chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 62 old female who on 10-OCT-2007 was vaccinated with ZOSTAVAX. Concomitant vaccination included PNEUMOVAX 23 and tetanus toxoid. On 11-OCT-2007, it was reported that she developed shingles on her face. It was reported that the patient was seen by a physician. Current patient status was not reported. No product quality complaint was reported. No further information was available. Additional information has been requested.
Noticed rash left upper arm (deltoid) within 4 hours after injection. By 11 PM rash had extended to both arms, chest and abdomen. And legs. I have seen 3 providers, been on 3 prednisone tapers, CLARITIN and PEPCID. Rash waxes and wanes but gets worse if not on antihistamines.
Headache, Myalgia, Fever, Shakiness Narrative:  On 1/21/21, day after 2nd vaccine, patiet awoke with headache, shakiness, low grade fever and increased myalgias. Missed work x 1 day. Symptoms lasted x 48 hours. No known prior COVID infection.  Other Relevant History:
I was fine the night of the vaccine. The next morning I woke up with extreme tinnitus and it has not stopped. It has now been two weeks
Moderna COVID-19 Vaccine EUA Few minutes after receiving the vaccine, felt slight nausea and light-headed. Very soon after the vision went blurry. Takes about 3-4 seconds to refocus. Vision becomes blurry again when glancing around. Did not inform pharmacist and learned how to refocus. The second day the blurriness is still there but takes only half a second to refocus each time. By third day vision is back to normal.
This spontaneous report was received from a registered pharmacist concerning a patient of unknown age and gender. On 17-JUL-2013, the patient was vaccinated with a dose of PEDVAXHIB (lot number reported as H0257D, expiry date, dose and route unspecified) which was improperly stored at temperatures below 32 degrees Fahrenheit (F). No concomitant therapy was reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a nurse referring to unspecified amount of patients of unknown age and gender. The patient's medical history, concomitant therapy and drug reactions were not reported. On multiple dates, the patient were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # reported as M02734, expiration date 01-JUN-2018, dose, dose number and route were not provided). There was no store information provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Body aches, muscle aches come up from the muscles of the spine on the right side up the back and into the neck; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches, muscle aches come up from the muscles of the spine on the right side up the back and into the neck) and HEADACHE (Headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 020B21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2022, the patient experienced MYALGIA (Body aches, muscle aches come up from the muscles of the spine on the right side up the back and into the neck) and HEADACHE (Headache). At the time of the report, MYALGIA (Body aches, muscle aches come up from the muscles of the spine on the right side up the back and into the neck) and HEADACHE (Headache) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.
Patient received PENTACEL and PCV7 on 8/13/10 45 min later, mother found baby stiffening, eyes open but dazed look, lasted 5 sec, Pt also holding her breath - 911 called. Pt threw up once, taken to ER at hospital.
retrosternal pain w/deep breathing lasting, approx 24hr w/radiation to the lt shoulder, not w/cough;temp elevated;
On 11/30/2020 @ 3:15 pm i received both vaccines One and Shingles. I had second thoughts about getting both at the same time.  Ans expressed this to the MA I was told It would be fine.  I still was anxious. I was trusting the doctor aa rhe MA said if there were any concerns he would go get the doctor.  The first side effect was  shivering, followed by headache and my right arm swelled and started to itch at 6:33 pm  The next day (11/1) around 8 pm. I couldn't stop shivering, my teeth were clattering headache was dibilitating. I felt nauseated and very off. My entire body muscles, joints ached horribly. I was immobilized and could hardly make it to the bathroom. Headache continued, no appetite. I used cold compress on right arm. It helped. I called the PCP  (11/2) office and was told to take tylenol by PCP I called immunologist office (ordering doctor) and still have not heard back from the office.  Later that evening the shivering and clattering of teeth was very bad. Could not get warm. I had a fever of 102 I did my best to stay hydrated. The headache wouldn't budge.  My right arm has calmed down. My left arm is VERY SORE.
Initial report received from a Consumer on 09 September 2013. A 66-year-old male patient whose demographic details including gender, date of birth and age at the time of event were not reported, had received a dose of Tetanus vaccine (Manufacturer unknown, lot number, dose number, route and anatomical location site of administration were not reported) and Whopping Cough vaccine (Pertussis vaccine) (Manufacturer unknown, lot number, dose number, route and anatomical site of administration were not reported) both on an unspecified date. The patient's medical history and concomitant medication were not reported. The patient's concurrent condition included smoker. On an unspecified date, the patient experienced wheezing and coughing. Laboratory details were not reported and received Sinus Medicine as corrective treatment. The outcome of the adverse events was not reported. Documents held by sender: none.
Palpitations Narrative:  REPORTED INCREASE PALPITATIONS. employee w/ hx of heart palpitations over last 10 yrs
Information has been received from a physician concerning an approximately 33 year old female patient no known allergies and no pertinent medical history who in October 1998 and November 1998, was vaccinated with a first and second dose, respectively of varicella virus vaccine live.  Subsequently the patient failed to seroconvert.  It was reported that she was revaccinated with a third dose on 09/22/2004.  No additional information was available.  Additional information has been requested.
2 episodes of vomiting; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Fever of 100.0; Chills; Extreme fatigue; Headache; Muscle aches; Nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received 1st dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm on 18Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included covid-19 from Oct2020 to an unknown date. No known allergies. The patient was not pregnant. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). No other vaccine received in four weeks. The patient experienced fever of 100.0, chills, extreme fatigue, headache, muscle aches , nausea and pain/redness/tenderness/swelling injection site on 19Dec2020 13:00, 2 episodes of vomiting on 19Dec2020 23:45. Patient received tylenol as treatment. No COVID tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 100.0 on 19Dec2020, Covid test: positive in Oct2020. The outcome of fever of 100.0, chills, headache, muscle aches was recovered on 20Dec2020, nausea was recovered on 21Dec2020, extreme fatigue and pain/redness/tenderness/swelling injection site was recovered on 22Dec2020, 2 episodes of vomiting was recovered on an unspecified date. This case was reported as non-serious.
Intern administered vaccine that had been open 17 hours ago on 7/18, Vaccine expired 5 pm on 7/17. Unable to contact patient.
Tightness in chest / lungs at approx 1800 10/23/13. Injection given approx 1300 10/23/13. Hx = asthma until 27 yo = (as child). Keep inhaler for emergencies = took 2 puffs inhaler / albuterol = symptoms decreased.
About a month after receiving 2nd dose(in April), he started noticing red marks (burst blood vessels) on both forearms; On his right arm, he has red marks (purple blotchy) about 0.5 inches big/He thought that these blotches may be coming from vaccine/He never had anything like this in the past.; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (About a month after receiving 2nd dose(in April), he started noticing red marks (burst blood vessels) on both forearms) and RASH MACULAR (On his right arm, he has red marks (purple blotchy) about 0.5 inches big/He thought that these blotches may be coming from vaccine/He never had anything like this in the past.) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 031M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE), IRBESARTAN (AVAPRO), CARVEDILOL, ATORVASTATIN and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (About a month after receiving 2nd dose(in April), he started noticing red marks (burst blood vessels) on both forearms) and RASH MACULAR (On his right arm, he has red marks (purple blotchy) about 0.5 inches big/He thought that these blotches may be coming from vaccine/He never had anything like this in the past.). At the time of the report, ERYTHEMA (About a month after receiving 2nd dose(in April), he started noticing red marks (burst blood vessels) on both forearms) and RASH MACULAR (On his right arm, he has red marks (purple blotchy) about 0.5 inches big/He thought that these blotches may be coming from vaccine/He never had anything like this in the past.) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received and patient demographics updated.
Patient developed a rash down both arms and on upper chest.  Rash itched and blistered.  Itching and blistering resolved, but redness is still clearly visible approx. 2 months later.
Accidentally gave a 0.5ml booster shot to NON-immunocompromised patient; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Accidentally gave a 0.5ml booster shot to NON-immunocompromised patient) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GLIPIZIDE for an unknown indication.    On 15-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 15-Oct-2021, the patient experienced EXTRA DOSE ADMINISTERED (Accidentally gave a 0.5ml booster shot to NON-immunocompromised patient). On 15-Oct-2021, EXTRA DOSE ADMINISTERED (Accidentally gave a 0.5ml booster shot to NON-immunocompromised patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Added Patient initials, Age, gender ,Suspect product details, Concomitant Glipizide.
Information has been received from a pharmacist concerning an unspecified patient of unknown age or gender. No concurrent condition, medical history and concomitant therapies were reported. On an unspecified date, a dose of improperly stored ZOSTAVAX (lot # L027321 with expire date 21-OCT-2015) (dosing and route not reported) was administered to the patient. The storage of the vaccine was 35F for 3 hours. There was no previous temperature excursion. No adverse effects were reported.  Additional information has been requested.
Patient describes pain, swelling and redness at injection site 3 days post-vaccination. Range of motion reported normal.
Swelling in arm, heat in arm. Swelling in face, redness in face & arm.
3x4 inch reddened area, warm to touch; no elevated temp; cont peds APAP; return to clinic if redness doesn't dec;
Reaction included chronic migraines and headaches 3-4x/week for a year resulting in missed days of work. Nausea and vomiting for 2 days starting 9/23/21. Menstruation every 2 weeks for 6 months and then irregular and painful menstruation, missing periods or having prolonged heavy menstrual flow, starting 9/23/21 and continues today.
Hyper inflammation syndrome, and Psoriasis Arthritis, Tremor, Endothelitis, TH1/2 Shift.
Fever of 101.7 at 730pm on 11/29/21 up to 102.7 by 9pm with arm pain and headaches and lots of shivering, and treated with Tylenol.  Fever returned to 102.5 on 11/30/21 by 3pm and treated again with Tylenol, she also had another headache then.  Low grade fever of 100.8 at 6am on 12/1/21 but acting like normal self.
From initial information received on 02May06 from a literature report. It was reported that a four year old male pt who had missed his previous Dtap booster vaccination at 12-18 months of age had received his fourth dose of a 3 component acellular pertussis vaccine combined with diphtheria and tetanus toxoids (Dtap) into the right thigh, and a measles mumps rubella vaccine injection into the left thigh. Manf, routes and lot numbers were not reported for either vaccine. 12 hrs post immunization, he presented to the ER room with diffuse swelling and erythema of the right thigh. The erythema and swelling progressed to involve the entire right thigh with mild pain noted around the Dtap injection site. No other systemic reactions such as fever, nausea, vomiting, diarrhea, abdominal pain or dyspnea were noted. Physical examination in the ER revealed a well appearing child in no acute distress. The right anterior thigh was markedly erythematous, warm to touch and mildly painful with movement. An erythematous papule surrounded by an area of pallor marked the injection site of the Dtap vaccine. The remainder of the physical examination was normal. Lab studies showed a white blood cell count of 8700/mm3 a platelet count of 118,000/mm3 and a negative blood culture. Because of concern for infection, therapy with intravenous oxacillin was initiated. Over the course of several hours, area became increasingly pruritic and diphenhydramine was administered. A contrasted computed tomography scan of both thighs revealed extensive edema and soft tissue swelling of the right anterior thigh. The thickness of the soft tissues between the anterior surface of the thigh and the patella on the right was 1.10cm and that on the left was 0.43cm. The thickness of the muscles in the right thigh was 6.92cm, and that on the left was 6.64cm. No evidence of abscess or bone abnormalities was seen. A venous Doppler study of both lower extremities demonstrated no evidence of deep venous thrombosis. During the hospitalization, the child remained afebrile and playful, with normal appetite and normal leg mobility. The reaction resolved completely by the end of the second hospital day, and the child was discharged.
really sleepy can barely  keep eyes open      cold to the bone,    rapid -pounding  heart beat,   and fever of 100.8
Patient was scheduled to receive flu vaccine at clinic, arrived to appointment with registered nurse and admitted to needing flu vaccine, completed flu pre-vaccination checklist. RN later checked System which revealed that patient had already received flu vaccine on 9/20/22 at Health Center. RN informed patient of situation, explained risks (higher likelihood of experiencing side effects. RN informed patient that she can take Tylenol PRN for fever/pain. RN answered all of patient's questions.
My arm is still itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (My arm is still itching) 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 06-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (My arm is still itching). At the time of the report, PRURITUS (My arm is still itching) had not resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.
This spontaneous report was received from a medical assistant and refers to a 62-year-old female patient. The patient's concurrent conditions included diabetes and hypertension. The patient's drug reactions or allergies were reported as onion, aspirin, gluten, erythromycin, latex, soy, tetracycline, sulfa, PERCODAN and PERCOCET. On 16-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular injection, lot # R009163, expiration date 06-JAN-2020 (dose and anatomical location of injection were not reported) for prophylaxis. Concomitant therapies included albuterol, alprazolam, EDARBI, NORVASC, LIPITOR, CARDURA, FARXIGA and FLEXERIL. On 16-AUG-2018, the patient experienced swelling at the injection site. The patient sought medical attention via calling a physician. There was treatment given for the event. Lab diagnostic and studies were not performed. On 18-AUG-2018 (reported as within 48 hours), the swelling at the injection site resolved. The causality assessment between the event and PNEUMOVAX 23 was not provided. This is one of the two reports from the same reporter. Sender's Comments: US-00950713-1808USA009424.
The vaccine was given late Friday afternoon, 7/8/22. For the next 2 days (Sat & Sun) I had a 101° fever, body aches, exhausted feeling, and headache. I took TYLENOL every 4-6 hours for those symptoms. On the Monday morning I started getting a rash on both my arms. Rash started out as small red spots that eventually turned into small blisters and extremely itchy. I just wanted to tear my skin off! The next day the rash spread to the back of my right knee. The area looks like a 4x4 inch blister. Again, extremely itchy. A few days later the red spots came out on my left thigh, abdomen, chest, and right side of my neck. On Friday, 7/15/22, I saw a nurse practitioner at a health clinic. She gave me a steroid injection and KENALOG cortisone cream. The steroid injection only gave me relief for about 12 hrs. The KENALOG cream didn't really help at all. On Thursday 7/21/22 I saw (physician assistant) at a dermatology office. She gave me prednisone 10mg, hydrolyzed pam 25mg, and clobetasol .05% cream. It's helping a little. I'm also taking either SINGULAIR or ALLEGRA 1xday and BENADRYL every 3 hrs. Also calamine lotion.
Right arm with 5 X4 inch erythematous patch over the deltoid injection site, minimal redness and warmth to the rest of the arm.
Initial misuse report received from non-healthcare professional on 02 Sep 2014. A 67-year-old male patient, whose medical history and concomitant medication were not reported, had received a dose of FLUZONE HD, (route, site, dose in series and batch number was not reported) on 26-Aug-2014. On 26-Aug-2014, patient has been feeling weak, tired since vaccination and FLUZONE HD was administered to him, which had not been stored properly. Patient will need to come in for a repeat dose. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify): NKA, diabetes, high cholesterol, takes metformin, lisinopril and ACTFOREN. The patient's laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome of the events was reported as not recovered. Documents held by sender: none.
mild swelling @ inj site-severe muscle cramps from armpit, back of arm to elbow, swollen, hot, inflamed, T104.4, unable to walk d/t muscle cramps, nerve in rt leg;cannot walk;
Very red, swollen left arm about 5 inches in diameter. Hot to the touch. Patient is taking Benadryl, Zyrtec, Ibuprofen, and using ice packs. She stated she will be contacting her primary care doctor for an appointment but has not yet done so.
Patient's current age is due for Pfizer Pediatric COVID vaccine, however, immunizer gave patient the Toddler vaccine which is for patient age 6months to <5 years old.
LOW GRADE FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 an unspecified date, the subject experienced low grade fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever. This report was non-serious.
Seizure 2 days after shot. No history of seizures at all. Hospitalized for a week so far and still in there.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration), via an unspecified route of administration in right arm on 11Mar2021 at 13:00 as a single dose for COVID-19 immunisation.  Medical history included chronic obstructive pulmonary disease (COPD), diabetes, and COVID-19 (if COVID prior vaccination: Yes). No known allergies. Concomitant medications included metformin; insulin lispro (HUMALOG); metoprolol; amlodipine; atorvastatin; vitamin D; and pioglitazone. The patient also received first dose of BNT162B2 on 18Feb2021 at 01:00 pm (at the age of 79 years old) for COVID-19 immunisation. On 13Mar2021 at 12:00am, the patient experienced seizure 2 days after shot. No history of seizures at all. Hospitalized for a week so far and still in there. Patient did not receive other vaccine in four weeks. The patient underwent lab tests and procedures which included COVID test: negative on 13Mar2021. The event resulted in emergency room/department or urgent care visit. The patient received treatment for the event. The patient had not yet recovered from the event. The event was assessed as serious (hospitalization).  Information on the lot/batch number has been requested.
The patient forgot that he recieved the Fluvirin shot on 8/12/14 and received it again 9/20/14. He did not experience any adverse reactions, but the duplicate vaccination needed to be reported. He actually needed to receive the Zostavax vaccination instead. Our computer system was not proficient in catching the duplicate claim for the vaccination and our corporate office is working on it.