chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stillbirth-child died. Infection of the placenta but not in blood.; Stillbirth-child died. Infection of the placenta but not in blood.; Stillbirth-child died. Infection of the placenta but not in blood.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jul2021 09:00 (Lot number: EW0185) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Herpes 1" (unspecified if ongoing), notes: Herpes 1; "PCOS", start date: 2019 (unspecified if ongoing), notes: PCOS but hormones have been regulated since 2019. Date of last menstrual period: 24Oct2020. The patient was 39 weeks pregnant at the time of exposure to bnt162b2. The patient was 39 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 31Jul2021. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]; ACYCLOVIR. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (hospitalization, life threatening) with onset 27Jul2021 09:00, outcome "recovered", PLACENTAL DISORDER (hospitalization, life threatening), STILLBIRTH (hospitalization, life threatening) all with onset 03Aug2021 09:00, outcome "recovered" and all described as "Stillbirth-child died. Infection of the placenta but not in blood.". The patient was hospitalized for maternal exposure during pregnancy, placental disorder, stillbirth (hospitalization duration: 1 day(s)). The event "stillbirth-child died. infection of the placenta but not in blood.", "stillbirth-child died. infection of the placenta but not in blood." and "stillbirth-child died. infection of the placenta but not in blood." was evaluated at the physician office visit and emergency room visit. The pregnancy resulted in still birth (31Jul2021). The fetal outcome is intrauterine death. Therapeutic measures were not taken as a result of maternal exposure during pregnancy, placental disorder, stillbirth. Additional information: The patient had no other vaccine in four weeks and had no covid prior vaccination. The patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200151417 Same reporter/drug, baby case
3 days after 2nd Hepatitis B injection, this patient developed itching rash, to the lower abdomen only. Had same amount of itching after injection. Injection site without rash.
Admit 6/28. Vaccine 2/3, 2/24. Admit for SOB, cough. COVID +, COID PNA. Treated with abx, steroids, O2. Weaned down from 4L to RA at the time of DC. Returned to baseline at DC, DC'd home.
Strong local reaction to INFANRIX in left thigh, redness 8x8cm slightly tender.
Fever 101.5 degrees & fussiness last night, nurses less. TYLENOL given, provided some relief. "Hardly slept last night." Condition resolved on Feb 1st. Also mentioned pt had swelling on Rt at site of DTaP also resolved.
Swollen deltoid muscle and a large red area of skin  below the injection site,  skin is hot to touch and sore still on Monday 11-8-2021.  I had no reaction at all to the first two Moderna COVID vaccines.  I am a nurse and will continue to monitor symptoms.
pt exp fever of 102; rt leg pain, swelling, inc warmth, induration or lump w/o abscess;
Gave a 14 year old the pfizer vaccine. Afterwards he felt dizzy and ears were ringing. Stated he had not eaten in several hours. Gave him water and a snack. He felt better about 10-15 minutes later.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12Feb2022 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions. No treatment medication was provided.  This case contains information for the 8th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:Master Case
Left arm muscle soreness about 1000am on 3/14/2021. Lasted 2 days until 3/16/2021 Mild headache about 1000am on 3/14/2021. Lasted that day. Took to Advil OTC.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Arm pain that radiates down the whole arm Narrative:
Initial and follow-up information has been received from a physician's assistant concerning a female who was vaccinated with Gardasil.  Subsequently the patient fainted.  Unspecified medical attention was sought.  Subsequently, the patient recovered from fainting.  There were no laboratory or diagnostic tests performed.  Additional information is requested.
While administering second doses of Moderna at nursing home, facility LPN brought client and paperwork filled out for vaccine. Client verbalized her name. Moderna dose given and then RN discovered through conversation with client/vaccine card that last name was incorrect. Since there was a question about client identity, facility staff reviewed their information and realized the wrong client had been brought for vaccination. She had previously received Pfizer.
Immediate pressure on bridge of nose and strange taste in mouth lightheaded ness Next morning severe right hip pain .felt like a screw in the joint . limped for three hours? then pain went away? two hours late could  not raise right arm shoulder felt like a screw was in the joint  Now? September 12, toes are painful and separating (?) both knees difficult to climb stairs, left thumb is stiff and very painful  I walk 40!minutes a day and do yoga and exercises 5 days a week Now every joint in my body aches!!!   All since the shot!!!
reddened area, raised & firm formed immed upon inj of flu vax;no report of diff breathing, itching or feeling of apprehension;bleeding @ inj site;
pt c/o indigestion: since 31JAN96 severe;no n,v,d;burning sensation in throat;relieved w/eating;started zantac last evening 1FEB96;5FEB96:started on Prilosec w/improvement in last 2 days;
A nurse reported that a 41 year old female received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated on 06/30/00 as part of wound management following a cat bite. The patient also received therapy with Amoxicillin / Clavulanate. On 07/06/00, the patient was seen by the physician, who diagnosed cellulitis at the Tetanus and Diphtheria Toxoids injection site. The patient was hospitalized. Follow up info received 08/02/00 indicated that the patient recovered. MANUFACTURER'S COMMENT: On the following up, the reporter indicated that 2 additional patients developed cellulitis following receipt of Tetanus and Diphtheria Toxoids adsorbed, Purogenated; however, the report did not identify these patients. Neither of them was hospitalized.
Patient had anxiety prior to receiving vaccine and after. She said she felt very nauseas and wanted to puke. Was having trouble breathing. Patient did end up puking a few times. She was sweating and overheating, her tongue was starting to go numb, but she said her throat was not closing up. Her lips started to become white and she said she was having trouble seeing. her vision came and went at different times. EMS arrived and did diagnose her with an allergic reaction, gave her benadryl, and an ice pack. And sent her home.
Information has been received from a consumer concerning her now 22 year old son with an allergy to yeast who in "1988" at approximately 12 months old was vaccinated with MMR II. There was no concomitant medication. "Shortly after being vaccinated" in 1988 the patient experienced autism. The patient had sought unspecified medical attention. No lab test was performed. "Few years ago" the patient recovered from autism. The patient's autism was considered to be other important medical event. No further information is available.
soreness; redness; Muscle was missed and went SQ; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 7532P, expiry date 18-AUG-2024) for prophylaxis.   On 13-SEP-2023, the patient received Shingrix (subcutaneous). On 13-SEP-2023, less than a day after receiving Shingrix, the patient experienced pain (Verbatim: soreness), erythema (Verbatim: redness) and intramuscular formulation administered by other route (Verbatim: Muscle was missed and went SQ).The outcome of the pain and erythema were not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the pain and erythema to be related to Shingrix.    It was unknown if the company considered the pain and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-SEP-2023 The reporter wanted to know if Shingrix was not administered IM (intramuscular) and the muscle was missed and went SQ, which led to intramuscular formulation administered by other route. On 13th September 2023, the patient still had redness and soreness. The reporter consented to follow up.
Swelling, huge red spot at vaccine site, large lump-quarter size. Itchy with pain for 3-4 days. Redness & warm to touch with lump still at day 7 after onset.
Injection site was sore and now extremely red. Soreness and redness is improving and patient does not think he needs to be seen by MD. I encouraged him to seek attention if needed and/or have it looked at by RPh.
Repeated vomiting & diarrhea, upset stomach, headache. Lasted beyond 24 hours. Treated by resting and drinking fluids.
Mild pain right after the injection lasted for about 30 seconds. About 8 hours later, I started getting some nausea and an upset stomach, along with some mild aches and pains. After taking a short nap, I woke up feeling a little feverish (though no fever).
Dull pain for 2 months to right shoulder, at approximately 2 months pain became intermittent with numbness/tingling from right upper shoulder that radiates to fingers. Severe pain at night, about 3-4 nights per week. Pain is increasing over time. 06/15/18 seen PCP, was given steroid shot, currently doing physical therapy, 3 times a week. EMG performed with normal results on 05/31/18. (Burning with vaccine injection.)
a 2 inch by 3 inch area of swelling and redness on her arm near the injection site; a 2 inch by 3 inch area of swelling and redness on her arm near the injection site; This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 21-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On 22-JUL-2020, the patient experienced a 2 inch by 3 inch area of swelling and redness on her arm near the injection site. The outcome of the events was not reported. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Exaggerated local reaction with warmth, erythema, swelling from shoulder to elbow in arm where vaccine given (left). Also with fever up to 102.
pt recv vax 17OCT97 & that evening pt exp itching of lower legs, back & lt side of chest;application of hand lotion did not relieve the itching;application of neosporin ointment relieved the itching of back & chest p/10hr;
Mouth is full of sores, like canker sores. Red rings with white center, do not ulcer into the tissue. All over tongue, inside the lips, and cheeks. 100?s of these clusters vary in size causing extreme discomfort with burning feeling. Make it so that speaking and eating are difficult to not possible.
Foot joint stiifness and pain, stifness level from 7-8 from 10. Disturbed walking. Daily activity and walking disturbed for 3 weeks already and still didnt resolve.  It started second day'morning after vaccine day and continues still untill today -3 weeks already. First day after one hour after vaccination had unexplained strong nervousness, headach, flack pain, hand pain, depression.
Narrative:  Agency received notification from Hospice of the patients death on Nov 8,2021 while at Hospital, exact time not reported. Patient was 61 yo male with the following medical issues: CAD (S/P MI), COPD, GERD, HLD, Hypothyroid. Also he is followed by Oncology for tongue cancer & in community hospice care. Pt also had received covid vaccines on 10/8/21 & 9/10/21. This death is not related to covid vaccines.
Patient received booster on  11/19/2021 and began having  symptoms 11/20/2021. Patient has fever, chills and redness to injection site with swelling measuring  9.5mmx10mm with bruising
Cold Symptoms: hoarseness, sore throat, and cough; After food and over-the counter cough medicine:  feverish, light-headedness, faint, dizziness. I've been very feverish and nauseus for the last 2 or 3 night before the vaccination. But the nurse said it would be fine because I was not sick at the present moment.
In the beginning of March, I had congestion and a drainage and productive cough with sore throat. I may have had a slight fever. I went to the urgent care clinic, and they diagnosed me with strep.  I was given Amoxicillin and that's when I discovered that was not the best for me. It gave me a rash and redness. I thought I got better my throat was fine. The rash went away and no sore throat.  That last Friday I rolled a certain way, and it was a awful terrible pain in my elbow, I went to urgent care the found fluid on my elbow and I had a high fever. They gave me pain medicine and Bacterium. That night I had a fever of 105. My blood pressure was 70/40 something. I went to the ER, and they admitted me into the Intensive Care Unit And pumped me antibiotics. The next thing two days later they did surgery on my elbow to remove remaining fluid and repair damage. I stay in the hospital. In all I had Septic Shock in my left elbow. The fluid that was drawn out the first time in urgent care it created cultures that spread though out creating a infection. I am now taking Fluconazole an antifungal.  Today I feel really good, I am not feeling any pain in my elbow. It's not fully back to normal, but it's better each day.
Patient c/o severe pain to right arm after receiving Pneumovax vaccine went to ER - was kept overnight -.  11/30/07 Reviewed hospital medical records which reveal patient experienced severe right shoulder pain, dizzy & near syncope beginning 11/1/07.  Admitted 11/2/2007 overnight only.  Exam revealed marked swelling of deltoid. FINAL DX: severe drug reaction to pneumonia vaccine, reactive inflammatory response of deltoid.
Information has been received from a woman in a physician's office concerning a 7 year old male  who on 06/05/96 was vaccinated SC in the left arm with a first dose of Varivax. On 01/09/02, the patient developed chickenpox. The patient was examined by a physician ant it was reported that there were 50-60 pruritic varicella lesions all over. The patient's temperature was 99.4 F (tympanic) and he experienced vomiting. The patient's brother  (WAES 0201USA00781) also developed chicken pox following exposure to Varivax. Additional information has been requested.
R thigh red, warm to touch, hard, swollen per Mother.  Child complains of pain and itching in leg.  Mom unsure of where symptoms are in relation to injection site due to diffuse swelling.  Advised to contact PCP to see if they want her to be seen and to let us know if she does.  Advised to use warm compresses for comfort as needed.  Reports school nurse put "itch cream" on leg.
At approximately 1:04pm on 04/30/2021 patient during 10 minute observation had a syncopal episode and fall from standing to floor with loss of consciousness. Trauma assessment found contusion to occipital region of skull. No bleeding, no other trauma findings. Pt moved to wheelchair, and then to cot without incident. Pt AA&Ox4, airway patent, breathing shallow and non-labored. Pulse strong and regular with delayed perfusion. Pt skin pale, cool and dry. Pt eyes PERRL bilaterally. Pt complains of pain 7/10, dull, localized, to the base of skull, and ringing of ears, as well as dizziness without nausea. Pt administered 650ml oral water with improvement to skin and respirations.  Vitals and report continued on next page Pt however post oral hydration still stated no change to headache, and new onset tinnitus to left ear. Pt parent was consulted for transport to emergency department for assessment for potential injury post fall, and consented. EMS was contacted, who transported patient to hospital.   Vital signs as follows 1312 108/68 93p 14r 98%RA 1323 106/62 82p 17r 98%RA 1335 104/60 74p 16r 97%RA
Patient died the night he was given immunizations; he had a chronic neurological condition of unknown etiology.  5/2/08 Reviewed ER medical records which consisted of EKG strip showing asystole & a copy of death certificate which states DOD as 12/12/2007 & COD stated as cardiopulmonary arrest; aspiration; congenital brain malformation.  No autopsy was done.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L010595, expiration date 10-SEP-2016, dose and route unknown). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
About four days after I receive the first Pfizer vaccine I got a bright red itchy rash on my throat lower left jaw and into my neck area, it was difficult to touch it finally went away I tried an expired Halog ointment on  which expired in  2017.  I only use that once, it left the skin dry on my lower jaw for several days.
This spontaneous report was received from an office manager refers to a patient of unknown age who on 27-SEP-2012, was vaccinated with a dose of RECOMBIVAX HB (lot number 671326/1522AA) (dose and route not reported) that was improperly stored. No symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Adverse event was PE and DVT - PE identified on 6/2/21, LEFT LE DVT identified on 6/3/21
got (Td) in (R) deltoid on 08-10-07. Later that evening, pt noticed increased red, increased swollen, tender at site. Used Tylenol prn. Seen by me again 08-13-07 in office; had approx 7 cm diam. swollen, tender, erythematous area (R) shoulder/deltoid
10-17-07 Client received flu vaccine at 900 a.m. and started having swelling and redness and chills (did not take temp). Back of neck was hot. Had redness on abdomen and legs. Took 1 cap Benadryl. Redness and swelling were approx 1-2m above right elbow. 10/18/07 redness and swelling reported. 10/18/07 no chills.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The pharmacist reported that on an unspecified date in January 2013 the patient was possibly vaccinated with a low dose of ZOSTAVAX (dose, route and lot # unknown). The patient stated "her arm was wet" around the injection site after ZOSTAVAX was administered and there was a possibility that "some of the ZOSTAVAX leaked out of the syringe". No adverse effect reported. No PQC identified. Additional information has been assistant.
diarrhea; Nausea; muscle aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), NAUSEA (Nausea), MYALGIA (muscle aches) and FATIGUE (fatigue) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced DIARRHOEA (diarrhea), NAUSEA (Nausea), MYALGIA (muscle aches) and FATIGUE (fatigue). On 05-May-2021, DIARRHOEA (diarrhea), NAUSEA (Nausea), MYALGIA (muscle aches) and FATIGUE (fatigue) had resolved.      No treatment information was provided. No relevant concomitant medications reported.
9-14-07 Pt's mom called and stated (R) arm and hands were swollen after injection on 9-13-07. Pt received Hep A and Menactra in this (R) deltoid. Mom advised by health department to call physician and come by so nurse to see. Saw PCP - received Benadryl at office, came by HD - nurse stated had some swelling.
pt exp decrease vision OD & transient eye pain. Later devel blurriness in left eye, superior accurate defect OD, inferior latitudinal defect OS. Both optic discs moderately edematous w/ splinter hemorrhages & couon-wool spots;atrophy disc