chrisvoncsefalvay/vaers-outcomes huggingface dataset:
postural orthostatic tachycardia syndrome; experienced symptoms of syncope; Collapse; Heart palpitations; Dizziness; Initial information regarding an unsolicited valid serious case received from the other healthcare professional via phone at call center (Reference number: US-SANOFI-00426245) on 12-Jan-2021.  This case involved a 19-year old female patient who experienced postural orthostatic tachycardia syndrome, after receiving INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (FLUZONE).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient received no concomitant medications.  On 19-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED 0.5 mL multi-dose vial (lot number: UJ477AB, expiry date: 30-Jun-2021) via an unknown route in the right deltoid for prophylactic vaccination.  On 22-Oct-2020, 3 days following the suspect product vaccinations, the patient experienced symptoms of syncope, collapse (Fall), heart palpitations (Palpitations), and dizziness. Reporter that the patient had visited the emergency room. After being symptomatic for a while, the patient was seen at the reporting primary care practice on 12-Nov-2020, where an electrocardiogram was performed, which was abnormal. Patient was referred to a neurologist on 11-Dec-2020, Doctor who suspected postural orthostatic tachycardia syndrome (POTS), and the patient was referred to Genetics on 21-Dec-2020.   On 21-Dec-2020, 2 months 2 days following the suspect product vaccinations, at genetics, patient underwent a tilt table test, which confirmed postural orthostatic tachycardia syndrome (POTS). Patient had a follow-up appointment with neurologist on 28-Dec-2020.   Final diagnosis was postural orthostatic tachycardia syndrome.  The event of postural orthostatic tachycardia syndrome associated with accompanying symptoms of syncope, palpitations, dizziness and fall were assessed as important medical event as the accompanying symptom of syncope was assessed as medically significant as per important medical event list.  It was not reported if the patient received a corrective treatment.  Outcome of the event of postural orthostatic tachycardia syndrome with its accompanying symptoms was unknown.  The neurologist and other members of the patient's healthcare team believe that the patients POTS was related to the Fluzone vaccine the patient received.; Sender's Comments: This case involved a 19-year old female patient who presented with postural orthostatic tachycardia syndrome (POTS) accompanied with symptoms of fall, dizziness, syncope and palpitations three days (although  diagnosed on a later date) following INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (FLUZONE). Time to onset is compatible. Although, medical history, comorbidities, concomitant medications, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
11/28/17 started w/nausea. 11/29/17 fever 101 (ear temp), periods of sweat and chills. L arm sore and tender to touch. Took ADVIL during the day and ADVIL PM at nite. 11/30/17 temp 99. Then dropped to 94. White finger tips and toes. Temp in evening 100 ADVIL PM. 12/01/17 went to PMD. (Temp 99.0 oral) who said it may be cellulitis and noted to be red, swollen, with a streak going down. Prescribed BACTRIM. Started at 11:00 AM 1 tab every 12 hour.
- Fever (101.9 highest recorded) began morning after vaccination, lasted more than 4 days. Acetaminophen & Ibuprofen reduced temp to 99s, but spiked back to 101 when medicine wore off.  - Cough began morning after vaccination. Began as occasional dry cough. Developed to more frequent productive cough and hoarseness over the next few days.  - At-home COVID-19 test on 12/23/2022 was negative. - Went to facility on 12/24/2022 (day 4 of fever). Lungs good. All vitals good (was using fever reducing medication). RSV and Flu test done (results negative). - Fever continued until 12/25/2022.  - Cough continued through 12/28/2022, but was much improved by 12/26/2022.
Arm pain at injection site. Continuous from 4/9  at 9pm.   Fever 99-101, with body aches, from 4/10 2pm-4/11 4am  Swollen lymph node in left armpit, with pain. Onset 4/10 at 5pm.
beginning after one week, I was in bed with a fever and chills every week or ten days for approximately 6 months.  The same thing plus other reaction problems happened after I had the first two Pfizer doses.  I was in bed asleep mostly all day on the days this occurred.  Then i was about 50% of normal for a few days recovering to about 80-85% before the next fever and chill episode.  I underwent every test the doctors (many doctors in various specialties) could think of.  All tests normal.  Two doctors recently retired from Clinic who did not see me, said it sounds to them like "vaccine-induced long covid).  So since I got the second Pfizer shot on 2/19/21, I have been in bed like this every 7-10 days.  I am now 8 months from the Sept booster and feeling mostly back to normal.  Episodes are milder and coming every 3 weeks instead of weekly.  This happened last August as well, but started again shortly after I got the booster on Sept 24 and have lasted about seven months.  Not the worst thing in the world but a lot of time in bed and a lot of time not up to normal.    I now need the 4th booster but not looking forward to what I will need to go through once I get it.
received an MMR vaccine in hopes that if they contract COVID-19; This spontaneous report was received from a patient of unknown age and gender referring to himself or herself. Information about medical historyand concomitant therapies was not provided.      On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) on the advice of the patient's physician in hopes that if the patient contract coronavirus disease 2019 (COVID-19) the patient may possibly have an attenuated response to that disease based on a current plausible medical theory (product use in unapproved indication).
Same restricted mobility as first dose on left arm near vaccination location lasted 24-48h after second dose. Persistent fatigue (not after first dose), specially arms and legs.  No other side effects until 06/1@8:00am blood in stool, foul-smelling. Usual shape/color.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a physician 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:unknown, expiry: unknown) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. The patient did not receive any concomitant medications.  It was reported that the physician was providing antibody test 4 to 6 weeks after receiving the JANSSEN COVID-19 VACCINE on all office staff and immunosuppressed patients. The antibody test was named. The patient received antibody test 7 weeks after receiving the JANSSEN COVID-19 VACCINE. On an unspecified date, he experienced confirmed immunological vaccine failure and the laboratory data (dates unspecified) included: antibody test (NR: not provided) with result as 0 antibodies (negative). The MD (Doctor of Medicine) was telling all the patients to function as if they never had received the vaccine at all. The physician knew that the vaccine did not had to go in the freezer, but it can only be out of the fridge for 2 hours and suspects that these people received vaccine that were in prefilled syringes and kept out of the refrigerator for more than 2 hours, thus rendered them useless. The physician wanted for his patients to be able to get a booster of Pfizer or Moderna and would like a medical director from JnJ (Johnson and Johnson) to directly call him to discuss regarding these tests. The physician already called the CDC (Centers for Disease Control and Prevention). It was reported that the patients who received Pfizer and Moderna produced strong results. It was reported that the patient was a healthy individual. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to.; Sender's Comments: -COVID-19 VACCINE -Confirmed immunological vaccine 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
This spontaneous report as received from an office manager refers to a 5-year-old female patient. Her medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 04-APR-2018, the patient was vaccinated with a dose of Oka/Merck VARIVAX (dose, route and site of administration, lot number and expiration date were not reported) that was reconstituted with an improperly stored sterile diluent (dose, route and site of administration were not reported, lot # M009799, expiration date: 11-SEP-2018). The sterile diluent was stored in temperature below 32 Fahrenheit degrees (F) (-11 F) for 120 hours. There was a previous temperature excursion of 32 F up to 35 F (34.5 F) for 45 minutes. Temperature excursion occurred as a result of a reading from a Digital Data Logger. It was confirmed that Oka/Merck VARIVAX had no temperature excursion prior to being administered. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1804USA004764: US-009507513-1804USA013048.
Information has been received from a pharmacist concerning a 67 year old female with leukemia and an allergy to heparin who on 08-MAY-2008 was vaccinated with zoster vaccine live (Oka/Merck) 0.65 mL subcutaneously (Lot 659760/0159X). Concomitant therapy included lisinopril (MSD), iron (unspecified) and PROTONIX. On 10-MAY-2008, the patient developed an injection site reaction approximately 2 X 2 inches in area after receiving zoster vaccine live (Oka/Merck). There was redness and hardness underneath the injection site. The patient was told to take BENARYL. The patient had a complete blood count on 08-May-2008; the results were normal. The pharmacist did not know if the patient's leukemia was in remission. The patient will be having a follow-up appointment with her physician for the injection site reaction. At the time of this report, the patient had not recovered. Additional information has been requested.
A pediatrician reported that a 2 month old female received a dose of Prevnar, DTaP, Comvax and IPV vaccines on 27-SEP-2001. On 14-OCT-2001, at the age of three months, the child was found apneic. Resuscitation measures were performed by the child's mother and by emergency personnel prior to transporting the child to a local ER where she was pronounced dead. Bacterial CSF and blood and viral culture samples yielded negative results. An autopsy returned inconclusive but sudden infant death syndrome was possible. This report of a serious, labeled event is being submitted in a 15-day time frame as requested by the FDA.  COD as per autopsy report -- undetermined. Follow-up info from a physician stated that her practice, "did not have any concerns regarding the haemophilus b conjugate vaccine hepatitis b vaccine recombinant. Additional info from a nurse in the physician's office stated that this pt, who was previously healthy, received haemophilus b conjugate vaccine hepatitis b vaccine recombinant. Additional info from a nurse in the physician's office stated that another infant (WAES 0203USA00661) also received Hib + Hep-B (lot 638216/1539K) and Prevnar and died of SIDS. The physician's office reported that they did not believe there was any association with Hib + Hep-B, but that both infants received the same lot of Prevnar. This report was also received from the Center for Biologics and Evaluation and Research and was assigned Vaers Id 180019. F/U info noted that there was no illness at the time of vaccination. The pt died of apparent SIDS, 2 1/2 weeks, post vax. The autopsy report was SIDS vs. anphyxia. The reporter listed the cause of death as SIDS. No further information is available. The follow up info received on 12/30/02 indicated that the pt's birth weight was 4 lbs 15 oz, it was also reported that the pt was a "second twin," had hyyperglycemia, hyperbilirubinemia and was premature at 35 weeks gestation. No further info is available.  Follow up on 10/20/2003: "This report was received from Wyeth Ayerst for streptococcus pneumoniae vaccine (Prevnar) and assigned manufacturer report number HQ9063604DEC2001 (also noted to be HQ9063504NOV2001, HQ7304118OCT2001 & HQ0646611FEB2002).  This report is concerning a 10 week old female."  A 15-day report received 10/24/2003 adds no new info.
I became suddenly very dizzy, passed out, and woke up on the floor. I don?t remember falling. When I woke up I had bladder incontinence, was very dizzy, and became nauseous. I threw up over night from dizziness. Today I am still dizzy.
Upon receiving vaccine patient c/o feeling flushed.  BP 124/70, HR 110, RR16, 95%O2Sat.  Skin warm and dry. good cap refill.  Pt placed supine cool cloth to forehead.  Repeat vital signs  BP 120/72, HR 115, RR 16, 96%O2Sat.  Skin warm and drMy, breath sounds clear bilaterally.  Pt tolerating sips of water.  Cool cloth of forehead.  Vital signs repeated: BP 112/.70, HR 99,  RR 16,  97%O2Sat.  Skin warm and dy.  Patient discharged home accompanied by husband.
One week after Vaccine #1 I began to have swelling & itching of the face-eyes, lips and cheeks, extreme itching of both hands, massive diarrhea and some difficulty swallowing. I took oral benadryl (50 mg) and prednisone (@ 50 mg) and applied cold packs to my face and hands. I also took Allegra 180 mg LA 2x/daily for two weeks after the reaction. Vaccine dose 2 was administered on 2/17/2021 (Pfizer, Lot # EN6201) at Hospital, . One week after that (2/25/2021) I again had facial swelling and itching and massive diarrhea. I took Benadryl 25 mg and Allegra 2x/day and continue to do so.  The facial swelling/itching continued.             In addition I had, since the first vaccine, extreme fatigue, resulting in a decrease in my ability to walk (down from 3 miles to just over 1 mile) and to swim (shortness of breath, reduction in ability to swim laps). I visited my Rheumatologist on 3/2/2021 and he administered an injection of methylprednisolone to try and tamp down the continuing reaction. That seems to have made a difference.
Mom reports pt had slight fever the evening p/the immun 22FEB91 but no other adverse signs;
BLURRED VISION; This spontaneous report received from a consumer concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included blurred vision. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blurred vision. This report was non-serious.
Patient started complaining of being short of breath, weak and dizzy a day or two after receiving the shot.  He started taking the asthma inhaler constantly rather than just once in months.  He lay down for a nap and never woke up exactly 3 weeks after getting the shot. (more exact details will need to come from his wife).
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/14/2022 LEFT FEMORAL NECK UNSPECIFIED TYPE FX, INIT RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/2/2022 LEFT FEMORAL NECK UNSPECIFIED TYPE FX, INIT CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/14/2022 LEUKOCYTOSIS RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/2/2022 LEUKOCYTOSIS
I experienced numbness in my right hand. It switched between my hand and 2 middle fingers. Since I have had covid, my nose would run off and on. My head would hurt and I always had some type of congestion and high bpm. When I received the shot, my congestion and runny nose dried up. It felt as if the shot was pulling something through my veins and drying up the congestion instantly and clearing up my head congestion as well.
A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache the next day.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) headache the next day.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache the next day was unknown.; Sender's Comments: MOD_2021_018652:
Blood Clot leg/broke off went to lung  Blood thinner    Very weak tired cough Emergency room 4/72021  hospital two days 372021-3/9/2021
Patient experienced radiating pain over her entire arm. She mentioned having similar side effects with her first 2 vaccines but was not aware they were from the vaccine at the time. After her 3rd dose, she experienced the same but worst pain.
specific side effect swelling in the face, eyes and nose; specific side effect swelling in the face, eyes and nose; specific side effect swelling in the face, eyes and nose; itching in her throat; Cough; This is a spontaneous report from a contactable consumer or other non hcp. A 24-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EP7533), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 16:15 (Age at vaccination: 24 years old), as DOSE 1, SINGLE for covid-19 immunisation . Medical history included food allergy, complex regional pain syndrome. Concomitant medication(s) included duloxetine (DULOXETINE) taken for complex regional pain syndrome from an unspecified start date and ongoing.  Prior Vaccinations within 4 weeks not any other vaccinations administered. On 25Mar2021, patient stated that she got first dose of the Pfizer Covid vaccine yesterday at 4:15 PM, states she woke up this morning, her face was swollen, her eyelids and in between bridge of nose specifically, states she has had a reaction like this before to environmental allergies, states she was allergic to tree nuts but not any medications. Stated her throat was kind of itchy and had a cough last night that has now resolved. She was breathing fine.  The outcome of the event cough was recovered and rest all event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe arm pain at injection site as well arm. Fever 100.7. Pain affected ability to participate in usual activity, continues for 5 days and left large lump on arm.
Patient was administered the Pink Cap Moderna Bivalent COVID-19 vaccine instead of the Blue Cap Moderna Bivalent COVID-19 vaccine on Friday, June 9th, 2023.  Upon audit on June 12th, 2023, the error was found and mother was immediately contacted via phone call. Mother did not report any side effects and scheduled to bring patient back to receive the correct Blue Cap dose on Monday, June 19th, 2023.
Report of fever and body aches 4 hours post vaccination. Treatment include Tylenol outcome: complete resolution of symptoms
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting CHILLS AND SWEATING, ARM PAIN Narrative:
I experienced soreness in arm, fever, chills, fatigue, and, cough. I was not prescribed any medication for my symptoms. These symptoms persisted for 3 days before they resolved. I am fully recovered with no lingering symptoms.
Information has been received from a physician and a medical assistant concerning a female patient who on approximately 21-MAR-2011 ("last week") was vaccinated with her second dose of GARDASIL (lot # not reported). On approximately 21-MAR-2011 immediately after receiving the vaccine, the patient fainted. The patient did not seek medical attention. Subsequently, the patient recovered from faint on an unspecified date on therapy (also reported as no treatment was given to the patient). The physician reported that the patient did not have any adverse effect from the dose of GARDASIL vaccinated on an unspecified date. The medical assistant contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose number, lot number and date of event. The medical assistant was asked to speak with the physician to see if the identities could be determine so that additional details might be obtained. Additional information has been requested.
Patient complained of arm soreness and chills after she arrived home yesterday, about an hour following her vaccinations. She said she had chills and body aches last night and today. She said her left arm is tender, even on the inside of the arm and still has a lot of weakness, chills and aching.
I received my first vaccin 4/2/21 and second 4/23/21. At the time of each vaccine I had severe injection site pain which turned into greater arm and shoulder pain. Pain lasted approximately 4 days each vaccine. In late June I could no longer move my arm, head, neck and was in extreme pain. 10 out of 10. I called my husband's shoulder surgeon and received an appointment 2 days after the call (call on 6/21/21, appointment 6/23/21). I was diagnosed with  adhesive capsulitis or "frozen shoulder". I was given a cortisone shot and prescribed physical therapy. After approximately 3 days I was able to move my arm, head and neck again but was still in extreme pain. 8 out of 10. I started physical therapy on 6/28 and as of 7/9 will have completed 4 physical therapy sessions. I have 2 remaining. My pain level is lower, perhaps 2 of 10 and my range of motion is improved.