chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart rate shot up to 170 with numbness of feet.; Heart rate shot up to 170 with numbness of feet.; Chest pain; feeling like I was going to vomit and faint; feeling like I was going to vomit and faint; This is a spontaneous report from a contactable other hcp (patient). A 25-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at 11:45 at single dose in left arm for covid-19 immunization. There was no medical history. Concomitant medication included valaciclovir hydrochloride (VALTREX), topiramate (TOPAMAX), lamotrigine (LAMICTAL), duloxetine hydrochloride (CYMBALTA), ziprasidone hydrochloride (GEODON). On 06Jan2021 at 12:30, The patient experienced heart rate shot up to 170 with numbness of feet, started to feel chest pain, and feeling like she was going to vomit and faint. The events required emergency room visit and were reported as serious per hospitalization. Heart rate at the hospital was 135-140 where two EKG were done and fluids were given. An x-ray of the heart was done and blood work was completed. The patient didn't receive treatment for the events. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and has not been tested for COVID-19 since the vaccination. The outcome of the events was resolved in Jan2021.   Information on batch/lot number has been requested.; Sender's Comments: There is a reasonable possibility that the event "feeling like she was going to vomit" was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported serious events with BNT 162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Initial report received from a health care professional (medical assistant) on 23 Jun 2010: This patient was vaccinated with only the diluent portion of MENVEO (batch number: 090901), (dose: 0.5 ml) intramuscularly on 20 Jun 2010. The lyophilized portion was not reconstituted. The patient had not yet received additional dosing with MENVEO. No adverse event was reported following this administration.
neck pain; pain in eyebrows and around the eyes; backache; everyday has a different part of pain; shoulder pain; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), EYE PAIN (pain in eyebrows and around the eyes), BACK PAIN (backache), PAIN (everyday has a different part of pain) and ARTHRALGIA (shoulder pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (neck pain), EYE PAIN (pain in eyebrows and around the eyes), BACK PAIN (backache), PAIN (everyday has a different part of pain), ARTHRALGIA (shoulder pain) and HEADACHE (severe headache). At the time of the report, NECK PAIN (neck pain), EYE PAIN (pain in eyebrows and around the eyes), BACK PAIN (backache), PAIN (everyday has a different part of pain), ARTHRALGIA (shoulder pain) and HEADACHE (severe headache) outcome was unknown.            No concomitant medications were provided.  No treatment information was provided.
sneezing; runny nose; warm to touch; really swollen; nauseous; really red; arm got sore and it turned pink/started fading; arm got sore; arm got sore and it turned pink and swelled up; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous), PAIN IN EXTREMITY (arm got sore), PERIPHERAL SWELLING (arm got sore and it turned pink and swelled up), VACCINATION SITE ERYTHEMA (really red) and VACCINATION SITE SWELLING (really swollen) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced NAUSEA (nauseous), PAIN IN EXTREMITY (arm got sore), PERIPHERAL SWELLING (arm got sore and it turned pink and swelled up), VACCINATION SITE ERYTHEMA (really red) and SKIN DISCOLOURATION (arm got sore and it turned pink/started fading). On 13-Mar-2021, the patient experienced VACCINATION SITE SWELLING (really swollen), VACCINATION SITE WARMTH (warm to touch), RHINORRHOEA (runny nose) and SNEEZING (sneezing). At the time of the report, NAUSEA (nauseous), PAIN IN EXTREMITY (arm got sore), PERIPHERAL SWELLING (arm got sore and it turned pink and swelled up), VACCINATION SITE ERYTHEMA (really red), VACCINATION SITE SWELLING (really swollen), VACCINATION SITE WARMTH (warm to touch), SKIN DISCOLOURATION (arm got sore and it turned pink/started fading), RHINORRHOEA (runny nose) and SNEEZING (sneezing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-044704 (E2B Linked Report).
Headache, nausea, chills, vomiting, swollen armpit lymph node, dizziness, light headed, body weakness and pain
Patient complained of right arm, knot formed, tender, pain radiating down arm and resp right side neck. Treated with Keflex 500 mg tid #30.
Previously asymptomatic. Severe vertigo/dizziness immediately 1 day post injection. Also with nausea, vision changes, diaphoretic. ED visit at 3 days with blood labs, EKG, CXR and CT with contrast (all results negative).  Discharged with referral to MRI for unrelated suspicious area. Follow-up with PCP prescribed Meclizine 25 Mg with no improvement. Follow-up MRI with contrast and consult with neurosurgeon showed no connection to vertigo symptoms. Symptoms very slowly improved by early January. As of early February symptoms have resolved.
He tested positive for Sars-CoV-2 in the interim; He tested positive for Sars-CoV-2 in the interim; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program Pfizer First Connect. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included exposure to a patient who was positive. The patient's concomitant medications were not reported. The patient received his first Pfizer-Biontech Covid19 vaccine on 30Dec2020, and was scheduled to receive his second dose today, 18Jan2021. He tested positive for Sars-CoV-2 in the interim and is looking for guidance on receiving the second dose. He was exposed to a patient who was positive. The patient has also tested positive. He wanted to know when he should get the second vaccine. The patient should have gotten the second dose today and was told they could get him in on Thursday which was in that 4-day window. Now, he has just been informed that they can't get him in for the second dose until Monday, which is outside to of the 4 days window and he wants guidance on this since his hospital was unsure. The outcome of the events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: The patient received only one dose of BNT162B2 injection and then tested positive SARS-COVID-2 on an unspecific date. Given the incomplete protection from single dose of vaccine BNT162B2 , the COVID infection is unlikely related to suspect BNT162B2 administration, but may be pre-existing/intercurrent condition.
pt recvd DTP/MMR/OPV/HIB 21OCT PM; 1 hrs later became cranky, crying, awake for 40 hrs, t105 R; 21OCT mom called MD; 22OCT refused to eat or drink; no rash; shaking, no sz;
Sore arm after the first dose of the Covid Vaccine; Felt Cold after the First Dose of the Vaccine; This is a spontaneous report from a contactable consumer or other non hcp (Patient herself). A 70-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 01Apr2021 (age at the time of vaccination was 70-years-old) as 1st dose, single for COVID-19 immunization. Medical history included herpes from 1970 to an unknown date. Patient had been treated for Herpes on and off since the 1970s. Patient had undergone 3 surgeries in 2016 for knee revision. Patient had shingles three times in her life and received her shingles vaccine 3 years ago. Family history included that her husband had heart valve replacement in 2016. The patient's concomitant medications were not reported. On 02Apr2021, the patient experienced sore arm and felt cold after the first dose of the vaccine. The outcome felt cold was recovered on 02Apr2021 and sore arm was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
hands got warm and red; hands got warm and red; veins from hands and forearms were heavy; stomach feels tight; tired; can't make her normal routine; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL9269), via an unspecified route of administration administered in arm left on 09Feb2021 08:45 as dose 2, single for covid-19 immunization. Medical history included Parkinson's disease. The patient was not pregnant. There were no concomitant medications. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) administered in left arm on 19Jan2021 at 08:45 AM for covid-19 immunization at the age of 69-years-old and had no reaction. The patient previously took azithromycin (ZITHROMAX) and ciprofloxacin (CIPRO) and experienced allergies to both. The second covid-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. After the second dose, on 12Feb2021 12:00 PM, the patient's hands got warm and red, veins from hands and forearms were heavy, stomach feels tight, felt tired and the patient can't make her normal routine. No treatment was received for the said adverse events and at the time of the report, the patient had not recovered from them. Since the vaccination, the patient has not been tested for covid-19.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a nurse prescriber via a company representative and refers to a 20 year old non-pregnant female patient. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown dates in 2008, the patient was vaccinated with all three doses in the GARDASIL series, injection, (dose, route of administration, lot#, expiry date and anatomical location were not reported) to prevent human papillomavirus. On an unknown date, the patient experienced vaginal warts. On 26-JAN-2017, the patient sought medical attention in the nurse prescriber's office. At the time of the report, the patient did not recover and was still experiencing the warts. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
New information was received in dose details and source details. Information regarding PREVNAR was received from a mother and a physician regarding a 4-year-old female patient who experienced antibody test abnormal. At 6-months-of age, the patient received the third dose on 31-Dec-2003. The patient experienced antibody test abnormal on 08-Apr-2008. The mother stated that her daughter failed to mount antibodies after receiving 3 doses of PREVNAR. The outcome is not resolved. No additional information was available at the time of this report.
felt a lump in the back throat; difficult to swallow; breathing difficulty; panic attack; mouth became increasingly dry; throat becoming more sore; hot flashes to my face; urgency to use the restroom; swollen  throat; This is a spontaneous report received from a contactable consumer, the patient. A 34-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route in the right arm on 18Mar2021 at 07:15 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included Benign tumour removed schwanoma (3.5lbs).  The patient had a history of allergy to penicillin, latex (nurse used latex free gloves) and normally that just cause a rash. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received macrogol 3350 (MIRALAX) for unknown indication within two weeks of vaccination. On 18Mar2021 at 07:15, the patient was very excited to get vaccine, within seconds of the shot she felt a lump in the back of her throat and difficult to swallow but was able to breathe and swallow. The patient also stated that throat was still very sore but she could breathe and swallow easily. The patient went back to paramedics in observation they told her she was having a panic attack which she never had before. The patient went back to her seat for a few minutes but her mouth became increasingly dry with difficulty to swallow and throat became sorer along with a few hot flashes to face, and felt an urgency to use the restroom. Nurse wheeled her out to bathroom and then took her to paramedics. They took her blood pressure and heart rate and told that she had a panic attack. The patient was not nervous about getting it so she did not know why that would be. Her throat stayed sore and swollen for about 48 hours. The patient had taken Miralax 3 days prior with no reactions. Doctor still wanted her to get second vaccine but she was scared of anaphylaxis. The patient did not receive treatment for the reported events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of felt a lump in the back throat, difficult to swallow, breathing difficulty, panic attack, mouth became increasingly dry, throat became more sore, hot flashes to my face, urgency to use the restroom and swollen throat were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Pfizer / BioNTech / Tested positive; Pfizer / BioNTech / Tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart attack w defibulator implant" (unspecified if ongoing), notes: Other medical history: Heart attack w defibulator implant, ; "Heart attack w defibulator implant" (unspecified if ongoing); "loss of hearing" (unspecified if ongoing); "cold/lung disease" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Pfizer / BioNTech / Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown results, notes: Treatment of COVID-19; (14Jul2022) positive, notes: Tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient received Paxlovid for COVID 19 Treatment from 05Jul2022 to 10Jul2022. The patient received other medication in 2 weeks. The patient had no known allergies.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itchy rash spreading from left arm to neck, upper chest, and lower abdomen.; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an intramuscular route of administration on 02Feb2021 (Batch/Lot Number was not reported) as dose 2, single (at the age of 66 years old) for COVID-19 immunization. The patient's medical history included allergies with gadolinium contrast media (history of hives) and iodinated contrast media (causing anaphylactoid reaction); osteopenia, allergic rhinitis, and mild aortic regurgitation. Concomitant medications included butalbital, caffeine, paracetamol (FIORICET); sucralfate (CARAFATE), calcium carbonate (CALTRATE); and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN EXTRA STRENGTH); all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2, intramuscularly on an unspecified date for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility type vaccine where the patient received the vaccine was unknown. On 05Feb2021, the patient experienced itchy rash spreading from left arm to neck, upper chest, and lower abdomen. The result of the adverse event was doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as the result of the event included recommendation to take second generation antihistamine which the patient declined. Outcome of the event was recovered on Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Area became very sore and swollen, noticeable red area around injection site. Affected area started about size of quarter and increased to area about  2"x4". Applied ice packs for 24 hours and swelling went down but still store and noticeably red. Small raised area around injection point surrounded by generalized swelling and redness. Still sore four days later, but slowly improving. Now is itching. Seems in line with listed side affects so did not go to the doctor.
Pt came into clinic 10 days after injection with redness, fever, and tenderness. Dr prescribed rx cephalexin and recommended BENADRYL for redness and a cold compress for thigh. Possible reaction to MMR or varicella live vaccines. Child's leg has since improved/ resolved reaction.
Patient was to receive the Moderna Booster 0.25ml. But actually received the Moderna 0.5ml. Patient notified and no adverse effects noted
This is a 58yo F with history of thyroid cancer. She underwent routine pre-travel assessment with PCP in 2006. She was found to be varicella non-immune. Vaccination was advised. She ultimately proceeded to varicella #1 L deltoid 7/1/2016. There was possible local site reaction, self-limited, improved with benadryl. I saw her in follow-up 7/29 (28d after varicella #2). Risks/benefits discussed. We proceeded to varicella #2 in the R deltoid that day. The following day she appreciated RUE rash and discomfort/tingling, localized. No lesions elsewhere. rash emanating from injection site. there is a well-circumscribed and stable dark erythematous patch. no vesicles. distally there is a minimally erythematous patch. there is discomfort to light touch. no palpable collection, no fluctuance. examination is not consistent with cellulitis. there is some hypersensitivity at the site. onset was associated with chills. no fever. improved with benadryl. has no trialed any other medications. seen today 8/1 for acute visit attention complaints. the more proximal, darker patch remains stable. the associated lighter patch waxes and wanes, maximally 5"x 2", but otherwise stable. treatment with po benadryl and topical emollient (e.g. sarna) advised.
patient developed profound sudden sensorineural hearing loss in the left ear (her only hearing ear) and is now deaf
She has had noses bleed and numbness her left side of her body from top to bottom. She can't feel anything on that side. She don't have taste or smell and have sharp shooting headache. She also has difficulty of breathing. An she is very fatigue. She can't get in to see her primary doctor until next month.
This spontaneous report was received from a physician via a company representative and refers to a 68 year old female patient. The patient's pertinent medical history included ulcerative colitis. The patient's drug reactions or allergies and concomitant medications were not specified. On an unknown date, the patient was vaccinated with a single dose of ZOSTAVAX (lot # and expiration date were not reported), 0.65 ml, subcutaneously. On an unknown date, the patient was diagnosed with cellulitis in her arm where she received the ZOSTAVAX injection. It was reported that the patient sought medical attention, she contacted her physician and unspecified antibiotics were given to her at the urgent care center. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Within seven hours: asthma attack, very red eyes, copious weeping of eyes, and fever.
Patient stated on 9-8-17 that arm swelled up softball size at injection site and was warm and painful to touch. Day after that 9-9-17 swelling went down and warmth and pain went away.
Moderna 4/14/21, 5/2/21. Pfizer 11/14/22. Positive on 1/25/23
More problems with psoriasis; Having more cold sores than usual; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores and psoriasis. Previously administered products included Shingrix (1st dose received on 2nd May 2019).   On 8th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced cold sores. On an unknown date, the patient experienced psoriasis aggravated. On an unknown date, the outcome of the cold sores and psoriasis aggravated were recovering/resolving.   It was unknown if the reporter considered the cold sores and psoriasis aggravated to be related to Shingrix.  Additional details were provided as follows Within 1 week of receiving the 2nd dose she started having more cold sores than usual. The less than a month after receiving 2nd Shingrix, the patient experienced having more problems with psoriasis but menopause they have not caused her problems except for the past 1.5 months. The reporter consented to follow up.