chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-DEC-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L023936, exp. date: 15-MAR-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
TINGLING IN LIPS; LIPS GOT WARM; UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's past medical history included cold sores. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unexpected therapeutic benefit. On 08-APR-2021, the subject experienced tingling in lips. On 08-APR-2021, the subject experienced lips got warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in lips, and the outcome of lips got warm and unexpected therapeutic benefit was not reported. This report was non-serious.
Shortness of breath, hypoxia, Pulmonary Embolism, intubation death.
Light headed, assed out in hallway, wife called ambulance Still light headed, fatigued, loss of appetite
Per parent description: "Day after vaccination after lunch fainted in his class. He was sitting in his classroom desk and fainted as he was reaching to put away folders, hitting his head on another desk.  No loss of consciousness, episode passed quickly. He was seen in pediatrician's office the day of fainitng.
received only liquid portion; received only liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 72A32, expiry date 8th July 2023) for prophylaxis.   On 26th April 2022, the patient received Shingrix. On 26th April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-MAY-2022 Reporter's comments: The patient received only liquid portion of Shingrix, without being reconstituted. The reporter wanted to know if they had to be revaccinated since it did not seem like a full dose and in case revaccination needed, which would be the recommended interval between doses. The reporter did not have any demographic details from patients since she send them over to the manager. The reporter provided batch number but was not sure if it was for liquid portion or lot number from the box.  The reporter consented to follow up. Additional Supportive Information: The patient first received only liquid portion of Shingrix, without being reconstituted, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. This is 1 of 7 link cases reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070806:Same reporter US-GLAXOSMITHKLINE-US2022070807:Same reporter US-GLAXOSMITHKLINE-US2022070808:Same reporter US-GLAXOSMITHKLINE-US2022072616:Same reporter US-GLAXOSMITHKLINE-US2022AMR073092:Same reporter US-GLAXOSMITHKLINE-US2022AMR073094:Same reporter
I went to the ER yesterday (28th Dec, 2021) but unfortunately told them I had the Pfizer booster about 2 weeks prior to the start of symptoms. I mentioned I'd made a connection between the itch at the injection site and the appearance of other symptoms as they followed each other so closely. ER thought the time span made the connection remote. However, when I came home, and checked the booster date, it was the 20th at about 11:45 a.m. at my doctors office.   First Pfizer vaccine (24th March 2021): no symptoms Second Pfizer vaccine (14th April 2021): fever and fatigue that lasted only 1.5 days Pfizer booster (20th Dec 2021): Mild fatigue and vague illness the next day, felt normal until Xmas eve.  Xmas eve (24th), the injection site (left arm) became very itchy. Only lasted that evening. Xmas day (25th, aka 5 days after injection) to today (29th Dec).  Chills - moderate to severe (today, 29th Dec, they are finally mild chills) Tremendous itchiness mostly on hands, feet, front of lower legs, front of thighs. This lasted from 25 Dec ? 28 Dec. Itchiness ? random and everywhere, including private parts, hands, feet, front of legs and front of thighs. (25th ? today, ongoing). Deep pain and tingling in feet (25-28 Dec). I can describe the foot pain accurately. Have you ever frozen your hands or feet in the winter? When they ?defrost? there is that awful tingling and pain. That is exactly how it has felt on my feet and quite often the front of the thighs. Today (29th) they have reduced to the ?deep and dull? pain described below. Deep and dull pain in random locations. These have felt like a deep pinch to the bone ? I?ll suddenly feel a deep pain on an arm, on my chest ? it moves around the body and it is a localized dull and deep pain, unlike the feet where it covered the entire feet.  Deep pain in lower back ? more like a typical lower back pain, but consistent and seems to get worse at nights. Last night it was much better, but I also used a heat patch. Tendon pain (especially where inner thighs meet the body). This has been on going, but not consistent.   Overall, I have not fully recovered from the adverse events, but feel much improved this morning.
Approximately 10 minutes after injection, patient stated she started experiencing shortness of breath and chest tightness.  Rph monitored for about 20 more minutes and patient condition did not change one way or the other. Advised patient to seek medical treatment and offered to have EMS come evaluate her. She stated she would monitor at home and seek treatment if condition worsened.  On 1/25/2022, patient stopped by the pharmacy to advise that she contacted pfizer and they stated she was experiencing a severe adverse reaction. She also stated that her symptoms had not improved and she was still experiencing shortness of breath, chest tightness, increased heart rate and wheezing.  It was advised again that the patient seek medical treatment by both Pfizer representative and pharmacist on duty, which she refused.
Weakness, fever, headache, aches all over, joint involvement, upset stomach, balancing problem, trouble focusing, lasted about 1-2 days.
Bruse line circle 2 inch in diameter around area where injection given. Appeared day after and getting better to day looked like blood vessels leaked under skin.
No additional AE reported; A dose of improperly stored PEDVAXHIB was administered; This spontaneous report as received from an office manager, refers to a patient of unknown age and gender. Information regarding the patient's medical history and concomitant medications was not provided.   The reporter stated that between 15-OCT-2021 to 18-OCT-2021, 11 below temperature excursions occurred for haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB). On 18-OCT-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (strength ad route of administration were not reported; lot # T026962 and expiration date of 06-APR-2023) 0.5 mL, for prophylaxis (product storage error). The reporter was unable to provide the minimum temperature reached and the total temperature excursion time for each excursion. No additional Adverse Events were reported.
Left elbow to hand excruciating pain from day after shot until 8 days later when going in to see a doctor. Swollen elbow down to the hand.
Patient received Moderna Vaccine #1 1-6-21     #2 2-3-21 Patient had positive COVID-19 tests on #1, 11-19-20 and #2, 4-14-2021
Hives covering back 2 hours after vaccine. Mom gave Benedryl & child saw family physician. Hives gone on Monday, October 24.
Reactions after the vaccine; Feel sick; Headache; Hurt where it was injected; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Reactions after the vaccine), MALAISE (Feel sick), HEADACHE (Headache) and VACCINATION SITE PAIN (Hurt where it was injected) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (Hurt where it was injected). On an unknown date, the patient experienced VACCINATION COMPLICATION (Reactions after the vaccine) and MALAISE (Feel sick). At the time of the report, VACCINATION COMPLICATION (Reactions after the vaccine), MALAISE (Feel sick), HEADACHE (Headache) and VACCINATION SITE PAIN (Hurt where it was injected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.  Patient stated that she didn't get the second shot.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Dec-2021: Reporter's contact details and additional event of Feeling sick were updated.
06/10 Allergy fallout and by 06/11 Chest burning with bronchitis. 6/16 saw doctor @ 03:00 CT. Issues persist
Constant nerve damage pain is gone; This case was reported by a consumer via interactive digital media and described the occurrence of unexpected therapeutic effect in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had been dealing with shingles for 35 years) and nerve pain. Previously administered products included Shingles vaccine (got the one shot solution about 5 years ago and it did not work).   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 unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   Linked case(s) involving the same patient: US2022AMR139444   Additional Information: GSK Receipt Date: 25-SEP-2022 and 27-SEP-2022 Reporter's Comment: This case was reported by patient via interactive digital media. The patient just got first dose of the new two shot treatment and he/she could already told that it was working.  The patient would get the second shot in 3 months.  The patient would highly recommend it.  The patient had a constant nerve damage pain in the area where his/her shingles would come up and it was gone. The patient asked what was the shingles. The patient did not thought he/she reached out to GlaxoSmithKline. The patient had just been tried to told people who were suffering his/her experience. The patient reported that Acyclovir to get to temporary remission and now patient had gotten his/her first shot. The one shot offered a few years back did not work for him/her. Additional supportive information: This case had been linked with case US2022AMR139444, reported by the same reporter. The follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GSK-US2022AMR139444:same patient
Patient presented to pharmacy 3 days after vaccine administration. He complained of arm swelling. He did have a large welt that was probably 3-4 inches tall and 2-3 inches wide around the site of administration. I recommended he apply ice and take some ibuprofen to reduce the swelling and told pt we would call him in 2-3 days to see how his arm is doing.
Hives on both thighs; red, warm, swollen, and tender injection site 2 inches in diameter; low grade fever; sore throat. Treated with topical corticosteroid and ibuprofen...fever persisted as well as redness and swelling of the site.
This case was reported by a healthcare professional and described the occurrence of stroke in a 90-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included high cholesterol and osteoporosis. Concurrent medications included Fish oil, OSCAL D, EFFEXOR, MAXZIDE, Vitamin E, ARICEPT, CELEBREX, NORVASC, ZOCOR, B12, LIDODERM, Potassium, Vitamin D, BONIVA, Mylanta, Duoneb, TRAMADOL, CATAPRES and Tylenol. On 25 September 2009 the subject received 1st dose of FLUARIX (0.5 ml, unknown route, right arm). On 25 September 2009, 30-60 minutes after vaccination with FLUARIX, the subject experienced stroke, with right-sided facial twitching, tremors and slurred speech. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with FLUARIX.
Patients were administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered from an expired vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered from an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient administered expired vaccine which was initially stored on 04-Nov-2021 patients were administered with dose in which some vaccinated on 05-Nov-2021 and 12-Nov-2021. The vial did not undergo any temperature excursions.  No Treatment medications were reported.
Sore arm, chills, muscle aches, back pain, fatigue all within 1 day after shot. Metallic taste in mouth immediately following injection and still lingering 3 days later.
I became very swollen at the injection site. 48 hours after the flu shot injection I had a large welted up hive that extended across my bicep, the raised hive was hot and itchy and my arm was so sore I could hardly move it.  My lymph nodes in my armpit were also swollen and I had a difficult time controlling my emotions on the forth and fifth days following this shot.
Pt presented one day post vax with swollen eyes, upper lip and tongue and swollen hands.
swelling in fingers day after getting vaccine; This is a spontaneous report from a contactable consumer (Patient). A 21-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation; and received tofacitinib citrate (XELJANZ XR, Lot Number: EH9982), 11mg oral taken once daily from an unspecified date to an unspecified date for an unspecified indication. Medical history included psoriasis vulgaris, rheumatoid arthritis, psoriatic arthropathy. Concomitant medications included losartan potassium (MANUFACTURER UNKNOWN), clarithromycin (CLARITIN [CLARITHROMYCIN, naproxen (MANUFACTURER UNKNOWN) , lisinopril (MANUFACTURER UNKNOWN), indomethacin [indometacin] (MANUFACTURER UNKNOWN]), sertraline hcl (MANUFACTURER UNKNOWN) , prednisone (MANUFACTURER UNKNOWN) , fexofenadine hydrochloride (ALLEGRA ALLERGY) taken for hypersensitivity, hydrochlorothiazide (MANUFACTURER UNKNOWN), dicyclomine hydrochloride (MANUFACTURER UNKNOWN). On an unknown date, Patient experienced symptoms of swelling in fingers day after getting vaccine. Patient has been prescribed prednisone and meloxicam by mdo, neither of which seem to work. Advised if allergic reaction, can try taking over the counter (otc) allergy medication to see if these work, advise if worsens to contact mdo. Patient understood. The reporter assessed the event as non-serious. The outcome of the event was unknown. Information on Lot/Batch number has been requested.  Information on Lot/Batch number has been requested.
Information has been received from a registered nurse concerning an 79 year old male with type 2 diabetes mellitus, coronary artery disease and prostate cancer who on 08-NOV-2007 was vaccinated with 0.65 ml of ZOSTAVAX (Oka/Merck) subcutaneously.  Concomitant therapy included LANTUS, GLUCOPHAGE, GLUCOTROL XL, LIPITOR, PREVACID, VASOTEC, ATENOLOL, aspirin, CYANOCOBALAMIN, PROCARDIA, FLOMAX and AVODART.  On 05-FEB-2009 the patient experienced shingles.  The patient was experiencing a painful shingles rash on the right side of his body.  As of 11-FEB-2009 the patient's shingles persisted.  Additional information has been requested.
administration of Infanrix on a 15 y/o; administration of Infanrix instead of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-year-old male patient who received DTPa (Infanrix) (batch number 4L9EF, expiry date 7th February 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 9th June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-AUG-2022 Reporter's Comments: The reporter stated that the administration of Infanrix on a 15 year old patient instead of Boostrix. The reporter gave Consent to follow up. Additional supportive Information: The 15 year old Patient recived Infanrix instead of Boostrix which lead to wrong vaccine administration and Inappropriate age at vaccine administration.
Patient called today reporting itching all over her body as well as rashes. She got the vaccine (SHINGRIX) 1 month ago but her rxn started 3 to 4 days ago she said.
COVID arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm after first dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0001a21a) for COVID-19 vaccination.     Concomitant products included TRAZODONE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE REACTION (COVID arm after first dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 16-Mar-2021, VACCINATION SITE REACTION (COVID arm after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had COVID arm after the first and second doses, but it occur 8 day after each vaccine and lasted for two weeks.   This case was linked to MOD-2022-477285, MOD-2022-477313 (Patient Link).
Very nauseous; Arm hurt and was tender; Had chills; Felt tired; A spontaneous report was received on 14-Feb-2021 from a non healthcare professional concerning a 85 years old female patient who received Moderna's COVID-19(mRNA-1273) vaccine and experienced chills, felt tired, very nauseous, arm hurt and was tender.  The patient medical history was not provided. No concomitant medications were reported.  On 13-Feb-2021, one day prior to the onset of events, patient received mRNA-1273(Batch:013M20A) intramuscularly on her left arm for the prophylaxis of covid-19 infection.  On 13-Feb-2021, patient experienced chills, felt tired, very nauseous, arm hurt and was tender.  No laboratory information was provided. Treatment information includes ginger ale and crackers.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events were recovered/resolved.
This case was reported in a literature article and described the occurrence of vaccination failure in a 82-year-old male patient who received Influenza vaccine Quadrivalent. Co-suspect products included M-M-R. The patient's past medical history included paroxysmal atrial fibrillation and aortic valve stenosis (severe calcific aortic valve stenosis status post replacement with a tissue valve). Concurrent medical conditions included hypertension. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose and M-M-R at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), influenza A virus infection (serious criteria hospitalization), parotitis (serious criteria hospitalization), soft tissue inflammation (serious criteria hospitalization), cough (serious criteria hospitalization), myalgia (serious criteria hospitalization), sore throat (serious criteria hospitalization), swollen mouth (serious criteria hospitalization), fever (serious criteria hospitalization), parotid gland enlargement (serious criteria hospitalization) and hyperemia (serious criteria hospitalization). The patient was treated with azithromycin and Amoxicillin + Clavulanic Acid. On an unknown date, the outcome of the vaccination failure, influenza A virus infection, soft tissue inflammation, cough, myalgia, sore throat and fever were unknown and the outcome of the parotitis, swollen mouth, parotid gland enlargement and hyperemia were recovered/resolved. The reporter considered the vaccination failure, influenza A virus infection, cough, myalgia, sore throat and fever to be related to Influenza vaccine Quadrivalent. The reporter considered the parotitis, soft tissue inflammation, swollen mouth, parotid gland enlargement and hyperemia to be possibly related to Influenza vaccine Quadrivalent.