chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This prospective pregnancy case was reported by a consumer and described the occurrence of near death experience in a female subject of unspecified age who was vaccinated with DTPa (with small D + P), manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date, the subject received an unspecified dose of DTPa (with small D + P) (administration site and route unknown, batch number not provided). The last menstrual period and estimated date of delivery were not provided. The subject was exposed to the vaccine at 7 months of pregnancy, during the 3rd trimester. At an unspecified time after vaccination with DTPa (with small D + P), the subject nearly died. This case was assessed as medically serious by GSK. At the time of reporting, the event was resolved.
The patient states he had some side effects from the Janssen vaccination.  He had some shortness of breath (trouble breathing) starting the evening of 5/28/21 (day of vaccination).  He also had some fever.  Both were "tolerable".  He did not need to seek any care from MD.  He says adverse effects lasted for 2 days then resolved.
About 5 minutes after vaccine was given c/o neck feelingstiff and headache. He of migraines, asthma,, and sinuses. States burning feeling is easing yard headache spending to top of head.   Client instruct to go home and have husband drive. Plans to take her migrain meds. Says her migraines can start this way too. Left AR 12:13
Rash presented on left arm (but not directly at the injection site). It was raised, warm, painful, and sometimes itchy. It was about 4 inches in diameter. The rash presented for about 2 weeks before disappearing.
1/27 10:30 PM - arm soreness, headache, elevated temp at 99.8 (took tylenol) 1/28 1:30 AM - moderate muscle stiffness, chills, joint pain  headache, nausea , temp 100.4 (took motrin) 1/28 8:30 AM -  nausea, arm pain, difficulty movong ar/limited ROM, fever 101.5, migraine, joint pain, chills, muscle aches (took tylenol) 11:30 AM - fever 100.2, arm less pain/improved ROM some, migraine, hungry/nausea,  chills, muscle/joint aches (took motrin) 12:30 PM - migraine, nausea, vomiting, arm pain, chills 2:00 Pm woke up, headache, farigue, muscle waekness, (took tylenol) 3:30 PM - temp 99.8, headache, fatigue, joint aches/muscle aches, chills  5:00 PM - mild headache, fatigue, arm pain, temp 97.8  7:30 PM - Headache worsening, fatigue, aches, chills, temp 100.0, (took tylenol) 9:00 PM  same as above, did not recheck temp, (took motrin) 10:00 PM fever broke, sweating 1/29 - 1/31 headaches and neck stiffness, fatigue
The day after experienced severe chills, fever, body aches and a loss of appetite. These all lasted about 24 hours.
Rash surrounding injection site - 5-7  inch area  - for approximately 1 week - no rash now.
palms of hands started to swell and itch.  diaphoretic, then neck started to itch.  extended to throat leading to difficulty swallowing
Pt received J and J vaccine on 3/31/21.  She had some initial reactions including headache and body aches that resolved  24 hrs post injection.  She is now reporting  new leg  pain, it began behind her  Lcalf, now is behind her L knee.  Her L arm also aches.  The pain in her L leg has been getting progressively worse.  She has not tried OTC meds.  Encouraged pt to go the ED for evaluation based on these symptoms. She understands, and agrees.
has experienced painful lymph nodes in the left arm which was the injection arm; First dose received 05Jan2021, /Second dose received 22Jan2021; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (left arm) second dose on 22Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021 for Covid-19 immunization and experienced vomiting. On 23Jan2021, the patient experienced painful lymph nodes in the left arm which was the injection arm. The patient First dose received 05Jan2021 and Second dose received 22Jan2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
1 week after the first Moderna dose, experienced loss of taste that lasted about 48 hours. Covid testing on day two of the symptom was negative. Experienced significant arm pain and swelling for nearly 3 weeks after the first and second doses
Information has been received from a nurse concerning a patient who in April 2009, was vaccinated with a second dose of VARIVAX (Merck). The nurse reported that the patient reported a case of chickenpox this week. The patient did not seek medical attention. At the time of this report the patient had not recovered. No further information is available.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 01-JUL-2014 the patient was administered with a dose of MMR II (lot# H012133, expiration date 29-JUN-2014, dose, route, indication not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter (other MARRS# 1407USA004631). Additional information has been requested.
arm "swole -up" for 3 weeks; really bad and painful; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at a single dose in arm for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm "swole -up" on 21Oct2019 for 3 weeks, really bad and painful on 21Oct2019. The outcome of events was unknown.   Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a five year old female patient who on an unspecified date was vaccinated with varicella virus vaccine live.  The patient broke out in a few lesions and the physician sent a lesion for testing to confirm that it was chickenpox / breakthrough.  It was noted that the lesion test results were positive for chickenpox.  It was noted that the patient recovered on an unknown date.  There was no product quality complaint reported.  No further information is available.  Unspecified medical attention was sought.  Additional information has been requested.
Pt has had a fever with rash on face/arms/chest- Mom notes small raised red lesions, no blisters.  -Recommended TYLENOL for fever, BENADRYL for itch limited contact with other children.
I started getting symptoms of sore throat, and dry cough. The next day, I had a deep cough, low grade fever of 101, and chills. I went to an urgent care and had a negative COVID-19 test. I tested again on a home test 4/24/2022 and that was positive. I started a prescription Paxlovid. It is now day 11 and I am still testing positive. My symptoms are better except for cough and chills.
pt recvd vax 17oct94;devel flu synd, joint & muscles aches & pain; t of 101-102;on 28oct94 rash at inject site,size of 1/2 a $;spread to stomach & arms;29oct94 felt better; 30oct94 neck broke in rash;apap & DPH given for fever & itch;
fever to 103 occuring 12 hrs post vax; had sz w/fever;
Pfizer-BioNTech COVID-19 Vaccine EUA: nine days after vaccination patient presents to clinic with pruritic erythematous plaques on right proximal lateral arm near injection site. Symptoms started eight days after vaccination. No signs or symptoms of cellulitis. Vital signs all within normal ranges. Prescribed topical steroid ointment and able to manage at home.
running 100.1 fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th May 2022, the patient received Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date:13-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient received Shingrix on the day before the date of reporting. The patient experienced the fever and it was running 100.1 degree Fahrenheit. The patient asked if it could run the fever.
Shingles outbreak. Went to her PCP on the 18 and was Prescribed an antiviral.
5 minutes after vaccine stomach and sides felt heat, upset stomach, lightheaded and blood pressure elevated way up. felt very sick, went thru 3 extended observations that lasted about 1 hour and things started to calmed down except light headed and anxious. Finally felt like I could drive home then while driving home my temple and side face started tingling and went numb, pain in the back of my right eye this lasted about 20 minutes and the numbness went away however I had a sensation for a week in my temple and forehead. Could not go to work the next day, felt bad on and off for 8 days.  Triggered anxiety for several days, did not get second dose..
On Friday, April 23/ 2021 @4PM I began to feel pressure built up on my chest. @ 4:15 the pressure also built up on my neck. I was short of breath and I can feel the heartbeat way too high. I recall the person that gave me the first Pfizer shot to get ready for side effects after the second shot. @ 4:30pm the pressure was all over the back, the chest and the neck. Making things worse the jaw and lower teeth were also in extreme pain.  I laid down on the sofa and must have passed out. 20 minutes later I began to come around but I was way weak and the heart beat was beginning to relax. The body pressure was present till 6pm I did not know what to do at that time other than take a nap. I was not able to eat any food until Saturday 6PM.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient "in her sixties". On an unknown date,  the patient was vaccinated with one dose of ZOSTAVAX (lot#, expiry date, dose and route of administration unknown) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT)(lot#, expiry date, dose and route of administration unknown). On an unknown date, sometime after the patient was vaccinated, she experienced shingles rash. She went to an urgent care facility on an unspecified date for treatment. The pharmacist was unaware if any treatment was provided to the patient at urgent care facility, and the patient had not presented back at pharmacy in which she received ZOSTAVAX since the date of administration. The outcome of shingles rash was unknown. Causality was not provided.      Additional information has been requested.
1st dose on 2018 received 2nd on 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number k735h, expiry date 13th September 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 20th April 2018).   On 8th February 2022, the patient received the 2nd dose of Shingrix. On 8th February 2022, 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: GSK Receipt Date: 28-Apr-2022 Reporter's Comments: The patient was administered delayed 2nd dose of Shingrix. The reporter did not consent to follow-up. Additional Supportive Information: The patient was administered delayed 2nd dose of Shingrix, which led to lengthening of vaccination schedule.
CHIEF COMPLAINT:   pt to ed via ems for shortness of breath pt tested postive for covid on wednesday   HISTORY OF PRESENT ILLNESS:     Patient is a 71-year-old female.  She was positive for Covid on November 23.  She had worsening shortness of breath tonight and therefore she contacted EMS EMS gave her DuoNeb put her on CPAP.  The patient does have COPD and is a smoker.  She was also given dexamethasone by EMS did have improvement.  Here her O2 sat is 96% EMS tells me that it was 80% in the field.  No vomiting no fever no rash.  Was vaccinated as per the note from the primary care provider several months ago with 1 Johnson & Johnson vaccine.  Location as above quality as above severity moderate duration as noted context this occurred at home associated symptoms none modifying factors none.
Splitting headache; Joint pain; Injection site pain; Injection site swelling; Full body aches; Chills; Pain in eyes; Pain in breast tissue; Cramps; Middle back pain; Crying every half hour; Intense nausea; Loss of apatite; Shallow breathing; heavy head; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 22Sep2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included heart failure, COVID-19 and known allergies to sulfa drugs. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included acetylsalicylic acid (ASPIRIN), escitalopram (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN); all  for an unknown indication from an unknown date and unknown if ongoing. On 23Sep2021, the patient experienced splitting headache, joint pain, injection site pain and swelling, full body aches, heavy head, chills, pain in eyes, pain in breast tissue, cramps, middle back pain, crying every half hour, intense nausea, loss of appetite and shallow breathing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events splitting headache, joint pain, injection site pain and swelling, full body aches, heavy head, chills, pain in eyes, pain in breast tissue, cramps, middle back pain, crying every half hour, intense nausea, loss of appetite and shallow breathing was not resolved at the time of this report.
01/06/22 presents to Surgery for "elective total pancreatectomy". PMHx of "former tobacco use, DM, RA, fibromyalgia, CVA 2008 w Left LE weakness, neuropathy, liver ds, hep C, and pancreatic CA (lst chemo 12-3-21)"
soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004c21a and 027b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in her arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in her arm) outcome was unknown.            No concomitant medication was reported by the reporter.   This case was linked to MOD-2021-416998, MOD-2021-417005 (Patient Link).
pt c/o arm being sore;mom noted red raised area on upper rt arm about the size of a quarter;10AUG98 c/o more tenderness & redden area now size of silver dollar;child T101;advised to see PMD;MD unsure of cause of fever;itchy rash;
Chlamydia; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 04-Nov-2019, concerning a 31-year-old, pregnant, female subject of body weight: 136 lbs, height: 63 inches and body mass index (BMI): 24.1 enrolled in a prospective observational safety study.  The subject's obstetrical history was collected and it was noted that the subject did not have any previous pregnancies, nor maternal and paternal history with major congenital malformation (MCM). The subject did not consume tobacco, alcohol and illicit-drugs during pregnancy.  The subject's medical history was not provided. The subject's concomitant medications included Prenatal vitamin (unspecified vitamins) for unknown indication.   The subject's last menstrual period (LMP) date was 23-May-2019, and estimated delivery date (EDD) was reported as 27-Feb-2020. The corrected estimated date of delivery was not reported. The type of pregnancy was singleton.  On 15-Aug-2019, the subject performed Sequential 1 and Nuchal translucency prenatal tests and no MCM was noted.  On 12-Sep-2019, the subject performed Sequential 2 and no MCM was noted.  On 10-Oct-2019, the subject underwent targeted ultrasound and bilateral choroid plexus cysts were noted.  On the same date, at gestational age of 20 weeks, the subject was administered Flu Vaccine Egg Split QIV CSL (Afluria QIV) [Influenza Vaccine, batch number: P100112488, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation.  On 05-Nov-2019, pregnancy status was collected, and it was noted that the subject was positive to chlamydia. No further details were reported.   At the time of initial reporting, the outcome of the event was not reported.   This case was assessed as serious (medically significant).   The reporter did not provide causality assessment.  This case is linked to 201905904, the corresponding child case.  Company comment: The subject experienced chlamydial infection after vaccination with the suspect product Afluria QIV. Reportedly, vaccination occurred during pregnancy at gestational age of 20 weeks. Chronology is plausible. Pregnant state may have contributed to development of the event. Vaccine exposure during pregnancy is assessed as not related per company's conventions. For the event chlamydial infection, causality between suspect product and the event cannot be totally excluded and is assessed as unlikely related.; Sender's Comments: The subject experienced chlamydial infection after vaccination with the suspect product Afluria QIV. Reportedly, vaccination occurred during pregnancy at gestational age of 20 weeks. Chronology is plausible. Pregnant state may have contributed to development of the event. Vaccine exposure during pregnancy is assessed as not related per company's conventions. For the event chlamydial infection, causality between suspect product and the event cannot be totally excluded and is assessed as unlikely related.
The Chief Complaint is: 27 y/o F at the COVID vaccine line to get her first COVID-19 vaccine.  Within 5 minutes of vaccination she complained of "head expanding", worsening headache, blood rushing to her head and feeling off balance like the room was moving.  Did not feel like she was going to pass out.  Vital obtained initially showed slight hypertension with BP 139/85, HR 75, RR 20 and SPO2 98% on room air.  She denied any dyspnea/itching/pain (other than HA), GI symptoms.  She noted she had a miscarriage on Monday but had been feeling well and staying hydrated over the last 2 days.  She was observed, moved to a gurney, given water, and vitals monitored.  Within 20 minutes after getting her injection she noted her head was feeling worse, hurting more and that she was starting to get nauseated.  No abdominal pain.  Vitals improved to BP 126/89, HR 78 and 97% on room air.  EMS was called for evaluation due to worsening symptoms, recent miscarriage, ddx includes migraine/thrombosis/vagal reaction/anxiety/do not suspect allergic reaction.  EMS evaluated the patient and took her for further evaluation.  Will file VAERS report.  Once medical issues addressed, can discuss with PCM whether she can get the 2nd dose.  At this time no evidence of allergic reaction.  No hives/angioedema/wheezing/abnormal vital signs.
pt was not moving one leg & one arm; for about a month; became hospitalized w/severe resp infect resulting in the need for a trachestomy tube & gastrestomy tube;
Starting the next morning, I woke up with a severe migraine (worse than normal ones) and the lymph nodes on the left side of my neck were very swollen. It felt like I had 3 bumps under my skin on the left side of my neck and I could barely turn my head. So, I called the nurse and she called the health office. They told me to go in to urgent care because they were worried about blood clots given it was the neck area. I went to urgent care and they told me it was just swollen lymph nodes and they sent me home. It took 3-4 days for that to resolve.
Redness swelling warmth left arm below the site of the injection from mid upper arm to mid forearm, fever to 100°, arthralgias, fatigue.
Approximately 3 to 4 minutes after receiving Janssen Covid-19 vaccine pt became dizzy, diaphoretic and nauseas.  Pt vomited a few minutes later.  Applied ice packs and gave pt cold water to drink.  All symptoms resolved within 15 minutes of onset.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 24-FEB-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J006953, expiration date: 07-JUN-2015. that may had been improperly stored since February2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be   confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported.  This is one of several reports received from the same reporter. Additional information has been requested.
50yo male received pneumococcal vaccine in left deltoid on 7/7/09. Later that evening he called the medical center complaining of pain, warmth, and redness in the same arm. He presented to urgent care the following day, with fever of 100, and swollen, erythematous R elbow and soft tissue proximal to elbow. Was treated for cellulitis with clindamycin. Returned the following day unable to move the joint and evaluated and admitted by surgery to observe for necrotizing fasciitis (determined not to be necrotizing cellulitis). Was treated with IV vancomycin and clindamycin for two days with significant improvement and was discharged 2 days later on po BACTRIM and clindamycin. The affected vial was already completely administered by the time he presented, no other reports from other patients. The erythema and swelling started closer to the elbow than the deltoid where the injection was given.
Pt immediate response was that he said (I feel Tachycardic). Pt900 is an MD.  Brought over to EMS  1316 BP 197/90  Pulse 97 slightly diaphoretic, stated that he felt hot and nervous 1321 BP 157/108, pulse 71, sat 9Pt states feeling better