chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives further down the injected arm and wrist area.; hives 6 hours after the first dose; . This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE URTICARIA (hives further down the injected arm and wrist area.) and URTICARIA (hives 6 hours after the first dose) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE URTICARIA (hives further down the injected arm and wrist area.) and URTICARIA (hives 6 hours after the first dose). At the time of the report, VACCINATION SITE URTICARIA (hives further down the injected arm and wrist area.) and URTICARIA (hives 6 hours after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications reported. no treatment medications reported.
Pt recvd 3 doses of Engerix-B & demonstrated lack of seroconversion; A 4th or booster dose has been made available to pt;
Information has been received from a nurse concerning a 15 year old male who in approximately 2002 was vaccinated with varicella virus vaccine live (Oka/Merck). In approximately 2002 when the patient was 10 years old, he developed chickenpox but the rash resolved two and a half weeks later. Medical attention was sought. The reporter did not know that exact date. No product quality complaint was involved. Additional information has been requested.
p/vax pt started scratching face, arms & neck;mom brought child back for nurses to see rash, hive like rash, reddened & sl swollen note on face, neck, upper chest & arms;child scratching badly;no diff breathing;
Initial: Headache; Neckache; Complete Loss of muscle use; Generalized Pain; Incontinence; Numbness in hands and feet Midway: Developed PRES; Became Paralytic; Developed tachycardia; Developed Very High BP; Very High Sugar Levels; Intolerable Pain to which no Oxycodone could remedy; worsening numbness and burning pain in arms, hands, legs, and feet; Hallucinations; Confusion & slurred speech; memory loss; angle perception; Numbness in abdomen.  End of Third week: symptoms begin to subside.
MODERNA: Point of injection is now red with a 5 inch by 2 inch welt, similar to the reaction I have gotten from a honey bee sting, that i treated with epipen.
14 y/o M patient brought to clinic by mother for Covid 19 booster.  Mother presented pt's CDC vaccine card with 2 doses of Pfizer from Sept 2021 written on it.  Pt received dose of purple cap 12&up pfizer today.  Upon entering vaccine into Pt's module in EMR, it was noted pt already had a booster in April 2021.   Mother was unaware of this April 2021 booster because father had brought the patient in without notifying mother. Mother was educated on s/s of myocarditis and advised to bring pt in for signs of illness/infection.
Day 1 headache and sore arm. Day 2 intermittent weakness in both legs and cramps in the calves. Day 3 gradual withdrawal of reactions.  Early am Day 4 , while sleeping stabbing pain in liver and gallbladder area (under right rib).  Pain came on 5-10 minute intervals for 4 hours.  Day 4 was at a hotel in another city. Pain was gone by Day 5.  Neck was sore throughout the 5 days post vaccine.
Back pain worse on moving; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Back pain worse on moving) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     Concurrent medical conditions included Back pain since May 2021.    On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced PAIN (Back pain worse on moving). The patient was treated with PREDNISONE for Back pain, at a dose of 1 dosage form; CYCLOBENZAPRINE for Back pain, at a dose of 1 dosage form; PARACETAMOL (TYLENOL) ongoing since an unknown date for Back pain, at a dose of 1 dosage form and LIDOCAINE ongoing since an unknown date for Back pain, at a dose of 1 dosage form. At the time of the report, PAIN (Back pain worse on moving) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.   It was reported that patient has another appointment on 15-Jun-2021 with his doctor and is scheduled for an x-ray.
This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported. Administered vaccines experienced a temperature of -4.4 degrees Celsius for undetermined time. There was no previous temperature of excursion. Data logger was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA007967.
diagnosed with stage 4 plus ovarian cancer in December 2018; This case was reported by a consumer via call center representative and described the occurrence of ovarian cancer in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2018, the patient received the 1st dose of Shingrix. In December 2018, between 2 and 4 months after receiving Shingrix, the patient experienced ovarian cancer (serious criteria GSK medically significant). The patient was treated with fluvastatin sodium (Vastin) and chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the ovarian cancer was not recovered/not resolved.   It was unknown if the reporter considered the ovarian cancer to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The reporter stated that his wife received first dose of Shingrix in September 2018 and was diagnosed with stage 4 plus ovarian cancer in December 2018. Second dose Shingrix was not yet received.  The patient underwent surgery and chemotherapy due to ovarian cancer. Currently, patient had been taking Vastin for over one year, and this drug inhibits future growth of tumors.
I am very weak and stillhave some nausea and abdominaldiscomfort.; I am very weak and stillhave some nausea and abdominaldiscomfort.; I am very weak and stillhave some nausea and abdominaldiscomfort.; Upon waking the next morning,I had a fever of 101.8, very badheadache and body aches. My feverwas as high as 103 and continued fora total of approximately 60 hours.; I started to feel unwell; My first symptoms were headache and bodyaches along with diarrhea.; My firstsymptoms were headache and bodyaches along with diarrhea.; My first symptoms were headache and bodyaches along with diarrhea.; I did not sleep well that night and woke severaltimes.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E P 6955) via an unspecified route of administration in the right arm on 25Mar2021 at 09:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included recent emergency appendectomy on 19Feb2021 and meningioma. Concomitant medications received within 2 weeks of vaccination included escitalopram oxalate (LEXAPRO), mirtazapine (REMERON) and alprazolam (XANAX). Allergies to medications included penicillin and quinolones (quinolones caused throat tightness). The patient did not get any other vaccines within 4 weeks of COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E N 6206) via an unspecified route of administration in the right arm on 04Mar2021 at 08:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 25Mar2021, at 17:00, 8 hours after vaccination, the patient experienced feeling unwell, headache, body ache and diarrhoea. The diarrhoea was constant with 10 to 15 bouts a day, lasting for 72 hours. On the same day, she experienced sleep unwell that night and woke several times. On 26Mar2021, the patient experienced fever of 101.8 and later her fever was as high as 103 and continued for a total of approximately 60 hours. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for fever included extra strength tylenol, 1000 mg, every 6 hours and for diarrhoea included pepto bismol. The clinical outcome of the events feeling unwell, headache, body ache, diarrhoea, sleep unwell, fever, weakness, nausea and abdominal discomfort was resolving.  No follow-up attempts are needed. No further information is expected.
Next morning  after shot my Chest or lungs  felt very  impacted.  Hurts to breath in.  Similar feeling  to when you have bronchitis.  Been feeling this for 5 days
Pt presented day after shot admin with a small bruise at area of injection (on lower half of left deltoid). Below this bruise was a large, red rash that extended down to the patient's elbow. Upon physical exam this rash had significant heat. Pt stated it also had a slight itch. Recommended to patient that she go home and take Benadryl and call the next day. She did so and stated the rash had reduced. Spoke with patient today (9/18) and she stated the rash had completely dissipated.
Arm sore first day next day 5pm quarter size rash spots around injection site, felt slight S.O.B- To seem + given Prednisone 10mg x 3 + Cortisone cream at site doing fine subsided no compilations.
Tested COVID positive; Tested COVID positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 included: "Chemotherapy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Tested COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was taking 4th dose of the antiviral regimen and was amazed at how quickly she started improving after starting that medicine. she then noticed Pfizer was the brand.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Systemic: patient reported difficulty breathing and numbing of legs and arm. Severity unknown.s-Medium, Additional Details: Patient called and reported having difficulty breathing and legs and hands feeling numb. Severity Unknown.
Patient stated she had shortness of breath, syncope and weakness in extremities during the night.  Pt called us the next afternoon with mild syncope and weakness in extremities. Pt stated she felt better than last night.  Pt was advised not to drive due to syncope and to seek medical care immediately.
Enlarged lymphnodes, extreme fatigue. 36 years after polio vaccines. Groin mass right, biopsy performed. 4/25/96 results: follicular mixed small navel large cleared non Hodgkin's lymphoma. Cytoxyn, Nitoicristone, Thydurtme, Rituprn.
A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  There was no adverse event associated with this medication error;  therefore;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information was received on 24-Nov-2008 that included the following:  demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Was alarmed by sensations that I would lose consciousness as I was lying on the couch watching a movie with my kids. Used a pulse oximeter and heart rate was dipping into 50's during the sensation.  Intestinal spasms started and was followed by diarrhea.  I decided to go to sleep.  The next morning woke fine, then was seated doing some computer work and the sensation started again, accompanied by sharp, stabbing chest pain, again intestinal spasms and diarrhea.  Pulse rate was again dipping.  I went to urgent care, had an EKG, they felt it was slow so sent me to the ED.  Had another EKG and some monitoring.  Chest pain continued, and sensation that I would lose consciousness continued into the following day. The only diagnoses was Vasovagal presyncope.
visual problems/had visual changes like the color; migraines; severe headache; This spontaneous case was reported by an other health care professional and describes the occurrence of VISUAL IMPAIRMENT (visual problems/had visual changes like the color), MIGRAINE (migraines) and HEADACHE (severe headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, lot 010M21A ) on 03-Feb-2021, Moderna COVID-19 Vaccine (Dose 2, lot 013A21A ) on 03-Mar-2021, Moderna COVID-19 Vaccine (first booster and lot 033F21A ) on 10-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concomitant products included ELASOMERAN (MODERNA COVID-19 VACCINE) from 06-Oct-2022 to an unknown date for COVID-19 prophylaxis.    On 27-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2022, the patient experienced VISUAL IMPAIRMENT (visual problems/had visual changes like the color), MIGRAINE (migraines) and HEADACHE (severe headache). At the time of the report, VISUAL IMPAIRMENT (visual problems/had visual changes like the color), MIGRAINE (migraines) and HEADACHE (severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: She had tests done, but everything came back normal..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took second Moderna booster on 27May2022.  Moderna bivalent booster on 6Oct2022. Patient had some visual problems. She had the shot about 3 o'clock. That evening she had visual changes, like the color. She went to see the eye doctor. She wasn't sure if it was related to the vaccine because she also took the bivalent and she was fine. The patient also did not have any problems with any of her previous 3 Moderna shots.  Treatment drug was not reported.
I started having right foot pain in 6 hours after second vaccine. I was treated with steroids and continued having pain. Over a 6-week period, pain continued and moved into calf. I had a venous ultrasound on fourth doctor visit. I continued having pain. My foot was numb, so an arterial ultrasound was done on the 5th doctor visit. I was referred to a hospital.  The doctor was unable to remove blood clot. I had to have an amputation in August.
Information has been received from a physician's assistant concerning an 18 to 25 year old female patient who in 2007 was vaccinated the first 0.5 ml dose of with GARDASIL in 0, 2, 6 months. In 2008 she completed the series of GARDASIL injections. In 2008 subsequently the patient had problems with "ASCUTS" and tested positive for HPV. It was unknown if the patient sought medical attention. At the time of report the patient's status was unknown. Follow up information has been received from the physician's assistant (PA) concerning the female patient who had a normal PAP in fall of 2009 (in approximately September 2009). The patient received the first, second and third doses of GARDASIL from 2009 to 2010 (conflicting dates from initial information). The patient had her next PAP test in the "fall" of 2010 which showed ASCUS (+) HPV. There were no new partners but she was sexually active. She likely already had HPV and it was not detected on the original PAP or she contacted it in the middle of the vaccination course. Additional information has been requested.
Flu shot was administered in the glut. Wrong administration site (e.g. gluteus maximus rather than the deltoid).
Pt recv vax on 10/22/98; on 10/23/98 pt exp redness & hotness of vax site; tx=antibiotics
This is a spontaneous report from a non-contactable consumer.   A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Left Arm on 17Apr2021 09:15 (Batch/Lot Number: EW0169) as 1ST DOSE, SINGLE (at the age of 29 years) for covid-19 immunisation.  Medical history included gastritis from an unknown date and unknown if ongoing and covid-19 from an unknown date and unknown if ongoing.     The patient's concomitant medications were not reported.  The patient experienced hemorrhages for more than 1 month on 19Apr2021 with outcome of not recovered, allergies throughout the whole body on 19Apr2021 with outcome of not recovered, body pain on 19Apr2021 with outcome of not recovered, bad breathing on 19Apr2021 with outcome of not recovered and fever at night on 19Apr2021 with outcome of not recovered.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID 19 since the vaccination.    No follow-up attempts are possible. No further information is expected.
Felt numbness in the tongue as well as taste of anesthetic for 5 days.  Had 3 minutes after the injection redness of the face and chest.  Had  bodyaches 7 days after and persisting since that time for now nearly 2 months.
Pretty sick; Felt bad after the shot; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, refer case US2021AMR266214).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and feeling bad. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the sickness and feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and felt pretty sick for a day or so and felt bad after the shot. The patient thought that he/she was the only one who felt bad after the shot but since then many of his/her friends had the same reaction. The patient stated that one should still get the vaccine but they should tell them that there were side effects for some people. The patient stated that the shingles would be worse than the reaction from the vaccine. The follow-up would not possible as no contact details were available. This case has been linked with cases US2021AMR266217 and US2021AMR266243, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR266214:Same reporter. US-GLAXOSMITHKLINE-US2021AMR266217:Same reporter. US-GLAXOSMITHKLINE-US2021AMR266243:Same reporter.
Chills; Diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills) and DIARRHOEA (Diarrhea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced CHILLS (Chills) and DIARRHOEA (Diarrhea). At the time of the report, CHILLS (Chills) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported.
I was 5 weeks 2 days pregnant when I recieved the vaccine, at 11 weeks 4 days pregnant I was informed the baby had died sometime in the 9th week. During the ultrasound the doctor informed us that the baby had some malformations.
shingles; flu like Symptoms; shingle rash; This is a spontaneous report from a contactable consumer (patient).  A 76-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6205), via an unspecified route of administration, in Left Arm on 03Mar2021 as a 2nd dose, single dose for COVID-19 immunisation. The patient's Medical history reported as None. The patient's concomitant medications were not reported. Patient had not COVID prior vaccination and not tested COVID post vaccination. No known allergies reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EM9809), via an unspecified route of administration, in Arm Left on 10Feb2021 as a single dose for covid-19 immunisation. On 04Mar2021 at 10:00 AM, the patient experienced shingles, flu like symptoms, shingle rash. Reported that patient was diagnosed with shingles 5 days after receiving COVID vaccine. Had flu like Symptoms 20 hours after receiving 2nd dose. Had shingle rash 3days after receiving 2nd dose of vaccine. Still have shingle rash. The patient stated that please contact me as I have several questions. Reported that patient visited doctor or other healthcare professional office/clinic after AE. Patient had not received treatment for events. Explicit consent was yes. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.