chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaginal bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (vaginal bleeding) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding). At the time of the report, VAGINAL HAEMORRHAGE (vaginal bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter Treatment information was not provided
Tenderness for 7 days and counting Redness in an area of 5 to 6 inches around the injection site Ongoing dizziness, and light headed feeling (7 days and counting)
Within the next month after receiving vaccine my hair started falling out by the handfuls. By Thanksgiving I broke out in a rash and developed a fever, By December 21, 2021 I had several large lymph nodes and very ill. I went to ER and I was put on antibiotics. Since then the rash has become vasculitis. I saw a dermatologist Dec 10th I believe and a biopsy was done. Still waiting on results of biopsy.
Iz given at primary care physician's office in right deltoid, area red, painful. Treated for local cellulitis.
mostly recent outbreak was 60 plus people that was fully vaccine booster; mostly recent outbreak was 60 plus people that was fully vaccine booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (UNKNOWN MANUFACTURER, DOSE 1,SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "mostly recent outbreak was 60 plus people that was fully vaccine booster".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Felt tired at 2:15pm, stayed awake a bit longer than napped for a couple hours. At about 10:30pm I started feeling sick, fever of 99.6, muscle and joint pain, chills, dizziness, weakness. Left arm where I got injected also felt like it was falling asleep at some point when it shouldn't have been based on how I was positioned. I finally took an ibuprofen so I could sleep around 2:30am, and felt better a couple hours later or so. Today so far I feel fine but my resting heart rate is about 30 beats higher than normal so I'm still responding to vaccine.  I think overall my symptoms aren't out of the ordinary, just way stronger than I was expecting. I felt miserable.
Patient called pharmacy to report she began experiencing left leg pain on the evening of 1/19/18. Immunization was administered several hours prior. She described it as a dull pain that occurs when standing up after sitting down. She denied any swelling or redness on her leg and injection site. She stated this was the first time she received an influenza vaccine and has never experienced an adverse reaction to a vaccine in the past. I advised her to monitor the pain and if it worsens or does not improve, to make an appointment with her Dr.
Swelling and rash started at knees and upper thighs, and also wrists and lower arms. Burning sensation that gets worse with activities. Need to apply ice packs every two hours to relieve pain. Doctor visit on Wed., Oct. 5, 2019; got prescriptions for: Prednisone 20 mg twice per day and Hydroxyzine 25mg taking 2 before bed. Also taking OTC Claritin or Benadryl.  The ?rash? spread or upper thighs and upper arms quickly. Over the past week, the rash has become more localized back at the knees and lower thighs, and also the wrists and lower forearms. The rash is very symmetrical on body location a when it appears anywhere.  Also applying Rx for Triamcinolone Acetonide Ointment, 0.1% to help relieve pain.
First COVID-19 vaccine: arm sore; First COVID-19 Vaccine: body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 15:40 (Lot number: ER6207) at the age of 32 years as dose 1 single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DUPIXENT taken for dermatitis atopic. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "First COVID-19 vaccine: arm sore"; PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "First COVID-19 Vaccine: body aches".  Additional information: Anatomical Location: Left shoulder.  No follow-up attempts are possible. No further information is expected.
Hep B #1 adm. 2:30pm,Fri.22 May 2009.  3 days later 2am woke up with difficulty breathing, productive cough with green phlegm, no fever.  All day (3rd day-Monday) felt lethargic, decreased energy and sick.  Used albuterol inhaler of mother's at 1pm on 3rd day(Monday).Had shortness of breath all day through Wednesday.Today, Friday, has productive cough.Came in today for TB test and MMR (both given)
AFTER GIVING SHOT IN 10MIN , PATIENT STARTS FEELING UNWELL, HER JAW LOCK, STARTING UNCOUNCIOUS, SHE WETS HER PAINT, HER TOUNGE OUT, UNRESPONSE, HER EYES WIDE OPEN , BLOOD PRESSURE DROP LOW
No adverse event; During vaccine administration the patient pulled the syringe out resulting in incomplete dose.; During vaccine administration the patient pulled the syringe out resulting in incomplete dose.; This spontaneous report was received from a licensed practical nurse concerning a 1-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were reported as no.   On 20-APR-2021, the patient was vaccinated with a partial dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (dosage regimen and anatomic site were not provided) (lot number T005737 and expiration date 10-JUN-2022 were verified as valid) as routine vaccination for Haemophilus influenzae type b. The reporter stated that the patient pulled the syringe out resulting in incomplete dose (underdose) (incorrect dose administered). . However, it was reported that the patient recovered on the same date (discrepant information). No additional adverse event was reported. It was also reported that no treatment was given, no diagnostic laboratories or studies were performed, neither medical attention was sought because the event occurred while in a clinical setting.
Information has been received from a pharmacist concerning a 61 years old female patient with no drug reactions/allergies and no pertinent medical history, who on 02-OCT-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. Pharmacist reported that on 03-OCT-2012, the patient developed rash on her triceps area after receiving a dose of ZOSTAVAX. The patient also developed 4 inches of redness at the injection site and muscle pain on her ribs. Ibuprofen was given as a treatment. The outcome of the events was reported as not recovered. The relatedness for rash on her triceps area, muscle pain on her ribs and 4 inches of redness at the injection site was unknown for ZOSTAVAX. No laboratory diagnostic studies were performed. The patient sought medical attention via calling the pharmacist. Additional information has been requested.
Received varicella vaccine on 8/24/11 left post arm and noticed red, swollen area on 9/03/11 at injection site. Seen my office on 9/07/11 area was 13.5cm x 9.5cm area cellulitis.
High blood pressure and cholesterol; High blood pressure and cholesterol; Sinusitis; allergy; This is a spontaneous report from a contactable consumer (patient). A 40- year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 14:30 (40- year-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. Concomitant medication(s) included lisinopril taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (CETRIZINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. No prior covid vaccination was taken. Therapeutic measures were taken as no for all event. The patient experienced high blood pressure and cholesterol, sinusitis/ allergy on 18Sep2020 (as reported). The outcome of all event was recovering.     Information on Lot/Batch number was available. Additional information has been requested
The patient was given 0.3 ml of undiluted Pfizer Covid vaccine, resulting in 6 times the authorized dose.  The error was discovered 1 hour after the vaccine was given and the patient was notified via phone 3 hours after administration.  Patient was advised by the pharmacist to take 2 extra strength Tylenol before bed and again in the morning to help with possible side effects.  The patient was followed-up by the pharmacy the following morning and only reports a stuffy nose.  No other adverse events have been reported to date.
conjunctivitis bilat eyes from hep B vax @ birth @ 2mos; both times w/in 24hrs of vax lasted 3-4 days; tx w/Maxitrol opth drops;
For over two weeks my son has presented with a lack of appetite and less BMs. On 10/08/13 he presented with a virus, but the virus is long gone and he still is not eating. He is losing weight. Also, he become moody and temperamental. He has fits, in which he is inflicting pain upon himself. HE DID NOT DO THIS PRIOR TO THE SHOTS. Still working on treatment.
rash started 2 days p/vax on face spread to nose, ears, chest, groin & back; no itching appetite dec x 4 days; no temp taken but felt a little warm for a couple of days; playing, eating & acting nl but rash still present today;
Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% Normal Saline, preservative free. Consulted with FDA and CDC to determine next steps for patient after discovery. Re-vaccination advised and team contacting impacted patient and offering to speak with a physician to discuss.
A week to the day of getting the vaccine the injection site became itchy and developed a rash and became red.  Over the counter med.
During monitoring period post Pfizer COVID-19 vaccine, pt experienced *Hypertension, Slower Heart Rate, Nausea, Facial Flushing and Chills. o  Patient declined medications. Water, blanket, distraction techniques and comfort measures initiated. Patient discharged to home with family. Left the clinic in stable condition.
Pt administered tetanus at local hospital not in deltoid - erythema 17 cm x 15.5 cm, bruising center about 4 cm x 5.5 cm, induration present.
extreme tiredness; Have lots of purple bruising on my legs, both legs/had dark blue bruising/blushing down both legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 (Lot number: FH 8028) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraines" (ongoing). Concomitant medication(s) included: IMITREX taken for migraine (ongoing). Vaccination history included: Bnt162b2 (Dose:1,, Anatomical site of injection: left arm, Batch/lot number: ER2613), administration date: 17Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose:2, Anatomical site of injection: left arm, Batch/lot number: EP7533), administration date: 08Apr2021, for COVID-19 Immunization; Flu (Anatomical site of injection: left arm, No. of previous doses:1), administration date: 05Nov2021. The following information was reported: CONTUSION (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Have lots of purple bruising on my legs, both legs/had dark blue bruising/blushing down both legs"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "extreme tiredness". The event "have lots of purple bruising on my legs, both legs/had dark blue bruising/blushing down both legs" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of contusion. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). After Pfizer booster had dark blue bruising/blushing down both legs. Did not hurt, no swelling. Gone the next morning waves of extreme tiredness 1 week after booster.  No follow-up attempts are possible. No further information is expected.
Transient numbness inside mouth buccal mucosa for about 3-5 minutes; Slight swelling upper left lip; 2cm petechia on border of left upper lip stopping at the midline; This is a spontaneous report from a contactable Other HCP (patient). A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), Intramuscular at left arm on 15Jan2021 11:00 at SINGLE DOSE for covid-19 vaccination. Medical history was reported as none.  The patient's concomitant medications were not reported. On 15Jan2021 11:15, the patient experienced transient numbness inside mouth buccal mucosa for about 3-5 minutes, slight swelling upper left lip, 2cm petechia on border of left upper lip. Stopping at the midline. No treatment received for the events. No covid-prior-vaccination, no covid-tested-post-vaccination, no known allergies. The outcome of the events was recovering.
Symptoms started 24 hours after TDAP vaccine. Reported to clinic this AM at 48 hours post injection. Circular red raised circle measuring 60 cm. No redness, streaking extending below injection site. Reports this AM neck soreness on the side of the vaccine site.  Took meloxicam yesterday and today.
I was given a Varivax vaccine along with an MMR vaccine and allowed to leave the facility. Approximately an hour after I left I got a call that stated that the Varivax vaccine that I was given was outdated and that it should not cause any problems and that I would be able to get another one that is not out dated in the coming week (7/11- 7/18) when the pharmacy restocked. In the following 3 days, the injection site became inflamed and swelled. The diameter of the redness was about 2 inches, and it is painful to touch.
Itching, hives over trunk, arms, legs, & neck. Called Dr, took Benadryl. Hives almost gone by next day, 1/7/00.
i had the expected reaction of aches, fever, starting the night of the shot.  i also had an intense headache.  those symptoms subsided, i then stated having intense diarrhea every day, multiple times a day, along with headaches.  so much so that i could not be very far from a restroom without the possibility of having an accident.  i reached out to my doctor and was told i may be having a residual inflammation response, and that it should decrease after a week or two. the headaches were intermittent but the diarrhea  was ongoing.
Really sick; Vomiting; Chills with no fever; lost appetite; Weight loss, lost 6 pounds; no taste; This is a spontaneous report from a contactable consumer (parent, mother).   A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date (age at vaccination was 62 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hernia repair from 2020 to an unknown date, covid-19 (he had Covid in Nov 2020 he lost 6 pounds) from Nov2020 to an unknown date, weight loss (he had Covid in Nov 2020 he lost 6 pounds) from Nov2020 to an unknown date. Family medical history was reported none. Prior vaccination within 4 weeks was reported as none. Additional vaccines administered on same date of the pfizer suspect was reported as none. Concomitant medications were not reported. Report stated that the patient received the first dose of the Covid-19 vaccine a week and a half ago (exact dates not clarified). On an unspecified date in Apr2021, within a couple days the patient was really sick. It was reported that the patient only vomited once and it was a small amount. He had chills the next day that lasted only for a day. He had lost his appetite a couple of days later. He had lost 6 pounds and the weight loss was due to having no appetite. He also had no taste. The events did not result in visit to ER or physician office. No investigation assessment was reported. The patient underwent laboratory tests that included: weight: lost 6 pounds on an unspecified date in Apr2021. Outcome of all the events was recovered on an unspecified date in 2021 while outcome of event weight loss, sick was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
SHORTNESS OF BREATH.  HAD VIRTUAL CALL WITH DR. SYMPTOMS DID NOT GO AWAY. WENT TO ER ON MONDAY APRIL 5 DUE TO STILL NOT BEING ABLE TO BREATH AND HAVING SHORTNESS OF BREATH.
the patient may have been pregnant when she received this dose of GARDASIL 9; This spontaneous prospective pregnancy report was received from a pharmacist via company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose 1 (route of administration, lot # and expiration date were not reported) for prophylaxis. The reporter stated that the patient may had been pregnant when she received this dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), but it was not certain. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known and could not be calculated. The pregnancy outcome was pending.  The outcome of the event and the causality assessment between the event and suspect therapy were not reported.
INDIGESTION; FELT LIKE SHE SWALLOWED A ROCK AND IT IS IN HER CHEST; HAS NOT EATEN MUCH TODAY; CHILLS; HEADACHE; TEMPERATURE 101.6; This spontaneous report received from a patient concerned an 80 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.6 F. On 04-APR-2021 01:30, the subject experienced chills. On 04-APR-2021 01:30, the subject experienced headache. On 04-APR-2021 01:30, the subject experienced temperature 101.6. On 06-APR-2021, the subject experienced indigestion. On 06-APR-2021, the subject experienced felt like she swallowed a rock and it is in her chest. On 06-APR-2021, the subject experienced has not eaten much today. Laboratory data included: Blood pressure (NR: not provided) 136/81 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature 101.6, chills, headache, indigestion, has not eaten much today and felt like she swallowed a rock and it is in her chest was not reported. This report was non-serious.
At the injection site my arm became red, swollen and pain full. The site was as large at 1.5in circle. It was also hot to the touch. I called the office and they put me on Augmentin since this was the second time this has happened. I had the same reaction with my first COVID vaccine. I was one an antibiotic for about 3 weeks then. As of today 07/05/2022 there is still swelling and discomfort but it has improved. I still have 1 day of antibiotic's left.
One day post vax pt experienced redness at injection site of 5.5 X 5 cm; no other symptoms.  Two days post vax redness increased to 7 X 7.5 cm with slight tenderness.
Cough, congestion, fatigue, SOB. COVID Pneumonia; BIPAP due to O2 sats in 60s in route, changed to 4-7 L NC; treatment - dexamethasone, remdisivir, baricitinib, Zinc and Vit C. 2/5 worsening CKD stage 3. stop Losarten, O2 increased to 15L.  transferring to LTAC
The patient passed out for a minute or two; This is a spontaneous report from a contactable pharmacist. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, (Batch/Lot Number: FC3180)), dose 1 via an unspecified route of administration on 03Oct2021 (age at the time of vaccination was 22-Year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient passed out for like a minute or two. This event was assessed as medically significant. At the time of this report, the outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Patient had a raised red lump/rash on arm at injection site- it was hot to touch and when reported on 10/24 had not gone down yet; She reported rash did not itch and was not bothersome, but was larger than a half dollar in size
INCORRECT DOSE ADMINISTERED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced incorrect dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of incorrect dose administered was not reported. This report was non-serious.