chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First, when the vaccine was administered, it felt like hot liquid going into my left arm and then my left arm down to my elbow felt on fire.  Around 4:45 I began to have chills, and when I arrived home about 5:15 I was shivering and freezing and full of body aches.  During the night I developed a fever of 103.7, 103.5.  My husband woke me to help cool me down with cool cloths and water.  My fever went down to 102 by morning and I still had body aches but not as bad.  I was lethargic and mentally fuzzy for a few days.  I did not feel well until Wednesday, March 24, 2021.
After I got the vaccine, on July, I woke up with cough, sore throat, chills, it lasted for two days. On Monday, I had the COVID-19 home test and it was positive. I called the doctor and she prescribed medicine, the next day I felt better.
developed significant erythema and pruritis just distal to injection site 8 days after vaccination, required one application of hydrocortisone cream to control symptoms for 2 days, then flared and used once more. I am now 15 days post vaccination and fine except skin is still rough with small scabs from prior pruritis/scratching. I have photo of original problem if helpful.
Not clear which of the two vaccines is giving me the side effects, though, my suspicion lies more with the Shingrix than with the Pneumo.   Side effects became more pronounced about six hours after administration. They have included fatigue. some lethargy, and body aches, that started in my arms, radiated to the remainder of my upper torso, then quickly spread throughout my entire body.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 19-NOV-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokw Tip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.77777778 Celsius) for 408 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No concomitant therapies not adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Itchy; red sore/pink; IM injection given SC; site soon became tender; pocket of fluid; warm; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (pocket of fluid), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (Itchy), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (IM injection given SC) and VACCINATION SITE PAIN (site soon became tender) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, DENOSUMAB (PROLIA) for Osteoporosis, HYDROCHLOROTHIAZIDE for Renal disease.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced BLISTER (pocket of fluid), VACCINATION SITE WARMTH (warm), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (IM injection given SC) and VACCINATION SITE PAIN (site soon became tender). On 07-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (red sore/pink). On 06-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (IM injection given SC) had resolved. At the time of the report, BLISTER (pocket of fluid), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (site soon became tender) and VACCINATION SITE ERYTHEMA (red sore/pink) had resolved.            Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Approx. 3 minutes after receiving vaccinations, patient had a syncopal event that was witnessed by me (the provider). The patient was OK initially after receiving the vaccine, was moving arms around as directed, and was given a lollipop to eat. Without warning, the patient lost consciousness and fell from the exam table where he was sitting. He was unconscious for approx. 30 seconds before an ammonia packet was opened, waved under the patient's nose, and he regained consciousness. 9-1-1 was called since patient hit his head when he fell off of the table. EMTs recommended that patient go to ED for a CT scan. Per coworker who worked the next day, the patient's mother returned and advised that the patient was fine. 1 additional attempt was made to follow up with the patient from this office on 4/17/19 without a returned phone call.
Patient developed intussusception symptoms 7/17/18. Diagnosed on 7/20/18 at one location; transferred to MC another location; she required ileocecectomy-still currently hospitalized.
fatigue; headache; body aches; mild nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 73-year-old patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Oct2023, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset Oct2023, outcome "unknown"; HEADACHE (non-serious) with onset Oct2023, outcome "unknown"; NAUSEA (non-serious) with onset Oct2023, outcome "unknown", described as "mild nausea". The events "fatigue", "headache", "body aches" and "mild nausea" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, headache, pain, nausea. Additional information: Visited doctor on 24Oct2023. Doctor told to treat the symptoms. Patient was taking aspirin.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Arm swollen; Sore arm; Very Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Sore arm) and SOMNOLENCE (Very Sleepy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Sore arm) and SOMNOLENCE (Very Sleepy). At the time of the report, PERIPHERAL SWELLING (Arm swollen) and PAIN IN EXTREMITY (Sore arm) had resolved and SOMNOLENCE (Very Sleepy) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-073940 (Patient Link).
Information has been received from a registered pharmacist concerning an "over 65 year" old female patient who on 04-MAR-2009 was vaccinated with ZOSTAVAX (Merck) SQ. On 06-MAR-2009 the patient developed a shingles like rash. The patient "was convinced that she had gotten the shingles like rash from the vaccine". The patient had sought unspecified medical attention. The patient's shingles like rash improved after stopping therapy. Additional information has been requested.
administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported as unknown when the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: The recent follow-up received on 08-JUN-2022 contains non significant information.
Patient was seen in hospital after receiving 2nd Moderna vaccine at 8am on 1/21/2021.  He developed  left sided chest pain a few hours earlier.  Presented to hospital next day with multiple bilateral pulmonary emboli
?covid? arm, red circle, about 1.5 inches in diameter, hard, sensitive to touch, warm to touch.
chest pains. went to get x-rays and ECG scan and was told that the doctor assumes that there is inflammation around my chest by my heart.
p/vax pt devel fever;sweating;h/a;sinus discharge; nocturnal leg cramps; imbalance & dizziness;
Patient had fever about 6 hours after vaccination. Patient fever reached 101 degrees, he was given Motrin. Temperature was 104.2 degrees 30 hours after vaccination, also had watery glassy eyes.
Patient had previously received the Pfizer vaccine on 6/7/2021.  This violates the EUA for both vaccine parameters.
little bloodshot/spots; This is a spontaneous report from a contactable consumer. A female patient (wife) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced little bloodshot on 01Aug2021. The consumer reported that his wife received the vaccine on 01Aug2021 and has since then broke out and it has not went away. He was in fear for his wife these were not like hives but look like little bloodshot, his wife has already went to urgent care and they prescribed her a steroid and told her to get Claritin, this only made the spots fade but not go away, And at time of reporting that the steroid was finished the spots were back and slowly spreading. This all started the day she took the vaccine. The outcome of the event was not resolved.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Intense hot flashes.    The number of hot flashes I was getting reduced when I began my Levothyroxine medication.   They were drastically reduced for 4 months.   After my first shot they started three days later.  They were more frequent and more intense.   After my second shot,  two days later,  the frequency increased tremendously along with the intensity.    I immediately sweat.   I have close to 10 -15 a day now.     My period also leveled out after my medication.  My last period came two days after my first shot and it was 7 days long and light.    I am now 13 days late.  I am not pregnant.  I have one ovary and no tubes.
Terrible ringing in her right ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Terrible ringing in her right ear) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-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 TINNITUS (Terrible ringing in her right ear). At the time of the report, TINNITUS (Terrible ringing in her right ear) outcome was unknown.            Treatment medication was  not reported. Relevant concomitant medications were not reported.   Reporter did not allow further contact
pain radiating from the injection site to her chest; pain radiating from the injection site to her chest; rapid heart rate; blurred vision in the eye on the side of the injection; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A 7 decade female patient (reported as "approximately mid-60's") received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on 07Apr2021, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 12Apr2021 she experienced pain radiating from the injection site to her chest, rapid heart rate, and blurred vision in the eye on the side of the injection. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1 week after, my arm suddenly had a rash at the site, and sore again. 2 weeks after, my feet and ankles have started to swell.
Hospitalized for failure to thrive He was hospitalized elsewhere in late Jan for COVID 19.
neurologic side effect; This spontaneous case was reported by a patient and describes the occurrence of NERVOUS SYSTEM DISORDER (neurologic side effect) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Head injury.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (neurologic side effect). At the time of the report, NERVOUS SYSTEM DISORDER (neurologic side effect) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Height: Somewhere between 5feet 5 inches and 5feet 6 inches. Ethnicity was reported. Concomitant medications details were not reported by the reporter. Reporter began to clarify neurologic side effects after getting the Pfizer Covid-19 Bivalent 12 year plus vaccine. She had serious neck pain. The serious neck pain was so painful she had to use two pillows to sleep on to elevate her head. The pain was all around her entire neck; the pain was so bad. This started within the week of getting the vaccine. Reportedly, patient wondered and believed that she was having side effects from mixing both Modena and Pfizer vaccines.  Treatment details were not reported by the reporter.
severe flu sx in pain throughout whole body; fever, did not eat for 2 days; slept most of 2 days-still tired; did not see MD;
passed out for 15 minutes; Felt woozy; felt so overheated; Felt feverish; felt extraordinarily tired; extreme chills; extraordinarily nauseous; A spontaneous report was received from a physician concerning their patient, 66 years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed passed out for 15 minutes/loss of consciousness, felt woozy/dizziness, felt feverish/pyrexia, felt extraordinarily tired/fatigue, extreme chills/chills, extraordinarily nauseous/nausea, felt so overheated/feeling hot.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Vitamin D NOS, levothyroxine.    The patient received the first of two planned doses of mRNA-1273 (Batch number: 014M20A) on 25 Feb 2021 intramuscularly at her left non-dominant deltoid for prophylaxis of COVID-19 infection.    On 26 Feb 2021 the patient experienced noticeably sick, felt woozy and felt not quite there. By the evening of  26 Feb 2021, she felt feverish and extraordinarily tired. She got extreme chills later that night. She discloses that she normal does react to other vaccines such as the flu vaccine. The strangest side effect that happened to her was that she woke up in the middle of the night and felt ill and extraordinarily nauseous. She went to the bathroom and felt so overheated that she passed out and woke up on the floor (15minutes). Treatment of the events was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The event passed out for 15 minutes was considered resolved.The outcome of the events felt woozy, felt feverish, felt extraordinarily tired, extreme chills, extraordinarily nauseous, felt so overheated was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Aprox.  two hours after vaccine I had one small blister show up on the palm of my left hand. Later that day it was three blisters and over the next several  days turned into a cluster of blisters. After conversations with PCP and vaccine administration site, I got an appointment with new PCP on May 7, 2021 where he said the blisters were consistent with herpetic vesicles and I was treated with acyclovir which dried up the blisters.  On May 18, 2021 I had my second Covid vaccine at the same facility as the first vaccine. (Pfizer  ER8727). The blisters returned the next day (May 19, 2021). I contacted Dr via email message and he gave me another 7 day round of acyclovir. The blisters dried up almost completely. On aprox. June 3, 2021 I had 3 or 4 blisters and by June 4, 2021 I had multiple blisters covering an area. Went back to Dr on June 7, 2021 where he referred me to a Dermatologist. That appointment is scheduled for June 23, 2021
Pt was vaccinated at outside facility on 11/1/2022. He is a student at the school where the public health clinic is located however he had never been seen at the clinic before. He presented to the clinic with moderate-severe urticarial erythematous and pruritic rash that started last night. Per pt and his mom he was given the flu and COVID vaccine at the same time. Mom denies known history of immunization reaction however youth was adopted by mom at age 5. Previous history unknown. He has had known flu and COVID shots prior to the onces given yesterday with no reaction.
hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss) in an adult 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 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 ALOPECIA (hair loss). At the time of the report, ALOPECIA (hair loss) outcome was unknown.            No concomitant product use was reported.  The patient received an additional booster dose.  The patient stated that the peoples on the internet are saying they got hair loss from taking the Moderna. Patient stated it could have been the first vaccine or any of them.  No treatment information was provided.
Approximately 10-14 days after vaccination I experienced brain tremors and extreme dizziness, problems walking(I would drift to the right) loss of appetite, night sweats, loss of weight (10 lbs in one month) brain fog, memory loss. One year later and I am still seeking medical help for my symptoms.
Left shoulder and arm soreness. Pain with ROM persistent after 1 week. Advised trial of Tylenol or Advil. Call if sx don't resolve.
Information has been received from a physician concerning a female (age unreported) who was vaccinated with a dose of GARDASIL vaccine (yeast), lot number not reported. Within five minutes the patient passed out for an extended period of time, hit her head on the wall and went to the emergency room. This is one of 2 reports from the same source. Additional information has been requested.
A patient received and expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from nurse via Regulatory authority (Reference number- 00640469) and transmitted to Sanofi on 14-Jun-2021.  This case involves a one-year-old female patient who received and expired 0.5 mL dose of 1st dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ320AAB and expiry date: 13-Jun-2021) via an intramuscular route in the left thigh for prophylactic vaccination on 14-Jun-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) for prophylactic vaccination.  The nurse wanted to know that the vaccine it still viable or not and another shot should be given or not to the patient.  This was a case of actual medication error due to Expired vaccine used (latency same day).  At the time of reporting, no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I had an EKG a few months prior to my first vaccination and it came out normal.  I had to have surgery in June 2021 and my EKG came out abnormal three times at two different locations.
01/12/2021 reported redness in face, neck, stomach, and minimal on arms. Swelling on eyelids, slightly nauseated. Instructed by employee health to take Benadryl STAT and report to ED for worsening symptoms. 01/13/2021 Pt reports symptoms are no longer present and has no complaints.
I waited for 15 minutes in the waiting area as instructed and I felt okay to leave. Exactly 2 minutes after I left the parking lot, I lost consciousness and crashed into a large truck in an intersection.
mom reported that 4 hrs p/inject pt had episode of going limp, pale, cool & unresponsive lasting 2 mins; very hot; mom gave APAP