chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7 to 10 days afterwards I woke up, my legs started to itch. Before I realized I started itching other places. It started to change a lot more throughout the day. Before the day was over, I had big welled rash and hives on my chins, legs, underneath my breasts and armpits, on my breast, and everywhere. I scratched them so bad they started to bleed. I called the doctor and told them and asked them what to do. They told me to take Benadryl and stuff like that but it was not working. I did go to the doctor and they gave me a steroid shot and it did not help. I asked the doctor if there was a cream or anything that could help me. He sent me to the dermatologist. He was the one who finally gave me a steroid cream and helped with the itching. It took 3 weeks for the itching to go away. They did take a sample of my skin and they were going to provide me the results but I did not want to hear about that because it was already gone. I know it was from the vaccine because I do not have any allergies and I did not do anything differently.
Dizziness / Very dizzy after 36 hours of receiving vaccine; This is a spontaneous report from a contactable consumer (patient) from a program. A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6204, Expiration date: Unknown), via an unspecified route of administration in left arm on 04Mar2021 at 17:00 as dose 1, single, at the age of 56-years-old for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The patient did not receive any other vaccine in four weeks of vaccination. The patient's medical history included hypertension/high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications included METOPROLOL, LOSARTAN, and steroid taken for an unspecified indication, start and stop date were not reported. The patient previously took CODEINE for and had known allergies CODEINE. On 06Mar2021 at 07:00, the patient experienced dizziness/very dizzy after 36 hours of receiving vaccine. It was reported that the patient had Pfizer vaccine his first one, given on Thursday. That past week, on March and Thursday night he felt good. Friday, he felt good and he woke up Saturday with severe dizziness and he still had it yet today. He had taken dramamine each day, except for today and it was not helping at all. He takes his daily medication. The outcome of the events was recovering.   No follow up attempts are possible. No further information is expected.
Dizziness, SOB, heaviness to chest, diophratic, tachycardia, elevated BP, unresponsive  911 called epi given
Pt fully vaccinated for COVID. Received Moderna. Unknown dates. Pt admitted with abdominal pain and vomiting. Did receive gastric bypass revision 12/2021
very very tired; hurting all over the body; bad headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very very tired), MYALGIA (hurting all over the body) and HEADACHE (bad headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included OLMESARTAN, OMEPRAZOLE and HYDROCODONE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced FATIGUE (very very tired), MYALGIA (hurting all over the body) and HEADACHE (bad headache). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, FATIGUE (very very tired), MYALGIA (hurting all over the body) and HEADACHE (bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2020, SARS-CoV-2 test positive: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 20-FEB-2014, the patient was vaccinated with second dose of PROQUAD (Merck) subcutaneous, Lot #J009886; Expiration date: 15-FEB-2015 (dose, strength and expiration date were not reported). Secondary and concomitant therapies were not reported. Nurse originally called on 13-DEC-2013 requesting stability information for PROQUAD (Merck) that was improperly stored. During the call she was told that based on company stability data PROQUAD (Merck) would had to be used within 1 month or by 13-JAN-2014. Nurse reported that improperly stored PROQUAD (Merck) was administered to patient on 20-FEB-2014. No adverse effect were reported. This is one of 3 reports concerning same reporter (MARRS #1403USA012819 and 1403USA012820). Additional information is not expected.
At 3:12 p.m., immediately after all three of the client's vaccines were administered, the client stated he did not "feel well." His head drooped to his chest and he was pale. His eyes were open. I called for someone to grab a cot and juice. I held the client's shoulders to hold him up in the chair. He was shaking slightly and making a sound with his voice. I stated his name and a few seconds later, he became alert and brought his head up and said "What?" Another RN and I attempted to assist him from the chair to the cot. I asked him if he could use his legs and he slightly moved them. I asked him if he could help the other nurse and I with moving to the cot. He was able to follow direction and bare some weight on his legs during the transfer. The client laid with knees bent on the cot. The client was diaphoretic and pale. He drank sips of juice and was able to answer questions appropriately. He told me what he had for lunch at 11 a.m. He had not eaten anything since then. At 3:15 p.m., his radial pulse was 56 beats per minute. He was able to follow directions and squeeze my hands and tap his feet on the cot when I asked him to. He drank a second juice. After a few minutes, I asked him to sit on the side of the cot. He did so without assistance. The client denied dizziness. I asked him if he remembered what happened and he stated after his last shot, he could see but couldn't hear. After another minute, he was able to stand up on his own without dizziness. I monitored him for another 10 minutes in the clinic room. He was fully alert and oriented when he left the clinic. I advised him and his mom that before his next appointment, he should eat something a few minutes before. They both voiced understanding.
6/2/11 red, warm large area (L) upper arm at injection site. 6/3/11 area measured 6.5" x 4".
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Since 01-MAY-2015, unspecified number of oral, ROTATEQ (lot # K003524, expiration date 29-JAN-2016, dose and route were unknown) which were exposed to temperature outside of the recommended range on 01-MAY-2015 have been administered to these unspecified patients on unspecified dates. This is one of several reports received from the same source. Additional information has been requested.
patient states she is having chest tightness and pain around 10 minutes after vaccination. BP 160s/110s. Clinic provider notified. Transferred to ED at patient request.
This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of chills (1st dose received an unknown date, refer case US2021AMR249126). 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 unwell. On an unknown date, the outcome of the unwell was recovered/resolved. It was unknown if the reporter considered the unwell to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient. The reporter reported that the patient was actually in bed for about two days after the second. The reporter said that second shot hit the patient pretty hard.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR249126:same reporter.
On day 7 post vaccine I woke up and my right arm was sore again and a huge red circle (roughly the size of a baseball) formed below the injection site and it became slightly swollen. No rash appeared but it was very red and sore to the touch. It has since started to fade but there is still an outline as of day 10.
Early menstruation and heavier than normal. I was not expecting to have my next cycle until May 24th or 25th. It started on May 16th Also, it is generally light as I have an IUD and does not last more than a few days. I am on my 5th day and it has not started lightening yet.
This spontaneous report as received from a register nurse concerning a patient of unknown age and gender. Medica history and concurrent conditions were not reported. On 04-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose number and  route were not reported), 0.5 ml. lot # K005182, expiration date 10-APR-2014 for vaccination. Co-suspect and concomitant therapies were not reported. The register nurse reported patient experienced 26 patients received doses of (Oka/Merck) VARIVAX (from lot # K005182, expiration date 10-APR-201 only) that were improperly stored. No adverse experiences reported. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
waking up next morning with headache; fever; chills; body aches; fatigue; This is a spontaneous report from a contactable consumer. This consumer reported for a 45-year-old female patient that.  A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 as (At the age of 45-years-old) dose 2, single for covid-19 immunisation. Medical history included Ibuprofen allergy. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. No covid prior vaccination. No covid tested post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 Prior to vaccination. Patient did not test for COVID-19 Since the vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 04:00 PM as dose 1, single for covid-19 immunisation. It was unknown Facility where the most recent COVID-19 vaccine was administered. The patient experienced waking up next morning with headache, fever, chills, body aches, and fatigue on 22Apr2021. It was reported patient reported waking up next morning with headache. By that afternoon crawled into bed with fever, chills and body aches. Also reports fatigue. Patient did not receive any treatment for events. The outcome of events was unknown at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Female was well, alert, on no medications, active with family. Then just fell to the floor , was sweaty and drooling, taken to the ER.  Tests revealed massive stroke and heart attack. Due to clot.  No chance of recovery, no ability to gain speech or function was incubated and on a sedative.  She was taken off life support 2 days later  and passed away on 8/5/21
Patient reported L neck and shoulder stiffness, sore throat with difficulty swallowing, and bumps on the back of her tongue that developed 1 day after receiving the second dose of the Moderna vaccine and resolved with Alka-Seltzer cold and flu tablets by January 27 (time of visit with provider).
36 yo man with hx  developmental disabilities here with caregiver and mother for second Covid vaccine.  In  observation area he was noted to become poorly responsive,  pale at 12:55 pm.  Initial VS  P 127, thready but regular,  pulse ox 98%,, B/P  90/50 and difficult to hear.  Oxygen started at 3 L NC. Patient placed supine on mat.   He remained pale, arms cool and diaphoretic, tachycardic.  He was able to answer questions. Denied c/o chest pain or SOB. Denied headache.  No rash noted, no stridor.  1:11 pm 99% sat, P 127.  1:15 pm given three small pieces of fruit snack.  No change noted .  1:22 pm VS: 120/80, P 123, Sat 99%.  Pulse remained thready but stable and B/P remained difficult to auscultate.  1:27 pm VS 95/78, P 120 sat. 99%.  1:41 pm B/P 110/85, P 124 99% sat.  Paramedics called at 1:43 pm. Paramedics  arrived 1:51 pm and report given.  Patient transported to ER for further eval. Mother and caregiver present throughout observation period.
Patient was given Moderna Vaccine and under 18 years old. No immediate adverse reactions occurred.
ABDOMINAL PAIN; SORENESS; TIREDNESS; This spontaneous report received from a patient concerned a 36 year old male. The patient's weight was 190 pounds, and height was 175 centimeters. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no pertinent medical history. the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Pain scale (NR: not provided) 4/10 (unit not reported). On 03-MAY-2021, the subject experienced abdominal pain. On 03-MAY-2021, the subject experienced soreness. On 03-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness, and tiredness on 06-MAY-2021, and had not recovered from abdominal pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall; the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall; chills; a low grade fever today of 99.5 F/She had a fever last night with shakes; Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall), VACCINATION SITE ERYTHEMA (the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall), CHILLS (chills), PYREXIA (a low grade fever today of 99.5 F/She had a fever last night with shakes) and EXTRA DOSE ADMINISTERED (Extra dose administered) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced CHILLS (chills), PYREXIA (a low grade fever today of 99.5 F/She had a fever last night with shakes) and EXTRA DOSE ADMINISTERED (Extra dose administered). On 18-Aug-2021, the patient experienced VACCINATION SITE WARMTH (the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall) and VACCINATION SITE ERYTHEMA (the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall). At the time of the report, VACCINATION SITE WARMTH (the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall), VACCINATION SITE ERYTHEMA (the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall), CHILLS (chills) and PYREXIA (a low grade fever today of 99.5 F/She had a fever last night with shakes) outcome was unknown and EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved.            No concomitant medication was provided. No treatment information was provided.   This case was linked to MOD-2021-290761 (Patient Link).
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 at 12:00 as dose 1, single (Lot number: EJ1685), in right arm, on 11Jan2021 at 13:00 as dose 2, single (Lot number: EL0140), in left arm, on 14Aug2021 at 15:00 as dose 3 (booster), single (Lot number: EW0198), in right arm and on 16Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FP7135) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not received any other medication within 2 weeks. The patient received antiviral Covid-19 treatment with Paxlovid form 23Aug2022 to 27Aug2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure is : expected. The case will be reassessed further upon receipt of additional information.
Pt has rash/injected. MD's treatment is KEFLEX 500 mg 1 TID.
Initially, there was brusing and terrible pain -- soreness. Within weeks I could not move my shoulder. I went to Dr. orthopaedics and was diagnosed with frozen shoulder. I was in PT for months -- and although I gained 81 percent mobility, the pain is still horrible. The doctor ordered MRIs -- had one on shoulder and one week later one on the neck. The shoulder revealed very minor fraying -- BUT there are five issues -- and I realized this evening these match exactly those of the rare cases that result in in a small tear to rotator cuff, tendon trouble and adhension capsultis due to flu vaccine administration. I have been asking the PT people for months if they believe the vaccine caused this. They said no. But this evening -- rather early this morning, the pain was so bad. I got up and began reading medical articles and found not only the exact situation but matching MRI findings. I will call Dr. Monday morning and tell him what I have found out and I will tell Dr. He did not mean to hurt me. I like him very much -- but I know this condition I have is related to the vaccine injection and that the vaccine itself in that area has caused this extreme inflammation. You may call me and get more details, and I do not mind showing you my medical records. The result is pain that keeps me from sleeping properly and requires I be in PT 2x weekly and do PT at home additionally.
She received her booster of the Moderna vaccine/  received a dose from a lot that might have been improperly stored; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (She received her booster of the Moderna vaccine/  received a dose from a lot that might have been improperly stored) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (She received her booster of the Moderna vaccine/  received a dose from a lot that might have been improperly stored). On 27-Oct-2021, PRODUCT STORAGE ERROR (She received her booster of the Moderna vaccine/  received a dose from a lot that might have been improperly stored) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.
Patient received mixed dose series: 1st dose Pfizer 1/12/2021, 2nd dose Moderna due to no Pfizer vaccine available at vaccine site. Patient counseled on unknown safety/efficacy of mixed dose series and advised to wait for Pfizer vaccine availability at a later date. Patient refused and demanded to be vaccinated with Moderna which was the only vaccine available at the site.
Rash is all over his body looks like poison ivy and it's itchy; his lips are very dry; Feels dehydrated; mouth feels very werid his tongue and the inside of his mouth feels; mouth feels very werid his tongue and the inside of his mouth feels; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash is all over his body looks like poison ivy and it's itchy), LIP DRY (his lips are very dry), DEHYDRATION (Feels dehydrated), PARAESTHESIA ORAL (mouth feels very werid his tongue and the inside of his mouth feels) and STOMATITIS (mouth feels very werid his tongue and the inside of his mouth feels) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced RASH PRURITIC (Rash is all over his body looks like poison ivy and it's itchy), LIP DRY (his lips are very dry), DEHYDRATION (Feels dehydrated), PARAESTHESIA ORAL (mouth feels very werid his tongue and the inside of his mouth feels) and STOMATITIS (mouth feels very werid his tongue and the inside of his mouth feels). At the time of the report, RASH PRURITIC (Rash is all over his body looks like poison ivy and it's itchy), LIP DRY (his lips are very dry), DEHYDRATION (Feels dehydrated), PARAESTHESIA ORAL (mouth feels very werid his tongue and the inside of his mouth feels) and STOMATITIS (mouth feels very werid his tongue and the inside of his mouth feels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
employee received flu vaccine at 11am, 10-15min later she began to experience extreme itchiness in her right arm (arm of injection), warmth, and redness that spread up the right side of her neck, ear, chest, and down her right shoulder blade/back. experience hives on her back and chest. no breathing difficulty. she took 50mg of PO benadryl, a Pepcid, and an antihistamine to help with the itching. spoke with her at 3:30pm and she still has some itching, but it has lessened since taking the medications  and the amount of hives has decreased as well.