chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning an approximately 17 year old female with none drug reactions/allergies and pertinent medical history who on 26-JAN-2012 was vaccinated with the first dose of GARDASIL (lot # 670048/0963AA, exp on 09-NOV-2013), 0.5 ml, IM on left arm. There was no concomitant medication. The nurse reported that the patient contacted the office on 16-FEB-2012 and informed them that she did a home pregnancy test and the result was positive. The patient's LMP was 02-JAN-2012 and estimated delivery date 08-OCT-2012. No adverse event reported. No treatment was given. Nurse stated that the patient would be following up with an Obstetrics and Gynecology (OB/GYN) physician in March 2012 (doctor unspecified). Follow up information has been received from a registered nurse which reported that the patient had a single pregnancy, estimated delivery date 14-SEP-2012 (previously reported as 08-OCT-2012). On 25-JUN-2012, ABO/Rh test and glucose A1C were performed at 25 weeks. The pregnancy outcome was live birth, no complications during the delivery. Neonate was normal female length 20", weight: 6 lb 3 ozs, head circumference 13" 3/4 without congenital anomalies. Additional information is not expected.
Immediate nausea and diarrhea.  Aches, headache and nausea all the same day.  Went away after that day
Moderna COVID?19 Vaccine EUA  Symptoms: strong phantom smell of car exhaust which has caused headaches and nausea.  Still occurring 2 weeks after injection.
myalgia, subjective fever, slight diarrhea, joint pain inability to lift hand.
4-5 water filled blisters @ inj site;largest was 1cm in diameter;pt exp no discomfort;
Heart rate increased to high 160s.  Blood pressure 165/105 (normal BP around 117/80). Face/neck/chest very red.  Felt dizzy and nauseous. Felt like brain wasn't working while answering questions like year and president.  Almost like an intoxicated feeling.
5 minutes after receiving shot wave of dizziness and weakness.  Head spinning, nausea.  Burning in throat and arm (opposite of arm that got the shot).  Didn?t pass until almost an hour and a half later.
This case was reported by a physician via call center representative and described the occurrence of bell's palsy in a 71-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (in October 2018). On 4th February 2019, the patient received SHINGRIX. On 15th April 2019, 70 days after receiving SHINGRIX, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown. It was unknown if the reporter considered the bell's palsy to be related to SHINGRIX. Additional details were provided as follows: The retired pediatrician reported that his wife developed bell's palsy after receiving SHINGRIX vaccine.
Case number PHEH2015US023887 is an initial spontaneous report received from a health care professional on 13 Nov 2015. This report refers to a patient whose identifiers were not reported. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1517701) subcutaneously on 09 Nov 2015. It was reported that on the same day after vaccination, the patient had a localized reaction. The outcome of the event was reported as complete recovery on the same date. The seriousness and causality were not reported.
On 2/5/2021 vaccination injection site was noted to be red/warm and itchy, PCP was contacted and orders given for use of Benadryl, Tylenol and cold compress; area did resolve without further intervention
Myalgia, NauseaVomiting, left sore arm, back pain, Narrative:
received first dose of the vaccine on 29Dec2020 and tested positive for COVID on 11Jan2021; received first dose of the vaccine on 29Dec2020 and tested positive for COVID on 11Jan2021; This is a spontaneous report from a contactable pharmacist (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 29Dec2020 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that the patient received first dose of the vaccine on 29Dec2020 and tested positive for COVID on 11Jan2021. Patient was scheduled for her second dose this week and stated she is trying to figure out what to do. Patient asked if there are side effects if she get is earlier that the suggested 90 days. Patient also asked if there is a recommendation on what to do if it ended up running out of the vaccine before she gets her second dose. The patient underwent lab tests and procedures which included sars-cov-2 test with result of positive on 11Jan2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Right thigh (injection site) with 4 in x 7 in red, indurated, warm to touch, antibiotic (po. given to tx cellulitis.
Day 2: severe headache; bad pain in joints and muscles; trouble walking and standing, legs and arms felt very heavy; Day 3: fatigue Day 6: severe dizziness from 7am to 1pm; sick at stomach but no vomiting; could not walk--had to crawl, fatigue rest of day
Acute onset fever chills and SEVERE ARTHRITIS IN LEFT ANKLE WITH EXQUISITE PAIN AND TENDERNESS.  THE FEVER CHILLS SUBSIDED BY MORNING but the arthritis gradually disappeared in 24 hours.
Patient described the first symptoms as fairly intense itching and a local ache similar to a bruise. She noticed a red, oval rash on her upper arm that covered a fairly large area after a hot shower. Itching is improving. No fever or other s/s. Generally consistent with "covid arm" but onset was 15 days after vaccine. Patient at first though it could be a reaction to a drink which she had just tried for the first time. I advised second dose in opposite (Right) arm.
fainting, vertigo, migraine headaches (lasting several days) all symptoms persisting for several weeks
COVID 19 Treatment adminitered; COVID 19 Treatment adminitered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), on 07Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation. The patient had no relevant medical history. The patient's 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 "COVID 19 Treatment adminitered". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. No Known alleries.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No symptoms no adverse effects. Incorrect reconstitution of complete vial.  Diluent applied to vial 0.8 of saline instead of recommended 1.8ml as directed Patient received correct dose of 0.3ml  Parent instructed to contact clinic if symptoms arise and to go to ER if life threatening symptoms occur.
Patient stood up after injection, felt burning at the sight, walked 5 feet to the door and collapsed.  His legs buckled oddly under him and Dr. came to the rescue.  He went stiff and came to.
Severe agitation, complete inability to sleep, dry mouth, elevated heart rate, elevated blood pressure, severe anxiety, constipation, difficulty urinating, violent behavior
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the Reporter  No Treatment Information were provided by the Reporter
About 2 hours after my vaccine I had crippling pain in my entire arm where I'd received the vaccine (from shoulder all the way down to fingers) that lasted almost over 12+ hours.  I was completely unable to use my left arm for at least ~10 hours.  Around 2 hours after the vaccine I also began experiencing lightheadedness, severe wooziness, and skin sensitivity (feel like minor tingling and my clothing tickled and felt strange against my body and back).  The wooziness lasted until the next morning, so at least 12 hours.  As of 23 hours later, my arm is still very, very sore but most other symptoms have gone away.
1 week post vaccine now have a raised red blotch at site of injection.  Approximately 2 inches in diameter. Hot to the touch. Itchy. Muscle under skin feels hard. Slight pinching pain in left armpit.
Case number PHEH2014US006155, is an initial spontaneous report from a nurse received on 27 MAR 2014. This report refers to a 15-year-old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on an undetermined date. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction ws done for the information received on 27 MAR 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".
The event started on the 23rd. I ate breakfast at about 10AM and immediately had diarrhea the whole day. The following day I had dialysis and had two more bouts of diarrhea and then while I was there, I had two more bouts. My regular session is 3-hour sand 40 minutes and was only able to make it 2 hours and 40 minutes. When I got home, I tested for COVID-19, and it was positive. I called dialysis center to see what they would like me to do for my Monday appointment. I called my primary and spoke with anther physician and explained wat was going on. She called in a prescription for MUCINEX extended and azelastine HC1 nasal spray. She also told me to use saline nasal drops. Due to me being on dialysis I couldn't take the antiviral. I quarantined for 5 days. I just stopped taking the MUCINEX on April 1st. I tested positive I would have thought I had a cold. I had a lot of coughing; the first three days were the worst and then after that t settled a little bit. I was really tired. The first three days were the worst and after that it started getting better.
Immediate lightheadedness, dizziness, weakness, racing heart, scratchy throat, short of breath (for a few minutes)
Patient rec'd Moderna COVID vaccines 1/30/21 and 2/27/21.  On 4/3 she presented to the emergency department following a syncopal episode.  Prior to syncopal episode she had a 2 week history of dry, nonproductive cough, left side rib pain (Pain rating 8/10).  She was admitted and treated for PE and possible pneumonia.  She was discharged 4/5 on warfarin anticoagulation.  She had follow up appointments with PCP and hematology and will likely be on anticoagulation for unprovoked PE x 6 months.
Pt. stated she had fever, extreme dizziness and felt like she is going to pass out after the administration of vaccines. Had to lie down to feel better. Presented today, 07/29/2019  redness, swelling, warmness, pain 8 cm to the L arm and same symptoms but smaller size of 3.3 cm to the R arm.
Employee was fully vaccinated with Pfizer on 01/28/2021 and 02/18/2021. Employee became ill on 8/15 and tested positive for COVID on 8/16 with a PCR test @
01/14/21 got first shot (Moderna). First week experienced soreness in right upper arm and shoulder. 01/23/21   started experiencing cramps, cold chills, headaches,and dry cough. Blood pressure even dropped one time. 02/05/21 experiencing bad vertigo.  Ended up calling Moderna @ 1-866-633-3762.  Was given case # MOD21024718. Was told this was an experimental drug and to call your doctor. 05/03/21  was able to see Md for vertigo, left ear discomfort ( itching and pressure), and head aches. 05/26/21 saw ENT and Allergy to check ears and do a hearing test. 06/22/21 went to Emergency Room at Medical Center for head hurting , dizziness
pregnant; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported information for both mother and fetus/baby. This is a maternal report. A 38-year-old pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 38-year-old and pregnant at the time of vaccination), via an unspecified route of administration on 13Apr2021 at 09:48 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 24Mar2021 at 10:41 as single dose for covid-19 immunisation. On an unspecified date, the patient experienced pregnant. The mother reported she became pregnant while taking BNT162B2. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) :PFIZER INC-2021868616 same reporter, drug/ fetus case
cold sore on her lip; fever of 105; states she was incoherent; This case was reported by a consumer via call center representative and described the occurrence of fever in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th December 2020, several hours after receiving Shingrix, the patient experienced fever and incoherent. On 11th December 2020, the patient experienced cold sores lip. On 9th December 2020, the outcome of the fever and incoherent were recovered/resolved. On 13th December 2020, the outcome of the cold sores lip was recovered/resolved.   The reporter considered the fever and incoherent to be related to Shingrix. It was unknown if the reporter considered the cold sores lip to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The patient had no underlying disease and medication history The patient received her dose of Shingrix , on the same day, within few hours she developed fever and incoherent, after 1 day fever was resolved. Three days after, the patient developed a cold sores lip and it resolved in 2 days. No Lot or Expiration date was known.  No permission given to contact HCP. The reporter did not consent to follow-up.
Red area at site of injection appeared yesterday,  8 days after injection.  It is itchy, painfull, swollen and not to the tough.  Started out around 3 inches in diameter.  It's increased in size since yesterday and now covers most of the outside of me left upper arm.
got Shingles Vax & got shingles/suspected vaccination failure; shingles, so bad theywere in eyes, 4 times since; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   The reporter considered the vaccination failure and ophthalmic herpes zoster to be possibly related to Shingles vaccine.     Additional Information: GSK receipt date: 2-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shingles vax and got shingles from it so had they were in her eye. The patient have had shingles 4 more times since. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
The day after the injection, I had headache, chills, sweats, bad taste, fatigue, lethergy.  One week after I developed stabbing head pain, that continued off and on for several hours and several days.  18 days after I developed migraine that caused me to take time off work and go to bed.
Patient was given two of the same vaccine in error. First dose was given 10/31/17, second dose given 12/11/17. The patient is pregnant with an EDD of 01/22/2018.
Mother stated child had staring episodes within 24 hrs of immunizations. Pt admitted to Hospital on 1/26/06 with abnormal EEG. Hosp providers did not think pt had a seizure. Dioscharge summary states urinary tract infection, eyes deviated upward. msv
1/24/12 - vaccination given. 1/25/12 - warmness, pain of (L) deltoid, fever in the evening. 1/26/12 - itching, nausea, increased redness, increased pain of (L) deltoid. 1/27/12 - same as above.
no other AE; expired vaccine administered; This spontaneous report was received from a physician and refers to a 73-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 15-OCT-2020, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R034248, expiry date 07-AUG-2020 (also reported as 08-AUG-2020) (dose, route of administration and anatomical location were not provided) for prophylaxis. There was no temperature excursion. No adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R034248; expirationdate: 07-AUG-2020; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Redness and warmth to right arm encompassing 1/3 of entire upper arm.
A non-serious, spontaneous report of administered expired product was received from a nurse concerning a four-year-old female, subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Information has been received from a consumer referring to a 64 year old female patient. The patient had drug reactions/allergies to penicillin and codeine. Pertinent medical history was not provided. On 04-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX, (lot#, expiration date, dose, and strength were unknown), subcutaneously. Concomitant medication included unspecified thyroid medication. On an unknown date in August 2016 (reported as " a couple of days ago"), the patient began to experience tingles in her face, and then pain in her stomach and straight through to her back. The patient also experienced itchy feet. She also stated that she had no rash anywhere on her. No treatment was given for the events. No lab diagnostics studies was performed. The outcome of all the events was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Shoulder Injury Related to Vaccine Administration (SIRVA). The person administering the vaccine on behalf of CIC Health, whose name I later learned, injected the vaccine too high (roughly level with the acromion process) and far back. Initially there was only a quick burning sensation. The pain started about an hour later, but at that point it was mild and only notable because of the quick onset and slightly different feel from the first dose. Over the next few hours, it intensified and I began to lose the majority of the range of motion in that arm due to excruciating pain. I saw my primary care physician the next morning, he confirmed the positioning of the injection was incorrect. As of writing, ~56 hours after vaccination, the pain and limited range of motion have not yet resolved.
Information has been received from a Registered Nurse concerning a 24 year old female with no drug reactions/allergies and no pertinent medical history who on 27-OCT-2011 was vaccinated with a dose of GARDASIL (Lot# 669796/0840AA, expiration date 14-OCT-2013), intramuscularly. There was no concomitant medication. The nurse reported that on 28-OCT-2011 the patient's throat swelled up and her eyes became swollen. The patient went to the emergency room. No lab diagnostics study was performed. BENADRYL, TORADOL and REGLAN were given for the adverse effects. The patient was recovered by 07-NOV-2011. All the adverse effects were considered to be life-threatening by the reporter. A lot check has been initiated. Additional information has been requested.
Pain and swelling at injection site; fever; chills; body aches; headache; weakness.  Treatment:  Bed rest; Tylenol (2) 500mg 3x day; sleep, sleep, sleep.  From approx. 6:30 am 10/20 was feverish, body aches, chills, etc.  Suddenly at 4:25 pm, woke feeling too warm and sweaty because fever had broken; body aches subsided; arm still swollen and sore.  Felt weak still, also was cold but not chills.  Bed rest continued.  Weakness persisted through 11:30pm 10/20.  At 6:00 am, 10/21/2021, was able to get up and go to work.  Felt 100% better.    Arm still sore at injection site on 10/21/2021, all day.
15min p/vax began inconsolable crying which persisted throughout noc;phone call to nurse 2PM following day;parent advised to seek med attention & eval for possible vax rxn, parent encouraged to report back p/same;
pt stated that she had developed swelling, itching, redness and hot to the touch around the injection site. Pt went to her PCP today.  She was told she was having an allergic reaction so gave her a celestone injection in left hip and was told to take Benadryl at night.  Pt has also been using cortisone cream.  She was advised not to take the 2nd dose.