chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a two years old patient received fourth dose of Ipol vaccine/ No AE; Initial information received on 06-May-2021 regarding an unsolicited valid non-serious case received from a Nurse via physician.  This case involves a two years old female patient who received a 0.5 ml fourth dose of IPV (VERO) [IPOL] (batch number R1F8O1M, expiry date: 28-Sep-2021) frequency: once, strength: standard via intramuscular route in the right thigh for prophylactic vaccination and patient also received third dose at 6 to 18 months of age (Inappropriate schedule of product administration).  The patient's past vaccination included IPOL [POLIO VACCINE INACT 3V (VERO)] at 2 and 4 months of age for prophylactic vaccination.  The patient's medical history, medical treatments and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE for prophylactic vaccination.  It was an actual medication error due to drug dose administration interval too short (latency same day).   Potential Product Technique Complain: No. A nurse wanting to know how to proceed after a 2-year old received an extra dose of Ipol described as getting a dose of Ipol at age 2-years old after getting doses at 2 months, 4 months, and 6 to 18 months.   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 holders 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.
No other AE; administered after the expiration date; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 01-JUL-2021, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # s011951 with expiration date on 16-APR-2021, 1 dosage form (route of administration was not reported) for prophylaxis. No adverse event was reported.
Fever Chills Weakness Pain in Ankles, Knees Extreme body aches (especially in my spine/lower back) Headache Ear Pain Vomiting Tightness and pain in my chest When blowing nose, coagulated blood
Patient received MMR vaccination within seconds after injection was given a lump was noted at injection site approximately 1 inch in diameter. Lump was also noted to be red in appearance but was not warm to the touch. The Medical Provider was called to inspect the site.
patient was given a COVID Monovalent vaccine instead of a COVID Bivalent vaccine. No adverse reaction to vaccine.
6" x 4" raised red multiform rash on inner right arm. Onset of rash 01/08/2006 at 0900.
On my left side in my arm, hand, leg, or foot it will turn red, swollen, itchy, and it throbs/painful. After many hours it goes away. This happens every couple of weeks ever since I got my shot.
I felt funny. I started to shiver but I was sweating. My blood pressure rose and I was rushed to the ER and was given fluids, Benadryl and steroids.
Patient said her arm is hard to move and it spread to her lymph nodes. Appears red. Clinic told her to let us know.
The patient recieved the Pfizer vaccine as her first dose on 6/24/21. On 7/15/21 we administer the incorrect second Covid vaccine as Moderna instead of Pfzier. We followed CDC guidelines with educating the patient their were considered fully vaccinated after reciving two mRNA vaccines.
This spontaneous report was received from a registered nurse referring to a 1 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included a sterile diluent (manufacturer unknown). On 22-MAR-2018, the patient was administered an improperly stored M-M-R II (lot: N009172, expiry date: 20-MAR-2019) (product storage error). The vaccine was exposed to 47 degrees F to 77 degrees F (52.1 degrees F) for 11.25 Hours. There were no previous temperature excursions. The call was because of a digital data logger. The sterile diluent (manufacturer unknown) used to reconstitute M-M-R II was properly stored. No adverse effects were reported.
Contracted COVID-19 5 days later. I was coughing and sneezing.
Pediatric Pfizer vaccine batch/lot# FK5127, improperly stored in an immunizations freezer, which maintained a temperature between -15ºC and -24ºC. Per manufacturer's guidelines, the vaccine must be stored in a refrigerator maintaining temperature of 2-8ºC or an ultra-low cold freezer maintaining temperature of -90ºC or lower. The patient received an improperly stored vaccine. Treatment: Not required, patient did not report any adverse reactions to the vaccine. Outcome: Patient's guardian notified and offered to restart the Pediatric Pfizer COVID-19 vaccine series again stored at the proper temperature. Signs, symptoms course, etc. None reported by the patient's guardian.
premature ovarian failure; This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported. 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) (lot #, expiration date, dose and route of administration were not provided) for prophylaxis. On an unknown date, after finishing regimen of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient was evaluated for premature ovarian failure. The outcome of premature ovarian failure was unknown.  The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-1910USA015759:
Anaphalactic Reaction treated by double dose of hydroxyzine on site at clinic.  Throat swelling - hard to swallow all day - went away next day.  4/22 - Legs heavy, tired for two days. May 8:  Spasms/Twitching - Left side of head behind ear, which continues to this day.  May 10 - Hearing loss - ear muffled, full feeling; Entire left side head felt inflamed, swollen at base of skull.  Dr. sent bloodwork which showed high inflammation marker.  Said I needed temporal artery biopsy.  Consulted with surgeon that day and scheduled for biopsy on 5/11, which came back negative for arteritis.  During surgery recovery started 16 day prednisone taper after inflammation still high crp levels.  this helped my ear in the long run.  still have tinnitus.  Since 5/10 I've been seeing Drs for all left side symptoms of:  tinnitus, nerve pain, sharp stabbing pains in head, moving nerve pains in head, base of skull pain, left side head soreness - dull, achy, burning, sharp - ever changing in nature, insomnia, new allergic reactions to different foods, anxiety, new electrical shocking/zaps in left toes and in front teeth, PTSD from th severity and frequency of symptoms, eye floaters/damage, spasms/twitching.  Been in physcial therapy for 6 weeks.  New nerve pains in limbs.  Lightheadedness and some speech changes.  Similar to COVID long haulers - never had COVID.
occasional heart palpitations after first dose; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 31-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Apr2021 15:30 (Lot number: EW0168) at the age of 31 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Known allergy: Asthma" (unspecified if ongoing), notes: Known allergy. Concomitant medication included: LEXAPRO; IBUPROFEN. The following information was reported: PALPITATIONS (non-serious) with onset 11May2021 11:00, outcome "unknown", described as "occasional heart palpitations after first dose". The event "occasional heart palpitations after first dose" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of palpitations.  Additional information: He had occasional heart palpitations after first dose. Doctor told him to just pay attention to it as long as it wasn't bad. The patient had not COVID-19 prior vaccination and he was not tested for COVID-19 post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021535843 Same patient  different drug/event
About 20 minute after vaccine was administered I felt a subtle numbness feeling to the right of my mouth.  Then it was felt on most of my right cheek.  It lasted the whole day and the next morning it was mostly gone.  Since then my right eyelid and under eye have been a little red which isn't normal for me.   Some tingling in right leg felt as well.  Mainly concerned about the face sensation and not sure if I should proceed with second shot.
8/14/2021 Admit Hospital.  Patient presented to emergency room with shortness of breath for the last 4 days with weakness and decline in status and diarrhea. Her oxygen saturation was low in the low 90s.  home oxygen dependent. Tested positive for COVID-19 from PCR on 8/15/21. Diagnosed with: COVID-19 pneumonia, acute on chronic hypoxic respiratory failure. Transferred to Hospice 8/20/21. patient died on 8/25/21.   Note: COVID-19 Moderna vaccine previously given: First dose: 03/08/21 Lot Number 025A21A; Second dose: 04/14/21 Lot Number 030B21A
Scabbed lesions on trunk, arms when patient came to the office 11/5/02. Patient started getting lesions about a week after vaccination.
Vaccine was being administered to patient.  Needle was inserted into deltoid muscle. When vaccine was being injected, un unknown large amount of the vaccine spilled out onto patient from where the needle and syringe attached.  It is unknown how much vaccine, if any, was administered to patient.  Upon discussion with the medical team at the clinic, it was determined to administer a full dose of the vaccine.  Another dose of the same vaccine, same lot number, was administered to the patient in the right arm. Patient was observed for 15 minutes. No adverse reactions.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 to left arm for prophylactic vaccination. Age at time of vaccination 54 years old. No concomitant medications were reported.  On 29-APR-2022, the patient experienced suspected covid-19 infection along with bad headache and had suspected clinical vaccination failure. The patient slept well enough. Laboratory data included: COVID-19 rapid POC (rapid antigen) test (NR: not provided) positive. The patient was treated with the physician. Treatment medications (dates unspecified) included: ascorbic acid, magnesium, diphenhydramine hydrochloride, zinc, and ergocalciferol. The symptom bad headache was resolved on 30-APR-2022. The patient had not taken any booster shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on 02-MAY-2022, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000229988.; Sender's Comments: V0: 20220516398-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
I received my first dose of the COVID19 Pfizer vaccine in my left arm on 8/20/2021. On 9/8/2021, I started with some pain in my left hand muscle and a tooth ache on the left back side. Within an hour, my left hand muscle swelled immensely. On 9/9/2021, I started with some pain in my left knee that only lasted a few hours. I got my second dose of the COVID19 Pfizer vaccine on 9/10/2021 and had no issues until I woke up on 9/12/2021 with a painful ball of pressure on the underside of my left foot that quickly swelled to the point I thought my foot was going to pop due to the incredible pressure building. My left foot swelled so much, I couldn't move my toes. around 4pm on 9/12/2021 the same this started in my right foot. It didn't swell as bad but it still had a lot of pressure and pain. around 5:30pm on 9/12/2021, the muscle in my right hand started to ache & swell. On 9/13/2021, the swelling subsided a lot but my feet remained sore & sensitive.
pt states had flu type, cold sx p/1st & 2nd dose of hep B vax;
pt recv vax 30SEP96 & 1JUN97 pt devel a mild case of varicella consisting of 20-30 lesions;
hair thinning/hair loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 (Lot number: FD7218) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high", start date: 2018 (ongoing), notes: Verbatim: Blood pressure high, Diagnosed three years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose,/LOT/EXP: Unknown , Dose amount: Unknown , Route: Injected into left arm), administration date: 26Mar2021, when the patient was 62 years old, for COVID-19 Immunization; Bnt162b2 (Second Dose, /LOT/EXP: Unknown , Dose amount: Unknown , Route: Injected into left arm), administration date: 16Apr2021, when the patient was 62 years old, for COVID-19 Immunization. The following information was reported: ALOPECIA (non-serious) with onset Jan2022, outcome "not recovered", described as "hair thinning/hair loss". Therapeutic measures were not taken as a result of alopecia.  Additional information: Caller mentioned that her husband had already 3 doses of Pfizer COVID vaccine. On 04Jan2022, her husband received his booster shot/third dose. Caller stated that 2 weeks after, they began noticing "hair loss and hair thinning". Caller was asking for information if "this is a side effect or something else or if it will comeback." Caller also mentioned that they will call their family doctor after asking Pfizer if this is a common side effect. Caller stated that there were comments from website that mentions hair thinning or hair loss after being vaccinated. Response: Spoke as per No Info, "A review of prescribing information of Pfizer BioNTech COVID Vaccine, failed to find any information about hair loss or hair thinning. Please consult with your doctor or health care provider for further guidance, as your doctor/healthcare provider is the most familiar with your medical condition." Mentioned that reported side effects during clinical trial did not include hair loss or hair thinning as well. Provided website for further information about the reported or listed side effects of the vaccine. Caller disconnected before survey was offered. Patient just started freaking out about this last week. Patient got his hair cut and caller initially thought the hairdresser put a divot in his head. Then all of a sudden, the divots kept going all over patient's head. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No Emergency Room and Physician Office. Hair loss and hair thinning: Now has bald spots on back of head and the top of his hair. His hair still looks ok, but was really thinning. No follow-up attempts are possible. No further information is expected.
pt recvd approx 1030AM approx 6PM same day pt devel 102, myalgias, h/a seen next day; t100.4, nl PE; f/u phone call the following day showed pt had fully recovered;
Pt brought to ER 11/4/06 by grandma with chief complaint of unresponsiveness. T-101.5 rectally in ER. Dx-probable febrile seizure, probable febrile illness, unresponsive, resolving, probably secondary to the immunization. Thought she had afebrile fever from ER- but since then MRI showed hydrocephalus and a cyst in brain.
PATIENT COMPLAINED OF REDNESS ON AND AROUND INJECTION SITE, SLIGHT SENSATIONS OF HEAT ON SKIN, BEGINNING 8/23/18, TWO DAYS POST INJECTION. NO COMPLAINTS OF SWELLING NOR OF ITCHINESS OR OTHER IRRITATIONS. PATIENT CAME IN TO THE PHARMACY LATER IN THE AFTERNOON AND WE DETERMINED THAT THE REDNESS WAS TRAVELING SLIGHTLY DOWN THE ARM, BUT RESOLVING SLIGHTLY NEAR THE ORIGINAL INJECTION SITE. PATIENT HAD CONTACTED HER PRIMARY DOCTOR, AND WAS TOLD TO USE A HOT COMPRESS. WHEN I CALLED THE PATIENT ON 8/27/2018 TO FOLLOW UP ON HER SYMPTOMS, SHE SAID THEY HAD COMPLETELY RESOLVED BY 08/24/2018-08/25/2018, 4 DAYS AFTER THE INJECTION.
Patient called on 7/24/17 to report symptoms of low grade fever, sore throat, difficulty breathing from the night before.
After testing completely negative with rapid home tests 10 days after initial positive test (01Jun2022) I again tested positive the next day (11Jun2022); After testing completely negative with rapid home tests 10 days after initial positive test (01Jun2022) I again tested positive the next day (11Jun2022); This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 06Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 09Aug2021 as dose 3 (booster), single (Lot number: FC3181) at the age of 25 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Nov2021 as dose 4 (booster), single (Lot number: 013F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "OCD" (unspecified if ongoing). Concomitant medication(s) included: DESCOVY, start date: Apr2016, stop date: 03Jun2022; BUPROPION HYDROCHLORIDE [BUPROPION HYDROBROMIDE], start date: Jan2012; FLUOXETINE, start date: Feb2016. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jun2022, outcome "recovering" and all described as "After testing completely negative with rapid home tests 10 days after initial positive test (01Jun2022) I again tested positive the next day (11Jun2022)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (01Jun2022) Positive; (12Jun2022) Positive; (19Jun2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical cource: It was reported that after testing completely negative with rapid home tests 10 days after initial positive test (01Jun2022) patient again tested positive the next day (12Jun2022) and proceeded to test very positive for the following week, until 19Jun2022. Symptoms such as congestion, coughing, headache and fatigue returned for about 5 days. He was still awaiting a second rapid home test to confirm my negativity.
On April 3, 2023, I noticed I didn't sleep very well on Sunday night.  I was exhausted Monday.  Tuesday I had cold symptoms and fatigue.  I called in sick Wednesday morning and was fatigued.  Then I had more cold-like symptoms and a sore throat and progressed to feeling like I was swallowing broken glass.  Thursday my throat was still painful and fatigue.  I tested positive on Friday, April 7, 2023.  I began taking Paxlovid and started to feel better the following Sunday.  As of today, I still have nasal congestion and fatigue.
Post vax the patient developed whelps, swelling and redness across the entire left thigh measuring 34cm in circumference, and the entire right thigh measuring 38.5cm in circumference. The patient was treated with Cefzil and Orapred.
This spontaneous report was received from a Registered Nurse concerning a patient of unknown age and gender. On 14-OCT-2013, the patient was inadvertently vaccinated with an intramuscularly 0.5 ml dose of PNEUMOVAX23 (route and dose not reported) (Lot # 671680/1489AA) that had expired on 12-MAY-2013. No adverse effects reported. This is one of five reports concerning the same source. Additional information has been requested.
Headache, chills, aches starting day of shot.  Keen pain started 3 days after injection requiring steroid injection in knee.
Swollen lymph nodes (neck), sore throat - more sore externally than internally, redness and swelling at injection site, mild vertigo. All presented 8 days post injection, lasted 4 days
Chills, fever of 102.9 for about 12 - 16 hours.
period started on 19Sep and it ended on 23Sep/ experienced cramps; My period started on 19Sep and it ended on 23Sep/ spotting; Other Vaccine on Same date product: Flu shot; Other Vaccine on Same date product: Flu shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Lot number: Gj2524) at the age of 34 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 17Sep2022 as dose 1, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "Nocturnal epilepsy" (unspecified if ongoing), notes: Nocturnal epilepsy; "If COVID prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; NORETHINDRONE [NORETHISTERONE]. Vaccination history included: Bnt162b2 (DOSE 3, lot number: Fh8030, vaccine location: Arm), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURE UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1; MANUFACTURE UNKNOWN), for COVID-19 Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 17Sep2022, outcome "unknown" and all described as "Other Vaccine on Same date product: Flu shot"; INTERMENSTRUAL BLEEDING (non-serious) with onset 29Sep2022 at 13:00, outcome "recovered" (2022), described as "My period started on 19Sep and it ended on 23Sep/ spotting"; DYSMENORRHOEA (non-serious) with onset 29Sep2022 at 13:00, outcome "recovered" (2022), described as "period started on 19Sep and it ended on 23Sep/ experienced cramps". The events "period started on 19sep and it ended on 23sep/ experienced cramps" and "my period started on 19sep and it ended on 23sep/ spotting" required physician office visit. Therapeutic measures were not taken as a result of dysmenorrhoea, intermenstrual bleeding.  Additional information: Patient period started on 19Sep and it ended on 23Sep. On 29Sep, she experienced cramps and spotting. This was not normal for her. She never had spotting before. Patient received the COVID vaccine two weeks prior. AE resulted in Doctor or other healthcare professional office/clinic visit. COVID was not tested post vaccination. No known allergies.  No follow-up attempts are needed. No further information is expected.
on 20MAY98 exp red splotchy rash on abd (no papular);child scratches abd occasionally;no fever;good appetite;sleeps well @ noc;referred to primary MD if rash cont;cont to exp rash;