chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received the vaccine, when she got up to leave, she started feeling faint.  She walked approx 20 ft away from the pharmacy when she fainted.  Her boyfriend caught her and another bystander asked for help.  The pharmacist went out to help, lowered the Pt to the floor, pt lied supine until pt became conscious.  Pt was asked to  stay supine for 3-5 minutes before she was helped to a chair.  Pt's pupil were initially dilated, pt's radial pulse was hard to find initially.  After pt was seated in a chair, her pulse was 98, pupils were perl, no N/V, no abdominal discomfort.  Pt stayed seated near the pharmacy for 30 minutes for further monitoring,  Pt said she felt fine,  pulse 78, strong and regular, pupils perl.  Pt's  boyfriend took her home.  Pt called vaccinator a hour later and reported she felt fine .
Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were administered improperly stored GARDASIL 9 (lot # L007560 with expiration date 15-JUN-2017, lot # L019297 with an expiration date of 18-AUG-2017, lot # L043213 with expiration date of 28-AUG-2017, dose, strength and route unknown). The vaccines were exposed at 8.5 degree Celsius for 15 minutes. There was no previous temperature excursion. No adverse event reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient passed out shortly after vaccination, patient fell to floor and hit his head, he was immediately attended to, patient had legs elevated and was monitored and evaluated for 45 minutes.
already positive for COVID.; already positive for COVID.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "already positive for COVID.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: already had the 4 shots (Unspecified Shot); he recently took the bivalent booster but he was already positive for COVID. I have a caller on the other line, She is calling because her dad is taking Paxlovid and he is going to be taking his last dose tonight. He is feeling a lot better, he is not coughing that much and they just want to know how do you know if her dad needs to take more of it? She has mentioned that her dad already had the 4 shots (Unspecified Shot), he is fully boostered and he recently took the bivalent booster but he was already positive for COVID."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Four days after receiving the 3 vaccines stated (HepA, HPV and Meningo) my daughter noticed a significant patch of her hair had fallen out/was missing. The area where this occurred was on the right side of her head just behind her right ear. The patch was roughly the size of a 50-cent piece.
Raised red skin in an oblong shape over bicep on left arm, hot to the touch not very itchy. Top of rash is at injection site
Clients mother reported rash at injection site of varicella injection, denies any other s/s.
Headache, Sedation, Myalgia, Arthralgia & Nausea Vomiting
No adverse event occurred. Vaccine was administered one day before the patient turned 6 months old.
Mother called a day after immunizations given. Mother reports that left arm is swollen; "doubled" in size. Mother told to give ibuprofen and cool compresses.
12 hours after injection, fainted, had nausea, tunnel vision, shaking. Now has likely dx of POTS. Continues to have nausea and increased anxiety.
In January of 2022, I felt really exhausted, I wanted to sleep all day and I started to have really bad headaches, I use to have hair down to my waist and now my hair is up to my shoulders. The headaches are so bad that I throw up. I am also having mental blocks, when I am driving I can forget things. I got my first appointment in June with my neurologist. I was having trimmers and the medicine they gave me, made me feel sick. My neurologist ran an EEG test. The EEG results came back normal. I am waiting on approval from my insurance for a MRO with or with contract. My teeth are also chipping off.
A spontaneous report (United states) was received from other health care professional on 11Feb2021, concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced   Headache, stiffness and arm sore  The patient's medical history not provided by reporter. Concomitant medications reported include vitamins, coq10 supplements and garlic.  On 09Feb2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number:  031L209 - 0311209 not sure) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On an unknown date, she experienced Headache, stiffness and arm sore Laboratory details were not provided  Treatment information not reported. Action taken with mRNA-1273 in response to the events were not applicable. The outcome of the events, Headache, stiffness and arm sore were not recovered.
This case was reported by a pharmacist via call center representative and described the occurrence of hypertensive episode in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced hypertensive episode. On an unknown date, the outcome of the hypertensive episode was unknown. It was unknown if the reporter considered the hypertensive episode to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional (HCP) did not have batch number or expiry date of SHINGRIX that was given. The HCP reported that a patient had hypertensive episodes after dose of SHINGRIX. The reporter did consent to follow up.
Intramuscular injection for COVID-19 (1st injection - Moderna) was given in the left deltoid. Immediately after injection I felt some stinging in the site location, which lasted for around 20 minutes. During the next 10-45 minutes, I experienced profuse cold palm sweats. Heart beat and respiration remained normal, as far as I could tell. Went home and felt moderately OK for the rest of the afternoon / evening. In the middle of the night, I woke up and wasn't able to move my left arm, due to intense pain and a heavy feeling in the limb. This feeling continued throughout the rest of the night (interrupting sleep), and for the entire day following (day after vaccination), accompanied by extreme fatigue and joint aches. Was not able to work or perform simple household tasks on that day. 2 days post-vaccination woke up with moderately less pain in the arm and more energy - but was experiencing some brain fog and a headache that limited activities somewhat. 3 days post-vaccine energy has returned, but the site of the injection is still a little swollen and sore to touch. Mobility of arm has returned.
Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. On 02 Apr 2021, there have been a power outage and the vials were in freezer and refrigerator where temperature dropped to -13.79 C for frozen vaccine for about 47Minutes and 12 C for refrigerator for about 59 Minutes. No treatment information was provided.   This case was linked to MOD21-068620 (E2B Linked Report).; Sender's Comments:  MOD21-068620:crosslinked case
Dizziness / light head feeling; Nausea; This case was reported by a physician via sales rep and described the occurrence of dizziness in a male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 28th April 2019, the patient received Boostrix. On an unknown date, less than 2 years after receiving Boostrix, the patient experienced dizziness and nausea. On an unknown date, the outcome of the dizziness and nausea were not recovered/not resolved.   It was unknown if the reporter considered the dizziness and nausea to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. Sales representative reported on behalf of a Doctor of medicine a patient who after receiving Boostrix, the patient developed dizziness, nausea, light head feeling and the symptoms persisted after 1 year now. The reporter consented to follow up.
Sore arm; Difficulty breathing at times; Achy; Having difficulty urinating; Chills; Fever; Fever 101.6; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DYSPNOEA (Difficulty breathing at times), PAIN (Achy), URINARY TRACT INFECTION (Having difficulty urinating) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COVID-19.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DYSPNOEA (Difficulty breathing at times), PAIN (Achy), URINARY TRACT INFECTION (Having difficulty urinating), CHILLS (Chills), PYREXIA (Fever), PYREXIA (Fever 101.6) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm), DYSPNOEA (Difficulty breathing at times), PAIN (Achy), URINARY TRACT INFECTION (Having difficulty urinating), CHILLS (Chills), PYREXIA (Fever), PYREXIA (Fever 101.6) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 101.6 (Inconclusive) Fever of 101.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
I received the 1st Pfizer dose on 1/30/21 and 2nd Pfizer dose on 2/20/21. After the 2nd dose,  I  developed mild fever (under 100)*F, a bad headache, blurred vision, nausea, joint pain and fatigue. I took Tylenol for the fever and headache and  recovered after 2 days. However, on 2/28/21 I developed a SECOND SERIES OF SIDE EFFECTS starting 8 days after the 2nd dose.  I developed a fever of 100.7*F , a bad headache, nausea, palpitations, and severe joint pains and strong fatigue. I consulted my PCP, who recommended I fill out this report. I took Advil on 2/28, improved after 2 days, and now have a slight headache and some fatigue but otherwise recovered.
No reaction the day of the vaccination. Day two (36 hours later) Fever that put me to bed (Unknown temperature), took 2 TYLENOL around 7:00 PM, woke up in the morning and fever was gone. At that time, there was a fist size red area on the left upper arm. It took about two days to disappear.
A non-serious spontaneous report of an 89-year-old female with kidney disease got H1N1 was received from a son/consumer. The patient's medical history included chronic kidney disease. The patient did not take any medications for her kidney disease and was not on dialysis. The concomitant medications included cilostazol and blood pressure medications. On 18-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
after recv vax pt exp poor appetite, funny taste in mouth, fever about 5-6 hr after inject, inject site hot, arm throbbing, very tender, very sore underarm, swollen, firmness, cold but perspired, tired, sleeping a lot. still having problem
warm to the touch; couldn't keep her eyes open; arm from shoulder to elbow started to get red; tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), SOMNOLENCE (couldn't keep her eyes open), VACCINATION SITE ERYTHEMA (arm from shoulder to elbow started to get red) and FATIGUE (tired) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History reported).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), SOMNOLENCE (couldn't keep her eyes open), VACCINATION SITE ERYTHEMA (arm from shoulder to elbow started to get red) and FATIGUE (tired). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), SOMNOLENCE (couldn't keep her eyes open), VACCINATION SITE ERYTHEMA (arm from shoulder to elbow started to get red) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Initial and follow-up information has been received from a physician concerning a 61 year old female with a history of chickenpox as a child who on 31-JUL-2007 was vaccinated with a single 0.65 ml dose of ZOSTAVAX (lot no. 658086/0761U) into the right arm. Concomitant therapy included METFORM, lorazepam, LIPITOR and lisinopril (manufacturer unknown). On 07-JUL-2008, the patient developed "shingles with pain." It was reported in follow-up that the patient had classic erythematous, vesicular rash in the right trunk around the right side the right breast (Dermatome: right thorax). The number was too numerous to count. The outcome was unknown. The patient sought unspecified medical attention. Additional information is not expected.
Case number PHEH2014US004180 is an initial spontaneous report received from a nurse on 27 FEB 2014. This report refers to an 11-year-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly on 21 DEC 2013. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 01 APR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Rash, red hives, itching. Took CLARITIN & BENADRYL. Body ached.
Headache  Nose felt funny  Left ear was hurting  top throat itchy  then bottom of throat was itchy     08:40 Inserted 24 gauge IV in Left AC Space  08:43 - Epi 0.5mg IM Left thigh  08:44 - Benadryl 50 mg administered via IV  ear/nose/throat s/s improved  Developed chest tightness, moved to floor elevated feet.  EMS called.  Transported via ambulance to ED.
3 tiny little lumps/blisters appeared on the left hand near the wrist approximately 10 days after receiving the vaccine. In addition in the wrist, there is a spot that is painful to the touch (possible neuralgia).  The pain still persists to this date (when the area is touched)
headache; This is a spontaneous report from a contactable pharmacist.   A 30-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL1284, Expiration date not reported), intramuscular in left arm on 23Dec2020 at 13:15 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to azithromycin and ibuprofen. Medical history included covid-19 prior vaccination. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced no reaction with 1st vaccine 1155 c/o headache on an unspecified date. The seriousness of headache was reported as non-serious. The outcome of headache was reported as recovered.  No follow up attempts are possible. No further information is expected.
Congested; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (reporter's child). A child patient of an unspecified gender and age received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (first dose) on an unspecified date for COVID-19 immunisation. On an unspecified date, the patient experienced congested. The reporter is the parent of a child who called doctor's office who told her to call Pfizer. Her child had the second Pfizer COVID-19 shot and was congested. Caller does not know if that was a reaction. She wanted to speak to someone to answer her questions about the child being congested after the second Pfizer Covid shot. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Swelling redness extreme  pain within 8 hours of vaccine. Injection site and whole deltoid muscle Hot to touch swollen hard very red. Fever. Agitated climbing the walls. Saying arm felt dead or dying. Had to mark arm with black perm marker to check the swelling.  Weird birthmark shaped marking from vaccine. I've used ice packs.. Zyrtec for antihistamine.  Ibuprofen  and Tylenol  for pain. Rest.
Continues with soreness in the left deltoid region after receiving vaccine 10/26/23  (18 days).  Referred to primary care physician for further evaluation 11/13/2023.
Pfizer 5-11y was pulled on accident, then reconstituted with 1.8ml and 0.3ml wad administered. Then on recommendation of Pfizer Inc and CDC a second full dose of Pfizer covid vaccination  was administered to the patient 4 hours later.
On 9/19/23 while on vacation and I woke up and my left hand felt like it had fallen asleep. The next night the pain was so much that it kept me awake, I massaged my arms and took anti inflammatory medication to help relieve the pain. Each day the pain got worse in my back and hands. When we to home on Saturday September 24th the pain was horrible. I was told to go to emergency room. They ave me steroids, muscle relaxer and sent me home. I followed up with my PCP and she had me start physical therapy which I did for approximately 3 months. She did not give me the 2nd dose of Shingrix. She ordered an electromyogram study which I just had on 2/7/23 and it showed I had bilateral carpal tunnel.
On 9/1/2021 he developed abdominal pain.  On 9/3/2021 he underwent surgery for an appendicitis
He woke up during the night with a 104 degree temp and began to vomit. The high fever and vomiting continued for around 24 hours. He was given Tylenol but even with that his fever would only get to around 102 degrees.
Date of 2nd dose received 1/17/21.  HCW (Physician) pregnant at 32wks 5 days (due date 3/10/21) with preterm premature membrane rupture on 1/18/21. Was working entire weekend and overnight in hospital on call before event happened (?stress). Currently hospitalized in Labor&Delivery, received latency antibiotics, steroids and currently under expectant management.
After Moderna shot #2 and the booster (#3) I have developed dermographia if I scratch my skin it immediately becomes inflamed and develops swollen welts. This is everywhere from my scalp to my feet. Both reactions have showed up between a week and two weeks after vaccination and never any other time in my life. The first time this happened it lasted almost three weeks and I was told to take Zyrtec. This round I became itchy Friday and welts started developing worse Saturday.
pt recv vax & w/in 12hr post vax devel hives on legs & back & itching;pt recovered 12-24hr;
30 hours post vaccine developed diffuse symmetric muscle pain. Muscles became rock hard/10/10 pain at night; rigidity; diffuse muscle weakness; Unable to get out of bed or up from chair without assistance; weakness; This is a spontaneous report from a contactable physician. A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jan2021 13:00 (Batch/Lot Number: EL8982) as SINGLE DOSE for covid-19 immunisation. Medical history included hyperlipidaemia. Concomitant medications included rosuvastatin; escitalopram; ubidecarenone (CO Q 10 [UBIDECARENONE]); colecalciferol (VIT D3); all taken for an unspecified indication, start and stop date were not reported. The patient previously took augmentin and experiencedknown allergies. On 26Jan2021 19:00, 30 hours post vaccine developed diffuse symmetric muscle pain. Muscles became rock hard/rigidity. Over next week developed diffuse muscle weakness. Proximal worse than distal. Unable to get out of bed or up from chair without assistance. Persisted for over 6 weeks: 10/10 pain at night. Muscle pain, weakness, rigidity. The events were assessed as serious (hospitalization, and disability). Number of days in the hospital: 1. Therapeutic measures were taken as a result of the events. No covid prior vaccination, and no COVID tests post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on known safety profile and/or temporal association, the contribution of the suspect drug to the onset of events 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 RAs, Ethics Committees, and Investigators, as appropriate.
May 9, 2008- office visit with complaint of redness and pain below site of injection, left arm, started 1 day after had PNEUMOVAX. Some itching on left arm. Area of redness and pain has moved down over past 4 days.
2.5 x 3.5 cm are induration, & local redness w/tenderness @ site of inject rt deltoid muscle; no fever, or neuro sx;