chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They itch; Kind of bug bites; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Kind of bug bites) and PRURITUS (They itch) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Kind of bug bites) and PRURITUS (They itch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Kind of bug bites) and PRURITUS (They itch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.
Patient was in waiting area after vaccination and after a few minutes it was noted that his head had hyperextended and his eyes rolled. Laid on floor as he was unresponsive. Mask removed and gurgling noise and saliva noticed in his airway. Vitals assessed and it was detected in both his carotid and radial arteries that there was not pulse.  CPR initiated. After only two compressions patient opened his eyes and started breathing on his own. He was awake, not oriented with a weak pulse. Patient provided juice sitting up in case this was diabetic reaction. EMS arrived.  They did an EKG. Patient denied being transported to ER. Patient was released to care of wife at 12:30 who was instructed to bring him to ER if any symptoms reappeared.
MODERATELY SICK; LOW GRADE FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 09-APR-2021, the subject experienced moderately sick. On 09-APR-2021, the subject experienced low grade fever. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the moderately sick, low grade fever, nausea and headache was not reported. This report was non-serious.
Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked with Case ID 2018SA201498, 2018SA201512, 2018SA201513 and 2018SA183350 (same reporter). This case involves a four-years old patient (gender not reported) who received 0.5 ml dose of IPOL lot N1K92 via unknown route in unknown administration site on an unspecified date, from a IPOL shipment should be returned due to it being in transport a day longer than it should have, no adverse event. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. This is the case of actual medication error as the vaccine was administered to the patient, which was incorrectly stored. It was reported that the reported had reported that by the time they received notification that their IPOL shipment should be returned due to it being in transport a day longer than it should have, they had administered 5 doses to patients already. All of the patients were 4 years of age. It is unknown who administered each dose. There were no adverse reactions reported for any of the patients who received the doses. The doses were administered on June 8th, June 12th, June 13th, June 14th, June 18th and June 21st. Reporter stated they were aware that the parents will have to be notified and the children will have to be re-vaccinated. Reporter stated that she had already talked to someone about returning the shipment. It was unknown if the patient experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. Documents held by sender: none.
About three days after the dose 4 I began to have chills and feeling like I couldn't really catch my breath. I had a headache, and I had no appetite. I was nauseous. I had a fever, temp of 101.5. My stomach was really turning a lot. They symptoms began slowly and got worse. I am slowly recovering. Since I have asthma, I am still having trouble. I have taken two sets of steroids, one five-day and one-seven day. They said I had all the symptoms of RSV but they were unable to test me.
Arm pain; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 14 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 30Sep2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Oct2023, outcome "recovered", described as "Arm pain"; FATIGUE (non-serious) with onset 07Oct2023, outcome "recovered" (08Oct2023), described as "tired". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional information: Arm pain, she stated it felt like the shot went up her neck and also into her heart. She panicked a bit but then calmed down. She went home and took an hour nap. She was tired for the rest of the day. Recovered except for sore arm today (next day). Covid not tested post vaccination. The patient had no known allergies.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Itchy rash on left arm; Red rash on left arm; Itchy (no rash) on legs and right arm; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 5H29x, expiry date 6th July 2023) for prophylaxis.   On 14th July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th July 2022, 4 days after receiving Shingrix, the patient experienced itchy rash, red rash and pruritus. On an unknown date, the outcome of the itchy rash, red rash and pruritus were recovering/resolving.   It was unknown if the reporter considered the itchy rash, red rash and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comment: The patient stating that she got her shingrix vaccine in the left arm and then  she broke out in an itchy red rash on the left arm.   She stated the rash went from her shoulder to her elbow and then she also got itchy (with no rash) on both her legs and right arm.  The rash and itching had improved, but it isn't completely gone. The patient did not give a HCP for follow up.
Complex seizures; Explosive diarrhea; Profuse vomiting; Chills; sweats; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration in the left arm, on 22Mar2021 at 09:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced complex seizures, explosive diarrhea, profuse vomiting, chills, and sweats on 22Mar2021 at 19:00. All of the events required hospitalization from an unspecified date to an unspecified date for one day. The patient underwent lab tests and procedures which included nasal swab: negative on 22Mar2021. Therapeutic measures were taken as a result of all of the events, which included intravenous fluids. The clinical outcome of complex seizures, explosive diarrhea, profuse vomiting, chills, and sweats was recovered on an unspecified date.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
7/18/22 nausea and vomiting 7/18-7/28 dizziness  8/8 - 8/31 vertigo (ER visit 8/8) fatigue optical migraine (light followed by headache)  no period for 54 days after the 4th shot (previous menstrual cycle was normal)
not feeling very good; really achy all over; feels tired; little bit of a headache; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of   in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CELECOXIB (CELEBREX), ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN B12 NOS and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.            On 17-Feb-2021 around 4:00 AM, the patient was not feeling well. She felt tired, achy all over, had a little bit of a headache, and a low-grade fever. She wanted to know if it was okay for her to take Tylenol or Advil as she had read conflicting information regarding the effect on the efficacy of the vaccine with these medications. Treatment information was not reported.
I have been sick for four weeks; Initial information received on 26-Nov-2020 regarding an unsolicited valid non-serious case from a non-health care professional via social media.  This case involves an adult patient with an unknown demography details who had been sick for four weeks (illness), while being received influenza vaccine and pneumococcal vaccine.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) and pneumococcal vaccine (batch number and other dosing details were not reported for both) for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapies, the patient had been sick for four weeks (illness) since getting the flu and pneumonia shots at the same time.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case. No further relevant information was reported.
This spontaneous report was received from a pharmacist refers to a patient of  unknown age and gender. No concurrent condition or medical history was reported. On 08-OCT-2015 the patient was vaccinated with expired dose of PNEUMOVAX23 (lot # K010016, dose and route of administration not provided). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information is not expected.
Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) was resolving.            No concomitant medications were reported.  The reporter's causality for the event of cough with Adalimumab solution for injection was reported as reasonable possibility.  No treatment medications were reported.
This is a serious case from a consumer whose son developed JUVENILE RHEUMATOID ARTHRITIS, considered medically significant, after receiving FluMist (OMIC). The reporter did not provide causality between events and FluMist vaccine. A mother reports her son developed juvenile rheumatoid arthritis, considered medically significant, after receiving FluMist. On 23Dec03, a 12 year old male received FluMist and in mid January, his knee became swollen. When he was taken to the doctor they gave him a temporary diagnosis of juvenile rheumatoid arthritis. The JRA has progressed symmetrically into his hands, knees, toes, and jaw. He went back to the doctor in early September 2004. He had a positive ANA test and was diagnosed with polyarticulate JRA. The patient has not recovered. Lot number is unknown and additional information has been requested. Additional information received from mother on 26Oct04 incorporated into above narrative. Follow up 03/14/05: Patient has not recovered from the adverse event(s). Stiffness of joints with less swelling and pain his jaws. A VAERS follow up report was submitted in accordance with 21CFR600.80. 04/26/2005 Per the reporter, the patient continues to have swelling and pain in his joints but the severity is less.  The patietn's white blood cell count also dropped below normal.  The drop in WBC count is being attributed to his methotrexate intake.  The WBC count will be reported next week.  Currently, his WBC is 4.
03/13/21 Woke up with rash at injection site and from elbow to wrist.  Area raised, hot, painful, prickly and burning.  Also noted same rash on left forearm.  03/15/21 Rash and pain in both arm continue and worsened.  03/17/21 Rash and pain worsening  and was seen by provider.  Started on Gabapentin at 300mg 1-2 times per day, recommended to take  Claritin one daily  and also recommended to take Pepcid complete.  03/18/21 she became sleepy and unable to drive after taking the Gabapentin.  Rash and pain continued on both forearms.  03/18/21 MD recommend to stop the Gabapentin and increase the Claritin to twice daily.  Also prescribed a steroid salve ( Triamcinolone 0.1%)  and ordered an Epi Pen for her.  As of 03/24/21 Rash and pain still continue in both of her forearms.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received few years back before the date of reporting). Concurrent medical conditions included shingles. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced shingles and condition aggravated. On an unknown date, the outcome of the shingles and condition aggravated were unknown. It was unknown if the reporter considered the shingles and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's information, batch number, expiration date were unavailable. The patient had ZOSTAVAX a few years back, and recently had a shingles outbreak. The patient still had signs and symptoms of it, when she was given dose of SHINGRIX. After a couple weeks, she had a further outbreak. The patient asked reporter if she should have had that new dose. The reporter told her that he did not think she should have. The reporter felt it should have been put off awhile. No phone number was available, agent was unable to contact for additional details.
6:10pm Light head, shaky about 5 min after flu mist. Pale, thirsty BP 140/88. 6:20 10 min BP 120/80, feeling better, color better.
Patient received the second dose of Moderna before the due date. Patient reported to our office requesting the second dose of Moderna vaccine, said she received a reminder from another clinic that she was due. She did not check her vaccine card or present to our staff until after she received the vaccine. Patient received her first Moderna dose 3/16/21 at pharmacy and her second dose 3/30/21 from our clinic. She had no adverse events, monitored and discharged without incident.
Fatigue.  Extreme Diarrhea. Dizziness  headache  nausea
Pain injection site; 1 week later severe migraine -- vomitted 2x in result to migraine; no other side effects until 2nd dose 11/25/20 -- sore arm, chills, fever, body aches, sweating ; 11/27-11/29 migraines - for 2 days. After 11/29 no further symptoms.
Patient is 27 weeks pregnant and received her first dose of the vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is 27 weeks pregnant and received her first dose of the vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Oct-2020 and the estimated date of delivery was 18-Jul-2021. On 15-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is 27 weeks pregnant and received her first dose of the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  On 15-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient is 27 weeks pregnant and received her first dose of the vaccine) had 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.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
pt recvd vax & w/in 24hrs exp flu-like sx which resolved w/o treatment;
pt had deep hacking cough, congestion of the lungs & vomiting;pt had fever of 103.5;saw MD who stated this was a virus & didn't think this had anything to do w/vax;
Chills; fever; fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 10:00 as dose 5 (booster), single (Lot number: gh9694) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE ; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Manufacturer Unknown), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 19Oct2022, outcome "recovered" (Oct2022); FATIGUE (non-serious) with onset 19Oct2022, outcome "recovered" (Oct2022); PYREXIA (non-serious) with onset 19Oct2022, outcome "recovered" (Oct2022), described as "fever"; HEADACHE (non-serious) with onset 19Oct2022, outcome "recovered" (Oct2022). Therapeutic measures were not taken as a result of chills, pyrexia, fatigue, headache.  Additional Information: The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination.
Chills; A high heart rate, sitting still it was 125 bpm; Had cold chills; He was not feeling good,he felt bad all day; Had 102 fever which then went normal,102 fever,101.5 fever; Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (A high heart rate, sitting still it was 125 bpm), FEELING ABNORMAL (He was not feeling good,he felt bad all day), CHILLS (Had cold chills), ARTHRALGIA (Sore shoulder) and PYREXIA (Had 102 fever which then went normal,102 fever,101.5 fever) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, the patient experienced ARTHRALGIA (Sore shoulder). On 16-Aug-2021, the patient experienced FEELING ABNORMAL (He was not feeling good,he felt bad all day) and PYREXIA (Had 102 fever which then went normal,102 fever,101.5 fever). On 17-Aug-2021, the patient experienced HEART RATE INCREASED (A high heart rate, sitting still it was 125 bpm) and CHILLS (Had cold chills). On 18-Aug-2021, the patient experienced CHILLS (Chills). At the time of the report, HEART RATE INCREASED (A high heart rate, sitting still it was 125 bpm), FEELING ABNORMAL (He was not feeling good,he felt bad all day), CHILLS (Had cold chills), ARTHRALGIA (Sore shoulder), PYREXIA (Had 102 fever which then went normal,102 fever,101.5 fever) and CHILLS (Chills) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
ABOUT A MONTH AFTER TAKING THE VACCINE I STARTED LOSING TASTE AND FEELING MY TONGUE SWOLLEN, i WENT TO THE DENTIST YESTERDAY 8/1/2022 AND SHE NOTICED MY TONGUE WAS SWALLON AND RECOMMEND ME SEE MY DOCTOR
Localized area of erythema tenderness, warmth at site of vaccine, which began 24 hours after administering & began resolving 48 hours after
Itching and burning at injection site, then spread throughout body, worse at hairlines, chest, arms, and stomach
Approximately 3 weeks after shot, developed dermatographia (hives that make marks when I scratch it touch skin) all over my body. Benadryl helps but they have continued over a week like this
uncontrollable crying X 3 days, phenobarbitol 50 mg now, repeat in 4 hours, then 1 1/2 tsp. BID X two days.
Less than 30 seconds after receiving vaccines she reported tingling sensation from upper arm to tip of fingertips. She also reported "twitching" at base of thumb. Twitching lasted few seconds.