chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hypersensitivity reaction to COVID-19 Vaccine; throat pain that progressed to a little bit of tightness; ear pain; wheals develop on her back bilaterally; This is a spontaneous report from a contactable pharmacist. A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685 and Expiry date: 31Mar2021, strength: 0.3ml) (NDC number: 59267-1000-2) via Intramuscular on 21Dec2020 12:21PM at 0.3ml single dose for COVID-19 immunization. The patient's medical history and concomitant drug was reported as none. The patient experienced a hypersensitivity reaction to COVID-19 Vaccine late last night on 21Dec2020. Hypersensitivity reaction: Further described as patient developed throat pain that progressed to a little bit of tightness; some ear pain; and had wheals develop on her back bilaterally. She was transported to the emergency room on 21Dec2020 where she received treatment and was under observation. The outcome of events was unknown. Since whether outcome recovered completely, recovered with lasting effects or just improved is unknown. She was not admitted to the hospital; she was sent home from the emergency room after 2.5 hours. Caller reported seriousness criteria as medically significant because event required medical intervention. Causality was very likely. Patient at time of this report is scheduled to receive the second dose of vaccine; they have not determined if she will receive the second scheduled dose or change/stop dose in response to this event. First dose; scheduled to receive a second dose; have not determined if will be continuing with it.; Sender's Comments: Based on the compatible time association, the hypersensitivity reactions are reasonably related to suspect BNT162B2 administration.
Achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057G20A and 012A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, METOPROLOL SUCCINATE and ATORVASTATIN for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Achy). At the time of the report, PAIN (Achy) had resolved.            Action taken with vaccine was not applicable.  No treatment information was provided.
BACK PAIN; LEG PAIN; HEADACHE; ELEVATED TEMPERATURE; NAUSEA; This spontaneous report received from a consumer concerned a 29 year old female. The patient's weight was 82 kilograms, and height was 159 centimeters. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient has no known allergies. the patient had no drug abuse or illicit drug usage. the patient was not pregnant at the of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered at left arm on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced back pain. On 06-APR-2021, the subject experienced leg pain. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced elevated temperature. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain, leg pain, headache, and elevated temperature, and the outcome of nausea was not reported. This report was non-serious.
Rash about 3 inches wide, hot/warm to the touch. Rash not associated with any pain or itching. No fever, Patient feels fine/healthy.
Symptoms began 8hrs.  after receiving dose: - Cold sweats - Chills - Nausea - Rapid heart rate - Vomiting
Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: patient received vaccine. shortly after she stated she felt like her throat was numb. after this patient started to panic and became sweat and flushed and had slight difficulty breathing. 911 called and epipen administered. patient originally did not want to go with EMS but after speaking to them she did go in an ambulance.
Pediarix, HIB, Prevnar were given at a regular 6 months check by visit on 2/20/07. Pt developed a seizure episode that evening. Taken to ER.
swollenness of their neck; pain in their neck near the lymph nodes on the left side; it is a little annoying/It bothers them every once in a while; numbness in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollenness of their neck), NECK PAIN (pain in their neck near the lymph nodes on the left side), IRRITABILITY (it is a little annoying/It bothers them every once in a while) and HYPOAESTHESIA (numbness in the arm of the injection) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 032M20A and 026B21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA (numbness in the arm of the injection). On an unknown date, the patient experienced SWELLING (swollenness of their neck), NECK PAIN (pain in their neck near the lymph nodes on the left side) and IRRITABILITY (it is a little annoying/It bothers them every once in a while). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK, qhs. In November 2021, HYPOAESTHESIA (numbness in the arm of the injection) had resolved. At the time of the report, SWELLING (swollenness of their neck), NECK PAIN (pain in their neck near the lymph nodes on the left side) and IRRITABILITY (it is a little annoying/It bothers them every once in a while) had not resolved.            No medical history were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Non-significant follow-up received.
fever, irritability, muscle/joint aches, headache, diarrhea X4 days
Pt recvd MMR vax on 16JAN92 & 10 days p/vax devel severe bilateral blepharospasms to point that it was difficult to keep eyes open;
This is a spontaneous report received from a contactable consumer or other non-HCP. A 62-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunisation. The patient experienced palpitations (heavy pounding of the heart), and abnormal blood pressure (has blood pressure problems now), with outcome of unknown. The events evaluated at an emergency room visit. Relevant laboratory tests and procedures available in the appropriate section. This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (very sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (very sore). At the time of the report, PAIN (very sore) outcome was unknown. No concomitant medication were reported. No treatment medication were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
shingles; circles on her chest; Covid arm; stiffness; soreness; raised red rash that is circular and itchy; raised red rash that is circular and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), MUSCULOSKELETAL STIFFNESS (stiffness), PAIN (soreness), RASH PRURITIC (raised red rash that is circular and itchy) and ERYTHEMA (raised red rash that is circular and itchy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Primary sclerosing cholangitis (liver disease). Concomitant products included URSODIOL and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), MUSCULOSKELETAL STIFFNESS (stiffness), PAIN (soreness), RASH PRURITIC (raised red rash that is circular and itchy) and ERYTHEMA (raised red rash that is circular and itchy). On 13-Mar-2021, the patient experienced RASH (circles on her chest). On 20-Mar-2021, the patient experienced HERPES ZOSTER (shingles). At the time of the report, VACCINATION SITE REACTION (Covid arm), MUSCULOSKELETAL STIFFNESS (stiffness), PAIN (soreness), RASH PRURITIC (raised red rash that is circular and itchy), ERYTHEMA (raised red rash that is circular and itchy), HERPES ZOSTER (shingles) and RASH (circles on her chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Cellulitis in area of arm where Tdap was given. Treated with KEFLEX.
Pt recvd 1st dose of vax 13MAY92 & w/in 24 hrs, exp nausea, w/in 48 hrs devel diarrhea & vomiting; w/in 72 hrs devel fever & chills, flu-like sx cont for 1 wk; also exp lethargy for 2 wks following inject;
Pt came back with inflamed, red injection site spanning 8-10". Pt also complained of fever for 2 days.
Headache for 4 days now; 10 hours post vaccination, patient's entire arm (not injection site) hurt horribly, unable to lift; 10 hours post vaccination, patient's entire arm (not injection site) hurt horribly, unable to lift; At times her face will feel tight; 30 min post starting itching very bad; Have experienced insomnia since the injection, followed by exhaustion; Have experienced insomnia since the injection, followed by exhaustion; eyes itch and have been red; eyes itch and have been red; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration (left arm) from 18Dec2020 09:45 at a single dose for COVID-19 immunization. Medical history included migraine, depression, anxiety, allergies, poly cystic ovary syndrome, asthma, different food allergy and sensitivity to all antibiotics. It was reported that 30 min post vaccination, patient started itching very bad and none of her allergy meds would calm it. Have experienced insomnia since the injection, followed by exhaustion. The itching decreases daily but even 10 hours post vaccination, patient's entire arm (not injection site) hurt horribly, unable to lift. She had headache for 4 days now. At times her face will feel tight. She added that she has allergies and sensitivity to many medications/ environmental/ scents. Outcome of events was recovering. No treatment was received due to events.  Follow-up attempts are completed. The following information on the batch/lot number has been obtained.
Red, itchy rash in area of injection site notice 9 days (2/19/2021) after vaccine injection.   Also mild headaches but not sure if they are related to injection.
I did not see a doctor the itching and soreness went away after about 4-5 days
Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m..  The following day she noted a low-grade fever.  On January 26 she noted edema of her eyes and lips associated with facial redness and itching that she treated with Benadryl intermittently for the past 2.5 weeks.  She was seen in follow-up by her dermatologist who suspected an inflammatory reaction and prescribed anti-itch facial cream.  She was also seen by her primary care who suspected angioedema and prescribed her an EpiPen which she has not needed to use.   Pfizer shot #2: 2nd shot delayed due to snow. Above sx resolved before shot #2. She had her 2nd COVID injection February 20 at 3:50 p.m. About 1.5-2 hours later she noted onset of itching to her eyes and nipples along with itching of the skin in the locations of her usual eczema.  She noted that her lips and eyes were a little puffy but less severe swelling to the eyes and lips than the 1st injection.  She took 2 Benadryl shortly after onset of these symptoms.  This seemed to lessen symptoms about 50%. Later she noticed that her voice sounded raspy and hoarse and she had a sensation of swelling to her tongue and throat but she was able to swallow.  Her throat felt scratchy.  She denies having lightheadedness, urticaria or GI symptoms. She went to the ED and was treated with benadryl, solumedrol and pepcid, monitored for a few hours and then discharged on 60 mg prednisone X 3 days and advised to continue benadryl 50 mg Q6h. She takes zyrtec 10 mg BID for seasonal/perennial allergies.   Allergy history: She has a history of both idiopathic urticaria in early childhood and idiopathic angioedema in her early 20's. States she had extensive testing but the cause was never exposed. Took high dose prednisone for 4-5 months, angioedema resolved spontaneously and then flared again a few months later. Finally resolved with n additional 3 months of prednisone. She has both seasonal (feb-may) and perennial allergies to cat and dust, asthma and allergy to ampicillin--rash in childhood, and humira--fevers.
Fever (102.4), headache, fatigue, neck pain, chills, body ache, sore arm at injection site.  Fever ,chills, neck pain gone after 24 hours. Fatigue, minor headache and sore arm ongoing
On 6/21/99, pt experienced headache and malaise. On 6/25/99, his headache worsened and he experienced a rash on his groin and ankle and a fever of 101 degrees. The fever ended on 6/29/99. On 6/30/99, he had heavy sweats and a stiff neck. On 7/1/99, his rash was present on his chest and leg. The groin rash was resolved. He had calf cramps. The pt was seen by physician several times and treated with Motrin, Excedrin, antibiotics, and anti-fungal lotion. He was dx with viral syndrome.
Vaccine administered 3/9-within a few days my son was making involuntary neck/shoulder movements. 2nd vaccination was on 5/27-started having involuntary jaw movements a few days later.
Stiff neck, headache, photophobia phonophobia, petechial rash local 2 cm red, warm area at injection site.
pt recv vax 12JAN98 & around 3PM that evening & the next day pt woke up Wednesday 14JAN97 w/fever & irritability;had fever all day 100-101;that evening @ 6PM had T101 & had sz;pt drowsy prior to sz;911 was called & pt taken to hosp;
This patient complained of pain in the left shoulder area. She was examined at the doctors office on 12/09/00 ( 2 month later) and found no physical signs of reaction nor disability (no swelling, no ecchymosis, no wasting, full range of motion intact, sensory and motor intact.) Expected re-examination on 03/09/01, but did not go.  Follow up: adverse event onset date/time is not clear.
Client received Pfizer # 1 @ 09:26  Hx of fainting w/ blood draws and injections in past but did not inform staff  Mother present at all times  Client had vasovagal episode with syncope within seconds of receiving vaccine  Was unresponsive for < 15 seconds.   Did not fall or slide off chair at vaccinator's table  Taken to EMS area for observation via W/C  BP/P 100/60, 60 lying, sitting and standing  Client felt back to normal within minutes of episode  EMS advised transport to hospital.  Mother declined.  Observed for 30 minutes in EMS area    Client and mother left EMS area independently @ 10:00
On December 14, 2014  the Flu and PNEUMOVAX shot were administered on the same arm (Left).  The same day the arm became swollen, and turned red and warm.  Patient had fever and a headache.
mom noticed a knot in child lt thigh;MD described it as subcutaneous nodule 2cm x 1.5cm;
No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 01-JUL-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA001345: US-009507513-2207USA004688: US-009507513-2207USA004690: US-009507513-2207USA004679: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
Tinnitus (bilateral) Date of onset:  2/27/2021; persists 3 weeks to present No treatment
Information has been received from a consumer concerning his 8 weeks old daughter who on 02-AUG-2011, was vaccinated with the first dose of ROTATEQ (dose and lot number not reported). "After receiving her first dose on 02-AUG-2011, the consumer stated that his daughter vomited. The patient did not seek medical attention. At the time of the report the outcome of the patient was unknown. No further information is available.
weakness; This is a spontaneous report from a contactable Other HCP. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Patients medical history included rheumatoid arthritis from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Patient reported blood work being just fine 2 months ago; however, an abdominal test finding showed white fatty liver and some bladder stones; missing 2-3 days of xeljanz due to running out of refills on her script (prescription) but also skipped one day of xeljanz for the first dose of the covid-19 vaccine; patient experienced weakness after the first dose and then experienced major headaches and body weakness after the second covid-19 (vaccine) dose. Patient was advised to notify MD. Patient underwent lab test for blood work, results: blood work being just fine 2 months ago; and an abdominal test finding showed white fatty liver and some bladder stones on an unspecified date. The outcome of event was unknown.   Information on the lot/batch number has been requested.
No additional AE's/Patient was asymptomatic; temperature excursion of a vaccine which was administered to a patient.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The reporter did not provide information about the patient's pertinent medical history, drug reactions, allergies, and concomitant medications.  On 19-APR-2021, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) which went through a temperature excursion of 12.5 degrees Celsius (C) for a timeframe of 24 minutes (product storage error), lot number S029455, expiration date 19-SEP-2021 (anatomical site of vaccination, route, dose, strength, scheme of vaccination, formulation were not reported), as prophylaxis. There was no previous temperature excursion, and a data logger did detect the temperature excursion.   No additional adverse event (AE), the reporter stated that the patient was (no adverse event).
pmhx of CKD3a, prostate cancer, asthma, HLP, essential HTN whom presents with the complaint of bilateral foot swelling and weight loss.  Upon arrival his HR was noted in the 160s, regular. ECG confirmed wide QRS complex tachycardia.  He has no CP, tightness. He has mild SOB but has asthma, used his inhalers today. He has no h/o CHF.  He has pedal edema x 1 month. No medication changes.  He is 15 months s/p radiation therapy for prostate cancer. Minimally symptomatic from joints - more concerning is possible extra-articular manifestations, namely DOE with cMRI demonstrating pericarditis with mild constriction (likewise without symptoms suggestive of acute pericarditis) and chronic cough with abnormal chest CT c/f RA-ILD vs more likely underlying chronic bronchitis. He also has persistent LEE with prior elevated BNP c/f HFpEF. In this setting, favor advancing immunosuppression. Would typically choose MTX but depending on pulmonary involvement - though this appears more chronic-  may favor RTX. Will discuss cMRI demonstrated pericarditis with cardiology - possibly related to RA - MTX would be reasonable treatment but pending inflammatory markers may start colchicine in the interval. Will need longitudinal follow up with cards of constriction and potential diuretic for LEE.
pain, redness, swelling up to neck site of TD inj; hard nodule underneath redness;
Patient received Zostavax vaccine on 2/11/15. One week later, patient states pain, itching, and blisters on left arm where the vaccine was adminstered. On 2/26/15 when the adverse event was discovered, patient states itching, tingling and postinflammatory reaction.
Reported by parent swelling and redness with fever of greater than 103 same day as the shot Redness over two thirds of upper arm. Some pain.
Pt exp febrile seizure on 24JUL91 lasting 5min;
POSITIVE COVID TEST 9/6/21. DRY COUGH FOR 10 DAYS PRIOR TO TEST