chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my numbers went up; This is a spontaneous report received from a Pfizer sponsored program a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiry Date: Not reported) via an unspecified route of administration on an unknown date as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient administered Ibrance 100mg with an unknown start date and stop date: Not applicable. Patient verbally stated my numbers went up. Patient verbally stated I think it may be due to taking the COVID vaccine. Therapeutic measures taken as a result of events were not reported. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Moderna COVID-19 Vaccine EUA Oval, red, raised skin around injection site @ 8 days post vaccination. Slight soreness and itching. 9 days post vaccination; red area has increased in size, approx 5 x 2 inches. Swelling and redness very slightly reduced. Itching and soreness the same.  Staff health examined but had no conclusive treatment. Four other employees called to report similar reactions from the same vaccine clinic.
After vaccine I began to have sore throat, shoulder and neck discomfort.  I experienced also right arm soreness which has diminished.
Small bump under skin at injection site on left arm. Painful to touch. No treatment given. Not aware of when it started/formed.
low 02 sats ( 39%) increased congestion in lungs with shortness of breath crackles through out lungs  increased heart rate above 100
Pt has moyamoya, frequent dizzy spells, symptoms were similar. BP 143/90, given water, felt better, discharged in stable condition
Patient received her 1st dose of Moderna COVID-19 vaccine at 17:45 and stated she felt faint at 17:49 and possibly ?blacked out? as she was sitting.  She ?came to? and called for help, and PHN came to assist noting she looked pale and diaphoretic, and checking VS; 17:52 BP- 79/46, P-64, R-18, O2-99%; 17:57 BP-107/60, P-76, O2- 98%; 18:01 BP-109/66, P-84, O2- 98%; 18:06 BP-106/72, P-78, O2- 97%; 18:11 BP- 109/71, P-79, and reported symptoms had improved; left clinic at 18:15
His arm was swollen and sore,  felt like fever in it, coughing until he would strangle. He also had really bad headaches, extreme tiredness and not feeling well.  Last night he was given Tylenol, which helped him.
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient brings this action for personal injuries and damages suffered as a result of being inoculated with the ZOSTAVAX. The patient was inoculated with the ZOSTAVAX for the long-term prevention of shingles. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. In 2006, the patient was inoculated with the ZOSTAVAX (lot number and expiration unknown) unknown route by a physician, for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. On or about 01-OCT-2015, the patient was treated by a physician, for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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.
Arm slightly swollen and itchy around injection site. There is a slightly raised reddened area about the size of a half-dollar.
Slight fever; fatigue; soreness in arm; intermittent chest tightness; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the arm left on 06Apr2021 at 17:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included the patient was diagnosed with COVID-19 on an unknown date, prior to the vaccine. The patient had known allergy to amoxicillin. Concomitant medications were not reported. 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 the patient experienced slight fever, fatigue, soreness in arm and intermittent chest tightness. The patient did not receive any treatment for the events. The clinical outcome of the events slight fever, fatigue, soreness in arm and intermittent chest tightness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
10/14/11 Hot swollen (L) arm at site of flu shot given 10/13/11. (L) arm uncomfortable.
Case previously recorded as MA2009-6271. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Reference no. NA09-008851.
Fatigue and fever of 99.9. Major side effect was muscle aches in lower to mid back to the point that I was doubled over and could not straighten up for several days. Legs were like jelly as well.
pain in right arm where she had the injection for about 5 days; really, really bad pain in both arms; pain in joints; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date in Mar2021 as dose 1, single for covid-19 immunisation. Medical history included fibromyalgia. The patient's concomitant medications and other Products were not provided were not reported. On an unspecified date, the patient experienced pain in right arm where she had the injection for about 5 days, really, really bad pain in both arms, pain in joints. It was reported that the patient got her first Pfizer Covid-19 vaccine around 11Mar2021 and they gave her all these papers and she experienced pain in right arm where she had the injection for about 5 days. She stated she has fibromyalgia and after about 11 days she had pain in joints. She stated she had really, really bad pain in both arms, right and left. She went to the doctor and they said because she has fibromyalgia that could have given her the reaction. They gave her anti inflammatory to take. Reportedly, it felt better but then it would come back again. The anti inflammatory they told her to take it once a day because it is not really that great to take. She was only taking one a day and then she would take the Tylenol. She stated the pain would get better but then it would come back. She was going for her second one on Thursday. She stated she wanted to know if it was okay to get the second dose, her doctor wanted her to take it but she wanted to get in touch with her rheumatologist but was unable to get in touch with him so she called Pfizer to ask if it is okay. She stated her doctor told her to get the second dose, she experienced more pain than other people and just wanted to make sure it was safe. This report is not related to a study or programme. Investigation Assessment was not provided. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Pt. experienced Syncope, has dizziness, light headed, cold-sweat, and almost fainted.  Pt. did not faint had remain in chair while being observed by pharmacist, administered a cold-compress to pt. with pt. reported immediate relief and continued to observe for 30 min.  Pt reported feeling better and no signs or symptoms and left with parents.  Told to check back with us if any new or further problems.
Vaccines given at 10:30am 8/27/10 parents noticed erythema on arm and arm was twice the normal size by 8:30 PM 8/27/10. Pt taken to ER given antibiotic injection and antibiotics for home use. Parents state fever was 101.2 - 101.6. ((L) deltoid).
Patient felt dizzy and had lump in throat immediately after injection.  Took some benadryl and felt ok after about 10 more minutes
Body aches that started within 24 hours Low grade fever tmax 100.3 started late on the 25th and today.
Severe muscle and joint pain; chills, headache, SOB, diarrhea and palpitations. Treated muscle/joint pain with OTC NSAIDs. Seen in ER for palpitations; had Holter monitor.
I was very sicker or I was just really sick; My arm hurts really bad all day along; it still hurt; Nausea and vomiting was worst even than the first one; Nausea and vomiting was worst even than the first one; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Sep2021 13:30 (Lot number: FF2588) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Acid Reflux" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Time: 19:45, Anatomical site of injection: Right arm, Route of administration: Intramuscular, Batch/Lot number: FC3181), administration date: 09Aug2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "I didn't feel good", "I was nauseous that whole day", "I did vomit", "My arm hurts really bad all day along; it still hurt". The following information was reported: ILLNESS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "I was very sicker or I was just really sick"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "My arm hurts really bad all day along; it still hurt"; NAUSEA (non-serious), VOMITING (non-serious) all with onset Sep2021, outcome "recovered" (Sep2021) and all described as "Nausea and vomiting was worst even than the first one". Therapeutic measures were not taken as a result of illness, pain in extremity, nausea, vomiting.  Additional information: I saw as the side effect you know no big deal my arm hurts really bad all day along and then the second dose which I got on 06Sep which was last Monday it was worst except my arm didn't hurt as bad but I don't know because I was very sicker or I was just really sick. Consumer stated, Well it still hurt but not at bad but the nausea and vomiting was worst even than the first one. Patient never had taken flu vaccine, before.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. From on unknown date in February 2014, the patients were vaccinated with M-M-R II (strength, dose, route of administration and lot # were not reported). This vaccine was exposed to unknown temperatures. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
back pain; Diarrhoea; stomach hurting; HEADACHE; NAUSEA; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), DIARRHOEA (Diarrhoea), ABDOMINAL PAIN UPPER (stomach hurting), HEADACHE (HEADACHE) and NAUSEA (NAUSEA) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Heart disorder.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced BACK PAIN (back pain), DIARRHOEA (Diarrhoea), ABDOMINAL PAIN UPPER (stomach hurting), HEADACHE (HEADACHE), NAUSEA (NAUSEA) and VOMITING (Vomiting). At the time of the report, BACK PAIN (back pain), DIARRHOEA (Diarrhoea), ABDOMINAL PAIN UPPER (stomach hurting), HEADACHE (HEADACHE), NAUSEA (NAUSEA) and VOMITING (Vomiting) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medications include heart medication and blood pressure medication. No treatment medication details was reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
flu; Initial information was received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves a patient with unknown demographics who had flu after being vaccinated with Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Oct-2022, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for influenza. Got higher dose because of patient's age.  On an unknown date in Oct-2022 the patient got flu (influenza) (unknown latency) following the administration of Influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Chest pain, Pericarditis, Tachycardia and ST elevation.  Anxiety.
PEDI PFIZER GIVEN UNDILUTED INTO THE MUSCLE ON 5/30/2022 EARLY AFTERNOON. HAVE BEEN IN CONTACT WITH PARENTS WITH NO ADVERSE EFFECTS AS YET
This spontaneous report as received from a certified medical assistant refers to 3 patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored (Oka/Merck) PROQUAD (lot #, strength, dose, frequency and route unspecified). No adverse symptoms reported. The outcome of the events were unknown. This is one of several reports received from the same source. Additional information has been requested.
For two days severe body aches, very tired, had to stay in bed most of the time. Nausea so didn?t eat much during this time. Headache too. Joins painfull.
Rash spread to face, arm and neck; Diagnosed with Cellulitis; "fever" at site of injection; Rash at site of injection; Muscle aches; Redness at site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash spread to face, arm and neck) and CELLULITIS (Diagnosed with Cellulitis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy, Anxiety, Blood pressure high, Fibromyalgia and Pain.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH ("fever" at site of injection), VACCINATION SITE RASH (Rash at site of injection), MYALGIA (Muscle aches) and VACCINATION SITE ERYTHEMA (Redness at site of injection). On 20-Apr-2021, the patient experienced RASH (Rash spread to face, arm and neck) (seriousness criterion medically significant) and CELLULITIS (Diagnosed with Cellulitis) (seriousness criterion medically significant). At the time of the report, RASH (Rash spread to face, arm and neck) and CELLULITIS (Diagnosed with Cellulitis) had not resolved and VACCINATION SITE WARMTH ("fever" at site of injection), VACCINATION SITE RASH (Rash at site of injection), MYALGIA (Muscle aches) and VACCINATION SITE ERYTHEMA (Redness at site of injection) outcome was unknown.            Concomitant medications included anti-anxiety medications, high blood pressure medications, fibromyalgia medications and pain medications.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Treatment included Keflex, Tylenol, Ibuprofen.  Company comment: This case concerns a 65-year-old female with a serious unexpected event of rash and cellulitis, nonserious unexpected vaccination site warmth, and expected myalgia, vaccination site rash, vaccination site erythema. Event onset the same day as second dose mRNA-1273. Events ongoing. Based on 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.; Sender's Comments: This case concerns a 65-year-old female with a serious unexpected event of rash and cellulitis, nonserious unexpected vaccination site warmth, and expected myalgia, vaccination site rash, vaccination site erythema. Event onset the same day as second dose mRNA-1273. Events ongoing. Based on 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.
06Apr90 pt vax;  devel blotchy rash at inject site on upper left arm.  Rash spread to neck & chest.  Tx w/ Benadryl & rash resolved.  Tx continued every 6 hrs until pt recovered.
Vaccine on Friday, for the flu. By Sat morning, hot and swollen Sunday, got vesicles, which increased in number and size rapidly over 4 hours. Treated with tacrolimus and hydrocortisone otc, and oral benadryl and ibuprofen. By last night, the vesicles were coalesced into just 4, and there was less swelling. Gave zyrtec today instead of the benadryl and she is acting herself. Never got red eyes or red lips.
7/7/21 @ 9 AM: ONSET OF HEADACHE FOLLOWED BY VOMITING. CHILDRENS TYLENOL GIVEN. 7/7/2021 @ 8PM: ONSET OF LOWER CHEST/ UPPER ABDOMINAL PAIN AND VOMITED 3 TIMES. WENT TO ER @ HOSPITAL @ 9 PM-11 PM HAD EKG & ZOFRAN GIVEN
Brusing and bulge in right bicep 12 hours after infection. After 36 hours, bulge size started to reduce. Only slight swelling and bruise now 72 hours after injection.  There were no known feelings of queasiness or sickness post-COVID shot. This was Booster #2, or the fourth shot of Pfizer for COVID-19. Just the temporary physical damage to the skin/bicep, as both are healing now.
she had no symptoms but tested positive; she had no symptoms but tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: Gj6742) at the age of 33 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and as dose 3 (booster), single (Lot number: FF2589) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 16Feb2023, outcome "recovering" and all described as "she had no symptoms but tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Feb2023) Positive, notes: post vaccination. There was no other vaccine in four weeks. Child with COVID first then she had no symptoms but tested positive 16Feb2023 PM.  It was unknown if therapeutic measures were taken as a result of drug ineffective, asymptomatic covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Fever began on 6/27 and cont'd on 6/28 as high as 102. Afebrile on 6/29/03. Significant swelling and redness of left leg began 6/28. Erythema extended from below groin to well demarcated area under knee.  Mod. edema of ant quadricep muscle. No tenderness at insertion site of needle or any red throughout muscle tissue.  On 6/30 went to ER for worsening of tenderness and swelling.
diagnosed with COVID; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and he got possitive with COVID-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 31-12-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  The patient told he only had symptoms for couple of days. The symptoms are not given by the patient.  Laboratory details are not provided.   The patient didn't take any medication.  Action taken with mRNA-1273 in response to the events was not reported.   The events are not resolved .  At the time of this report, the outcome of the event was not resolved.
LPN administered an undiluted .5ml of vaccine. No adverse reactions after 15 minute observation. Error was not recognized until the clinic had ended. This patient was the last to be vaccinated.  PDPH physician followed up with parent to report error and to provide support and guidance. Was informed that following initial minor post-vaccination complaints treated wtih Tylenol, patient had improved.
pt woke up 10OCT98 w/rt eye swollen & completely shut;pt went to hosp ER for tx DPH given as per pt dec swelling;
Arm be red; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient asked how long should arm red after receiving dose of Shingrix shot. No other information was available.