chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a consumer on 15 August 2016. This case involves a nine-years-old female patient who was vaccinated with a first dose of FLUZONE (batch number, expiry date, dose, site of administration were not reported) via intramuscularly on unspecified date. Illness at time of vaccination reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as eczema allergies. Concomitant medications were not reported. On unspecified date, following the vaccination patient experienced large raised red area at the injection site with heat and pain. It was reported that patient visited to pediatrician who circled the area. The patient's mother was instructed to call in about condition of the site as they were concerned about a blood infection. It was reported that it required patient to stay out of school. Lab data was reported as none. Patient received corrective treatment with ATARAX and patient's mother was instructed to compress. On unspecified date, (few days later) patient recovered from event. Follow up report received from a nurse on 22 Sep 2016. It was reported that Based on information received from the reporter case was not medically confirmed (as vaccine was not administered in their clinic). List of documents held by sender: none.
Since getting the vaccine I have shortness of breath, chest pains (inflammation); elevated blood pressure; my left ankle swells majorly; my rheumatoid arthritis has been sent in a tail spin.  Before the vaccine I had none of these problems and my RA was managed with my medication.  Now my medication doesn't work.
Urticaria that developed about 15 min after vaccine administration. The family thought it was eczema and did not contact our clinic. The hives were pruritic and lasted about 2 days. They did not give an antihistamine. Now that we know, we have referred to a pediatric allergist for evaluation before going ahead with the bivalent booster. Visit to allergist was referred today - has not yet occurred.
ACUTE RESPIRATORY FAILURE 6/21/2022 HTN (HYPERTENSION)
On July 31st I started out having a very sore throat. Probably the most extreme I have had in my life. That was about 11AM. I started feeling achy and sweaty, I wasn't running a fever at that point. I felt completely fine the day before. I took a rapid test that was negative. The symptoms started that following day around 2PM. I took another rapid test that came back positive. I started running a fever of 101 degrees. The next few days I had a sore throat, some congestion, postnasal drip, dry coughing. I had about three days of fever and chills. I wasn't able to sleep through the night. I had extreme fatigue. After about day four the fever broke and I started feeling quite a bit better but very fatigued and foggy. The fatigue and fog lasted for about 6 weeks. I lost my sense of smell on day 3. I spoke to my doctor because I am asthmatic, and they knew I would need some treatment. On about day 14 I contacted my nurse practitioner, and they started me on a dose of prednisone. After about four hours after I gained my smell back. I was using my albuterol inhaler. They put me on a FLOVENT inhaler. They gave me benzonatate for the first 7 days.
Breakthrough COVID first dose 3/4/2021. 35 year old female Denies any fevers or chills.  No chest pains or shortness of breath.  No nausea vomiting diarrhea.  No headache numbness or tingling.  Denies any excessive fatigue.  No abdominal pain.  No melena or hematochezia.  No hemoptysis.  Denies any hematuria.  Denies any dizziness or lightheadedness.  Does complain of low back pain.
Red raised single hive/lesion 6? long by 3? wide, amorphous shape
pt ran fever 101, had a severe rash around the shot spot, & this caused swelling & bruising in the lt thigh;this happened day p/;1wk later more fever & a rash all over the body;pt was allergic to the pertussis;
Vasovagal reaction noted at time of visit immediately following injection of vaccine. Bradycardia and hypotensive; prolonged reaction, x 20 min. ultimately transported via EMD to local ED for further eval. - Pt. was d/c'd after 1-2 h observation.
05/18/2021 pt. tested for surgery. "PMHx of HTN, COVID-19 2/2021, CKD Stage 3, and known thoracic aortic aneurysm. The patient presents for carotid subclavian bypass in preparation for thoracic stent graft for thoracic aneurysm; Admitted to Hospital s/p Carotid Subclavian Bypass. Plan for TEVAR 5/19"
Arm pain, chills, headache, vomiting, fatigue, brain fog, joint pain and aches. Chills lasted a couple hours. The rest approx. 8-12 hours.
DIZZINESS; HEADACHE; ACHES; CHILLS; This spontaneous report received from a consumer 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, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced aches. On 07-MAR-2021, the subject experienced chills. On 10-MAR-2021 20:30, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, aches, and chills on 09-MAR-2021, and had not recovered from dizziness. This report was non-serious.
Vaccine was at 9:50am on 5/18, patient called pharmacy back at 4:30pm on 5/18 to state hives and itching started at 3pm on 5/18. No S/S of anaphylaxis. Informed pt to follow up with MD.
Myalgia  INJECTION SITE PAIN AND SWOLLEN  AXILLARY LYMPH NODES  Narrative:
Fever, Chills, Body Aches (back), Headaches.  High blood sugar readings occurred on day 2 (300+), day 3, and day 4.   Felt "functional" on day 3 and "normal" on day 4.  despite exercise and lowered food intake, sugars did not lower.    Visited health care professional to discuss.   discussion was over not much known about side affects and that each person reacts differently.  course of action to monitor and drink plenty of fluids.  used an extra 2 unit shot of lantus on day 3 to lower blood sugars in evening (5PM).  on day 4 used a +4 unit shot of lantus to lower sugars in evening (5 PM).  This is in addition to my normal lantus shot in the evening at 10 PM.  Day 5 sugars returned to normal -- operating in 120-160 range.
This spontaneous report was received from a nurse concerning to a 3 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot #' K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Pt had a large lump about the size of a small saddle bag on upper left thigh. No fever, no streak. Pt was seen in ED, Keflex for cellulitis.
Per patient's mother, the patient began experiencing redness, pain and swelling in the left bicep within a few hours after receiving the flu shot in the same arm. The patient was taken to an urgent that evening and was given antibiotics by the physician to treat for possible cellulitis. The patient's mother states that symptoms are clearing up with the antibiotics when contacted the following week.
Redness, swelling, warmth & itching of injection site on (L) arm x 3 days. Patient is to take OTC Ibuprofen as needed for pain & swelling and use cold compresses on area.
fever for about 2 days; headache; chills the first night; This is a spontaneous report from a contactable consumer (Patient). This is part one of two reports. A 62-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: er8732) via an unspecified route of administration in the left arm on 26Mar2021 at 08:45 (at the age of 62-year-old) as dose 2, single for COVID-19 immunization. The Patient's Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Gradual swelling over days due apparently to some inactive ingredients of some medications, seasonal allergy from an unknown date and unknown if ongoing hay fever, cough variant asthma from an unknown date and unknown if ongoing mild, cough-variant asthma. The patient had no food allergies. The patient received other medications in two weeks which included vitamin b complex (VITAMIN B [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported. multivitamin (MANAFACTURER UNKNOWN), Nutritional yeast (MANAFACTURER UNKNOWN), turmeric (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: en6199 and Expiry date was not reported), via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 62-year-old) as dose 1, single for COVID-19 immunization and experienced headache. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since, the vaccination the patient had not been tested for COVID-19. On 26Mar2021 at 20:00, the patient experienced chills, fever, headache. Chills the first night and fever for about 2 days, headache starting the first night and lasting on and off for 8 days so far, often mild but sometimes moderate. Patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, chills, and headache was resolving at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Diarrhea; severe abdominal pain; This is a spontaneous report from a non-contactable nurse. A 42-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Pfizer COVID-19 vaccine; lot number: EN5318; expiration date: unknown) at vaccination age of 42-year-old via an unspecified route of administration in the right arm on 31Jan2021 at a single dose for covid-19 immunization. Medical history included Pcos (polycystic ovaries). The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no known allergies. Concomitant medication included unspecified medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of bnt162b2 (BNT162B2 reported as Pfizer COVID-19 vaccine; lot number: EL3246; expiration date: unknown) at vaccination age of 42-year-old intramuscular in the left arm on 11Jan2021 09:00 AM at a single dose for covid-19 immunization. The patient received the most recent COVID-19 vaccine in a hospital. On 01Feb2021 12:00 PM, the patient had diarrhea and severe abdominal pain staring 24 hours post second vaccine which lasted for 24 hours. The patient did not receive treatment for the adverse events. The patient has not been tested for COVID-19 since vaccination. The events were non-serious. The outcome of the events was recovered on 02Feb2021 12:00.  No follow-up attempts are possible. No further information is expected.
The night of the immunizations patient reported having Fever, Shivers, and a red rash at and below the injection site. The rash was warm and tender and approximately 4 x 2 inches. Same symptoms occured Sunday (the next night)
This spontaneous report as received from a medical assistant refers to multiple unspecified patients who on unspecified dates were administered with PNEUMOVAX 23 (dose, frequency and indication not reported) that went through a supported temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Main events include fever (temporary) and a cough that has persisted from the day after the vaccine until now.  She says that she has been to the ER because of her cough multiple times.  Tested negative for COVID on all occations since.
Initial physician report received on 13 Aug 2010: This patient was vaccinated with the MenCWY liquid conjugate component of MENVEO (batch number: 0900901), (dose: 0.5 ml) intramuscularly on 13 Aug 2010. No adverse events were noted following this medication error. Follow-up report received from a physician on 24 Aug 2010: The date of vaccination was reported as 16 Jul 2010 (previously reported as 13 Aug 2010). The reporter stated that no adverse events were reported and the patient was in healthy condition.
This spontaneous report as received from a consumer of unknown age refers to himself. The patient was vaccinated with ZOSTAVAX (lot number unknown) on 28-APR-2012. No other co-suspects were reported. No concomitant medications were reported. On 06-JUN-2012 the patient experienced severe pain in upper back, right side. Pain persisted for left few days and after a week the patient had a case of shingles, completed with blisters up and down his right arm. The patient still had pain, but it was alleviating, so the patient was confident pain was temporary. The outcome was unknown. Additional information has been requested.
This spontaneous report as received from a medical assistant that refers to a 4 weeks old patient and unknown gender. On 09-NOV-2012, the patient was inadvertently vaccinated with a single dose of ROTATEQ, oral, (Lot number was not reported)orally. No other co-suspects were reported. Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
This spontaneous report as received from a physician refers to a patient of unknown age and gender, who on an unknown date, was vaccinated with improperly stored VARIVAX (lot # M000998, expiration date 07-JAN-2018; dosage and route of administration not provided). Excursions were reported as 9.9F for 10 hours, 15F for 20 hours, 6F for 17 hours, and new excursions of 6F for 15 hours. No adverse effects were reported. Additional information was received from the physician on 20-JUL-2016. The physician reported that an unspecified patient received the improperly stored VARIVAX dose #2, 0.5 ml subcutaneously, on an unspecified date in June 2016. Lot # M000998 has been determined to be a valid lot number for VARIVAX. Additional information has been requested.
Patient came into the pharmacy on 12-28-2018 with a rash surrounding injection site on upper left arm. Rash was red. Patient also stated they had pain and tenderness at the injection site. They also stated they had a headache as well. I recommended that they take BENADRYL to help with the rash and could also use either BENADRYL cream or hydrocortisone cream. I consulted the patient that if the symptoms continued to get worse to follow up with their doctor and seek medical attention.
after the 2nd shot on 16Apr2021 she got a grapefruit sized lump; 2nd dose was significantly more painful; It burned; the pain went up and down her shoulder, then went over to her other shoulder and back.; the pain went up and down her shoulder, then went over to her other shoulder and back.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 16Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Mar2021, for COVID-19 immunization, reaction(s): "marble sized lumps under her arm after the 1st shot". The following information was reported: NEOPLASM (non-serious) with onset 2021, outcome "not recovered", described as "after the 2nd shot on 16Apr2021 she got a grapefruit sized lump"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "2nd dose was significantly more painful"; THERMAL BURN (non-serious) with onset 2021, outcome "not recovered", described as "It burned"; ARTHRALGIA (non-serious), BACK PAIN (non-serious) all with onset 2021, outcome "not recovered" and all described as "the pain went up and down her shoulder, then went over to her other shoulder and back.". The events "after the 2nd shot on 16apr2021 she got a grapefruit sized lump", "2nd dose was significantly more painful", "it burned", "the pain went up and down her shoulder, then went over to her other shoulder and back." and "the pain went up and down her shoulder, then went over to her other shoulder and back." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Caller states that she got the shot last Mar and Apr. She got marble sized lumps under her arm after the 1st shot, and after the 2nd shot on 16Apr2021 she got a grapefruit sized lump and it's still there. States that she doesn't have any health insurance, but she did go to one doctor who looked at some cells under a microscope, and said that she didn't see any cancer or anything. Caller states that she has not had any blood tests done because she can't afford it. Caller explains that the lump got larger after the 2nd injection. States that the 2nd dose was significantly more painful. States that when she got the 2nd dose, it started to burn and the pain went up and down her shoulder and then went over to her other shoulder and back. States that her husband got sick after his 2nd dose, but she did not. The lot number for bnt162b2 was not provided and will be requested during follow up.
11:30 PM - itchy at vaccine site, warm to touch.  Next day - low grade fever, erythema, & swelling from top of left shoulder to elbow.  Tiny vesicle type rash on left arm, left side of neck & to midline of chest & back.  Pt took CLARITIN, MOTRIN, BENADRYL.  Hydrocortisone applied topically.  S/S decreased over course of 7 days.  Did not seek medical help or advise.
I received a MMR Vaccine on left arm and a flu shot on right arm on 9/9/2020 at pharmacy.  Both shots were painful when they were given . Where the  MMR vaccine was given started to hurt me in the area 1 - 1/2 days later.  To date having pain, aching, and a sore left arm where the MMR vaccine was given.  I have been using a heat pad, Ben gay, ice and ibuprofen and has not helped.  Amount of aching pain varies throughout the day, sometimes severe.  Sometimes it keeps me from having a good night?s sleep.
Blurry vision, muffled hearing, body feels heavy and weak, dry mouth, drowsy
Close to twenty four hours post vaccination, I began to have severe swelling, redness and heat at the injection site. Fever and body aches. I felt as though I actively had the flu. Very weak and sore. This lasted for 3 days and got so severe I was unable to even move my arm. I began to have relief Sunday 9/6/2020. Today ( 9/8/2020) it is bruised still and has a small mass right at the injection site. I feel back to normal today. I felt i should report this for the purpose I don't think the vaccination was studied in people who have actually had shingles and at my age as well. I have had shingles 11 times from the age if 18-30.
8 days post injection arm around injection site swelled up like a grapefruit. Was sore & hot to the touch. Swelling resolved after 2 days. Soreness remained for a full week.
Redness and swelling @ inj. site-> DTaP (right thigh), warm to touch, fussy, redness size- 5"  X 3". Taking Tylenol, to give Motrin every 6-8 hours and use warm compresses.
Breakthrough case admission after 3 vaccines Moderna 1/4/21 lot# 039K20A;  Moderna 2/1/21 lot# 012L20A;  Moderna 11/10/21 lot# 013F21A;
WITHIN 5 MINUTES OF RECEIVING VACCINE COMPLAINED OF ITCHING HEAD, MOUTH, LIPS. BP 158/UNABLE TO HEAR, HR 88, GIVEN BENADRYL 50 MG PO AT 10:40AM. AFTER 10 MINUTES, ITCHING GONE BUT COMPLAINED OF DIZZINESS/NAUSEA.  GIVEN SNACK AND A SODA AND TRANSPORTED TO SCHOOL CLINIC.  RESTED 1 HOUR BP 150/80-160/90.  PRIVATE PHYSICIAN NOTIFIED.  HE RECOMMENDED ER.  HUSBAND TRANSPORTED HER TO ER BY PRIVATE VEHICLE AT 12:15.  ER GAVE BENADRYL, PEPCID AND STEROID INJECTION AND SENT HOME. RETURN TO WORK ON 1/15 WITH PEPCID AND PREDNISONE XQD.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 16-NOV-2015 at time- 02:05, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 4.1 and 2.3 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
hives on face; rash on right shoulder; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on face) and RASH (rash on right shoulder) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced URTICARIA (hives on face) and RASH (rash on right shoulder). At the time of the report, URTICARIA (hives on face) and RASH (rash on right shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Pt  was seen today in the office and report new onset of balance instability and falls that started the day after received the vaccine. states one week later and symptoms remain
Information has been received from a physician concerning a female (age unknown) who was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 vaccine (Lot #651356/0089F). On approximately 13-NOV-2006 ("within the last week") the patient developed redness and a rash from the shoulder to the elbow. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a health professional refers to a 4 year old patient. On 07-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J009164, expiration date 07-AUG-2014, dose and route not reported) and M-M-R II (lot # J003785, expiration date 28-MAR-2015, dose and route not reported) which were stored improperly. There was no adverse effect reported. This is one of several reports from the same source. Additional information is not expected.