chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she did have pain at the injection site with the first vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0180, expiration: unknown) via an unspecified route of administration in arm left on 05Jun2021 17:00 (at the age of 62 years) as single dose for COVID-19 immunization. Medical history includes high cholesterol, high blood pressure and still ongoing from last 3 years, Acid reflux: About 2 years ago patient started using this medication and still ongoing. Prior to vaccination (within 4weeks) patient didn't had any other vaccination. No adverse event prior vaccination. Concomitant medications included simvastatin (ZOCOR) taken 10 mg tablet by mouth once a day for high cholesterol: she has been on it for more than 3 years, lisinopril (LISINOPRIL) taken 10 mg tablet by mouth once a day for high pressure: she started it 2 years ago, omeprazole (PROTONIX [OMEPRAZOLE]) taken 40mg tablet by mouth once a day for acid reflux: she started it about 2 hours ago. Patient really had no issues with first vaccine. But she did have pain at injection site with first vaccine and with second vaccine too. Patient received treatment for the event. The outcome of the event is unknown.  PSCC Communication:   Caller not answering questions directly, in adverse event section.  Details are as provided by caller with clarifying attempts.
Developed hives/vomited x 1 at home lasted for 1hr treated with Medical record states anaphylaxis. msv
Patient received Moderna Covid booster 0.25ml IM on 10/29/21. It was discovered on 11/1/21 that the vaccine had been stored in the refrigerator beyond the 30 days and the vaccine was expired. The box was labeled with the manufacturer expiration which is for frozen vaccine.
Cellulitis diagnosed 2 days after vaccine given 8 1/2cm red area, warm, swollen. Treated with Augmentin 875mg BID x 10 days.
Seen in our practice on 6/10/2022 for small, raised, blistered bumps all over body, from his neck down to his toes. Itchy. No fever. 6/11 and 6/12/2022 bumps started to feel and look "crusty", scabbed and started to fade.  His body had more than 100 blistery bumps.
Patient reports noticing little bruises not like petechia, a little bit bigger but really small in weird spots first noticed 25DEC2021 yesterday and then noticed a couple more on the upper body; This spontaneous case was reported by a nurse and describes the occurrence of CONTUSION (Patient reports noticing little bruises not like petechia, a little bit bigger but really small in weird spots first noticed 25DEC2021 yesterday and then noticed a couple more on the upper body) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     Concomitant products included NORETHISTERONE (SHAROBEL) for Birth control pill, FLUOXETINE, VITAMIN D [VITAMIN D NOS], ASCORBIC ACID, RUTOSIDE (VITAMIN C COMPLEX [ASCORBIC ACID;RUTOSIDE]) and VITAMIN B COMPLEX for an unknown indication.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Dec-2021, the patient experienced CONTUSION (Patient reports noticing little bruises not like petechia, a little bit bigger but really small in weird spots first noticed 25DEC2021 yesterday and then noticed a couple more on the upper body). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) from 22-Dec-2021 to 23-Dec-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, CONTUSION (Patient reports noticing little bruises not like petechia, a little bit bigger but really small in weird spots first noticed 25DEC2021 yesterday and then noticed a couple more on the upper body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is not on any blood thinners.
One day after the first Moderna vaccine, this gentleman developed hand and wrist pain. There was then hand numbness and swelling across the right wrist and MCP joints. He had pain in the hands, wrists, shoulders, and hips. He felt weak in hands and with rising from a chair or climbing stairs.
no adverse effects; pt was given pfizer monovalent instead of pfizer bivalent as the booster dose
Sore throat, right ear pain and most severe:  shooting pains on right rear portion of head that lasted 20 hours and then all symptoms disappeared.
Approximately 10 minutes following vaccine administration, the patient complained of tingling in his fingers and shortness of breath. The pharmacist asked the patient if they needed emergency services and checked for signs and symptoms of allergic reaction. The pharmacist called for emergency services. The patient walked out of the building with the EMTs.
Patient presented for Physical. Vaccines were updated.  Patient had already completed MMR series prior to appointment.  Patient was given an extra dose of MMR.  No adverse reactions noted.
In December, 2021, a few weeks after receiving the Moderna COVID booster, I began to feel weak and tired. On January 3, 2022, I received a CT scan for another issue (monitoring aortic aneurysms) and Dr. (Privacy) noticed a pulmonary embolism in my right lung. I have read that blood clots are a possible result of the vaccine. I don't know whether or not the vaccination caused this blood clot. I had one prior pulmonary embolism, in 2018.
Intense stomach pains 3 days after shot, 6 days after shot,  stomach pains, blurry vision, almost like the beginning of a migraine, cold, headache, droopy left face, shaking, weak left arm and leg, front head in a vice, back of head tingling with fire, cottonmouth, back left side of neck hurts too
Pt recvd MMR vax as a child; Pt currently exhibited a lack of response to measles; No further details were provided;
he got sick with COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (he got sick with COVID-19) 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 06-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced COVID-19 (he got sick with COVID-19). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. In January 2022, COVID-19 (he got sick with COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided.  Reporter was daughter who was calling on behalf of her father. She said that her father had travelled to receive the Moderna shot and he had contracted COVID-19 likely in the family resort or at the airport. Patient had received the first dose of the Moderna Vaccine. One week later (or 5 days later), he got sick with COVID-19. He had just recovered and having no symptoms. The symptoms lasted for about 1.5 weeks and he stopped having fever and cough. His test results came back negative.  Company comment: This case concerns a male patient of unknown age, with no medical history reported, who experienced the unexpected event of COVID 19. The event occurred one week after the third dose of mRNA-1273. As reported, the patient had received the first dose of the Moderna Vaccine and one week later (or 5 days later), he got sick with COVID-19. The symptoms lasted for about 1.5 weeks and he stopped having fever and cough. The patient had recovered. His test results came back negative, as reported. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a male patient of unknown age, with no medical history reported, who experienced the unexpected event of COVID 19. The event occurred one week after the third dose of mRNA-1273. As reported, the patient had received the first dose of the Moderna Vaccine and one week later (or 5 days later), he got sick with COVID-19. The symptoms lasted for about 1.5 weeks and he stopped having fever and cough. The patient had recovered. His test results came back negative, as reported. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
a blood clot in his leg behind his knee; blood clots on both of his lungs; leg pain and cramps that got worst as time went by; A spontaneous report was received from a consumer concerning a 65 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced leg pain and cramps that worsen as time progressed, a blood clot in his leg behind his knee, and blood clots in both lungs.  The patient's medical history include high blood pressure.   The relevant concomitant medications are Lisinopril, Paroxetine, and Multivitamins.  On 31 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 026l20a) intramuscularly for prophylaxis of COVID-19 infection.   On 28 Jan 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (lot/batch: 004m20a) via unknown route in left arm for prophylaxis of COVID-19 infection.   On 01 Mar 2021, the patient experienced leg pain and cramps that worsen with time.  03 Mar 2021, the patient developed a blood clot in his leg behind his knee and blood clots on both lungs. The seriousness criteria for the events, blood clot in the leg behind the knee and blood clots in both lungs was were life threatening and medically significant.   The Laboratory findings include an ultrasound showing a blood clot in the leg behind the knee on 03 Mar 2021.  On unknown day of Mar 2021, chest CT showed blood clots in both lungs.   Treatment medication included rivaroxaban prescribed earlier by his physician.  Action taken with mRNA-1273 in response to the events was not applicable.   At the time of this report, the outcome of the events, leg pain and cramps that got worst as time went by and a blood clot in his leg behind his knee was unknown. The event, blood clots on both of his lungs was considered recovering on an unknown date.; Reporter'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.
rash at the site of injection (redder, more raised and not getting better); redder at the site of injection; interesting, very weird pain within armpit of the same arm; very very stiff and tight neck; continued headache; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE RASH (rash at the site of injection (redder, more raised and not getting better)), INJECTION SITE ERYTHEMA (redder at the site of injection), AXILLARY PAIN (interesting, very weird pain within armpit of the same arm), MUSCLE TIGHTNESS (very very stiff and tight neck) and HEADACHE (continued headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE RASH (rash at the site of injection (redder, more raised and not getting better)), INJECTION SITE ERYTHEMA (redder at the site of injection), AXILLARY PAIN (interesting, very weird pain within armpit of the same arm), MUSCLE TIGHTNESS (very very stiff and tight neck) and HEADACHE (continued headache). At the time of the report, INJECTION SITE RASH (rash at the site of injection (redder, more raised and not getting better)), INJECTION SITE ERYTHEMA (redder at the site of injection), AXILLARY PAIN (interesting, very weird pain within armpit of the same arm), MUSCLE TIGHTNESS (very very stiff and tight neck) and HEADACHE (continued headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment or concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: No specific follow-up information recorded.
expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: The reporter had called to inquired for data related to expiration of Twinrix.  Additional Supportive Information: The patient was administered with Twinrix vaccine, which was already expired, which led to expired vaccine used.
Severe migraine NOT relieved by migraine medication.  My migraines are controlled and will dissipate with medication-this headache would not respond to medication
Within 8 hours of dose experienced migraine with photosensitivity, low grade fever (99.9), full body myalgia, severe joint pain, and general weakness.  Burning sensation felt at old dermal scar tissue sites.  Bed ridden for 24 hours.  Able to return to work after 48 hours.
Large red, swollen area approximately 3 inches in diameter in vicinity of injection site. Area is warm and painful to the touch. Area around swelling is itchy.
Pt was here for a M. V vaccine order was in EMR. Correct vaccines were given. But when immz record was pulled up to be printed, it was noted pt had already had those vaccines in 10-4-12. MMR-Varicella-Kinrix. Dr was advised. No adverse effect was noted.
After receiving the COVID vaccine, Patient started to develop itching all over her body. She was brought back to exam room. Heart and lung sounds normal. Vitals stable: BP: 115/67 and Pulse: 88, O2 sat 95%. No visible rash but patient scratching a lot and causing  excoriation on skin. No SOB, chest pain. No swelling or tightness of throat. Patient breathing comfortably. Also reported dizziness which resolved when laying down. Patient was given 25 mg Benadryl with little improvement. Given an additional 25 mg after 15 minutes. Patient then reported she felt like her hands were swelling-palms of hands were pink and warm to touch. Because patient was not noticing any improvement in her symptoms and scratching a lot, patient was sent to ER via ambulance for further evaluation and monitoring
COULDN'T WALK; FELL DOWN; LEGS, THIGH, CALF AND FOOT PAIN AND MUSCLE CRAMPS; SWEATING; BODY ACHES; COULDN'T PUT FOOT FLAT ON FLOOR; CHILLS; LEGS, THIGH MUSCLE CALF AND FOOT WEAKNESS/FEET STILL FEEL WEAK; ARM PAIN AT THE INJECTION SITE; FEVER OF 101; This spontaneous report received from a patient concerned a 51 year old of unspecified sex. 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: 042A214 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced couldn't walk. On 09-APR-2021, the subject experienced fell down. On 09-APR-2021, the subject experienced legs, thigh, calf and foot pain and muscle cramps. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced couldn't put foot flat on floor. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced legs, thigh muscle calf and foot weakness/feet still feel weak. On 09-APR-2021, the subject experienced arm pain at the injection site. On 09-APR-2021, the subject experienced fever of 101. Laboratory data included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, couldn't put foot flat on floor, chills, and fever of 101 on APR-2021, was recovering from legs, thigh, calf and foot pain and muscle cramps, and couldn't walk, had not recovered from arm pain at the injection site, body aches, and legs, thigh muscle calf and foot weakness/feet still feel weak, and the outcome of fell down was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard operating procedure as the case is assessed as non-serious
I received the vaccine on March 15. I went for an annual eye exam at a clinic on March 16th. The doctor said everything was fine and gave me a prescription for glasses. On March 21, 2021  I got out of my car in a supermarket parking lot and had difficulty seeing out of that eye. It was as if a bright light was beaming into the eye. I went into the store and had to keep the eye closed for about 10 minutes before I could see out of it. I received  my 2nd dose of the vaccine on April 12th at the same location at 12:45 pm.  With each passing week, my vision was becoming more blurry in the left eye. It got to the point that I could barely read out of the left eye,  On May 3, I called an eye clinic and requested an urgent visit. I was seen by the same doctor who saw me on March 16. I told him that I had floaters in my eye and my vision was blurry. After running tests, he said I had blood in my eye. An additional test was ordered to look at the back of my eye. After the test I was seen by another Dr. I was told that I had retinal vein occlusion and that it is usually the result of high blood pressure or diabetes. Although I have had a lot of stress in 2021 due to caregiving duties, etc., my blood pressure has not been high in 2021 and when my A1C was checked by my primary care doctor in 2021, I was not prediabetic. They are planning to start injections in my eye July 20th. I spoke with another eye doctor for a 2nd opinion who told me that it is likely due to the protein spike from the vaccine that I had this eye issue.
In a retrospective chart review that was conducted in 2 HIV primary care clinics, Patient 2, is an HIV positive patient, at least 18 years of age, with documented history of HBV vaccination administration prior to November 2017, and negative for both HBsAg and anti-HBs after previous HBV-vaccination. Baseline laboratories included HIV RNA undetectable, CD 4 count 318 cells/uL, CD 4 35%, negative for anti-HBc and HCV co-infection. On an unspecified date, the patient received and completed both doses of HEPLISAV-B vaccine. On an unspecified date, the patient was noted as not having achieved seroprotection. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's concurrent conditions, medical history and concomitant medication use were not provided. On an unspecified date, in approximately 2012, the patient was vaccinated with  ZOSTATAVAX (lot# and route unknown) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX vaccine, the patient developed and was diagnosed with bilateral leg pain and paresthesia of the skin. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (excruciating pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 500 milligram. On 19-Jan-2021, VACCINATION SITE PAIN (excruciating pain at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.   This case was linked to MOD-2021-020922 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received on 16 Apr 2021 included no new information (Patient mentioned she is feeling fine now and that she didn't experience any other events and has nothing else to report.)
Vasovagal syncope following COVID vaccine. Patient passed out during the 15 min post-vaccine monitoring period-- Slumped/Fell out of chair in waiting area. Came to in about 10 seconds
Swelling, itching and hives starting at the injections site with itching spreading on the left arm all within a 10 minute time-frame. Itching intensified and hive was > 5 inches in diameter. Took (2) 25mg diphenhydramine tablets orally. Itching slowly subsided. Twelve hours later, skin remains blotchy in place where hive was, but itching completely gone.
Moderna COVID-19 Vaccine EUA. On the morning of 02/17 at 04:20 I woke up with chills and muscle cramps that felt just like the flu. One additional symptom was muscle spasms in my upper back between the shoulder blades. This experience I had never had before. Now that it has been 7 days after the vaccine; all the after effects were gone after the second day. All is well. Thank you.