chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information regarding an unsolicited valid non-serious case received on 27-Sep-2018 from Physician Assistant. This case is linked to cases 2018SA269762, 2018SA274507, 2018SA274519, 2018SA274521, 2018SA274524, 2018SA274525, 2018SA274520 and 2018SA274522 (same reporter). This case involves a 74 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UI993AB, expiry date: 18-MAR-2019 via unknown route (site of administration not reported) on 10-Sep-2018. The patients past medical history, concomitant medication(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that vaccine shipment took 3 days and doses were not viable from shipping excursion, doses were given to nine patients. It was unknown whether patient experienced any adverse reaction after vaccination. 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 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. Documents held by sender: none.
Breakthrough case admission after 2 vaccines Pfizer 5/4/21 lot# Ew0161;  Pfizer 5/20/21 lot# Ew0182
generalized rash & swelling in all joints, pain in joints, chills, low grade fever, chest pain that felt like pleurisy pain; rash devel on 7JUN92 then other sx followed; tx DPH, Medrol, arthritis med;
diarrhea; This is a spontaneous report from a contactable nurse (patient).  A 57-year-old female patient received BNT162b2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and expiration date: not reported, ), via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient reported side effect after the first dose of Pfizer-BioNTech COVID-19 vaccine. Patient had diarrhea. Patient asked what is the likelihood that you'll experience diarrhea again on you second dose, after getting it in the first dose. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 27-JAN-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB injection, lot # L042846, expiration date 15-SEP-2017 (route and site of administration were not reported). No adverse effects were reported. The administered dose of RECOMBIVAX HB was stored in the temperature above 46 degrees Fahrenheit but below 77 degrees Fahrenheit for 5 hours and 45 minutes. Data logger was involved. There were no previous temperature excursions reported. Additional information has been requested.
pt recv vax;immediate pain; large area of redness 12x8cm at inject site; became flushed & again scratching; sx resolving w/ dph; discharged p/ 30 mins;
Immediate swelling, quarter sized blueish area.  1 hour post inject patient reports tingly feeling and an arm that "hurts like hell."
This spontaneous report has been received from a pharmacist who reported that M-M-R II (lot #, dose, strength not reported) reached 75'F for 96 hours, and was unsupported. It was not established whether the M-M-R II vaccine had been administered to any patient. Since possibility of administration which could not be ruled out this was considered as an adverse event. Additional information has been requested.
red patches itchy between toes and fingers at first then on arms and chest, patches of itchy areas come and go in different spots. NO new meds or detergents being used, taking benadry to releive itching.  decreased symptoms just before second covid vaccine and next night had bad itching again,
Patient received SHINGRIX subcutaneously instead of the recommended IM injection site. Other than pain at injection site, patient appears to be in good health. In accordance with website, the dose has been shown to be immunogenic and does not need to be repeated.
Vaccine was taken around 8:40 AM. Side effects started around 12:30 PM. On the day of vaccine nausea was experienced in the afternoon. Vomiting happened twice in the afternoon few hours after the shot was given. Nausea was severe that I could not eat anything because body was not holding it down. In addition, fever, chills, body aches, headache were experienced on the day of vaccine. I took a tylenol around 9 PM (12 hours after vaccine shot - Thursday). On Friday, nausea and vomiting had ceased, but fever, chills, body aches and headache continued. On Friday I took a tylenol in the morning, and again at bedtime.  On Saturday side effects were still present but in much less intensity (lack of energy was still present so I spent another full day just lying down). Fever, chills and body aches had ceased by Saturday and only headache remained. I took tylenol twice that day. On Sunday I considered myself recovered from the side effects of the second shot of the Moderna vaccine, however, I felt some dizziness and headache in the afternoon and took tylenol again. I assume dizziness was experienced because I had little to eat during the prior 3 days due to the side effects.
Patient developed rash in abdominal area 1 day after receiving Hep B vaccine. No respiratory distress or any other symptom reported. Patient has a sibling who had an anaphylactic reaction to Tdap when he was 2 years old, evidenced by seizures and behavioral changes. Patient visited subspecialist MD, who recommended patient should not have vaccines because he has medical condition that makes vaccine harmful.
Pt took a nap when he got home and when he woke up about an hour later he had swelling and a knot at injection site. He applied ice and it has gone down considerably today.
Fever just measured at 100.3F; feeling pretty miserable; Joint pain; aches; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249), via an unspecified route of administration on 21Jan2021 10:15 at SINGLE DOSE for COVID-19 immunisation. The vaccine location was at the right arm and patient received the first dose of the vaccine. The patient was administered COVID-19 vaccine at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included diagnosis of COVID-19 prior to vaccination, chronic sinusitis, anxiety, depression, and attention deficit hyperactivity disorder (ADD). The patient had no allergies to medications, food, or other products. Concomitant medications included sertraline hydrochloride (ZOLOFT), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), clarithromycin, and clonazepam. The patient stated, "I have tested covid + the day after Thanksgiving and this feels just like it minus the respiratory symptoms. Pretty much all the signs of an immune response. Fever just measured at 100.3F. I'm feeling pretty miserable. Joint pain, aches, chills." The events started on 22Jan2021 at 05:00 AM. The reporter considered the events as non-serious. There was no treatment received for the events. It was also reported that since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab test and procedure on 27Nov2020 which included COVID test which showed positive. The patient had not yet recovered from the events "Fever just measured at 100.3F. I'm feeling pretty miserable. Joint pain, aches, chills."
Patient with congenitally brown eyes states with each of 3 GARDASIL injections right iris became increasing depigmented inferiorly (blue). Lower half of iris involved.
Severe rash, swelling that was hot and itchy that peaked at 14 days post vaccination.  Only mildly improved at day 15.
Vasovagal response. Pt requested to lie down following vaccination. Reported feeling faint, nauseous and "seeing stars." Team applied cool compresses, patient instructed to lie on the floor with feet on a chair. Vitals were BP: 124/82, hr 53, o2 97% at 1200. Pt moved to sitting shortly thereafter. Then, at approximately 1210 requested to lie down 2/2 ringing in ears, sweating, and feeling nauseous again. At 1212 vitals were bp 124/78, hr 58, o2 97%. At approximately 12:25 symptoms abated, pt moved to sitting. Continued to monitor until 12:50 with no recurrence of symptoms.
This spontaneous report was received from a female consumer refers to her grandson unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number not provided). The patient was due to receive the second injection in the series of GARDASIL Friday, on 13-SEP-2013, but missed the dose because his physician's office did not have GARDASIL in stock. No adverse effect was reported. Additional information is not expected.
ROTOVIRUS - Severe stomach cramping, and severe screaming for 24 hours  DTP- Chronic cough for 2 months.  Loss of breath, baby turned blue, severe coughing at night
Lt arm swelling, redness, warm to the touch. 2+ swelling. Swelling and redness extending from site of injection to just above elbow area.
Pressure in head, body aches,  head feels pretty hot, very fatigued.  3days now
breaking out in welts on her bottom the size of his thumb; This is a spontaneous report from a contactable consumer (husband). A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date after vaccination, the patient experienced breaking out in welts on her bottom the size of his thumb. He stated his wife has already seen a dermatologist who prescribed a cream but that didn't appear to be helping. Event was assessed as non serious. The clinical outcome of the events was unknown.    Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
12-year-old male received 0.2mL pediatric Pfizer vaccine. No treatment needed. No adverse events noted or reported.
Severe hives; A spontaneous report was received from a health care professional who received the Moderna COVID-19 Vaccine mRNA-1273) and experienced severe hives (urticaria).  The patient's medical history was unknown. Concomitant pantoprazole, levothyroxine, Vitamin D, and hydroxychloroquine use was reported.  On 31Dec2020, nine days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number:011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08Jan2021, 9 days after getting the vaccine, the patient experienced severe hives and reported they were terrible on the 9th, 10th, and 11th. They would not go away. The medication administered to treat the reaction was intravenous diphenhydramine, famotidine, and prednisone. The patient stopped taking prednisone after a couple of days because the reaction got worse and she thought she might be allergic. She stated she was going to see her doctor and they may give her something else.  Treatment information was intravenous diphenhydramine, famotidine, and prednisone.   Action taken with mRNA-1273 in response to the events was unknown.  At the time of the report, the outcome of the event, severe hives, was not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I could not drive, and had no energy; blood pressure was high 150/80 - which is not normal; lost 10 lbs; hypoglycemia; b/c y Dimer was elevated; Her blood sugar is also elevated; felt extremely short of breath while driving; This is a spontaneous report from a contactable consumer reported for self. This 47-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Right arm on 12Apr2021 13:00 at the age of 47-year-old (Batch/Lot Number: ER8732) as DOSE 2, SINGLE for COVID-19 immunisation. No pregnancy at time of vaccination. Medical history included Hashimotos, Penicillin allergy, still have reactive hypoglycemia, allergies: Phenothiazines. No Covid prior vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO) 10mg, and thyroid (ARMOUR THYROID). No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Right arm on Mar2021 11:15 AM at the age of 47-year-old (lot number: ER2613) for COVID-19 immunisation. Approx 4 days following 2nd shot on 16Apr2021 10:45 AM, she left a spin class and felt extremely short of breath while driving. She went to the urgent care and then ER, b/c y Dimer was elevated. They ra tests and chest MRI was normal. One week Later, she went back to urgent care with same symptoms, blood pressure was high 150/80 - which is not normal. Over a period of three weeks she lost 10 lbs. She could not drive, and had no energy. (endo, cardio and primary) ordered a battery of test. Her endo figured that had an autoimmune attack on blood sugar. She still had reactive hypoglycemia - she wear a continuous glucose monitoring device. Her blood sugars drop at night to 50. Her blood sugar is also elevated. She took acarbose to manage it. Cardio has her on a zip patch to monitor her heart rhythm which is also affected. went to urgent care 6 times, had numerous # Appt. and ER once. Believe it is related to the vaccine, she was completely active and normal bef. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Seriousness criteria-Disabling/Incapacitating. No Covid tested post vaccination. Treatments were received for the events. Continuous glucose monitor, acerbose, and beta blocker were received. Outcome of the events was recovering.
LARGE AREA OF REDNESS AND SWELLING ON HER LEFT THIGH WITHIN 12 TO 24 HOURS AFTER IMMUNIZATIONS
increased weakness in legs; loss of balance and 5 or 6 falls a week caused by my legs collapsing on me.I was diagnosed with MD about 5 years ago and I have previously had problems with muscle weakness, Using a cane or walker to  get around.  After the vaccination, the symptoms got worse within 48 hours.
L4-L5 shingles-documented VZV vaccine on right leg by CDC.
Fever 100.1; arm very red and sore lump at injection site, then extreme headache and fatigue. Next day redness really increased to nearly all of upper arm. But fever HA gone.
Patient c/o Red hot streak to left arm from vaccine site to arm pit onset approximately 10 days s/p smallpox vaccine, lasting for approximately 4 days. Was seen in the Emergency Department (ED) on 08/16/03. Denies fever, chills, N/V/D, or chest pain. Was told to keep covered and released.
pt wakened by parents @ 5AM-7 hrs p/APAP given t101 & pt having grand mal sz; treated @ ER & admitted;
Drowsy, SOB, lightheadedness. Evaluated by EMS-Transported to Emergency room/department or urgent care.
14 y/o female came in for a routine physical had had no lunch with last meal breakfast. Patient passed out in chair while receiving vaccines. No bradycardia. No hypotension.
I have a red bump on my arm that is a knot and tender to the touch or painful when touched. It is very itchy and had a headache for the past few days
SkinRash Narrative: hives to face, 8/19/21 took otc diphenhydramine with improvement
1. Nausea 2. Tremors 3. Lack of ability to speak 4. Lack of ability to sit  EpiPen administered and EMS called
Very painful to move arm and red bumps developed 1 week later that have gone away with BENADRYL.
pt had fever in 24hr @ 102;fever lasted on & off for 48hr;pt then started breaking out into rash all over body then head;pt recv DPH x 2 days;last seen 2MAR99 still had rash all over body;
After Injection, cough worsened greatly and lasted (with treatment) for approx 3-4 months with many medications given. Since then every start of a cold develops a cough that worsens in severity and lasts the average of 3-4 weeks. Requiring strong medication. This has occurred 5 times since the injection in 2002.
- Sore arm - Headache - Head Tingling lasted 4 days (still continuing) - Chest pressure (still continuing)  - Dizziness -
Itchy rash started PM of 12/4/09. Exam 12/5_ Urticaria on feet / hands. Treatment: ZYRTEC/MEDROL DosePak..
pain and swelling in arm where injected, high fever, chills, muscle twitching, extreme full body pain. All lasted about 18hrs
This spontaneous report received from a consumer and refers to a patient of unknown age and gender. The information about patient's pertinent medical history, drug reactions and allergies, and concomitant medications were unknown. On an unknown date, the patient vaccinated with Zoster Vaccine Live (ZOSTAVAX) (reported as shingles vaccine) (route of administration, frequency, indication, lot number and expiration date were not reported. The patient reported that, the first bout of shingles was over 5 years ago and still had post herpetic neuralgia. The patient had three lesser flare ups in the 5 years and confirmed that had all shingles shots. The patient had first shot years ago and had shingles three years ago. Because of the vaccine the patient did not realize and had only rash one evening and it was gone the next morning. The patient suffered with neuralgia since then (very painful) no cure. The patient had new vaccine to prevent another outbreak. Outcome of the events was unknown. The reporter did not assess the causality between Zoster Vaccine Live (ZOSTAVAX) and events shingles and post herpetic neuralgia.
Slight redness noted on right deltoid with swelling.  area felt warm to the touch.  oral temp 99.2 on 10/8, BP 110/60 patient going to pmd for check up
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 87-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. Concurrent medical conditions included hemorrhagic disorder (patient bleeds easily). On 2nd July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd July 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling and injection site hemorrhage. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved and the outcome of the injection site hemorrhage was recovered/resolved. It was unknown if the reporter considered the injection site swelling and injection site hemorrhage to be related to SHINGRIX. Additional details were provided as follows: The caller was the pharmacist calling on behalf of the patient. The caller stated that immediately after she administered the SHINGRIX vaccine to the patient, there was bleeding and swelling at the injection site. The caller described the swelling was about 2 cm with raised circle.
Patient had loss of Vision. Patient stated seeing round black spots immediately and could not see. Patient started experiencing loss of hearing around may 30th. Patient only had simple side effects from the first shot. The patient had chills, shakes and headaches.
On 15Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 31Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech; Lack of energy; Needle Phobia; Fatigue; Lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4167016-00.  A 42 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 15Mar2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "On 15Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 31Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Lack of energy"; FEAR OF INJECTION (non-serious) with onset 2021, outcome "unknown", described as "Needle Phobia"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; LETHARGY (non-serious) with onset 2021, outcome "unknown", described as "Lethargic". The action taken for adalimumab was unknown.   Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for suspected product Pfizer biontech covid-19 vaccine with events Loss of energy, Fear of needles, Fatigue, Lethargic is reported as Possible. The reporter's causality for the event(s) of pen misfire with humira (adalimumab) was a reasonable possibility and for event(s) of lack of energy, needle phobia, fatigue and lethargic was not Provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A 15 year old was given a booster vaccine that is indicated only for those who are 16 years of age or older at this time.
ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) WORSE THAN EVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: attention deficit hyperactivity disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced attention deficit hyperactivity disorder (adhd) worse than ever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of attention deficit hyperactivity disorder (adhd) worse than ever was not reported. This report was non-serious.
crying, irritable, swollen quadriceps area, red, warm w/crying suspect breath holding