chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Painful continuous spasms in left sacro iliac region; Painful continuous spasms in left sacro iliac region; This is a spontaneous report from a contactable consumer, the patient. A 81-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 20Mar2021 (at the age of 81-year-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis lower spine, cancer. Concomitant medications included ramipril (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and pravastatin (MANUFACTURER UNKNOWN) all started from unknown dates and for unspecified indication. The patient had known allergy to sulfa drugs. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 26Feb2021 (at the age of 81-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021, at 04:00, two days after second dose, the patient experienced painful continuous spasms in left sarco-iliac region of back lasted all day and declined in severity over next few days. On the day of report, almost after 4 weeks of vaccination, the area was still painfully sore. On 01Apr2021, the patient underwent Nasal Swab COVID-19 virus test and the results were found to be negative. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as the result of adverse events.  The clinical outcome of the event's painful continuous spasms in left sarco-iliac region of back was recovering with sequelae.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
After receiving the vaccine, the patient felt dizzy and fell to the floor in her father's arm. He lifted her into his lap and sat with her. After a few minutes, the patient vomitted. We let her finish and cleaned her up, wiping her face with wet paper towels. We gave her water and had her take only a few sips. The patient sat with her father until she felt ok to stand up and walk out.
Mild pain started about 8h after vaccination with the COVID-19 vaccine at the side of vaccination (left arm); This is a spontaneous report from a contactable consumer (patient himself). A 38-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3247, expiration date was unknown), via an unspecified route of administration in the left arm on 27Jan2021 at 13:00 at a single dose for COVID-19 immunization. The vaccine facility type was reported as the workplace clinic. The patient's medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination. The patient was not tested for COVID-19 post-vaccination. On 27Jan2021 at 21:00, the patient experienced mild pain started about 8 hours (8h) after vaccination with the COVID-19 vaccine at the side of vaccination (left arm). The patient did not receive any treatment for the adverse event (AE). The patient was recovering from the event.
Pt. received 3rd HPV vaccine in (R) deltoid 6/27/13, swelling started 6-27-13. Two days later 6/29/13, was evaluated by physician c/o mild discomfort with movement. Pt. had been swimming as well. No fever, no URI. Tx ice, ibuprofen, BENADRYL.
Began with worsening of pain to injection site, then pain spread throughout arm. Shortly after began with body aches, chills and fatigue, then incontrollable shivering and fever of 101 F.  Continue with fever next day and redness/swelling to arm, body aches. Low grade fever, fatigue and body aches continue through today (3 days), but feeling way better than before.
covid19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid19) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In July 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid19). At the time of the report, COVID-19 (covid19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. On an unknown date patient received Moderna Covid-19 Vaccine.  Suspect product dosage text was reported as unknown. It was reported that patient had some mild symptoms, achiness, muscle aches, fatigue, no respiratory issues. No treatment medication was reported.   Reporter did not allow further contact
approx 5min p/vax pt sat down in waiting area & passed out;when pt came to a few seconds later, c/o tightness in chest;pt was seen by MD & released;
High degree of muscle pain for 48 hours around the injection site; within a week possible exacerbation of athritis leading to an unusual flare of severe unexplained arthritis pain resolving just prior t 2nd sot at week 4 - severe in all sites with preexisting hx of osteoarthritis in  multiple limbs and multiple joints
The first attempt at administering an Intradermal dose did not yield a wheal. Shortly after the dose was administered the patient reported feeling lightheaded and dizzy. The patient also appeared pale. The duration of the symptoms lasted approximately 5 minutes. A second attempt of ID was successful and the patient reported that their symptoms resolved.
This is in follow-up to report(s) previously submitted on 11/14/2006. Information has been received from a healthcare worker concerning a 72 year old female breast cancer survivor with high blood pressure, high cholesterol, sulfonamide allergy and streptomycin and NORFLEX allergies and a history of kidney stone and on 30-AUG-2006 at 14:00 PM was vaccinated SC in the right arm with a 0.65 mL first dose of ZOSTAVAX (Merck) (lot # 652965/0622F). Concomitant therapy included celecoxib (CELEBREX), lisinopril (ZESTRIL), hydrochlorothiazide (manufacturer unknown), lovastatin, verapamil, tamoxifen citrate, and loratadine (CLARITIN). There was no illness at the time of vaccination. On 30-AUG-2006, the patient developed a "very large spot that was red, raised and itchy." No fever was noted. The patient took diphenhydramine hydrochloride (BENADRYL), but the spot was still present at the injection site as of 30-OCT-2006. The spot was smaller, but still present. The patient did not seek medical attention and no diagnostic laboratory tests were performed. The patient has no known adverse events following prior vaccination. There was no product quality complaint involved. Additional information has been requested. Additional information has been received from the healthcare worker who reported that the immediately after the patient's immunization, in the early evening of 30-AUG-2006, the site was softball-sized and interfered with her sleep. One month later, her injection site was still itchy, red, and raised. The patient recovered in October 2006. No further information is expected.
pt recvd vax & arm began to swell & turn red approx 30 min after vax; pt taken to md; fever ranged from 99 to 100 per mom; pt exp also n & v approx 30 min after vax;
PATIENT RECEIVED FIRST COVID VACCINE (MODERNA) BUT SYRINGE WAS DEFECTIVE AND LEAKED DURING ADMINISTRATION. PER IMMUNIZING TECHNICIAN "ABOUT 20 PERCENT WAS GIVEN AND THE REST DRIPPED DOWN HER ARM" PER THE CDC COVID-19 VACCINE ADMINISTRATION ERRORS AND DEVIATIONS FACT SHEET: IF LESS THAN HALF THE DOSE WAS ADMNISTERED - ADMINISTER THE AUTHORIZED DOSE IMMEDIATELY IN THE OPPOSITE ARM. NOADVERSE EVENT REPORTED
pt recvd vax 5AUG92 w/no noted problems; pt recvd 2nd dose of vax & devel swelling in lt arm from the shoulder to the mid upper arm;
was sick as a dog; Initial information was received on 13-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves a patient (unknown demography) who was sick as a dog (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatments, concomitant medications, vaccinations 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 date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick as a dog (illness, non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that the patient had not got one since and had been fine every flu season.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Patient presented with facial droop and slurred speech.  Workup was was negative for acute stroke. Patient was noted to have COVID-19 incidentally. Neurology has evaluated this patient for the facial droop and evaluation of a stroke and subsequently have determined that the patient has transient ischemic attack in the setting of COVID-19.  Acute cerebrovascular accident was ruled out.  He was recommended to continue dual anti-platelet therapy with outpatient follow-up.
Breakthrough COVID-19 case: I started feeling achy in my arms. Like if I had done 50 push ups. Then I started to feel like I was getting the Flu or a Sinus infection. I had post nasal drip that was causing a sore throat and a wet cough. I did not have an appetite and I was tired. I took some Sudafed and an over the counter expectorant. It did work very well. On 05/10/2022, I decided to go to the pharmacy and test for COVID-19 and it came back negative. On 05/12/2022, I took a rapid test and it came back positive. The next day I went into a drive through test site and did a PCR test and it came back positive as well. On Friday 05/20/2022, I tested myself twice and they came back negative. I also went back to the drive through test site and tested negative again. My throat are still a tiny bit sore and my muscles are still sore.
rash lt arm-1 wk, Triamicinolone cream; swelling glands-2 days; joint stiffness 2 days; hearing loss-4 wks, Ceclor, Guiatex, ATB ear suspension;
This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No current condition was reported. No pertinent medical history was reported. On 03-SEP-2014, the patient was vaccinated with VARIVAX (Merck), .5 ml, subcutaneous. No concomitant medication was reported. On 03-SEP-2014, the patient received improperly stored VARIVAX, exposed to 23F for 3 hours. No adverse effects were reported. The outcome of patient received improperly stored VARIVAX was unknown. No further information was provided. No PQC was involved. This is one of the several reports. Additional information has been requested.
Left lower lobe pneumonia, diagnosed 3 weeks later. Symptoms began 2 weeks after vaccine administered. Fever/cough and bronchospasm.
red at the injection site; Rash at the site of shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at the site of shot) and VACCINATION SITE ERYTHEMA (red at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031220A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (her lymph nodes were taken out) and Lymph node excision. Concurrent medical conditions included Penicillin allergy, Drug allergy (Sulpher), Drug allergy (Codeine), Tremor and Acid reflux (esophageal). Concomitant products included ESOMEPRAZOLE for Acid reflux (esophageal), NADOLOL and TOPIRAMATE (TOPAMAX) for Tremor.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at the site of shot). On 18-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red at the injection site). The patient was treated with ACETAMINOPHEN at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site rash, at a dose of UNK dosage form. On 15-Jan-2021, VACCINATION SITE RASH (Rash at the site of shot) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red at the injection site) had resolved. Not Provided          Reportedly, diphenhydramine and antihistaminic were rubbed on the site of shot and rash on the site of shot    Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Additional information received included: reporter details, Patient demographic details, Medical history, concomitant medication, Vaccination dates, lot# event start date, stop date, outcome and treatment details.
Elevated thyroid levels; This spontaneous case was reported by a consumer and describes the occurrence of THYROID FUNCTION TEST ABNORMAL (Elevated thyroid levels) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced THYROID FUNCTION TEST ABNORMAL (Elevated thyroid levels). At the time of the report, THYROID FUNCTION TEST ABNORMAL (Elevated thyroid levels) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Thyroid hormones test: Elevated.     mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication was reported.  The co-suspect Humira formulation was reported as solution for injection in pre-filled pen. It was unknown if patient was enrolled in COVID-19 Vaccine Trial.  No treatment information was reported.  The reporter causality for event Elevated thyroid levels with co-suspect Humira was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
A 16 year old female pt experienced post exertional fatigue (with symptoms being very tired and needing to sleep more), headache, swollen glands, and shortness of breath after receiving RabAvert for post exposure vaccination (a bat in the house). Concomitant medications included Imovax, human immunoglobulins anti rabies (HRIG), and oral contraceptives. The pt reported the events one day after receiving the fourth dose of rabies vaccine on 19Feb04. The pt received her first dose of rabies vaccine (IMOVAX) and human immunoglobulin anti rabies (HRIG) on 05Feb04. The three subsequent doses on 08Feb04, 12Feb04 and 19Feb04 were with RabAvert. The physician assessed the events as being related to the drug. Follow up information received on 17Mar04: The onset latency for fatigue was changed from 13 days to 1 day. The onset latency for headache, lymphadenopathy and dyspnea was changed from 15 days to 12 days. On 19Feb04 headache, swollen glands and shortness of breath were reported.
7/29/09 - Client called Health Department at approximately 3:40 with complaints of severe abdominal pain and "white foam coming from her mouth, after receiving GARDASIL vaccine. Client spoke with Administrative Assistant, who advised to call 911 and client was then transferred to the "Nurse of the Day, " for further evaluation. Client had hang up requiring Nurse to return call to client. No answer - Message was left for client to seek medical attention by calling 911 or going to ER. Documented time of Service (vaccine administration) at the Health Department was 12:30. 7/31/09 - Follow-up: Telephone call to client, client not available, spoke to family member. Family member states all signs and symptoms have resolved and that the Hospital diagnosis was a reaction to GARDASIL. Asked family member to provide copy of discharge instructions and advised that VAERS Report would be completed by this PHN. Family member verbalizes understanding and states that she will provide the requested documentation. 7/31/09 - Receipt of documentation: Family member presents to clinic with documentation of client's ER visit. Documentation received by Administrative Assistant. 8/04/09 - Completion of VAERS Report.  9/2/09 ER records received DOS 7/29/09. Assessment: Vaccine side effect. Abdominal pain. Patient developed intermittent abdominal cramping and difficulty swallowing. Shortness of breath. Diminshed breath sounds bilaterally. Abdomen is tender. Scar on chest. On day one of menstrual cycle. Throat initially felt tight but not now. Symptoms spontaneously resolved.
Patient had syncopal episode approximately 2 minutes post-vaccination.  Patient rested, recovered, and was released to home.
3 days post vaccine fatigue started. 4 days post vaccine my legs started getting tingling/burning and some numbness in lower legs and feet. I also started getting constant muscle twitches in legs and sometimes in arms. Headaches also started after one week. Ear pressure also began 9 days post vaccine.  I spoke to my primary doctor 12 days post vaccine and she suggested taking in electrolytes in the form of gatorade or Liquid IV packets. She ordered lab work which was drawn on 9/16/21 and she ordered a B12 shot. I will follow up with her on Monday 9/20/21. I continue to have muscle twitches in legs and arms, headaches on and off, fatigue, low energy, numbness and tingling in legs and feet.
This solicited report has been received f rom a 62 year old female patient enrolled in a study conducted by MSW Research. The patient's concurrent condition, historical conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with dose of PNEUMOVAX23 (dose, route and anatomical location were not reported).  On an unknown date, patient reported that she suffered from vertigo after receiving the last vaccine. The outcome of vertigo was unknown. Action taken with the therapy was unknown (not applicable). The causality between the event and PNEUMOVAX23 was anot reported. Additional information is not expected as the reporter did not consent for further follow-up.
Red, swollen, itchy, headache, vomiting, chills Today is Friday July 22, 2022 and symptoms are still prevalent.
This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 08-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA007574: US-009507513-1802USA007580: US-009507513-1802USA006448: US-009507513-1802USA007577: US-009507513-1802USA007578: US-009507513-1802USA007579: US-009507513-1802USA007573: US-009507513-1802USA007572: US-009507513-1802USA007575:
Tightness in throat, trouble swallowing 3 hours after injection.  Since my experience a year before (9/24/2020) I took diphenhydramine HCI 50 mg  (2 Benadryl tablets) and symptoms calmed.  Took another 50 mg  4 hours later and became symptom free.
Pt. With history of multiple allergies, began to experience itching to her scalp and face 5 minutes after Pfizer COVID-19 vaccine. 25mg benadryl PO administered at 1pm. Pt. Reported no improvement and reported itching throat. 80mg of solu-medrol IM administered at 1:20pm. No reported SOB, throat tightening. No urticaria noted, pt. Appears flushed. At 1:25pm pt. Reports neither worsening nor improvement of symptoms. SPO2 100% on room air, HR 87, BP 132/86.  Discussed pt. With Dr., additional 25 mg dose of PO Benadryl administered at 1:45. Pt. Began to feel tightening in her throat and itching intensified. Medical First Response called and pt. Was sent to the ER under care of Dr.
Information has been received from a registered nurse concerning an approximately 17 month of female patient who developed rash that appeared to be similar to "mosquito bites" on the patient's arms and legs after receiving a dose of 0.5 VARIVAX (Merck) (lot # 660341/0371X) subcutaneously on 06-JUL-2009 and MMR (lot # 661732/1290X) on 01-JUN-2009. There are less than 50 lesions on her. Unspecified medical attention has been sought. The patient was recovering at the time of reporting. Additional information has been requested.
Febrile seizure requiring hospitalization with intubation/IO line.  15 month old previously healthy female with new onset twitching movements with fever.  She had her well child visit today and received her MMR, DTaP, and HIB.  Later that evening, she awakened from a nap and felt subjectively very warm.  She also was repeatedly touching her neck with her right hand.  She then developed twitching of her left eyelid and right hand/wrist.  She was not responsive to her parents attempts to break her from this spell.  Her father picked her up and noted that the rest of her body was limp except for the arm that was twitching.  She was taken by her father to the local ED.  Her movements spread to all extremities during the 5 minutes it took to arrive at the ED.  In the ED, she was given rectal diazepam 1.25mg and the seizure abated.  She then had saturations in the 70s and several attempts were made at intubation.  The 9th attempt was successful but was in the right mainstream by CXR.  The ETT was withdrawn to better position.  Importantly, in between intubation attempts she was successfully bagged to saturations in the 90's.  Several attempts were made for an IV and ultimately an IO was placed.  Patient had two more twitching episodes and received diazepam 1.25mg via IO.  Total time with the twitching was estimated by the family to be about 30 minutes.  NS was started through the IO.  Saturations were in the 90s and transfer to UIHC was done.  5/9/08 Case closed w/medical records that accompanied report. Reviewed hospital medical records of 4/24-4/26/2008. FINAL DX: complex febrile seizure Records reveal patient experienced fever, new onset twitching movements, unresponsive, limpness beginning on day of vaccination.  Taken to ER where arrived seizing.  Tx w/antiseizure meds.  O2 saturations were 70%.  Difficult intubation but O2 sats w/bagging remained in the 90% range.  Seizures recurred in ER x 2.  Transferrd to higher level of care.  Admitted to PICU.  Extubated following day.  Tx w/IV antibiotics x 2 days.  Remained afebrile.  Tx w/steroids for airway edema due to repeated intubation attempts. No further seizure activity while hospitalized.