chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling very tired; lethargic; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration, administered in arm right at the age of 53 years old on 15Feb2021 08:45 at single dose for covid-19 immunisation. Medical history included diabetes diabetes and HBP (high blood pressure). No known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247) via an unspecified route of administration, administered in arm left at the age of 53 years old on 26Jan2021 09:45 at single dose for covid-19 immunisation. The patient experienced feeling very tired and lethargic. The patient noticed the symptoms about 2hrs after the second dose on 15Feb2021. On the next day 16Feb2021 the symptoms were worse but later that evening all symptoms were gone on 16Feb2021 and the patient was back to normal. No treatment was received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered on 16Feb2021.
Patient waved down observation nurse 5 minutes after receiving her 2nd dose of Moderna. Patient felt nauseous and observation nurse brought over trash receptacle and patient vomited. Charge nurse was called over and vitals taken at 1:50 pm B/P 168/87 HR 104 Temp 96.9 Resp 18 O2 97%. Patient's skin was wet and clammy Both patient and mother informed nurses that this reaction was common for patient when receiving "shots". Patient also informed nurses she did not experience any reactions to 1st dose of Moderna.  B/P was taken at 2PM 132/103 and then again at 2:05pm with patient standing 132/86 HR 86. Patient said she felt "much better" and left with mother without requiring further treatment.
This spontaneous report as received from a nurse practitioner refers to an 18 year old male patient with no medical history and no drug reactions/allergies. On 18-NOV-2013 the patient was vaccinated with the first dose of GARDASIL (typical dose and typical route). Nurse practitioner mentioned a patient was given the first dose of GARDASIL while sitting in a chair and the patient's face turned pale yellow/green and the patient would not respond to any questions and eyes were still open - the patient almost fainted. The patient was given an unspecified flu vaccine (manufacturer unknown and AFLURIA could not be ruled out) on the same day as GARDASIL but the patient had received this flu vaccine in the past with no problems. Concomitant therapies included TOPAMAX. Laboratory studies performed included vital signs such as blood pressure and pulse. The patient was placed on his back on a table and legs were elevated. The patient was still in the office. The outcome of event was reported as recovered/resolved on 18-NOV-2013. Additional information has been requested.
Information has been received from a certified medical assistant (CMA) referring to multiple unspecified patients. On unspecified dates, the patients were administered improperly stored M-M-R II injection (lot # K000737, expiration date 16-JAN-2016; lot # L007577, expiration date 05-MAR-2017 and lot # L010488, expiration date 26-MAR-2017) (dose and route were unspecified). No adverse effects were reported. Additional information has been requested.
pt recv vax OCT96 & w/in 30min pt exp extreme pain in the area of lt upper deltoid;1wk post vax pt exp a limited ROM;2wk post vax the limited ROM persisted;
Pt recvd vax in 1985 & 2 days following vax devel a rash & a fever to 104; seen by MD who stated that the pt had measles; No further details were provided;
Worst infection; Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case from social media via consumer/non-health care professional.  This case involves a patient (unknown demographics) who had worst infection (infection) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious worst infection (infection) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got the worst infection last year 7 days on antibiotics never"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  The patient received corrective treatment antibiotics for the event.  At time of reporting, the outcome of the event was unknown.  There will be no information available on the batch number for this case.
worsening hot flashes; worsening hot flashes; tiredness; headache; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, DOSE NUMBER UNKNWON, SINGLE, Primary immunization series complete.), for Covid-19 immunization; Covid-19 vaccine (MANUFACTURER UNKNOWN., DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: HOT FLUSH (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "worsening hot flashes"; FATIGUE (non-serious), outcome "recovered", described as "tiredness"; HEADACHE (non-serious), outcome "recovered".  Additional information: Reported worsening hot flashes after receipt of the 2nd booster. Also reported tiredness and headache starting about 24 hours after the booster both which resolved. Prevnar 20 was co-administered with the 2nd booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme tiredness the day of. Headache beginning  the following day and still ongoing.  Subsides with a dose of Tylenol but then returns. Early menstrual cycle - three weeks early  - on day three post vaccination.
2:15pm- The patient experienced the following reaction(s) during the immediate  of observation: pt reported feeling "hot" and "dizzy".  2:20pm- Patient was treated/managed as follows:  Pt brought to treatment area, VS taken: BP-124/82, HR - 81, 02-99%, RR -18. Pt asked to lay down and given Gatorade. Pt states she hasn't eaten today and had a stressful morning. 2:25pm-  Pt states she feels and symptoms have resolved. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.
Prolonged screaming, irritability of >1 hour duration. No recorded fever. Less responsive than usual. Follow up exam in our office normal.
Patient reports development of brain fog, visual disturbances, and muscle spasms in lower extremities approximately 4 weeks after Covid-19 vaccines.
No other AE information; HCP calling to report patient was given PNEUMOVAX 23 that was recalled; Information has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 15-OCT-2020, the patient received a recalled pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml as prophylaxis (lot number: S036495 with expiration 13-SEP-2021) (strength, route of administration and anatomical location were not reported) (recalled product administered).  No adverse events reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
01/06/2020  Patient complained of dizziness 45 minutes after vaccination, resolved in 15 minutes 01/07/2020  Patient complained of Headache, dizziness, nausea onset at 0400.
On, February 3, the 7th day after vaccine, patient began itching all over her body (torso, arms, and hands).  there was no rash visible.  On February 7, Sunday, at 7:00 pm, her lower lip started burning.  At 9:00 pm, her tongue began feeling unusual - slightly swollen.  the itching had continued all this time since February 3.  At 11:15 pm on February 7, she took 50 mg of benadryl and no zolpidem that night.  the next morning, the itching had stopped and burning of lips stopped.  Tongue did not feel normal until 3:30 pm that day, February 8.
Covid-19; Covid-19; Eye pain; Headache; Fatigue; Weakness; Sore throat; Stuffy nose; Cough; This is a spontaneous report from a contactable consumer (patient reported for herself). 26-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an intramuscular route of administration, administered in Arm Left on 19Feb2021 (at the age of 26-year-old) (Lot Number: EL9266) as DOSE 1, SINGLE and dose 2 via an intramuscular route of administration, administered in Arm Left on 12Mar2021 (at the age of 26-year-old) (Lot Number: EN6206) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Jul2021, the patient experienced Covid-19, Headache, Fatigue, Weakness, Sore throat, Stuffy nose, Cough, and Eye pain. On 29Jul2021, post vaccination, the patient underwent SARS-CoV- 2 rapid ag (Nasal Swab) test, which was positive for covid-19. Patient received treatment with Tylenol to treat the events. The outcome of all the events was not resolved at the time of this report.
hearing impaired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOACUSIS (non-serious), outcome "unknown", described as "hearing impaired".  Additional information: It was reported that Sign language interpreter number was made. Calling was done to ask some questions about covid vaccine. Not happy had to be transferred. Not clarified if caller (patient) had either dose of covid vaccine and if had vaccine was hearing impaired before or after.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
m her fingers in her right had began to have a tingling sensation; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (m her fingers in her right had began to have a tingling sensation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PARAESTHESIA (m her fingers in her right had began to have a tingling sensation). At the time of the report, PARAESTHESIA (m her fingers in her right had began to have a tingling sensation) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Updated the event outcome
like if someone punched it in the arm; like worked out; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (like if someone punched it in the arm) and FATIGUE (like worked out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 LIMB DISCOMFORT (like if someone punched it in the arm) and FATIGUE (like worked out). At the time of the report, LIMB DISCOMFORT (like if someone punched it in the arm) and FATIGUE (like worked out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information provided. No treatment information given.
Bell's Palsy (severe) beginning on May 15. No response or movement until about two weeks after the onset. Four weeks later still not fully recovered.
Had normal sore arm after a few days but a month later couldn't get up out the bed without help. Have no use of her hands she can barely write. Both shoulders are not working so her grandkids have to come pull her up.  Hurt all over.
pt recv vax 25JAN96 & motor tics entire body, primarily shaking of head & arms w/in 12hr;attending MD said these were tourette-like sx;
Development of alopecia areata May 2022 (one month post receipt of 2nd COVID-19 booster).
Extreme tenderness, soreness and stiffness on entire upper left arm (injection site) and soreness and stiffness of lower right back and glute muscle (old injury); took over 10 days for symptoms to subside enough for me to walk normally and without pain.
Mother states that on Sunday the child developed an itchy rash that started on face and has spread to the torso. The rash are pinpoint red papules on face, torso, arms and legs; no papules on hands or feet. Child also started to have diarrhea, along with the rash.
About 22 hours after the vaccination, I had chills.  During the night I sweat so much my gown was soaking wet, and when I awoke, I had a foul odor on my body and gown, as if my body had expelled something foul during the night.   The day after the injection, my arm felt sore and 2 days later I would have more described it as hurting and itching.   8 days after the injection, a red spot developed on my arm.    3 days before I had the 1st dose, I got a headache and still had the headache at the time of the vaccination.   The pharmacy person questioned me about the headache, but decided to give me the vaccination.  Personally, I think the headache is related to eye strain since I have had this type of headache before.  I have an appointment next week to see the optometrist.    I had no fever before the vaccination or after the vaccination.
loss of appetite; Migraines; Nausea; Body aches and pain; Swollen lymph node under right armpit; Skin on the right breast started peeling to the white; Fatigue; Pain in right breast; Pain in right breast, right shoulder, right arm, right back, right chest and right hand; Pain in right arm/right hand; Pain in right breast, right shoulder, right arm, right back, right chest and right hand; Pain in right breast, right shoulder, right arm, right back, right chest and right hand; Dose number: 3; This is a spontaneous report from a contactable other HCP (patient). A 41-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FH8028), via intramuscular, administered in arm right on 28Oct2021 at 19:00 (age at vaccination was 41 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization; influenza vaccine (INFLUENZA VACCINE, Batch/Lot number was not reported), via an unspecified route, administered in upper right arm on 28Oct2021 as DOSE NUMBER UNKNOWN, SINGLE for immunization. The patient was not pregnant at the time of vaccination. The facility where most recent covid-19 vaccine administered was pharmacy or drug store. No other vaccines were received within four weeks prior to the administration of Covid vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Medical history included asthma from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had known allergies to Codeine. The patient previously took first dose of bnt162b2 (Batch/Lot Number: EN6202), via intramuscular, administered in arm right on 24Feb2021 (age at vaccination was 40 years) as DOSE 1, SINGLE and second dose of bnt162b2 (Batch/Lot Number: ER8730), via intramuscular, administered in arm right on 24Mar2021 (age at vaccination was 40 years) as DOSE 1, SINGLE for covid-19 immunization. On 28Oct2021 19:00, booster was administered. On 29Oct2021 at 12:00 am, the patient experienced migraines; nausea; body aches and pain; swollen lymph node under right armpit; fatigue; loss of appetite; pain in right breast, right shoulder, right arm, right back, right chest and right hand and skin on the right breast started peeling to the white. The events resulted in visit to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The case was non-serious. Therapeutic measures were taken as a result of the events. Treatment was ongoing for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Internal hemorrhage of upper left arm. Arm appears purple/black, as one enormous bruise, from shoulder to elbow laterally. Area is painful and swollen. Today is 9-19-14 and symptoms have only worsened, not improved. Patient has even sought care from the emergency department at local hospital.
The possible adverse event I'd like to report is nummular eczema in my 5 month son. I received two doses of the Moderna vaccinate at the end of my pregnancy and am still breastfeeding. My son's name is (private) and his date of birth is (exact). His symptoms first appeared in mid-August. The circular rash remains on his chest and abdomen, even with steroid treatments. I can give more information about his pediatrician. I've seen on social media that other infants of vaccinated mothers have an increased incidence of eczema, so I wanted to report.  Otherwise he is a healthy growing baby.
Narrative:  Patient reports that she waited the 15 minutes, but 10 minutes after that she began to have sx of heart palpitations, racing, dry throat, she felt like her throat was closing up and felt her breathing was restricted. This last about 5 hours total and gradually resolved. She states that she felt continuous drinking water helped her feel like it was keeping her throat open. She states that she felt restricted but was still able to breathe.
large bump noted to lt upper arm; father reports that pt does not complain; no redness or warmth noted to arm; father states that this is where MMR #1 was given 21APR93;
AFTER PT GOT COVID-19 JANSSEN VACINE HE IS WAITING IN WAITING AREA AND ALLOF SUDDEN HE PASS OUT FOR COUPLE SECONDS HIS WIFE WITH HIM AT THAT TIME WE GAVE WATER TO HIM AND OFFER JUICE AND EMERGENCY SERVICES BUT HE AND SHE REFUSE AND STATS THAT HE IS NOW ABSOULETLY FINE .
Received 2 vaccines 6/2/11 PNEUMOVAX RA, Tdap LA. Per pt fever 6/4/11 to 102 F-103 F, swelling, pain, warmth, redness RA. Eval 6/6/11 by MD. Started on methoxazole (allergy to PCN, clindamycin) 1 tab BID x 10 days. Area of redness marked. Eval 6/7/11 for increased redness & warmth beyond markings with limited ROM of Right arm. Only 3 doses of antibiotics at this time.
In September 2022, I went on a cruise, I got COVID-19 which was an extremely mild case and started getting sick on 09/14/2022. I was given PAXLOVID medication the day after I tested positive and within 5 days it was negative. I did not test positive until Saturday 09/17/2022. The week that I got COVID and PAXLOVID. On 10/04/2022 I had a complete CDC blood work, kappa light chain. I have since March 2022 I have been dealing with neuropathy in my toes. I was over the highest level where a person should be and my doctor wants to send me to the hematologist. There is something wrong with the protein in blood. My doctor said I have monoclonal neuropathy and have been referred to me a hematologist. I had a full CBC blood panel. I am concerned this can lead to leukemia or multiple myeloma. In 03/2022 I started to see a neurologist due to the numbness in my toes. I have covered from my COVID-19 symptoms.
Around 7:00 p.m., I became feverish, had chills with shaking. Covered up and fell asleep. When awoken at 11:30p.m., was feverish and confused. Temperature was 107.0 but as soon as cover was removed, temperature began to decrease. Was unable to stand without the help of two people and continued to be confused. Called 911 who found my blood pressure was elevated (150's), temp was 102.0. Was taken to emergency room by ambulance.
Numbness in hands and feet, advised Dr I thought it was Guillain-Barre, she said it may be a pinched nerve and prescribed Steroid, went back on 10/1, doctor suggested going to ER. Had CT scan, 3 MRI's and finally a lumbar puncture. diagnosed with GBS.
- Fever - Headache - Chills - Nosebleed - Congestion
immunocompromised patient received 0.25 ml as third dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient received 0.25 ml as third dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 20-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient received 0.25 ml as third dose). On 20-Aug-2021, ACCIDENTAL UNDERDOSE (immunocompromised patient received 0.25 ml as third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The physician stated that the booster should have been 0.5 ml but received 0.25 ml.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.