chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: COVID infection following COVID vaccine series 02/15, Pfizer, dose #1 03/16, Pfizer, dose #2 07/27 pt cc: chest heaviness, dyspnea, chest pain exposure: unknown 7/29 pt cc; dyspnea 08/04 pt cc: diarrhea, headache, fever, 08/04 COVID swab, result: detected 08/04 ED admission with cc: dyspnea, cough, diarrhea x3 days 08/04 admitted to medicine dx: COVID-19 PNA 08/04 PT/APTT/INR 10.7/ 32.9/0.6 08/049 CXR impression: there are increased interstitial markings throughout both lungs, which could reflect chronic parenchymal disease, or an infectious/inflammatory process. There is a possible subtle focal opacity in the left mid lung. Short-term follow-up radiograph is recommended to confirm resolution. Focal opacities in the left lower lung suggest atelectasis. No pleural effusion or pneumothorax is identified. Cardiomediastinal contours appear stable. 08/04 ABG result: i-pH 7.48 iPCO2 44.0 iPO2 76 i-HCO 32.6 08/05 Ferritin result: 34.6 08/05 DDMINER result: 0.43 08/05 CRP result: 0.775 08/05 TToponin I <0.0160 08/06 ESR 24 08/06 FIBRINOGEN/ DDIMER results: 261/ 0.39 08/07 FIBRINOGEN/ DDIMER results: 261/ 0.61 08/07 ESR result: 18 08/07 pt discharged: 08/10 pt cc: improvement in symptoms and returned to work 08/09 08/10 clinically resolved
I got a real burning pain from the top of my mouth down through my wind pipe down through my stomach; I got a real burning pain from the top of my mouth down through my wind pipe down through my stomach; I am getting really afraid now; I have been sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 Immunization. The following information was reported: BURNING SENSATION (non-serious), PAIN (non-serious), outcome "unknown" and all described as "I got a real burning pain from the top of my mouth down through my wind pipe down through my stomach"; PANIC DISORDER (non-serious), outcome "unknown", described as "I am getting really afraid now"; ILLNESS (non-serious), outcome "unknown", described as "I have been sick". Additional information: The patient reported that "I am calling because I am getting really afraid now. I took my second dose of Pfizer last Saturday. I thought I would wait and ever since I took it, I have been having these side effects. But I thought if I wait a week it would probably go away but it is not. It just continuously appearing to get worse and I need to know what I should do. It is like I got a real burning pain from the top of my mouth down through my wind pipe down through my stomach. I took the second dose last Saturday."  Additional information: Consumer stated, "I am calling because I am getting really afraid now. I took my second dose of Pfizer last Saturday. I thought I would wait and ever since I took it, I have been having these side effects. But I thought if I wait a week it would probably go away but it is not. It just continuously appearing to get worse and I need to know what I should do. It is like I got a real burning pain from the top of my mouth down through my wind pipe down through my stomach. I took the second dose last Saturday." I had it last Saturday. What can I do to get rid of the side effects? I want to know how to get rid?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
covid; covid; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 14Feb2022 at 12:00 as dose 4 (booster), single (Lot number: CV59749) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "Lung cancer" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: Other medical history: HTN; "Hypothyroid" (unspecified if ongoing), notes: Other medical history: hypothyroid; "Osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTIN, start date: 30Apr2010, stop date: 16Jun2022; PLAVIX, start date: 30Apr2020, stop date: 16Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: indication=Treatment of COVID-19; (23Jun2022) Negative, notes: Tested negative one day after completing Paxlovid course; (26Jun2022) Positive, notes: Positive test 4 days after completing course. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Tested negative one day after completing Paxlovid course. Recurring nasal congestion and positive test 4 days after completing course. Having nasal congestion, mild cough, no fever, no body aches. Mild headache.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Headache; Chills; Muscle Pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0813M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint pain) 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.
Pt vaccinated with Pneumovax 23 developed a cough. 1 wk later, developed episodes of laryngospasm, especially at night w/difficulty in breathing for some 15 to 30 seconds. A dx was made of pertussis.
This spontaneous report as received from a physician refers to multiple unspecified patients of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX injection (lot# L029469, expiry date: 06-AUG-2017) (dose, strength, route 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. Additional information has been requested.
On 3/24/21 small round nickle size pinkish-red cirlce 1/2 inch below infection site.  3/26/21 she noticed it got larger about size of  golf ball and slightly raised area. It was very itcy and has not resolved. Currenlty it is lighter red now it's a 3/4 quarter moon size about 2 inches now. Took benadryl childrens meltaway  (Waldryl) one a day . Put coritisone cream on that two times a day. More red in shower.  Fagitue-overwhelming fatigue- not usual. Travleled last week and had lunch with friends at their who were vaccinating.. She felt fatigued since then.  Advised to take an adult dose of benadryl if possible and call Dr. or go to a walk in. RN
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 14 year old patient. On 08-SEP-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
Pt felt "lighthead" c/o nausea.  Slightly pale in color @ 11:20am.  LOC, start feeling better after (one(11:28).  No treatment given.  No fainting occurred, no vomiting.  BP 103/58 + Sx 11:25am.
Projectile vomiting initially, then followed with several days of fever, vomiting and loose stools.
Shingles; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported a male patient with unknown age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient had received 1st dose of Covid vaccine and developed shingles about 17 days later. He is wondering if he should wait to get the Covid vaccine until after he in recovered from Shingles. The outcome of event was unknown.  Information on the lot/batch number has been requested.
3 days after injection, started with increase of pain to the left upper arm with 8.5 x 11cm circular area of erythema  surrounding 3 x 4cm induration, warm and tender to the touch. Treatment: Motrin 600mg BID and apply ice 10-15min intervals BID-TID. Cipro 500mg BID for 7days.
an unspecificied female patient was given the GARDASIL Quadrivalent vaccine on an unspecified date and subsequently developed leukemia on an unspecified date over ten years ago; This spontaneous report was received from a physician via company representative referring to a female patient who was in her twenties. Information about her concurrent conditions, pertinent medical history, previous drug reactions or allergies and concomitant medication was unknown by the reporter.  On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as prophylaxis (strength, dose and frequency were not provided; route of administration, anatomical location, lot number and expiration date were unknown by the reporter). Subsequently, on an unspecified date (reported as over ten years ago), the patient developed leukemia, she sought for medical attention and an unspecified treatment was given. It was unknown by the reporter if any laboratory diagnostic or studie were performed. The patient recovered from the event on an unspecified date, also reported as "she was doing fine".   The causality assessment between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) administration and the occurred event, was not provided.  Upon internal review, leukemia was considered to be medically significant.
gave the DTaP-IPV only portion of Pentacel; Initial information received on 18-Apr-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a four months old male patient who received only Dtap-IPV portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 17-Apr-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number U6397AA via intramuscular route in the right thigh. (Package portion: lot- UJ122AAA expiration date: 29-Sep-2020; DTaP portion-Lot number: U6397AA expiration date: -29-Sep-2020; ACTHIB portion- lot number: UJ122AA expiration date: 29-Sep-2020)  It was a case of actual medication error due to inappropriate reconstitution technique.  It was not reported whether the patient experienced any adverse events following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
1st dose Oct2021, 2nd Nov2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received her first dose of Shingrix in October 2021).   In November 2022, the patient received the 2nd dose of Shingrix. In November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's Comment: The case was reported by the patient. The patient provided limited information.  The reporter needed to end call as she needed to see patients (reporter was also an healthcare professional). The reporter did not consent to follow-up.  Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Left Deltoid 5cm x 3 1/2 cm circular erythematous tender and warm to touch lesion arm very tender.
Pt had his original covid 19 Moderna vaccine on Jan 22, 2021 and got his second dose on Feb 3, 2021, too soon. Manufacturer was called. They informed us no risk of overdose. Pt had no SEs with first vaccine.
Varicella #2 given on 10/8. Developed rash on 10/10. Itchy, red bumps. Examined on 10/13/08; mult. erythematous papules over legs, abdomen, neck. No vesicles. Otherwise well. No contacts with rash at this time.
Information has been received from a physician and medical assistant concerning a 18 year old female who received all 3 doses of GARDASIL.  The patient received her third dose of GARDASIL in November 2007 (dates of other doses and lots were not available).  Subsequently, the patient had a PAP and HPV test in December 2007 that were normal.  On 16-FEB-2009 the patient had a HPV tested positive for high and low risk HPV and the result for her PAP test were normal.  The patient was not recovered and sought unspecified Medical attention.  Addition information has been requested.
metallic taste; dry mouth; Making him miserable; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration in Feb2021 as dose 2 single in left arm for COVID-19 immunization. Medical history and Concomitant medications were not reported. Prior Vaccinations (within 4 weeks) were none. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date in 2021 for COVID-19 Immunization. Patient reported having metallic taste in his mouth and a dry mouth for the last 2-3 months in 2021. Says they are persisting. stated it was making him miserable in 2021. For adverse events dry mouth, very metallic taste in mouth patient visited to Physician Office. About 3 weeks ago he had a Covid 19 Test done and it was negative in 2021. The outcome of events was not recovered.  Information about lot/batch number has been requested.
1040:  Received patient via which post in Covid Vaccination Clinic. History of fainting post Covid Vaccine injection with seizure activity.  Mother states that patient faints with injections or blood draws. Patient is alert on arrival.  Skin warm and dry.  Color pink.  She desires to sit instead of lay down as she is not dizzy.  Given water as requested. BP 119/66, HR 78.  Dr. in to evaluate patient. 1105:  Dismissed to home care by MD.
Information has been received from a physician concerning a 67 year old female with a history of sjogren syndrome who on 06-Oct-2008 was vaccinated with influenza vaccine in the left arm. On 07-Oct-2008 was vaccinated with a dose of ZOSTERVAX (lot#659408/0300X) "under the right arm 1 finger away from the arm pit". Within hours after of the vaccination, the patient experienced a large injection site reaction consisting of warmth, in duration, pain, extending from the elbow to the breast and chest, along with systemic symptoms including fever, malaise and severe headache. The vaccine had been administered at a clinic from a single vial with a physician's prescription. The patient experienced 1/2 dollar size pink spot within 30 minutes of receiving vaccine which over the next several days continued to spread down the arm to the elbow and across the chest. No rash but involved area was very swollen, red warm to touch, painful and was also described "hard as a rock". The area on the arm and chest then "broke up" after about a week into smaller knots. The patient also described a sore knot developed across her right shoulder blade approximately quarter size which lasted about a week. Patient was in bed one week with extreme headache, fever of 100.5, malaise with the injection site, arm and chest inflammation. The patient called physician because she thought she had the flu and was not seen by physician but prescribed Z-PAC on 22-Oct-2008. The patient felt better by 25-Oct-2008. On 30-Oct-2008, the patient had blood work but the patient was not sure why or what type of blood work was being collected and would be contacted by a physician next week. Currently injection site was red, pinkish blue 2 inches by one inch in size with no pain. The patient questioned whether the vaccine was kept adequately frozen since the patient and her husband heard it had been transported from another pharmacy 40 minutes away and also there was a delay of about a half hour from the time they where told that the vaccine was being prepared till the actual receipt of the injection. The clinic clarified that the vaccine was stored transported from another pharmacy off site in a cooler with ice packs. The clinic also mention that the company was contacted and mentioned that a lot check was done on the vaccine lot and found no problems in their data. This is one of several reports received from the same source. Additional information has been requested.
Head jerking that often continues through sleep, looks like a seizure. No shrugs shoulders toward head and jerking involves shoulders also. No fever, but do suffer of nose bleedings which coincide with the head shaking, sibling (sister) suffered of similar problems after same vax adn lasted for 1 year, now suffers of epilepsy.
PT FELT INSTANT HEADACHE, FOGGY FOLLOWING ADMIN OF 1ST DOSE OF ENGERIX-B. PT RECOVERED
Pt stated he got bumps, swelling and rash on face and neck the next day after receiving the flu shot. Pt took cetirizine the next day in evening. He came to pharmacy the following day. I advised him to take BENADRYL 25mg at night. Pt said his swelling and bumps had decreased but he was going to his primary care for follow up.
I am still technically sick. I had a fever and stomach pain. I also had tiredness. I went to the doctor and I was tested during the appointment and the test was positive. They advised me to go home and rest and drink lots of fluid. I have been drinking water and taking an occasional ibuprofen. I am still on the mend. I am still experiencing a low fever around 99 and the pain is off and on in my stomach. I have also had a part of my colon removed so I thought that it was related to that. I did complete 4 home test for COVID-19 and they all came back negative.
Patient was given vaccine too soon. First vaccine was administered on 5/4/21 and second vaccine was administered on 5/26/21.
No symptoms; got the GARDASIL shot in April 2015 and received the 2nd dose of GARDASIL in January of 2016 and the 3rd dose in March of 2016"; This spontaneous report as received from a physician via a company representative refers to a patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in April 2015, the 14-year-old patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. The patient received a second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) on an unknown date in January 2016. On an unknown date in March 2016, the patient was vaccinated with a third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). There were no symptoms reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA005894:
the vision in my right eye became blurry; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el9262), via an unspecified route of administration in the left arm on 26Jan2021 09:00 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no known allergies. Concomitant medication included metoprolol succinate (TOPROL 25 mg) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el3246), via an unspecified route of administration in the left arm on 05Jan2021 11:30 for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. She was not pregnant. The patient experienced "the vision in my right eye became blurry" on 26Jan2021 09:15. The patient reported that the event was "still is" as date of the report. The event was reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. The patient had not been tested for COVID-19 since the vaccination.