chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experiencing an new allergy to the covid bivalent pfizer shot; hives; rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023SA054066 (Sanofi).  A 29-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since Oct2022 (Batch/Lot number: unknown) at 300 mg weekly, subcutaneous for eosinophilic oesophagitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "experiencing an new allergy to the covid bivalent pfizer shot"; URTICARIA (non-serious), outcome "unknown", described as "hives"; RASH (non-serious), outcome "unknown". The action taken for dupilumab was unknown.  Additional information: It was reported "since the last fill experiencing an new allergy to the covid bivalent Pfizer shot, patient got hives and a rash". it is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. it is unknown if there were lab data/results available." It was not reported if the patient received a corrective treatment for the events (experiencing an new allergy to the covid bivalent Pfizer shot, hives, rash).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives throughout my whole body that fade and reappear. Very itchy. Developed hives that went through my whole body at different times.  Very itchy from head to toe.   They would appear on my torso, then go away and move to my chest the face and scalp then my feet and palms. I never had any allergic reaction like this before except by the sting of a bee in which I am allergic to.  I went to my physician on December 10 in which they administered a steroid shot with an antihistamine and my hives disappeared.  I was told to take Zyrtec in the morning and night.  Hives are still wanting to come out, especially on my torso.
Pt recvd 3 Engerix-B vax on 9OCT89, 11NOV89, 11APR90 & following these titer=15; one yr later, titer=5; pt given 4th dose on 18JUN91; titer not repeated;
I'm having a lot of pain in my arm into the left side; my hand is numb; hand and arm are tingling; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 23Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She received her first dose of the Pfizer covid vaccine the day before yesterday. She was having a lot of pain in her arm into the left side Feb2021. For a day and 1/2 now her hand was numb what was causing it? It's kind of scary. Her thumb, hand and arm. It doesn't hurt any more but it's numb, it's tingling. it's crazy. It's like her whole arm and hand was asleep. Her left arm was numb, it hurt for a day and a half. Now her left arm and hand are numb. Her hand and arm are tingling. was that shot that bad with everyone? It hurts. COVID19 Vaccine. Reporter considered events as non-serious. The outcome of I'm having a lot of pain in my arm into the left side was recovered on an unspecified date in Feb2021, my hand is numb, hand and arm are tingling was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Blood in the stool; Diarrhoea; Stomach cramping; Head ache; Little dizzy; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in the stool) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported adverse event.). Concomitant products included METOPROLOL and LOSARTAN for Blood pressure.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Little dizzy). On 16-Apr-2021, the patient experienced HAEMATOCHEZIA (Blood in the stool) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea), ABDOMINAL PAIN UPPER (Stomach cramping) and HEADACHE (Head ache). At the time of the report, HAEMATOCHEZIA (Blood in the stool), DIZZINESS (Little dizzy), DIARRHOEA (Diarrhoea), ABDOMINAL PAIN UPPER (Stomach cramping) and HEADACHE (Head ache) outcome was unknown.            Patient stated that he has discharged blood 3 or 4 times more but said it is just a splatter on top of the water and on the paper when clean itself. The patient has no history of gastrointestinal issues or bleeding. Patient had taken 2 Aleve.  This case concerns a 56-year-old male with a serious unexpected event of hematochezia, and nonserious unexpected abdominal pain upper, dizziness, diarrhea, and expected headache. Event onset 2 days after second dose mRNA-1273. Event outcomes unknown. Based on 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.; Sender's Comments: This case concerns a 56-year-old male with a serious unexpected event of hematochezia, and nonserious unexpected abdominal pain upper, dizziness, diarrhea, and expected headache. Event onset 2 days after second dose mRNA-1273. Event outcomes unknown. Based on 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.
No additional AE information; temperature excursion; Information has been received from an administrator referring to a 13 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 11-MAY-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 0.34 degree Celsius. The time frame was 0.77 hours on 18-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751:
Discharge Provider: MD Primary Care Provider at Discharge: MD  Admission Date: 10/21/2022 Discharge Date: 10/23/2022  PRESENTING PROBLEM: Acute respiratory disease due to COVID-19 virus  COVID-19    HOSPITAL COURSE:    Patient is a 84 y.o. male with a prior medical history of chronic kidney disease stage 3, hypertension, hyperlipidemia, coronary artery disease, BPH, coronary artery disease, PVD, PAD, and basal cell carcinoma the skin who presents to the hospital on 10/21/2000 with cough, shortness of breath and fever.  The patient's wife tested COVID positive about 1 week prior.  The patient began having symptom onset on 10/21/2022 and also tested positive for COVID-19.  He noted shortness of breath that was worse with activity.  Nonproductive cough and postnasal drip A fever of 101.1 at home and generalized weakness.   Upon evaluation in emergency department the patient had a CTA of the chest completed which was negative for pulmonary embolism or pneumonia.  He was found to be hypoxic with ambulation and given a dose of Decadron in the emergency department. The patient was admit for can you had observation and IV Decadron.  The patient has remained off of supplemental oxygen since admission to the hospital.  Will discharge home with an additional 3 doses of Decadron to complete a 5 day course.  He was also given Mucinex for expectorant and Claritin to help with post-nasal drip.  Remdesivir was not initiated IV was not persistently hypoxic during stay. PRN Albuterol inhaler provided significant relief for the patient therefore will continue this upon discharge as well.
Arm swelling followed by diffuse red warm areas.  Headache. Rigors late evening the vaccine was given. Rapid heartbeat late evening the vaccine was given, Fever for 24 hours.  Facial flushing and swelling 24 hrs after vaccine (still present after 48 hours.)
sore arm following the vaccine; This is a spontaneous report from a contactable consumer (patient wife reporting for her husband) via Pfizer sponsored program. Report 2 of 2 which is for the caller calling about her husband. A 69-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in arm (as reported) on 29Jun2021 as dose 1, single (at the age of 69-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The wife called to report that she had a sore arm that was swollen at the injection site after her Pfizer Covid-19 Vaccine at which time she also reported her husband had a sore arm following his vaccine. She and her husband had their first vaccine yesterday (29Jun2021) and she was not aware about whatever the purpose of calling here was but she had a sore arm, sore and swollen arm at the injection site. Her husband also had a sore arm. They were senior citizens. She confirmed that she and her husband both received the Pfizer Covid-19 Vaccine yesterday (29Jun2021) and are now both experiencing sore arms. She stated they were fine, she guessed they wanted her to register that they had the shot.  She did not know, she called like they said. The outcome of the event was unknown.     Additional information has been requested. Information about lot/batch number has been requested.
Initial report was received on 21 September 2011 from another manufacturer national service center (service request number 1-4487450697), who received the report from a consumer who is also the patient's parent. A 19 year-old male patient (name not reported) who had symptoms of mononucleosis and received the meningococcal vaccine (manufacturer, lot number, route, site and date of administration not reported). Two days later the patient was diagnosed with mononucleosis and then a week later he was admitted to the hospital with a "very sore throat". Treatments were given but the type of not reported. According to the parent, she did not feel the meningitis vaccine resulted in the mononucleosis. No further information was available at the time of the report. No contact information was provided for the reporter. The patient's outcome was not reported. Document held by sender: none.
Extreme red area size of palm of head - some soreness & "heat" in area. Lasted about 2 weeks or more, skin slightly rough in area, about 4 inches by 6 inches. No swelling no treatment.
bad headache; whole body muscle ache,; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration on 18Mar2021 (at the age of 45-year-old) for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, she was not diagnosed with COVID-19. Since the vaccination, she had not been tested positive for COVID-19. Concomitant medications were not reported. On 18Mar2021 at 22:00, she had experienced bad headache and whole body muscle ache which was getting worse overnight. The patient took Tylenol for the reported adverse events as a part of therapeutic measures. The clinical outcome of the events bad headache and whole body muscle ache was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Broke out with the hives on stomach.  They could have appeared earlier but did not check stomach until she woke up the next morning.
Pt cried immediately after shots for 45 minutes, every hour for 24 hours.
Developed muscle and joint aches along with severe anxiety a week after receiving the second dose.  Lasting over a week.
Client reports tachycardia of 120-130 bpm from 1800 on 2/4/21 until 0700 on 2/5/21, when bpm decreased to about 100. She returned to baseline, 80 bpm, by 9am. No other symptoms.
-Redness, swelling at injection site of both vaccines PNEUMOVAX > then FLUVIRIN.
Very red, warm, and swollen 4 inch area around the site of injection - has been putting ice on area and moving arm around; recommended that patient continue doing what she is doing and that this has been a common reaction to the second dose of SHINGRIX. Advised her that if it became unbearable, to either call us or go to urgent care for further treatment.
No additional adverse effects; administered expired GARDASIL 9 and if it is supported; This spontaneous report was received from a certified medical assistant refers to a 44-year-old male patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication.   On 23-SEP-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe, dose:0.5 milliliter,  lot # 1602283, expiration date: 16-AUG-2021(expired product administered), for prophylaxis (dose number, and  route of administration, were not reported). The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  did not experience any temperature excursion.   No further information provided. No additional adverse effects and no PQC. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602283; expirationdate: 16-AUG-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Pt was given Moderna Bivalent vaccination without having received the 2 initial Moderna covid vaccinations
This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 12-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.
1. Pain at site of injection started about 6 hours post second vaccine injection (7-8 on a 0-10 scale) that lasted for almost 48 hours, most intense during the day following injection. No treatment for that. 2. Significant fatigue on the morning  14 hours following the injection (could have started during the night) . Difficult to maintain balance. Just rested the whole day. Unable to exercise on stationary bike. 3. Low grade fever (just under 99 F; base line for me has been 97.6 F) in the evening following injection, gone next morning. No treatment.
unconscious when mom went to feed;turned pale & blue around the lips;In ER was nl;events lasted approx 15m T101 when taken in ER:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: FH9894) at the age of 58 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRESTOR, start date: 02Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti viral details: product=COVID 19 Treatment, brand=Paxlovid, Treatment start date=02Sep2022, Treatment stop date=06Sep2022, Indication=Treatment of COVID-19.
a really bad headache; a very sore arm; fever with temperatures of 100.3 to 101F; She's not feeling good at all; Feels miserable/horrible and woozy; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (Formulation: Solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 as SINGLE DOSE for covid-19 immunisation.  Medical history included , thyroid disorder from an unknown date and unknown if ongoing Thyroid is low ,diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included metformin at 500 mg taken for diabetes mellitus, start and stop date were not reported and levothyroxine sodium (SYNTHROID) at 100 mcg taken for thyroid disorder, start and stop date were not reported. The patient previously took  Historical Vaccine BNT162B2  (she got her first shot on 19Jan2021 with no side effects; Batch/lot number: EN9581; Dosage text: Once by injection in the left arm )on 19Jan2021 for Covid-19 immunisation. The patient experienced a really bad headache, a very sore arm , fever with temperatures of 100.3 to 101f, she's not feeling good at all , feels miserable/horrible and woozy on 10Feb2021. she received the 1st dose of the vaccine last 19Jan2021 and had no side effects. She received the 2nd dose yesterday and woke up in the middle of the night due to a really bad headache and a very sore arm. She woke up today and still had the symptoms along with a fever with temperatures of 100.3 to 101 F. She's not feeling good at all and is asking if these are all common side effects of the vaccine and on what she should do. The patient underwent lab tests and procedures which included body temperature: 100.3 fahrenheit on 10Feb2021 she took it again at 1:25 and it got up to 101.  The action taken in response to the event for bnt162b2 was not applicable. The outcome for the events a really bad headache, fever with temperatures of 100.3 to 101F, and Feels miserable/horrible and woozy not resolved and for other events was unknown.   Information on the lot/batch number has been requested.
I had numbness in my feet and hands. The numbness progressed to the point where I could not walk. It took almost 56 days of difficulty walking when I finally needed hospitalization.
20OCT95 5PM itching on lower arm where inj given, progressed to other arm, legs & trunk;6PM hives began developing;began DPH immed then q 6 hrs 21OCT95 AM began looking better, by 5PM hives returned;went to ER given Solumedrol 630PM;
After about 20 minutes, the patient stated she felt short of breath, chest tightness, and her face became red. The nurses took her vitals which showed hypertension and tachycardia. She was lowered to the ground and given some juice while a code was called. When the code team arrived, the patient was alert and oriented within the vaccination clinic, she was then transferred to the ER by nursing staff and hospital security.
left arm around my elbow is painful and sore and painful to move; second dose of the vaccine is bothering his joint and muscle; second dose of the vaccine is bothering his joint and muscle; This is a spontaneous report from a contactable consumer. This 68-year-old male consumer (patient) reported for himself. A 68-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number: ER8732, expiry date: 31Jul2021) via unknown route in left arm on 31Mar2021 at 03:30PM as single dose (at the age of 68 years old) for COVID-19 immunisation. The patient medical history included Blood Pressure High from an unknown date in May2021. The concomitant medications were not reported. It was reported that he was diagnosed with high blood pressure several years ago and was taking medication for that regularly. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number: unknown, expiry date: 31Jul2021) via unknown route in right arm on 10Mar2021 as single dose (at the age of 68 years old) for COVID-19 immunisation and never bothered his right arm. After the one week ago, his left arm where he had the injection at and his elbow are painful and sore, and painful to move and his second dose of the vaccine was bothering his joint and muscle, which started about a week ago. He said when it started he was not sure if it was something he did that day, but he hadn't done anything strenuous. Patient received treatment with Ibuprofen (LOT number: P121258, EXP: Aug2023) 200mg via orally in the morning two days ago, then used Aspirin 81 mg (LOT number: P113296, EXP: Dec2020) took four of them, at different times, starting probably Tuesday 04May2021, he was not sure if they helped or not, because his arm still hurt. He says he didn't take them today. He also reported the bottle had 300 small, coated tablets, and it was sealed and intact when he got it. It was reported that his arm pain is maybe a little better on its own, after he uses it a while it seems to be a little less painful. At the time of this report the outcome of the events were recovering.  Follow up attempts were completed. No further information was expected.
6 month old patient who received VAXELIS at 2 months and PENTACEL at 4 months/ Requesting information on whether VAXELIS can be given now for the 6 month/3rd dose; patient has a temperature today; This non-serious spontaneous safety report with reference number # 22022SA164823 / 01090895 was received by a partner on 05-May-2022 and forwarded on 09-May-2022 from a health care professional.  The causal relationship between Vaxelis and the reported event, "patient has a temperature today" was not provided by the reporter. The causal relationship between Vaxelis and the reported event,"6-month-old patient who received VAXELIS at 2 months and PENTACEL at 4 months/ Requesting information on whether VAXELIS can be given now for the 6 month/3rd dose" was assessed as not applicable due to the nature of the event.  No further information is expected since the reporter did not give consent to follow-up.