chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myalgia Report chills, congestion weak, loss of appetite and redness @ injection site. Narrative:  Other relevant History:
This was the second Pfizer covid vaccine for the child.  No adverse events post vaccinations reported.  Approximately 10-15 minutes post vaccine the child complained of tightness in her chest from the vaccine arm to her chest and racing heart.  She was given a bottle of water and we continued to observe.  She still was not feeling right.  She was anxious.  We took her blood pressure and it was low the first time 95/74.  The second time it was 131/81.  Mom wanted us to call paramedics to have her examined.  We called and they came.  Vital signs were normal but mom wanted further evaluations. They were transported to Hospital.
Information has been received from a nurse practitioner concerning a 12-year-old female who in approximately 1993 at 12 to 18 months of age, was vaccinated subcutaneously with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). On approximately 11/22/2005, the patient presented with a case of chickenpox. She had 24 lesions located mainly on her trunk. Unspecified medial attention was sought. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
No adverse event; Patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine).    Patient's age reported as 36 year 9 months. Concomitant medication was not provided. The lot O70H21A had been received by patients between 08-Apr-2022 and 15-Dec-2022.  A second past Lot 065F21A had also been administered after expiration to patients. Treatment information was not reported. Order date and Completion date reported as 10-Feb-2022. NDC ID reported as 80777027398 and Person Number as Unknown.
G62.9 NEUROPATHY 5/24/2021 AORTIC VALVE STENOSIS
Pt felt diaphoretic and dizziness approximately 5 minutes after vaccine.   Pt was laid on floor given ice packs to neck, elevated feet BP 180/100 pulse 71 pulse ox 98%   resp 14.     After approximately 10 min pt was sat up  BP 160/100  pt given 2 bottles of water to drink.   Pt monitored for additional 15 minutes was feeling well and was able to go home with family.
pt recvd vax;reported significant soreness;swelling at inject site for approx 1 day p/ inject;PC 8 days later & was still having pain & soreness in lt shoulder;lt upper back pain;
no additional AE; Customer reported that when a nurse tried to administer GARDASIL 9 to a patient, the patient moved and some of the medication leaked out. Agent filed this AE for the patient and precautionary AE filed in case 02254778 for potential nurse exposure to; This spontaneous report was received from a customer and refers to a 12-year-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 23-SEP-2022, nurse tried to administer hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection 0.5 ml intramuscularly, lot # 1775808, expiration date 20-AUG-2023 to the patient, the patient moved and some of the vaccine leaked out (incomplete dose administered). No additional adverse events were reported.
Patient received vaccine on 8/16/2018. Her arm broke out in a skin rash and began swelling the next day. She went to ER doctor and he told her she had reaction to PNEUMOVAX vaccine. She received a prescription for some (clindamycin) antibiotics from emergency room doctor.
Patient received varicella vaccine left arm 5/19/08. Developed increasing redness and swelling. No fever. Not ill appearing; Induration, Erythema about 14cmx11cm left arm
Patient had 6 inch diameter rash on right arm at site of injection, upper arm was swollen. Patient reported rash appeared on 11/16/17 but didnt not come into pharmacy until 11/24/17. No treatment provided, recommended to apply cold pack to help with swelling.
Per dad, "large hard lump" on right leg at site of injection.  Denies edema or erythema. Phone call today 3/11/08.
Patient's upper arm around the injection site is red and pus-like. Pt reports hotness and pain around the area, as well as hardening of the skin around injection site.
Patient had a syncopy type reaction for about 1 minute.  Right after the vaccine was given, patient stopped responding to verbal or physical cues.  Her eyes were open and she was sitting upright.  Her pulse was normal.  About that time the emergency personnel were contacted.  After about a minute or two she slowly started responding.  Water was provided and she felt better after drinking some.  EMS checked her BP and BG that came back normal.  They asked her to go to the doctor or to sit at the pharmacy for about 20 minutes.  The father decided to stay at  the pharmacy for 20 minutes and she seemed normal at that point.
distorted vision in left eye, loss of vision, floaters,  peripheral vision loss and its continued to get worse,  went to eye specialist at Clinic he could not see anything wrong. Doctor who is an ophthalmologist only thing he said was the vitreous had loosened some due to age.
69 year old female patient received a expired dose of FLUBLOK , no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 69 year old female patient who was vaccinated with an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 03-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA1964 and expiry date: 30-Jun-2020) via an unknown route in the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient falsified DOB when registering for vaccination, stating the minor was 02/24/2005. Guardian consented to the vaccination. Also verified with statistical records that the patient's actual DOB is 02/24/2007 which made the vaccine a contraindication. No known adverse reactions noted.
LUE pain; bone pain; mialgia/muscle aches; all over joint pain; fatigue; chills; sore Left deltoid; body aches/all over body aches; Headache; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK5730), intramuscular on 19Dec2020 07:00 am at single dose at left arm for covid-19 immunization. Medical history included hypertension, covid-19 (prior vaccination). No known allergies. Concomitant medications in two weeks included amlodipine besilate (NORVASC), ascorbic acid (VIT C), ergocalciferol (VIT D), magnesium chloride (MAG), zinc and daily multivitamins. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. The patient experienced sore left deltoid, body aches, headache all on 19Dec2020 16:00, all over body aches, headache, fatigue and chills all on 20Dec2020, mialgia/muscle aches, fatigue, headache and all over joint pain all on 21Dec2020, headache, LUE pain, muscle and bone pain, fatigue all on 22Dec2020, patient finally felt better with decreased symptoms on 23Dec2020. Outcome of all events was recovered on unspecified date. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient received paracetamol (TYLENOL), motrin for events.
I BROKE OUT WITH A SEVERE RASH A FEW DAYS AFTER TAKING THE FIRST PART OF THE SHINGRIX VACCINE. I ENDED GOING TO MY PRIMARY DR. ON THURSDAY, DEC. 27TH. SHE GAVE ME ANTIBIOTICS. I HAD TO RETURN TO A URGENT CARE ON SUNDAY, DEC. 30TH 2018. THE DR. THERE GAVE ME AN OINTMENT. RASH IS MUCH BETTER. TODAY IS TUESDAY, JAN. 8TH 2019 AND I STILL ITCH A LITTLE. IT IS MUCH BETTER. NEEDLESS TO SAY I WILL NOT TAKE 2ND PART OF THE VACCINE.
Low-grade fever (99.9 F - 100.4 F) Extreme fatigue Muscle aches Headache Neck pain Soreness at injection site
within 12-14 hours post 2nd dose experienced diarrhea, fever, muscle aches;  diarrhea resolved within 36 hours; muscle aches/malaise resolved within 36 hours
1. Had a severe gout flare up in left knee same night as I received shot. Sought treatment 2 days later. Received a steroid injection (10mg of Decadron) at urgent care faciilty. Received Rx for 50mg Indomethacin capsules. Overnight, the combination of the 2 drugs greatly lowered the pain and helped the swelling go down a little. 2. Second night after shot, I had a brief attack of severe chills, which woke me up, They went away after adding a blanket and dressing warmer.
I have severe brain fog. I have struggled to get my thoughts together to make sentences. I try to write work emails and can't think straight enough to comply one. Its hard to explain it just seems like a blur over my brain and I'm just confuy.
Information has been received from a registered nurse concerning a 36 year old female patient who on 28-FEB-2008 was vaccinated with an 0.5 mL adult dose of VAQTA (Lot# 659288/1377U) instead of the first dose of GARDASIL (human error not product quality complaint). No adverse events were reported. No product quality complaint was involved. Additional information has been requested. Follow-up information was received from a nurse investigator who is investigating this event. The nurse reported that the vials were stored alphabetically in the controlled-temperature unit. The practitioner stored the GARDASIL under its brand name which did not place the vaccine near the VAQTA. A student grabbed the incorrect vial from the unit and filled the syringe with 0.5 mL. The practitioner dosed the 0.5 mL of the incorrect vaccine. According to the nurse investigator, the incident appeared to be human error rather than product confusion. Additional information has been requested.
My water broke and I went into preterm labor at only 35 weeks pregnant. I had a perfectly healthy pregnancy with no signs of anything wrong until I got the Tdap vaccine and 8 hrs later if went into labor.  Additionally, I developed a bad egg allergy/intolerance from the date of the shot.
Adverse Reaction Notes 1. 49 y/o female c/o nausea and headache 2/10 15 mins after receiving the second dose of the vaccine, had no reaction to 1st dose. She reported hx of HTN years ago but not on any meds. She was assessed and monitored by NP, EMT, and paramedic. BP -152/98, 144/92, HR - 88, resp -14, temp - 96.7, 100% on RA, has mild anxiety. She was taken outside for fresh air, given H2O. She was kept at site until she reported that her nausea was gone, her headache 1/10. Instructed to take Tylenol 650mg Q6h PRN headache, monitor her BP and parameters to notify her PCP and to get rest today. She was given the Vaccination information sheet, reinforced instructions on ADRs/ SEs to call 911 and go to the ED, follow up with her PCP. She was with her husband, both verbalized understanding and willingness to comply. She left site in no acute distress, awake, alert, oriented to person, place, time and, situation.
Fever 104.1, local rxn lt fore arm onset 14MAR90, rash onset 18MAR90, adenopathy, allergic event, hives onset 18MAR90.
Hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair loss). At the time of the report, ALOPECIA (Hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter. No Treatment medications were provided by reporter.
Burning pain going down into the forearm on the same side vaccine given; This is a spontaneous report from a contactable pharmacist.   A 77-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730) via an unspecified route of administration on 13Jan2021 12:30 single dose for covid-19 immunisation. Vaccine location was left arm. Patient did not receive any other vaccines that day and none 4 weeks prior. Medical history was none. There were no concomitant medications. The patient experienced burning pain going down into the forearm on the same side vaccine given on 17Jan2021. She has never experienced anything like this before having that vaccine. The event was reported as medically significant. The outcome was not recovered.; Sender's Comments: Based on the reasonable temporal association and considering he known safety profile of COVID-19 vaccine, BNT162B2, the Company considers there is a reasonable possibility that the reported "burning pain going down into the forearm on the same side vaccine given" is related to BNT162B2 administration.   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 RA, IEC, as appropriate.
Fever 102.1, chills, headache, body aches x48 hours, swollen axilla today is day3.
The client stated that approximately 30 minutes after receiving the vaccine she noted mild itching on her right arm. The client stated the next morning she noticed a rash on her stomach and arms bilaterally. The client described the rash as "little red bumps" and stated that the rash was itchy. the client took Benadryl at home, which relieved some of the itching but did not improve the rash. The client stated the rash lasted 2 days. The client denied any shortness of breath, dizziness, or other s/s of anaphylaxis. The client states she received approval to proceed with the 2nd COVID vaccine Pfizer from her primary care physician.
3 days of irritability p/3 hr of screaming the noc of the shot;
pt reported to have choking episode & resp distress & lethargy;led to resp arrest then cardiac arrest;
3 days PV shingles flare up on mid-chest and R arm; This is a spontaneous report from a contactable Physician. A 74-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as single dose for covid-19 immunisation. The patient medical history included HX of kidney failure, anemia, HTN (hypertension), gout, heart failure, A-fib. Treated with valacyclovir and mupirocin, clinically diagnosed. Concomitant medications were not reported. On unspecified date, the patient experienced 3 days PV shingles flare up on mid-chest and R arm. Event took place after use of product. The patient received treatment for the event. The outcome of event was unknown.  Information on the lot/batch number has been requested.
aggravated flare up of shingles; mild shock in back, intense nerve activity in the back; burning and stinging in the back; burning and stinging in the back; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (aggravated flare up of shingles), PAIN (mild shock in back, intense nerve activity in the back), BURNING SENSATION (burning and stinging in the back), PAIN (burning and stinging in the back) and FATIGUE (Felt tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced HERPES ZOSTER (aggravated flare up of shingles), PAIN (mild shock in back, intense nerve activity in the back), BURNING SENSATION (burning and stinging in the back), PAIN (burning and stinging in the back) and FATIGUE (Felt tired). At the time of the report, HERPES ZOSTER (aggravated flare up of shingles), PAIN (mild shock in back, intense nerve activity in the back), BURNING SENSATION (burning and stinging in the back), PAIN (burning and stinging in the back) and FATIGUE (Felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This is a spontaneous report from a contactable consumer (patient's mother). A male patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiry date: not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced psoriasis on an unspecified date. Reporter stated she and her son take Stelara every 3 months for psoriasis. The outcome of event: unknown. No follow-up attempts needed. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): PFIZER INC-2021525511 same reporter/drug/AE, different patient.
Disoriented, couldn't remember her own name or where she lived, talked gibberish, presented with all signs of stroke and immediately taken to ER by caregiver.
Fatigue on evening of vaccination, followed by severe, debilitating, bilateral,  nonradiating low back/flank pain the next morning and for at least the next 24 hours (at the time of reporting)
Periodic Lightheadedness every day since injection ( 3 1/2 days at time of reporting
HPV vaccine second dose administered by the RN with the patient sitting in the chair, 15 seconds later child slid down from the chair never lost consciousness and was assisted back into the chair. BP 97/60 HR 76, Pupils equal, round and reactive to light, able to track my finger held up when moving side to side. Drank 2 small cups of water.  Mother/Aunt were speaking as was the patient were in the room said he would be fine. Patient was assisted to the car.
Late getting my second shot the Moderna vacinne; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Late getting my second shot the Moderna vacinne) in a patient of an unknown age and gender 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. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Late getting my second shot the Moderna vacinne). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Late getting my second shot the Moderna vacinne) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.
rash, from knuckles to wrists on the back of both hand; little blister; red; very itchy; redness/rashlike around both eyes (but no blisters) --looked kind of raccoon-like; started 3 days after 2nd vaccine,  still going a week later, although starting to dissipate; started using topical benadryl a couple days after it began; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: ep7534), via an unspecified route of administration in the left arm on 25Mar2021 at 17:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included mild eczema; the patient reported that the area around the eyes was prone to redness; on the hands though, it usually hit the knuckles. The patient never had it on the back of hands or wrists like this and it was never blistery. The patient said that she held off another 3 days before using a steroid cream, as she understood that steroids should be avoided for 2 weeks after second vaccination. The patient had known seasonal allergies; suspected nut and coconut sensitivities. Concomitant medications included Fexofenadine hydrochloride (Allegra) and amp, and vitamin D. The patient previously received her first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: en6202), via an unspecified route of administration in the left arm on 04Mar2021 at 05:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to 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 vaccine within four weeks prior to the COVID-19 vaccination. On 28Mar2021, three days after the second dose of the vaccination, the patient experienced rash, from knuckles to wrists on the back of both hands - little blisters, red, very itchy; redness/rash like around both eyes (but no blisters)- looked kind of raccoon-like; started, still going a week later, although starting to dissipate. As a therapeutic measure, the patient started using topical benadryl a couple of days after the events began and later switched to benadryl tablets on 04April2021. The clinical outcome of the events was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Every morning,  following the vaccination, I woke up with a moderate headache. Tuesday through Thursday I was able to control the headaches with 600 mg of Ibuprofen. But Friday I had a migraine with light sensitivity and it was not relieved by using Ibuprofen or Aleve. It finally spontaneously resolved at around 1330. I've been otherwise fine.
Mother stated since Monday (6/9/03) afternoon child has been vomiting.  Also had high fever.