chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This serious clinical study case, initially received from other non-health professional on 26-Sep-2017, concerning a 33-year-old adult female pregnant subject of body weight 245 lbs, height 73 inches and (BMI) body mass index 32.3, enrolled in a study. The subject had no maternal and paternal history of major congenital malformations. The subject received birth control medications prior to pregnancy. The subject's concomitant medication included prenatal vitamins for healthy pregnancy. The subject's last menstrual period (LMP) date was 10-May-2017. The type of pregnancy was singleton. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. On 21-Jul-2017: NxGen genetic prenatal test was done and no major congenital malformation was noted. On 25-Sep-2017, at gestation age of 19 weeks (second trimester), the subject was administered with FLUCELVAX vaccine (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported). On 26-Sep-2017, the subject experienced little dizziness. It was reported that, the event dizzy did not get better since it started, and it was continuous. There were no treatment measures associated with event. On an unspecified date, the subject was diagnosed with gestational diabetes mellitus. The subject started the treatment with Metformin (750 mg, BID, orally) (from 06-Dec-2017 to 28-Mar-2018) and LEVEMIR (100 units, QHS, subcutaneously) (from 20-Dec-2017 to 28-Mar-2018). At gestational age of 38.1 weeks, the subject delivered a live birth to a female infant by cesarean delivery method. The infant's body weight was 3770 gm at birth and Apgar score at 1 minute was 8, at 5 minutes was 9 and at 10 minutes it was 10. There was no congenital malformation (MCM) identified at birth. At the time of this report, the outcome of the event (gestational diabetes mellitus) was not reported. The estimated date of delivery was reported as 14-Feb-2018. Follow up report from investigator received on 06-Oct-2017: The outcome of the event dizziness from not recovered to recovered (within 24 hours of its starting) was updated. The narrative was amended accordingly. Follow up report from other health professional received on 10-May-2018: The subject's body weight (245 lbs), height (730 inches), BMI (32.3), prenatal test (NxGen genetic test on 21-Jul-2017), new serious event (gestational diabetes mellitus), treatment medications (Metformin and LEVEMIR) for gestational diabetes mellitus were updated. It was reported that, at gestational age of 38.1 weeks, the subject delivered a live birth to a female infant by cesarean delivery method. The infant's body weight was 3770 gm at birth and Apgar score at 1 minute was 8, at 5 minutes was 9 and at 10 minutes it was 10. There was no congenital malformation (MCM) identified at birth. The narrative was amended accordingly.
body aches; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The day after receiving the first dose of BNT162B2 on an unspecified date, the patient experienced body aches for a few hours. The patient recovered from the event on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left sided facial neuropathy, cheek, nose, ear and tingling lips; Left sided facial neuropathy, cheek, nose, ear and tingling lips; This is a spontaneous report from a contactable Other HCP.  A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL3246, intramuscularly on 05Jan2021 16:00 at single dose  for covid-19 immunisation. Medical history included arthritis (degenerative arthritis). There were no concomitant medications. Anatomical Location: Arm Left  Facility location: Hospital. The patient did not eceived any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced left sided facial neuropathy, cheek, nose, ear and tingling lips on 05Jan2021 16:45 with outcome of not recovered. The action taken was not applicable. No treatment received; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported events due to temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
At about 4:30am on 12/24/20 she woke up with an itchy throat and hives all over body. Took 50mg Benadryl and symptoms cleared up in 3 hours. Developed hives again that evening. Took Benadryl 25mg and resolved. This has continued to occur approximately once daily with relief of Benadryl 25mg. Was advised by Dr. that this could be from an allergy to the filler.
pt fainted mins p/vax;feet were elevated, pulse BP taken 90/60;pt recovered well & rapidly;observed for 15min;BP taken @ 110/60 pulse 68 child stated felt fine & dismissed @ father care;
Swelling in her arm; Pain in her legs; Difficulty standing up from a chair; Becoming short of breath; No Energy/weakness; Difficulty with walking; Pain in her joints; Extreme tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in her arm), PAIN IN EXTREMITY (Pain in her legs), DYSSTASIA (Difficulty standing up from a chair), DYSPNOEA (Becoming short of breath) and ASTHENIA (No Energy/weakness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATENOLOL, CHLORTALIDONE (ATENOLOL/CHLORTHALIDONE), ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], LEVOTHYROXINE, MEMANTINE, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), POTASSIUM, MAGNESIUM and VITAMIN D3 for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling in her arm), PAIN IN EXTREMITY (Pain in her legs), DYSSTASIA (Difficulty standing up from a chair), DYSPNOEA (Becoming short of breath), ASTHENIA (No Energy/weakness), GAIT DISTURBANCE (Difficulty with walking), ARTHRALGIA (Pain in her joints) and FATIGUE (Extreme tiredness). At the time of the report, PERIPHERAL SWELLING (Swelling in her arm), PAIN IN EXTREMITY (Pain in her legs), DYSSTASIA (Difficulty standing up from a chair), DYSPNOEA (Becoming short of breath), GAIT DISTURBANCE (Difficulty with walking), ARTHRALGIA (Pain in her joints) and FATIGUE (Extreme tiredness) outcome was unknown and ASTHENIA (No Energy/weakness) had not resolved.            Patient had no adverse event after first dose. Treatment details include oxygen taken for shortness of breath. Action taken with mRNA-1273 in response to the events was  not applicable Patient still have not recovered with the muscles and weakness. She consents to follow up.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Additional information received and Outcome of the event "asthenia" was updated from unknown to not recovered
This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 55-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. The patient's past medical history included breast cancer. On 7th May 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 7th May 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. In May 2018, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were recovered/resolved and the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the swelling arm and pain in arm to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to the physician. The patient received a SHINGRIX vaccine underneath her left arm, in the subcutaneous tissue instead of the recommended deltoid region, which led to inappropriate route of vaccine administration and vaccine administration at inappropriate site. The patient stated that, next day after receiving a dose of SHINGRIX, she experienced swelling and soreness in the left arm. The patient reported that the swelling seemed to get worse each day and lasted for approximately 1 week. For tolerance to next dose, refer case US2018GSK153681.
Raised, red circle around injections site. about 3 inches in diameter. itchiness
Immediate reaction: redness, rash, hives, swelling, itchy-ness, pain in neck/jaw/head.
Information has been received from a registered nurse concerning a 26 year old female with a history of seasonal allergies and no known drug allergies who on 20-DEC-2007 was vaccinated with the first dose of GARDASIL (Lot # 659435/1265U).  Concomitant therapy included montelukast sodium (MSD) and ethinyl estradiol/norethindrone (NECON).  One to two days after receiving GARDASIL vaccine (approximately 21-DEC-2007), the patient developed a rash on her face and arms.  The patient reported the rash at the next office visit.  Subsequently, the patiente recovered.  Additional information has been requested.  follow up 2/15/2010 - 21 dec 2007 the patient developed a urticarial rash with large hives or wheels. the patients reported the rash at the next office visit. the duration of the urticarial rash was 24 - 48 hours. subsequently, the patient recovered on 25-dec-2007. the second injection has not been administered.
About an hour after booster vaccination I felt a sensation of something spreading underneath the skin from the injection site up to the shoulder, up the neck and under the arm a bit and then Ringing in the ear started 1 hour after booster vaccination and have had it for the 13 days since. Still have it. Also some congestion and pain in the ear. Some vertigo the first 3 days as well.
left eye swollen severely, right eye swollen as well but less severe than right eye. patient noticed it upon awakening in morning.
NUMBNESS IN THE FACE WITH A 30 MINUTE ONSET. 50MG LIQUID BENADRYL GIVEN. NO FURTHER TREATMENT NECESSARY.
Breathing worsened - hard to breathe, no energy, coughing a lot & choking, couldn?t swallow - thickened throat and then felt like shards of glass for a time, bloody nose ? I changed tier 4 meds to Dupixent - loading dose is a double dose ? within 1&1/2 weeks of starting Dupixent (11/30) breathing and swallowing much improved.
Upper arm muscle sore full range of motion no longer possible without pain, doesn't seem to be getting any better.
C/o left upper extremity numbness and weakness started 9/11/09 At 11:00am. O/E : decrease sensation in L thumb and tremor of L hand. Rx with ATIVAN 0.5mg @HS.
The injection site felt "achey" immediately after the injection and this discomfort lasted several hours despite my gently massaging the band-aid site. My left arm felt "heavy" for the rest of the day. Within 18 hours of vaccination, I was awaken from sleep shaking violently. I thought that someone was shaking me violently. When I realized that my body was shaking so, I wrapped myself in a comforter; then I passed out or went back to sleep. When I was aware of myself again, I was too hot wrapped in the comforter and removed it. I was very concerned about what had happened to me so I moved slowly getting up and starting my day. I live alone so there was no one to help or advise me. For the next few days, I rested often, not sleeping, just feeling the need to lay about.   By week 2 after the injection, I was "dragging" but not sleeping. When I laid down, my mind roamed about, when I tried to read or engage in meaningful activities were not successful.  By week 3, I have full-blown insomnia. I go to bed at 4 am to be awake for hours while in bed, then being exhausted during the day. I am normally active, but I do not have the stamina to do what I love such as mowing my own lawn and working in garden. My heart rate jumps to 122 after 10-20 minutes of activities when in the past I could work steadily for 40 minutes and my heart rate never get above 90 beat per minute ( I  wear a charge 2 watch that monitors exercise parameters.) I had to stop to rest up to 4 times to complete the yard work that I could normally complete in less than 40 minutes.  Currently, I have "hay fever" symptoms: itchy runny nose, tickle in the throat with dry cough, tired, runny eyes  and frontal headache; I take benadryl  and other allergy medicines. I have poor sleep habits.
improperly stored MMR II were administered to 9 patient; No additional adverse symptoms reported; This spontaneous report has been received from an officer manager, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and, previous drugs reactions or allergies were not provided by the reporter.  On an unknown date, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (therapy type: Digital Data Logger), lot number S006051, and expiration date 27-FEB-2021 for prophylaxis. Details about strength, dose, dose number, frequency, route of administration, and anatomical location were not provided. It was unknown if the sterile diluent (DILUENT MRK) (lot number and expiration date were unknown by the reporter) used for reconstitution of the vaccine, was stored at proper temperature.  The highest temperature was above 47 degree Fahrenheit (°F) (53 F), for a timeframe of 17 hours, with no previous temperature excursion. The call was due to the digital data logger.  No additional adverse symptoms were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA005516: US-009507513-2001USA005522: US-009507513-2001USA005523: US-009507513-2001USA005524: US-009507513-2001USA005525: US-009507513-2001USA005519: US-009507513-2001USA005518: US-009507513-2001USA005520:
This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M041509, expiration date 09-APR-2018 (dose, route and site of administration were not reported). No adverse effects reported. Administered doses of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 1 hour and 28 minutes. The vaccine experienced previous temperature excursion between -14 to -10 degrees Celsius for 22 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information is not expected, because there was no consent to contact the reporter. Sender's Comments: US-009507513-1706USA007130: US-009507513-1706USA006072.
covid vaccine breakthrough case  dose 1 Moderna  1/27/21  012M20A dose 2 Moderna  2/24/21  001A21A dose 3 Moderna  10/24/21  039D21A dose 4 Moderna  3/30/22  083J21A
The pt experienced erythema, warm to touch approximately 6" x 4" area. The pt also experienced redness, pain and swelling which lasted about 1 week.
High fever (for 2 days, above 102), chills, body aches, pain in left shoulder blade, swelling under collar bone, headache, dizziness, back ache, minor ear ache, diarrhea, nausea, extreme fatigue, cough redness near shot site, soreness near shot site, low grade fever (persisted for a week, 99 degrees)
About 1 hr and half , Developed redness started in my neck spreads to my face and both ears. Rashes noted in face and felt heart palpitations.  Took ibuprofen and Benadryl twice. Redness and rashes dissipated. Generalized Muscle ache started at night lasted for 2 days.
Lower extremity pain followed by paresthesia and hyporeflexia. Workup concerning for Guillain Barre Syndrome
Pt described sore arm, headache and (L) leg pain, and a fever of 100.8.
Headache, arm pain, lethargy, flu like symptoms, fever. Subsided in 2 days.
This is a spontaneous report from a contactable consumer reported (herself). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration in left arm 28Apr2021 16:15 (at age of 78-years-old) as 1st dose, single dose for COVID-19 Immunization. Patient medical history includes ongoing blood pressure, ongoing (Gastroesophageal reflux disease) GERD reflux, ongoing back pain. Patient had allergies to things like hay fever, pollen, dust, mold. Historical vaccine include Shingles shot on unspecified date and experienced flu. If she had the booster, she would not have shingles. Patient past drug includes Zantac for about 6-8 months ago. Other conditions include scoliosis, has had back operations. She has lost a lot of height due to scoliosis. Patient concomitant medications include irbesartan used for prevention of high blood pressure from unspecified date and ongoing, metformin hydrochloride (METFORMIN ALPHARMA) (1000 mg, 1x/day frequency) used for preventative for Diabetes, she does not have Diabetes from unknown date and ongoing, Famotidine (20mg) taken for GERD reflux from 6 to 8 months from unspecified date, Vitamins taken from unspecified date and unknown till ongoing. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On Apr2021, Patient experienced shingles, pain in her back, rash on lower back which are ongoing and does not feel great, itching or burning in her back was worse. She is unsure if it started the day before or the day of the vaccine. Patient received treatment for events by Mederol/ Methylprednisolone 4 mg for pain as prescribed by the doctor only taken for 1 day/ 6 pills. Also took an Advil the day before and the night of the shot. Patient didn't visit any emergency room but just called her physician. she had a rash on back which doctor confirmed was shingles. The patient had a side effect after the first dose of the vaccine. She asked should I get the second dose. The patient wanted to know if it is accurate that she can delay the 2nd dose up to 6 weeks. She is supposed to get her second dose of Pfizer Covid Vaccine this coming Wednesday, 19May2021, but she still has shingles and does not feel great. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. In response to caller, they suggested to consult healthcare provider they know your health situation and has access to information that can better help inform this decision. Second Pfizer Covid Vaccine shot, she said it is scary, and the doctor said it was scary for her not to take it, all. The Outcome of events was recovering.    Follow up attempts are needed. Further information has been requested.
Report received from a consumer on 16-NOV-2009. A female patient (date of birth: unknown) received a 'flu shot' (manufacturer and lot number not provided) in her right arm on 06-OCT-2009. The medical history and concomitant medications are unknown. At an unknown time after the 'flu shot' was administered, the female reported experiencing a "serious" reaction to the flu shot and loss of the use of her right arm. The female presented to the emergency room on 27-OCT-2009 with severe right arm pain. After seeing several orthopedic doctors and two neurologist, she learned that the long thoracic nerve in her back had been severely damaged. She noted that the long thoracic nerve controls the muscle that holds down the scapular shoulder blade. Because the long thoracic nerve was not working, her scapula was dislocated and deformed, sticking straight out of her back, leaving her shoulder completely unstable. The patient stated that her doctors were 100% sure this was caused by the flu shot. She was advised by her doctors that there was no surgery that can help or treatment that would bring the nerve back. She reported being told this may be permanent. She reported that once the muscle in her right arm completely atrophies, which it was doing, her arm will become weaker and weaker. The patient was told she may never play tennis again if this was the case. The patient reported being told there was a chance for recovery, but only after months and months have passed. The female noted she was devastated and hadn't slept in two weeks. The patient believes that the proper individuals needed to be alerted about this event and wanted to know whether anyone else had suffered the same reaction, where the 'shot' originated from and if the 'shot' could have been tainted. The female reported she will need a lot of physical therapy and assistance with medical bills. An EMG was scheduled for 16-NOV-2009 to see if any [thoracic nerve] was left. Additional information has been requested.
This spontaneous report was received from a consumer concerning some patients (demographics unknown). On an unknown date the patients were vaccinated with a dose of M-M-R II (dose, route and lot# not provided). On an unknown date, the patients experienced regressive behavior reported as "regression" and fever. At the time of the report, the outcome of the patients was unknown. Additional information is not expected because the reporter declined to provide further information.
Cold extremities, warm face & diarrhea - Monitored for 47 minutes, no abnormal finding except for elevated BP.  Client did not have any rash, hives, angioedema, difficulty breathing, wheezing or altered level of consciousness.  She reported all symptoms resolved and discharged home.  Additionally, she reported diarrhea  overnight which had resolved by the next day.
Influenza Vaccine. Right arm pain/swelling. U/S  Mild swelling/inflammatory changes within the lateral aspect of upper arm in the region of recent vaccination. Multiple mildly prominent lymph nodes within the left axilla in the region of palpable abnormality. RX lortab, augmentin.
This spontaneous report as received from a registered nurse refers to 4 patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. Between 22-MAR-2016 and 23-MAR-2016, the patients might be vaccinated (nurse stated: "I don't know which ones were administered" but might included VAQTA with improperly stored doses of VAQTA injection, lot# L043209 with expiration date 17-SEP-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a pharmacist concerning a female who in March 2008, was vaccinated with zoster vaccine live (Oka/Merck) (lot# 659268/1430U). Concomitant therapy included amitriptyline hydrochloride (MSD) and rosuvastatin calcium (CRESTOR). In April 2008, the patient developed shingles. As of 08-MAY-2008, the patient was recovering. Additional information has been requested.