chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blurred vision (particularly on left side); noticeable change in heart beat in response to excitement about 6 hours post vaccine; dose number: 3 (Booster); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 14:45 (Lot number: Ff2587) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "allergies: Some pet dander allergy" (unspecified if ongoing), notes: Known allergies: Some pet dander allergy. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0173, Location of injection: Arm Left), administration date: 09May2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Er8735, Location of injection: Arm Left), administration date: 18Apr2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 14:45, outcome "unknown", described as "dose number: 3 (Booster)"; VISION BLURRED (non-serious) with onset 07Dec2021 20:45, outcome "recovered" (2021), described as "Blurred vision (particularly on left side)"; HEART RATE ABNORMAL (non-serious) with onset 07Dec2021 20:45, outcome "recovered" (2021), described as "noticeable change in heart beat in response to excitement about 6 hours post vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vision blurred, heart rate abnormal. Additional information: known allergies: Some pet dander allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. Blurred vision (particularly on left side) and noticeable change in heart beat in response to excitement about 6 hours post vaccine. AE resulted in any of the seriousness conditions. Follow-up attempts completed. No further information expected.
Lip blistering; Lip Swelling / bilateral lip swelling; rash below her armpit; Bronchitis; Lip burning; Lip chapping; This case was reported by a physician via call center representative and described the occurrence of lip blister in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced lip blister, lip swelling, rash, bronchitis, burning lips and chapped lips. The patient was treated with methylprednisolone (Medrol Dose Pack) and acyclovir (Acyclovir Oral). On an unknown date, the outcome of the lip blister, bronchitis, burning lips and chapped lips were unknown and the outcome of the lip swelling was not recovered/not resolved and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the lip blister, lip swelling, rash, bronchitis, burning lips and chapped lips to be related to Shingrix.  Additional details were provided as follows: The physician who is an allergist and was on telehealth call with the patient for bronchitis reported that, the patient received 1st dose of Shingrix and developed a rash below her armpit rash. Two weeks later, she experienced lip blister and lip swelling. She also had burning lips and chapped lips. The patient was treated with oral Acyclovir and a Medrol dose Pack. The reporter states that the patient completed the course of medication and then lip swelling returned. The reporter consented to follow up. This case is linked with the case US2021AMR237990, reported by same reporter.
COVID twice; COVID twice; shortness of breath; chronic fatigue; headaches; ear infection; shingles; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old male patient received bnt162b2 (BNT162B2), on 02Jul2021 as dose 1, single (Lot number: FA6780), in left arm and on 16Aug2021 as dose 2, single (Lot number: FC3182) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cold sores" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Sep2021, outcome "not recovered" and all described as "COVID twice"; FATIGUE (non-serious) with onset 01Sep2021, outcome "not recovered", described as "chronic fatigue"; EAR INFECTION (non-serious) with onset 01Sep2021, outcome "not recovered"; HEADACHE (non-serious) with onset 01Sep2021, outcome "not recovered", described as "headaches"; HERPES ZOSTER (non-serious) with onset 01Sep2021, outcome "not recovered", described as "shingles"; DYSPNOEA (non-serious) with onset 01Sep2021, outcome "not recovered", described as "shortness of breath". The events "covid twice", "shortness of breath", "chronic fatigue", "headaches", "ear infection" and "shingles" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were not taken as a result of drug ineffective, covid-19, dyspnoea, fatigue, headache, ear infection, herpes zoster. Clinical course: The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient reported that he immediately went from jogging 6-8 miles at 10:30 pace. To only being able to run 2-3 miles at 12 min pace. This continues 2 years later. The patient stated, "I experience random shortness of breath - I battle chronic fatigue - I have headaches - I got an ear infection, COVID twice, and shingles all in one year since the vaccines." The patient had no covid prior to vaccination. The patient was tested for covid (nasal swab) post vaccination. The patient has no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300360531 Same product, patient, different AEs, different dose;
3 INCH DIAMETER REDNESS THAT SLOWLY DECREASED OVER 2 DAYS.
Did not return to receive 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th May 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received first Shingrix dose, however did not return within the recommended time frame to receive the second dose. till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient did not receive the 1st dose of Shingrix at the pharmacy, so lot number, expiration date, and site of injection is unknown. The reporter consented to follow up. This case has been linked to US2021216650, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021216650:Same reporter.
w/in 2hr of vax pt devel sudden onset n/v, T101, very sleepy, temp dec w/APAP;2MAR99 T101 630AM;no swelling or redness @ inj site;no rash, no hives, no difficulty w/swallowing or breathing;
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator-24Sept2021 No concomitant medications were provided.  No treatment medications were provided.
Information has been received from a physician concerning a 23 year old female who on 29-APR-2008 was vaccinated with the first dose of GARDASIL (lot # 557622/0388U). On 29-APR-2008 the patient developed a localized rash at the injection site. As of 06-MAY-2008, the rash spread over the body and still persisted. The patient sought unspecified medical attention. Additional information has been requested
After 1 week hands and feet itching and heels started burning . After 2 weeks thick crust on hands and feet.
This spontaneous report as received from a medical assistant refers to a 22-year-old female patient. The patient's concurrent conditions included asthma and homosexuality. It was also reported that the patient previously had heterosexual relationships. The patient's concomitant therapies included SINGULAIR, ASMANEX and albuterol. No information regarding the patient's drug reactions or allergies was provided. On unknown dates, the patient was vaccinated with 3 doses of GARDASIL (strength, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date in August 2018, the patient had abnormal Papanicolaou (PAP) test and colposcopy which demonstrated cervical intra-epithelial neoplasia 2 (CIN2) so the patient was recommended for loop electrosurgical procedure (LEEP). On an unknown date, the patient had a follow up colposcopy and was not recommended for LEEP surgery. On unknown date in December 2018, she had a follow up PAP smear which was negative. It was reported that the patient did not have LEEP surgery. The relatedness between the events and GARDASIL was not reported.
2-3 days post vax the pt experienced an itchy, warm rash at the injection site. The rash spread to the entire deltoid area, according to the pt. The reporter saw the pt on 11/22/1999 and stated that the rash looked like ringworm (dry, round bumps). Treatment was no given. A doctor visit was required. The most recent information received reports the condition of the pt is recovering.
I appear to have a mild allergic reaction. I began itching under my skin (all over) within 1-1 1/2 hours. Then I began having pain/burning sensation in my veins, mostly in my arms. Treated at home with 50 mg of Benadryl. Helped significantly! Continued to take 50mg (along with Tylenol) every 4-6 hours over the next 24 hours. Dropped down to 25mg every 4-6 hours on 4/7/21, and have been able to maintain on that. I also developed a rash on my chest on 4/7/21. It has now faded. I have other symptoms, such as body aches, low grade fever, and fatigue, which I understand are typical reactions.
Noticed a 3 quarters of an inch area at injection site that looks like a mosquito bite that has been scratched; Feel mild itchiness at vaccination site; Redness at the injection site with a diameter of 3/4 inch; This is a spontaneous report from a contactable Consumer. This 68-year-old non-pregnant Caucasian female Consumer received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an Intramuscular injection in left arm on 25Jan2021 at 15:45 as a single dose for COVID-19 immunization. The patients medical history included allergic to penicillin. The patients concomitant medications were not reported. The patient did not undergo any investigations. The patient had not received any additional vaccines on same day of the COVID vaccine. The patient had not received any vaccines with 4 weeks of vaccination. The patient received other unspecified medication with 2 weeks of COVID vaccination. Prior to vaccination the patient was not diagnosed of COVID-19. Post vaccination the patient was not tested for COVID 19. On 02Feb2021 at 14:00, 8 days late, the patient noticed a little bit of itchiness. The patient did not think much of it and the patient did not think it was anything really noticeable, but her husband told her that she had some mild redness. On 03Feb2021, the patient noticed 3 quarters of an inch area that looks like a mosquito bite where it gets bigger and redder as one scratches. The patient not scratching the area, but it looks the patient had a mosquito bite and scratched it. She confirms this was located at the injection site of her left arm. The patient explained that this area at the injection has not got any worse. It was the same. It just started; she did not imagine it was going to get any worse. The patient did not require any emergency room or physician office. The patient did not receive any treatment for the events. While she was sitting on hold waiting to speak to someone, she was reading online and found a doctor that had the same reaction as her except it was with Moderna's vaccine, and the patient also found others that had what they call an 8-day reaction. From reading these articles, it seems she has this reaction because its building up her immune system. The caller just wanted to make sure this is okay and that she can received the second vaccine. Caller states what she read was that it was okay to receive the second vaccine but just to receive the second one in her other arm. Outcome of events was not recovered.
The following day she had gout in the middle toe of the left foot, which was in the same area that she had had a reaction about 4 years prior.  She continues to have the pain.  He did blood work and her uric acid is high, put her on Colchicine and it lowered her uric acid 1/2 point and followed the diet.  He then put her on Allopurinol and will do more blood work in about 40 days.   Also had arm soreness and tiredness, but they were no big deal.
Bleeding; heavier menstrual bleeding; Along with a week and a half of heavy Fatigue; Sneexzing; Allergies; Hot flashes; Nausea waves for two weeks; This is a spontaneous report received from a contactable consumer (patient). A 36-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 (Batch/Lot Number: EW0151) as 2ND DOSE, SINGLE for covid-19 immunization, at the Age at Vaccination of 36 years old.  The patient medical history was not reported. Patient was not Pregnancy at time of Vaccination. Historical vaccine included first dose of BNT162B2 on 20Mar2021 (Lot number: EP6955; Dose number=1; Vaccine location=Left arm) for covid-19 immunization, reported the first shot she had a slight headache hours after the shot and then got light embryos bleeding a few day afterwards. Concomitant medications (medications the patient received within 2 weeks of vaccination) included Implanon, Straterra, adderall, multivitamin, ashwa (as reported), all taken for an unspecified indication, start and stop date were not reported.  The patient experienced bleeding (medically significant), along with a week and a half of heavy fatigue (non-serious), sneexzing (non-serious), allergies, hot flashes, nausea waves for two weeks (non-serious), heavier menstrual bleeding (non-serious), all on 25Apr2021 with outcome of unknown. Reported as she never have period due to her birth control methods. She got heavier bleeding a few days after her second dose that lasted about a week, along with a week and a half of heavy fatigue, Sneexzing and feeling like she had allergies, with occasional hot flashes and nausea waves for two weeks. And even heavier menstrual bleeding starting 15 days after second shot. No treatment received for events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.
Redness of skin and swelling in arm where vaccine was given. Also hurt to move arm.
I have a rash on torso I am unsure of whether or not this was caused by the Flu shot I received.  Rash looks like hundreds of small bumps (small looking pimples).
Information has been received from a concerning a female patient who on 07-JAN-2011 was vaccinated subcutaneously with a first dose of GARDASIL (lot # not provided). No adverse effect was reported. It was unknown if the patient sought medical attention. At the time of reporting, the patient's status was not provided. Follow-up information received by the licensed visiting nurse indicated that the patient was a 20 year old female student with no known allergies and no illness at time of vaccination, who on 07-JAN-2011 11:10 AM was vaccinated subcutaneously on left upper arm with a first dose of GARDASIL (lot # 666118/1539Y). In the afternoon of 07-JAN-2011, the patient experienced sore arm at injection site which lasted for approximately 48 hours. No lab diagnostic studies were performed. At the time of reporting, the patient had recovered. The recovery date was reported as 07-JAN-2011. It was reported that the patient did not require emergency room/doctor visit. Additional information is not expected.
Diagnosis ? Anemia affecting pregnancy in third trimester ? Status post vacuum-assisted vaginal delivery ? Hypothyroidism ? Blood type, Rh positive ? Rubella immune ? Abnormal glucose tolerance test (GTT)   Please see the prenatal record and admission history and physical for details.   Labor Analgesics: Epidural;Local     OB Complications:    Cervical Ripening Type: None  Cervical Ripening Comment:      Induction: None   Induction Indications:   Augmentation: Oxytocin    Delivery Date: (Privacy) Delivery Time: (Privacy) Gestational Age(weeks days/7): 39 1/7      Method of Delivery: Vaginal, Vacuum (Extractor)     Birth Weight: 3.58 kg (7 lb 14.3 oz)   Sex: male   Apgar Score (1 min): 9   Apgar Score (5 min): 9     Laceration  Episiotomy: Midline   Laceration Type: 2nd   Perineal Laceration:      Quantified Blood Loss (ml):    Est Blood Loss      For further details of the delivery see the delivery summary.    Her post partum course was complicated by:  None   Patient with uncomplicated post-partum recovery.  On the day of discharge pain was well controlled with oral pain meds, she was ambulating and voiding without difficulty, and was tolerating diet without nausea/vomiting. Patient reports constipation and a Rx for a stool softener was sent to her pharmacy. Patient was requesting discharge home.  Following complete examination and review of recovery course, patient was deemed stable for discharge. Patient will need 2hr GTT at her 6 week post partum visit.   Procedures performed: VA-VD w/ RML episiotomy    Discharge       All Hospital Problems (Other diagnoses): Active Hospital Problems   Diagnosis ? Principal Problem: Status post vacuum-assisted vaginal delivery [Z87.59] ? Hypothyroidism [E03.9] ? Blood type, Rh positive [Z67.90] ? Rubella immune [Z78.9] ? Abnormal glucose tolerance test (GTT) [R73.09] ? Anemia affecting pregnancy in third trimester [O99.013]   Resolved Hospital Problems No resolved problems to display.
Pt recvd Hep B vax 23JAN91 & 24 hrs post vax devel flu-like sx including nausea & vomiting; sx resolved w/in 1 day; 1wk p/vax psoriasis flaired up; MD felt skin condition could have been an allergic rxn to yeast in vax; tx meds;
Information has been received from a physician concerning a male, who was vaccinated with varicella vaccine, live (Oka/Merck). Subsequently the patient developed breakthrough chickenpox, approximately 50 lesions. Unspecified medical attention was sought. No other information was provided at the time of this report. There was no product complaint. No further information is available.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 08-JUL-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Subsequent to receiving vax, the pt developed redness and swelling at the injection site. Two days post vax the injection site was clear, but left arm mid arm to elbow swollen on the inner side, area was reddened and hot to touch. Pt called her physician who placed her on an antibiotic, using warm soaks and slightly elevating arm. The next day the area had improved and the swelling had decreased.
12/29/20 Headache, dizziness.  Woke at midnight with headache, flushed face, could not get warm. Heart rate 95, respiratory rate 25.  At approximate 2:00 am woke with HEADACHE, flushed face, Temp 101.1. 12/30/2020 Continues to c/o of dizziness, Huge headache, Ibuprofen not effective
Chest was tender; Trouble catching his breath; Site of injection is swollen (like a ball); Site of injection is tender to touch; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Oct-2021 and was forwarded to Moderna on 09-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Chest was tender), DYSPNOEA (Trouble catching his breath), VACCINATION SITE SWELLING (Site of injection is swollen (like a ball)) and VACCINATION SITE PAIN (Site of injection is tender to touch) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A or 05GE21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID (VITAMIN C ACID) and IBUPROFEN for an unknown indication.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Chest was tender), DYSPNOEA (Trouble catching his breath), VACCINATION SITE SWELLING (Site of injection is swollen (like a ball)) and VACCINATION SITE PAIN (Site of injection is tender to touch). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Chest was tender), DYSPNOEA (Trouble catching his breath), VACCINATION SITE SWELLING (Site of injection is swollen (like a ball)) and VACCINATION SITE PAIN (Site of injection is tender to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The patient reported that on 08-Oct-2021, the patient noticed that the site of injection was swollen (like a ball) and was tender to touch. The patient also had trouble catching their breath and their chest was tender on 08-OCT-2021 but felt better on the day of reporting. (09-Oct-2021).  stated that they do not drink a lot, no smoking or use of drugs.
Had varicella vaccine 09/05/1997 and on 12/31/2001 was diagnosed with varicella disease.