chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8:30 pm started - very cold/ then very bad body aches and slight headache; then dizziness and 4 hours later started vomiting for about 15 hours; slept all of next day and night/ waves of nausea; dizziness gradually faded after 24 hours, nausea faded after 26 hours
Mom states patient awakened with c/o of ithy legs-Mom observed "welts" on legs & a few on back & abdomen-she gave 25 mg Benadryl and had patient take a shower s/s resolved in 1/2hr. Patient went to school-Mom received a call from school nurse around 2pm stating "welts" had returned and she had administered Benadryl- Mom p/u patient and took him to pediatrician. Mom states Benadryl took longer to work this time. per Mom Dr. placed patient on Benadryl every 5 hours until s/s resolve. Mom states patient is allergic to eggs (parent did not disclose on consent) but has received flu shot every year without incident.
Patient received Moderna booster dose on Wednesday, 11/3. Called pharmacy on Saturday, 11/6 at 11:20 am to complain that the injection site was still very itchy, tender, red and swollen, with a lumpy feeling. Patient said had been icing the arm and applying Calamine, but wanted advisement because still itchy and swollen. Pharmacist on duty suggested to take ibuprofen, but patient said unable to since has stomach issues; pharmacist then suggested to take Tylenol for the tenderness and Benadryl for the itching. Pharmacist also advised to continue monitoring her arm and if it got worse to contact her provider.
mom called clinic stating pt had no problems p/vax yesterday however, woke up this morning w/vomiting & fever; mom states did not take pt's temp but that felt warm & gave pt some fever med; advised to call PMD for further instructions;
extreme pain all over; headache; tiredness; This case was reported by a consumer via call center representative and described the occurrence of generalized aching in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized aching, headache and tiredness. On an unknown date, the outcome of the generalized aching, headache and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the generalized aching, headache and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had extreme pain all over, headache, tiredness. The reporter asked how long did the vaccine side effects last. The reporter asked could you get shingles and not had any rash.
Hot , itchy rash on DAY 2!!.....in addition to flu symptoms with major headaches
pt recv vax;4 hr later, had T 102; irritable, lethargic & anorexic x 4 days; beginning to clear on 4th day;
Developed dull headache within 2 hours of vaccine with fatigue.  By 6-7 hours later, her headache escalated to a severe migraine and she had chills, nausea, vomiting and a temp of 101.  Severe symptoms lasted for 24 hours and she didn't feel better until 4 days later. By 5th day felt fine.
CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; VACCINE EXPOSURE BEFORE PREGNANCY; This spontaneous pregnancy report received from a patient via other company (Pfizer Inc.) concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and drug allergy, and other pre-existing medical conditions included: Patient was pregnant at the time of reporting. The patient was gravida 1 and para 0. The date of the patient's last menstrual period was 02-JUN-2022 and expected delivery date was 10-MAR-2023. The patient received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on 22-MAR-2021 at 12:00 to right arm for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 32 years old. On 22-MAR-2021, the patient experienced vaccine exposure before pregnancy (Dose number in series 1). On an unspecified date, the pregnancy resulted in an unknown. The patient received dose 2 with non-company suspect Moderna covid-19 vaccine (elasomeran), (Dose number in series 2), (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 22-NOV-2021 at 12:00 to right arm for covid-19 prophylaxis. Concomitant medications included metformin, and metoprolol.  On 15-JUL-2022, at 19:00, the patient experienced confirmed covid-19 infection (Dose number in series 2), and had confirmed clinical vaccine failure (Dose number in series 1). The symptoms were very mild (sore throat and mild cough). The patient was treated with non company co-suspect Paxlovid (form of admin and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 15-JUL-2022 to 19-JUL-2022 for treatment of COVID-19 as per her obstetrician-gynecologist. The symptoms disappeared completely by 18-JUL-2022 and reappeared again from 25-JUL-2022. On 26-JUL-2022, Laboratory data included: COVID-19 antigen test Positive. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccine failure and vaccine exposure before pregnancy was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000245108.; Sender's Comments: V0:20220806607-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Individual received MMR shot. Individual stated then the next few days started in with itchy rash.
Normal soreness in arm for 2 days after vaccine.  Woke on 1/25/21 with arm soreness.  Throughout day arm soreness increased, swelling to arm and warm to touch.  Next day 1/26/21 arm swollen from 2 inches above elbow to shoulder, hot to touch, unable to move arm without extreme pain.  Went to physician and diagnosed with cellulitis from vaccine.  Given Solumedrol IM in office and sent home with Keflex 500mg three times daily and Prednisone 4mg dose pack.
Local site reaction on Rt.thigh. Hydrocortisone cream 2.5% as directed.
Patient finished observation, then suffered a seizure and fall on the way out of the clinic. Paramedics were called and the patient was monitored and transferred to the hospital on site
Fever, chills, body aches, cough, sore throat, congestion, shortness of breath, rash, fatigue, dizziness
40 minutes after vaccine, I got hives and itching on whole body that progressed to throat itching. I had to take Zyrtec, Pepcid, and Benadryl to make the itching and throat itching subside.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 81-year-old female patient who received BOOSTRIX (batch number X9YP3, expiry date 2nd October 2020) for prophylaxis. On 26th July 2018, the patient received BOOSTRIX. On 31st July 2018, 5 days after receiving BOOSTRIX, the patient experienced pain in arm, injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the pain in arm, injection site swelling, injection site warmth and injection site erythema were unknown. It was unknown if the reporter considered the pain in arm, injection site swelling, injection site warmth and injection site erythema to be related to BOOSTRIX. Additional details were provided as follows: The patient reported feeling pain in her arm approximately 5 days after receiving a BOOSTRIX injection in the right arm. The patient also reported that the injection site was warm, red, and swollen.
patient stated she developed posible shingles, and still fills like she has the flu , and tired had it for 25 days now
The afternoon of the shots felt warm and developed rash from head to chest. Temp 100.6 degrees in PM. Rash was gone by 6 pm. Called clinic and advised to take Benadryl.
No additional adverse events; that patient received VAQTA pediatric dose instead of adult dose.; This spontaneous report was received from a licensed practical nurse referring to an adult patient of unknown age and gender.      The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 17-OCT-2019, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (strength, dose, frequency, route of admiistration and anatomical location were not reported) lot # S021092, expiration date 18-MAY-2020, for prophylaxis, instead of an adult dose.
Muscle aches, head ache, nausea, dizziness, fainting, BP 85/54 at 8am day after vaccine, gradually feeling better over the course of the morning with mostly improved by 12pm. Took regular doses of acetaminophen (2 tablets, 500mg).
Information has been received from a physician concerning a 11 year old female patient with no pertinent medical history and no drug reactions or allergies, who on 16-OCT-2008, was vaccinated, IM, with the first 0.5 ml dose of GARDASIL. Concomitant therapy included influenza virus vaccine administered on 16-OCT-2008. On 20-OCT-2008, the patient experienced left-side facial swelling, left neck pain and "a feeling like her throat is swollen". The patient was examined in the office on 21-OCT-2008, and a cervical x-ray has been ordered. The patient was scheduled for a consultation with an unspecified ENT specialist on the afternoon of 21-OCT-2008. At the time of reporting, the adverse events were ongoing. Additional information has been requested.
is sick; arm and muscle is hurt; arm and muscle is hurt; This is a spontaneous report received from a contactable reporter (Consumer).  A 20 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 15Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Apr2021, outcome "unknown", described as "is sick"; PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious) all with onset Apr2021, outcome "unknown" and all described as "arm and muscle is hurt".  Additional information: Caller was calling on behalf of her grandson, 20 years old. She said that her grandson got the first dose last Thursday April 15. This whole week, her grandson was sick (arm and muscle was hurt).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient complained of numbness in her leg 25 minutes after vaccination. Patient has dealt with sciatica in that leg before.
This case was reported by a physician and described the occurrence of nearly passed out in a 36-year-old female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, 45 min after receiving FLUVIRAL, the patient experienced nearly passed out (serious criteria GSK medically significant and clinically significant/intervention required), lightheaded, feel thirsty, feeling hot and cold and seeing spots. On an unknown date, the patient experienced product complaint. On 27th September 2014, the outcome of the nearly passed out, lightheaded, feel thirsty, feeling hot and cold and seeing spots were recovered/resolved. On an unknown date, the outcome of the product complaint was not reported. The reporter considered the nearly passed out, lightheaded, feel thirsty, feeling hot and cold and seeing spots to be probably related to FLUVIRAL. Additional details received: The patient did not have breakfast on 26th September 2014 morning. She received FLUVIRAL at 8:30. She felt lightheaded as if she was going to pass out at 9:15. She drank some water and sat down, but continued to teach. After the class, she had some popcorn, drank more water and felt better. Then she felt thirsty, and hot and then cold. She was seeing spots at 10 and sat down again. She had a coke at 10:45. She felt a lot better after lunch but not quite herself throughout the day. On 27th September 2014 morning, after her normal breakfast of a protein shake, she felt normal again. She indicated that she didn't think she got the flu vaccine because her arm was not sore (she didn't have to sleep on her left side, which she always does after receiving a flu vaccine, because she is left-handed and always gets her flu vaccine on her right arm). The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). These cases have been linked in the GSK database (see case US2014GSK000221). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.                     Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.
Vomited suddenly without knowledge of being nauseous; only happened once but nausea remained after. After about an hour and a half muscle aches and headache kicked in.
Approximately 10 minutes after administration of vaccine, patient reported numbness and tingling in left arm continuing down to thumb and pointer finger. No other side effects were noted. Patient and parent were asked to remain in waiting room for a full 30 minutes following vaccine to ensure no other adverse reactions would occur. None were noted and patient was released.  Advised patient and parent to follow up with physician if numbness and tingling does not resolve within 48 hours.
This spontaneous report as received from   a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. The patient received the first dose of the series of three of GARDASIL on an unspecified day in November 2014, and the second dose of GARDASIL was administered on an unspecified day in AUGUST 2015 (inappropriate schedule of drug administration). Also, it was confirmed that the third dose of GARDASIL was not administered to the patient. No adverse effects reported. There was no product quality complaint involved. Additional information has been requested.
Approximately 12 hours after administration of hepatitis A vaccine, pt developed hives over entire body. No other known cause for hives.
Patient called Saturday, 2/12/2022, and told pharmacist that after receiving the COVID-19 Pfizer vaccine the day before, her left arm had swollen to the size of a golf ball around the injection site, it was hot to the touch, and she had a rash all over her body. Pharmacist  initially instructed her to add ice to the injection site, and  take Diphenhydramine.  However, once the patient made it clear that this was a systemic reaction, the pharmacist instructed her to go to Urgent Care to be checked by attending provider.
Patient pre-medicated with diphenhydramine due to infusion-type reactions in past.  Patient with hoarse voice, itchiness to upper back, arms, and face, hives on bilateral arms.  Per health system protocol (patient is health system employee) Patient administered diphenhydramine, famotidine, methylprednisolone succinate, epinephrine.  All symptoms resolved by 1440.
Pain in arm, shot area and continued to get worse.  It radiates in upper arm, unable to move arm above head, over head, back wards, etc. without pretty severe pain.  Feels like a rotator cuff injury. Can't carry heavy things, raise arm.  Doesn't respond to Advil, no other treatment tried.  I have had this reaction one other time about 3 years ago after a flu shot.  did not put the 2 together at that time, and thought it was rotator cuff, went through therapy, eventually got better.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. 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 30Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 57 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09May2022 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "Known allergies: Perfume gives me migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 01May2023 to 06May2023.
Numbness in limbs and face and sharp headaches starting the day after vaccination.  Symptoms, to a lesser degree, are still present three weeks following vaccination.
Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24-year-old male patient who had received MENACTRA (lot number, route, site and date of administration not reported) and one month after vaccination developed meningococcal sepsis, year reported as 2008 (Q 4). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08248, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
The night after I got the first dose, I lost a lot of blood from my chains and my heart experienced a bit of pain. This happened for a few days and went away. Similar thing happened after my second dose on 8/5 for two days. But heart pain still persists. A new thing that came up is that my left leg feels like I pulled a nerve. I can?t bend down or life things as good as I used to. It is painful to walk too. Occasionally I get lightheaded and feel like vomiting.
Patient started having tightness in chest area a week after receiving the vaccine. Patient stated that she has a inhaler that she has not used in about a year and has had to use it very frequently.
patient developed swelling of the lymph nodes under her left arm ( site of the injection  ) the swelling was the size of a golf ball ( per her describing ) and  she noticed it about 24 hours after the vaccine and went away on its own after another 24 hours.
This spontaneous report as received from a nurse refers to 3 patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On 10-JUN-2016, the patients were vaccinated with improperly stored (72 degrees Fahrenheit for 12 hours) dose of M-M-R II lot # L009214, expiration date 17-MAR-2017 (dose and route of administration were not reported. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
6:50pm rash on left side of face and swollen eye lid. 7:00pm went completely limp was not responding as normal. EMS arrived to do a full check up. Doing a follow up appointment with her pediatrician ASAP.
Deceased Narrative: Patient was a 82 yo male with multiple co-morbidities consisting of AF (on warfarin), prio PE, HFrEF, CAD, HTN, mixed CSA/OSA, hypothyroidism, COPD and GERD. Patient was admitted to facility on 7/12/20 after he was found down in his home for 3 days, dx with right MCA ischemic stroke with hemorrhagic conversion. Etiology of CVA was presumed to be secondary to AF/warfarin failure. No treatment with tPA or thrombectomy was initiated as he was outside the window for intervention. Patient was also found to have bilateral DVTs. Patient was then admitted to facility 08/14/20 for end of life care.
Large DVT in left leg. Put on blood thinners in the ER. Still undergoing treatment
Report covid 19 who did not meet age requirement for vaccine; Report covid 19 who did not meet age requirement for vaccine; Cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "Report covid 19 who did not meet age requirement for vaccine"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.