chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness like "lights out"/ Lightheadedness; her elbow is bruised and sore, and it goes to her wrist or her shoulder; falling backward; room spinning; spent whole day in bed; my arm hurt so bad; swelling in her left wrist, elbow, and shoulder; sore to touch, almost like being bruised "like its in my joints"; discovering "knots" on her left arm, "knots" on her head; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 62-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ECU0161, Expiration date: not reported) via an unspecified route of administration, administered in left arm on 17Apr2021, In the morning between 09:00-10:00 at the age of 62-years-old as single dose for COVID-19 immunization. Patient's had no medical history and concomitant medications. On 29Apr2021, patient experienced discovering knots on her left arm, knots on her head, my arm hurt so bad, swelling in her left wrist, elbow, and shoulder, sore to touch, almost like being bruised like its in my joints, falling backward, room spinning, spent whole day in bed, on an unspecified date, dizziness like lights out, Lightheadedness, her elbow is bruised and sore, and it goes to her wrist or her shoulder. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Patent did not receive prior Vaccinations within 4 weeks. The outcome of event discovering knots on her left arm was recovered in 29Apr2021, dizziness like lights out, Lightheadedness, her elbow is bruised and sore, and it goes to her wrist or her shoulder was unknown rest events outcome was recovering.  No follow-up attempts are needed. No further information is expected.
Since getting the vaccines she has been dizzy; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13) and varicella zoster vaccine rge (cho) (SHINGRIX), both via an unspecified route of administration on Jun2019 at a single dose for an immunization. The patient's medical history and concomitant medications were not reported. It was reported that since getting the vaccines she had been dizzy. She did not know if they were bringing her potassium down. When she eats a banana, she feels a little better but this morning when she woke up she was dizzy again. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Got the vaccine. Hurt like hell; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported for him/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per the vaccine indication. The patient received vaccine and it hurt like hell but not gotten shingles.
BlurredVision, Confusion, Headache, Vaccine administered in arm and sx began 11pm with "worst H/A ever, brain fog, and blurred vision". Member did not seek medical care but called out of work and sx resolved with ibuprofen by 4/9/21 om, She will report sx to PCP have office follow up by 4/27/ Narrative: Unable to work due to sx
This spontaneous report was received from a pharmacist and refers to a 25 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications and the patient had not known drug allergies. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, strength, anatomical location, route of administration, lot number and expiration date were not reported). On 20-JUN-2018, the patient was vaccinated with the second dose of GARDASIL 9, lot number N017686 and expiration date on 02-FEB-2020 (dose, strength, anatomical location and route of administration were not reported). On 28-AUG-2018, the patient presented to the emergency department and was admitted to the hospital with headache, fatigue, shortness of breath (dyspnoea), tachycardia, and a hemoglobin of 5 (haemoglobin abnormal). It was unknown if treatment was given for the events or if laboratory diagnostics or studies were performed. At the time of reporting, the patient still in the hospital and the outcome of the events was unknown The reporter did not assess the causal relationship between vaccination with GARDASIL 9 and the events.
Angina, possible coronary artery thrombosis  I  was running regularly 15-20 miles per week.  Four days after my second dose developed angina while running. Within a  couple of weeks couldn?t go up a flight of stairs.
Suspected vaccination failure; had recurrent Shingles outbreaks before Shingrix; Pain; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included varicella zoster virus vaccine, live, oka strain (Zostavax) for prophylaxis.   On 14th June 2019, the patient received Shingrix. On an unknown date, the patient started Zostavax at an unknown dose and frequency. On 14th June 2019, less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster and pain. On an unknown date, the outcome of the vaccination failure, herpes zoster and pain were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster and pain to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient had recurrent Shingles outbreaks before Shingrix series and after complete series along with pain.  This case was considered as suspected vaccination failure, since the details regarding the, time to onset for event and laboratory confirmation for herpes zoster were not provided. The reporter did not consent to follow-up.
Adverse event:   Increasing difficulty breathing, swelling of throat and sinuses, dizziness Time:  starting at 4:30pm Took Ventolin  resulting in immediate   reaction to  Ventolin. extreme  difficulty breathing, throat swelling and choking, heart racing, excessive nasal drip and saliva,    Took 2 Capsules of Advil Cold and Sinus Extreme stmptoms, choking and unable to breath subsided after 45 minutes.   Difficulty breathing, dizziness lasted until 10am the following morning.
$6 yo nurse vaccinated on 9/30/03 that had prolonged scab. Had some bleeding at site on 10/5. 10/6-7 noted to have robust take with greater than 5 cm or redness and some swelling of arm noted. Also had enlarged and tender axillary nodes. Used 2x2 guaze as a dressing with long sleeves. Used waterproof covering when showering only. Scab fell off on 12/2, size about 1 cm. No known medical problems.
Patient called pharmacy to let us know that she had diarrhea/runny stools for approximately 1 day after vaccination.  It has since resolved and she is doing fine.
At 2:08pm patient received dose #1 of Moderna COVID-19 vaccine. She began having lip tingling, lightheadedness and chest pounding at 2:10pm. On exam her BP was 126/82, HR 113, 95% O2 sat on RA. Patient was administered 50 mg of oral Benadryl at 2:17pm. She developed a rash on her chest and neck ? not hives. Lip tingling and chest pounding improved. Rescue arrived and upon discharge from the clinic to EMS her HR was 100, 99% O2 sat on RA.  PMH significant for chronic urticaria and angioedema with 4 lifetime episodes of severe allergic reactions, but never to a vaccine. Had had epi administered x 2, last in 2016.
Patient's arm swelled up at the site of injection and was red/hot to the touch. It was approximately the size of a tennis ball.
Patient received second shot Moderna 4/9/21 and first shot was Pfizer 3/19/21.
Deep muscle aches 4/25/21-4/28/21 Severe Headache 4/28/21-4/29/21 Swollen arm, hot, itchy 4/30/21 - ?
swelling, redness, and pain at injection site. vomiting, diarrhea, and fatigue
Pain is constant, sharp, pressure; refers to it as having contractions in labor that don't stop.  CT results: The appendix appears to be within normal limits with no definite adjacent inflammation. However if there is high clinical concern for early acute appendicitis, close clinical follow-up and possible follow-up CT could be considered to reassess.  2. Mild wall thickening in the urinary bladder which is probably secondary to incomplete distention.  will follow up with primary provider
Patient reported that she is "shaky and shivery", her arm is painful, and she cannot lift her arm.
face felt hot/burning/on fire; face was red/chest red; chest red/flushed; numbness and tingly on face- right side of face and neck/head/right side; numbness and tingly on face-right side of face and neck/head/right side/some tingling under neck; slightly itchy face; high blood pressure 153/93 - high bp for 4 days; extreme gerd which resulted in not being able to sleep for 4 days; extreme gerd which resulted in not being able to sleep for 4 days; heart racing; have tingly hypersensitive feeling in face 2 weeks later; This is a spontaneous report from a contactable consumer. This 48-year-old female consumer reported for herself that: A 48-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EI.9266), via an unspecified route of administration, administered in Arm Left on 18Feb2021 at 11:30 (at the age of 48-year-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included hashimotos thyroid, GERD (Gastroesophageal reflux disease), ana positive -connective tissue disorder, raynauds, fibromyalgia and right eye proptosis from an unknown date and unknown if ongoing. Patient not diagnosed with covid-19 prior to vaccination. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]); liothyronine (LIOTHYRONINE); omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient previously took benadryl and experienced drug allergy (side effect can't go to the bathroom). Patient was not received any other vaccine four weeks prior vaccination. On 18Feb2021 at 11:45 the patient experienced face felt hot/burning/on fire, face was red, chest red/flushed, numbness and tingly on face-right side of face and neck/head/right side, slightly itchy face, some tingling under neck, high blood pressure 153/93 - high bp for 4 days, extreme GERD which resulted in not being able to sleep for 4 days would wake up to heart racing, still have tingly hypersensitive feeling in face 2 weeks later. Since vaccination patient not tested for covid-19. Event resulted to visit Doctor or other healthcare professional office/clinic. Therapeutic measures were taken as a result of the events with Pepcid, Claritin and ice packs on face. The patient underwent lab tests and procedures which included blood pressure measurement: 153/93 on 18Feb2021 High. The outcome of the event still has tingly hypersensitive feeling in face 2 weeks later was not recovered and all other events were recovered with lasting effects.    No follow up attempts are possible. No further information is expected.
Patient is a health 47 year old male physician.  Annual attenuated virus flu vaccination received for the past five years without any sequelae. 36 hours post flu-mist innoculation, Patient developed persistent, extremely bothersome rhinitis and fatigue.  No fever, myalgia, or other symptoms.
Right paresis, paresthesia, aphasia, fall and incontinence found to have left MCA occlusive CVA
1 hr p/vax pt reported feeling itchy all over body & had two hives on rt forearm; sent to ER & given DPH p/exam by MD; 24 hrs later still had hives & state fever & chills;
MMR, flu, VARIVAX given 8/30/13. On 9/7 pt developed fever, on 9/8 pt had fever, and a syncopal like event that made her limp and blue lips. She aroused within 2 minutes. Possible febrile seizure. No rhythmic movement. Taken to ED. Labs, EKG, Neuro referral, EEG, Cardio referral.
normal blood glucose range for me is 85-135.. for 2 weeks following my first moderna shot I had a hard time keeping blood levels above 50...... dangerously low!   after getting my second dose of Moderna, my glucose levels are skyrocketing up to 385...and it's been about 8 hours since the dose was administered.
No adverse effect, but an error in administration. Patient is under 18 years old received Moderna Vaccine. At the time of vaccination it was understood that , anyone 16 and older could receive Moderna. Since it was pointed out by the  that it is not the case, our facility stopped vaccinating 16 to 18 year olds with Moderna.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot# unspecified) intramuscularly on 12-OCT-2012 and 0.65 ml ZOSTAVAX (lot# unspecified) subcutaneously at the same time on the same day. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. The patient was in pharmacy when this happened. Additional information has been requested.
MOTHER REPORTS PT'S RIGHT THIGH AT INJECTION SITE WAS RED, SWOLLEN, HOT TO TOUCH, AND VERY PAINFUL. ON DATE OF REPORT, PT'S INJECTION SITE IS MILDLY RED AND TENDER. PT IS LIMPING DUE TO PAIN.
similar to bell's palsy; 30 mins later, the shoulder, lower jaw and upper right eye became numb; shoulder was numb for 40 minutes; right eye and jaw were numb all day Thursday and Friday; right eye and jaw were numb all day Thursday and Friday; right eye and jaw were numb all day Thursday and Friday; A spontaneous report was received from a reporter like consumer concerning a 46yr old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 30 mins later, the shoulder, lower jaw and upper right eye became numb, shoulder was numb for 40 minutes, right eye and jaw were numb all day Thursday and Friday.  The patient's medication history was not provided. Concomitant medications reported include5mg Levocetirizine daily.  On 11th Feb 2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch016M20A) in the anatomical location on the right arm for prophylaxis of of COVID-19 infection.  On 11th Feb 2021, 30 minutes after vaccine administration the patient experienced events like the shoulder, lower jaw and upper right eye became numb, shoulder was numb for 40 minutes, right eye and jaw were numb all day, thursday and friday. Event similar to bell's palsy was considered medically significant.  Laboratory details were not provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  On an unknown date, the outcome of the events,30 mins later, the shoulder, lower jaw and upper right eye became numb was resolved. On 11 Feb 2021, the outcome of the event, shoulder was numb for 40 minutes was resolved. On 13 Feb 2021, the outcome of the event, right eye and jaw were numb all day Thursday and Friday was resolved. On an unknown date, the outcome of the event,similar to bell's palsy was unknown.; Reporter's Comments: This case concerns a 46 Y/O F with a serious unexpected event of facial paralysis, and nonserious unexpected hypoaesthesia, hypoaesthesia eye, sensory loss. Event onset 30 minutes after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Fever of 102 F, chills, insomnia, excessive urination resolved by 24 hours after injection.  Excessive urination treated by hydration with electrolytes.  Moderate headache resolved around 36 hours after injection, treated with Ibuprofen at 24 hour mark.
Soon after the vaccine were given the patient's body became stiff, his eyes rolled into the back of his head, and he became very pale. This episode lasted for approximately 2 minutes.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 02-AUG-2011, patient received improperly stored VARIVAX dose 2, from batch/lot # 669601/0138AA (expiry date, dose units, route and anatomical location were not specified (incorrect product storage). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Flu-like symptoms - fever @100.3, shivering, aches, mild headache beginning approx 12 hours after shot, lasting about 5-6 hours. The next 15 hours were relatively calm, and then fever spiked followed very quickly by shivers and shakes so strong that it seemed like a seizure - uncontrollable, frightening, including neck pain and leg thrashing, lasting approximately 5 minutes. We went to the ER, where I was admitted with a fever of 101 (I think) low BP, which dropped into the 70's over 40's and remained there for hours, despite massive amounts of fluids and antibiotics. Fever eventually came back to normal, but BP took 6 hours to get to the high 80s over 50s with consistency.
a little tired; This is a spontaneous report received from contactable reporter(s) (Consumer). The reporter is the patient.  An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 06Mar2021 (Lot number: EN6205) at the age of 86 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Afib", start date: Jul2020 (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing), notes: She was diagnosed at 50 years old, so 36 years ago.; "High blood pressure", start date: Jul2020 (unspecified if ongoing); "Osteoarthritis in her left hand" (unspecified if ongoing), notes: She already was diagnosed with osteoarthritis in her left hand before the COVID vaccine. Concomitant medication(s) included: ELIQUIS taken for atrial fibrillation, start date: Jul2020 (ongoing). Vaccination history included: Pneumonia shot; Shingles vaccine; Hiv vaccine; Flu shot (Flu shot: Route: Injection; Anatomical Location: Left arm; No. of Previous Doses: Not provided; Date: Sep2020), administration date: Sep2020.vThe following information was reported: FATIGUE (non-serious) with onset 07Mar2021, outcome "recovered" (09Mar2021), described as "a little tired".  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age who on 25-APR-2012, was vaccinated with a dose of VARIVAX (Merck) (lot number 669557/1700Z, Exp. Date: 09-DEC-2012 (dose and route not reported) that was stored in the refrigerator since it was received in the pharmacy in April 2012. No adverse symptoms were reported. Additional information has been requested.
?Covid arm?:  hard, red, itchy, warm, raised welt approximately diameter of a grapefruit at injection site.  Similar to reaction after shot #2
Patient had arm being sore at end of day.  Cannot raise arm above shoulder today.  Patient complains today of nausea but not sure if attributed to health condition patient feels deltoid popping.
DIZZINESS, NAUSEA, TINGLING/NUMBNESS IN EXTREMITIES, BEGAN HYPERVENTILATING.
Immunization given patient fainted after administration patient seen by MD. Patient had BP taken. Patient rested for 20-30 min before sent home.
Pt recvd vax & exp nausea, fatigue, malaise & elevated liver enzymes;
Swelling on face and lips; rash  -- red dots -- all over face; dizziness; fever >103.
Very enlarged lymph nodes/One of the lymph nodes being palpable; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), solution for injection, administered in arm right, administration date 22Feb2021 16:15 (Lot number: EN6202) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; GABAPENTIN; MAXZIDE; ESTRADIOL. Past drug history included: Agumentin, reaction(s): "Known allergies: Augmentin". Vaccination history included: Bnt162b2 (dose number=1, product=COVID 19, brand=Pfizer, lot number=EL8982, administration date=01Feb2021, administration time=04:15 PM, vaccine location=Right arm), administration date: 01Feb2021, when the patient was 55 years old, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 22Apr2021 12:00, outcome "not recovered", described as "Very enlarged lymph nodes/One of the lymph nodes being palpable". The event "very enlarged lymph nodes/one of the lymph nodes being palpable" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Other vaccine in four weeks: No. Covid prior vaccination: No. Covid tested post vaccination: No.  Follow-up attempts completed. No further information expected.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. Developed severe bone pain and joint pain following vaccination. He also lost a great deal of weight and developed lesions on his pelvis and ribs. (OMIC)
no adverse event ---just mixing error --multi dose diluent was used twice to  mix with covid
42 yo f c/o acute onset of itchy rash to LUE and neck x2-3d after receiving J&J covid19 vaccine approx 2d prior to onset of sx's; additionally reports mild intermittent ha w/dizziness w/o nv or other sx's x24hrs; Pt states concerns for covid19 rxn; pt states mild improvement in rash sx's after total 3x doses of 25mg benadryl; pt denies any other rashes, cp, sob, dyspnea, abd pain/cramping, vaginal bleeding/discharge, urinary sx's, visual changes, neck pain.  Pt denies any ha sx's at time of provider evaluation
No additional AE; The MMR II was administered to a patient on 19-MAY-2021; This spontaneous report was received from a physician concerning a 12 year old patient, gender not provided. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.    On 19-MAY-2021, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (expired product administered) for prophylaxis (lot # S012944 has been determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and establish as 28-APR-2021) (strength, dose, route of administration and anatomical location were not provided) .       No adverse event reported.
Patient was told and documented as receiving Jansen vaccine but was given Moderna vaccine in error.  No ADRs noted immediately after vaccination.