chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pediatric dermatology fellow concerning a 15 month old boy patient. The patient did not have pertinent medical history or drug reactions/allergies. On an unknown date in 2016, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) (lot#, expiration date, strength, dose, frequency route were not reported) for prophylaxis on left thigh. On an unknown date (90 days following the varicella vaccine), the patient experienced numerous vesicles on erythematous plaques on two left thighs (medical), knee extending onto anterolateral skin L4 L5 derivational dermatan distribution. The outcome of vesicular rash was unknown. The causality assessment between the event and varicella virus vaccine live (oka/merck) (manufacturer unknown) was unknown. Additional information has been requested.
Generalized aches and pains in muscles and very fatigued for around 10 days after high dose flu shot. Lateral aspect of left in arm at site of injection resulted pain similar to tendinitis. Could not lift or pick up anything with left arm. Went for acupuncture but that did not work still have pain. Been taking ALEVE and TYLENOL. Never had reaction to low or single dose prior to this double dose.
pt recv vax & exp a hard red lump on the arm;mom stated that the nurse had administered a cloudy liquid to the child;
Nasal Swab result positive; Nasal Swab result positive; I took the 2nd Covid vaccine a month after the first and the dry eyes started sooner about day 2 and was extremely severe; This is a spontaneous report from a contactable physician(patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunization. Medical history included hypertension and headache. The patient had no drug allergies. The patient had no COVID-19 prior to vaccination. Concomitant medications included doxazosin, metoprolol and amitriptyline for headaches, start and stop date unknown. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0178) via intramuscular route in left arm on 22Jun2021 as dose 1, single for COVID-19 immunization. The patient developed severe dry eyes with the first COVID vaccine, started day 3 worsened and lasted 2 weeks. The patient had to use eye drops frequently. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination patient has been tested for COVID-19. The patient delayed the second dose because of it. The patient figured it was autoimmune related. The patient took the 2nd COVID vaccine a month after the first and the dry eyes started sooner about day 2 and was extremely severe. The patient explained it was as if he was rubbing his eyes against sandpaper not his eyelid. The patient visited the Ophthalmologist on 26Jul2021. She voiced her concerns and she noticed changes in eye gland. The patient was on cyclosporine eye drops, within 2-3 days of using cyclosporine her severe dry eyes started to resolve. The patient stopped the eye drop one day in mid-August and symptoms returned, and quickly resolved after resuming cyclosporine drops. The patient did not have any need for hydrating eye drops while on cyclosporine eye drops. On 20Aug2021, the patient noticed that her cyclosporine stopped working. The severe dry eyes returned despite being faithful with Cyclosporine eye drops. On 20Aug2021 the nasal swab result was positive for COVID 19. Seriousness criteria for dry eye-Disabling/Incapacitating: Yes. The event outcome for dry eyes was not recovered and that for covid-19 it was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events DI , Covid 19, dry eye and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Medic on site working in the observation area witnessed patient in his car, slumped into the seat and not moving forward as expected per protocol of this drive through mass vaccination site.  Upon assessment by medics, the patient had very pale skin color, eyes were closed, but he was responsive to questions.  Patient was able to state that he had a history of syncope and that this is not an unusual response for him to needles.  Patient was able to place his vehicle in park and wait in place for about 15 minutes and until he recovered.  When fully recovered, patient traded seats with one of the other passengers in his vehicle and had one of the other passengers drive as they left the vaccination site.
After the second shot I started getting what feels like cramps in my thighs, buttocks, and calves along with pain in my lower back; at night it's hard to sleep with the pain and the leg stiffness that accompanies the pain.  Getting up in the morning is agonizing as my legs are stiff and almost immovable.   Symptoms  usually appear late in the day, especially before bedtime!  Pain is bad, and I've been going to my doctor but all he wants to do is give me painkillers that have bad side-effects, so I'm getting by with OTC pain relief products, both oral and topical.
Information has been received from a licensed practical nurse concerning a 12 year old female with no pertinent medical history reported and no known drug allergies who on 03-JUL-2009 was vaccinated intramuscularly with her first 0.5mL dose of GARDASIL (Lot number 659054/0315Y). There was no concomitant medication. On 03-JUL-2009, the patient experienced fainted in the waiting room of the office a few minutes after vaccination. She exhibited jerking movements and her eyes rolled back. The patient was monitored and fully recovered while in the office. It was reported that on 02-SEP-2009, the patient was vaccinated intramuscularly with the second dose 0.5mL of GARDASIL (Lot number 659054/0315Y). As the needle was withdrawn from her arm, she exhibited a blank stare and was unresponsive. She exhibited jerky movements and was diaphoretic. After regaining consciousness, she was pale and disoriented. Her blood pressure was "low", her pulse was 68, and her blood glucose was 98. The patient was monitored and fully recovered within 30 minutes. Follow up information was received from the licensed practical nurse. She reported that the patient did not received any vaccines at the time of the two GARDASIL doses. She reported that the physician did not comment as to whether or not the jerky movements were considered tonic-clonic, or whether or not the patient experienced a seizure. The licensed practical nurse felt that based on the speed and way in which the patient recovered, the patient did not experience a seizure. No further information is available.
Patient fainted and felt dizzy and weak. Has a history of allergies and made it known that she carries an EpiPen. Became unresponsive and had small convulsions, lasting less than a minute. Used an EpiPen (one dose) and she became responsive again. EMS was called and took over once they got to the store. They took her to the emergency room for evaluation. Patient maintained breathing and pulse through the entire event, no CPR was needed.
rash not around immediate area; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number unknown, Expiration Date: 03Sep2020, as reported), via an unspecified route of administration, administered in the left arm (also reported as left upper shoulder) on 23Mar2021, at 17:40 (at the age of 19 years old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing asthma, which she has had since birth. The patient also reported that her mother has multiple sclerosis and immunosuppressed so she was not sure if that came down to her since usually skips a generation. There were no concomitant medications. The patient did not have prior vaccinations within four weeks. On 01Apr2021, the patient had a rash but it was not around the immediate injection site. The patient stated she has not been checking since she thought she was past having the symptoms but it was fading a bit. The patient stated she has not been going to her practice as she was not happy with how she was doing her practice. She stated her doctor did not recommend her to get the vaccine and the doctor has not been contacted. The patient has been doing the daily COVID check in with the  app. The patient also reported that the expiry was 03Sep2020 and thought it was strange since she got the shot this year (2021). She said she was looking at the vaccination record card. The patient has not taken anything for the rash. She did take paracetamol (TYLENOL) and ibuprofen for period cramps and she only got the shot a week the day before and she did not see rash. The patient was not sure why the rash appeared. She was not thinking she would find a rash so she did not look. She also stated she did not think her asthma would cause the rash. The patient did not visit an emergency room or a physician office. The patient has not recovered from the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The evening of 3-21-07 child began to run a low grade temp. Prior to admission on 3-23-07 was noted to have fever 103 and some staring episodes where he was not responding fully. In the ED he was noted to have tremulous movements. Spinal tap done then developed respiratory distress, was intubated and transferred by ambulance to hospital. 05/02/07-ER records for 3/23 and 4/1/07-fever 103 along with staring episodes. tremulous movements. PE WNL. Responds to painful stimuli. Assessment acute new onset seizures. Follow up visit to ED with fever 102, vomiting and some diarrhea. Staring episodes. Did not eat. Rash spread all over his body. Assessment fever, rash and irritability. 05/15/07-DC Summary for DOS 3/24-3/28/07-DC DX:Status epilepticus, resolved. Sinusitis. Diaper dermatitis. Per 60 day follow up: Mother returned TL today 11-19-07. States they have been in for follow-up appt. @ hospital. Child underwent 3 days of testing including an overnight EEG that continues to show seizure activity in the evening hours. No conclusive diagnosis made whether immunizations caused the adverse event. Remains on 2 mes TOPAMAX & KEPPRA. Initially child lost speech and walking level, however is doing much better & is @ normal goal. Has had several different meds, some effecting his behavior but is hopeful these meds will be betters. He had severe allergic reaction to TRILEPTOL & TEGRETOL after inital d/c from hospital & developed open sores & was re-hospitalized with diagnosis STEVEN JOHNSON Syndrome. He now has eczema and sees dermatologist. Will continue to be under care of doctor locally & have F/U care in 6 months at other facility. Continues on Early-on services & referred to CSHCS.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 04-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot #1660991, expiration date: 27-APR-2021, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  On 04-AUG-2020, the dose of vaccine was exposed to temperature excursion at 1.1 Celsius degree (C) for 27 hours and 45 minutes and at 9 Celsius degrees for 1 hour and 15 minutes. There were no previous excursions reported. The call was due to digital data logger. No further adverse events were reported.  This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Swelling after receiving the Moderna Covid-19 vaccine (EUA)  Redness in arm, swollen lymph node in left arm where injections was given
While at physicians office for routine physicial, liver enzymes were elevated.  Experienced some shortness of breath.  Recheck of enzymes scheduled in 3 months.  Patient was a "no take" following smallpox vaccination.
Body aches, chills, fever , headache, conjunctivitis, hives No treatment
3 days after first dose patient experiences scattered, raised, red, itchy bumps on her arms/legs/torso/chest/back, after 2 weeks they went away then returned after her 2nd dose on 04/03/2021.
Case number PHEH2014US25331, is an initial spontaneous report from a medical assistant received on 16 Dec 2014. This report refers to a 56-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. On 22 Oct 2014, the patient was vaccinated with 0.5 ml of FLUVIRIN (batch number 145701, expiry date: Mar 2015) intramuscularly into right deltoid muscle that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse reaction was reported following this medication error.
About 3 weeks after the first vaccine I have developed allergies, which I never had in my life. The allergies were extreme itchiness in the eyes, nose, throat,  ears that lasted 3 weeks. I received the second dose on March 29th, 2021. I took antihistamines a couple of times and also did a 3 weeks food cleansing  (vegan, no gluten, no coffee, no wine...) which helped a lot until resolution. I did not have any other allergy episode since.
Little tired; their arm hurts only when they touch it.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (Little tired) and VACCINATION SITE PAIN (their arm hurts only when they touch it.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Heart disorder. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 15-Mar-2021 at 1:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (Little tired) and VACCINATION SITE PAIN (their arm hurts only when they touch it.). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, FATIGUE (Little tired) and VACCINATION SITE PAIN (their arm hurts only when they touch it.) had resolved.            Acetaminophen is used as treatment medication.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-046229 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up received on 06-MAY-2021. Consumer informed that she is recovered from all the AEs and declined further follow up
No additional AE details; expired MMR II was administered; MMR II experienced temperature excursion in the past; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Concomitant medication included sterile diluent. Pertinent medical history and drug reactions/allergies were not reported.  On 15-FEB-2022, the patient was vaccinated with expired and improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (lot #T001212, expiration date: 12-JAN-2022) for prophylaxis (strength, dose, and route of administration were not provided) (expired product administered and product storage error). Regarding the temperature excursion details were not available. Informed nurse stability date could not be given until having temperature excursion details.  No additional adverse event details were reported (no adverse event).  This is one of the two cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA006165:
pt recvd vax 14OCT93 & 29OCT93 devel a rash which resolved; pt exp arthralgia, arthritis & weakness in both hands which progressed to hips & knees;
Headache started at 8:00pm on 12/6/2021 11:45pm severe headache, chills, and fever. Body aches started 5:00am 12/7/2021
very sore arm and can't lift it; very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (very sore arm and can't lift it) and PAIN IN EXTREMITY (very sore arm) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (very sore arm and can't lift it) and PAIN IN EXTREMITY (very sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (very sore arm and can't lift it) and PAIN IN EXTREMITY (very sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. Treatment included ice packs.
Redness, pain, tenderness to Right arm.  Tender to touch. 7" x 8" area.  Patient treated with Keflex 500 BID and Medrol Dosepak.
Pregnant patient received 1st dose of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received 1st dose of the Moderna vaccine) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 immunization.     Concomitant products included LAMOTRIGINE and BUPROPION for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 12-Oct-2020 and the estimated date of delivery was 19-Jul-2021. On 04-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received 1st dose of the Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 04-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received 1st dose of the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported.
pt recv vax 11NOV96 & 27NOV96 pt devel a rash consisting of about 15 lesions;pt was brought into MD office;
About 12 hours after I received the Johnson-Covid vaccine I had moderate to severe flu like symptoms.  The symptoms  lasted in their intensity and severity for aproximatly 13 days. I was pretty much bed ridden. My symptoms were: moderate to severe chills and body aches, EXTREME fatigue, Lymphnodes swollen in neck, the lymp in the right side of neck is still VERY sore (oddly, the oposide side of where I recieved the vaccine).  Today is the 14th day, and the symptoms have finally decreased. I thought I should let you know.  I did contact my doctor twice to inform her. She suggested rest and lots of liquids.
pt states that 6 hours after recieveing the moderna vaccine he developed blisters on his right arm and right torso that were itchy. Blisters bled. Fever of 103. Pt states he took benedryl and blisters resolved with in 15mins. Pt states he has some labored breathing, howver, states it could have been from anxiety. ot denied any swelling of the throat  or difficulty swallowing. Pt also stated that  the area of the injection site turned black and that it has sinced resolved.  Pt went to see his PCP who advised him not to receive the 2nd dose of Moderna, however; to get the J&J vaccine insteasd.
12 hours after vaccine, woke to high fever and muscle cramps, violent shivering, splitting headache, spotty vision
Feeling bad; Benign fasciculation; Body aches; Chills; Numb in feet and hand; Muscle twitching; Mild foot cramping; Cramping in feet and hands/calf cramps; Lost feeling in feet; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad), MUSCLE SPASMS (Cramping in feet and hands/calf cramps), SENSORY LOSS (Lost feeling in feet), HYPOAESTHESIA (Numb in feet and hand) and MUSCLE TWITCHING (Muscle twitching) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L208 and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Patient allergic  to Ciprofloxacin). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from 13-Feb-2020 to an unknown date for Cholesterol, DOXYCYCLINE (ORACEA [DOXYCYCLINE]) for Rosacea.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced MUSCLE SPASMS (Cramping in feet and hands/calf cramps) and SENSORY LOSS (Lost feeling in feet). On 03-Mar-2021, the patient experienced MUSCLE TWITCHING (Muscle twitching) and MUSCLE SPASMS (Mild foot cramping). On 09-Mar-2021, the patient experienced HYPOAESTHESIA (Numb in feet and hand). On an unknown date, the patient experienced FEELING ABNORMAL (Feeling bad), MUSCLE CONTRACTIONS INVOLUNTARY (Benign fasciculation), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Feeling bad), MUSCLE SPASMS (Cramping in feet and hands/calf cramps) and SENSORY LOSS (Lost feeling in feet) was resolving, HYPOAESTHESIA (Numb in feet and hand) and MUSCLE TWITCHING (Muscle twitching) had not resolved and MUSCLE CONTRACTIONS INVOLUNTARY (Benign fasciculation), MUSCLE SPASMS (Mild foot cramping), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Patient stopped the liptore therapy on 09-Mar-2021  for the event of "numb in feet and hand" but facts did not show relationship with stain therapy .   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Patient demographics,allergic  condition ,Concomitant product   details , event details (Myalgia, Chills, Numbness of extremities ,Muscle twitching, Fasciculation, Mild foot cramping, Body aches, Chills) were updated.