chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This prospective pregnancy case was reported by a consumer and described the occurrence of injection site soreness in a 34-year-old female subject who was vaccinated with BOOTRIX (GlaxoSmithKline), FLUZONE during pregnancy. A physician or other health care professional has not verified this report. The subject's medical history included no previous pregnancies. The subject was not using contraception. The conception was by normal methods. There was no evidence of prenatal testing. There was no maternal history that may have an impact on the outcome of the current pregnancy. The subject's paternal history included mother with diabetes that may have an impact on the current pregnancy. On 11 March 2013 the subject received a dose of BOOSTRIX (unknown route, left arm), in January 2013 the subject received unspecified dose of FLUZONE (.5 ml, unknown details) and experienced unspecified dose of FLUZONE (.5 ml, unknown details) and experienced vaccine exposure during pregnancy. The gestational age at the time of vaccination was calculated to be approximately 25 weeks for exposure to BOOSTRIX and between 15 to 20 weeks for exposure to FLUZONE. The date of last menstrual period was reported to be in September 2012 per the reporter. The estimated date of delivery was reported as 19 June 2013. There was no evidence of defect from prenatal testing. On an unknown date the subject received an ultrasound examination and A (MS) AFP test (maternal serum-aminofetoprotein test). On 12 March 2013, 1 day after vaccination with BOOSTRIX, the subject experienced injection site soreness. The reporter stated that her arm was "slightly sore at injection site." The subject considered that this event was related to the BOOSTRIX vaccination. At the time of reporting the events were improved. The reporter also reported another case involving BOOSTRIX. See case A1016238A for details on the other case. Follow up from the subject received on 5 April 2013. The subject documented that her estimated due date was 19 July 2012, not June as previously reported. She documented that the date of her last menstrual period was middle to late September 2012. Follow-up information was received on 16 May 2013 via physician who reported the subject's pregnancy consisted of one fetus, was not by in-vitro fertilization but was not a normal conception. At the time of the report there were no pregnancy complications.
Diagnosed by physician as cellulitis at injection site.  Swelling (approx 5 inches in diameter), hot, itching, painful area. Treated by Dr. and prescribed Bactrim DS for 10 days.
Swollen lymoh node; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymoh node) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymoh node). At the time of the report, LYMPHADENOPATHY (Swollen lymoh node) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment medication was reported.
12/10/93 pt reported to Er-2 wk hx of mental status change. Pt received flu vaccine in Nov of 2003. Neuro exam-grossly nonfocal, profound confusion and memory loss. Other etiologies ruled out. pt independent to ADL's prior to this time. No aditional info available. Pt came into ER with reaction.
Second dose, I was tired first day.; felt aches all over; headache/lingering headache; nausea/3rd-5th still have nausea; no taste; congested; This is a spontaneous report from a non-contactable consumer (patient, self-reported).   A 41-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: Er8731 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 12Apr2021 at 10:00 AM, as DOSE 2, SINGLE for COVID-19 immunization at hospital (at the age of 41-year-old). The patient was not pregnant at the time of vaccination. The patient medical history included known allergies: Amoxicillin. Concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 22Mar2021 at 03:30 PM, as dose 1, single for COVID-19 immunization and experienced just tired the next day (First dose, I was just tired the next day). On 12Apr2021 at 04:00 PM, the patient was tired first day. second day, felt aches all over, headache, nausea, no taste, congested. Third to fifth still have nausea and lingering headache and going strong. The AE did not result in emergency room or physician office. The patient did not receive any treatment for the events. Outcome of the events were not recovered.  No follow-up attempts are needed. No further information is expected.
Patient stated she got dizzy, lightheaded and had seizure lasting 60 seconds (1st seizure occurred 12/11/17) and had 2 seizures following that occurred on 12/13/17.
had "abnormally high reading of A1c" a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2,single and (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: GLYCOSYLATED HAEMOGLOBIN ABNORMAL (non-serious), outcome "unknown", described as "had "abnormally high reading of A1c" a week".  Additional information: Reporter was asked if the vaccine could cause this abnormal HbA1c reading. patient then explained reporter "had done nothing different in the last 3 months". Patient later mentioned he  had "no repercussions/ no side effects" from both doses of the vaccine.  Unsuccessful warm-transfer attempt from (Privacy), no agent available.  reporter sated he'd prefer to be contacted back by phone if additional information is needed. E-transmitting AE.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It started like a head cold. I was coughing and then blowing my nose. I took Paxlovid. I was told I was getting pneumonia so I went back to the doctor. My lower lobes of my lungs had fluid and upper was fine. Gradually I felt better.
Right arm had a knot and was warm to touch where the BEXSERO Vaccine was given. Also, pt having trouble raising her arm and moving it around.
pt recv vax & 5OCT98 pt exp numbness down hand;this condition has improved but not resolved;
This is a spontaneous report received from a contactable consumer or other non-HCP (program ID: 005570). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Thepatient experienced ineffective drug (medically significant) and suspected COVID-19/rebound COVID-19 case (medically significant), with outcome of unknown. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
no adverse event; Varivax received four days earlier; This spontaneous report was received from a pharmacist and refers to a 34-year-old of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-JAN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (dose, frequency, lot #, expiry date, and route of administration were not provided). On 27-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (dose, frequency, lot #, expiry date, and route of administration were not provided).   The patient was supposed to wait with the administration of virus vaccine live (oka/merck) (VARIVAX) until 31-JAN-2021. The patient did not wait and received it on 27-JAN-2022, which was 4 days earlier than it was supposed to be (inappropriate schedule of vaccine administered). The patient did not experience any other adverse reaction.    This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA008274:
pt recv vax 5JAN96 & pt exp 12 erythematous papules & vesicles;pt recovered from exp;
01/03/23 presents to ED for "breathing problem, fatigue". PMHx of "A. fib, MI with stents, pacemaker placement, CHF, and adrenal insufficiency"
After about 3 days I got really sick and about 7day after getting the shot my boyfriend and best friend had time rush me to the hospital because we thote I was having a stroke
Child was given a Kinrix as the first dose in a catch up series, but the dose was expired by 2 days. Vaccine expired on 10/16/2021 and vaccine was given on 10/18/2021. No medical incidents occurred with the child.
Pain in arm and muscular pain in body, fever, diarrhea,  dizziness,, nausea , fatigue, chills and headache
SEVERE BODY ACHES; SEVERE SYMPTOMS; 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On an unspecified date, the subject experienced severe body aches, and severe symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe body aches and severe symptoms was not reported. This report was non-serious.
The patient received his second dose of GARDASIL 9 and when he sat down next to his mom, he had convulsion.; This spontaneous report was received from a office manager via company representative regarding a 17-year-old male patient. The patient's medical history, drug reactions/allergies, concurrent conditions, and concomitant therapies were not reported.  On 26-SEP-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis. Lot number U0368662 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and was reported with an expiration date: 10-AUG-2024. On the same day (reported as "when he sat down next to his mom"), the patient had a convulsion. When the nurses came to see him, he was already recovered. It was unknown whether the patient received treatment for the adverse event. He sought medical attention, he saw the physician.  The causal relationship between convulsion and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.   Upon internal review, the event of convulsion was determined to be medically significant.
Patient requested booster dose of Moderna vaccine but was given Pfizer instead. No adverse events were reported when I spoke with patient that same night.
left arm was sore for 2 days after initial shot.  On 03/14 a baseball size red spot showed up on my left upper arm.  It is still there today.  On 03/23 in the late afternoon I started itching all over with only relief from Benadryl.  No red marks show up anywhere else but I am still itching especially from the waist up.
The day after the 2nd shot "I" had severe vertigo, nausea, & vomiting/April 26th, 2 weeks & 1 day after 2nd shot, again had severe vertigo, nausea, &vomiting.; The day after the 2nd shot "I" had severe vertigo, nausea, & vomiting./April 26th, 2 weeks & 1 day after 2nd shot, again had severe vertigo, nausea, &vomiting.; Day of 2nd shot, after a couple of hours "I" had moderate vertigo/The day after the 2nd shot "I" had severe vertigo/April 26th, 2 weeks & 1 day after 2nd shot, again had severe vertigo.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Apr2021 at 11:30(at the age of 48-years-old) as a single dose for COVID-19 immunisation. The medical history included obesity and allergy to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included fluticasone (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN) and levocetirizine dihydrochloride (XYZAL), all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Mar2021 at 11:30(at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 11Apr2021 at 14:00, day of 2nd shot, after a couple of hours the patient had moderate vertigo and it lasted around 1 hour. On 12Apr2021, the day after the 2nd shot the patient had severe vertigo, nausea and vomiting which lasted for 2-3 hours. On 26Apr2021, 2 weeks and1 day after 2nd shot the patient again had severe vertigo, nausea and vomiting which lasted for 2-3 hours. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other health care professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vertigo, nausea and vomiting were recovered on 26Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
About 4:20pm patient received vaccines. Ambulated with mother to lobby. While mother was paying per clerk, child fainted/fell to the floor. Patient was brought into the room 911 was initiated. Child was assessed by medical personnel. Mother declined child to be transported to hospital for further evaluation.
extremely painful and swollen lymph nodes in armpit.... opposite arm of where the shot was administered.   I would say the swelling is almost size of golf ball in my right armpit.   This was Moderna first vaccine...
Pt responds to name faintly 5 mins post vaccine; per family "she did not eat lunch"; juice given; crackers given; pt AAO x3 after drinking juice ; vitals stable; bp @4:4595/65; BP @ 4:55 pm 110/75; Vitals stable ; pt able to verbalize needs and wants.
had her first Shingrix dose in 2019 and second dose last week (May 2021); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   In May 2021, the patient received the 2nd dose of Shingrix. In May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional information was provided as follows:  The age at vaccination was not reported. Last week before date of reporting, the patient received 2nd dose of Shingrix, which led to lenghtening of vaccination schedule. The reporter did not consent to follow up.
pt recv vax 7JUN96 in lt upper arm became red & larger;pt given ice packs, DPH, Keflex;
Patient had COVID-19 Moderna Monovalent on 07/13/2022 and 08/16/2022 and I administered a COVID-19 Pfizer Bivalent vaccination on 02/15/2023.  Mom wanted her daughter to get her COVID-19 booster and Influenza vaccine.  I explained to Mom that we are unable to administer the COVID Moderna Vaccine on the floor and they will need to schedule an appointment for it on a Tuesday.  Mom said that would like her to get the Pfizer so she could get it at the appointment.  The patient has not had any problems with receiving the Pfizer Bivalent.
body aches, chills, swollen right under armpit lymph node (3+ days)
Sore throat, feeling of throat closing, difficulty swallowing, hoarsness, dry cough, eyes watering and swelling shut, redness. Slight headache.  Lasted through night.  Eyes had heavy mucus on lid.  Exhausted following day.
sore and aching around injection areaon left arm; Itching around injectionarea; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via unspecified route of administration in the left arm on 18May2021 at 08:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient had a history of allergy to shellfish, Aspirin and Ibuprofen. The patient did not take any concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19.Since the vaccination, the patient had not been tested for COVID-19. On 18May2021 at 20:30, the patient experienced sore and aching around the injection area on left arm and itching around injection area. The patient reported that itching around the injection area initially lasted for an hour and then subsided and then again started. No therapeutic measures were taken. The clinical outcome of sore and aching around injection area on left arm and itching around injection area was not resolved.   No follow up attempts are possible. No further information is expected.
I began having occasional hives pop up and go away. On February 13, 2019, my lips became severely swollen. I had the 2nd SHINGRIX shot on February 20, 2020. and within 24 hours began severe hives on various parts of my body. They begin to ease up after a couple of days, but I still am having hives, swollen areas, and invisible itching. My top lip became swollen on February 28, 2019, and went away after about 24 hours. Then, again my top lip became swollen on March 5, 2019. I've been to an allergist and have a follow up scheduled on March 12, 2019.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: pt reported mild swelling and itching feeling of left hand only.  evaluated by pharmd immunizer; no significant swelling noted by this writer when comparing L vs R hand.  provided diphenhydramine 25mg po x 1 for itching per pt request (pt was not driving home).  w/in 10 min of taking dose, pt stated he felt much better.
Lymphatic Edema in both legs; Full body edema, including face, eyes, arms, hands, abdomen, legs, and feet.; Weight gain in excess of 50lbs; Shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 28Aug2021 15:15 (Lot number: FC3180) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure; "Sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; AMLODIPINE; POTASSIUM CITRATE. The following information was reported: LYMPHOEDEMA (disability) with onset 01Sep2021, outcome "not recovered", described as "Lymphatic Edema in both legs"; OEDEMA (disability) with onset 01Sep2021, outcome "not recovered", described as "Full body edema, including face, eyes, arms, hands, abdomen, legs, and feet."; WEIGHT INCREASED (disability) with onset 01Sep2021, outcome "not recovered", described as "Weight gain in excess of 50lbs"; DYSPNOEA (disability) with onset 01Sep2021, outcome "not recovered", described as "Shortness of breath". The events "lymphatic edema in both legs", "full body edema, including face, eyes, arms, hands, abdomen, legs, and feet.", "weight gain in excess of 50lbs" and "shortness of breath" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) negative, notes: Nasal swab; weight: (2021) increased, notes: Weight gain in excess of 50lbs within 4 months; blood pressure measurement: (unspecified date) high. Therapeutic measures taken as a result of lymphoedema, oedema, weight increased, dyspnoea included Acupuncture and Lymphatic drainage Massage. Clinical course: the patient received second dose of COMIRNATY (lot number: 320308D) on 31Oct2021 02:45 PM administered in Left arm. No other vaccine in four weeks. No covid prior vaccination. No known allergies.
COVID arm. Left arm injection site itchy, swollen,  on 4/10/21
Around 3:30am (13 hours after vaccination), I started a fever, intense chills, body aches, and headache. These symptoms lasted for about 4 hours, and then slowly went away.
pt recv vax 30JUL98 as part of preplacement eval;3AUG98 devel redness, itching, swelling @ inj site;requested eval on 13AUG98 & was seen on that date;found to have localized erythema (2cm) & soft tissue swelling & tenderness & inj site;
3/7/03 Left arm red/swollen. Returned to ASAP if Sx's gets worse. Suggested 1 cc packs use periodically for short periods of time.
gasping for air, holding his throat, shortness of breath...epipen was administered, and 911 called
At vaccine administration, lots of bleeding and very sore. Starting 2 hours after administration, lots of itching and redness. Bruising. 9 hours later, arm numbness and tingling lips. 1 day post immunization, lots of lips and arm itching and tingling.
On 10/1/21 at 0230, I woke up with sharp, stabbing pains in my left axilla. The pain was intensified while laying flat. Upon palpitation, lymph node were inflamed in left axilla and left clavicle region. They were extremely sore to touch and the pain intensified anytime my left arm of relaxing to my side. I took 1300mg of Tylenol. Symptoms are still present as of this report at 0832.
Patient presented requesting Hep B Vaccination. When looking up Energix I read information on energix recombivax and thought it was discussing Energix. Patient was given adult dose instead of pediatric dose around 2:45 pm. Patients family has been notified and has not reported any adverse events since the vaccine administration.
8/18/2021 complaints of chest pain, SOB, (0600) and headache (1700) with dizziness off and on through the day. Seen in ER 8/18/2021 (2300)diagnosed with acute pericarditis
3/8/17 - Pt walked in to clinic with LT arm swelling pain, redness of LT upper arm. Redness and swelling circumferential. Pt was evaluated by PCP treated with prednisone 40 mg daily x 5 days. Pt to follow up in 2 days. Aware prednisone may lower vaccine effectiveness. PCV-13 allergy added to pt's chart.
Pt is stating arm hurt soon after the injection and continued to feel pain in the arm through the weekend. It got so severe that he cannot move his arm and neck is very stiff.
woke up with mild fever, and severe headache, lasted through the day, was gone upon waking next morning.