chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm very sore, swollen and red all around injection site. I also have had a feverish for 2 Days, no energy and Headache.
Tested Positive for Covid-19 after vaccination.; Tested Positive for Covid-19 after vaccination.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27May2021 as dose 1, single (Lot number: EN6207), in left arm, on 16Jun2021 as dose 2, single (Lot number: EN6207), in left arm and on 09Jun2022 as dose 3 (booster), single (Lot number: FN2908) at the age of 15 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Jan2023 at 07:00, outcome "recovering" and all described as "Tested Positive for Covid-19 after vaccination.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2023) Positive, notes: nasal swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The patient has no covid prior vaccination and no other vaccine in four weeks. The patient has no known allergies.
He had previously received the Janssen on 3/10 in the community and no documentation was provided at intake.   He never mentioned having the vaccine.
Severe burning pain in left tricep surrounding shot site began within 3 hours after receiving shot.  Pain intensified over three days.  Day four brought numbness and tingling in the left arm primarily from the elbow to fingertips, a deepening intense ache in the upper arm and shoulder muscles, mild swelling of the upperarm and elbow area, extreme weakness in the left arm, painful muscle spasms in the left tricep, sensations of both burning heat and chills in the upper arm, lightheadedness, pressure headaches (like my head was in a vice grip), all over muscle aches, mild sporadic muscle spasms, severe fatigue, occasional rapid heartbeat, loss of appetite, and drenching night sweats.  Treatment prescribed was to take Alleve - it did not help.  These symptoms continued through the second week.  By the third week all symptoms had eased somewhat except for the burning pain in the left arm, left tricep muscle spasms, left arm weakness, mild numbness and swelling.  Elbow joint pain became more pronounced.  A six day dose of Prednisolone was prescribed.  This improved the arm pain by @30% in the first 48 hours, and then had no more improvement.  In this fourth week fatigue decreased, appetite improved, night sweats lessened, headaches stopped.  As of the fifth week there remains a deep burning ache in the left tricep, milder burning ache in the left shoulder and underarm, pain in the left elbow joint, mild numbness in the left arm primarily from elbow to finger tips, arm weakness in which any attempts to use the arm result in severe muscle spasms which last for an hour or two afterwards, mild swelling primarily around the elbow area, fatigue, mild night sweats, and occasional episodes of rapid heartbeat (when fatigue brings on lightheadedness).  No other treatment has been prescribed.
4AM Headache, dripping sweat but not feeling hot or cold.  Took Tylenol. 10AM Felt like I had a slight cold, upset stomach. 11AM Felt more like a mild case of the flu, body aches, chills.
Sore arm; Minor swelling at injection site; Headache; Low-grade fever the next day (99 degrees); This is a spontaneous report from a contactable consumer (patient). A 41-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection, Lot number: Unknown), via an unspecified route of administration in left arm on 28Jan2021 at 14:30 (at the age of 41 years) as 1st dose, single dose for COVID-19 immunisation. Medical history included being treated for Grave's Disease, hyperthyroidism, food allergies to tree nuts and pitted fruit. Concomitant medications included methimazole 2.5 mg daily taken for an unspecified indication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 29Jan2021 at 00:00, the patient experienced sore arm, minor swelling at injection site, headache, and low-grade fever 99 degrees. Patient received no treatment for the events. Patient did not test for COVID-19 post vaccination. The outcome of the events was recovering.  Information about lot and batch number has been requested.  Follow-up attempts have been completed and no further information is expected.
mom noticed hardness in lt let the day of vax in evening;still hardness & sl fever;pt also has coughing;MD gave cough syrup 2wk ago;
Patient came in to pharmacy on 5/13/2015 to report adverse effects from Zostavax administered on 5/8/2015: she said her arm developed blisters and a shingles-like rash on her arm, which had resolved, but today she had a bruise (about the size of two quarters) on the back of her arm, at the site of injection. She didn't report any other symptoms and was in good spirits at the time of her visit.
Day 1 - nothing                          Day 2 - nausea (mild progressing to severe), vomiting (x2), dull headache, no appetite, fatigue, chills (on/off) Day 3 - nausea (moderate), Pancreatitis-like symptoms (lasted 1 day), no appetite, fatigue, erratic blood sugars, chills (on/off) Day 4 - fatigue, chills (on/off), no appetite, generally feeling unwell. Day 5 and continuing, generally not feeling well, no appetite, chills (on/off) NO FEVER AT ANY TIME
Patient did not experience an adverse event or any negative side effects - administration error occurred as this patient received an unauthorized (booster) dose of a COVID-19 vaccine.
Patient received Janssen dose, after receiving 1 Moderna dose, that she had an allergic reaction to. Per CDC guidelines, this is a reportable event because mixed dose series are not FDA-authorized at this time. Patient was observed for 30 minutes post vaccination, due to Hx severe allergies, and allergic reaction to prior dose of COVID vaccine (mRNA). No adverse reactions noted or reported.
I've always received flu shots with no side effects. This time I encountered lots of itching and bumps initially around my neck. Then my head, upper legs, torso. This occurred roughly 2 days after the shot, but it's been close to 10 days now and still occurs off and on. It's not life threatening but felt it was important to report.
Antibody test that showed up negative for antibodies; This is a spontaneous report from a contactable healthcare professional (the patient) (also reported contactable consumer, pending clarification) from Pfizer. This reporter reported similar events for three patients. This is the first of three reports.  An 82-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 17Feb2021 16:00 (Batch/Lot Number: EN6200) as single dose for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medication included unspecified medication for high blood pressure. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 around 15:30 on right arm, for COVID-19 immunization. On 09Mar2021, 20 days after the second dose of vaccination, the patient had an antibody test that showed up negative for antibodies. The patient stated that she had an antibody test performed on 09Mar2021 exactly 20 days after her second dose of the COVID-19 vaccine. She reported that the test result showed no antibodies. She is inquiring if she is supposed to be showing antibodies after both doses of the COVID-19 vaccine and if she doesn't have any antibodies, does that mean shot doesn't work? The event did not require a visit to Emergency Room. The patient went to her physician after receiving the negative antibody test results. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296623 same reporter, drug, and event, different patient;US-PFIZER INC-2021296704 same reporter, drug, and event, different patient
Fever, Chills, swollen upper lip and eyes, rash on upper lip, tongue prickly and taste is some what lost
PT CAME TO THE PHARMACY WITH THE COMPLAINT OF PAIN ON HIS LEFT ARM. I CHECKED PT AND THERE IS NO INJECTION SITE REACTION, REDNESS OR SWELLING. JUST PAIN. I EXPLAINED PT IT IS DUE TO TETANUS VACCINE, WHICH TENDS TO HURT LONGER THAN OTHER IMMUNIZATIONS. SUGGESTED PT TO SEE DR TO EVALUATE FURTHER.
Pt came to the office 12/22/03-status post ED visit on 12/20/03 with hives following admission of Pneumovaccine on 12/19/03.  Also complained of left arm pain and redness.
Screaming and when picked up, patient turned "beet red" and tensed up. Crying to point of he couldn't catch his breath. Mother blew in face after which eyes rolled back and head fell back and he started convulsing with arms flexed. This lasted for about 1 minute. Afterwards patient was crying but not responsive to mom and just "staring off". Also had some upper body jerks intermittently for 20 mins. until EMS arrived.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JU-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of VAQTA (dose number, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up was received from a medical assistant and refers to a 4 years old patient of unknown gender. On 10-JUN-2014 the patient was vaccinated with a dose of VAQTA lot # J005010 and expiry date 23-OCT-2015 (also reported as 06-NOV-2016) (dose, route not reported) that on 10-JUN-2014 had been exposed to 51 degrees Fahrenheit for 51 minutes. This is one of several reports received from the same reporter. Additional information is not expected as no follow up was obtained.
Reported itchy throat, tongue, face apprx 10 mins after vaccine. Later that night she had all over body itching with no rash and mouth swelling, eye swelling. No SOB,  or difficulty swallowing.
Achy; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Achy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   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. On an unknown date, the patient experienced MYALGIA (Achy). At the time of the report, MYALGIA (Achy) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The concomitant medication was not reported by reporter. Patient got the first 2 Moderna and got booster and each time patient got achy. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662819 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662819:(same reporter).
Fatigue; numbing of left upper body up to jawline and area above the ear.  Headache on the left side as well.
He had soreness in the arm after receiving the 1st, 2nd, and 3rd dose; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 76-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single and a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer said patient already received 3 doses of the Pfizer-BioNTech Covid-19 Vaccine. He said he had his 3rd dose a couple of weeks ago. However, on the 20th, he said they will be releasing the booster dose and he wanted to know if he should still receive it. He also mentioned that he had soreness in the arm after receiving the 1st, 2nd, and 3rd dose on unknow date. The outcome of the events was reported as unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
(PM) On 2-16-12 patient received TDAP vaccine, (R) deltoid; 2 days later signs of redness & swelling & pain occured; area approx. 2" long x 1" wide; away from injection site about 3 inches; Advised TYLENOL & BENADRYL & compress.
Pt reproted a diffuse red rash with a bit of swelling, with no itching or pain in the area of the injection site approximately 3-4 inches in diameter that developed the day after the immunization. At the time of the report, pt denied any systemic effects. When the patient returned to the pharmacy on 5/31/2012, pharmacy manager recommended topical hydrocortisone cream 1% applied to the area to reduce redness. Pt went to see his PCP on 5/31/2012. Dr. recommended Allegra and prescribed cephalexin to treat suspected cellulitis. Pt returned to the pharmacy that day and purchased Allegra but has not filled the cephalexin prescription. Pt prefers to see if symptoms will resolve or worsen before attempting antibiotics.
Says vomited 3 times. Observed 30 min., no more vomiting. Gr.fa. picked up. Gave inst. to call MD if any illness continues.
DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a patient concerned a 17 year old female. 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: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced drug administered to subject of inappropriate age, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
a welt appears that lasts for 20-30 minutes and then it's gone/the welt still appeared; It is like tingling; Throughout the whole day he feelslike it is pain but it is not agony; It is slight pain, like an itch as if something is crawling on him; Itching/irritation all over his body/unbearable itching and irration; becomes inflamed and then goes back down; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (a welt appears that lasts for 20-30 minutes and then it's gone/the welt still appeared), PARAESTHESIA (It is like tingling), PAIN (Throughout the whole day he feelslike it is pain but it is not agony), FORMICATION (It is slight pain, like an itch as if something is crawling on him) and PRURITUS (Itching/irritation all over his body/unbearable itching and irration) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A, 009C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy and G6PD deficiency (Patient Got diagnosed when they did tests for the  either in 2017 or 2018).   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 17-Feb-2022, the patient experienced URTICARIA (a welt appears that lasts for 20-30 minutes and then it's gone/the welt still appeared), PARAESTHESIA (It is like tingling), PAIN (Throughout the whole day he feelslike it is pain but it is not agony), FORMICATION (It is slight pain, like an itch as if something is crawling on him), PRURITUS (Itching/irritation all over his body/unbearable itching and irration) and INFLAMMATION (becomes inflamed and then goes back down). The patient was treated with HYDROCORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, URTICARIA (a welt appears that lasts for 20-30 minutes and then it's gone/the welt still appeared) had not resolved, PARAESTHESIA (It is like tingling), PAIN (Throughout the whole day he feelslike it is pain but it is not agony) and FORMICATION (It is slight pain, like an itch as if something is crawling on him) outcome was unknown, PRURITUS (Itching/irritation all over his body/unbearable itching and irration) was resolving and INFLAMMATION (becomes inflamed and then goes back down) had resolved.            Concomitant medications included Medications through the  but no mention of the names.
cramps in the stomach; diarrhea; Pain in injection site; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (cramps in the stomach), DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (Pain in injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in injection site). On 26-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (cramps in the stomach) and DIARRHOEA (diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (cramps in the stomach), DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (Pain in injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient became pale, nauseous, diaphoretic, speech thick, numbness in the rt arm (from the injection site) extending to her face. Was given 50 mg of Benadryl po , sx's improved in 5 minutes. resolved in 20 minutes.
Pt recvd a series of Engerix-B on 15MAR91; 15APR91 & 10SEP91 & upon completion of series pt as discovered to have not responded;
immediate muscle contractions and spasms in the arm and neck upon injection.   Flu like symptoms (aches throughout the body and and fatigue started at about 8:00 pm.  And have continued through the next day
NUMBNESS AND TINGLING IN THE LEFT UPPER ARM THAT IS RADIATING TO THE PINKY AND RING FINGER ON THE SAME SIDE; PAIN IN THE BRACHIAL PLEXUS REGION WITH TINGLING AND PAIN AT VACCINATION SITE.
10 days p/MMR/HIB devel low grade fever & rash; by next day pt devel temp to 39.4 & maculo papular rash w/purpura & some urticaria; some target lesions c/w erythema multiforme;
3/19/07 PATIENT REPORTED TO WALK IN CLINIC WITH C/O CONTINUED LT UE PAIN AND IMMOBILITY. WAS PRESCRIBED A PREDNISONE TAPER. ON 3/20/07 PATIENT RETURNED TO REPORT NOT TAKING PREDNISONE AND SEEKING RESOLUTION OF LEFT ARM PAIN AND IMMOBILITY. WAS REFERRED TO ORTHOPEDIC CLINIC AT  MEDICAL CENTER AND WAS PROVIDED WITH A PHYSICAL THERAPY APPOINTMENT.
Muscle soreness and weakness. Limited range of motion. Pain and difficulty when getting undressed and lifting shirt over head. Pain and soreness in my arm when I lay on my left side. Symptoms have not subsided for 16 days.
This spontaneous report as received from the patient's friend refers to her friend a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. On an unknown date the patient was diagnosed with shingles after receiving ZOSTAVAX. The outcome of the event was unknown.  Additional information is not expected due to no contact details were provided.
Client's wife called health department and reported that client received his flu shot on Tuesday, October 5, 2004 and was feeling fine.  On Thursday, October 7th, client told his wife he didn't feel well, was having body aches.  Wife reported client continued to feel worse and that by Saturday he reported he hurt all over and wanted to stay in bed.  Sunday AM, October 10th, client ate a bowl of cereal then returned to bed where he watched a ball game.  After the game his wife went to read the paper and came back into the client's room about 5:15 PM to see what he wanted for supper.  He told his wife he still didn't feel good, was feeling cold and shivering, but would eat a little of whatever she was having.  A little later the wife sent their adult daughter to the client's room to get him for supper and found him dead, still sitting up in bed. Due to client's work in a local funeral home he had requested no autopsy be done so client was taken directly to the funeral home and buried on Wednesday, October 13th.  According to his wife he had suffered several previous strokes and was a diabetic.  The wife also reported that a friend who is also a physician stated it sounded like the client had a heart attack.  The client has received flu vaccinations through the health department since 1998 with no adverse events.  Nurse follow up on 11/01/04 states: "cardiovascular arrest; cerebrovascular ischemic disease; hypertension." -- 10/29/04 Copy of Death Certificate is received and lists COD as: cardiovascular arrest; cerebrovascular ischemic disease and hypertension.
45 minutes after the first vaccine of the Pfizer had a reaction that consisted of ears itching and getting hot. Patient took prednisone and better within hours.
This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in March 2017 (reported as "starting on or after 06-MAR-2017"), the patients were vaccinated with doses of M-M-R II, lot # M004899, expiry date: 27-JAN-2018, for prophylaxis (dose number and route of administration were unknown), which were improperly stored at 11.4 degrees Celsius (C) for 1 hour 10 minutes. A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA012132: US-009507513-1703USA012133: