chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 9/20/00 at 10:45, mom called and stated that shots given yesterday and last night she noticed bumps on face but thought they were mosquito bites. This morning same size but child began scratching. Now bumps on face are large, red and about a quarter size. Child scratching and near eyes. Denied fever or bumps anywhere else. Told to go to ER of closest hospital now with shot card. Mom states she will go to ER and let doctor know child received shots yesterday and will bring shot card with her.
PT IS INFORMED THE PFIZER GIVEN WAS EXPIRED BY 2 DAYS. NO ADVERSE EVENT AT THE TIME OF THIS REPORT
she felt really bad; fever; chills; body aches; flu; This is a spontaneous report from a non-contactable nurse (patient). A 35-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date of Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient said she already received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, and was scheduled to receive the 2nd dose today (unspecified date). However, due to her flu, she said she was unable to receive it. She wanted to know if she can receive the 2nd dose of the vaccine later than the 21-day timeframe. She also mentioned that her flu was unrelated to the vaccine. However, she also mentioned that after receiving the 1st dose of the vaccine, she felt "really bad," had fever, chills and body aches on an unspecified date. The outcome of events  was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event flu with BNT162b2 can not be fully excluded.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. On an unknown date, the unspecified patients were vaccinated with a dose of tetanus and diphtheria toxoids, adsorbed (manufacturer unknown), VAQTA and RECOMBIVAX HB (lot number, expiry date, route and dose were not reported for all) that was exposed to 30 Fahrenheit for 4 days and 52 Fahrenheit for 4 days. No adverse effects reported. Additional information is not expected.
5 DAYS AFTER SHOT 1 BECAME FEVERISH (102.4), EVERYTHING TASTED SALTY, TIED, DIFFICULTY BREATHING, PHYSICALLY WEAK
Information has been received from a 52-year-old female with allergies to penicillin, sulfa, phenylephrin HCL, ibuprofen; dystonic reaction to "phenothiazines"; increased heart rate and a sensation of bugs crawling on her skin after pseudoephedrine, "TCAs" and "phenoprophyline"; omeprazole (PRILOSEC) gave her a low grade headache and made her dizzy. On 10-DEC-2005 the patient was vaccinated with a 0.5 ml dose of MERUVAX II. There was no concomitant medication. On 19-DEC-2005 the patient developed swollen glands and rash. Unspecified medical attention was sought and no diagnostic laboratory tests were performed. It was reported that the patient recovered from the swollen glands and rash. On 25-DEC-2005 the patient developed painful and swollen knees, wrists and hands. At the time of the report, the swelling had gone down, but did not disappear completely. The patient is recovering from the painful and swollen knees, wrists and hands. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a nurse and refers to an unknown number of unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies, and concomitant therapy were not reported. The nurse reported that between 08-MAY-2017 and 24-MAY-2017, the patients were vaccinated with a single improperly stored dose of RECOMBIVAX HB, intramuscularly (lot # M036156, expiration date 23-FEB-2019, dose was not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of 49 Fahrenheit degrees, for 2 hours (supported). There were no previous temperature excursions. Data logger was not involved. No adverse effects were reported. This is one of 3 reports from the same reporter.; Sender's Comments: US-009507513-1706USA004264: US-0009507513-1705USA013741:
At first, just a very sore arm but in about 12 hours i had a terrible headache, nausea, fatigue and body ache, chills and low-grade fever.  Symptoms lasted exactly 48 hours.
Client formed a blister on lip approximately 1.5 hours after vaccination was given and a second fluid filled blister on the lip the next day.  No additional reactions after this point.
Severe persistent tinnitus (ringing) in both ears, beginning 6-7 months after completing series (prior to any booster). Absolutely no other medications prior to or during this time.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 01-SEP-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 for prophylaxis (strength, exact dose, route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions reported. Digital Data Logger was involved. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
I started having muscle pain, was tired, very congested, colder than normal. I had a friend and a sister who's household tested positive. I took the home COVID-19 test since I had been around them to be safe. Once my home COVID-19 test came back positive I called the doctor and had a telehealth visit. They advised me to use TYLENOL cold and flu, to use an inhaler to help me breath. I am still testing positive but I no longer have symptoms.
pt recv vax 22JAN96 & 11JAN96 pt exp nausea & muscle aches;these sx subsided w/o tx on 13JAN96;the reporter felt that the pt might have the flu;
Given Gardasil 9 - 3 min after shot , had al dizziness. Followed by heartbeat felt on finger tips in 10 min after injection finger to feet intermittent shaking. At 20 min started with slight itching throat and hard to breathe. Epipen 0.3 mg and Benadryl  28 mg po. Called 911 - ER room in am
Patient received the vaccine and experienced muscle soreness for 1 week.  This went away and about 1 week later the site of injection became warm to touch, erythematous, with soreness in the shoulder and upper arm.
Patient received second dose early, before 28 days.  He received it after 17 days. due to uncertainty of date of clinic he received first dose.  The health facility nurse and supervisor thought he received first dose at clinic on 3/18/21 but he received it on 3/29/21 according to immunization records.   When called by this nurse, he had mild symptoms of sore arm and body aches that were managed by ibuprofen.  He understands that he will need one more dose in about a month.  He will call public health or tell the nurse if his symptoms worsen.
Patient complained about being lightheaded.  Patient was pale.  Ice pack was used to keep patient cool.  Vitals were taken:  BP was low 86/43, O2 99%, heartrate 51, respiration 14.  Patient advised to take deep breaths and stay calm.  After 10 minutes patient felt better and vitals were taken again BP 126/84, heartrate 67.  Patient advised to see PCP and lookout for symptoms of reaction.  Call 911 if symptoms persist.
booster in Sep2021; headaches; gets dehydrated when she takes it; cuts the pill, taken it twice and not gone through an entire pill yet; it did stop her headaches.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): AGN282322 (Allergan).  A 68 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; atogepant (ATOGEPANT), oral since 2021 (Batch/Lot number: unknown) at cuts the pill, taken it twice and not gone through an entire pill for migraine. Relevant medical history included: "Migraines" (ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset Sep2021, outcome "unknown", described as "booster in Sep2021"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headaches"; DEHYDRATION (non-serious) with onset 2021, outcome "unknown", described as "gets dehydrated when she takes it"; PRODUCT USE ISSUE (non-serious) with onset 2021, outcome "unknown", described as "cuts the pill, taken it twice and not gone through an entire pill yet"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "it did stop her headaches.". The action taken for atogepant was unknown.  Additional information: It was unknown if patient was breastfeeding. The patient was not hospitalized as a result of the Adverse event. The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe right-sided Bell's palsy (House-Brackmann grade IV) starting the evening after receiving first dose of Moderna COVID vaccine
Initial unsolicited report received from physician on 15-Dec-2015. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of influenza vaccine (manufacturer: unknown, batch number, expiry date, route and site of administration was not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, patient had experienced bullous reaction to the Influenza vaccine. Lab tests and corrective treatments were not reported. Outcome of the event was not reported. Upon internal review, case was considered as serious due to important medical event: Bullous reaction. Documents held by sender: none.
I was sick for three days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021349331 (Pfizer). A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I was sick for three days".  Aditional information: it was reported that the patient had to take off for three days of work because he was sick for three days. He commented what kind of vaccine makes you sick for three days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
itching around injection site; redness around injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching around injection site) and VACCINATION SITE ERYTHEMA (redness around injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 VACCINATION SITE PRURITUS (itching around injection site) and VACCINATION SITE ERYTHEMA (redness around injection site). At the time of the report, VACCINATION SITE PRURITUS (itching around injection site) and VACCINATION SITE ERYTHEMA (redness around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment medications were not provided by the reporter.   Reporter did not allow further contact
within minutes of injection patient developed rash on chest extending just below collar bone, back of neck to shoulder blades. small red raised rash. not itchy but has persisted for almost three weeks with no change.
Redness at injection site, warm to touch, radiating toward armpit/left breast. Patient complained of swelling encircling upper arm beginning next morning (about 18 hours after vaccination) and fever of 102.4. She took acetaminophen and stayed home from work due to malaise. She had sweats that evening. Patient saw primary physician on 10/6/21. Sore arm for 3 days. Upon return to my pharmacy, symptoms resolved except for self-assessed swelling and redness of left arm. Difficult to observe swelling/redness compared to right arm and surrounding skin.
I just noticed what I thought were hives. They prescribed Predinsone 20mg oral, but I did not continue to take due to effects.  The other cream was a Tryiamcinolone acetonide 0.1% steroid cream. They were on my forearms, right and left. They were initially pea sized to a 50-cent piece. They now look like red scars on my arms. No raise and no dryness, just blotches. They are now on my legs. The ones on my legs are itchy.  They all started out raised and dried out.
Severe sudden vertigo attack.   ENT diagnosed vestibular neuritis.  Foggy feeling.   I've been in PT for past two weeks for treatment of dizzy vertigo sysmptoms.
I have the first two COVID shots I also had a booster so I tested positive on Friday; I have the first two COVID shots I also had a booster so I tested positive on Friday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "unknown" and all described as "I have the first two COVID shots I also had a booster, so I tested positive on Friday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) positive, notes: PCR.  Additional information: On Thursday that's when patient not feeling well then patient tested myself Friday and patient took a home test and patient had a PCR to confirm. So, my doctors yesterday prescribed to me Paxlovid and I'm just reading you website patient just had a one question patient have been it effective on people who have been vaccinated, such as myself, like fully vaccinated versus people who were never vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At site of smallpox vaccination, blisters formed around site approx. 1/4 in from center.  Blisters formed approx. 5 days after revaccination of smallpox.
Fever (101.1 degrees), ache in arm, injection site pain, arm pain, lower back pain.
Delayed blinking of left eye. Twitching on right side of mouth. Arching of right eye brows. Middle of tongue is numb.
Received 2nd Dose 3 Months After 1st Dose; Initial Report Received on 30-Dec-2021   A pharmacist reported that a 26-year-old male patient (race and ethnicity unknown) received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization 3 months after the first dose.   No relevant medical history was reported.    No relevant concomitant medications were reported.     On 12-Mar-2021, the patient received the first dose of HEPLISAV-B (Lot # 934601, expiration date 16 Mar 2022, and NDC # 43528-003-05) in the left deltoid from the pharmacist.   Three months later, in June-2021 (exact date unknown), the patient received the second dose of HEPLISAV-B (Lot #, expiration date, NDC #, and injection site unknown) from a different pharmacy. No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
autoimmune disorder; Sjogrens disease; tired; Headache; Joint pain; throat felt like it was closing; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EL9261, Expiration Date: May2021) via an unspecified route of administration in the right arm on 06Feb2021 (at the age of 74-year-old) as 0.3ml, single for COVID-19 immunisation. The patient relevant medical history included Lichen planus from an unknown date in Nov2020 and ongoing (get sores on her tongues and inside of her cheek and monitored by dentist every six months). The concomitant medication was not reported. On 06Feb2021, (Saturday) the patient experienced tired, headache, joint pain, states she also felt like her throat was closing. It was reported that she has been tested for sjogrens disease and the doctor stated she may have an autoimmune disorder on an unknown date. States her symptoms started several hours after the vaccine on the same day, states when she woke up the next morning, she felt fine. The patient stated that she had epi pen, wondered if when her throat felt like it was closing should she have used that. The outcome of the events autoimmune disorder, sjogrens disease was unknown while for other events tired, headache joint pain and throat felt like it was closing was recovered on 07Feb2021.
Day 8 after injection my arm is itchy, red, swallon, welped and warm and sore to the touch.
Pt vaccinated with Imovax Rabies developed hives & angioedema after receiving booster dose.  Had primary pre-exposure series.  Received injection 24SEP & 27SEP
Partial body rash on left side; Extreme lethargy; Weakness in left side; Dull ache on left side; This is a spontaneous report from a contactable consumer. A 73-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) Dose 2 via an unspecified route of administration, administered in the right arm on 06Apr2021 at 11:15 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant drugs were not reported. The patient previously received the first dose of BNT162b2 on 13Mar2021 (Lot Number: EN6204) via an unspecified route of administration in the left arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 12Apr2021 (starting 6 days post 2nd vaccine), the patient experienced partial body rash on left side, extreme lethargy, weakness in left side, and dull ache on left side. The patient received antivirals for 7 days, and currently on corticosteroids as treatment for the events. The patient had not recovered from the events, partial body rash on left side, extreme lethargy, weakness in left side, and dull ache on left side.
This spontaneous report as received from a registered nurse (also reported as the physician) refers to a 49 year old male patient. Medical history and current conditions were not reported. On 07-AUG-2014, the patient was vaccinated with (Oka/Merck) PROQUAD, 0.5 ml, subcutaneous, at age 49, because he was never vaccinated as a child.  No adverse effect was reported. Concomitant medication was not reported. Additional information has been requested.
pt recvd 1 dose of Engerix B & devel swollen red knee joints approx 8 hrs later; no hx of prior injury;
Janssen vaccine was given to a minor, patient was 15 years old at the time of vaccination. Patient was evaluated and the mother was notified. Patient left the facility stable.
Initial misuse report received from a healthcare professional on 09 September 2013. A 04-week-old patient had received a dose of ACTHIB on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Burning feeling when injected, pain in arm from shoulder to elbow, bruise at injection site.
SKIN RASH ON LOWER LEG BELOW THE CALF TO THE TOP OF THE FEET BOTH RIGHT AND LEFT. STARTING PEDNESONE ORALLY QID X 3 DAYS THEN TAPER
12/02/2021 Felt similar to when I missed a couple of doses of medication, but if I had miss any of my medication dosages. Experienced irritable, depressed, and anxious and this lasted 10 days with Dose 1 and with Dose 3 it was 5 days. 12/05/2021 Television visit with Psychologist because she was feeling the same symptoms after Dose 1 and with Dose 3. Psychologist said it happened with other people, but it would go away and to keep taking her medication and to contact him with any changes. Patient feels that she has recovered from this event.
This happened 3 days after the injection. I got Bells Palsy of my left eye. I have documents to concur from my eye doctor. It?s still current today. My muscles began spazzing across my neck and back and haven?t stopped. It?s 24/7 and sometimes extremely severe to the point I?m crying trying to figure out how to get comfortable. I had shocks and burning across my neck, back and upper legs. I had trouble walking, shaking in my left hand. The pain in my neck was so severe I literally couldn?t handle the pain. I did end up in the emergency room about 5 months into it with back and neck scans. They couldn?t find anything remarkable. At this point nobody can truly figure out where all the pain is coming from. I have been diagnosed with peripheral neuropathy now. I?ve had a brain scan and now diagnosed with dsymylenating disorder. I just want my life back. This vaccine has taken it away. I am walking better and it?s thanks to Ivermectin. God forbid I miss a dose. My body will be in a full body flare. I?ve also now had rhizotomy done on the top and lower half of my neck which has helped my pain there be more tolerable.
Bruising and soreness at site of injection,  3 days of constipation, 36 hours of lethargy.
Swelling, redness and warmth at site. Developed cellulitis that required ER visit.
Information has been received from a pharmacist concerning a 9 year old healthy female who was vaccinated with varicella virus vaccine live. Subsequently, one week after vaccination, she developed a very large cold sore on her mouth and lip. It was noted that the patient never had a cold sore before, Unspecified medical attention was sought. Additional information has been requested.
Shoulder pain, difficulty raising arm, muscle mildly inflamed, ultrasound negative for hematoma or fluid.