chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Wednesday evening -- about  6 hours after I received the flu vaccine, I started feeling &#8220;itchy&#8221;.  I went to bed and the next morning I was covered in hives  and had felt  &#8220;shaky&#8221;.  I had hives on my neck,  both arms, trunk, and both legs .  Nothing near the injection site. I took Benadryl.   From work that day, I contacted the administrator of the vaccine and talked to a nurse who told me to continue taking Benadryl and if my throat would start to close or I had shortness of breath, to go to the emergency room.   I continued to take the Benadryl.  The next morning  (Friday) my hives were worse. There were more of them and they were bigger.  Especially on both wrists.  They were extra thick on the inside of both wrists&#8212;about 4 inches long and &frac12; in wide.   The hives were more itchy and I feel more &#8220;shaky&#8221; and nervous.  The hives on my wrists were very thick, and swollen.  They were very painful.  The swelling seemed to cut off circulation to my hands and my hands were cold.  The hives  were warm to the touch.   I went to work, continuing to take the Benadryl.  The Benadryl did not seem to help.  The symptoms were continually getting worse.  I left work  at 10:30 to see a doctor.  By 11 am I was at the doctors office and I explained that I was having an allergic reaction to a flu vaccine.  This was about   45 hours after the vaccine.  With severe symptoms of an allergic reaction, I was given an injection of  DepoMedrol  80 mg IM.    I was also given a prescription of Loratadine 10 mg.    Within an hour of the DepoMedrol  shot,  the worst  hives  (on my wrists)  started to become less painful .  The &#8220;shakiness&#8221; that I was having went away.   Over  the next several hours,  and into the evening, the hives got lighter in appearance.   The next day,  Saturday ,  there was more improvement .   The next day , today (Sunday)  still more improvement.   You can still tell where the hives were &#8211;the areas look like light colored bruises.  There is some slight itchiness in hands and feet each day since but Benadryl  helps.    I am not allergic to eggs.     This was my first flu vaccine.    Needless  to say, I will not get a vaccine next year.
Felt really strange; My body kept heating up, heating up, and heating up and then I got a headache; My body kept heating up, heating up, and heating up and then I got a headache; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. patient received her first shot on Sunday afternoon and when she was there the first 3 minutes, she felt really strange and her body kept heating up, heating up, and heating up and then she got a headache. Patient asked if that was a side effect or if it was normal. It lasted anywhere from 8-10 minutes. Patient asked If she decide not the get the second shot will the first shot protect her. patient asked "I wouldn't die, would I?" patient was recovered from the events in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
FEVER; HEADACHE; FATIGUE; MUSCLE ACHE; This spontaneous report received from a parent concerned a male of unspecified age. 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced muscle ache. On 15-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 102.3 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, muscle ache, and fatigue. This report was non-serious.
Temp >104.  Extreme fatigue and body aches x 3 days. Was taken to Urgent Care. Blood tests done--no treatment given.
tested positive for covid; This is a spontaneous report from a contactable consumer (Father). A 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date: Not provided) at a single dose via unspecified route on 20Jan2021 for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On 28Jan2021 the patient tested positive for COVID-19. The reporter would like to know when the patient could receive the second dose. The reporter checked with treating physician regarding the same and contacted. Outcome of event was resolved.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unspecified age and gender. The healthcare worker reported that, on unknown date, GARDASIL (dose, frequency, route, anatomical location, lot number and exp. date were not reported) that underwent a temperature excursion has been administered to an unspecified amount of patients. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Redness on the face; The face feels hot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on the face) and HOT FLUSH (The face feels hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced ERYTHEMA (Redness on the face) and HOT FLUSH (The face feels hot). At the time of the report, ERYTHEMA (Redness on the face) and HOT FLUSH (The face feels hot) outcome was unknown.            No concomitant and treatment information were reported by the reporter.
Extreme swelling of left arm from shoulder to elbow. Burning/hot sensation in full arm, Red rash from shoulder down to forearm. Above lasted 4 days. Day 5 soreness and slight rash on upper arm.
Painful lymph nodes and very itchy at shot site. Swollen hot and slightly painful and red
Redness at the injection site / Redness traveling down left arm and about 7 inches long.  It was below the bicep area but above the elbow; Swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix. On 15th October 2019, couple of hours after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on the left arm.  A few hours later, the patient had redness and swelling at the injection site. The next day, the patient saw redness travelling down her left arm and about 7 inches long. It was below the bicep area but above the elbow. The reporter was did not consent to follow-up.
Information has been received from a nurse practitioner concerning a 1 day old male infant whose mother on 20-AUG-2009, was vaccinated with a dose of VARIVAX (Merck) (lot # 664235/0642Y). Subsequently the patient's mother was pregnant, with last menstrual period (LMP) approximately 23-JUL-2009, and estimated delivery date (EDD) approximately 29-APR-2010. On 27-APR-2010, 40 weeks from LMP, the patient's mother delivered the infant (see WAES# 1007USA00664). Pediatric medical records were received and reviewed and the following experience was identified: congestion, spitting up a lot and eyes matted. At the time of reporting, the outcomes were unknown. On 12-MAY-2010, the patient was found to have bilateral lacrimal duct obstruction. The tear ducts were blocked while drainage with massage. On 18-MAY-2010, the diagnosis was changed to left lacrimal duct obstruction. Treatment plan was massage left tears duct. At the time of reporting, the outcome was unknown. The patient's lacrimal duct obstruction was considered to be a congenital anomaly. The mother's experience has been captured in WAES # 1007USA00664. Additional information has been requested. All available medical records will be provided upon request.
Atrial tachycardia condition; This is a spontaneous report from a Pfizer-sponsored program a non-contactable consumer (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in Jan2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date, she had an atrial tachycardia condition, and she got the 1st vaccine 3 and a half weeks ago. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Booster; pain in the left arm neck and shoulder; pain in the left arm neck and shoulder; pain in the left arm neck and shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "pain in the left arm neck and shoulder".  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
The nurse administering the patient vaccine booster shot administered a 0.25 ml dose of Moderna intramuscular to a patient that was under the age of 18.  The patient that received the dose was 17 years of age.  The patient was observed for 20 minutes following administration of the vaccine and no adverse reaction was observed .
Patient received 1st GARDASIL, felt faint, eyes rolled back in her head & twitched.  Nurse helped her lay on exam table.  After 1-2 minutes she was alert asking what had happened. Remained laying & conscious for 20 minutes - attempted to have her sit up & continued to feel dizzy - laid her back down x another 20-30 min.  Felt better, but not well enough to walk to the car with mom.  Friday - stayed home because she was still dizzy when she got up.  Sat/Sun - felt better.  Mon - went to school & came into office because felt dizzy again - in office BP + blood sugar were stable at 120/70 + BS of 88.  Exam essentially normal.
Pt recvd 3 doses of Engerix-B vax & was determined to be a non-responder; pt recvd a booster dose of Engerix-B 11JUL91;
This spontaneous report has been received from a medical assistant and concerns a patient of unknown age and gender. The patient's medical history and concurrent conditions were unknown. It was reported that since on an unknown date, an improperly stored dose of with RECOMBIVAX HB (lot # L026598, expiry date 26-JUN-2017 (dose and route were not reported) was given to the patient on 04-FEB-2016. It was reported that the vaccine was at 27 Fahrenheit of temperature and its time frame was 35.5 hours/360 hours , there was not previous excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Patient received PNEUMOVAX and ZOSTAVAX (R) deltoid on 10/05/11 c/o severe pain, inability to move arm b/c of pain. Sought medical attention 10/06/11 at office where immunization administered. Arm sl swollen at deltoid, no redness, positive pain to touch, positive mobility. Also received flu (L) arm - no rxn.
Upper (R) arm swelling to twice its size. Swelling began approximately 48 hours after injection then it (swelling) resolved over the course of 1 week. No other symptoms experienced.
Right after vaccine - Started having horrible shoulder pain, limited range of motion of all arm. Taking pain killers prescribed by doctor so strong that I feel dizzy and nauseated. It's been over 6 weeks and overwhelming pain won't go away.
constipation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunisation. The following information was reported: CONSTIPATION (non-serious), outcome "unknown", described as "constipation". Therapeutic measures were taken as a result of constipation.  Additional information: Caller wanted to know if other people have experienced the side effect of constipation with second shot of the vaccine. She said she (50 years old female) her boyfriend (52 years old male) and sister (60 years old) are experiencing bad constipation after the Pfizer covid vaccine. Her doctor has prescribed laxatives and they are taking 8-9 prunes a day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021510552 Same Vaccine/event, different  patient;US-PFIZER INC-2021498931 Same Vaccine/event, different  patient
I received the 2 vaccine on Thursday Jan 21, 2021. Vaccine was given in my left arm. Injection site became hot and red. On Friday Jan 22 I started feeling unwell and had body aches. By Friday night I became very cold to where my body was shaking. My joints and muscles ached and I became very weak. Saturday Jan 23rd I spiked a fever to 101.7. I took Tylenol to help control the body aches and help bring down the fever. I got little relief. I continued to run a temp all day on Saturday, had body aches, joint and muscle pain. I also became very nauseated and lethargic. I had headaches the entire time
Patient fainted shortly after getting the Janssen vaccine.  She felt faint and let us know so we laid her down elevated her legs, and she fell out for a few seconds she continued to have a strong pulse.   We gave her an ice pack and water after she came back and had her lay down for 10 more minutes.  I checked with her a few days later she said she had fever and chills 8 hours after the vaccine but felt better.
Right cheeks (parotidal area) swelling, visited ER where pediatrics diagnosed condition.
Staff erroneously drew up 1 cc instead of 0.5 cc for each injection.  We, therefore, gave out approximately 200 immunizations instead of the 400 or so needed. a second wave delivery of Flu vaccines is reportedly, which will
Case number PHEH2016US027473, is an initial spontaneous report received from a health care professional on 20 Oct 2016. This report refers to a female patient of an unknown age. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX Quadrivalent (batch number 185325A) at a dose of 0.5 ml subcutaneously instead of intramuscularly on 19 Oct 2016. No adverse event was reported following this maladministration. This case was considered lost to follow up at initial.
fever, - up to 102,  chills, headache, muscle aches, joint aches, tiredness, injection site pain and swelling, swollen lymph nodes in underarms- more pronounced in arm where shot was received.
pt recv vax 24SEP96 & 10 to 12 days p/vax pt devel a mild, gen, not-itchy, varicella-type rash;it was also noted that pt was afeb;there was on indication that the rash was r/t vax;
SINUE CONGESTION, FATIGUE, COVID POSITIVE TEST RESULT Narrative: COVID infection after completion of COVID vaccine series 03/01: COVID vaccine dose#1 03/22: COVID vaccine dose #2 04/06: Pt tests positive for covid after reporting sinus congestion, muscle aches, fatigue, diarrhea, nausea, vomiting, coughing after exposure to covid at work 04/07: reports same symptoms plus headache 04/08: reports 4+ loose stools per day and requests diarrhea med; reports yellow sputum with cough, requests antibiotics 04/09: productive cough with yellow sputum, thinning out, runny nose, fatigue, generalized body aches especially in back, improving diarrhea, constant sinus pressure headache with migraine effects 04/12: diarrhea improving, headache 7 out of 10 pain, body aches improving, ongoing cough but improved, very fatigued 04/13: continued headache 9 out of 10 pain, all other symptoms resolved
My husband had a stroke one week after his 2nd dose. The blood clot affected his occipital lobe. Ten years ago he had a stroke in the same area below this area. On that Monday around 7 PM, he took our refuse out to the curb in front of our home. When he came in he did not recognize me or his surroundings.  I took him to the hospital by car as I was not sure what happened to him. After testing the doctors said he had a minor infarct. The stroke affected his memory. He was very confused and did not remember anything from the moment of the incident until moments before exiting the MRI machine, approximately 2 hours later. He still cannot recall anything surrounding the incident. We questioned if this was related to his recent vaccination and the doctors stated no, however, we believe it is something that should be reported since it occurred a week after the vaccination.
Information has been received from a registered nurse concerning a 47 year old male patient with no allergies and no pertinent medical history, who on 02-DEC-2005 was vaccinated SC with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot # 649229/0149R). There was no concomitant medication. On 10-DEC-2005 the patient developed a fever between 100-101 degrees Fahrenheit and a rash appeared on 13-DEC-2005, which was described as red bumps up to a 1/8 of inch that were papular and mildly itchy. He also felt fatigued. It was noted that the patient had sushi the weekend before the rash, but nothing else remarkable. The patient does not have insurance or a physician. No further information was available regarding the adverse events. The adverse event did not improve and the patient is not recovered. There was no product quality complaint reported. The patient sought unspecified medical attention. Additional information has been requested.
#Tingling in face - Ongoing intermittently since 6 Mar 2021 - Notes that symptoms started immediately after she received her COVID vaccine and have progressively become more noticeable since then - She did not notify the post-observer that she was experiencing symptoms - Tingling starts in right eye and goes down into right lower lip with occasional twitching - slight facial droop on right lower cheek/mouth - Denies facial pain or eyelid drooping - Denies shortness of breath, chest pain/tightness
eye infection; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (wife) reported that a male patient of an unspecified age received the first dose of bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller reported that her husband received the 1st dose of the Pfizer vaccine 2 weeks ago (Jan2021) and he had an eye infection unrelated to the vaccine. Caller was asking if he can take antibiotics and asking if that would be contraindicated with the vaccine that he got. Caller also mentioned that her husband was afraid to take antibiotics and wanted to know if it was okay to take antibiotics which was prescribed by his Doctor. Her husband was also an healthcare professional but he was an Orthopedic Surgeon and it's not his field. The reported wanted to know if that would reduce the immunity that he got from the vaccine. The patient developed the eye infection a week ago (Jan2021). He had not taken the antibiotic before. Second dose would be on 01Feb2021. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: The eye infection is most likely an intercurrent condition and unrelated to suspect vaccine BNT162B2.
4/1 pt complained of not feeling well after Janssen vaccine. Patient had a syncopal episode while at monitoring tent, patient was trying to lay down on medical bay cot but ended up falling back and passing out. Pt was clammy and pale. Heart rate 42, spO2 99%. Pt oriented to self but not time or place. EMT arrive to further evaluate patient, BP 90/60. heart-rate 55, respirations 18. Patient refused to go to hospital, felt well enough to go back to work. Charge nurse followed up with patient later that day, patient was still at work and said he felt a lot better.   One week later pt reached out on 4/8/2021 to inform on potential side effects. On the night of 4/7/2021 he began to develop hives/rash, and itchiness around the neck and legs. Next morning 4/8/2021 rash had worsened and pt had also developed swelling in the face and wrists. Pt was brought to urgent care where he was treated with prednisone. Pt was prescribed 20mg prednisone tablet twice a day. Charge nurse from day of vaccine followed up with patient, he will continue to take prednisone as prescribed and will follow up with allergist. Pt claims the itchiness is less, as well as, the swelling. Appreciates the follow-up phone-call and claims to feel better, will update us if any changes.
SKIN VERY SENSITIVE; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced skin very sensitive. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, tiredness and skin very sensitive was not reported. This report was non-serious.