chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cervical transverse myelitis, asymptomatic thoracic cord lesion as well; both enhancing on post-gado MRI; Cervical transverse myelitis, asymptomatic thoracic cord lesion as well; both enhancing on post-gado MRI; This is a spontaneous report received from a contactable physician (HCP). A 36 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration (age at vaccination 33 year) on 30Apr2021 as unknown single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of May2021, patient experienced Cervical transverse myelitis, asymptomatic thoracic cord lesion as well; both enhancing on post-gado magnetic resonance imaging (MRI). Patient visited to physician office for the event. The outcome of the event was reported as not recovered.  information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association of the product bnt162b2, the causal association between the event Cervical transverse myelitis and Thoracic cord lesion the suspect drug cannot be excluded. As there is limited information provided about the  patient medical history and concomitant drugs  ,the case will be reevaluated should additional information become available.  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.
Immunizations given. 2-3 hours after shots, began inconsolable crying for 5-6 hours then stopped.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient with drug hypersensitivity of Red dye, morphine, opiods, codeine, SULFA, COMPAZINE, fluoroquinolones, BENADRYL, SUDAFED. The patient had no pertinent medical history. On 04-FEB-2013 the patient was vaccinated with ZOSTAVAX (lot number reported as H019092) (dose and injection site were not reported) subcutaneously. On 06-FEB-2013 the patient experienced an injection site reaction that consisted of a "raised, red welt that was bigger than a quarter, but not hot, around the injection site". Treatment short course of prednisone was given for adverse events. The action taken and outcome of the adverse events was not provided. The patient had a phone call for medical attention. This one of two reports received from the same patient. MARRS number" 1302USA004670. Additional information is not expected.
Patient had no adverse effects from vaccine per nurse.; Nurse reported expired PROQUAD vaccine given to a patient today.; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 11-AUG-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, 0.5 milliliters (ml) given once (lot number S003865 which has been verified to be valid, expiration date reported and validated as 08-AUG-2020) (vaccination scheme, route of administration and anatomical site of injection were not reported), as prophylaxis (expired product administered). The nurse reported that, the patient had no adverse effects from the vaccine.
Swollen, painful lymph nodes above left collar bone, in addition to swollen, red, painful injection site.
Going to bed I had a mild achy right injection deltoid site. The next day the right anterior front of my armpit really hurt, my axilla hurt, it was red along the right front axilla, I had trouble moving my arm.  I had a mild headache. But my noon, my armpit and and somewhat radiating pain hurt enough I took 400 mg of Advil and soon later 500 mg of Tylenol.   I had trouble raising my arm.  I did not have a swollen lymph node.  One half dose in the am didn't help. I also had a mild headache.    The next morning, I woke with a fine pinpoint body rash, the redness of my right armpit was still there.  I did NOT have any itching or SOB, tearing etc.  By the next day, my symptoms were dissipating.
More than 36 days after the first dose without receiving the second dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
headache and aches for about 24 hours; headache and aches for about 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 11:00 (Lot number: EN6203) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XARELTO; AMLODIPINE. Vaccination history included: Bnt162b2 (lot number=EL3247, administration date=24Feb2021,, administration time=11:00 AM,, vaccine location=Left arm,, dose number=1), administration date: 24Feb2021, when the patient was 58 years old, for Covid-19 immunization, reaction(s): "Covid-19 immunization". The following information was reported: PAIN (non-serious), HEADACHE (non-serious) all with onset 18Mar2021 07:00, outcome "recovered" (Mar2021) and all described as "headache and aches for about 24 hours". Therapeutic measures were not taken as a result of pain, headache. Additional information: the patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination.   No follow-up attempts are possible. No further information is expected.
I experienced little bit tired during the normal hours. On day 4, I worked night shift as a nurse and I had this crushing headache and the most severe photophobia that I ever had. I could not tolerate the light.  I had to go into a dark room. This persisted for three weeks. I had a lot of brain fog, noise, and photosensitivity. I had an inflammatory response. I had been actively been managing my symptoms at the concussion clinic center and I did go back there after the adverse reaction. They treated me with 3 sessions.  I say my doctor Dr. and the concussion doctor for my care.  They did a series of neurological tests to determine standing and compared it to my baseline using a combination of head movements that are really specific as well as spatial awareness. The vestibular inputs, the sematory sensory, they had me listening to beats  and measure the distance of input of your brain. They gave me home exercise program. They put me on a inversion table with a pulse oximeter to determine when my brain felt stressed. They felt with my home exercise program that I should of been able to correct the disturbances from the vaccine. They put me on a stricter diet, gut healing and this was very helpful.  My chiropractor job was to keep my neck moving.
Breakthrough Case; Breakthrough Case; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient aged 18-64 years 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 DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
thirsty, metalic tate in mouth, then upper arm severely painful/heavy.  SEvere headache- no resolved, feverish, but max temp of 97/9F.  Dizziness- minimal improvement at this time.
A report has been received from a Health Professional concerning a 2 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 09-Jan-2014. The reporter mentioned that patient was inadvertently administered expired FLUMIST QUADRIVALENT which started on 09-Jan-2014. The outcome of the event of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Cough developed the evening the vaccine was given. Fever to 101 and abdominal pain w decreased appetite occurred 2 day after the vaccine was given  (2-8-2022)
On 1/10/19, patient's spouse a Dr. called and reported patient had some pretty bad reactions starting about bedtime. She experienced fever (102 F), chills, headache, shivering, myalgia, arthralgia, insomnia. He reported that the temperature had come down but she still felt pretty weak and fatigued.  After reinforcing that these were possible side effects of the vaccine, I asked him to let me know when she started feeling better and of course to call me if it did not get better. On 1/15/19 I called him back.  He reported that the worst of it lasted about 2 and 1/2 days but she was better now. He said she does still a bit tired and her arm is still sore.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: Spoke with nurse at md office and instructed to give sports drink (sugar) for shakiness
Case number PHEH2014US012139, is an initial spontaneous report received from a nurse on 16 Jun 2014. This report refers to a 13 year old male patient. Past medical history and concomitant medications were not reported. He received only MENVEO, (batch number: A12129), reconstituted with a sterile water instead of MENCYW-135 intramuscularly on 12 Jun 2014. He developed a rash and difficulty  breathing shortly after vaccine administration, but he was also administered other medications around the same time as MENVEO, that may have caused the allergic reaction. Corticosteroids were administered to the patient and allergic reaction is not present to the date (resolved). The seriousness and causality of the events were not reported.
In June 1999 the pt had a severe case of poison ivy last week and he was treated with steroids for 4 days. Three days after being off the steroids, he came down with a severe case of chickenpox.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 27-OCT-2014, the patient was vaccinated with (Merck) VARIVAX, 0.5 ml, subcutaneous (strength and lot number were not reported). Secondary and concomitant therapies were not reported. Healthcare worker reported that a patient accidentally received a dose of (Merck) VARIVAX instead of a dose of ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Information has been received from a health professional concerning an adult female who on approximately 27-OCT-2005 was vaccinated in the deltoid with an 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650302/1039P).  Within an hour of vaccination, the patient called the physician complaining of painful, red, swollen arm at the site of injection.  The physician prescribed diphenhydramine HCL (BENADRYL) and told her to call back if no improvement.  The patient called back the next day and reported that she was "fine".  Subsequently, the patient recovered.
This spontaneous report as received from a Licensed practical nurse refers to unspecified number of patients of unknown demographics. Patients concurrent conditions and relevant medical history was not reported. The reporter stated that, on an unknown date, unspecified number of patients were vaccinated with improperly stored PROQUAD (Merck) (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with suspect therapy was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician refers to unknown number of patients of unknown demographics. On an unknown date the patients were vaccinated with RECOMBIVAX HB (dose, dosage schedule, route of administration, lot number and expiration date were not provided). On an unknown date RECOMBIVAX HB was improperly stored and administration to unknown number of patients. The vaccine was exposes to 9 degrees C for total of 60 hours. No adverse effects reported. This is one of 5 reports received from the same reporter. Additional information has been requested.
Patient experienced dizziness and an elevated blood pressure of 155/100. He started experiencing symptoms during the mandatory 15-minute waiting period in the immunization clinic. A provider called for patient management. Manual BP retaken: 148/100. Doctor recommend blood pressure monitoring, severe ER precautions and a follow-up appointment booked.
Over all body itchy maculopapular rash to arms, legs with scattering rash to torso beginning 10 days post smpx vaccination (2/1/05). Seen 2/16/05 with diffuse maculopapular rash in groups to forearms and arms, lower anterior legs with single lesions scattered to chest and back.  Dx Non-viral pustulosis and dry skin.
She was diagnosed with strep throat; This is a spontaneous report from a contactable Other Health Professional (Patient herself). A female patient of an unspecified age received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 22Jan2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that she was diagnosed with strep throat today and her due for the next dose this Friday. The patient was asked that can she still get the second dose scheduled on Friday. Therapeutic measures were taken as a result of event with clindamycin and a steroid. The outcome of the event was unknown.  Information on Lot/Batch has been requested.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 30-JAN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 2.5 ml injection, lot # H022280, expiration date 16-JUL-2014 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 708 hours, with the lowest recorded temperature of 20 degrees Fahrenheit (-6.666666667 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
None.  Vaccination of a minor.  No side effects from vaccine.  Parents advocated for his vaccine to occur.
tinnitus - started at 2nd shot and is still continuing. It is significant enough to get medical treatment and is very annoying. Over Easter I was with family, the TV was on and people were talking. I had significant trouble understanding people talking to me.  I had significant joint pain of the left hand, knee's, and ankles which has decreased. I had headaches which have decreased but still continue
Strong joint pain; Strong nausea; This is a spontaneous report from a Pfizer sponsored program  received from a contactable consumer (patient's daughter). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route at the age of 55 years on 22Apr2021 (Lot number: not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date of 2021, the patient experienced strong joint pain and strong nausea, which the patient never had before. The outcome was unknown for the reported events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm, as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing). Concomitant medication(s) in 2 weeks included: METOPROLOL. The patient had no known allergies. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 28Aug2022, outcome "recovering", described as "Recurrence of Covid symptoms and recurrence of positive Covid test"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Recurrence of Covid symptoms and recurrence of positive Covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Treatment included Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No symptoms initially, then 3-4 hours having itching which got worse.  1/27/21 reaction was on face on the right side.  Last night the ears on the ride was red and having swelling.  Taking Benadryl (advised by son who is dr), cortisone with itching.   Not able to go to work due to side effects from taking the Benadryl.  Does have a call-in to her doctor.  Saw on website which said to have an injection of Benadryl and/or Cortisone which is waiting on instructions from him.
None; this was a medication error. Patient was given Pfizer vaccine 1 month prior to 16th birthday.
Yesterday after the shot, Heart racing after 40 minutes of injection, shortness of breath,  dizziness and nausea. then later moderate headache  and tiredness.  Today, diarrea, weakness, tiredness , headache,  body aches,  Trying to do my daily routine has been hard, I was not able to work, haven?t talk to a doctor yet
SIDE EFFECTS NO JOKE; This spontaneous report received from a consumer 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: Unk) 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 side effects no joke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects no joke was not reported. This report was non-serious.
Hives; Nausea; Chills; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (Hives), NAUSEA (Nausea) and CHILLS (Chills) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012420A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, URTICARIA (Hives), NAUSEA (Nausea) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-023426 (Patient Link).
My daughter started to develop severe spastic tic like movements of her arms, face and shoulders after receiving the DTaP shot. This worsened over a few months and made it hard to her to eat and perform simple tasks and slowly started getting better around December. The tics and spastic movements have now resolved.
hive locally to p-vax 45" p/vax given DPH @ 66 hrs later arm hot, red, swollen-ER; RTC w/ lg red confluent area, non indurated; given DPH;
immed following stated site ached by 12noon c/o general ache over entire body, nausea & lightheadedness-lasted approx 6 hrs; described as flu-like sx states felt better but low energy over weekend;
pt devel a red spot & lump approx 1" from inject site; lump & spot inc in size over next several days; pt also had mild fever; (per mom);  23AUg lump & spot were quarter size; 24AUG lump & spot were 1/2 dollar size; pt to MD