chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives on body, in various spots; itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives on body, in various spots) and PRURITUS (itching) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PRURITUS (itching). On 25-Feb-2021, the patient experienced URTICARIA (hives on body, in various spots). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) in February 2021 for Itching, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives on body, in various spots) had not resolved and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications included unspecified cholesterol medicines, blood pressure medicines and hormone replacement medicines.  Patient used unspecified cream on the spots as treatment.
[Casirivimab/Imdevimab] use for COVID-19 under Emergency Use Authorization (EUA): Patient received COVID 19 Vaccine less than 90 days from the casirivimab/imdevimab infusion. The patient received the infusion on 18 August 2021. The patient received the vaccine on 31 August 2021. The EUA states the patient must wait at least 90 days.
Wife had Covid-19, too.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Wife had Covid-19, too.) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Wife had Covid-19, too.). At the time of the report, COVID-19 (Wife had Covid-19, too.) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On unknown date, patient had received 2 doses of COVID-19 vaccine. Patient got COVID-19 within a month of husband. Patient COVID-19 was like a bad cold. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-715001 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715001:Husband case
Flu like symptoms, sore throat, headache, aches, pains through body, nauseated, stomach ache, diarrhea, area around injection was sore with a lump on it, chills
her hands started to shake; flu like symptoms; sense of smell and taste "went backwards"; sense of smell and taste "went backwards"; This is a spontaneous report from a contactable nurse.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EM9809) as dose 1, single for COVID-19 immunisation.  Medical history included COVID-19 on 15Jan2021 and 5 days later she lost her sense of smell and taste, in which a week ago, got it back.  The patient's concomitant medications were not reported.  The patient experienced after a half hour her hands started to shake, in which she took some deep breaths and got over that. She stated that she had flu like symptoms and took Tylenol and today is the best day she has had since receiving the vaccine. She reported that her sense of smell and taste "went backwards and it's not as keen." She asked, "Does this happen to people who have had Covid such as regression of senses in smell and taste? "When should I expect it to come back like before?" Caller asked who is stating that it is ok to receive the vaccine if you've had Covid. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
feeling sick; racing heart; chills went back and forth all day; really uncomfortable for hours; brain fog; stayed all day in bed; Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site), MALAISE (feeling sick), PALPITATIONS (racing heart), CHILLS (chills went back and forth all day) and DISCOMFORT (really uncomfortable for hours) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD since an unknown date. Concomitant products included FLUOXETINE and VITAMIN 15 for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). On 12-Mar-2021, the patient experienced MALAISE (feeling sick), PALPITATIONS (racing heart), CHILLS (chills went back and forth all day), DISCOMFORT (really uncomfortable for hours), FEELING ABNORMAL (brain fog) and FATIGUE (stayed all day in bed). At the time of the report, VACCINATION SITE PAIN (Sore arm at injection site), MALAISE (feeling sick), PALPITATIONS (racing heart), CHILLS (chills went back and forth all day), DISCOMFORT (really uncomfortable for hours), FEELING ABNORMAL (brain fog) and FATIGUE (stayed all day in bed) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient had to be picked up from school, she had involuntary muscle movements, numbness in her feet, fingers and legs. She also ends up with shortness of breath and she gets to the point u can not even touch her or move her. Her BP goes up n she sweats horribly. She has been home alot and missed alot of school of this. She was very healthy and loved to be with her friends, now shes staying home because this is taking over her life.
Client received shots at HD on 7/19/10 - client's mom noticed that her daughter's left leg was getting red on 7/21/10 where shots were given & she brought her into the HD on 7/21/10-child's left upper thigh had a red circle area 9 cm x 7 cm with a bruise in center, not swelling, not hot to touch-looks like a local reaction where Varicella and PREVNAR 13 was administered.
Weakness, fever, headache, pain in the body and loss of feeling in one leg, feeling faint.
On 12-15-22, 2 days after receiving the covid vaccine, started having nausea, vomiting, dizziness and vertigo.  She also had dehydration, orthostatic hypertention, fluctuating  b/p, episodes of passing out, constipation, reflux and a feeling of fullness.  She had multiple ER visits and hosptial stays. She developed gout.
Pt's mother called to report severe swelling/edema of legs which started about 2 weeks after 2nd moderna vaccine.
Patient's pediatrician called pharmacy on 1/7/10 asking about vaccine information patient was at doctor office complaints of muscle problems in arm after receiving vaccine. Doctor said arm shows signs of muscle atrophy (indentation of arm) starting approximately 2 weeks after vaccine occurring in same location.
Low grade fever, extreme fatigue and approximately 40 minutes of uncontrollably shaking.  Shaking was so hard the entire bed shook.
Patient stopped breathing about 7:00 AM 5/10/2006. CPR began by rescue personnel and continued in ER. Pt intubated and resuscitative effort continued for 45 minutes. Pronounced dead at 8:09 AM 5/10/2006. 6/30/06 Received ER medical records which reveal patient arrived febrile & in full arrest.  History of URI for approx 1 mon prior to death & wa co-sleeping with adult.  Resuscitation unsuccessful. 6/30/06 Received medical records from PCP with no new info. 7/18/06 Received autopsy report which stated COD as Sudden Death in infant cosleeping with adult/ss
heart problem; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 06Jun2021 (Batch/Lot number: unknown) as dose 2, single and administration date 30Apr2021 10:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications (blood thinner). The following information was reported: CARDIAC DISORDER (medically significant), outcome "unknown", described as "heart problem".  The patient (reporter) wanted to have a 3rd shot of Pfizer covid-19 vaccine. The first shot was on 30Apr2021 at 10:30 and the second shot was on 06Jun2021. Patient mentioned that she has a heart problem and blood thinner. Patient said she got a letter from Regulatory Authority for the 3rd shot and she wanted an ambulance to come because she didn't have a car.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain in Kidney-liver area; pain in Kidney-liver area and into right shoulder blade; pain in Kidney-liver area; This is a spontaneous report received from a contactable consumer (herself) reported that a 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: EN5318) via an unspecified route of administration in the right arm on 29Jan2021 17:15 at single dose for COVID-19 immunization. Medical history included Lymes, undiagnosed illness and CK levels doubled into the 550 level in November (unknown year). Concomitant medication was not reported. Patient was not pregnant at the time of vaccination. On 30Jan2021 07:00 patient experienced pain in Kidney-liver area and into right shoulder blade concern as her CK levels just doubled into the 550 level in November (unknown year). No treatment was received for the adverse events. Seriousness was reported as non-serious. Outcome of events was not recovered.  No follow-up attempts are possible. No further information was provided.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated orally with an unspecified number of doses of improperly stored Oral, ROTATEQ (lot # K009753, expiration date: 29-APR-2016, doses were not reported and lot # K013861, expiration date: 18-MAY-2016, doses were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Within a few days of second shot, my ears started ringing constantly.  Mostly the left ear. After 4 weeks, I have noticed a bit of trouble focusing my eyes.  I am not sure if it is related to the tinnitus or just an issue of my  monovision contacts.
Pt recvd 2nd dose Hep B vax 22MAR91 & exp fever 99.8 to 100.4, chills, achiness, n,v,d, & malaise; 2APR91 devel severe joint pain; 8APR91 lt shoulder & wrist pain w/rt shoulder & wrist & hand pain; BP dropped 80/60; Seen by MD; swell & red
Information has been received from an investigator concerning a patient who was enrolled in a study. On an unspecified date, the patient was vaccinated with a dose of PNEUMOVAX (manufacturer unknown). On an unknown date, the patient experienced erythema. The patient's outcome was unknown. The reporting investigator felt that erythema was related to study therapy. Erythema was considered to be an other important medical event. This report was part of a post-marketing surveillance program. No further information is available.
did not get her second dose; Lots of headache/I wake up with headaches; I have spasms in my back; Tightness in my chest/Lots of tightness; Numbness in my fingers; Pain in my arms and chest; Pain in my arms and chest; My body felt flushy and hot that lasted 2- 3 days; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (I have spasms in my back), CHEST DISCOMFORT (Tightness in my chest/Lots of tightness), HYPOAESTHESIA (Numbness in my fingers), PAIN IN EXTREMITY (Pain in my arms and chest) and CHEST PAIN (Pain in my arms and chest) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced MUSCLE SPASMS (I have spasms in my back), CHEST DISCOMFORT (Tightness in my chest/Lots of tightness), HYPOAESTHESIA (Numbness in my fingers), PAIN IN EXTREMITY (Pain in my arms and chest), CHEST PAIN (Pain in my arms and chest), HOT FLUSH (My body felt flushy and hot that lasted 2- 3 days) and HEADACHE (Lots of headache/I wake up with headaches). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get her second dose ). The patient was treated with METOPROLOL for Adverse reaction, at a dose of 1 DF twice a day. At the time of the report, MUSCLE SPASMS (I have spasms in my back), CHEST DISCOMFORT (Tightness in my chest/Lots of tightness), HYPOAESTHESIA (Numbness in my fingers), PAIN IN EXTREMITY (Pain in my arms and chest), CHEST PAIN (Pain in my arms and chest), HOT FLUSH (My body felt flushy and hot that lasted 2- 3 days) and HEADACHE (Lots of headache/I wake up with headaches) had not resolved and PRODUCT DOSE OMISSION ISSUE (did not get her second dose ) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) everything seemed fine.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medication of the patient was not reported.  The patient did not know if she had fever. The patient had different issues every day and was still experiencing all side effects.  The patient did not get her second dose because she was referred to her cardiologist who gave her medicine that did not work. Mother of the patient died with COVID in December and all of her family members tested positive for COVID, only her had not.
BNT162B2 on 25Jan2021; Right armpit, got swollen and hard; Right armpit, got swollen and hard; This is a spontaneous report from a contactable healthcare professional (patient) via a Pfizer-sponsored program. This female patient of unspecified age received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 on 08Jan2021 for COVID-19 immunization. The patient reported after getting the second dose yesterday (as of 26Jan2021), her right armpit got swollen and hard. The clinical outcomes of her right armpit got swollen and hard, and BNT162B2 on 25Jan2021 were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
pt devel an inj site rxn characterized by redness & induration, following vax;
April 18- severe headaches, abd pain April 21- fingers turning white in both hands, going completely numb and tingling  April 24- some fingers turning white and purple, cap refill sluggish longer than 5 secs May 1- whole hand turning white and numb May 2- hand and fingers taking longer to return to normal
Given IPV #3 , Prevnat #2 on 04/30/02. Next day right thigh SQ injection site became red, hard, tender, warm to touch. Induration appeared 2 inches in diameter on 05/02/02
When I first got the 2nd dose, my arm had a burning and tingling sensation that was very staring and lasted for a week. After that, I am still experiencing periodic intense burning and slight tingling except now it?s in both arms and hands. It can last for long periods of time (hours) and is typically from about the elbow down to my fingers. This is very hard to deal with and I am not sure what to do about it!
This case was reported by a physician to a sales rep and described the occurrence of swollen lymph node in an infant of unspecified gender between four and six months of age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On an unspecified date on or before 24Oct05, the subject received a dose of Infanrix (dose number and lot number not provided). At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 24Oct05, the subject experienced severe swollen lymph nodes that were hot to touch. The subject was seen in an ER. The outcome of the events were not reported.
Patient was inadverdently given the Pfizer vaccine (0.3ML) instead of the Moderna vaccine, due to human error. Patient consulted via phone call to determine outcome and next steps.   Patient had some swelling in mouth, trouble swallowing for 1-2 days. Feeling very "under the weather" and flu-like today. Symptoms consistent with other patients having received a second dose of a Covid-19 mRNA vaccine. Patient is improving daily.   Patient advised per CDC guidelines that vaccine series is complete, and he is fully vaccinated.
Headache, Arthralgia, Fever, Localized pain; chills, fatigue Narrative:  Other Relevant History:
This spontaneous report as received from a vaccine coordinator refers to a 13-month-old male patient. The patient's medical history was not reported. On 03-JAN-2018, the patient was vaccinated with improperly stored PROQUAD therapy type RHA, lot # N023001, expiration date 19-FEB-2019 or lot # N019249, expiration date 20-DEC-2018 for prophylaxis (dose, route and site of administration were not reported). The vaccine underwent a temperature excursion of 20 degrees Fahrenheit for 1 hour and 42 minutes. Other temperature excursions were: 6 degrees Fahrenheit for 48 minutes, 18 degrees Fahrenheit for 1 hour and 5 minutes and 8 degrees Fahrenheit for 1 minute. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. VARIVAX lot # N021315, expiration date 07-AUG-2019. Sender's Comments: US-009507513-1802USA005174: US-009507513-1802USA005175: US-009507513-1802USA005176: US-009507513-1802USA005177: US-009507513-1802USA005178: US-009507513-1802USA005179.
3 days of very bad headache; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (BIONTECH COVID-19 VACCINE lot number and expiry date not reported), via an unspecified route of administration in left arm, on 09Jan2021 19:00, at single dose, for COVID-19 immunization. Medical history included food allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines in four weeks. The patient experienced 3 days of very bad headache on 10Jan2021 at 08:00. No treatment was received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
"Light Sunburn on neck and back , chest and legs type rash-generalize light red rash skin felt like burning-itching.
arm is swollen; sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced swelling arm (Verbatim: arm is swollen) and pain in arm (Verbatim: sore arm). The outcome of the swelling arm and pain in arm were not reported.   It was unknown if the reporter considered the swelling arm and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the swelling arm and pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 01-JUL-2023 This case was reported by a patient via interactive digital media. It was reported that three days after getting second Shingles shot, patient experienced swollen and sore arm. The follow-up could not be possible as no contact details were available.
PATIENT HAD MODERNA BOOSTER DOSE 11/26/21 AND REPORTS HAVING CARDIAC ISSUES STARTING 12/2/21 DESCRIBED AS HEART "BANGS" INSTEAD OF HEART BEATS, HEART "BANGING AROUND" IN CHEST "POUNDING" STEADILY BUT FORCEFULLY UNTIL 12/17/21 AND COMPLETELY RESOLVED END OF DAY 12/18/21. SHE SPOKE TO HER DOCTOR AND DOCTOR SURMISES COULD POSSIBLY HAVE BEEN RELATED TO VACCINE / MYOCARDITIS / CARDIAC ISSUES AND TO REPORT TO PHARMACY TO REPORT TO VAERS. PATIENT HAD A FLU SHOT ON THE SAME DAY AS MODERNA BOOSTER.
Redness, warm at injection site. Area measured at 2 inches x 2 inches (at 6pm 11/11/16). Patient took BENADRYL before she got to pharmacy today.
Information has been received from a consumer concerning her son who was vaccinated with MMR II. Subsequently the patient experienced severe asthma. At the time of the report the outcome of the patient was unknown. It was unknown it the patient sought medical attention. The patient's brother also had an adverse event after vaccination with MMR II (WAES # 0902USA01522). No further information is available.
sore arm, muscle pain, headache, shivering, stomach pain, nausea, dizziness and see flashes when eyes were closed for a few hours.
Near Syncope, felt dizzy and lightheaded after Menactra given at mass vaccination clinic. States he passes out with needle procedures ie vaccines and blood draws.
pt recvd vax 29AUG94 & devel nighttime crying spells lasting as long as 3 hrs, inconsolable, changing in feeding behavior, taking only a couple of ounces @ a time; had not fever; nl bowel movements; no emesis; afebrile;
burning of left ear; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (burning of left ear) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced EAR DISCOMFORT (burning of left ear). At the time of the report, EAR DISCOMFORT (burning of left ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included vitamins and OTC allergy medications. Treatment information was not provided.   This case was linked to MOD-2021-116615 (Patient Link).