chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling in legs; Increased pain in joints within a week of shots; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 09Mar2021 at 00:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MOTRIN) for an unknown indication from an unknown date and unknown if ongoing. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on Feb2021 at 12:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. On 16Mar2021, the patient experienced swelling in legs and increased pain in joints within a week of shots that not only had not gone away but was getting worse as time went on. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On an unknown date in Mar2021, the patient underwent SARS-COV-2 test and the result was negative. On an unknown date in Apr2021, the patient underwent SARS-COV-2 test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events swelling in legs and increased pain in joints was not resolved at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
This spontaneous report as received from a 51 year old female patient with no pertinent medical history and no drug reactions or allergies, refers to herself. On 07-NOV-2013 the patient was vaccinated with the dose of ZOSTAVAX one time vaccine (dose, lot number and route of administration were not reported) in the right arm. On 07-NOV-2013, the patient become ill, had to call ambulance and was taken to Emergency Room. It was reported that the patient was hospitalized. The patient had headache, it was hard to open her eyes, could not focus, was sweating and had chills, had rush down her body. Blood work was done on 07-NOV-2013 (reported as yesterday) in emergency room for vaccine reaction (results not provided). The patient was treated for the events with generic BENADRYL given intravenously (IV) as fluid in emergency room and was prescribed 2 medication, hydroxyzine (unspecified) and hydrocortisone (HCO) (unspecified) as needed. The patient was feeling better at the time of the report. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review reported events were considered to be medically significant due to generic BENADRYL used by intravenous route for treatment. Additional information has been requested.
Throat scratchiness; Cough; This is a spontaneous report from a non-contactable healthcare professional reporting for a patient. A 24-year-old female patient received the first dose of bnt162b2 (BNT162B2, Pfizer, lot number: EH9899) and second dose (lot number: EK9231); both via an unspecified route of administration on an unspecified date at a single dose for COVID-19. Medical history and concomitant medications were not reported. During her 15-minute waiting period after the injection, the patient began to experience throat scratchiness and cough. The patient denied difficulty breathing, difficulty swallowing, throat tightness, dizziness and facial swelling. Treatment included antihistamines: diphenhydramine (BENADRYL) 25 mg oral. The patient denied any symptoms on discharge. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Very sore arm.; Very very sleepy.; This is a spontaneous report from a contactable consumer, the patient. A 34-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 right arm on 16Apr2021 at 08:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Concomitant medications included estrogen (MANUFACTURER UNKNOWN) and phendimetrazine tartrate (BONTRIL), both taken for unspecified indications from unknown dates. 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 16Apr2021 at 14:00, the patient experienced very sore arm and very very sleepy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events very sore arm and very very sleepy were resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Large red oblong spot approximately 2 inches by 3 inches approximately 2 1/2  inches below injection site.  A little puffy and very itchy.
She had hit the bone under the eye brow on left side.; she had a black out for 5-10 minutes while walking; She lost lots of blood; She had concussion; She had constant headache.; This spontaneous case was reported by a consumer and describes the occurrence of SKELETAL INJURY (She had hit the bone under the eye brow on left side.), LOSS OF CONSCIOUSNESS (she had a black out for 5-10 minutes while walking), HAEMORRHAGE (She lost lots of blood), CONCUSSION (She had concussion) and HEADACHE (She had constant headache.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and ACETYLCYSTEINE, CALCIUM LEVOMEFOLATE, MECOBALAMIN (CEREFOLIN NAC [ACETYLCYSTEINE;CALCIUM LEVOMEFOLATE;MECOBALAMIN]) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced SKELETAL INJURY (She had hit the bone under the eye brow on left side.) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (she had a black out for 5-10 minutes while walking) (seriousness criteria hospitalization and medically significant), HAEMORRHAGE (She lost lots of blood) (seriousness criteria hospitalization and medically significant), CONCUSSION (She had concussion) (seriousness criterion hospitalization) and HEADACHE (She had constant headache.) (seriousness criterion hospitalization). The patient was hospitalized on 12-Mar-2021 due to CONCUSSION, HAEMORRHAGE, HEADACHE, LOSS OF CONSCIOUSNESS and SKELETAL INJURY. The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SKELETAL INJURY (She had hit the bone under the eye brow on left side.), LOSS OF CONSCIOUSNESS (she had a black out for 5-10 minutes while walking), HAEMORRHAGE (She lost lots of blood), CONCUSSION (She had concussion) and HEADACHE (She had constant headache.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Patient received her 1st dose on 02Mar2021 on her left arm. On 12Mar2021, she had a black out for 5-10 minutes while walking. She had hit the bone under the eye brow on left side. She ended up in hospital on same day. She had lost lots of blood. She had concussion. She had constant headache. Concomitant product included as Cerefolin Nac.  Company comment- Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-269924 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TADALAFIL (ADCIRCA) for an unknown indication.   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. and TREPROSTINIL SODIUM (unknown route) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown. Not Provided          Patient began therapy with IH Tyvaso, delivered by Tyvaso Inhalation Device (TD-300/A) (device only). The current dose was reported as 60-120 microgram (10-20 breaths) four times a day (QID) (off label use) via inhalation (IH) route.  The action taken with mRNA-1273 in response to the event was not applicable.
The second the shot was given a very intense metal  taste filled my mouth.  My throat was also itchy within 30 minutes of the shot. The metal taste  that filled my mouth lasted for 4 days and  went away but still to this day  I get a metallic feel in my teeth  every few days
Second dose scheduled after 36 days from the first dose; Heart flutters; Episodes of heart racing; Heart miss a beat; A spontaneous report was received from a 49-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced episodes of heart racing/palpitations, heart miss a beat/extrasystoles, heart flutters/cardiac flutter and second dose scheduled after 36 days from the first dose/Inappropriate schedule of product administration.  The patient's medical history was not provided. Concomitant product use was not provided.  On 16 Feb 2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 20 Feb 2021, approximately 4 days after vaccination, the patient experienced episodes of heart racing, heart miss a beat, and heart flutters. Also, second dose scheduled after 36 days from the first dose. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, episodes of heart racing, heart miss a beat, heart flutters, were unknown. Action taken with mRNA-1273 in response to the event, second dose scheduled after 36 days from the first dose, was not applicable.  The outcomes of the events, episodes of heart racing, heart miss a beat, heart flutters, were considered to be unknown. The outcome of the event, second dose scheduled after 36 days from the first dose, was considered to be resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273 (lot# 012L20A). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I went to see my doctor because of swelling and pain on both ankles, feet, and legs. The doctor said I have edema. The pain and swelling is still ongoing on my ankles, feet and legs.
Pt complaining of left arm pain (site of administration); arm warm to the touch; unable to lift arm without pain, generalized aching and weakness.
second dose given on day 22; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given on day 22) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A and 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given on day 22). On 29-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given on day 22) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter wants to know if this patient needs to repeat that second dose or restart the series, how does she proceed?   Reporter did not allow further contact
3 minutes after receiving GARDASIL - pt c/o feeling faint, had seizure activity lasting 10 sec. Nonresponsive 5 second following episode. 911 called, pt transported to hospital.
I Hade joint pain I have difficulty to work on my left leg because  I have muscle pain after 5days a hade headache
Arm redness, swelling, hot; 104 fever, weakness, chills, headache
This spontaneous report was received from a pharmacist via a company representative on 07OCT2015 which refers to an unspecified number of patients (gender and age not reported), who on unknown dates, were vaccinated with ZOSTAVAX (route, dosage, dose number and lot number unknown). The pharmacist reported to the representative that, in "1 out of 100 patients, there is a red, inflamed wheal that scabs up at the injection site" after he administers ZOSTAVAX. The pharmacist did not provide any additional information about these unspecified patients. the outcome of the events was unknown. Additional information has been requested. This is one of several reports from the same source.
Headache, Fever Fatigue, Flu-like symptoms Fever 101.2
This non-serious initial spontaneous case, was received from Other Health Professional on 26-Nov-2017, concerning an adult male patient of unspecified age (51 to 64). On an unspecified date (6 to 10 years ago), the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient developed fever, muscle aches, coughing and chills. At the time of this report, the outcome of the events was not reported.
injury; This spontaneous report was received from a lawyer and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (dose, route, lot number and expiration date were not reported).         On an unknown date, the patient claimed that experienced injury.      The outcome of injury was unknown.     The reporter considered injury to be related to Zoster Vaccine Live (ZOSTAVAX).
Patient found kneeling on the floor with family member holding him. Other staff member in clinic was taking photos of the family and seen patient kneels quickly and was already assisting. Patient lost awareness of the surroundings for a second. Patient states " I got slightly dizzy after the vaccine and I dont know what happened after I stood up to take a picture." Pt found alert and verbally responsive. Patient was put into wheelchair and assisted to gurney. Placed in supine position with both lower extremities elevated. Patient denies dizziness, w/o headache, no nausea/vomiting. Vital signs monitored w/i 15 mins. 9:55 am bp-103/66,P-96,RR-18, o2 sat 99% 10:15 am bp-95/66,P-88,RR-17, o2 sat 99% , 10:35 AM BP-104/62, P-93, RR-17, 02SAT 99%, Patient stable, after care vaccination explained to family, patient sent home.
1MAR93 h/a, cough 2MAR93 SOB, puffy, watery eyes; 3MAR93 breathing more difficult to hosp ER admitted; dischage dx asthmatic bronchitis-congestive heart failure;
This case was reported by a healthcare professional (pharmacy technician) via sales representative and described the occurrence of vaccination adverse reaction in a subject of unspecified age and gender who was vaccinated with Influenza vaccine unspecified (GlaxoSmithKline). In 2013 the subject received a dose of Influenza vaccine unspecified (unknown details). In 2013, at an unspecified time after vaccination with Influenza vaccine, the subject experienced vaccination adverse reaction. At the time of reporting the outcome of the event was unspecified.
Pt was given Hep A vaccine (2nd dose) 3 month after 1st dose. A minimum of 6 months is required between doses, this was not observed.
Initial unsolicited report received from a health care professional via other company (Pfizer) (Manufacturer Report Number: 2017289069) on 19 Jul 2017. This case involves a male patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (TETANUS VACCINE) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medication were not reported. On an unspecified date following the vaccination, the patient had allergy to vaccine. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Chest Pains Shortness of Breath Costochondritis - Per the Doctor These conditions were present after the first vaccine shot on April 6th and then again after the second shot on April 27th. Doctor initially thought it could be a simple case of Acid Reflux and gave her Nexium. Once that didn't work, she had her Chest X Ray done that came back all clear. She then had her blood tests done and that too came all clear except for Vitamin D3 that came in at 15 so doctor gave her a 50,000 unit Vitamin D3 dose. That also didn't do much to relieve the chest pains and shortness of breath so he had her EKG and Echo done and those were all clear as well. Finally, he gave her a  day steroid course of Prednisone at 40 mg/day which is where  she is currently. It is helping her a bit but she is still complaining of original two issues - chest pain and shortness of breath. She is also doing cold and warm compressions throughout the day that helps her temporarily.
burns when I shower; rash on both arms, underneath the upper arm, just above the armpit, localized right now; red splotchy color; This is a spontaneous report from a non-contactable consumer (patient). A 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: ER 8736), via an unspecified route of administration, in left arm on 30Apr2021 at 15:15 (at the age of 39-years-old) as a dose 1, single for covid-19 immunization. The patient's medical history included asthma, known allergies to dust, sulfa drug and scented items all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not tested for COVID post vaccination. The concomitant medications were not reported. On 30Apr2021 at 20:00, the patient experienced rash on both arms, underneath the upper arm, just above the armpit, localized at that time, burns when shower and red splotchy colour. Patient received the treatment of hydrocortisone cream for the reported events. The outcome for all the events was not resolved.  No follow-up attempts are required. No further information is expected.
After administering Pfizer 0.3ml into Right Deltoid, patient was instructed to sit in observation  seats.  Did not have contact with patient after incident
Headache that lasted a week and a sore arm that lasted 15 days began the day after the 2nd dose. Only a sore arm after the first dose.
double vision & visual distrubances; confused; paranoia; ataxia; creutzfeldt-Jakob; since admission pt become unresponsive w/random knee jerks & is in a stupor; dx encephalopathy (post-vax?) & r/o Creutzfeldt-Jakob disease;
My Uncle was cancer free in Jul, developed stage 4 cancer in most of his organs in Sep and died in Oct.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: METASTATIC NEOPLASM (death, medically significant), outcome "fatal", described as "My Uncle was cancer free in Jul, developed stage 4 cancer in most of his organs in Sep and died in Oct.". The patient date of death was unknown. Reported cause of death: "My Uncle was cancer free in Jul, developed stage 4 cancer in most of his organs in Sep and died in Oct.". It was not reported if an autopsy was performed.  Clinical course: My healthy 45 year old sister-in-law just died a few days before Christmas. She just got your new multi variant booster shot. Cause of death: Unknown. My Uncle was cancer free in Jul, developed stage 4 cancer in most of his organs in Sep and died in Oct. Are you mutating the COVID virus. Really I want to know. What have you people unleashed. This is criminal. We will not take this anymore. You will no longer be able to hide from us. You Are Killing Innocent People.  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.; Reported Cause(s) of Death: My Uncle was cancer free in Jul, developed stage 4 cancer in most of his organs in Sep and died in Oct.
pt felt weak after about 5 minutes and was feeling like passing out.  she then began to vomit.
Adverse reaction was immediate. Her eyes rolled back in her head and she convulsed four times. Had we not been next to her to hold her up, she would have fallen off of the table. It took a while for her to "come to" and then she proceeded to vomit several times. Her blood pressure dropped and her skin was clammy to the touch. Color was gone from her skin. She said she felt like her head was on fire. She was 90% better an hour later and was able to leave the clinic. She had a headache and jaw pain the rest of the day.
Awoke at 2:30 am on 08/28/2020 with stomach pain, nausea and dizziness, no vomiting.  Awoke 7:30 am 08/28/2020 with body aches, feverishness, very tired, and 4? x 1.5? area of warm redness around injection site.  Redness persists; other symptoms have resolved.
A few seconds after my first shot I had stabbing pain in my jaw on same side of shot.  That night I started to have pain and weird feeling on side of face, teeth, cheek, ear.  This sensation lasted for almost a week and started to get better. I called my primary care doctor and I was concerned to receive the second dose. She said to take it. Its is 2 weeks now after and symptoms seem to be gone.
Pt recvd 1st two doses of Recombivax & 3rd dose Engerix-B & was determined to be a non-responder; pt recvd 4th dose of Engerix-B;
Prominent pain/ erythema/ swelling of left thigh some pustules. Rxed as cellulitis MMR/Varicella