chrisvoncsefalvay/vaers-outcomes huggingface dataset:
excruciating pain in arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (excruciating pain in arm) and HEADACHE (headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (excruciating pain in arm) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (excruciating pain in arm) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient got new SHINGRIX vaccine and within 4 hrs had injection site reaction with redness/soreness/swelling that grew in size with time over several weeks to months into a large (approx 4-5) red rash then bruise on arm where injection was given. Pt came into office 4 months later and still has bruising that is now resolving.
20 minutes post immunization patient developed hives over face and neck, stated tongue felt like it was tingling, patient felt flushed and warm and stated she "just didn't feel right"  patient evaluated by provider - claritin 20mg given, vitals taken after another 30 minutes of being observed patient stated she"felt better"-hives gone
arm got red, had a little heat; arm got red, had a little heat; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (arm got red, had a little heat) and INJECTION SITE WARMTH (arm got red, had a little heat) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (history of breast cancer 20 years ago) and Lymph node excision (lymph nodes removed 20 years ago).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (arm got red, had a little heat) and INJECTION SITE WARMTH (arm got red, had a little heat). At the time of the report, INJECTION SITE ERYTHEMA (arm got red, had a little heat) and INJECTION SITE WARMTH (arm got red, had a little heat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.    No treatment information provided.
Red spots; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red spots) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red spots). At the time of the report, ERYTHEMA (Red spots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.
20 Y/O Male presented to a Corpsman with c/c of bump on his left forhead 1 1/2" above his eyebrow. Pt stated that he was experiencing h/a, pain behind the eyes, jaw pain, and lymph node pain in the neck. Pt received the smallpox vaccine 13 days prior, with no reaction when checked on the 12th. An occlusive dressing was placed over the affected site, and the PT was given direction to follow a strict hygiene regimen. Pt was also informed to report to sick call daily for dressing changes, along with a follow up to observe any changes in the lesion.
BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE. pt IS A 96 YO WITH COVID + Low grade Temp, Leukocytosis, Diarrhea, Dehydration, Generalized weakness, AND ESBL E Coli UTI.  PT ADMITTED WITH A Fever in this patient with coronavirus disease 2019, oxygenating well on RA, CXR shows mildly increased interstitial markings.  No particular treatment indicated for COVID-19 at this time.
Since getting both doses of Pfizer vaccine 9/2/2021 and 9/24/2021, patient has experienced severe cramps with menses (starting 2 days prior and lasting through 7 day duration, most painful first few days of menses). At baseline, she does not have any cramps.
Severe flu-like symptoms, fever of 101 degrees Fahrenheit, extreme body chills, red and swollen injection site similar to size of a baseball per patient
Narrative: COVID infection following COVID vaccine series 01/07, Pfizer, dose #1 01/29, Pfizer, dose#2 08/02 pt cc: cough, fatigue, loss of taste or smell exposure, myalgias, dyspnea exposure : COVID+ friend 08/05 COVID swab, result: detected 08/03-08/19 pt's symptoms continued 08/19 clinically resolved 08/12 SARS-COV-2 LINEAGE result: AY. 12 08/12 SARS-COV-2 clade result: 21A DELTA
metal taste in the mouth after eating any kind of meat; This is a spontaneous report from a contactable Physician via Pfizer sponsored program support. A 73-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9269) on 05Feb2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6205) on 26Feb2021 both doses via unspecified route of administration, administered in right arm, (at the age of 73-year-old) as single dose for COVID-19 immunisation. Medical history included Pneumonia. The patient concomitant medications were not reported. On an unspecified date in 2021 (after the second dose on 26Feb2021), the patient developed a metallic taste in her mouth, a metal taste anytime she ate meat which was mainly only with the meat. Patient had this metallic taste before with pneumonia which was on unspecified date, but this time she was unable to get rid of it. It stays with her after she eats any kind of meat and goes away only after eating any fruits, veggies, bread, fish was not bad either and she was fine. It could stay for hours. The outcome of the events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
5x5 cm area of redness and swelling around injection site with tenderness. RX antibiotics (Augmentin).
7.0 x 5.0 cm wheal. 25mg BENADRYL given & ice applied.
Tightness and sensation of obstruction in throat, coughing, feeling of illness, lethargy, unusual tiredness.
Erythematous macular blotching rash surrounding site of both Tdap and MENACTRA vaccine sites (bilateral deltoid areas) given on 8/13/08, mild warmth and tenderness.  Temp 99.2 without findings of new acute illness.  Both injection sites prepped with alcohol pledget.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Tachycardia-Mild, Additional Details: four hours after shot developed rapid heart beat and rash on the opposite arm
Patient experienced red, soreness, tenderness, and warm to touch at sight of injection. These symptoms started the evening of 2/24. Patient also developed nausea and diarrhea starting on 2/27 and continued this morning. Patient was recommended to follow-up with PCP.
he was not feeling well; he was so sick; fatigue; diarrhea; weakness; This is a spontaneous report from a contactable consumer(patient). A 57-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, (Batch/Lot Number: EW0180)), via an unspecified route of administration, administered in the left arm on 04Aug2021 18:15 (age at the time of vaccination was 57-year-old) as single dose for COVID-19 immunisation. The patient's medical history included other medical his heart murmur, controlled BP, Allergic reactions to many drugs/environmental, take sublingual drops, diverticulum disease, testing for hyperparathyroidism. The patient had Known allergies to Azor, Biaxin, Cardizem, Crestor, Cipro, Exforge, Ibuprofen, Lipitor, Sulfa, Tetracycline, Topamax,Ventol, Lisi. The patient concomitant medications include spironolactone (ALDACTONE ), ezetimibe (ZETIA), doxazosin mesilate (CARDURA), hydralazine(HYDRALAZINE), cetirizine hydrochloride (ZYRTEC) ) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19 was unknown. The patient had not tested covid post vaccination. On 04Aug2021, at 10:00 PM, the patient experienced Chills/severe shakes, joint pain, vomiting 2 days/Nausea 4 days, diarrhea, congestion, Extreme headache 2 days/mild for up to a week with fuzzy head feeling, little dizzy, would get a wheeze and then feel mildly out of breath for a couple minutes, twice felt mild chest pain briefly, hands tingling, extremely tired for 10 days. The patient not received treatment foe AE. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
On the evening of the injection, he had fever of greater than 104 degrees with shaking chills. He called the Health Dept. because he feels that the shot was given into the shoulder joint.  He describes pain in the shoulder joint at a level of 2-3 on a 10 point scale. By yesterday, his fever was down to ~99degrees. Today, he is feeling better, but his arm is still tender and he increased tenderness when he raises his elbow.
Itching, swelling, redness at injection side encompassing 13.5 x 13.5 cm and lasting 6 days at time of reporting.
Popping sensation on administration, severe pain in arm, unable to lift arm. Seen in Emergency Department 5/8/2021- given pain meds, steroids'
18hr post, start BMs, 21hr post, last diarrhea;; 18hr post, start BMs, 21hr post, last diarrhea;; Digestive track upset, no pain, but uncomfortable enough for no sleep;; Salivating with upset stomach; Salivating with upset stomach/ digestive track upset/ Digestive issue not related to food/drink/still mild tummy upset; Mild headache; Mild sore arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration in the left arm on 07Apr2021 at 10:00 (at the age of 60-year-old) as single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications included diclofenac 75mg (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), vitamin d nos (VIT D) and centrum silver (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 12Mar2021 at 11:30 hours (at the age of 60-year-old) as single dose for COVID-19 immunisation. Prior to 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 COVID-19 vaccine. On 07Apr2021, after 8-hours of receiving 2nd vaccine, the patient experienced mild headache, mild sore arm, and took TYLENOL. After 10-hours, the patient was salivating with upset stomach but no nausea. After 12-hours, the patient took TUMs and had digestive track upset, no pain, but uncomfortable enough, for disturbed sleep. Post 18-hours of vaccination, the patient had BMs (infrequent bowel movements). On 08Apr2021, after 21hr the patient had last episode of diarrhoea. On 08Apr2021, after 24-hour the patient had mild headache and still mild tummy upset. The patient felt that digestive issue was not related to food or drink and can only be attributed to vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of mild headache, pain in arm which included treatment with acetaminophen (TYLENOL) and for the event stomach upset with calcium carbonate (TUMs) on 07Apr2021. The clinical outcome of the event diarrhoea was recovered on an unknown on 08Apr2021, while that of the events of headache, pain in arm, salivation, stomach upset, sleep loss, infrequent bowel movements was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
After the second dosage, my arm was sore for about three days; This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 12Feb2021 as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccines included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization and experienced there was a mix up, and he is not sure if the product was administered correctly, said he asked person at facility of 1st dose, if he actually received vaccine, they said yes he did get vaccine but he doesn't think so and the patient received INFLUENZA (influenza shots), via an unspecified route of administration on an unspecified date for immunization and experienced sore arm. It was reported that, the patient thinks, he only received 2nd dose of covid vaccine and didn't believe he received 1st dose. Stated that, the caller has reason to believe, he did not get the first dose of Pfizer covid vaccine. Stated that, when he was at site where giving doses. Stated that, he had gotten many influenza shots, he always experience some after effect, like sore arm. At the time that he did it, he didn't feel anything, there was no mark or after effect like he got following an injection. At facility, the person administering the injection stated that, there seemed to be some sort of an issue with the hyper dermic needle. Looked at his arm there was no sign of injection, no pain in arm, nothing. Stated that, there was nothing, not a dot of blood or anything and the next day there was no soreness or anything. He received the 2nd dose of vaccine on last Friday. Stated that, on an unspecified date in 2021, after the second dosage, his arm was sore for about three days. Stated that, he wanted to know what implications are of not getting 1st dose. He was looking for information whether he did not receive the first dose and got the second dose. Stated that, he asked the person at facility, at the time of first dose, whether he actually received vaccine, they said yes, he got the vaccine, but he didn't think so. Enquired, how did he verify that, he actually got his first dose. Was there a test. He wanted to know whether he had full protection. Stated that, he believed, he only received one dose and that the first dose was not administered due to no side effects following first dose. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
pt recvd vax & had elevated t of 102; irritable leg was warm to touch & reddened;
Mother stated client had a fever 4/28/16. Mother stated she noticed a rash and itching to clients body 5/5/16. Advised Parents to take client to pediatrician.
This spontaneous report was received from a registered nurse who reported that GARDASIL, was given to multiple unspecified subjects after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported after the vaccine was administered. This is one of several reports from the same reporter source. Additional information has been requested.
About 3 min after injection I felt numbness in left arm, fingers swollen, about tenminutes later, lips started to tingle
This is a spontaneous report from a contactable other Healthcare professional (physician assistant) via a Pfizer sales representative. A 64-year-old female patient received on 23Oct2017 PREVNAR 13 at 0.5 ml single in the left arm as routine vaccination. Medical history included diabetes, hypothyroid, gout, hypertension and hyperlipidemia, all ongoing. Concomitant medications included allopurinol, bumetanide, clonidine, levothyroxine, losartan, lovastatin, metformin, metoprolol, pantoprazole and venlafaxine, all ongoing. In Oct2017 the patient experienced cellulitis and abscess with outcome of recovering. Course of the event was reported as follows: Patient received the injection at a local pharmacy. She went to the ER on 26Oct2017, 3 days after the injection and it was found she had left upper arm cellulitis and an abscess. Treatment included oral clindamycin. Then, on 06Nov2017, patient was seen again by primary physician and at that time cellulitis and abscess have improved. It was also noticed that the patient had a pretty hard lump on the left upper arm. On 06Nov2017 patient was visited because she developed a rash under breast, inguinal folds and under her left arm, possible due to clindamycin. She was started on MEDROL for the rash. Sender's Comments: A possible contributory role of the suspect product cannot be excluded for the reported events cellulitis and abscess as it is possible to be from injection. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Information has been received from a registered nurse concerning a 25 year old female patient who on 01-APR-2010 was vaccinated IM with a first dose of GARDASIL (lot # 665768/1377Y) in her left deltoid. Five minutes after injection, the patient experienced metallic taste in her mouth, which lasted 12 hours. The patient did not report this side effect until 20-MAY-2010, prior to her second dose of GARDASIL vaccine. The physician recommended to proceed with a second injection of GARDASIL. The patient did not seek medical attention. On 02-APR-2010, upon awakening, the patient recovered. Additional information is not expected.
03/25/2021 got the vaccine in my right arm --- > everything fine. 03/26/2021 arm pain at the site of injection. 03/30/2021 calf muscle pain (left leg), back pain. 03/31/2021 calf muscle pain continued and pain in all over my back and I had to leave my work at the middle of the day. 04/01/2021 developed fever of 102 f to 104 f. doziness, tiredness and I have taken a COVID-19 test based on my symptomes. 04/02/2021 covid test result returned negative. some fever at night only and sweating at the morning I had a stomach pain, abdomen sharp pain and I had a diarrhea (one time) with continues abdominal pain. No fever but general tiredness.
Internal bleeding in the lung; Fall down; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY HAEMORRHAGE (Internal bleeding in the lung) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Renal cancer stage IV (He had stage 4 renal cancer but was stable.).    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced FALL (Fall down). On an unknown date, the patient experienced PULMONARY HAEMORRHAGE (Internal bleeding in the lung) (seriousness criteria death and medically significant). The patient died on 09-Feb-2021. The reported cause of death was internal bleeding in the lung. It is unknown if an autopsy was performed. At the time of death, FALL (Fall down) outcome was unknown.            No concomitant medication information was mentioned by the reporter.  It was reported that the patient was admitted to the emergency room (ER) on Sunday, 07-Feb-2021 after a fall down. It was non-serious as nothing broke. The ER admitted the patient for observation. He died on the 09-Feb-2021 from internal bleeding in the lung. The reporter felt that moderna vaccine was responsible for his death but of course there was no proof. No treatment medication information was mentioned by the reporter.  Company Comment: This case refers to a male patient of unspecified age with a medical history of stage 4 renal cancer who experienced the unexpected serious event of Pulmonary hemorrhage approximately 4 days after the second dose of mRNA-1273 vaccine. The patient eventually died 2 days later. No causality assessment was provided by the reporter. The medical history of stage 4 renal cancer remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case refers to a male patient of unspecified age with a medical history of stage 4 renal cancer who experienced the unexpected serious event of Pulmonary hemorrhage approximately 4 days after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. stage 4 renal cancer. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Internal bleeding in the lung