chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She has a superficial clot, not a deep vein clotted, not in the vascular system; This is a spontaneous report from a contactable pharmacist reported for a female patient. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported; NDC/ UPC number/ Expiry date: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. It was reported that (patient) she has a superficial clot, not a deep vein clotted, not in the vascular system on an unspecified date. Additional information included reporter (pharmacist, United States) from a pharmacy stated that they have had a patient to get her second Pfizer COVID Vaccine. Reported, patient has a superficial clot, not a deep vein clotted, not in the vascular system. So, wanted to know the protocol. When asked about date of first vaccination, pharmacist replied as they don't have that right in front and wanted to know the recommendation if they should proceed with the vaccine or not. When probed, pharmacist said no information about lot number was available. The outcome of the event was unknown.  Follow-up attempts completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event thrombosis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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.
Information has been received from a nurse concerning an approximately 21 year old female with no drug allergy and no medical history who on 15-NOV-2007 was vaccinated with her first dose of GARDASIL (expiration date 16-JUL-2010), in February 2008 was vaccinated with her second dose of GARDASIL (lot#659439/1267U) and on 26-JUN-2008 was vaccinated with her third dose of GARDASIL (659964/1978U). There was no concomitant medication. The nurse reported that the patient developed seizures beginning in November 2008. No treatment specifics available and it was unknown if the patient was admitted. The patient was seen by physician to seek medical attention. At the time of report, the patient did not recover. Upon internal review, seizures is considered to be other important medical event. Additional information has been requested.
Routine Kindergarten shots given on 9/6/11 & patient was afebrile. Mom called on 9/23/11 reporting blistered, rash areas (L) shoulder, (L) ant chest, Rt chest with vesicular lesions on erythematous base.
egg-sized lump in left armpit; I got a rash on chest, face, neck, and behind the ears; I got a rash on chest, face, neck, and behind the ears; I got a rash on chest, face, neck, and behind the ears; I got a rash on chest, face, neck, and behind the ears; This is a spontaneous report from a contactable consumer or other non hcp.     A 54-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 18:00 as dose 2, single for covid-19 immunisation Medical history included blood cholesterol increased, hypertension, depression. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was Reported that, egg-sized lump in left armpit and about 40 hours after injection, got a rash on chest, face, neck, and behind the ears on 07Mar2021 14:30 with outcome of recovering  No follow up attempts are possible. No further information is expected.
Light headedness, diaphoresis, and pale skin color after HPV vaccination. These symptoms resolved within 5 minutes after patient was assisted to a seated position and a cool compress applied to her forehead.
OFF-LABEL USE; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; ADVERSE REACTION; This spontaneous report received from a parent concerned a 16 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced adverse reaction. On 10-APR-2021, the subject experienced off-label use. On 10-APR-2021, the subject experienced inappropriate age at vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off-label use, adverse reaction and inappropriate age at vaccine administration was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Swollen arm, knot at site of injection, acheyness, swollen and sore lymph nodes in left underarm
Severe pain at injection site still ongoing. 101.7 degree fever had photo showing 101.6 chills body aches lasting 2 days. Still feel very weak and tired. Joint pain lethargic. I slept 12+ hours for 3 days so far and drank lots of fluids. What would a doctor have done?
24hr p/vax pt rash started itching tx w/DPH;40hr p/vax eval in office diffuse edematous, red macular blotches covering entire legs, torso, head & upper arms, welts on back & legs;child irritable; no SOB or wheezing;tx w/pred;
urticarial rash erupted on trunk, face w/in 30 mins of vax administration; VS no resp distress administered Epi w/partial resolution of eruption;
patient developed red papules on arm. no itching, swelling or respiratory symptoms. instructed to monitor and take benadryl 25mg prn.  (Patient left vac clinic with no reaction and came back next day to report rash.)
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 01-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degree for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
I started with  pain in my arm all day and then around 6pm started to get body aches, especially around my neck area.  By 9:00pm the body aches were worse and onset of chills.  By 10pm, I was shaking uncontrollable from chills and had a 102.5 fever all night.  It wasn't until about 12:30pm the next day for the fever to break.
Wheezing, coughing within hours of receiving vaccine. BENADRYL, MEDROL injection site size of baseball within 6 hrs. Over next 5 days continued wheezing - added Albuterol inhaler with steroids and antihistamine medications.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-OCT-2015, the patient was vaccinated with the involved in the temperature excursion dose of VAQTA (lot # K012457, expiration date 04-JUN-2017; dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Initial report was received on 19 October 2011 from a health care professional, at which time this case was assessed as non-serious listed. Based upon follow-up information received on 06 January 2012 from a health care professional, it was determined this case now meets seriousness criteria (OTHER-MEDICALLY SIGNIFICANT) and this case has been upgraded from non-serious to serious. This narrative includes information reported on both dates. A four-year-old female patient had received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur Inc. lot number U4231B on 14 November 2011. On 15 November 2011, the patient experienced hives and a urticarial rash. The patient was treated with BENADRYL by mouth (PO) every six hours (q6h) for two days. The patient then went to an urgent care center and was prescribed prednisolone 15 milligrams (mg) twice a day (BID) for three days. When the patient came off prednisolone, she complained of knee and wrist pain. No swelling of the joints was noted and the patient was diagnosed with serum sickness type of reaction. The patient responded to slowly tapering the course of prednisolone but later had achy episodes and was referred to a rheumatologist. The patient took no concomitant therapy, had no any other vaccinations within four weeks prior to the administration of FLUZONE, no illness at time of vaccination, no known allergy and no relevant medical history. The patient had not experienced adverse events following prior vaccination. The patient's birth weight was 3420 grams (g) and had two brothers and sisters. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
reported getting 4 shots; reported getting 4 shots; he still had the after-effects of a really serious concussion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Jan2021, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: Mar2021, for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: Aug2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), INCORRECT DOSE ADMINISTERED (non-serious) all with onset 28Dec2021, outcome "unknown" and all described as "reported getting 4 shots"; CONCUSSION (non-serious) with onset Dec2021, outcome "unknown", described as "he still had the after-effects of a really serious concussion".  Additional information: The patient reported that he still had the after-effects of a really serious concussion. The patient already got 3 shots of the vaccine and got another shot on 28Dec201 (also reported as yesterday). The patient mentioned that he could not understand and had a concussion.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient's mother called reporting that patient is feeling exceptionally ill today. Reports fever, intense stomach cramping, and stiff joints after receiving the vaccine from a different location.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 07-MAR-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L049314, expiration date 03-DEC-2017. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742.
pt recv vax 1995 & 27SEP97 pt exp severe case of chickenpox w/pox over entire body & also on mouth;pt seen by MD who dx chickenpox;@ time of report pt was still developing new lesions & some other are crusting over;
My face started feeling very hot / feeling warm; my arms were looking mottled; first got hives under my neck on the left side and then it traveled to the tight side of my neck/ had hives on my arms legs neck chest and back; within 5 more minutes my neck was red / my face started getting red; This is a spontaneous report from a contactable Health Professional, the patient. A 63-year-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3242), via intramuscular route in the left arm on 22Jan2021 17:00 (at the age of 63-years) as a single dose for COVID-19 immunization. Medical history included Thyroid -Hashimoto's thyroiditis, Penicillin allergy, Brussels sprouts and avocados allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine and ibuprofen (ADVIL). The patient previously took erythromycin and experienced allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  On 22Jan2021 at 17:15, after approximately 10 minutes of receiving vaccination, the patient started feeling warm, she noticed her arms were looking mottled and she went to the nurse. She first got hives under her neck on the left side and then it traveled to the tight side of my neck. Within 5 more minutes her neck was red, and her face had started feeling very hot. Her face started getting red. The patient was taken to the emergency room and she had hives on her arms, legs, neck, chest, and back. The patient was treated for feeling very hot, arms mottled, hives, and neck and face red with intravenous (IV) Benadryl 50mg with Famotidine IV and saline solution IV. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event for feeling very hot, arms mottled, hives, and neck and face red were recovered in Jan2021; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to the events is possible . 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.
Pfizer-BioNTech COVID-19 Vaccine EUA Diarrhea, shortness of breath, tachycardia, elevated blood pressure, 101F fever, dizziness, weakness, fatigue, flushing, chills
This spontaneous case, initially received from other non-health professional on 24-Oct-2018, concerning a 3-year-old, child patient of unspecified gender. On an unspecified date, the patient under (age of 4 years) administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number and expiry date: not reported). At the time of this report, no adverse event was reported after the vaccine administration. The reporter assessed this case as non-serious.
On Monday 11/20/17, Rt eye dry-noted at 8am, eye slow to blink, by 3pm Rt sided mouth droop, Rt eye not blink. Lips numb, Rt eye dry-vision worse. Went to Urgent Care. Neuro exam good except paralysis on Rt side face given script to start Prednisone and VALTRAX. Vaccine exp. date 7-6-2019. Not all symptoms have improved. At Urgent Care on 11-20-17, the Forehead had no paralysis but over next 24 hours the Forehead also on Rt side did show paralysis. Symptoms worsened first week, now today are better, but still slight droop in mouth, eye brow. Rt eye still slow to blink and focus able to not wear eye patch after 2 weeks. 50% better after 2 weeks. On 11/20/17 told I had Bells palsy.
pt recv vax & devel a rash all over w/erythematous, crusty papules on trunk & genital area w/pruritus;
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not feeling good), SOMNOLENCE (Wants to sleep all the time), DECREASED APPETITE (Did not eat anything today) and PYREXIA (low grade fever of 99 degree) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced VACCINATION COMPLICATION (Not feeling good) and SOMNOLENCE (Wants to sleep all the time). On 02-May-2021, the patient experienced DECREASED APPETITE (Did not eat anything today). In May 2021, the patient experienced PYREXIA (low grade fever of 99 degree). At the time of the report, VACCINATION COMPLICATION (Not feeling good), SOMNOLENCE (Wants to sleep all the time), DECREASED APPETITE (Did not eat anything today) and PYREXIA (low grade fever of 99 degree) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Body temperature: 99 (High) 99 degree.         No relevant concomitant medications were reported.  Treatment information was not provided.   Reporter did not allow further contact
Cellulitis on (L) thigh 7 cm x 5 cm reported on 1/13/12. Patient was treated with KEFLEX 125 mg/5m. 5ml PO tid for 7 days & warm compress.
Diffuse urticaria that started about 12-24h after vaccine administration. Treated with diphenhydramine.
headache; This is a spontaneous report from a contactable consumer or other non hcp.    A male patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date were not reported), via an unspecified route of administration on an 29May2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date. Outcome of the event was unknown.  No follow up attempts are needed. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician as recommend for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-JUL-2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient has been prescribed VALTREX and lidocaine for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Pt was seen in office on 08/19/2002 with red, swollen and hot reaction to DTaP . Reaction covered 3/4 of upper arm. pt was put on Keflex 250 mg 1.25 tso TID X 10 days.
tested positive for the COVID-19 virus; tested positive for the COVID-19 virus; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information team. A 78-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9269, expiration date was unknown), via an unspecified route of administration on the right arm on 04Feb2021 at 15:00 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital; the vaccine was not administered at a military facility. The patient's medical history and concomitant medications were not reported. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on the same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). The patient tested positive for the COVID-19 virus on 22Feb2021. The patient requested guidance on when to receive his second dose. The patient stated he was scheduled to get his second COVID-19 vaccine shot on 02Mar2021 and asked if he should get the second COVID-19 vaccine shot, since he tested positive for the COVID-19 virus. He had a COVID-19 virus nasal swab test administered on 22Feb2021 that provided almost an immediate positive result. He clarified he had gone to an emergency care clinic for his COVID-19 virus test. He was prescribed some medication after he was diagnosed with the COVID-19 virus. He said he did not have all the medications with him as he was on his way to the emergency clinic to be retested for the COVID-19 virus. He stated he was prescribed a liquid cough medicine, promethazine 6.25-15mg/4/5ml. He said he did take promethazine liquid cough syrup. He said he was also prescribed prednisone 20 mg tablets, and that he was taking the prednisone 20 mg tablets twice a day. He was also prescribed an albuterol sulfate inhaler (NDC Number: 0093-3174-31; lot number: DAF07A, and expiration date: Aug2022) to use every 4 hours, as needed. He said the albuterol sulfate inhaler seemed to help. He also reported that his girlfriend had an extra (new and unopened) azithromycin (Z-PAK) that he took when he first started feeling bad. He said he took his girlfriend's Z-Pak at 2 tablets the first day, and 1 tablet a day for 4 days from an unspecified date in Feb2021 and completed that. The adverse event did not require a visit to a physician office. The patient underwent lab tests and procedures, which included COVID-19 virus test: positive on 22Feb2021. Therapeutic measures were taken as a result of the event "tested positive for the COVID-19 virus." The outcome of the event was unknown.
This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. An elderly (around 70 year old) female patient of an unspecified ethnicity received PREVNAR 13 at single dose in one arm, TETANUS VACCINE in the other arm, both intramuscular on an unspecified date one year before this report for immunisation. The patient medical history was and concomitant medications were not reported. The patient experienced arm swelled up all the way down to her elbow on an unspecified date with outcome of unknown. The nurse knew that swelling was an adverse reaction, but this swelling was much more significant: the woman's arm swelled up all the way down to the her elbow.
Starting that evening and he was skin transiting some leg pain and started having panic attacks or surrounding.  He's never had any trouble with panic before.  He is his usual behavior continued for a couple days.  Mother looked this up on the computer and found that other people had similar reactions.