chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 09-NOV-2012 21:52, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
pt exp nausea, chills, fever w/in an hr of vax;low grade fever lasting 24hr;+tachycardia resolved w/in 24hr;mild systemic adverse rxn;dizzy, malaise, mild flu like systemic rxn;
Lips swelling and tingling, scratchy throat. Treatment: PREDNISONE 40 MG EVERY DAY.
itching "really bad"; couldn't sleep; her bottom lip was swollen up; bad rash on her hands, arm, face and under her chin; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching "really bad"), INSOMNIA (couldn't sleep), LIP SWELLING (her bottom lip was swollen up) and RASH (bad rash on her hands, arm, face and under her chin) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003AHA) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included INSULIN and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PRURITUS (itching "really bad"), INSOMNIA (couldn't sleep), LIP SWELLING (her bottom lip was swollen up) and RASH (bad rash on her hands, arm, face and under her chin). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form and PREDNISONE at a dose of UNK dosage form. On 17-Mar-2021, PRURITUS (itching "really bad"), INSOMNIA (couldn't sleep) and LIP SWELLING (her bottom lip was swollen up) had resolved. At the time of the report, RASH (bad rash on her hands, arm, face and under her chin) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was treated with ice patches.  Concomitant medicines include insulin and Vitamin D  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-074758 (Patient Link).
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 11-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of MMR II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of increased heart rate in a 59-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 9 June 2010 the subject inadvertently received 2nd dose of ENGERIX B via incorrect route (intravenous), and experienced intramuscular formulation administered by other route. On 9 June 2010, less than one day after vaccination with ENGERIX B, the subject experienced increased heart rate. At the time of reporting the events were resolved. The healthcare professional reported that the subject was stable and no other adverse events were observed.
I had pain for a few days from the shot. The day after I slept all day. And the next day I was extremely fatigued, no appetite, and extreme body chills. After sleeping an additional day, I began to feel better and normal, however I had lots of fatigue, chills on and off, headache on and off, and in general it was taking longer than normal to bounce back. Pain was about an 8/10. I am gaining more strength now, eating more, headaches are no longer there and chills are no longer there. First two doses of Pfizer no issues in comparison.
chest pain; This is a spontaneous report from a Pfizer-sponsored program, via Pfizer Epsilon Escalation team from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 07Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE, dose 2 via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient experienced chest pain on an unspecified date with outcome of not recovered.  The patient had chest pain since got a First vaccine on 07Mar2021, 2nd vaccine on 28Mar2021, chest pain not going away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
01/01/23 presents to ED for "corona virus concern". PMHx of "hypertension, chronic diastolic congestive heart failure"
Fever, slight chills, and tiredness. All symptoms went away after 24 hours.
Pt has about 4 quarter-inch red dots on the left side of her body. Two on her arm (not near the injection site) and one on her hip, and one behind her knee. They are not itchy but appear dry. Pt has no fever or any other signs of a reaction to date. She reports having headaches within the first 2-5 days but has since resolved. She was given advice to monitor and if more spots appear or if other symptoms occur contact her doctor. Benadryl was advised to see if the spots would disappear and to follow up with us in a week.
Pt advises the area where vaccine was received 2-3 days later site became red/started itching and she also experienced redness down her arm approximately 2-3 from vaccine site.  Pt advises she took Benadryl and it helped with the itching but the redness remained.  She continues to have some redness but advises it is starting to fade some.
Loss of appetite; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite) and ASTHENIA (Weakness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite) and ASTHENIA (Weakness). At the time of the report, DECREASED APPETITE (Loss of appetite) and ASTHENIA (Weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information not provided. Treatment information not provided
Cold; Chills; Feeling tired; Fever; This spontaneous case was reported by a physician and describes the occurrence of NASOPHARYNGITIS (Cold), CHILLS (Chills), FATIGUE (Feeling tired) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 013L20A) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for Plaque psoriasis.    Concurrent medical conditions included Chronic obstructive pulmonary disease since 1998, Psoriatic arthritis since 2011, Rheumatoid arthritis since 2011, Drug allergy (Codeine allergy), Heart rate irregular, Osteoarthritis, Psoriasis, Arthritis and Pain in hand since 2020. Concomitant products included MELOXICAM for Arthritis, Osteoarthritis and Psoriatic arthritis, ACETYLSALICYLIC ACID (ASPIRIN 81) for Cardiovascular event prophylaxis, ALBUTEROL [SALBUTAMOL] and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Chronic obstructive pulmonary disease, METOPROLOL for Heart rate irregular, DESONIDE for Psoriasis, VITAMIN D2 for Supplementation therapy, BETAMETHASONE DIPROPIONATE, CALCIPOTRIOL MONOHYDRATE (ENSTILAR) for an unknown indication.   In 2020, the patient started RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) (Subcutaneous) 150 milligram. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced NASOPHARYNGITIS (Cold), CHILLS (Chills), FATIGUE (Feeling tired) and PYREXIA (Fever). On 10-Mar-2021, NASOPHARYNGITIS (Cold), CHILLS (Chills), FATIGUE (Feeling tired) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 104 High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NASOPHARYNGITIS (Cold), CHILLS (Chills), FATIGUE (Feeling tired) and PYREXIA (Fever) to be probably related.    Action taken with mRNA-1273 in response to the event was not applicable.  Treatment medication was not provided by the reporter.
body hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included sepsis (It was painful).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, [the patient experienced general body pain (Verbatim: body hurt).The outcome of the general body pain was recovered/resolved.   The reporter considered the general body pain to be related to Shingles vaccine.     The company considered the general body pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR039602   Additional Information: GSK receipt date: 07-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she had 2 shingles shot. They made his/her body hurt for days so he/she didn't want to know what shingles was. The reporter had sepsis once that was painful. The follow-up could not be possible as no contact details were available. For tolerance to the 2nd dose refer case US2023AMR039602.; Sender's Comments:  US-GSK-US2023AMR039602:same patient, different dose
Seizures Narrative:  Hospital employee found aphasic & altered gaze, then tonic-clonic seizure witnessed. Employee intubated in internal ED. Employee drank 1/2-1 gallon Vodka, last drink 24 hours prior to onset. Employee has history alcohol-induced seizure.
No adverse event; 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 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. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD).    Concomitant medication was not provided. Dosage text was reported as unknown. It was reported that 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15MAY-10JUN2023. Treatment information was not reported. This case contains information about patient 12 out of 14.   This case was linked to US-MODERNATX, INC.-MOD-2023-732456 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732456:Master case
patient received the Shingrix vaccine and emailed her yesterday, 30/OCT/2023 reporting swelling under her left arm in the axillary region; This non-serious case was reported by a other health professional via call center representative and described the occurrence of local swelling in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number TF3A9) for prophylaxis.   On 27-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 28-OCT-2023, 1 days after receiving Shingrix, the patient experienced local swelling (Verbatim: patient received the Shingrix vaccine and emailed her yesterday, 30/OCT/2023 reporting swelling under her left arm in the axillary region). The outcome of the local swelling was not resolved.   It was unknown if the reporter considered the local swelling to be related to Shingrix.     It was unknown if the company considered the local swelling to be related to Shingrix.   Additional Information: GSK receipt date: 31-OCT-2023 The nurse was reported on behalf of the patient. Reporter stated that the patient received Shingrix vaccine and emailed the reporter one day before the reporting day, reporting swelling under her left arm in the axillary region. Referred to health care professional for further information. The reporter consented to follow up.
Started having fatigue and a little brain fog on date given, about 3/23/2021
no additional AEs were reported; patient received an expired Proquad; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) 0.5 milliliter / once, lot #T027117, expiration date: 07-FEB-2022 (expired product administered) (formulation, strength, dose number, site and route of administration were not provided) for prophylaxis. No additional adverse events (AEs) reported.
Pt w/ hx of medication allergies PCN (rash),  ciprofloxacin (rash), "septrum" (anaphylaxis).  Pt c/o pinched nerve pain, arm numbness on left side (neck and arm).  BP 142/84, HR 90, RR 12 -- > 125/84, 70, 14 -- > 127/84, 72, 12.  Pt provided juice and crackers.  Pt improved.  Pt stable and released from the vaccination site.
13 yo old girl c/o difficultly swallowing and scratchy throat approximately ten minutes after receiving the second dose of the Pfizer vaccine. She appears well but has a nasal tone to her voice. Auscultation of her larynx did not reveal stridor.  No rash, wheezing, or other associated signs or symptoms. She was treated with 25 mg of oral diphenhydramine with a resolution of symptoms after an extended monitoring period.
Case number PHEH2014US021271, is an initial spontaneous report from a pharmacist on 21 Oct 2014. This report refers to a female patient of unknown age. Her concurrent condition included allergies to formaldehyde and arsenic. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscular on unknown date. She began to feel ill with flu-like-symptoms immediately after vaccination. The patient was completely recovered now and the pharmacist suspects that she already had the flu prior to FLUVIRIN administration. Seriousness and causality assessment was not reported. Final outcome of the event was recovered.
Arm started to be painful about 2 hours after injection. By evening I could barely move my arm. Around 10pm pain was so bad I was crying.  Could not lift arm. Could still move my hand. Woke up multiple times in pain.  By morning arm pain had decreased but felt lethargic and weak. By noon I had taken a nap. My 15 year old daughter said she came to check on me and I woke up but my eyes were rolling on the back of my head. I slept for over 3 hours. Woke up sweating  achy. Still felt tired and lethargic. Arm was still sore but was able to move it around. Went to bed again around midnight- woke up today (Thursday) and felt much better.
Immediately following first shot I had the normal pain associated with vaccinations. Pain continued throughout a 2 week period where 3 of those days were bad enough to be bed ridden. Heat rash formed after 2 weeks with red splotchy skin around injection site. Moderate to severe burning sensation in muscle different from initial reaction.  Pain subsided for another week and came back with a now worse burning pain when moving (my) left arm and rash is now currently scaly and dry with continued burning pain up to 6/24/21 one month after injection. Pain has reduced but stinging still continues and rash still present
Had a difficult time breathing; Cold sweat; Diarrhea; Nausea; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA, COLD SWEAT, DIARRHOEA, NAUSEA, and FATIGUE in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Oct-2021, the patient experienced DYSPNOEA. 31-Oct-2021, the patient experienced COLD SWEAT, DIARRHOEA, NAUSEA, and FATIGUE. On 01-Nov-2021, DYSPNOEA, COLD SWEAT, DIARRHOEA, NAUSEA, and FATIGUE had resolved.            No concomitant medication was provided.             No treatment information was provided.
This spontaneous report as received from an office manager (also reported as healthcare worker) refers to an unspecified number of unspecified patients. The office manager reported that GARDASIL (lot number, strength, dose, route and site unspecified) and MMR II (lot number, strength, dose, route and site unspecified) might have been stored at temperature outside of the prescribing information since an unspecified date in March 2013 and administered to an unspecified number of patients. No adverse effects reported. It was unspecified if the patient had sought medical attention. The outcome of the event was unknown. Additional information has been requested.
The incorrect vaccine given to the patient was discovered while the patient was still at the medical office. Instructions given to the patient's mother regarding potential signs and symptoms to watch for. Patient left facility without presenting adverse symptoms.
Stiffness and debilitating pain in joints of hands for 30 days; Stiffness and debilitating pain in joints of hands for 30 days; Inflammatory arthritis; This is a spontaneous report from a contactable health care professional (Physician).  A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via intramuscularly, in Left Arm on 30Mar2021 (at the age of 31-years) as DOSE 2, SINGLE for covid-19 immunization. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via intramuscularly, in Left Arm on 11Mar2021 (at the age of 31-years-old) as DOSE 1, SINGLE for covid-19 immunization. Patient medical history and patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no known allergies. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19 and Since the vaccination, it was unknown if the patient been tested for COVID-19. On 31Mar2021, the patient experienced Stiffness and debilitating pain in joints of hands for 30 days, beginning the day after he received the second dose of vaccine. Preliminary workup for inflammatory arthritis is pending. Patient had attended Doctor or other healthcare professional office/clinic visit for the reported events. Patient was not hospitalized for the reported events. Patient received treatment as NSAID for the reported events. Outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.
blood pressure drop; nearly fainted; chest pain; jaw pain; loss of vision; Multiple bilateral pulmonary embolisms in my lungs; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 39 years of age), via an unspecified route of administration, administered in arm left on 04Feb2021 (Batch/Lot Number: EN6202) as 2nd dose, single for COVID-19 immunisation. Medical history included MTHFR blood clotting gene mutation. Concomitant medications included citalopram, metoprolol, omeprazole and minastein fe24, all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (lot number: EN9581) dose 1 on an unknown date (also reported as 04Feb2021) 01:00 PM in left arm for COVID-19 immunisation. The patient was not pregnant. The patient did not have any other vaccine within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She had not been tested for COVID-19 prior since vaccination. It was reported that 6 weeks after the second dose on 21Apr2021 12:00, the patient had a blood pressure drop, nearly fainted, chest pain, jaw pain, loss of vision. She went to emergency room (ER), they did tests and found multiple bilateral pulmonary embolisms in her lungs. The adverse events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events, Eliquis (reported as 'Eloquis') blood thinners given. The patient was hospitalized for the events for one day. The outcome of the events was not recovered. Information on the batch lot/batch number has been obtained.
Fever, irritability, sleeplessness, painful crying, gas, drop in white blood cell count to 200 which is extremely low, cough. Currently treating with Amoxicillin.
02/21/21- Resident has been refusing meds and meal with continued poor PO nutritional intake, and lethargic.  She continue to have periods of medication refusal and continued poor PO intake. 3/8 She developed shingles to her R buttock and was started on Acyclovir cream x7 days. She continues to decline medically. Admitted to Hospice on  3/12, poor PO intake and weight loss. 3/23 Resident passed.
Patient had significant swelling at the injection location.  She was instructed by her doctor to not get the second shot.
Red, swollen bumps 1 cm square x 4 around injection site, not on injection site, swollen painful axillary node.