chrisvoncsefalvay/vaers-outcomes huggingface dataset:
-PATIENT INADVERTENTLY RECEIVED A 3RD DOSE OF PFIZER VACCINE.  WHILE DOING VACCINE HOME VISITS IN THE COMMUNITY, PATIENT REPORTED TO PHARMACIST THAT HE WAS DUE FOR 2ND DOSE IN THE FIELD.  -CALLED PHARMACY TO VERIFY AND WAS ONLY TOLD ABOUT HIS 2/5/21 DOSE OF COVID, SO ANOTHER DOSE WAS ADMINISTERED WHEN HE HAD A 2ND DOSE ON 2/25/21. -CALLED POISON CONTROL 3/25/21 AND THEY SAID THERE WAS NO DATA ON 3RD DOSES ON CDC OR PFIZER WEBSITE BUT TO JUST MONITOR FOR SIDE EFFECTS.  -CALLED PFIZER HOWEVER WAS HUNG UP ON AFTER WAITING 3 HOURS ON HOLD.  -ATTEMPTED TO CALL PT EVENING OF 3/25 AND MORNING OF 3/26, BUT NO ANSWER TO ANY OF THE NUMBERS LISTED -WILL CONTINUE TO CALL OR VISIT THE PATIENT TO CHECK ON PATIENT -WILL CONTINUE TO ATTEMPT TO CALL OR VISIT TO CHECK ON PT
PATIENT RECEIVED VACCINE BEFORE ELIGIBLE AGE OF 12 YEARS OLD. PATIENT RECEIVED 2 DOSES OF THE PFIZER VACCINE WHILE STILL 11 YEARS OF AGE. PATIENT HAD SORENESS AT INJECTION SITE AFTER INJECTION THAT RESOLVED WITHIN 48 HOURS. NO OTHER ADVERSE EVENT/SYMPTOMS.
I developed an oval rash exactly 1 week (7 days) after I received the vaccine near the injection site on upper left arm, near the shoulder. The rash is about 2" long and 1.5" wide. Minor itch, warm to the touch, looks a little swollen. Also developed small itchy red bumps near the injection site. Keeping an eye on it to see how long it takes to go away.
24 hours after administration, right thigh swollen 15 x 10cm where 5th DTAP was given.  Advised Benadryl every 6 hours PRN.
large painful swollen lymph node on side of vaccine injection above collarbone with peripheral swelling across chest/armpit. pain radiating down back, neck, and arm.
Narrative: Fully vaccinated, COVID positive on admission for chest pain and fatigue wile on home O2. Treated for COVID and CAP
I experienced a very heavy period the next month that lasted well over a week. This continues and I have been diagnosed with Iron Deficiency Anemia and I have a fibroid that has enlarged significantly since the vaccine.
This spontaneous report was received from a healthcare worker regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored VAQTA lot # L023232/expiration date- 25-FEB-2017, (incorrect product storage). No adverse event. Excursion temperature was 51.22 F and timeframe was 42 hours. There was no previous temperature excursion. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sore right arm; Had a passing "twingy" headache; This is a spontaneous report from a contactable consumer or other non-health care professional. A 75-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Right on 16Jun2021 12:30 (at the age of 74-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After first dose patient experienced sore right arm. She clarified she also had a passing "twingy" headache on unspecified date Jun2021, beside her right sore arm. Her right sore arm had eased up with her first vaccine dose, as well as, today with her second COVID-19 Vaccine shot. It was reported that patient received her 2nd COVID-19 Vaccine dose yesterday. Reported she had called to get her question answered, and really wanted to know if she could take a second Tylenol. Caller was transferred to Pfizer Medical Information for further assistance. The outcome of the events was reported as unknown.
Large herpes outbreak in the genitalia area; Burning; Rash; Migraine; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05Apr2021 at 15:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune arthritis, connective tissue disorder and complex syndrome, chronic migraine, depression, anxiety and COVID-19. The patient has taken unspecified concomitant medications. The patient had no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the arm left on 14Mar2021 at 15:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 19:00, the patient had a migraine every day since her second shot on March 5. She was taking medicine every day for the migraine. On 15Apr2021, which was 10 days after the second vaccine she developed a large herpes outbreak in the genitalia area. She also had burning and a rash in the crease of her legs near her genital area. Therapeutic measures were taken as a result of the events which included treatment with unknown migraine medication and valcyclovir. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events migraine, herpes, burning and rash was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Migraine for 5 days Shingles 5 days after shot Numbness on left side of body starting one week after shot and lasting one and a half weeks.
Breakthrough case admission after 5 vaccines Moderna 1/18/21 Lot# 029L20A;  Moderna 3/23/21 Lot# 010A21A;  Moderna 11/10/21 Lot# 933906;  Pfizer 4/4/22 Lot# FK9895;  Pfizer 11/15/22 GJ3275
Vertigo, dizziness, temp 102. Got some Meclizine. 9/17/2014 Temp 100. Stayed home from work. 9/17/2014 2:00 pm symptoms resolved.
patient described no unusual symptoms at time of vaccine and for the rest of that day.  patient reported waking up the next morning feeling strange sensation in nose/throat. patient then noticed a loss of smell/taste that day that has persisted to this day  (11/30/21) without significant change. no other side effects or symptoms reported, negative covid antigen test x 2 since vaccination. recommended patient seek pcr test for increased sensitivity and to follow up with primary doctor for further recommendations
pt recvd vax; red 2" side to side; 1" from top to bottom around area where inject was given; feels fine;
- redness, swelling, itching since vaccine was administered. Pt treated at home with Benadryl. - Pt sought treatment at our facility - given oral Keflex 500mg one QID x 5d and Prednisone 5mg one QD x 7d.
HIVES BOTH LEGS within 24 hours of dose 1 and dose 2
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-AUG-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Dizziness and severe imbalance (feel like I'm in a boat 24/7) and increased tinnitus which I already had.  I also already had imbalance problems, but they are worse since the vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: EK5730), in right arm, on 19Jan2021 as dose 2, single (Lot number: EL1283), in right arm and on 07Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Benign prostatic hyperplasia" (unspecified if ongoing); "allergies to Sulfa" (unspecified if ongoing); "allergies to penicillin" (unspecified if ongoing); "Allergy to iodine" (unspecified if ongoing); "Allergy to shell fish" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN; FISH OIL; VITAMIN D3. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, covid-19 and the suspect drug BNT162B2 cannot be excluded.
Severe anaphylaxis with SOB, angioedema requiring 3 doses of Epipen, 1 dose of Benadryl 25 mg, Solumedrol. Transported to ER and was on Epinephrine drip for 10 hours.
Difficulty catching her breath; Her heart was pounding out of her chest; Cramping in calf behind the knees; Fever; Nausea; Chills; Arm soreness; Aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), PAIN (Aches), DYSPNOEA (Difficulty catching her breath), PALPITATIONS (Her heart was pounding out of her chest) and MUSCLE SPASMS (Cramping in calf behind the knees) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information reported .  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), PAIN (Aches), MUSCLE SPASMS (Cramping in calf behind the knees), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills). On 09-Mar-2021, the patient experienced DYSPNOEA (Difficulty catching her breath) and PALPITATIONS (Her heart was pounding out of her chest). The patient was treated with PARACETAMOL (TYLENOL) for Cramps calf, at an unspecified dose and frequency and MAGNESIUM for Cramps calf, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm soreness), PAIN (Aches), DYSPNOEA (Difficulty catching her breath), PALPITATIONS (Her heart was pounding out of her chest), MUSCLE SPASMS (Cramping in calf behind the knees), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 09-Mar-2021, the patient felt like her heart was pounding out of her chest and difficulty catching her breath. This happened about 3-4 times thought the next couple of days.
4"x6" area on right deltoid red with welts. Swollen and tender to touch. Patient sent to local ER for further evaluation.
Starting shortly after the injection she had severe left arm pain. Symptoms have varied over the last 2 months, but she has noticed decreased ROM in the shoulder, pain sleeping on the left side at night, a lump at the site of the injection and ongoing pain. She has taken Aleve and ibuprofen intermittently with some relief.
with shaking and diaphoresis and ?itching? in her throat? she took 5 of her Zyrtec (which she stated was her usual dose ??) drank some water and I put ice pack to her neck? within 5-10 minutes, she stated she felt better, stayed with us for about 30 min total? BP was normal ? she stood without incident and left
Pain and swelling at the injection site that began 3/12/2021 and remain 3 days later Muscle soreness beginning 3/12/2021  to 3/14/2021 Fatigue beginning 3/13/2021 to 3/14/2021
Initial sore arm, approximately 31 hours after injection developed a slight headache. By 6am on the 2nd day had an intense migraine headache.
Headache, low temp of 99.6 before bed. In morning temp was 101.3. Temp has gone down to 99.5. Very tired
At 1:00 PM, telephone call from client, complaining of feeling like his forehead was on fire and was breaking out with hives. States he is on his way to the Health Dept. At 2:00 PM, the client never arrived to the clinic. On 09/04/01, unable to contact the client at home.
I95.9 HYPOTENSION 1/27/2023 HYDRONEPHROSIS I95.9 HYPOTENSION 1/27/2023 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION I95.9 HYPOTENSION 1/27/2023 ALZHEIMERS DISEASE
As warned I experienced fever and chills and general malaise starting about 24 hrs after the shot, lasting about 72 hours with lessening severity. The first 48 hrs I felt too ill to participate in much and spent most of the time laying down.  The swelling in my arm is getting worse, 96 hours later the injection site and an oblong area about 4 inches wide and 2 inches tall surrounding it is hard and hot and itchy, with a less red area around it.
Re: CDC-INFO; Topic CDC fifth booster for COVID-19; [CDC-2737312-R6L9C6] CRM: From:  To: cdcinfo@cdcinquiry.onmicrosoft.com <cdcinfo@cdcinquiry.onmicrosoft.com> Date: Wed, Dec 21, 2022 12:33 pm Best response is noted below:  The adverse reaction was that after receiving the "fifth" dose of Omicron (Pfizer) on 10/24/2022, within three/four days was placed in hospital for fifth days.  Have never, ever, been hospital before.  The adverse event was a dysphasia, with side effects or reaction for such.  No recommendations for this was had nothing to do with MEDICAL GROUP CARDIOLOGY.  The only side effects was from the somewhat tingling on my right arm & then episodes later the next day.  The only change to medicines was nothing to do with side effects, with exception of Atorvastatin, which has nothing to do with high blood pressure.  Please advise & as the practitioners not now nothing about this, or otherwise.  Thanks -----Original Message----- From: CDCInfo <cdcinfo@cdcinquiry.onmicrosoft.com> To:  Sent: Wed, Dec 21, 2022 11:45 am Subject: CDC-INFO; Topic CDC fifth booster for COVID-19; [CDC-2737312-R6L9C6] CRM:  Greetings,  Thank you for your inquiry to CDC-INFO.  To provide the best response to your inquiry, would you please elaborate further on your question. Please specify if you want to report an adverse event, side effect, or reaction from the COVID-19 vaccine.  This information will help us respond to your inquiry.  Sincerely,  CDC-INFO Correspondence Team   CDC-INFO is a service of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR). This service is provided by the contract with CDC and ATSDR. PWG PR#        --------------- Original Message---------------   Sent:  12/21/2022 From:   Clinician Subject:   CDC fifth booster for Cov-ID Email Address:    Question:   I am 69 years old & just received my Fifth Booster.    I received CovID Pfizer 3/3/2021;  3/24/2021 from.  Received CovID Pfizer on Little Clinic 9/29/2021;  4/22/2022.   Received ?10/24/2022? CovID from Pfizer (Omicart) BH9697 on ?Pharmacy,? that afternoon.  After receiving the 10/27/2022 after about 8:00 pm, went to the for hospital on 10/28/2022.  None had appeared at that time for many years.      What are the indications of this happening from 10/24/2022 to 10/27/2022?  Please advise.    My address is      (0)<<PII>>   Optional Information   Name:    Title:   Organization:   Phone:   Other Email:   Address:   PII Extraction:
Patient observed a palm sized hive approximately 5 days following vaccination (10/31).  Hive grew to size of hand with fingers spread by 11/2.  Patient began taking Benadryl per urgent care visit ~ 11/2 and had just seen PCP today (11/4) and was prescribed a 12 days Prednisone course.
This case was reported by a consumer and described the occurrence of abnormal sensations arms in an adult female subject who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). At an unspecified time after vaccination with Flu vaccine, the subject experienced abnormal sensations arms. The subject reported that everytime she gets a flu shot, she can feel it go down her arm. At the time of reporting the outcome of the event was unspecified.
Moderna Covid-19 Vaccine EUA  After 3 days, upon scratching an itch on my back,  I felt bumps on my back and found my back covered with reddish bumps.  The itch was slight and increase when scratched.  On day 4, upon further examination, I found the same bumps  an my front torso and shoulders.  All the bumps are prone to mild to moderate itching (not intense).
she felt dizzy first.; Within 2 minutes heart was racing; felt numb in stomach area; she couldn't sleep; She felt like contractions in her stomach, like cramping; her whole stomach area getting hard; Her legs/knees were weak.; felt weird; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 31Mar2021 (at the age of 56-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Within 2 minutes of receiving the vaccine, heart was racing, felt numb in stomach area and felt weird. It lasted for two weeks. Primary care physician and cardiologist checked her out. It has been 6 weeks and was advised not to get the second dose. Should she get the dose? She feels like this is a severe reaction. She states she felt dizzy first. When she got home, she thought she was going to die.  She laid down and thought she was going to pass out. A few hours later, her heart was racing, and she couldn't sleep. Symptoms alternated between feeling dizzy and her heart racing. She felt like contractions in her stomach, like cramping, and her whole stomach area getting hard. Her legs/knees were weak. She's dealt with this for 4 weeks "really bad". An ultrasound was done, and her heart is fine.  The cardiologist said there is nothing to worry about. She feels better now since 6 weeks ago. She went to a cardiologist and her heart is fine, so it's nothing with her heart, but they don't know what it is. The extreme dizziness lasted for 4 weeks and it got a little better. Now she is kind of fine, she is not getting dizzy that bad anymore. Her heart is also fine, it's not that bad anymore. She was asking if she can get the second dose, can it happen again, and should she not take it? Her doctor told her she should wait. She went to her doctor who advised her to not receive the second dose of the vaccine. Should she take the risk of getting the second dose of the vaccine or maybe no? Her doctor doesn't know what to do. Now the first dose was 6 weeks ago, and she doesn't know how long she has to get the second dose. The patient underwent lab tests and procedures which included ultrasound scan: no result on an unspecified date. The outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
Patient developed chest pain at about 3:30AM the following morning. Ultimately diagnosed with anterior STEMI requiring stent placement.
Information has been received from a physician concerning a 11 year old female who early in July 2008, was vaccinated with the first dose of GARDASIL vaccine (yeast), and soon after she became pale and proceed to vomit for about 30-45 minutes on and off. The patient sought unspecified medical attention. Additional information has been requested.
Patient came to pharmacy on 5/14/15 at 5:45 pm and said she has a rash on arm where I had injected ZOSTAVAX 2 days earlier. There is a small rash about 2" x 1" around injection site. Little warm to touch but not hard or swollen. I had her buy BENADRYL and told her to take one capsule every 6 hours and to call me in the morning and let me know if that helped the rash.
pt recvd vax in the morning, had low grade fever evening, last dose of APAP approx 4PM; mom awoke in the middle of the noc, crib was shaking; pt had sz, was hot to touch; mom placed pt in luke warm tub p/sz 20 mins later temp 104;
This is a spontaneous report from a contactable physician. A 20-year-old female patient received the second dose of TRUMENBA, via an unspecified route of administration at 0.5 ml, single on 07Oct2016 for immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of Trumenba (Lot # N77282, Expiry Date 30Jun2017) on 08Jul2016 for immunisation. On 11Oct2016, the patient experienced nausea, sweatiness, injection site was a little itchy with outcome of recovered on 12Oct2016. The event inject site started to turn red on 11Oct2016 with outcome of unknown, injection site was swollen on an unspecified date with outcome of not recovered.
Pts right leg, red, swollen 4 " x 2" mid thigh.
Moderna COVID-19 Vaccine EUA  New pain/tenderness at injection site. Swelling and hardening of muscle. Large reddened area around site and very hot to touch.
pt recvd vax devel rash, sl fever, h/a & achy joints following vax; No further details were provided;
6 days after my 2nd booster shot  i was having trouble breathing,  the next day after that  i was in the ER diagnosed with viral cardiomyopathy (critical)
Shivering/ Chills; High Fever (100 deg. F); Slight pain in joints due to the shivering; Dose received: 3; This is a spontaneous report received from contactable reporter (consumer or other non-HCP).  A 66-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 20Dec2021 (Lot number: FL3197) at the age of 66 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hyperthyroidism" (unspecified if ongoing) and "Graves' disease" (unspecified if ongoing), notes: Graves disease. Concomitant medication included: METHIMAZOLE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: Unknown), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: Unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021, outcome "unknown", described as "Dose received: 3"; CHILLS (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Shivering/ Chills"; PYREXIA (non-serious) with onset 21Dec2021, outcome "not recovered", described as "High Fever (100 deg. F)"; ARTHRALGIA (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Slight pain in joints due to the shivering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia and arthralgia.  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Morning of April 29 ...severe joint point unlike normal related to chronic conditions. Knees and hips of both legs felt and appeared to be swollen. Mobility was limited due to discomfort. Treated with 800 MG OTC ibuprofen 1x and later in evening treated with 1,000 MG Acetaminophen. Pain got to be enough that 1 5 mg Oxycontin was taken around 9pm.