chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was given original dose at another location.  Patient stated to pharmacist that she did not have any issues with first dose but had a long list of allergies. All of which we have on file. She came in at 4:19 pm and the dose was administered at 4:35 pm she was kept 30 min due to allergies,  at 5:08 the technician (who is CPR trained) gave the patient her card and was walking along side patient just past the pharmacy the patient said she felt light headed. The technician brought her back into the clinical services area and knocked on window to alert pharmacist she was slumped over. The pharmacist instructed staff to call 911 and a code white. I ran out and when I arrived the patient was not alert and slumped back into the technician.  The pharmacist and technician at that time helped the patient to the floor gently as to not hit her head and remove the chair. An ice pack was brought out and place behind the patients neck. . I checked for pulse and asked the patient if they could hear me. The patient kept opening her eyes and closing them but had airway and pulse. The store Coach showed up and was assisting. The patient then stated she was itchy and felt her throat closing. She said her husband was in the pharmacy parking spots so the technician  went to look for him in his car. At 5:13 an Epi pen was administered into the patient and a second retrieved in case of necessity. The patient was talking and alert and stated she felt her airway was tightening.  She then lost consciousness again in which I checked for pulse and tried to check airway. Pt started having what seemed a seizure with eye movement back and forth and slight head movement. I did feel a faint pulse. I instructed (Coach) that I thought patient was having a seizure and that most important thing is to keep patient from hitting her head on ground. We removed the clinical services room and table and chairs. Pt started with full tonic clonic seizure movement and moved at least 2-3 feet from original position.  At times it seemed patient would almost vomit so moved her to her side and just made sure she did not hit her head on cement. I instructed not to fight the movement just keep her head  from hitting ground. At 9:17 I instructed staff  to call 911 again to verify coming. During this time coach and myself just kept her from hitting her head. I did not feel it safe to administer an second dose of Epi as the patient had too much movement. The paramedics arrived at 9:18 slowly walking to the scene and took over.  At the time the paramedic saw the epi pen and asked why we administered. I stated to the paramedic that the patient was telling us her throat was closing and had multiple allergies and received a second dose of COVID just before so it was part of our protocol.  The husband came in at the same time as paramedics and also told paramedics that the patient always has epi pen and uses for situations. The EMT showed up a few minutes later and an IV was administered and patient was taken to hospital.  She was able to speak a few times but was unconscious most of the time.
initial and follow up information has been received from a registered nurse, concerning a 19 year old female student with allergy to codeine, who was vaccinated with a first dose of (date not specified) Gardasil with no reported problems, and on 11-MAY-2007 at 10:30am was vaccinated with the second dose of Gardasil (Lot #657617/0384U). Concomitant therapy included ORTHO TRI-CYCLEN. On 12-MAY-2007 the patient started feeling nauseous; on 13-MAY-2007, she started feeling a tingly sensation in her shoulder, neck and scapula (reported by patient's phone call on 14-MAY-2007); she was instructed to alternate between hot and cold packs every 20 minutes and was prescribed MOTRIN 800mg, every 6-8 hours as treatment. On approximately 15-MAY-2007 ("later"), she experienced itching all over her body (reported by patient's phone call on 21-MAY-2007). The nurse reported that by 21-MAY-2007, the patient had completely recovered from all the symptoms. Follow up information indicated that the reporter considered one or more of the events to require medical intervention to prevent more serious symptoms, and were therefore considered to be other significant medical events. No further information is expected.
This spontaneous report was received from a medical assistant and refers to a 60 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 14-MAR-2018, the patient was vaccinated with an expired dose of ZOSTAVAX vial 19400 PFU, lot number N011366 with and expiration date on 12-MAR-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. It was stated that the expired dose did not had a temperature excursions prior to administration and the sterile diluent (manufacturer unknown) used for reconstitution was properly stored. There was no adverse effect reported. No product quality complaint was involved.
Severe pain, swelling of arm around injection site and below, fever, possible cellulitis. Treated with percocet and clindamycin.
SEVERE INJECTION SITE REACTION, BRUISING REPORTED THAT SPREAD TO THE LOWER ARM FROM THE SITE OF ADMINISTRATION. VERY RED, INFLAMED AND HOT TO TOUCH.
Cough; Low grade fever; Body aches; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PYREXIA (Low grade fever), MYALGIA (Body aches) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 COUGH (Cough), PYREXIA (Low grade fever), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, COUGH (Cough), PYREXIA (Low grade fever), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
pt seen in ER 12APR w/ c/o t37.9;dx viral synd;15APR red raised rash trunk,extremities face dx LOM and began pediazole;seen in ER 22APR p/sz-like activity @ home;described as shaking&stiffening <3mins-staring&dazed afterwards;t40.8R;rash
eczema lesion on the leg that spread to both legs, arms and part of the torso; This case was reported by a consumer via call center representative and described the occurrence of eczema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced eczema. On an unknown date, the outcome of the eczema was unknown.   It was unknown if the reporter considered the eczema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed an eczema lesion on the leg that spread to both legs, arms and part of the torso. No further data available.
my neighbor is experiencing lower leg pain that is debilitating; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (my neighbor is experiencing lower leg pain that is debilitating) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (my neighbor is experiencing lower leg pain that is debilitating). At the time of the report, PAIN IN EXTREMITY (my neighbor is experiencing lower leg pain that is debilitating) outcome was unknown.            No concurrent and treatment medication was reported by patient.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received on 9-7-2021 contains significant information. patient demographic updated.
brain fog, memory loss of words, nerve pains radiating throughout body, heart palipitations and flutters.
This spontaneous report was received from a pharmacist, and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not reported. On unknown dates, the unspecified patients were vaccinated with ZOSTAVAX (dose, route, lot #, and expiration date were not reported) for prophylaxis. Later, on unknown dates, the patients complained of redness and soreness at the injection sites (injection site erythema and injection site pain). At the time of reporting, the outcome of injection site erythema and injection site pain was unknown. Additionally, the relatedness between the aforementioned events and ZOSTAVAX was not provided. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1706USA007406.
1/8/2021- 1/12/2021-  complaints of intermittent L thigh pain 1/8/2021- Moderna Vaccine given 1/12/2021-  continued c/o pain to Left hip/thigh, Rash noted to L inner thigh/groin. 1/13/2021- VS: 97.1-69-18-110/70-SpO2 97% on RA. Notified PCP regarding rashes/lesions with vesicles to left inner thigh and left posterior leg and left lower back. With orders to start on contact/droplet precautions.  Famciclyclovir 500 mg tab PO QD x 7 days. Dx. Shingles.   1/13/2021- Medical director advised reporting to VAERS.
Allergies: Penicillin, Sulfa drugs, Pneumococcal vaccines; This is a spontaneous report from a contactable physician. A 58-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergies to penicillin, sulfa drugs, pneumococcal vaccines on an unspecified date. Outcome of the event was unknwon.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  Information on the batch number has been requested.
0.125 mL of a dose was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (0.125 mL of a dose was administered) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included METFORMIN, ATORVASTATIN, INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN 70/30) and LOSARTAN for an unknown indication.   On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .125 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (0.125 mL of a dose was administered). At the time of the report, ACCIDENTAL UNDERDOSE (0.125 mL of a dose was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable No treatment medications were reported
I exp fever on Fri and Sat. On that Sat night I was starting to become sensitive to the light and had a headache. On Sun/Mon still exp headache while at work. I went to Urgent care on Monday got Benadryl injection left arm. I woke up that Tues felt better no headache and sensitivity to light.
sore arm; tired; This is a spontaneous report from a contactable consumer reported for her father (a male consumer age not provided) that: A male patient of an unspecified age received unknown dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient relevant family medical history include: she says her parents and sister all were vaccinated and were fine but her dad and sister have heart conditions but have been fine, no one had any effects other than like sore arm and tired. The patients concomitant medications were not reported. On an unknown date the patient experienced sore arm and tired. No other products provided and Investigations not provided. The outcome of events was  Communication: Report 2 of 3. AE identified after the caller unable to clarify with the caller the specific product received by her father. No further information provided.  Information on the lot/batch number has been requested.
Swelling in lymph node area under left arm and sensitive to touch.; This is a spontaneous report from a contactable other HCP (patient). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266), via an unspecified route of administration in left arm on15Feb2021, at 09:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient medical history included IGA Nephropathy. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included atorvastatin, losartan and aspirin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302), via an unspecified route of administration in left arm on 25Jan2021, at 09:15 for COVID-19 immunisation. On 16Feb2021 at 05:00, the patient experienced swelling in lymph node area under left arm and sensitive to touch. The patient treatment details for the event was unknown. The outcome of the event swelling in lymph node area under left arm and sensitive to touch was unknown.
Pt reported chest pain with exertion occurring approximately one week after the second dose of the COVID-19 vaccine. He was seen in the ED on 06/10/2021. At the time he described midsternal chest pain and shortness of breath.  Which occurred with exercise. In the ED he had a normal ECG and echocardiogram but had elevated troponins 0.24 and with observation in the ED decreased to 0.18.  He has since been refraining from any competitive sports or swimming.
Information has been received from a pharmacist regarding a 68 year old male patient with a history of a case of shingles (6 years ago) and asthma, who on 07-JAN-2010 received a dose of ZOSTAVAX (Merck), 0.65ml, SQ on the left deltoid (lot # 1197Y, exp. date 21-FEB-2011). The patient contacted the pharmacist and reported that in the "second week of December" he came down with a case of shingles. The pharmacist reported that the patient stated the vaccine failed to protect him from shingles. The patient sought out medical treatment from his physician, who sent him for blood work on 04-JAN-2011 at 10:45 which confirmed a low antibody titer to varicella zoster IgM. The level was reported as 0.37. The patient was treated with FAMVIR. The pharmacist stated the patient reported a lot of pain with the rash. No further information provided. The patient's outcome was unknown at the time of the event. Additional information has been requested. This is an amended report. In the therapy screen was added vaccine purchased with (unknown) and vaccinated at (unknown).
I was in fever; you would have to wait for two weeks to get done; I had shingles shot back / So I waited almost a month; shingles shot swelled my arm; This case was reported by a consumer via other manufacturer and described the occurrence of swelling arm in a 68-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included Herpes zoster (Shingles vaccine).   In May 2020, the patient received the 2nd dose of Shingles vaccine. In May 2020, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced swelling arm, fever and drug schedule prescribing error. On an unknown date, the outcome of the swelling arm and fever were recovered/resolved and the outcome of the drug dose administration interval too short and drug schedule prescribing error were unknown.   It was unknown if the reporter considered the swelling arm and fever to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient was calling due to she had questions regarding side effects. The patient received the dose of Shingrix and experienced swelling in arm and fever.  The patient received Shingrix 1 month after the 1st dose and that the patient was indicated by the druggist to at least wait two weeks between doses, which led to shortening of the schedule and drug schedule prescribing error. The patient received the dose of Covid-19 vaccine on 4th February 2021 and experienced soreness in arm for one day. The soreness in arm was resolved till th time of reporting The batch number for covid-19 vaccine reported as EL3249. The patient would go for 2nd covid-19 vaccination on 25th February 2021 and for blood work on 10th.  Note:- As per narrative its not clear about after which dose patient had swelling in arm and fever so as per conservative approach latest dose considered as suspect and all the events linked with 2nd dose.
numbness and tingling to lips, tongue and bilateral arms within the first 15 minutes of injection.  Pt given 50mg of IM Benadryl  and sent to Urgent Care for observation
6PM 5JUN92 t104, emesis tepid bath, APAP, ice chips, unable to dec temp; 12MN 5JUN92 to ER; 2AM 6JUN92 T101-fine until noon; 12 noon 6JUN92 T104 APAP, tepid bath, ice chips, T dec 101 restless in eve but slept;
3 hours after I received the vaccine my blood pressure raised to 160/100 (I never had high blood pressure before) due to the spike in blood pressure I had headache and nausea. The blood pressure slowly went back to normal after a few hours; 3 hours after I received the vaccine my blood pressure raised to 160/100 (I never had high blood pressure before) due to the spike in blood pressure I had headache and nausea. The blood pressure slowly went back to normal after a few hours; 3 hours after I received the vaccine my blood pressure raised to 160/100 (I never had high blood pressure before) due to the spike in blood pressure I had headache and nausea. The blood pressure slowly went back to normal after a few hours; This is a spontaneous report from a contactable pharmacist, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 00:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to food, medicine or other products. The patient did not receive any medication within two weeks prior to vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 16:00, three hours after the patient received the vaccine, her blood pressure raised to 160/100 (units unspecified) (The patient never had high blood pressure before) due to the spike in blood pressure she had headache and nausea. The blood pressure slowly went back to normal after a few hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events three hours after the patient received the vaccine her blood pressure raised to 160/100 (units unspecified) (The patient never had high blood pressure before) due to the spike in blood pressure she had headache and nausea, the blood pressure slowly went back to normal after a few hours was resolving at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4495359-00.  A 33-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 01Aug2021 as dose 1, single (Batch/Lot number: unknown) and on 18Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 33 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen from 07Oct2021 (Batch/Lot number: unknown) to 13Jul2022 at 40 mg (40 mg, 1 in 14), subcutaneous and second regimen since 24Jul2022 (ongoing) (Batch/Lot number: unknown) for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID, positive for corona virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive. The action taken for adalimumab was dosage not changed. Clinical course: In Jan2022, the patient experienced COVID. On 13Jul2022, the patient experienced positive for corona virus. on 24Jul2022, the positive for corona virus resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter did not provide the causality for Pfizer BioNTech Covid-19 Vaccine. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of positive for corona virus and covid with humira 40mg/0.4ml (adalimumab) was no reasonable possibility.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200040486 same patient, different drug/event;
FEELING HOT; FEVER; This spontaneous report received from a parent concerned a 32 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-SEP-2021, the patient experienced feeling hot. On 10-SEP-2021, the patient experienced fever. The action taken with covid-19 vaccine was not applicable. The outcome of the fever and feeling hot was not reported. This report was non-serious.