiration date 06-JAN-2017 (dose, frequency and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
No additional AE; Caller reported that VARIVAX and PROQUAD that underwent a temperature excursion were administered; This spontaneous report has been received from a health care worker concerning to patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, a temperature excursion occurred for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) in which the maximum temperature was from 6 to 14 degrees Fahrenheit for a timeframe of 50 minutes and from 14 to 46 degrees Fahrenheit for a timeframe of 1 hour. No previous temperature excursions were reported.  On 30-AUG-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) lot # W004026, expiration date 02-AUG-2023 (dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). No additional events were reported.  This is one of three reports from the same reporter.
Initial headache and irritation at the injection site. Within 12 hours developed red raised area measuring 1 x 2 inches, continued headache, feeling feverish, dizziness. Area over the next 48 hours doubled in size and then dissipated within 72  hours to the size of a dime at the injection site. Headache and other symptoms fully resolved.
Information has been received from a nurse concerning an 18 years old male patient who on 22-DEC-2011 was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported). On 21-MAY-2012 the patient received the second dose on 20-APR-2012 and the third dose on 21-MAY-2012. No adverse experience has been observed or reported. Additional information has been requested.
Medical assistant asks for stability information following several temperature excursions. On 16Feb2023 2100: 8.51C 2115: 8.87C 2130: 8.52C 2145: 8.05C On 19Feb2023 2315: 8.05 2330: 7.86C 2345: 8.01C On 20Feb2023 0145: 8.36C On 25Apr2023 1545: 9.18C; This non-serious spontaneous safety report was received by company on 22-JUN-2023 from a physician.   It was reported that the patient did not experience any adverse event (Temperature excursion only).  Due to the nature of the event, the causality between the event "Medical assistant asks for stability information following several temperature excursions. On 16Feb2023 2100: 8.51C 2115: 8.87C 2130: 8.52C 2145: 8.05C On 19Feb2023 2315: 8.05 2330: 7.86C 2345: 8.01C On 20Feb2023 0145: 8.36C On 25Apr2023 1545: 9.18C" and Vaxelis was not applicable.  For reference purposes, the case is linked to MCM-004924 and MCM-004931.  No further information is expected.
chills; feverish; weak; arm  soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 28th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 28th May 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 29th May 2019, the patient experienced chills, fever and weakness. On an unknown date, the outcome of the pain in arm, chills, fever and weakness were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, chills, fever and weakness to be related to Shingrix.  Additional details were reported as follows: In the evening, the patient received a dose of Shingrix. Later that evening the patient's arm started feeling sore.  On the date of reporting in morning, 1 day after vaccination, the patient woke up feeling chills, feverish and weak. The reporter did not consent to follow up.
Swollen arm, hot to touch, severe arm pain, fatigue, redness at sight,
Twice I experience blood in my urine. I saw a urologist. The plan is to have a Cystoscopy and a CT scan.
Headache; Pain injection site (right arm); Fever; Chills; This is a spontaneous report received from a contactable consumer (parent) for a patient. A 21-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, solution for injection, Lot number: Not available), via an unspecified route in the right arm on 14Apr2021 (age at vaccination: 21-year-old), as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included Oral Birth Control and Isotretinoin (ISOTRETINOIN AN). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 14Apr2021, patient experienced pain injection site (right arm), fever chills and headache. Patient did not receive any treatment for the events. The clinical outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Persistent Left Deltoid Pain x2.5 months. Pain associated with movement of left arm such as weight lifting, raising arm above head and across chest.
2 hours post vaccine runny nose, next day myalsia, back pain injection site discomfort, fatigue through Friday and Saturday I felt better and Sunday I lost sense of smell Monday I tested positive for covid, the rest of that week I felt sick and slowly symptoms resolved , I took one tylenol on 22nd
rash on arms and chest, pt felt like lips and face were swelling Narrative: stat page called: Patient complained that it felt like her lips and throat were swelling. She was given an IM dose of Epi-Pen. Assessing doctor did not believe she was in anaphylaxis and said there was no sign of airway compromise. Stated her lips and and throat were not swollen. Patient refused to go to Urgent Care. A second state page was called: o2 dropped to 70%. Second dose of Epi-Pen given. Hives broke out on face and arms and patient felt like she couldn't breathe. IV meds were ordered but not administered since transport arrived to take her to ER. Patient was take to ER and discharged the same day.
Extreme menstrual bleeding that would not stop for weeks.  I had to be put on hormonal treatments to try and control the bleeding. The bleeding was lighter when I first started the treatment,  but I still bleed daily and it is progressively  getting heavier. I have had 2 breaks that were approximately 2-3 days that there was no bleeding. Once when I was sick with Covid in January of 2022 and another  about a month after that. As you can imagine it is terrible to deal with this in daily life and it has surely ruined any intimacy.
The MMR vaccine administered to this person expired on 9/19/2021.   She was receiving it due to documented  low titer.
The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022; Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The healthcare professional (HCP) wanted to know whether the patient should revaccinate or not.  The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022.  The vials did not undergo any temperature excursions.  No treatment medications were reported.   This case was linked to MOD-2022-500959 (Patient Link).
Sinus congestion, nasal drip causing persistent coughing.  Took aspirin and cough medicine, better after 2 hrs. But then fever started, approx. 101 deg, lasted all night until morning, somewhat better with fever aids.  Slight fever and achiness for next day. I would consider this a severe reaction given I have not had anything like this from flu shot before.
After second dose patient reported to me via email on 3/5/21 communicated : " I had my 2nd dose of Covid vaccine on 2/19/2021 a few days after I started having rashes on my trunk. Now its scattered on my back, abdominal area going to legs and arms. No pus or drainage. Its dry, itchy and has scab. It looks like healing cigarette burns. I went to see my Dr and she instructed me to continue monitoring.
He stated 2 patients reported being tired, fatigue and had ache and pain; He stated 2 patients reported being tired, fatigue and had ache and pain; Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients/  He stated 2 patients reported being tired, fatigue and had ache and pai/ The patients were male and female; This spontaneous case was reported by a physician and describes the occurrence of PAIN (He stated 2 patients reported being tired, fatigue and had ache and pain), FATIGUE (He stated 2 patients reported being tired, fatigue and had ache and pain) and EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients/  He stated 2 patients reported being tired, fatigue and had ache and pai/ The patients were male and female) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (He stated 2 patients reported being tired, fatigue and had ache and pain), FATIGUE (He stated 2 patients reported being tired, fatigue and had ache and pain) and EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients/  He stated 2 patients reported being tired, fatigue and had ache and pai/ The patients were male and female). At the time of the report, PAIN (He stated 2 patients reported being tired, fatigue and had ache and pain) and FATIGUE (He stated 2 patients reported being tired, fatigue and had ache and pain) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients/  He stated 2 patients reported being tired, fatigue and had ache and pai/ The patients were male and female) had resolved.        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.   No concomitant products were reported. No treatment information was reported by the reporter.
Been vomiting daily at least once if not more (generally more), exacerbated migraine, pancreatitis
My 20 month old recently received the Tdap instead of the DTaP. We had to reschedule due inability to have doctors order for it the first visit. Then on the revisit they ended up going the wrong vaccination.
10 h after vaccination (12/1/2021), I had extreme chills for around 3h. My body was racked with shivering and I took cover under a blanket and two down comforters. The chills resolved.  The next day (12/1/2021), my partner thought that my face was very hot to the touch. I was lethargic and slept a lot under a comforter. The next day (12/2/2021), I woke up with new psoriatic plaques at my hairline and itching became progressively worse throughout the day until I took 50mg hydroxyzine in the evening. My body itched head to toe and it was intolerable.
03/03/2021 NT-PRO BNP Result 36 pg/ML 11/30/2021 COVID VACCINE 03/14/2022 NT-PRO BNP Result 80 pg/ML 10/09/2023 NT-PRO BNO Result 236 pg/ML
Upper outer left leg has a small red spot where injxn given and pink rash 1"x1" around site. Denies rash elsewhere, denies SOB, denies fever. Normal activity level. Mild itching at site where Varicella vaccine was given.  Reaction is not as bad as brother's rxn.  No treatment tried. Reviewed common mild reactions w/mom soreness/swelling at injxn site, fever, rash, reviewed what to watch for for moderate, severe rxn. Advised add 4 T baking soda to bath tonight. Can give Tylenol.
Urticaria. Patient developed hives, redness at the injection site and low grade fever two days after receiving DTaP vaccine. Treatment: Atarax
This spontaneous report as received from a consumer refers to himself, who is a male patient of unknown age with no known pertinent medical history and no known drug allergies. The patient was vaccinated with a dose of VARIVAX (lot # not reported) on 12-JUL-2012. Concomitant medications were reported as none. It was reported that on 12-JUL-2012 the patient experienced injection site sore and 12 days following vaccination the injection site was still sore, and had started to have a stinging sensation at the time of report as well. Consumer denied swelling and redness, denied that he could have been bitten or stung by an insect, and stated that he had full movement capability in the arm. The patient sought for unspecified medical attention via calling pharmacy. No treatment was given. The outcome was reported as not recovered. Additional information is not expected.
Information has been received from a registered nurse concerning a patient who may have been vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The nurse reported that it was not known if the patient received measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) or mumps virus vaccine live (Jeryl Lynn) (MAD) or no vaccine. In April 2006, the patient developed a suspected case of mumps. Unspecified attention was sought. A product quality complaint was not involved. Additional information has been requested.
he is having lower back pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the 1st dose of the Pfizer covid19 vaccine, but he was having lower back pain. He would like to confirm if he can take any pain reliever. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
This spontaneous report was received from a consumer referring to her 84 year old male partner. The patient's medical history included bypass surgery. Drug reactions/allergies: penicillin and lisinopril. On an unknown date (also reported as a couple of years ago) the patient was vaccinated with ZOSTAVAX, route: injection, frequency: one time injection. No concomitant medications were reported. The reporter was the patient's wife. She was reporting that on 23-NOV-2015 the patient got shingles after getting the ZOSTAVAX vaccine. Treatment given was gabapentin 300mg. Patient sought medical attention. No further information was provided for documentation. The outcome the event was reported as resolving. Additional information has been requested.
Sunday Morning (27th) and felt like my tonsils was touching  my tongue. I ended up going to an Urgent Care. They gave me Isalemedral, they sent me home with a prescription of Predisone.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 15:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressured controlled with valsartan. Concomitant medication(s) included: VALSARTAN taken for hypertension, start date: 01Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Rash/bruising around injection site, 6 inch diameter. Lasted for one week.  Treated with  corticosteroid cream.
Got vaccine at 2:30 pm and developed severe pain in my left arm at around 6:00 pm. I quickly developed a fever of about 100.1, fatigue, muscle and joint pain, chills, and insomnia. I had pain in my chest and could not walk due to the muscle pain in my legs, I was awake all night with feelings of my adrenaline rushing on and off about every 2 hours. The symptoms have continued into the next day.
Patient received vaccine after the expiry time allowed in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist stated she is on Medication but no concomitant medications were mentioned. No treatment details were reported.
Received flu shot at 2:00 at work (free flu shots); this was my first flu shot ever. Throat started getting scratchy at about 4:00. Throat started tightening and started wheezing by 6:00.  One eye felt dried out.  By 8:00 had severe body aches, difficulty breathing, eyes red & puffy, bad headache.  Took inhaler (I have mild allergy to cats) to help with breathing, and took ibuproferin.  Told husband to keep an eye on me & went to bed.  Besides a slight headache & mild body aches, I felt better in the morning. I have not visited an emergency room since I was 5 yrs old and I seriously considered going that evening.
Shortness of breath, left arm pain radiating down arm, abdominal pain all lasting approximately 15-20 hours
Patient developed a rash on her left bicep that spread down her arm and then spread to her trunk
Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hypercholesterolemia and GERD. Concomitant products included OMEPRAZOLE for GERD, ATORVASTATIN CALCIUM (LIPITOR) for Hypercholesterolemia, LOSARTAN for Hypertension.    On 17-Nov-2021 at 10:13 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 Vaccine to 6 Patients this morning) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2020, SARS-CoV-2 test positive: positive (Positive) PCR test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-389253, MOD-2021-407570, MOD-2021-407615, MOD-2021-407628 (Patient Link).
19 year old received an adult dose of Engerix-B (20mcg); 19 year old received an adult dose of Engerix-B (20mcg); This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 19-year-old male patient who received HBV (Engerix B adult) (batch number PE9G5, expiry date 19-MAY-2025) for prophylaxis.   On 10-AUG-2023, the patient received Engerix B adult. On 10-AUG-2023, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: 19 year old received an adult dose of Engerix-B (20mcg)) and overdose (Verbatim: 19 year old received an adult dose of Engerix-B (20mcg)).  The outcome of the adult product administered to child and overdose were unknown.   Additional Information: GSK receipt Date: 08-SEP-2023 The reporter stated 19-year-old patient was administered adult dose of Engerix-B (20mcg) which led to overdose and adult product administered to child. The reporter consented to follow up.
Pt reports severe left arm pain.  Pt also reports left sided chest pain and difficulty getting a full breath.