chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose of acthib was administered with no reported adverse event; Initial information received on 17-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient to whom experienced expired dose of acthib was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 17-Oct-2022, the patient received 0.5 ml of suspect HIB (PRP/T) VACCINE (lot UJ583AB and expiry-15-10-22) (strength and formulation: unknown) via intramuscular route in the left thigh for immunization.  On 17-OCT-2022 the patient developed a non-serious expired dose of acthib was administered with no reported adverse event (expired product administered) (latency same day).   Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of acthib was administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Box - Shingrix (Dose 1 of 2)  Vertigo that lasted 1.5 days, on and off. Meclizine taken at home.
Tingling in fingers upon administration. Within one hour patient developed numbness on entire left side of body (Arm, Leg, Toes, Eye, Tongue).
L ARM SWOLLEN AFTER RECEIVING VARICELLA ON 10/12/2011. 40 X 40 MM. RAISED AREA MEASURED ON 10/14/2011. TENDER TO TOUCH.
RECEIVED LESS THAN 0.5ML OF THE VACCINE AS THE INITIAL DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 26 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: 213D21A, and expiry: 11-APR-2022) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced received less than 0.5ml of the vaccine as the initial dose. On 01-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of the vaccine as the initial dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210058, 20211210160, 20211210409, 20211210610, 20211209679, 20211209706, 20211209740, 20211209775, 20211209782, 20211209843, 20211209874, 20211209880, 20211209884, 20211209912, 20211209921, 20211210019, 20211210067, 20211210106, 20211210107, 20211210112, 20211210141, 20211210143, 20211210159, 20211210165, 20211210165, 20211210180, 20211210350, 20211210385, 20211210408, 20211210549, 20211210555, 20211210588, 20211210733, 20211209551, 20211209976, 20211209798 and 20211210334.
Vaccine was administered 32 days after thaw. RN contacted Pfizer and was advised that vaccine may be stored at 2-8 degrees Celsius for a total of 32 days after thawed  (31 days labeled in prescribing information plus one day excursion time). Patient will not need to be revaccinated.
A non-serious spontaneous report of nose burning after receiving FLUMIST has been received from a health professional concerning an adult female, subsequent to FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on an unknown date. The patient felt burning in her nose after FLUMIST administration. No medical attention or other symptoms were reported. The reporter stated that the patient no longer worked at the office; so no follow-up information was available. The outcome of the event was unknown. Additional information was received on 23-Mar-2011 and incorporated into the narrative: reporter details.
This initial spontaneous case, was received from nurse on 16-Nov-2017, concerning a 21-year-old adult female patient. The patient's medical history included high functioning autism. The patient's concomitant medication included unspecified psychotropics for an unknown indication. On 10-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195211, and expiry date: Mar-2018). On the same day, after receiving the vaccine, patient experienced soreness in arm. No treatment was taken for the event. The same day (10-Oct-2017), the patient was recovered from the event after one hour. The reporter assessed the event as non-serious.
First dose 8 months ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose 8 months ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose 8 months ago). In February 2021, PRODUCT DOSE OMISSION ISSUE (First dose 8 months ago) had resolved.            Concomitant medications were not reported.  Treatment information was not provided.
almost like abscess tooth or something; became very, very sensitive; severe headache; pain in the upper jaw/teeth; pain in the upper jaw/teeth; This is a spontaneous report from a contactable male consumer (patient) reported that: A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for Covid-19 immunization. The patient medical history included BNT162B2 for Covid- 19 Immunization as Dose 1 and experienced Severe headache, Nausea, Pain in the upper jaw/teeth, Teething, Almost like abscess tooth or something, Became very, very sensitive on an unspecified date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced Severe headache on 03Mar2021, Pain in the upper jaw/teeth on 03Mar2021, Pain in the upper jaw/teeth on 03Mar2021, Almost like abscess tooth or something on an unspecified date, Became very, very sensitive on an unspecified date. Reporter was not a Healthcare Professional and was not a prescribing HCP. There were no unaddressed medical questions referred or forwarded to Medical Information. NDC and UPC number were not provided. Therapeutic measures were taken as Fiorinal for severe headache, Pain in the upper jaw/teeth. The outcome of event for Severe headache was recovering, The outcome for event for Severe headache, Pain in the upper jaw/teeth was unknown, The outcome for event Pain in the upper jaw/teeth (Teething), Became very, very sensitive and Almost like abscess tooth or something was not resolved.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Had MMR and Prevnar vaccines on 4/23/01. Exactly 20 days later, got a mild infection and was put on antibiotics. He then woke up at 3AM with fever and seizures. Also his illness got worse and worse over time. Went from ear infection in one ear to severe infection in both ears, chest infection and strep throat. Hospital test showed no reason for seizures. Diagnosed with autism one year later. A 60-day follow up report received 7/29/2003 adds: Pt not recovered. Nonverbal, sensory integration dysfunction. Diagnosed with autism.
Patient started complaining of itching.  Noted to have hives across the top of her chest approximately 15 minutes after her shot.  No shortness of breath.   She was reassessed before health staff left the facility.   She still had itching, now on arms, but no shortness of breath.  Patient was last assessed 1 1/2 hours after receiving the injection.
Swelling and pain surrounding the injection area.  Tissue was very puffy.  Pain subside after 12 hours but swelling persisted for 24 hours.   As of today, the njection area is discolored, small black area almost like a small, round bruise
pt recv vax 3DEC97 & 4DEC97 pt exp a fever of 103;
Patient received Moderna as a 1st dose on 5/28/21 and a Pfizer Booster doses on 6/25/2021
Approximately 30 min after vaccination, client came to school nurse office with severe GI upset. Vomited multiple times over next 30 min. No treatment was given at the school.
This case was retrieved via a search of the scientific literature on 17 July 2012. The following is verbatim: Case report with FLUZONE ID. "During this first influenza season, the company received only one report of exposure during pregnancy. A 31-year-old woman, who received FLUZONE ID experienced injection site inflammation after vaccination and recovered three days after the onset. The date of last menstrual period and expected date of delivery were not reported." Documents held by sender: None.
leg pain, used ice pack x >12 hours, when removed had rash, patient, went to ED on 4/12/2021 and diagnosed with shingles
pt recv vax & had episodes of shivering & an unusal gaze;12JAN96 dx complex partoid sz (epilepsy) w/Todd's paralysis;12MAR96 pt had a gen sz lasting (>60min);pt hosp @ least 1time/mo d/t sz;pt found dead in crib-position on abd;
shot given in left del. 24 hours later patient had redness and warm in whole upper arm.  patient seen by doctor on 11-12-02 pt was put on keflex and predisone
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age, race, and ethnicity. 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: 1808609 expiry: 07-SEP-2021) dose was not reported, 1 total, administered on 11-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient had an antibody test specific for IgG antibodies for Covid-19 under direction from family doctor. The patient was notified that the result was negative (suspected immunological vaccine failure). Laboratory data (dates unspecified) included: SARS-CoV-2 IgG antibody test (NR: not provided) Negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000194929.; Sender's Comments: V0.20210952901-covid-19 vaccine ad26.cov2.s-Suspected immunological vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
On 08/28/2022, I woke up feeling very tired and wanted to sleep all the time. I had a fever for 2 days that I treated with Tylenol. I did not test for COVID-19 because my son had recently tested positive. I did not require any medical attention. My symptoms lasted around 2 to 3 days before they got better.
March 19: Started feeling a little feverish and under the weather. March 20: Felt brain fog March 22: Started feeling a little off balance at times with brain fog March 23: Started feeling some anxiety with brain fog, off balance feeling continued March 25: Started feeling more anxiety and more difficulty concentrating. Noticed that I was having more bowel movements. March 26: Felt less anxiety and brain fog but felt "warm" and a little under the weather. March 27: Woke up and felt slight tingling in whole body but most noticeable in arms and hands, felt off balance.
This spontaneous report as received from a healthcare worker refers to an additional unspecified patients of unknown age and gender. The healthcare worker reported, that an additional unspecified patients received improperly stored VARIVAX (lot # K003420, expiration date: 06-MAR-2015) (dose, frequency route of administration and indication were not reported). No adverse effects were reported for the additional unspecified patients. This is one of the several reports received from the same source. Additional information has been requested.
Severe body and joint pain; Severe body and joint pain; migraine headache; cold symptoms; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 02Mar2021 (Lot number was not reported) (at the age of 58-years-old) as dose 2, single for covid-19 immunisation. Medical history included ankylosing spondylitis, chronic pain, osteoarthritis, migraine and recovery from 4 fusion surgeries. Concomitant medications included acetylsalicylic acid (ASPIRIN); gabapentine; diclofenac; topiramate (TOPAMAX); rosuvastatin calcium (ROSUVAS); all taken for an unspecified indication, start and stop date were not reported. The patient was currently going through treatment for ankylosis spondylitis, recovery from 4 fusion surgeries, and osteoarthritis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took morphine and experienced allergy. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) administered in left arm on 05Feb2021 (at the age of 58-years-old) as dose 2, single for covid-19 immunisation. The patient did not have covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 03Mar2021 02:30, the patient experienced severe body and joint pain, migraine headache and cold symptoms. The patient did not receive treatment for the adverse events. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
First Covid Vaccine: Aug 15 Second Covid Vaccine: Sept 6 2-3 days after second dose couldn't walk because of leg fatigue. Dragging legs because he felt like he could not move. Muscle cramps. Leg tingling in the morning and throughout the day. Bilateral jaw pain. Tylenol given. Running and jogging helps alleviate the pain. He is not having difficulty breathing.  I advised the following: Ibuprofen as needed for pain. Take a daily multivitamin. Continue to exercise as tolerated. Report his symptoms to the vaccine adverse effects hotline. Seek medical attention if he is having difficulty breathing. Mother aware and in agreement with this plan.
Transcription from 2/12/19; Typhoid vaccine 2 weeks ago. (1/31/19) 1st rash appeared 3-4 days post vaccine. Started with singular , larger patch on L anterior thorax. Headaches and fatigue for 1 week following onset. No nausea/vomiting. Penny-sized with defined border. Intermittent low-grade itching. No changes in skin care. No changes in may have allergy to soy-- gets small rashes on face ate tofu friday , scattered papular rash appeared friday night. No changes in laundry detergent, hygeine products. No itching in throat or tongue. No changes in vision. No numbness/tingling in extremities. No edema, swelling. No dizziness.
Patient reported on 04/12/21 approximately 9:25 AM, that she was experiencing side effects from receiving Moderna COVID vaccine (1st dose). Patient has a rash on her arm, fever, general fatigue, redness/swelling at the injection sight that has not gone away for over 7 days. Patient is also experiencing thoughts of suicidality and mood is not stable, patient stated she has not been feeling well at all since receiving the vaccine. Patient has not had any of the above symptoms prior to receiving vaccine. Patient has not taken anything to help with the symptoms. Patient has already spoken to primary care physician and received a referral to a counselor. Patient received 1st dose of vaccine on 03/30/21. Patient was also advised to take benadryl and/or tylenolto help with the symptoms. Patient stated she is weary of getting 2nd dose of Moderna COVID vaccine because of the side effects she is experiencing.
Swelling,redness and warmth past the injection site (about 5 inches total), painful to the touch, limited arm movement and exhaustion/fatigue. Symptoms started about 3-4 hours after shot. Took 2 advil and swelling went down. As of today still red and still painful to touch,less swelling in area
Area at site of injection-appx 6" long x 2" wide-red, swollen, warm to touch-bruising at needle site. Pt c/o arm hurting-referred to private MD.
I was not aware that the cut off time was 8-31-22.  The patient told me she was going out of town and couldnt wait for the Bivalent to come out.  Again I was not aware of the 8-31-22 cutoff and i even contacted another Pharmacy and they were also giving this shot.  So I did  also.   I was told i was suppose to fill out this form as a single, aggregate report.  there were no adverse effects.
Fatigue, my arm is painfully sore and uncoordinated dizziness, i had jittery and shaking feeling at first.
pt recvd vax postpartum & w/in 24 hrs devel a hypersensitivity type rash; No further details were provided;
Immediate warm face, swollen cheeks and forehead as well as at the injection site. Lated about 10-15 minutes and started to reduce.
On Saturday 12/24 I suffered a sudden heart attack, the first and only one in my life so far. Went to a nearby ER and was treated for heart attack. Received an angioplasty, that is examination of the arteries going to the heart. Cardiologist on staff that day discovered left circumflex artery to be 100% blocked and implanted 3 stents. I was hospitalized for two days.  While I have recovered with no discernable heart damage, I could have died that day per the cardiologist. It was my promptness getting to ER that saved me from a massive heart or possible death. He rated it as a moderate heart because of early response. However since then I have been very weak and fatigued. I was an avid cyclist, but now my abilities are cut in half and I no longer ride with the group I did previous to the heart attack. My cognition is hampered from the medications and I have yet to find work. The time period has been from 12/24/2022 to present.
A 26 year old female patient experienced medication error, swollen lymph nodes, injection site pain radiating to her shoulder neck and back and numbness of her hand and fingers after receiving her fourteenth RabAvert injection (lot number 309011, expiration date 10/5). The patient was being treated following a bat bite (right hand). Past medical history was unremarkable. Current medical history included breast feeding. Concomitant medication remained unspecified. On 6/5/04 and 6/8/04, the patient received IMOVAX from a recalled lot. The ER physician contacted the manufacturer and misunderstood re-vaccination instructions. The patient subsequently received seventeen RaBAvert injections between 6/8/04 and 9/15/04. After the first five doses of RabAvert, the patient experienced swollen lymph nodes (neck or arm pit) corresponding with the injection site side. This was treated with Advil, and resolved after ten days. On 8/16/04 she received her sixteenth RabAvert injection and subsequently experienced shooting pains from the injection site (left deltoid) up to her left shoulder, left neck and around to the left upper back. She also reported intermittent pins and needles sensation in her left hand and fingers that would occur for approximately five minutes then fade for several hours. The events were continuing at the time of this report. (OMIC)
Patient complained of palpitations 30 minutes after receiving the COVID19 vaccine. She had this same reaction after the first dose. She felt her heart racing and throat closing with chest pain.  She received diphenhydramine 25 mg IV, famotidine 20 mg IV, and methylprednisolone 80 mg IV.
she has a rash, rash on right cheek and rash on forehead; Stated that she has a rash that is quite red; Is kind of warm to the touch; like if she had a strep infection; This is a spontaneous report from a contactable consumer (patient). This consumer reported for herself that a 57-years-old female patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0167), (at the age of 57-years-old) via an unspecified route of administration on left arm on 02May2021 as single dose for COVID-19 immunisation. The patient's medical history includes fibromyalgia for 25 years which was still ongoing. Was not on medication anymore. Those medications gave her problems and made it worse. Concomitant medications were Modafinil (generic version of Provigil) has been taking for 10 years, at least for narcolepsy and Claritin (Clarithromycin) took daily during the spring and fall. Has taken for years but, only in those periods of time with seasonal allergies. The patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0151) via an unspecified route of administration on left upper arm on 04Apr2021 10:15 as historical vaccine single dose for COVID-19 immunisation. On 04May2021, the patient had a reaction to the second dose of the Pfizer Covid-19 vaccine which she administered on Sunday. She has a rash that was quite red where it bends, it was warm to the touch, but nothing was raised, looks like a sunburn, it was inside of her left arm on the elbow area, which was the same side as the injection. Her right cheek was red, as if she was slapped, she also has it across her forehead and in the back of her neck. She would like advice on how to treat it. Rash on inside of left arm: Noticed when she woke up this morning. Rash on right cheek: Developed soon after the rash on the arm. Was maybe an hour or so, when the cheek became red. Rash on forehead:  Not as bad but looks very similar to the rash on her arm. Is getting more intense now. Is also on her neck. States that she got up around 06:30. It was a very similar rash to viral rashes. The last time she had it was probably when she had the flu. It was not during the pandemic. It was around Feb 2019. No prior vaccinations within 4 weeks. There were no relevant tests proceed. The outcome of the event was not recovered.  Follow-up (04May2021): This is a follow-up spontaneous report from a contactable consumer (patient). This 57-years-old female consumer reported for herself.  Follow-up attempts are completed. No further information is expected.
Pt w/ unknown PMH or Medications.  Known allergies to Phenergan. 2mins post vaccination pt reported dizziness.  Pt has reported similar reactions to immunizations in the past.   Vitals: @17:44 BP 109/81, HR 73, RR 18  -- > @17:55 115/77, 66, 18, 100% O2 Sat Pt given apple juice.  Pt's symptoms resolved.  Pt denies any dizziness or unusual symptoms.  Pt stable and released from the vacciation site at 18:00.
Headache longer than 24 hours, minimally responsive to acetaminophen Mild nausea 12 hours Fatigue 18 hours Joint stiffness 18 hours