chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt tingle sensation to arm where vaccine injected; sniffles; felt really tired; arm feels sore; The initial case was missing the following minimum criteria: no adverse event and only medical inquiry. Upon receipt of follow-up information on 22Dec2020, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Dec2020, outcome "unknown", described as "arm feels sore"; FATIGUE (non-serious) with onset Dec2020, outcome "recovering", described as "felt really tired"; RHINORRHOEA (non-serious) with onset Dec2020, outcome "recovering", described as "sniffles"; VACCINATION SITE PARAESTHESIA (non-serious) with onset 22Dec2020, outcome "recovered" (Dec2020), described as "felt tingle sensation to arm where vaccine injected".  Additional information: The patient reported that within first 10 minutes, she felt tingle sensation to arm where vaccine injected but it lasted only 30 minutes. She did later have sniffles and felt really tired. She laid down for an hour and felt much better. The patient also stated that her arm feels sore but she expected that. At the time of reporting, it had been 10 hours since the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Day of vaccine and pretty immediately after injection, there was a feeling of brain fog and chronic fatigue and a fever of 101.  By Thursday evening, there was a cough, head congestion, chest congestion, body aches, and tons of mucous.  As of today, the cough has worsened and so has the congestion and mucous.  We went to see a doctor and she performed a COVID test.  The COVID test was negative as was the flu test.  The doctor said this was all a side effect of the vaccine.
Injection site started to burn area became red and deltoid area tender to touch. Redness spread to shoulder, back, chest area and hairline with some blotches to face. C/o being diaphoretic.
1wk p/vax pt devel cough & congestion;1wk later pt exp cough spasms w/some apneic periods lasting 5sec;CBC showed an absolute lymphocytosis 3 days later, an NP swab was sent for FA stain for pertussis & was presumptive positive
Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Dyslipidemia. Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (Sore left arm). At the time of the report, VACCINATION SITE PAIN (Sore left arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 antibody test: (Negative) Tested negative on antibodies test for covid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
The patient had received the Janssen vaccine already.  No boosters are required for this vaccine.  The patient stated that he wanted to get a Pfizer dose as a booster.  He was from (country) and that is what they are doing there.  The technicians refused and said boosters on Janssen are not allowed.  The patient then spoke with the pharmacist and he decided to give the booster anyway even though it is not allowed on the EUA or by company policy.  Pharmacist will receive coaching and counseling for give incorrect boosters.  Schedule of covid vaccine was reviewed with all staff.  Patient had minor injection site reaction and normal covid vaccine side effects.
Client received a booster dose of Covid 19 vaccine too early.   2nd dose given 6/14/21.  Client is not immunocompromised.
This is in follow-up to report(s) previously submitted on 6/13/2008. Initial and follow-up information has been received from a certified nurse midwife through the Merck pregnancy registry concerning a 16 year old white female that was positive for papilloma viral infection and a low grade squamous intraepithelial lesion in August 2007, with acne, and no drug allergies, who on 08-AUG-2007 was vaccinated intramuscularly with a 0.5mL first dose of GARDASIL (Lot# 658488/0930U).  Concomitant therapy included prenatal vitamins (unspecified), 1 tablet once daily.  Subsequently, the patient was pregnant.  The patient's last menstrual period was 06-JUN-2007 and her estimated date of delivery was 15-MAR-2007.  The patient was reported to be 15 weeks pregnant.  The patient had an office visit.  Prenatal labs were performed and the results were unknown.  On 18-OCT-2007 an ultrasound was performed for anatomy and the results were within normal limits "primary change discrepancy dates."  The patient had no previous pregnancies.  There was no adverse experience related to this event.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  Follow-up indicated that 40 weeks from her last menstrual period on 02-APR-2008 the patient gave birth to a normal baby with no congenital anomalies via vaginal delivery on 02-APR-2008.  The infant weighed 8 pounds 11 ounces, was 21 inches long, had a head circumference of 14.0, and had an apgar score of 8/9. It was noted that the patient experienced oligohydramnios and had to be induced due to low amniotic fluid.  Additional information is not expected.
"Broke out in red rash all over his face about 2 hours after receiving H1N1 vaccine. Allergic to eggs."  Mother marked "don't know" to question about egg allergy but she told this PHN that child is allergic to eggs.
Day 1 and 2: muscle and joint pain, injection site pain; weakness/numbness of limbs; fatigue.  Day 8, 9 continuing, redness and itching near injection site,  followed by raised firm skin legion and period Itching.
Patient stated that after recieving the COVID vaccine in April 2021 that she began to notice her lymph nodes on her right side (arm up to neck) began to swell. She had to seek medical care in July of 2021 due to the swelling, pain, welts, heart palpitations, and excessive sweating that occured. She went to the Emergency Room at Hospital and they completed ultrasounds and blood work. Ultimately she was not given an diagnosis for her symptoms (she stated that the team spoke about it being vaccine related). She was prescribed Meloxicam for 14 days. Since then her lymph node swelling and pain has resolved. Heart palpitations have ceased. She still has excessive sweating and has suffered from increased acne and red blotchy areas on her face.
Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown age and gender. No current or historical conditions were reported. On an unknown date, the patients were vaccinated with improperly stored (Oka/Merck) PROQUAD (Lot # L003222 and expiration date 30-JUL-2016, strength, route and dose not reported). No adverse experiences were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Within 2 hours of administration, pt c/o back pain between shoulder blades. Pain increased to involve entire back, especially rt paraspinal muscle, which is tight and spasmodic.
This spontaneous report was received from a Registered Nurse refers to a 32 year old patient (unknown gender). No medical history was reported. ON 17-FEB-2006, the patient was vaccinated with a dose of VARIVAX (lot#, expiry, route, dose not reported). No concomitant medications were reported. The nurse reported that the patient has been immunized 4 times for varicella and with each immunization she has not built up a titer. The last immunization was with VARIVAX. It is unspecified whether the other 3 immunizations were with Merck product. The dates of administration of other 3 immunizations are unspecified by the reporter. No medical attention was sought. No adverse effect reported. The outcome of she has not built up a titer was unknown. Additional information has been requested.
Upon receiving the tetanus and pertussis injection, TB test and flu shot I noticed light spotting when I used the restroom. The spotting did not reoccur after that. It happened during a time when no spotting was supposed to occur. Shortly after I noticed that my left arm became sore. Since then my left arm hurts anytime I sleep on my left side and anytime I move it in a wide range of motions.
HIGH FEVER AT 103-104 DEGREES, SEVERE DIARRHEA. DIARRHEA LASTED FOR 11 DAY, NO FOOD FOR THE FIRST 5 DAYS, THEN ONLY SMALL AMOUNT UNTIL 6/5/2010. ON 6/7/2010 PATIENT BROKE OUT IN CHICKENPOX, SO FAR ABOUT 150 LESIONS.
About 30 minutes after getting the shot I had very bad pins and needles both my arms and legs. My whole body felt very tingly all over .
had raised, red, painful, round area around injection that was approx 2 inches in diameter; said area eventually faded and returned to normal after approx 3 days; approx 1 week after injection, developed a severe cold (sneezing, nasal and chest congestion, productive cough, fever) that resolved after 2 weeks
pt recvd vax 20SEP93 & w/in 24 hrs devel red, raised rash @ inject site, size 1"x2"; no fever, no pruritis; as of 23SEP93, had not resolved; no treatment; not seen by MD;
Patient developed fevers of 102 and a large reddened and swelled area on left upper arm at area of injection, TX with Keflex 500mg teaspoons TID X 10 days.
Vertigo, sweating, nausea for two hours starting early morning day after vaccine. The 3 inch square red breakout, knot, and very sore around vaccine site. For at least 5 days after vaccine.
they said was she is COVID positive; could not wake patient up; it is like she is drunk; This is a spontaneous report from a contactable consumer reporting on mother. A 93-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9267 via unspecified route on 25Feb2021 as a single dose for COVID-19 immunisation. Reporter stated vaccine was given to her mother last Thursday, a week ago today (7 days ago).   Reporter stated that the vaccine card was handwritten, and she doesn't see NDC/EXP on it.  Medical history and concomitant medications were not reported. Reporter stated that before she was doing laundry, her mom was alert and was opening and closing her eyes, and she gave her Gatorade, and she had someone take her blood pressure and it was okay.  She says she gave her ice chips, and water and it was like pulling teeth, she can't wake her up, it was unbelievable, it was like she is drunk. They had to rush her mom to emergency room; ambulance came, and they kept her over 24 hours, she was admitted and they did observed her and released her the next day, and said she was COVID positive, and to make sure she got tested until it was negative, which she says was very surprising so she feels her mom got a false positive. Outcome of event COVID positive was unknown, could not wake patient up, was unknown and it is like she is drunk was unknown.
Arm has huge red rash, hot and painful in area of vaccine. 3 days after
Generalized Pruritus. Patient informed clinical staff that she was having body itching. Patient was given 50 mg oral diphenhydramine hcl as advised by PCP. Vitals were taken and patient was assessed by PCP.  Patient was kept in observation for 30 minutes, no further complaints or complications reported.
20MAR feel bad; 21MAR fever 100, rash, office visit approx 203 days symtomatic; 23MAR asymptomatic/MD rash torso-arms, neck;
I have had pretty intense arm pain since my second shot which was now almost 2 months ago. The pain is still as prominent as ever. I did not get sick after the second shot, only normal arm pain but it has continued up until now. Whenever I move my arm at all, the pain is on my left arm around the injection site.
Day 1: Started regimen of Tylenol and ibuprofen around 1am Tuesday morning, second dose around 9:30am after waking. Noticed slight lightheaded/faint feeling, stayed in bed due to known symptoms of first shot being pretty bad. Let Tylenol/ibuprofen cocktail wear off and did not take dose at scheduled interval (curious to see if symptoms would start) and that?s when chills, body aches started up. Took Tylenol/ibuprofen around 7pm and started to warm up after an hour or so. Went to bed and had night sweats/hot flash/fever. Arm was sore all day despite medication but not unbearable. Next day itching started. No other symptoms except sore arm. Continuing Tylenol/ibuprofen, seems to help keep symptoms away.
Limited mobility; Diarrhea; Fatigue; Severe muscle aches, especially in thighs; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (Fatigue), MYALGIA (Severe muscle aches, especially in thighs), NAUSEA (Nausea) and DIARRHOEA (Diarrhea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included GABAPENTIN, LISINOPRIL, OMEPRAZOLE, DICLOFENAC, TIZANIDINE and VENLAFAXINE for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced PYREXIA (Fever), FATIGUE (Fatigue), MYALGIA (Severe muscle aches, especially in thighs), NAUSEA (Nausea) and MOBILITY DECREASED (Limited mobility). 29-Apr-2021, the patient experienced DIARRHOEA (Diarrhea). On 03-May-2021, PYREXIA (Fever), FATIGUE (Fatigue), NAUSEA (Nausea) and DIARRHOEA (Diarrhea) had resolved. At the time of the report, MYALGIA (Severe muscle aches, especially in thighs) and MOBILITY DECREASED (Limited mobility) outcome was unknown.            Concomitant product used included Gabapentin, Lisinopril, Omeprazole, diclofenac, tizanidine, Venlafaxine.  Treatment medication included OTC potassium, Gatorade, pickle juice, mustard, and water.  Additionally, patient noted that she only experienced nausea following her first vaccine dose.
nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nausea".   Additional information: Patient is requesting to get information like wants to know that he can take (Gravol) Anti nausea medications.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sperm count dropped to zero. As recently as 1 year ago, my wife was pregnant, but now 1 month after getting the Jansen vaccine, I am testing at zero sperm.
w/in hrs p/vax pt devel rash on lower extremities then joint aches;    petechia devel over body; pt admit to hosp w/acute ITP; tx w/IVIG x1
Lethargic, change in behavior, fever (high) for approximately 6 days.  Refusal to eat, play, increase sleep, rash on arms and torso for approximately 2 weeks, ear irritation, cold (runny nose).
SWEATING. BLURRY VISION. TUNNEL SOUNDS. DIZZY. HOT.
Sore arm at injection site; Sneezing; Swollen eyes; Feeling sleepy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included seasonal allergy and systemic lupus erythematosus. Concomitant products included fexofenadine hydrochloride (Allegra).   On 01-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular). On 01-MAR-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Sore arm at injection site), sneezing (Verbatim: Sneezing), eye swelling (Verbatim: Swollen eyes) and sleepiness (Verbatim: Feeling sleepy). The outcome of the injection site pain, sneezing, eye swelling and sleepiness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, sneezing, eye swelling and sleepiness to be related to Shingrix.     It was unknown if the company considered the injection site pain, sneezing, eye swelling and sleepiness to be related to Shingrix.   Additional Information: GSK Receipt date: 02-Mar-2023 Patient was the caller asking if sneezing was an expected side effect of the Shingles vaccine or not. She also mentioned that she had a sore arm at the injection site, swollen eyes and was feeling sleepy. The reporter provided education, offered medical disclaimer, referred to HCP. The patient stated she did not want to bother them. Did not consent to follow-up.
Symptoms were pretty much the same as the adverse event from 1st dose. But this time, it hurt when they injected it. Like a huge sting. And my whole arm got really hot. Got really hot, dizzy. I immediately threw up. They wanted to call EMS but I told them not to do that - and that I would go to the doctor myself. I went home and did what the hospital told me to do the first time - rest; fluids, Tylenol; this time my fever went up to 103. 2 and it went down but shot back up. Started coughing an hour after I got this shot and it was more than last time. Dry mouth and horrible headache. I still have a knot in my arm. Didn't have that before the 2nd dose. My fever just broke today finally. Still have headaches; body aches a little bit.  Mostly resolved otherwise.
I got large round red rash over arms, legs & most of back & belly. There was a tiny blister in center of each red circle--a "bulls eye rash." So my whole body itched. Felt extremely anxious. Doc knew from the kind of rash that was not a "contact dermatitis-type rash. ER doc the night Before at Midnight when it got bad, No idea what to do about it. Just finally gave me one Benedril tab & sent me home. Saw My PCP next day. He prescribed 3 allergy meds + prednisone, each taken at dif intervals. Needed ex meds for 1 month. (Scars gone by end of November)
At 8:00am on 5/7/2021, I was using the toilet. I began to feel nauseated and sweaty, and then I passed out. I don?t know how long I was out, but I was extremely exhausted and cold after the event.
Allergic reaction; Rash around her mouth and all over the body; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction) and RASH (Rash around her mouth and all over the body) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history reported.     On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction) and RASH (Rash around her mouth and all over the body). On 27-Apr-2021, ALLERGY TO VACCINE (Allergic reaction) and RASH (Rash around her mouth and all over the body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient visited emergency room and treatment included Diphenhydramine and prednisone.  Concomitant medication was not reported.  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.; Sender'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.
elevated heart rate, racing heart rate for no reason, feeling lightheaded (like I'm going to pass out), dizzy spells, muscle weakness, nausea/lack of appetite, chest tightness, numbness in arms/hands, blurred vision
Site of injection red, swollen, painful. Told to: cool compress, draw circle around, TYLENOL &/or MOTRIN for discomfort. To call if worse or be seen if concern. Mother OK with this. Put on Abx for cellulitis.
Pain from her shoulder to her elbow that night after her flu shot. She stated she has seen 3 MDs and a bone & joint MD received a steroid shot with no relief. 11/06/09 T/c to Pt. She statedshe has seen for MDs and they all stated they felt pretty sure it was not the flu shot that caused the pain. She stated the MD she visited yesterday stated he suspected it may have been bursitis. Stated she is taking a pain med and Ibuprofen 600mg TID for pain.
At 12:29 patient asked for water. Once patient received water, he began to pass out. pharmacist had patient lie down on chairs with legs elevated.Technician called 911 at this time. While technician was on phone with 911 pharmacist began to take blood pressure readings. Blood pressure was low at a reading of 98/58. At 12:32 technician ended phone call with 911. Pharmacist was still monitoring patient. Patient was starting to stabilize. At 12:36 EMS arrives at pharmacy and pharmacist relays information to EMS. EMS evaluates patient, informed him of the choice to go to the hospital or not. At 12:46 After patient sat with EMS monitoring for 10 minutes patient refused to go to hospital. At this time patient was stable and left the pharmacy.
facial rash - distributed over nose and cheeks, started 1 day after vaccination and still present 10 days after vaccination, mildly itchy, no lip or tongue swelling, no difficulty breathing
Patient had an immediate reaction on the left leg. Received Hib, PCV7 and Varicella in left leg.  Erythema of 2cm x 3cm welt of .08cm x 1.5cm.  Dr came and evaluated will have patient stay in clinic for 30 minutes for continued monitoring. April 23, 2008 11:20 AM Vitals were retaken before patient left.   Pulse 120   Respirations 24  Temp: 36.6 C  April 23, 2008 11:42 AM No problems noted after 30 minutes of observation erythemia started to resolve at end of 30 minutes welt still present.  Advised if further issues to either call office or 911 depending on continued reaction. April 23, 2008 2:41 PM.
pt recv vax 11JUL96 in rt deltoid;pt reported 19JUL96 was having pain, numbness & tingling to rt arm/hand & shoulder area starting about 2 days p/vax which would have been about 13JUL96;