chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 38 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A ,and expiry: UNKNOWN) dose was not reported, administered 1 in total to the right arm on 02-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 36 years old. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received non-company suspect vaccine included: tozinameran (Pfizer vaccine) (Dose number in series 2) (batch number: FJ8757, and expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered to the right arm on 27-NOV-2021 for covid-19 prophylaxis.  On 27-NOV-2021, the patient experienced revaccination with different covid-19 vaccine (Dose number in series 2). On 2022, the patient experienced suspected covid-19 infection following vaccination with tozinameran (Dose number in series 2). The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered from 05-OCT-2022 to 10-OCT-2022 for treatment of COVID-19. No concomitant medications were reported. On an unspecified date in OCT-2022, COVID returned 7-8 days after finishing patient's last dose of Paxlovid and testing negative two consecutive days. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable and with Paxlovid was drug discontinued. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
fever 12 hours later interrupted menses (had been in progress, completely stopped from 12-36 hours after injection then resumed) loss of taste two weeks later, with no other symptoms and negative for COVID-19
Symptoms from vaccine: low fever, intense headache, extreme fatigue, very sore arm (couldn't lift arm for a few days), tingling sensation in left arm/hand/leg that would come and go, would get winded easily, chills, sweats. Most of the symptoms lasted 3-4 days but the extreme fatigue and sore arm lasted for a week. Symptoms were similar to when I had covid, but was surprised that some symptoms lasted a full week. Had to take off work for a few days.
Maybe it was sarcoidosis; Could be infection, but she is unsure; This is a spontaneous report received from a contactable nurse (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration on 15Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. On unspecified dates the patient experienced maybe it was sarcoidosis and could be infection, but she is unsure. The patient called to ask if there had been any reports of post vaccination autoimmune disorders or sarcoidosis developing. She reported that she received both doses of the COVID-19 vaccine and that she was "experiencing some unusual symptoms" that could be infection, but she was unsure. She stated that maybe it was sarcoidosis, but it was not diagnosed by a physician yet. The patient called to see if anything was reported regarding this. The clinical outcome of maybe it was sarcoidosis and could be infection, but she is unsure were both unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of infection and sarcoidosis  due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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.
fever of 103 for 3 days. reddness on injection arm continuing today.  Weekness also continuing today.
PARALYZED; STROKE/ BLOOD CLOT WAS IN BRAIN STEM AREA; This spontaneous report received from a consumer via a company representative via form and concerned a female of unspecified age.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 04-APR-2021, the patient experienced stroke. The blood clot was in brain stem area. She was now paralyzed, could not speak, could not eat and swallow food. It was reported by consumer that patient must be feed and take her meds through the feeding tube. The patient was completely depended on her husband and daughter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke/ blood clot was in brain stem area and paralyzed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220620875 -covid-19 vaccine ad26.cov2.s- Stroke/ blood clot was in brain stem area, Paralyzed . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
10/11/2010 5:00  pm. Musical ache, chills, fever and shortness of breath.No problems the next day.
pain on the arm; Swollen Lymphs on the same side of the arm as the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on the arm) and LYMPHADENOPATHY (Swollen Lymphs on the same side of the arm as the injection) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain on the arm) and LYMPHADENOPATHY (Swollen Lymphs on the same side of the arm as the injection). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain on the arm) and LYMPHADENOPATHY (Swollen Lymphs on the same side of the arm as the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported. Upon internal review on 4-Aug-21, the age was corrected to 47 years
mom went to WIC ofc p/shot given; as she was leaving building she noticed the baby was shaking & brought back to peds-tremors noted; 911 called pulse oxygen 97% to ER; MD impression underlying sz DO-prev episode of shaking noted by mom;
This spontaneous report as received from a 60 year old female retired nurse refers to herself with no drug reactions/allergies. The patient's medical history included rosacea. On 19-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot# not reported). Concomitant therapy included METROLOTION, 80 mg aspirin and ESTHEDERM patch. Sometime during the first week or second week of October, 2013, she developed pain in an area approximately the size of a half dollar that was very sensitive, "as if was a sting from a hornet". There was no redness or evident skin involvement and the pain moved from her back to her front, involving her left breast. She had burning pain on her skin surface, with excruciating sensitivity, stabbing pain in her left breast, excruciating pain in left nipple and in the ganglion under her left armpit. She further stated she couldn't wear a bra due to extreme sensitivity. At this time, the pain had mostly diminished with occasional burning pain at the original site on her back and stinging pain in left nipple. However, there was numbness under armpit and continuing neuropathy from her nipple line to above her pubic area on her left side. Patient sought medical attention by seeing her physician for further consultation. She stated she had information that she might need to have a spinal tap done for verification of disease involvement. TYLENOL and MOTRIN was given as treatment. And there was no lab diagnostics studies performed. The reporter considered the adverse events to be disability. Additional information has been requested.
Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient with hearing loss (had hearing aid) and myopia and a history of migraine convulsion and bipolar disorder who in February 2011, was vaccinated with the first dose of GARDASIL (lot number, dose and site of administration not reported). In April 2011, the patient was vaccinated with the second dose of GARDASIL. In September 2011, the patient was vaccinated with the third dose of GARDASIL. No adverse events were  reported and no other information was provided from the nurse practitioner. No treatment was given for the adverse event. The patient sought unspecified medical attention. The LMP was on 15-JUN-2011 and EDD was on 21-MAR-2012. Additional information was received from a nurse practitioner  regarding pregnancy outcomes. The patient gave birth to a full term healthy baby girl on 11-MAY-2012 with no congenital anomalies reported. Her corrected EDD determined by ultrasound was 15-MAY-2012. LMP was on 09-AUG-2011. The baby weighed 6 pounds (lbs) 11 ounces (oz). The infant's APGAR scores were 8 at one minute and 9 at five minutes. Upon delivery, the infant was noted to be a normal, healthy newborn. The patient delivered vaginally without complications. The patient was exposed to GARDASIL during trimester 1. Additional information is not expected.
20FEB99 loose stools x 2 days, fever 101 x 2 days, rash red faint lower abd (blanches w/pressure, alert given antipyretics;22FEB99 sl inc rash, T fluctuating 100-101, still w/diarrhea 1-2xday;25FEB99 rash improving pt w/diarrhea;
Narrative:  COVID infection following COVID vaccine series 06/18 Janssen, dose #1 10/04 pt admit to medicine cc: "altered mental status and diarrhea" dx: COVID pneumonia LOS: 18 10/04 COVID swab, result, detected 10/04 CXR Impression: No acute cardiopulmonary disease. Please note that subtle groundglass opacities associated with viral pneumonia may not be visible on plain radiography 10/05 CXR Impression: Low lung volumes with bibasilar streaky densities and diffuse prominence of pulmonary interstitial markings, increased compared to 10/04/2021. This could represent atelectasis and vascular crowding related to low lung volumes although infectious/inflammatory process or other process not excluded by radiography. 10/06 CXR Impression: Stable bilateral patchy consolidation and groundglass densities (history of Covid). 10/07 US EXTREMITY Impression: Negative examination for thrombosis in the bilateral lower extremity veins listed above. 10/09 i-pH 7.53, i-PCo2 28.1, i-PO2 61, i-HCO3 23.7 08/03 pt cc: exposure: unknown 10/05 i-pH 7.38, i-PCo2 26.6, i-PO2 67, i-HCO3 15.9 10/06 BNP: 30.3 10/08 CXR impression: 1. Patchy bilateral airspace opacities have decreased. 10/09 DDIMER: 1.73 10/09 PROCALCITONIN: 0.24 10/09 CXR impression: 1. Obscuration of the left hemidiaphragm suggestive of left lower lobe consolidation. Findings may be related to atelectasis though superimposed infectious process is not excluded. 10/09 CTA PE impression: No evidence of pulmonary embolism. 10/11 CXR impression: Interval worsening of mixed interstitial and airspace opacities, consistent with COVID pneumonia. 10/13 FIBRNOGEN: 440 10/13 DDIMER: 1.04 10/15 FIBRINOGEN: 515 10/15 i-pH 7.44, i-PCo2 37.8, i-PO2 70, i-HCO3 26.4 10/15 DDIMER: 1.08 10/15 PT/INR 12.9/1.15 10/16 FIBRINOGEN: 515 10/16 DDIMER: 1.43 10/17 i-pH 7.25, i-PCo2 67.7, i-PO2 89, i-HCO3 29.8 10/17 FIBRINOGEN: 638 10/17 DDIMER: 1.34 10/17 i-pH 7.28, i-PCo2 63.3, i-PO2 87, i-HCO3 29.4 10/18 PROCALCITONIN: 0.33 10/18 FIBRINOGEN: 586 10/18 DDIMER: 1.79 10/18 LACTIC ACID: 2.39 10/18 i-pH 7.36, i-PCo2 56.5, i-PO2 79, i-HCO3 31.7 10/19 LACTIC ACID: 2.88 10/19 i-pH 7.22, i-PCo2 80.4, i-PO2 66, i-HCO3 33.3, 10/20 FIBRINOGEN: 658 10/20 DDIMER: 2.42 1020 LACTIC ACID: 2.32 10/21 i-pH 7.28, i-PCo2 70.3, i-PO2 58, i-HCO3 33.1 10/21 i-pH 7.31, i-PCo2 63.9, i-PO2 48, i-HCO3 32.5 10/22 PROCALCITONIN 2.94 10/22 FIBRINOGEN: 638 10/22 DDIMER: 14.31 10/22 LACTIC ACID 2.13 10/22 i-pH 7.19, i-PCo2 85.7, i-PO2 42, i-HCO3 32.7 10/22 pt deceased
After the Pfizer dose 1, 02/04/2021 EL9261, intramuscular, Left deltoid,  and dose 2, 02/26/2021, Pfizer EN6198, intramuscular, Lt Arm. I noticed symptoms-itchy scalp, muscle aches, joint pain, brain fog, crud in my eye lid. I did not have any of these symptoms prior to Dose 1. Most of it was on the right side of my body. Definitely a pain on my right side. I had a CAT scan- everything turned up normal. I had pain on the top of my thighs and shins. I had interrupted sleep because of that pain. After the 3rd dose, on 09/29/2021, all the symptoms were exacerbated. I went to see my doctor and she thought the symptoms were all discreet. And because my father had died in July, the doctor thought this was all in my head. She recommended physical therapy, emotional therapy and a chiropractor. The PT prescribed exercises to mitigate the pain in my thighs and the chiropractor prescribed natural supplements. The biggest symptom was fatigue upon exertion. Anytime I tried to take a walk I was just wiped out. It was beyond just fatigue, every time after any activity, I had to have a nap. After dose 3, I was making great progress, after the PT and chiropractor visits. Then after the 4th booster on April 8, 2022, everything came back, along with tingling in my hands and feet. The treatment with the chiropractor is ongoing. I stopped the emotional therapist and the PT. Today is kind of the 1st day that I felt pretty good. I will see my chiropractor on 5/12/2022. The pain on my right side has just abated just in the last few days. I don't feel like my muscle strength is there. I don't think think my legs are going to hold me. In PT I have learned that my muscle strength is intact. There is like a disconnection between my brain and my muscle legs. The PT has  helped to relax my muscles. I am getting them to unwind. And the General physician is ongoing.
This patient complains of painful right arm from neck to fingers with difficulty lifting arm due to the pain. The patient has not yet sought treatment. She was advised to have her physician evaluate.
11/23/2021 Resident noted to have garbled speech, slight weakness to R arm, pupils fixed, R side weaker than L
2 days after receiving vax on 10/20/97, patient developed inject site rxn of induration, swelling,  itching, redness and warmth. This is 1 of 8 employees of the facility to develop and inject site using lot #4978139
(L) upper arm swelling after DTP/AP/polio/Varicella with diffuse erythema of (L) upper arm and shoulder. Very warm to touch. Denied pain-when seen at ED 4/24/10.
Death  5/21/2021 Causes of death listed on death certificate 1) COVID-19  2) ARDS  Other: Lung Transplant for cystic fibrosis
Patient received Pfizer COVID-19 vaccine instead of the Moderna for his 2nd dose. No reactions noted during the observation period.  Patient was discharged in stable condition. Patient was called at home an hour later and denies any problems. Advised to continue to monitor self; any  severe symptoms, to go the  ER. To follow up with PCP as needed. Also, instructed to call the clinic if any questions or concerns.
About 3 minutes after receving the vaccine patient was losing consciousness. Patient looked very pale and lips were turning blue/purple. We laid the patient flat on the ground and gave him some space and called 911 right away. Paramedics arrived within 5-10 minutes and by the time they came patient regained consciousness but was telling them he was feeling very weak and numb.
About 6 months after vaccine (did not have any initial reactions to vaccine), itchy rash that covers entire torso, breasts, back, buttocks, and back of thighs, still continuing this whole time. Never had previous allergies or had rash, have been to doctor and dermatologist who has diagnosed with hives, zyrtec daily and steroid pack. The rash has not left, plans to go to third doctor.
When doing initial assessment on 14 y/o F skin color pale cool classy. Complaining of nausea/vomiting went unresponsive with eyes rolling back.  Increased voice level to arousal.  Assisted pt to W/C with assistance to stand pt to cot.  4 sets of vitals with return of Pink warm dry skin.  Orthostatics were done with a positive sustained heart rate while standing.   Walked patient out to car without incident.  Recommended if recurring syncope, fevers, N/V/D TO call 911 or go to Urgent Care.
ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 9/1/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Just like I had the flu), PALPITATIONS (Heart was racing), PYREXIA (Fever), MYALGIA (Severe body aches) and VOMITING (Throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Just like I had the flu), PALPITATIONS (Heart was racing), PYREXIA (Fever), MYALGIA (Severe body aches) and VOMITING (Throwing up). At the time of the report, INFLUENZA LIKE ILLNESS (Just like I had the flu), PALPITATIONS (Heart was racing), PYREXIA (Fever), MYALGIA (Severe body aches) and VOMITING (Throwing up) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. Treatment medication was not provided by the reporter. Reporter did not allow further contact
MODERATE CHEST PAIN; MODERATE UPPER ARM PAIN; FELT LIKE PULLED MUSCLE; This spontaneous report received from a patient concerned a 66 year old male. 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: 1802068, and batch number: 1802068 expiry: 25-MAY-2021) dose was not reported, once a total administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced moderate upper arm pain. On 09-MAR-2021, the subject experienced moderate chest pain. On 09-MAR-2021, the subject experienced felt like pulled muscle. Treatment medications (dates unspecified) included: menthol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from moderate upper arm pain, moderate chest pain, and felt like pulled muscle. This report was non-serious.
No known adverse effects; on 10/05/2011, a 4 month old patient received a dose of VAQTA; This spontaneous report was received from a medical assisstant referring to a 4 month old patient of unknown gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.    On 05-OCT-2011, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) (dose, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). There was no known adverse effects.
11/20/21-11/24/21 high fever 103, loss of appetite, lethargy, aches, headache, coughing 11/25/21-11/27/28 loss of appetite, lethargy, headache, coughing (lost total 9lbs) 11/28/21 started eating a little, lethargy, coughing 11/29/21-12/4/21 slowly recovered
Within 48 hours I experienced my first 'zing' while brushing my teeth with an electric toothbrush.  As the days passed, the zing got worse, settling in my upper jaw on the left side of my face.  I went to 2 dentists (although the pain was different than dental pain) and had xrays both times, a mouthguard was also made to wear but they determined that it wasn't dental related. I got a referral to a neurologist, who sent me to get a head MRI, to rule other things out.  It was determined that my pain was probably Trigeminal Neuralgia (maxillary branch), and I was put on Carbamazepine.  I did half dose for 2 days then full dose. I did not tolerate it well, I was so zonked out that all I wanted to do was sleep, totally lost track of conversations and became unsteady on my feet.  I stopped after 9 days, as it had no effect on my nerve pain.  Today the pain is at a 7, my neurologist is sending me to a neuro-surgeon, and my chiropractor suggested that I send in this form.