chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning a 15 year old female patient with no known medical history and no known drug reactions/allergies who on 22-SEP-2010 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot # 665768/1377Y). There was no concomitant medication. "The patient's mother called on 23-SEP-2010 to report that the patient is pregnant. Gestation was unknown at this time. No adverse effects reported." No diagnostic laboratory tests were performed. The patient's outcome was unknown. The patient sought unknown medical attention. Follow-up information was received from a nurse indicating that the patient received the first dose of GARDASIL (lot # 665768/1377Y) and concomitantly received a first 0.5ml dose of hepatitis A vaccine (unspecified manufacturer) on 22-SEP-2010. The patient's last menstrual period was 05-May-2010, and estimated delivery date was 09-Feb-2011. Ultrasound was performed on 23-SEP-2010 for normal fetal anatomy. Amniocentesis was done for anatomy. The patient had one previous pregnancy and one spontaneous abortion, and no birth defect in previous pregnancy. Follow-up information has been received from a nurse who reported that the female patient on 02-FEB-2011 delivered a male baby. The baby was normal and there were no congenital anomalies. Follow-up information has been received from a registered nurse who reported that the female with a history of one elective termination and with no other medical history or concurrent conditions who was admitted with cervical shortening from approximately 17-NOV-2010 (28 weeks of gestation) to 29-DEC-2010 (34 weeks of gestation) and experienced polyhydramnios on an unspecified date. During pregnancy, from 04-NOV-2010 to 05-NOV-2010 she was placed on PROCARDIA 20 mg Q6h for tocolysis and betamethasone 12 mg Q24h x2 doses for fetal lung maturation. 02-FEB-2011 at 39 weeks of gestation, the patient delivered a normal, healthy male baby weighing 5 pounds 15 ounces. Baby length was 19 inches and head circumference was 32.5 cm. Apgar score was 8/9. The patient did not experience any complications during labor. Additional information has been requested.
the site was red, warm, might be a little fever in it, and hard; the site was red, warm, might be a little fever in it, and hard; she noticed her injection site was red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 14Mar2021, outcome "unknown", described as "she noticed her injection site was red"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE INDURATION (non-serious) all with onset 15Mar2021, outcome "unknown" and all described as "the site was red, warm, might be a little fever in it, and hard". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated on 06Mar2021, she received her first Covid 19 vaccine. She was out with her family yesterday and got home at 6pm. She took a shower. When she got out of the shower, she noticed her injection site was red. This morning, the site was red, warm, might be a little fever in it, and hard. Reports that she does not have a fever, and her temperature was taken this morning at work and was 97.6. It was reported that she got the vaccine through the hospital. 27Mar2021, second vaccine was scheduled. Caller reported that she does not have an HCP.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax;fever;water & apap given;snorting & rhythmically convulsing;eyes top of socket, saliva from mouth,mucous from nose,blue/white face,lasted >2 mins;911 called,to hosp;rt side paralysis for about 4 hours;0
I have a bad headache and the next day I took a COVID-19 Home Test the next day and it was positive. I reached out to my health care provider, and they gave me Paxlovid. I had horrible body aches, and this pain in my back and flank that was excruciating. I also had a sore throat; a headache and I was so exhausted but starting the medication did help. I did notice that the tinnitus in my ears got worse and it has not gone away as well.
Itching and erythema to left arm that lasted about 2 hours. Sweating without feeling hot or ill relieved by ibuprofen at hour 3 and returned at hour 9 post vaccine. Self resolved at hour 12 post vaccine.
Directly after receiving my vaccination, I began to feel hives beginning to spread and itchiness as well get worse from the vaccination site, however I was able to control it with Claritin. I became very fatigued and had body chills, feverish, and sluggish and began to have swelling in my lymph nodes.
My pregnancy symptom s started disappearing gradually and after a week I didn't feel pregnant at all/missed abortion; My arm was sore; I felt mild fatigue; This is spontaneous report from contactable consumer.  A 28 year-old female consumer (patient) reported that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number ER8735), on 03May2021 (at the age of 28-years-old) at single dose for COVID-19 immunization. The patient had received the first dose of vaccine on 13Apr2021 (lot EW0164). The patient had no known allergies and had not other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that she got her 2nd dose of vaccination when she was 7 weeks pregnant. The LMP was on 21Mar2021. Her arm was sore and she felt mild fatigue. Her pregnancy symptoms started disappearing gradually and after a week she didn't feel pregnant at all. When she went in for her first ultrasound appointment at 9 weeks, the doctor said that the growth stopped at 7 weeks 4 days and there was no heartbeat. She declared it missed abortion.  Information on Lot/Batch number was available. Additional information has been requested.
Shoulder pain and pain with certain shoulder movements since injection. Physical activity limited d/t pain. Pain has not resolved as of date of submission of this form. Have seen 2 providers . The first 11/5/21 . Visit notes: The following issues were addressed: Shoulder injury related to vaccine administration (SIRVA) and Acute pain of left shoulder.Left shoulder pain Flu vaccine on October 12, thought is was higher than usual Arm was sore for 2 days but pain never resolved Pain top of shoulder into back and neck Adduction and lifting like taking off shirt is very painful Wakes her up if sleeping on that side Constant ache Treating with ibuprofen 200mg twice per day Treatment plan: Aleve 220mg two tablets twice daily x 7-10 days voltaren gel If not improving may need face to face visit, consider steroid, PT and US  The second provider 11/24/22: Visit notes: l shoulder pain ever since had flu shot 10/12/21-- wondered if was given the shot too high- started smal area- now entire l sh and into th eneck   - seen 2 wks ago- alevel helped but pain returned when stopped stretch help ssomewhat   voltarin cream helps a little  Treatment Plan:XR SHOULDER LIMITED  2V AP/TRUE AP LEFT US SHOULDER LT   methylPREDNISolone  (MEDROL, PAK,)  4 mg Dose-Pack   Left shoulder pain status post flu vaccine injection. Patient wonders if the shot is getting too high and may have entered her joint space. No current sign of infection. Check x-ray and ultrasound, trial of Medrol Dosepak, consider orthopedic consult or MRI if not improving  Orthopedic appointment scheduled for 1/11/22
Mom reported on 5/19/06 that patient experienced a rash on legs after each set of vaccines. "Pruritis with knots." Bilateral thighs with dry raised rash and excoriated areas.
On a Friday I had gotten up and went downstairs to check the mail. As I was getting to the mailbox, I was starting to feel lightheaded. The next thing I know I woke up on the ground. I had passed out for about 30 seconds or so. When I woke up, I was out of it. I was able to get up and go back into the house. I wasn't feeling right. I had hot flashes, felt sweaty, and it was hard to catch my breath. I didn't feel like myself. I went to the ER and they ran multiple tests on me. I was diagnosed with Saddle Pulmonary Embolism. I was prescribed Eliquis 5mg blood thinner medication.
After receiving the vaccine, client experienced a syncopal episode for approximately 30 seconds.. Parent states this is exactly how the client's seizures manifest. Once client regained consciousness, client complained of lightheadedness and dizziness post vaccination. Vital signs taken. Vital signs: sitting  blood pressure initially: 97/68, Oxygen saturation: 98% on room air, pulse: 83, Respiratory rate 16.  Client was alert and oriented, but slow to respond. Client was assisted to a lying position with legs elevated. Vital signs taken again. Vital signs in lying position: Blood pressure: 128/83, pulse: 83, oxygen sauration: 99% on room air, Respiratory rate 18, temperature 97.8. Client remained slow to respond. EMS called.
Spreading redness, warmth and pain. Diagnosed with cellulitis, responded to Keflex.
Pt. Deceased cant confirm if in which system.  1st dose Moderna 1/7/2021 - 026L20a 2nd Dose Moderna 2/4/2021 -  012L20A
CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; FELT LIKE HIT A WALL; SUDDENLY FELT VERY EXHAUSTED; This spontaneous report received from a patient concerned a 57 year old female of unknown race, and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included many environmental allergies, alcohol user, non smoker, Hashimoto's disease, vitiligo, and autoimmune disease, and the patient had no known allergies. The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 at 14:30 to right arm for prophylactic vaccination. Concomitant medications included thyroid replacement medications [both triiodothyronine (T4) and tetraiodothyronine (T3) replacement]. On 09-APR-2021, almost exactly 24 hours after receiving the vaccine, the patient felt like she hit a wall, suddenly felt very exhausted and went to sleep immediately. The patient noted no unusual effects during sleep. On 10-APR-2021, in the morning, the patient felt fine and back to normal. The patient saw her physician quarterly routinely & her physician did bloodwork routinely at each quarterly exam. Her second quarterly routine examination of the year was on 11-JUN-2021 and bloodwork was done. The patient's physician reported that she had no antibodies post covid-19 vaccine ad26.cov2.s. The patient did not know what type of serological test was done to make that determination, although she did know that it was not the one for T-cell (T lymphocyte) testing and that the testing was carried out at diagnostics center. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like hit a wall, and suddenly felt very exhausted on 10-APR-2021, and the outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187497.; Sender's Comments: V0:20210757925-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-049659 (Patient Link).
Patient had a robust reaction to Smallpox at day 9 with onset of rash noted over both arms, chest/back consistent with Erythema Multiforme.  Treated with observation only and no lesions noted in conjunctiva/mouth or other mucous membranes.
Vomiting; sore throat; joint and muscle pain; joint and muscle pain; loss of appetite; cough; extreme fatigue; diarrhea; lost 10 pounds in one week; This is a spontaneous report received from a 69-years-old female consumer (patient) reported that. A 69-years-old female patient received bnt162b2 (BNT162B2;solution for injection; Lot no#EN6202), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 04:00 PM as single dose for covid-19 immunisation. Medical history included hypertension. Concomitant medications included lisinopril (LISINOPRIL) 20 mg once a day. On 03Mar2021, the patient experienced vomiting, sore throat, joint and muscle pain, loss of appetite, cough, extreme fatigue, diarrhea, lost 10 pounds in one week. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Mar2021 covid test type post vaccination=Nasal Swab. The patient was not received treatment for the adverse event. Outcome of events were not recovered. Patient was not pregnant at the time of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Severe stomach cramping; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Severe stomach cramping) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OLAPARIB (LYNPARZA).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Severe stomach cramping). At the time of the report, ABDOMINAL PAIN UPPER (Severe stomach cramping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up via telephone, patient reported she received second dose with no adverse events. No email or address to send ADR form.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Day 1 - Very sore around injection site, did not sleep well through the night. Day 2 -  More sore around injection site, tired throughout day, chills  and low grade fever, 100.4 peak in the evening. Day 3 - Less sore around injection site, temperature normal in the morning, 97.3.
Dizziness; Nausea; Headache; Fever; Chills; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0170) via an unspecified route of administration in the left arm on 02May2021 at 11:15 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included systemic lupus erythematosus (SLE). The patient has allergy to penicillin and blueberries. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 02:00 the patient experienced nausea, headache, dizziness, fever, chills and fatigue. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, headache, dizziness, fever, chills and fatigue were not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Vertigo; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Aug2021 at 17:00 (at the age of 48-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included metformin (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. 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 left arm on 06Aug2021 at 16:45 (at the age of 48-year-old), as a single dose for COVID-19 immunisation. On 29Aug2021 at 07:00, the patient experienced vertigo. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event vertigo was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical assistant referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 08-SEP-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, route, lot# L004005 and expiration date 05-AUG-2016). No adverse events were reported. This is one of two reports received from the same reporter. Additional information has been requested.
muscle aches; fatigued; Fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2020, the patient received the 2nd dose of Shingrix. On 1st September 2020, 1 days after receiving Shingrix, the patient experienced muscle pain and fatigue. In September 2020, the patient experienced fever. On an unknown date, the outcome of the fever, muscle pain and fatigue were unknown.   It was unknown if the reporter considered the fever, muscle pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and developed fever,fatigued and muscle aches. The reporter asked long did these side effects last.
Patient recieved his second dose of the COVID-19 vaccine on February 4, 2021. His complains consisted of overwhelming exhaustion. He was found dead in his hotel room on February 10, 2021.
blood pressure went up over 210/110; This is a spontaneous report from a contactable consumer reporting for herself. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6205/expiration date: not provided), via an unspecified route of administration, on 06Mar2021 at 13:45 (at the age of 63 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included high blood pressure. The patient had known allergies to sulfa drugs and  sulfamethoxazole and trimethoprim (BACTRIM). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included olmesartan medoxomil 20mg, naproxen, and fexofenadine.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Mar2021 at 03:00, the patient experienced blood pressure went up over 210/110. The clinical course was as follows: within 3 days of having the vaccine, her blood pressure went up over 210/110 (as measured by EMT).  The patient was on blood pressure medication but have never had a blood pressure reading that high before. One reading during that same day was 247/100 but dropped to 160/90 when she took a second reading.  The patient took blood pressure medicine but remained high. The event blood pressure went up over 210/110 was considered serious (medically significant). The event resulted in an Emergency Room visit. Treatment was received for the event blood pressure went up over 210/110, which included additional blood pressure medication and diazepam (VALIUM). The outcome of the event blood pressure went up over 210/110 was recovered on an unspecified date in Mar2021. Since the vaccination, the patient had not been tested for COVID-19.
Hyperesthesia - hypersensitive skin. Starting with back of left forearm. Then both arms. Progressing to sides and back. Mild version of one of the worst and most severe symptoms when I had covid.
Seen in office 02/09/15 for 18 mo WCE; pt was behind on imm., total of 4 given in thighs; 2 SQ's given-(1) in each arm. S/s began 02/11/15; Seen in office for eval-> 6 x 8cm area of erythema with induration to (lt0 thigh; afebrile; Tx=supportive ibuprofen of 6-8 hours; warm moist compresses; return if worsens.