chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The past week she can not even walk and as if it is  attacking her muscles; she could not even breath; She takes morphine for her back; She mentioned she had a birthday last Friday but she feels like she is 100 years old.; Then she reports that she has gotten sicker and sicker, something is up with these vaccines; Her neurological issues are extremely bad; The past week she can not even walk and as if it is attacking her muscles; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 48-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BOECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Apr2021 as single dose for covid-19 immunization. Medical history included covid-19 from Feb2021 to an unknown date She had Covid 19 back in FEB, illness from an unknown date and unknown if ongoing She had Covid 19 back in FEB. Since then she reports that she has gotten sicker and sicker. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on unspecified date for covid-19 immunization. It was reported that patient received her second dose of Pfizer Covid 19 vaccine on 15Apr2021. She had Covid 19 back in Feb. Since then she reports that she has gotten sicker and sicker something is up with these vaccines The past week she can not even walk and as if it is attacking her muscles. She takes morphine for her "back" and is not touching what is going on with her body. About a month ago she could not even breath and consumer was unsure if she had Covid again and confirms that she was not tested again for Covid 19. At that time she went to be evaluated by a physician. She has been on Lyrica and now is back on Gabapentin. Her neurological issues are extremely bad. She mentioned she had a birthday last Friday but she feels like she is 100 years old. She also reported that her neighbors have experienced similar side effects (specifics were not explained). She said that withheld is in his 50s and withheld is her 70s after getting the Pfizer Covid 19 vaccine. They think it is the weather. Her neurologist has told her that he is getting a ton of patients who have had Covid 19 and/or this vaccine that they are having neurological issues that are getting severely worse. She explains she is one of them and has seen 5 doctors and that they don't have a lot of information on the vaccine's side effects but have informed her what a Covid 19 infection can do physiologically. He patient visited physician office for the events. Therapeutic measures were taken as a result of her neurological issues are extremely bad, the past week she can not even walk and as if it is attacking her muscles, the past week she can not even walk and as if it is attacking her muscles, takes morphine for her back. The outcome of the events was reported as unknown at the time of this report.   Information on the batch/lot number has been requested.
injection site really hot; Strong headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 06-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site really hot) and HEADACHE (Strong headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, DONEPEZIL, FLUTICASONE PROPIONATE and VITAMINS NOS for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site really hot) and HEADACHE (Strong headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (injection site really hot) and HEADACHE (Strong headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications nose drops, eye drops.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Patient's current condition or medical history was not reported. On 09-FEB-2015 the patient was vaccinated with a dose of ROTATEQ (lot#, dose not reported, orally) which underwent a supported temperature excursion. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
pt came into office for dr appt, covid bivalent booster ordered, pt received monovalent covid vaccine
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL 9264), in left arm, on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: Ff2588), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: F7. 4554) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jul2022) Negative; (30Jul2022) Negative; (01Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid, treatment start date=21Jul2022 and treatment stop date=19Jul2022. . The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Arm pain, soreness, headache, muscle aches, a little shivering, much fatigue and nausea.
After 3 hours, after the shingle shot, patient feel dizzy, nauseated, going to pass out. Her friend called 911 and patient was seen in the emergency room. Everything was normal & pt was just given oxygen. The arm next day was swelling & red & very hot. It's the left arm. Flu shot was given on the right arm also on the same day but not much swelling.
Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 14-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Oct-2023, SARS-CoV-2 test: Positive.         Concomitant medication was not provided.  Patient only had Moderna vaccines and have had every vaccine available. Up until this vaccine, she would get very ill within about 8 hours of the shot(s) including fever, bone pain, and headaches. The last shot she had had no reaction whatsoever. She even commented to someone that she wondered if she got a "dud" shot. Exactly 2 weeks later, on October 10, 2023, She was exposed to Covid. At about 2 am 5 days later on Saturday, October 14, she tested positive for Covid and started taking Paxlovid. Her partner 87y old who had the Pfizer recent vaccine on Sept. 19, 2023, had so far, remained negative with no symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2023-745824 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745824:Same patient, different vaccine
Mother stated throat swelling and resp. distress, taken to ED.  ED instructed not to take Td in the future.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 16-FEB-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # K002036, expiry date 10-FEB-2016, albumin status rHA, dose and route of administration not reported). No adverse effects were reported. Additional information has been requested.
The patient reported a pounding headache the morning after vaccination, localized to her right side above her eyebrow. She reported muscle weakness and general fatigue, an inability to focus and described feeling like she was "drunk."  She began to have vision changes that affected just her right eye on 4/12/21 at 2:00 PM. She described it as blurriness and like looking through a kaleidoscope. The vision disturbances resolved 2 hours later after resting, but the headache remained. The only symptom that remains is the headache and it is improving and described as mild.
No adverse event occurred.  Patients received the monovalent booster, which was the only available vaccine booster at the time of visit.  Health Department had not yet received the shipment of bivalent vaccines at the time of the clinics.  Communication regarding the new approved recommendations was still being clarified and distributed by leadership team and the current standing order was in force at the time of vaccination.  Patients were contacted and notified that this resets the timeframe for their booster dose and were advised to return after 8 weeks for the bivalent booster.
lt hip-red hot swollen & a little itchy-6inch diameter;prev only given Dt d/t resp problem;
4:35 pm Post vaccination client c/o headache, denies any additional complaints; Po hydration/ water given. BP 110/78  P91  02 Sat 99% 4:52 pm Reports "feels better", no headache complaints; released from facility to home.
My second dose was my advert event. 20 minutes after vaccine I started to feel an immense tingling sensation all over my face and my face started to feel numb shortly after, my heart rate went up and I felt short of breath while driving. Went away after 1t minutes but was very intense.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID 19 INFECTION; This spontaneous report received from a patient concerned a 41 year old female. Initial information processed along with the follow up information received on 07-JAN-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer)  (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on unspecified date in APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: unknown) dose was not reported, 1 total administered on the left arm on 10-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-DEC-2021, the patient experienced symptoms tired, body aches and headaches (subsumed under confirmed covid-19 infection and confirmed clinical vaccination failure) (dose number in series 2). On 01-JAN-2022, patient tested positive for Covid-19. Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 02-JAN-2022, Covid-19 symptoms of tiredness, body aches and headache resolved. She was not aware of being in contact of anyone who was Covid-19 positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid 19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report is associated with product quality complaint number 90000210071. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the Regulatory Authority evaluation/investigation performed.   .; Sender's Comments: V0- 20220104848- covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Since Tetanus immunization, has had deep growing pain from neck to fingers. No loss of sensory good ROM and strength. No loss of function
Large swelling on the left side of the neck: it is warm and painful 2 days. After the vaccine she has a sharp pain on the side of neck and numbness and headache.
11:00 am feeling pain and could did not have any upper body strenght, severe body aches, nausea, chills,  second day felt feverish and third day 100.2 fever low grade fever, head arce .
Redness, edema, cobblestone rash and pan in upper left arm  8 days post injection.
3rd covid19 booster; thought I was having a stroke but kind of neurologist said, it's Bell's palsy as a result of getting my third Covid vaccine; This is a spontaneous report received from a contactable reporter, Consumer. The reporter is the patient.  A 60-year-old patient received bnt162b2 (COVID-19 MANUFACTURER UNKNOWN), administration date 12Dec2021 (Lot number: ER2613) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: Hypertension (unspecified if ongoing); Diabetes mellitus (unspecified if ongoing). Concomitant medications included: metoprolol taken for hypertension; empagliflozin (JARDIANCE); linagliptin (TRAJENTA). Vaccination history included: Covid-19 vaccine (Dose:1st, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose:2nd, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: immunisation (medically significant) with onset 12Dec2021, outcome unknown; bell's palsy (medically significant) with onset Dec2021, outcome unknown, described as "thought I was having a stroke but kind of neurologist said, it's Bell's palsy as a result of getting my third Covid vaccine". The event was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: (18Dec2021) unknown results, notes: I had it yesterday, I do not know, there was several test that they perform.  No follow-up attempts are possible. No further information is expected.
On 09/14/2022 severe tinnitus started  and mild/moderate hearing loss both ears. There has been no improvement or change at this time.
Itching/redness/swelling/hot. TX: removed latex free bandaid, Advil.
On 3/3/99, the pt experienced anaphylaxis consisting of an itchy rash and difficulty breathing. The pt took diphenhydramine (Benadryl),  and her symptoms resolved. This experienced was considered an other medical event. There were no adverse experiences after the first and second doses.  No further information is available.
Information has been received from a physician concerning a 20 year old female who was vaccinated with GARDASIL. Subsequently the patient experienced rash. The outcome of the patient was unknown. No further information is available.
I was awoken from sleep with violent chills and an sensation of severe cold. My chills became violent and coarse rigors, severe enough to contract the spine into hyperextension if I kept my body in a neutral position. I could still activate each muscle group to keep in a fetal prostration pose. I was knowledgeable of the event, did not loose any bowel, bladder, or smooth muscle function, and the intensity of the rigors was focused on the most developed skeletal muscles (thighs, calves, upper arms, forearms, paraspinal muscles, hands, respectively).  Jaw and muscles of the head/face seemed unaffected. Fingers and toes not distinctly affected. I was not sweating at this time and there were NO other symptoms to report; I remained lucid and able to self-reflect the entire time. Home temperature is kept to consistent 66F, no malfunctions to thermostat. No recent changes to bedding (sheet and quit on top of mattress); it is even optimized for me as I tend to overheat as I sleep.   At 50 minutes, I felt "less frozen" and confident enough to stand/ambulate for 220mg naproxen + 500mg APAP , cautiously and successfully swallowed. Robe was donned over existing pajamas and thick comforter was pulled from hallway closet. Rigors continued, but it appeared that intentional activation of the muscle groups could still overpower the rigors for safe (but shaky) ambulation. Greatest risk was coarsely shaking hands a bringing cup to mouth to swallow pills.   Above activity was completed in 5 minutes. I then sat upright in bed under layers above. I could feel the muscles calm and relax, with episode completely ending in 5 minutes. Total time of event: 60 minutes.   Post-event details: There was a mild sensation of muscle tension in the posterior cervical spine akin to whiplash, but no residual symptoms. I debriefed with my husband shortly thereafter (he has been in another room the whole time) and fell asleep by 23:30. Awoke to alarm at 05:00 and able to stretch, accomplish 30 min run, vacuum/mop the floors, and present to work by 08:00am without deficit.  Time of documentation: 11:22 am 1/15/2021
Patient broke out in a red rash all over her body; This is a spontaneous report from a contactable consumer or other non hcp. A 35-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown) via an unspecified route of administration, administered in left arm on 26Jan2021 as single dose for covid-19 immunization. Medical history included Allergies to Mushrooms. On 06Jan2021, patient had first dose of COVID 19 vaccination. Concomitant medication included naproxen sodium (ALEVE). Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Aleve within 2 weeks of vaccination. On 27Jan2021 18:00, the patient broke out in a red rash all over her body. The patient received Benadryl as a treatment for the adverse event. The outcome of the event was recovered.    Information on the lot/batch number has been requested.  Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Began to get extremely tired around 11/11:30pm on the day of the vaccine. Around 12:30am I started getting cold chills and sweating. I was able  to sleep off and on through the night. At 7:30am I got up and had very bad muscle pain throughout my body, along with the cold chills and sweating. Fever was around 101.5. The fever, cold chills/sweating, and muscle pain stayed consistent throughout the day, ranging between 100-101.5 depending on if I was awake for awhile or just woke up from sleeping. At 3:00am on May 1st it had gone down to 99.5, and at 8:00am the same day it was down to 98.7. My arm was also very sore at the vaccine injection sight very shortly after the vaccine and through the day of May 1st. By May 2nd it had stopped hurting.
Feeling achy several hours after immune. 24 hours later chills, hot, states in bed for 24hrs. with malaise, muscle aches States 80% recovered on 12/9/19
Information was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On 17-AUG-2018, the patient was vaccinated with an expired VARIVAX for prophylaxis (lot number M033906 and expiration date 20-JUL-2018) (dosage schedule, route of administration and anatomical location were not reported). No adverse effects were reported.
Patient came in 1 week after receiving Td booster, complain of  swelling locally, left deltoid, heat, pain at site, also had a patch of redness, left upper arm, approximately 4 inches below injection site.  Redness, one spot on lateral neck (anterior) and left area above lips.
lethargic, difficult to arouse, pallor;taken to Er-no abn findings;re evaluated 9SEP98 improved but still not self;
Site: Pain at Injection Site-Medium, Systemic: swelling near the neck-Mild
Patient had already received a flu vaccine on Dec 7, 2022. She was given another does without realizing he last administration of the vaccine.  Patient was stable and fine after the administration,  no reaction or adverse effects noted.
received dose 2 on 1/22/21,  began having neck pain 1/27/21, broke out with shingles 1/28/21. treated with valacyclovir for 7 days
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 29Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing); "h/o TIA" (unspecified if ongoing); "Chronic cough" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Feb2023) Positive, notes: positive at home covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment yes, patient previously receive a COVID-19 Vaccine yes, Product COVID 19 Treatment start date 24Jan2023, stop date 29Jan2023, Device Date 07Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2  to the reported events drug ineffective, COVID-19 cannot be ruled out.
Vaccinated with Pfizer on 3/3/21 and 3/24/21.  Symptom onset 7/6/21 with cough, chills, diarrhea, headache, weakness, shortness of breath, muscle aches, sore throat and abdominal pain.  Tested positive for Covid-19 on 7/14/21.  Client was given a 20 day isolation from her physician due to her being immunocompromised.  At time of interview 7/15/21, client still had cough, chills, diarrhea, headache, shortness or breath and muscle aches.  7/15/21 is day 9 of her isolation.
1-2cm red, raised lump @ inj site reported @ 245PM on 12MAY99 by mom;denies fever;some increased irritability when areas touched but not difficulty im movement of extremities;lt leg site seems sl larger than rt site;suggested ice, APAP