chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chronic pain in both of the shoulder joints; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 13Mar2021 at 07:00 (at the age of 56-years-old) as a single dose and his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734,) via an unspecified route of administration in the right arm on 05Apr2021 at 09:45 (at the age of 56-years-old) as single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergy to sweet potatoes. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), amfetamine aspartate (ADDERALL), amlodipine besilate (AML), multivitamins and gemfibrozil (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 15:00 the patient had experienced chronic pain in both of the shoulder joints which was not severe, but uncomfortable. The patient did not receive any treatment for the reported event. The clinical outcome of the event chronic pain in both of the shoulder joints was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
FEW MINUTES AFTER THE PATIENT RECIEVED THE VACCINE, HE STARTED TO SWEAT AND BECAME VERY PALE .HE FANTED FOR 1 OR 2 SECONDS. WE CALLED 911 .THE PARAMEDICS CAME AND TOOK HIS PRESSURE AND HEART RATE. PATIENT REFUSED TO GO TO THE HOSPITAL. HIS MOM AND GIRLFRIEND WERE AT THE PHARMACY TO DRIVE HIM HOME. HE SAT FOR ALMOST AN HOUR AND WENT HOME LOOKING GOOD. HIS MOM SAID HIS COLOR IS BACK TO NORMAL,AND HE FELT GOOD TO GO HOME
sore arm; flu like symptoms; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were unknown.   It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to Shingrix.     Additional Information: GSK Receipt Date: 5-APR-2022 Reporter's Comment: The reporter did not consent to follow-up.
Patient fainted but was conscious and hot. Patient felt dizzy and nausea. Patient was cold. Patient slept it off and rested over normal activities for the period of two days. Patient did not have fever. Note: Patient had no adverse reaction to the first SHINGRIX shot administered on July 2, 2020.
Patient received  Shingrix and Fluzone HD on 8/20/2020.  10 days later patient states she came down with the shingles viral infection.  She was diagnosed with shingles by her doctor and was given antivirals, and gabapentin.  She had a shingles rash on her left side of her body (back and left upper thigh) and nerve pain that radiated down her leg. Her rash cleared up after 2 weeks, however is still experiencing nerve pain that she is taking gabapentin for.  Patient is aware that this is very likely a coincidence that she got shingles before the vaccine became effective (takes about 2 weeks to have an effect and she only received 1 of the 2 doses so far).
"I got my vaccine on 1/15 and on 1/22 my shot site got hot, red, swollen and itchy"
Participant is vaccinated with Pfizer's Bivalent booster, when he was already vaccinated with it since 11/10/2022
Circumferential swelling of left leg (site of DTaP injection) 6 cm greater than right leg. 12/13/2001 Called mother, left leg still swollen however improving.
Throat tightness when swallowed (constricted). Patient took benadryl when she got home (one hour later). Symptom was lessened within one hour after taking benadryl. She didn't feel right until later that afternoon or the next day.
Mom reports child was irritable, poor feeding, poor sleeping, crying - all for 2 weeks child was not seen during this time - mom reported this 4 weeks later.
2 hrs p/vax pt started crying while having diaper changed (severe crying); would wake from sleep & cry; pt given APAP while @ clinic & again @ 315; rt thigh looks a little swollen; fever denied;
This 16 m.o. boy had onset of cough, fever on 4-14-10.  Fever reached 105, and child brought to Med. Center ED on 4-17-10 and admitted.  Discharged 4-19-10.  Diagnosed with positive Strep Pneumo Blood Cx.
The patient had an uneventful post-operative course and was discharged on post-op day 2. By report, on post op day 4-5, the patient began complaining of headache, back pain and abdominal pain. Continued home meds for post-op pain and constipation. On POD 8/9, the patient notified her daughter that she woke up short of breath. She was transferred by EMS to Hospital where she reportedly expired (this event was reported by the patient's daughter to doctor's office, the spine surgeon who managed her while inpatient at Hospital
Extreme pain in head and neck area body hot sometimes and head cold and vise versa dizziness inability to perform everyday tasks such as care for children bin to hospital at least 4 or 5 times since second dose
Day 2 - pain in arm and running a fever. Day 3 - redness/swelling.
He got the vaccine yesterday, woke up nauseated, dizzy, feeling like he is going to throw up but has not eaten anything.  Not other reaction other than being very weak and development of a bad cough.  Has not taken anything and has not called his doctor.
Information has been received from a nurse concerning a female patient who was vaccinated with Zostavax (Oka/Merck). Subsequently the patient developed chicken pox. Additional information has been requested.
COVID relapse with positive home test; COVID relapse with positive home test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 at 13:15 as dose 4 (booster), single (Lot number: FK9896) at the age of 75 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: "Parkinson's Disease" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Apr2022 at 12:00, outcome "not recovered" and all described as "COVID relapse with positive home test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) positive, notes: COVID relapse after Paxlovid treatment, after symptoms disappeared after negative home test. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Additional information: Patient took no other medications in two weeks. No anti viral details were provided. COVID relapse with positive home test, after Paxlovid treatment, after symptoms disappeared and after negative home test
Pt fainted post vaccination. His blood pressure was 90/52. Pt Did not have breakfast in the morning, and received his vaccination about 2 pm. Pt was also anxious about getting this vaccination. Pt recovered very quickly, sat up while seated on the floor, and left after 15 minutes without notifying us.
Developed lump in throat followed by difficulty breathing (3pm) went to Dr. (4pm) given DECADRON 6mg.
(actual time unk)  1 day after vaccine severe lung congestion.  5 days after vaccine total paralyzation on right side of body, diagnosed as "stroke."
1 week after Flu shot swelling & redness at injection site. Treatment - BENADRYL oral.
Tingling in arms, legs, lips and neck.  Skin is very irritable.  Difficulty breathing at full capacity Elevated heart rate, (+/-10 BPM) Overall muscle soreness and stiffness
Redness greater than 3 inches in diameter at injection site; swelling and pain at injection site; low-grade fever; body aches; headache.
Pt seen for pfizer dose 2, had no reaction after first vaccine.  She was asked to wait for 30 minutes post vaccine for monitoring.  At the 30 minute mark, pt came over to this RN to report "her tongue felt a little funny."  She stated she has chronic issues with a tingling sensation to her tongue, however this was different and her tongue felt "bigger and different than normal."  She denied having difficulty swallowing, SOB, scratchy throat.  25mg Benadryl was given PO per protocol.  She drank an entire bottle of water without difficulty and was able to hold a conversation without difficulty.  Pt waited 20 minutes post benadryl and stated she was feeling better, with one side of her tongue "feeling back to normal."  Recommended taking 25mg benadryl PO q6h x48h and calling PCP today to describe reaction and benadryl recommendations.  Explained they may want to see her or change medication recommendations and pt voiced understanding stating she was going to call her PCP, however she felt better and wanted to leave instead of further monitoring.  Educated on if symptoms worsened for any reason and pt experienced any SOB, difficulty swallowing, or worsening symptoms of any kind to go to the Emergency Department and pt voiced understanding.
Patient had huge reaction from the injection that was approximately 3 inches in length and 2 inches in diameter- site was reddened and slightly swollen
Patient felt light headed after receiving her shot.  She was pale .she stated she couldn't see or hear. she felt faint and sat down. she was given fluids and nutrients and regained her composure. Patient did not need further medical treatment. She was fine after about 10 minutes. Patient was ambulatory within 10 minutes
10/28/2006 client complained of pain on left arm where shot was given. Site noted red, hot to touch. 10/29/06 swelling got worse from collar bone to wrist with increased redness. Mom brought child to ER. Dr. ordered Benadryl. 10/31 talked to clients father he reports redness and swelling on left is down.
Patient missed his 2nd dose, more than 42 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed his 2nd dose, more than 42 days) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed his 2nd dose, more than 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed his 2nd dose, more than 42 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Pt received Flu shot on 10/15/07. Had seizure 10/16/07. Seen in ER for new onset seizure. Started on Dilantin.
BELLS PHALSY,  PARTIAL FACE PARALYSIS, RIGHT EYE & LIP TWITCH
Patient developed rash within 1 min of injection, with mottling of upper arm in area of injection. Patient reported itching with previous HPV vaccinations after injection today.  MD in to eval. Benadryl 50mg po given to treat rash. Monitored for 20 min after admin of treatment. Cleared by MD to leave office after treatment. Assisted leaving office. Guardian accompanied patient from office.
severe nausea, chills, sweats, ache in every joint, severe fatique, i have had shingles and the neuropathy started from that was acting , my scalp was sore and couldn't brush hair, muscle cramps. I took ibprofen and didn't go to hospital. it lasted from Friday night til Sunday  and i continue to have some fatique
Patient developed an itchy, dermatitis like rash with papules and erythema over her arms and trunk several hours after vaccination. Rash improved with steroid cream and time.
After receiving the Janssen vaccine, patient was observed for 30 minutes without complications.  Patient stated that after she got to her car, her face was flushed and warm.  She came back to observation area for further monitoring.  Writer noticed flushed face and neck. Vitals were BP 140/80, HR 90 Pulse Ox 98%, RR 16.  She stated her throat did not feel like it was closing.  Patient declined the need for Benadryl while observing, stated she will take it at home.  Writer observed patient for another 30 minutes without complications.  Flushing on face and neck slightly improved.  Instructed patient to go to ER or call 911 if symptoms became worse.
Severe swelling of the R knee including infusion of the joint and immobillity followed by 2 days later similar symptoms on the L knee. Accompanying Trigger Finger on the R thumb. Also Bruising/shadowing spotting noted to approximately 8 fingernail beds that did not go away until grew out.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer BioNTech Vaccine on 1/18/2021 and 2/06/2021. Presented to ED on 8/20/21 with worsening shortness of breath. Patient was diagnosed with COVID-19 on 8/18/2021. Patient was tachypneic upon arrival and did not improve with BiPAP and was subsequently intubated and transferred to ICU. Before admission patient developed poor appetite and mild cough and PCP ordered monoclonal antibody for patient. Bedside echo showed an underfilled, hyperdynamic RV. Patient developed ST elevations in inf leads. She underwent LHC on 8/22 which showed myocarditis and lvef of 10%. She had an IABP placed and started  on multiple pressors for cardiogenic shock. Patient also developed AKI, afib (started on amiodarone). Received vancomycin, cefepime, and azithromycin. Patient was transitioned to inpatient hospice on 8/28/21. Patient expired on 8/29/21.
Gave patient expired dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave patient expired dose of vaccine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007D21A and 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave patient expired dose of vaccine). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Gave patient expired dose of vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received included no new information. On 08-Aug-2021: Follow up information received contains significant information. Ethnicity and Race information of the patient added. Vaccination facility type updated.
Pt was given vaccines during a physical. Pt left office returned 5 minutes later with fatty, facial swelling, swollen lips and difficulty breathing. Epinephrine was administered by APRN immediately and 911 was called. Pt transported to ER via ambulance.
Client received her flu shot in (L) delt. at a F/U outreach held by agency and not by this nurse. Client states pain started at injection site at time of administration and has radiated to elbow. There is a 6cm w x 3cm edematous tender area at (L) antecube Pain 8/10 "toothache pain" to (L) arm. (R) elbow circumference =5cm, (L) elbow =6cm. Ibuprofen 200mg 2 tabs, cool compress, ace wrap at 50% compression applied to site.
(Note: Difficult to read handwriting on lot number, could also be DOV 6208 or DOV 6Z08) I woke up around 12 hours after having the vaccine and felt a strange sensation in my head, almost like a helmet of fog over my head, sort of a numb feeling, and I noticed that also my eyes and lips felt numb. I ate a grapefruit as I usually do (not sectioned by myself). I felt extremely lethargic, had joint pain and a weakness. I usually have tea and toast in the morning and as I was at the table buttering my toast, I had an overwhelming nausea come on. I then woke up on the floor. My companion told me I went unconscious and slipped off the chair. Perhaps the whole episode was a maximum of 20 seconds. My first words were "Where am I?" and my companion told me. I rest on the floor, directed my companion to read on the internet about stroke and we ascertained I was okay, so I was thinking completely clearly. In any case, I had the fog in my head the entire day, and also today, but I feel a little better and was able to eat after 4 hours of rest. I wasn't able to fall asleep but I rested the entire day and slept a couple of hours during the night, which is not like me. I usually don't have any problem sleeping.
06/18/2005 call from Mom, shot site left thigh swollen hot has purplish blotches, unable to walk this am, when first got up decreased appetite.  Mom reluctant to be seen at this time.  He'd go out and was playing outside using leg.  06/20/2005 patient's Mom called states site was 6x6 square.  Now has gone down about 4x4.  Not as hard, but still tender.  06/21/2005, patient's Mom states looks much better today.  Swelling down.
Left arm swelling form elbow to hand. Called doctor's office and was told to take Aspirin elevate arm and use warm/moist heat.
ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/22/2023,  2/7/2023,  2/16/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Covid Syndrome; Covid Syndrome; schizophrenic episode; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date Mar2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2022, outcome "unknown" and all described as "Covid Syndrome"; SCHIZOPHRENIA (medically significant) with onset Mar2022, outcome "unknown", described as "schizophrenic episode". The events "covid syndrome", "covid syndrome" and "schizophrenic episode" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Mar2022) positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19, schizophrenia.  Clinical course: Reporters wife informed me on 16Mar that the sister of her co-worker had a booster shot recently and experienced a schizophrenic episode. She reported it to her doctor who informed her that she had experienced covid syndrome. I was asked how she could report the event and I provided the link to Pfizer safety reporting website.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 23-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection, lot # K005402, expiration date 07-NOV-2015 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to the following temperature excursions (dates unspecified): the first lasting for 24 hours, with the highest recorded temperature of 46.6 degrees Fahrenheit (8.111111111 degrees Celsius), the second lasting for 48 hours, with the highest recorded temperature of 46.8 degrees Fahrenheit (8.222222222 degrees Celsius), the third lasting for 96 hours, with the highest recorded temperature of 47.2 degrees Fahrenheit (8.444444444 degrees Celsius), the fourth lasting for 24 hours, with the highest recorded temperature of 47.5 degrees Fahrenheit (8.611111111 degrees Celsius), the fifth lasting for 372 hours, with the highest recorded temperature of 59.9 degrees Fahrenheit (15.5 degrees Celsius) and the sixth lasting for 24 hours, with the highest recorded of 46.2 degrees Fahrenheit (7.888888889 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.