chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When the injection was given it was very high on my right shoulder. Once the needle was in I felt something pop and like a hard sucker punch in the arm. I then felt like I was going to throw up with a wave of nausea then light headed and then sweating lasted about 15-20 minutes. My arm continued to stay sore and as time went on become stiffer over the months with limited range of motion and constant pain in my shoulder down to my elbow. I have had 2 MRI's and then did physical therapy for about 5 weeks with not much improvement with range of motion, and had to have surgery and am now doing physical therapy again. This improper administration of the injection caused a small tear in my rotor cuff and bursa issues.
his brain has been foggy; mental issues; This is a spontaneous report from a contactable reporter (Patient brother) reported for a male patient that: A male patient of 51- or 52-years age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) dose 2 via an unspecified route of administration on an unspecified date in Feb2021 and dose 1 (Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that his brother got both doses of the Pfizer Covid 19 vaccine and after his second dose in February his brain had been foggy and was experiencing mental issues on an unspecified date. He stated that he went to different doctors and said that it is possible that it was due to the vaccine. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
PATIENT REPORTS EXPERIENCING INTENSE HEADACHE W/ DIZZINESS, AND STIFFNESS/PAIN SHOOTING ALONG LEFT SIDE OF NECK WITHIN 2 MINUTES OF RECEIVING SHOT AS SHE WAS BROWSING STORE AISLES. PATIENT WENT TO HER CAR WANTING TO GO HOME, AND REPORTS LOSING SHORT-TERM MEMORY WITHIN 5 TO 10  MINUTES OF RECEIVING INJECTION. INVOLUNTARY FASCICULATIONS (TWITCHING) STARTED AROUND 8PM, AND ALL THESE SYMPTOMS CONTINUED UNTIL PATIENT FELL ASLEEP AROUND 10PM. SHE WOKE UP AT 5AM THE FOLLOWING MORNING AND REPORTS NO MORE SYMPTOMS OTHER THAN PAIN/TENDERNESS AT INJECTION SITE. PATIENT ONLY CONTACTED PHARMACY AT 3PM THE DAY AFTER RECEIVING SHOT.
STOMACH PROBLEMS; BREATHING PROBLEMS; SORE ARM; DIARRHEA; This spontaneous case was reported by a consumer and describes the occurrence of GASTRIC DISORDER (STOMACH PROBLEMS), RESPIRATORY DISORDER (BREATHING PROBLEMS), PAIN IN EXTREMITY (SORE ARM) and DIARRHOEA (DIARRHEA) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced GASTRIC DISORDER (STOMACH PROBLEMS), RESPIRATORY DISORDER (BREATHING PROBLEMS), PAIN IN EXTREMITY (SORE ARM) and DIARRHOEA (DIARRHEA). At the time of the report, GASTRIC DISORDER (STOMACH PROBLEMS), RESPIRATORY DISORDER (BREATHING PROBLEMS), PAIN IN EXTREMITY (SORE ARM) and DIARRHOEA (DIARRHEA) was resolving.            No concomitant medications were reported.  No treatment medications were reported.  The reporter did not provided any causality for the events with Humira and for the event of diarrhea with Moderna vaccine.  The reporter assessed the events of gastric disorder, respiratory disorder and pain in arm possibly related to the Moderna vaccine.  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   This case was linked to MOD-2021-623852 (Patient Link).
Pt. received 1st dose at 5 mos. mistakenly thinking it was his 2nd dose. Given with other vaccine for 4 mos. Pt. developed necrotizing enterocolitis and had surgery.
Very painful upper arm at injection site day 1, developing day 2  into hard swelling and redness with pain/itch similar to a bee sting. Day 1 Body ache, nausea, fever (102 deg) w/chills. Tylenol helped so I could go to work but symptoms came back after Tylenol wore off. Day 2 could not do planned activities due to tiredness and nausea, arm still extremely painful. Day 3 body aches improving, nausea gone but arm still very painful.  Redness subsiding but hard knot still there.
Headache; Fatigue; Diarrhea, and had cramping/stool was watery on the first day but not anymore.; Diarrhea, and had cramping.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), administration date 29Apr2021 09:30 (Lot number: EW0171) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure", start date: Jul2017 (ongoing), notes: Verbatim: High blood pressure; "Irritable bowel syndrome" (ongoing), notes: Verbatim: Irritable Bowel Syndrome. Concomitant medication(s) included: LISINOPRIL taken for hypertension, start date: Jul2017 (ongoing); NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL taken for contraception, start date: Mar2020 (ongoing). The following information was reported: DIARRHOEA (non-serious) with onset 29Apr2021, outcome "recovering", described as "Diarrhea, and had cramping/stool was watery on the first day but not anymore."; ABDOMINAL PAIN (non-serious) with onset 29Apr2021, outcome "recovering", described as "Diarrhea, and had cramping."; HEADACHE (non-serious) with onset 29Apr2021 09:45, outcome "recovered" (01May2021), described as "Headache"; FATIGUE (non-serious) with onset 29Apr2021, outcome "recovered" (01May2021), described as "Fatigue".  Additional information: Additional vaccines administered on same date of the Pfizer suspect was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. AE(s) following prior vaccinations was reported as none. Patient did not require to visit emergency room or physician office.    No follow-up attempts are possible. No further information is expected.
Information has been received from a dentist concerning his 19 year old daughter with penicillin allergy who on 28-Jun-2007 was vaccinated with her third dose of Gardasil. Concomitant therapy included ethinyl estradiol (+) levonorgestrel (LEVORA). On 12-Jul-2007 the patient experienced a large tender lump at the injection site in her left deltoid muscle. The area became progressively more painful with pain radiating up to the left shoulder and clavicle and down to the left ring finger. The patient was seen in the office and referred to an orthopedist. X-rays and an MRI of the left arm revealed fluid collection. Ultrasound guided aspiration revealed granulomatous reaction. The pain continued to worsen and on 10-Oct-2007 the patient experienced transient numbness of left hand lasting 15 minutes and hand tremor lasting 5 hours. The patient was scheduled to have a neurologic evaluation on 12-Oct-2007. It was reported that the patient's adverse events were disabling. The patient has not recovered at this time. No further details were provided. Additional information has been requested.
no adverse event; patient received an improperly stored PROQUAD; This spontaneous report was received from a registered nurse referring to a 4 year old patient of unknown gender. No information regarding the patient's medical history or concurrent conditions was provided.  On 12-AUG-2019 and 13-AUG-2019, therapy of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) experienced two temperature excursions which were stored in the range of -14°C to -10°C (-11.91°C, multiple) for 8 hours.   On 21-AUG-2019, the patient was vaccinated with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R026722, expiration date on 17-MAR-2020 and R023499, expiration date on 13-FEB-2020 (strength, dose number, route and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No previous temperature excursion was reported. No adverse effects were reported.   Digital data logger was involved.
Participant received immunization at 1:00 PM, returned to the nurse at 1:50 PM stating that she had started experiencing difficulty breathing, dizziness, blurred vision. The nurse noted labored respirations, and the participant noted she was beginning to have "warm feeling all over and her throat was beginning to feel tight". Patient's BP was 132/92 at this time. Call placed to 911. At 2:04 PM, nurse administered Epinephrine 0.5cc IM injected into deltoid. 2:12 PM respirations 34-38, decreased but somewhat labored. 2:17 PM, respirations at 28 / min, pt able to speak without SOB, able to swallow with no difficulty. At 2:15 EMS arrived and took over care. Participant felt better, declined EMS taking her to ER. She notes that she took BENADRYL orally at home and had no further issues. She also was requested to contact her Primary Care physician, as of today 10/25/17, she noted it was not necessary as she felt better. Again encouraged to share the occurrence with her Primary Care so that this will be included in her records. Patient noted that she has never had a reaction previously to any other medication.
She is vaccinated with Pfizer vaccine, tested positive for Covid.; She is vaccinated with Pfizer vaccine, tested positive for Covid.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Dec2021, outcome "unknown" and all described as "She is vaccinated with Pfizer vaccine, tested positive for Covid.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Dec2021) positive, notes: took the rapid test today and it came back positive. The reporter stated, "She is vaccinated with Pfizer vaccine and received booster on 06Dec2021. She had a tickle in her throat yesterday, and took the rapid test today and it came back positive".   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101809716 same reporter/patient/product, different dose/event.
mom states pt had t102.8 p/Ibuprofen & was crying over 3hr;
Itchiness, redness, and swelling at injection site about one week after vaccine. Tender to the touch.
80 y/o male that underwent lumbar fusion on 1/22. Initially did very well. Was discharged home and was recovering well. Ambulating normally. Approximately 4 days ago he began noticing his leg giving out and parasthesias. Was seen in the ED on 2/1 and discharged home. Rerutned on 2/2 unable to walk. Surgical Wound was explored but did not demonstrate any unexpected findings - normal post-operative hematoma and seroma. Nerve roots were all inspected. Hardware was in place. POD#1 his weakness had worsened. POD#2 LP was performed which was normal except for a protein of appx 110. MRI showed mild enhnacement along the anterior surface of the lumbar roots. There was concern for GBS and patient was transferred in stable condition.
12/22 Developed chills; 12/23 Chills, sore throat, body ache, headache by 12/24 only c/o headache
Patient came in on 6/8 for her 4th dose of the covid vaccine. Peds Pfizer dose for ages 5-11 was given instead. Patient was notified right away and instructed to return to the facility right away for an adult dose per CDC guidelines. Patient returned on 6/10 for a repeat dose of the adult Pfizer vaccine. It was given in her right arm - lot # FK9893. No adverse effects reported and patient remained for 20 minutes before discharge.
The pt experienced an eruption of chicken pox rash approximately one week post vax. Treated with Zovirax.
Approximately 30 hours after 1st Moderna shot, I began to have elevated Blood Pressure and rapid pulse.  Day over day, I developed extreme abdominal bloating and elevated blood pressure and rapid pulse.  Symptoms have continued for 14 days post shot.  Treatment with 4,000mg Simethicone daily to treat bloating.  When bloating is reduced - Blood Pressure and Pulse are significantly lowered.  Had appointment with PCP on day 13 - currently stopping Metformin - extreme bloating is reducing.    Have previously experienced similar (but milder) side effects of extreme abdominal bloating twice (when starting Metformin), but did not have elevated BP or Pulse.
Shingles- on head, scalp, face - treatment  valacyclovir,  lost of 10 teaching days,  Atrial fibrillation -  irregular heart beat, 4 EKG ?s, 1 physicians care facility, 1 emergency room visit, 1 urgent care facility, 1 phone call to family doctor, 1 visit to Dr. cardiologist , suppose schedule of a cardiac stimulus procedure ; treatment apixaban and metoprolol
Pt recv vax on 11/10/98; on same day pt exp erythema of vax site, fever (104.2), chills, body aches & headache
Patient messaged our Doctor's office regarding an allergic reaction. She stated her temperature was elevated, site if shot pain and heat and sore leg muscles, she also noticed itchiness under her arm of where shot was received. Patient went on to say by afternoon after vaccine rash like with small pumps were near the armpit.
It feels like "long COVID"- still having side effects for weeks to months; difficulty concentrating/issues focusing; dizziness; memory issues/wooziness; balancing issues; Numbness in face; burning sensation in the tongue; difficulty articulating; fogginess; fatigue; have not got the 2nd shot; the whole left side was numb/got some numbness on the whole arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (It feels like "long COVID"- still having side effects for weeks to months), DISTURBANCE IN ATTENTION (difficulty concentrating/issues focusing), DIZZINESS (dizziness), MEMORY IMPAIRMENT (memory issues/wooziness) and BALANCE DISORDER (balancing issues) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced HYPOAESTHESIA (the whole left side was numb/got some numbness on the whole arm). On an unknown date, the patient experienced MALAISE (It feels like "long COVID"- still having side effects for weeks to months), DISTURBANCE IN ATTENTION (difficulty concentrating/issues focusing), DIZZINESS (dizziness), MEMORY IMPAIRMENT (memory issues/wooziness), BALANCE DISORDER (balancing issues), HYPOAESTHESIA (Numbness in face), TONGUE DISCOMFORT (burning sensation in the tongue), DYSARTHRIA (difficulty articulating), FEELING ABNORMAL (fogginess), FATIGUE (fatigue) and PRODUCT DOSE OMISSION ISSUE (have not got the 2nd shot). At the time of the report, MALAISE (It feels like "long COVID"- still having side effects for weeks to months), DISTURBANCE IN ATTENTION (difficulty concentrating/issues focusing), DIZZINESS (dizziness), MEMORY IMPAIRMENT (memory issues/wooziness), BALANCE DISORDER (balancing issues), HYPOAESTHESIA (Numbness in face), TONGUE DISCOMFORT (burning sensation in the tongue), DYSARTHRIA (difficulty articulating), FEELING ABNORMAL (fogginess) and FATIGUE (fatigue) had not resolved, HYPOAESTHESIA (the whole left side was numb/got some numbness on the whole arm) was resolving and PRODUCT DOSE OMISSION ISSUE (have not got the 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) The MRI is normal. On an unknown date, SARS-CoV-2 antibody test negative: negative (Negative) has no antibodies, has not contracted COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter was reported that he was experienced side effects are all intermittent and been suffering for about 2 months Reporter reported as  side effects at variant degrees of severity Concomitant medications includes Vitamins and Minerals.  On 09-Aug-2021, the whole left side was numb.
Patient received her 1st dose of Pfizer COVID vaccine on 3/29/21.  On ~ 4/11/21, the patient developed weakness, fatigue, and confusion. She was brought to the ER by her daughter on 4/13/21 and was found to be febrile and hypoxic. CXR consistent with COVID pneumonia and COVID test came back positive as well. Patient was then admitted to the hospital for COVID treatment and was started on dexamethasone and remdesivir.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 31May2022 at 16:30 as dose 4 (booster), single (Lot number: FM79992) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "seizure disorder" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "TBI" (unspecified if ongoing); "Shrimp" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: anti-viral details. Product: COVID 19 Treatment. Brand: Paxlovid. Treatment start date=19Aug2022. Lot number=G05198. Indication: Treatment of COVID-19. Other medication in 2weeks was Unknown. Patient was prescribed 5 days of Paxlovid. She was immunosuppressed. After the second dose, she got a sore throat and strong metallic taste in the back of her throat. she tried almost everything to stop it but can't get rid of it.; Sender's Comments: The reported COVID-19 positive after BNT162b2 COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
24FEB93 hypotonia-head lag, physical therapy; 14FEB93 irritability, refusing feeds; 24FEB93 UE tremors; 4MAR93 no head, trunk control, extremities flaccid, low grade fever, emesis, arching back, clonic activity in arms; lethargic, sz;
As patient was leaving the vaccination site, patient had a syncopal episode resulting in fainting. Dad was present during the fall. Patient reported feeling dizzy, lightheaded, and nauseous (no emesis). Patient breathing was not compromised. We observed patient for about 15 minutes. Water was provided and school staff gave her some Popsicles. Patient's parent reported patient did not eat prior to vaccination and was also out in the sun/heat for about 30 minutes in the registration line. Obtained vitals prior to patient being discharged home with parent. SpO2: 98, HR: 74, BP: 110/70. Patient recovered well and went home with no further issues.
pregnant; Based on the current case data, this case has been classified as invalid. This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
Itchiness at side of injection 6 days after first day of vaccine (no symptoms prior to the 6th day); within the next 24 hrs developed large hard red lump at side of injection. Warmth at site, itchy. Area of inflammation is around 3 by 3 inches in size.
Physician Discharge Summary: Patient: "PRIVATE", Age:82 y.o. DOB:3/8/1940. Admit Date: 7/6/2022- Discharge Date: 7/10/2022. Principal Diagnoses: Principal Problem: Pneumonia due to COVID-19 virus. Active Problems: PAF (paroxysmal atrial fibrillation); Essential hypertension; Type 2 diabetes mellitus, with long-term current use of insulin; Coronary artery disease involving native coronary artery of native heart without angina pectoris; Acute renal failure superimposed on stage 3b chronic kidney disease; Hyponatremia; Diastolic CHF, chronic; Metabolic encephalopathy; Morbid obesity; Elevated troponin. Discharge Diagnosis: Acute on chronic hypoxic respiratory failure, COVID 19, Hyponatremia. Elevated trop, Metabolic encephalopathy, Dm2, HTN. Hospital Course: The patient was admitted with the above. He was treated with 4 days of remdesivir and steroids. He also was placed on rocephin for possible bacterial super infection. He improved greatly and was on room air as I saw him on the day of discharge. It was not felt that a 5th day of remdesivir would improve him any more than he was so he was placed on one day of Omnicef. No steroids were given as he was not longer acutely hypoxic. His course was complicated by elevated troponin which cardiology felt was due to COVD and not ACS. He was asked to follow up outpatient. Consults to: cardiology. Significant Diagnostic Studies: none. Procedure(s): None. Disposition: home. Discharge Condition: fair.
vaccine received 11-14-08 and pt reports that he had a knot and redness at injection site, and states that afterwards the area turned purple and yellowish and remains tender to palpation.  A local adverse reaction that was explained to patient.  Pt reported problems today 12-1-2008
pt recv vax 9MAY97 1130AM & 10MAY97 pt devel a T-shaped dry skin rash & itching @ the inj site;
Patient was brought to the ED by EMS on 12/24/22 for progressive weakness for the past several days. She was found to be hypotensive and was admitted to the hospital on 12/24/22. Additionally, a COVID PCR test was performed which resulted positive. She was admitted 12/24/22 - 1/20/23 with the principal problem being hypotension. Discharge diagnosis also included COVID-19. During admission she was given ceftriaxone to cover for possible bacterial pneumonia.  By discharge, it is noted in the chart that the COVID-19 infection resolved.