chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash over entire body; itchiness; blisters; rash bleed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash over entire body), PRURITUS (itchiness), BLISTER (blisters) and PURPURA (rash bleed) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus. Concomitant products included INSULIN DETEMIR (LEVEMIR), INSULIN ASPART (NOVOLOG), DULAGLUTIDE (TRULICITY), METFORMIN, ATORVASTATIN, TESTOSTERONE, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY), TADALAFIL (CIALIS) and ACETYLSALICYLIC ACID (BAYASPIRIN) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced RASH (Rash over entire body), PRURITUS (itchiness), BLISTER (blisters) and PURPURA (rash bleed). The patient was treated with PREDNISONE at a dose of 1 dosage form and CLOBETASOL at a dose of 1 dosage form. At the time of the report, RASH (Rash over entire body), PRURITUS (itchiness), BLISTER (blisters) and PURPURA (rash bleed) outcome was unknown.            The action taken with mRNA-1273 in response to the event was not applicable. .   This case was linked to MOD-2021-080297 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up information was received on 19-APR-2021. The case was updated and crosslinked to MOD21-078352. Photos of adverse event was attached.
Moderna COVID-19 Vaccine EUA Severe fatigue 3 hours after injection that lasted 3 days. Brain fog, difficulty concentrating. Started day after injection, has not subsided 8 days after injection. Dime sized hard spot at injection site. Red. Very itchy. Noticed on day 8 after injection
Day of vaccine, experienced burning sensation in my torso along with the pain, redness and swelling at injection site. That evening went to sleep with the chills. Woke up at 0600 on 10/02, bad headache, nasal congestion and generally feeling unwell. Took Tylenol and went back to sleep. Woke up around 0900, extreme muscle and joint soreness. No desire to eat. Drank fluids for most of the morning. Ate toast and soup. Later in the evening I began to experience severe nausea. Vomited three times.  Sunday morning woke up again with a headache and body pains continuing. Experienced nausea on and off the rest of the day. Generally fatigued all day again.  Monday 10/04, symptoms of muscle pains and fatigue persist.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received SHINGRIX. On 2nd May 2018, the patient received the 1st dose of SHINGRIX. On 2nd May 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm. On 3rd May 2018, the patient experienced headache, nausea and fatigue. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the headache, nausea and fatigue were unknown. The reporter considered the pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the headache, nausea and fatigue to be related to SHINGRIX. Additional information was received as follows: On 2nd May 2018, at 17:30, the patient received SHINGRIX. The patient stated he awoke in the morning with the headache, fatigue and nausea to the point where he did not think he could drive. The patient stated that headache and fatigue have gotten worse over the day. The patient could not sleep on his right side last night due to the arm soreness. This case had been linked to the case US2018078810, reported by the same reporter (wife's case).
This spontaneous report was received from patient's mother regarding her son a 12 year old male patient. Patient had none pertinent medical history and drug allergies or reaction. On 20-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M004116/expiration date- 12-OCT-2017, dose 3 in the left arm. On an unspecified date the patient was vaccinated with GARDASIL 9, dose 1 and 2. Concomitant medication reported was CLARITIN. On 29-JUN-2016, 9 days later the therapy was given the patient experienced numbness and pain at the injection site. It was also reported during the call that the patient experienced unspecified side effects after receiving first and second dose in the series. Treatment was given for the adverse events. No laboratory diagnostics or tests were performed. Patient spoke to the physician to seek medical attention. Therapy with GARDASIL 9 was not discontinued. The outcome of numbness and pain at the injection site was reported as not resolved. The outcome of unspecified side effects was unknown. Causality was unknown. Additional information has been requested.
Post COVID Vaccine SVT; This is a spontaneous report from a contactable nurse. This nurse reported similar events for three patients. This is 3rd of three reports.   A female patient of an unspecified age received BNT162B2 (Lot/Batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient experienced Post COVID Vaccine SVT on an unspecified date. The patient had no known cardiac history at all. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021042313 same reporter, same drug and event, different patient.;US-PFIZER INC-2021042335 same reporter, same drug and event, different patient.
pt recvd vax SC instead of IM; the devel redness & induration @ the inject site;
Expected side effect to vaccine beginning at time of injection with pain at injection site. About 6 hours later, body pain, chills, body temperature dis-regulation (hot/cold/sweaty) throughout the night. At approximately 10:30 a.m. (approx. 20 hours post injection) I was standing at the kitchen counter getting some water, still experiencing extreme fatigue and body pain, about 4 hours after a dose of Extra Strength Tylenol, and had some kind of weird event where I began to feel faint and before I knew it, my body began convulsing (large shakes) and the next thing I knew I was seated on the kitchen floor and my husband was asking me "what happened". It never happened again and we decided an ambulance was not necessary. But I thought to report it because this kind of thing is not on the "the list" of expected side effects.
02/15/05 Patient was given MMR #1 at 10:45 AM. 2 hours later vomited and red raised welt right thigh like rash. Hives with confluent notches , red face , severe on face and arms. Temperature 99.1 2/16. Given benadryl and sent to er.
Patient became limp, dizzy. Body tremors approximately 45 seconds after Gardasil injected to left deltoid, while TDaP was given to right deltoid. Body tremors lasted a few seconds. Patient was placed on recumbent position, had no complaint of GI symptoms, no shortness of breath. Patient was observed for 45-60 minutes after incident.
Headache, Fever, fatigue Narrative:  Per nursing report: "took 2nd Moderna vaccine yesterday [2/10]. C/o low grade temp of 99.8 last night and headache and fatigue this morning [2/11]."  Other Relevant History:
Upset stomach, diarrhea, nausea all symptoms started just a few days after I received the Gardasil vaccine.
The employee received the flu shot at 0820AM and started having shortness of breath, tachycardia, full body rash, facial swelling at 0835am. She was given steroids and Benadryl via IV.
This spontaneous report as received from a veterinarian refers to a her currently 11 years old daughter with no pertinent medical history and known allergies. On 13-AUG-2014 the patient was vaccinated with first dose of GARDASIL (dose and route of administration were not reported). No concomitant medication were reported. On unknown date (approximately in August 2014) the patient experienced pain in the arm of the injection for two days after receiving the GARDASIL. Patient stated that her arm  "felt like it weighed a ton" and she had difficulty moving it and participating in sports. It was also reported that she would not go back to receive her second and third dose since the first dose was so painful. No treatment was given for the adverse events. Patient did not seek medical attention. The outcome of the events was reported as recovered after 2 days after vaccination (exact date unknown (approximately in August 2014)). Relatedness between the events and vaccination was not reported. This report is linked with MARRS#1410USA004370 (concerning patient's sister, same reporter link). Additional information has been requested.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved.            Concomitant medications included a medication that causes constipation, stool softener, and fiber medicine.  Treatment information was not provided by the reporter.  Action taken with the drug in response to the event was not applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt. fainted right after getting vaccinated.  B/P 110/70, HR 74, R 19.  Pt stated, "I faint most of the time when I see needles."  At 3:10 pm pt. stated, "I feel better now."  Pt. is alert and oriented x4.  3:26 pm pt stated , "I'm ok now I want to go  home."  Pt. went home at 3:25 pm.
Fatigue; sore lower left leg; sore arm; This is a spontaneous report received from a contactable consumer. A 44-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 23Mar2021 11:15 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included calcium carbonate, colecalciferol (VITAMIN D 2000); linaclotide (LINZESS). The patient experienced fatigue and sore lower left leg and sore arm (pain in extremity) on 24Mar2021 at 07:00. Tylenol was taken as a result of fatigue, sore lower left leg, sore arm. The action taken in response to the events for bnt162b2 was not applicable. Outcome of the event was recovering.  Information on the lot/batch number has been requested.
Administered prior to recommended dose date, due to mix up with sibiling. No adverse reactions to vaccines.
Patient describes large painful bump on arm of injection. She noticed it after working out in the heat a week after the injection.
Patient received vaccines 1/21/06. Evening of 1/22/06, started with new onset seizures. Found to have normal CT and MRI, abnormal EEG. Tests for inborn error of metabolism pending. Seizures appear controlled on Phenobarbital.3/2/06 Received Discharge Summary which revealed patient experienced seizures & had abnormal EEG w/right parietal/temporal brain abnormality.  Pregnancy was complicated & patient was preemie who had fetal distress.  H&P: umbilical hernia, plagiocephaly, cardiac murmur & enlarged liver.  Abnormal labs included: elevated lactic acid, pyruvic acid & 4-hydroxy pyruvic acid.
Tylenol given, recommended to continue tylenol every 6 hours as recommended, in addition advised to apply cold compress to forehead and axilla. If symptoms worsen, recommended for her to see primary provider.   3/28-Per mother, patient feeling much better, temperature has decreased from 101.4 to a low grade fever. Has taken Tylenol as prescribed. If symptoms worsen, recommended for her to see primary provider.
injection received 10:45am on Friday 4/16 and noticed red rash on upper left arm but below injection site around 7am Monday 4/19;   slightly swollen arm, warm and tender to touch.  occurred 3 days after injection.  as suggested taking tylenol for discomfort.
Nerve impingement; Searing constant pain in leg on right side only- occasionally that pain goes into her calf; Feeling was awful; Searing constant pain in lower back through the glute-puts her in tears from the pain; pain is a 9 out of 10 when she woke up this morning; Fever; This spontaneous case was reported by a consumer and describes the occurrence of RADICULOPATHY (Nerve impingement), PAIN IN EXTREMITY (Searing constant pain in leg on right side only- occasionally that pain goes into her calf), FEELING ABNORMAL (Feeling was awful), BACK PAIN (Searing constant pain in lower back through the glute-puts her in tears from the pain) and PAIN (pain is a 9 out of 10 when she woke up this morning) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVONORGESTREL (MIRENA) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On 17-Apr-2021, the patient experienced RADICULOPATHY (Nerve impingement), PAIN IN EXTREMITY (Searing constant pain in leg on right side only- occasionally that pain goes into her calf), FEELING ABNORMAL (Feeling was awful), BACK PAIN (Searing constant pain in lower back through the glute-puts her in tears from the pain) and PAIN (pain is a 9 out of 10 when she woke up this morning). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) from 17-Apr-2021 to 21-Apr-2021 for Pain, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) from 17-Apr-2021 to 21-Apr-2021 for Pain, at an unspecified dose and frequency. At the time of the report, RADICULOPATHY (Nerve impingement), PAIN IN EXTREMITY (Searing constant pain in leg on right side only- occasionally that pain goes into her calf), FEELING ABNORMAL (Feeling was awful), PAIN (pain is a 9 out of 10 when she woke up this morning) and PYREXIA (Fever) outcome was unknown and BACK PAIN (Searing constant pain in lower back through the glute-puts her in tears from the pain) had not resolved.            Treatment medication also includes muscle relaxers, pain meds, and steroids to relieve the pain.  Other concomitant medications include:Injectable steroids, oral steroids and Physical Therapy     Symptoms: Patient reported that she was still in pain and will require back surgery for her bulging discs on 23AUG2021. Patient reported her adverse events in April 2021. The patient was scheduled to have back surgery on 25AUG2021   This case was linked to MOD-2021-090283 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received on 26-Jul-2021, added outcome of the event as back pain is ongoing and planned for back surgery for the bulging discs.
The patient received the Janssen Johnson & Johnson vaccine from a certified immunizing technician. She was asked to wait 15 minutes after receiving the vaccine before leaving the pharmacy and remained seated in the post vaccination waiting area chair. She began feeling dizzy and lightheaded. She was caught by her family members and the pharmacist on duty before she fell. She briefly had a mild seizure and lost consciousness for a minute. When she regained consciousness she stated that she felt nauseous and was seeing double. 911 was called. EMTs arrived and checked her alertness and how she was feeling. The EMTs then took her off in a stretcher to the hospital out of an abundance of caution due to brief loss of consciousness.
Initial and follow-up information has been received from a physician and a health professional concerning a 13 year old female who was vaccinated with 0.5 ml dose of Gardasil. Subsequently she received her first period the day after. The patient contacted the physician. At the time of the report the patient's outcome was unknown. Additional information is not expected.
She was seeing black shapes, said it was trying to kill her, refused to go to sleep, said if she did she wouldn't wake up, she was put in hospital for 7 days, is on LEXOR 10 mg and SEROQUEL 100mg at night. Between patient's first and second shot, her stomach hurt a lot, after the 2nd shot her period messed up so bad that the doctor had to put her on ORTHOTRICYCLEN for that, and wrote the rest on the main paper. Dates of shot's 8-17-07 -10-12-07 - 2-13-08 could not get lot number.
COVID(+) ASYMPTOMATIC NO KNOW EXPOSURE; DETECTED ON WEEKLY SCREENING Narrative:
She found out she has covid before the second dose/her mom tested negative, but still has symptoms like stuffy nose, shortness of breath and wheezing, she is taking prednisone 10 mg; stuffy nose; shortness of breath; wheezing; She found out she has covid before the second dose; This is a spontaneous report from a contactable consumer. A female patient (Age: 84; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was due for her second dose on 27Feb, but she found out she has covid before the second dose. Patient did not received her second dose. Caller stated her mom tested negative, but still has symptoms like stuffy nose, shortness of breath and wheezing, she is taking prednisone 10 mg. caller wanted to know when she will be able to take her second dose. Outcome was unknown.  Information about lot/batch number has been requested.
20 yo male with PMR of HIV, primary syphilis, and gonorrhea presented for a follow-up visit. On 1/11/2017 he was given PNEUMOVAX 23 IM (left deltoid muscle) and PREVNAR IM (right deltoid muscle). During a follow up visit on 1/13/17 he complained of a red, sore streak on his left arm. Per the patient, the left upper arm erythema developed in the evening on 1/11/17 and was initially very tender, but the soreness had been resolving over the next two days. His ROS was notable for LUE redness. The patient denied fevers, chills, or swollen lymph nodes, and he was afebrile (T 97.9 F). He was prescribed cephalexin 500 mg Q6H x 7 days for the treatment of cellulitis. Per a telephone follow-up call on 1/19/17, the patient reported the redness and swelling to be completely resolved.
About 36 hours after vaccine was administered, the area around the site became reddish and painful, like a bruise (not like a rash).
After immunization on 7/16, patient developed symptoms of asthma beginning on 8/18 which have continued to this date with no relief. Additional booster immunizations cancelled.
Right leg 3 raised blanched papules appeared with 1 cm below MMR injection sight 4 minutes (1556) after injection, cold pack applied, 1610 blanched papules merged to form one, 3x4 cm red induration encompassing MMR and Varicella sights, Left legs redness or induration. Plan continue cold pack to right thigh hr x 15 until bedtime, f/u call at 1710. 1720 RN called, Mom reported hardly any redness, swelling remain after 2nd ice pack. 3/14/06 RN called mom. Mom stated no redness, no swelling, no firmness at right or left leg injection sites, only the little specks where the needles entered legs.
Moderna COVID vaccine was administered after expiration time for use after opened of 6 hours.  the Vial lot #- 030B21A   Vial Exp date- 9/20/2021
HYPERtension Swollen Lymph nodes arm pit bilat, R>L, vertigo, BP  150/110 Narrative:
her hands felt shaky; pain at the injection site; right side chest pain; This is a spontaneous report from a contactable consumer. A 52-year-old female consumer (patient) reported for herself via Medical information team. A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH Covid-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Apr2021, the patient experienced her hands felt shaky, pain at the injection site and right-side chest pain. The reporter asked if the symptoms have been reported. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
[Received injection ~8:30-9:00 AM.] "Noticed around 12:10 PM and went upstairs right away that my arm had all these red blatches, arm was swollen, itching really bad , felt my chest beating really fast,  [vaccine administrator] made me sit down and gave me 50mg of Benedryl.   I left and went home got there within 40 minutes and fell asleep right away. Slept for about 2 days straight. When I finally woke up my body was so sore and achey, felt pain all over had to take Tylenol (2) 500 mg every 6 hours for 3 days before getting some relieve.  Didn?t see a Dr. Felt 100% by Tuesday 1/12."
Temp greater than 105 degree F, within 48 hrs after the administration of the first set of Pediarix, Hib, PCV and Rotavirus vaccinations at 3 months of age. Infant had Hep-B after birth prior to this.  Treated with antipyretics and had an ER visit for the same.
2/19/21 1:00 pm, nausea; 2/19/21 9:00 pm, body ache, chills, hot flashes, took Tylenol; 2/20/21 11:00 am, body ache, chills, took Tylenol; 2/20/21 4:00 pm, hot flashes, took Tylenol; 2/20/21 8:00 pm, body ache; 2/21/21 7:00 am, body ache, nausea; 2/21/21 2:00 pm, nausea, headache
Pt given a PNEUMOVAX in (R) upper arm an FLUZONE QUADRIVALVENT in (L) deltoid on 11/28/16 at 8:42 A. Pt came in the morning to show underpart of (R) upper arm slightly red and swollen. No redness at injection site.
Reported felt ill w/ chills & myalgia the day after she was vaccinated w/ flu vaccine.
Symptoms: Headache, dizziness, feeling spaced out, and head fullness. BP elevated 152/75. Resolved on its own after 30 minutes from injection time.
Welts on face; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Welts on face) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     NO MEDICAL HISTORY RECORDED.  Concomitant products included ATENOLOL, OLANZAPINE, ESTRADIOL and VERAPAMIL HYDROCHLORIDE (VERAPAMIL EG) for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Welts on face) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, URTICARIA (Welts on face) and HEADACHE (Headache) had not resolved.        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.   Treatment information was not provided