chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was diagnosed with bell's palsy; A spontaneous report was received from a physician concerning a 64-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced one weak eye and was diagnosed with Bell's palsy.  The patient's medical history and concomitant medications were not provided by the reporter.  On 26 Dec 2020, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch number: unknown) intramuscularly in the deltoid muscle of an unknown arm for prophylaxis of COVID-19 infection.   On 27 Dec 2020, the patient had one weak eye.  On 28 Dec 2020, the patient went to the urgent care, was diagnosed with Bell's palsy. The event Bell's palsy was found to be medically significant.  Treatment medications reported were steroids and valacyclovir.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of Bell's palsy was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
body ache; headache; chills; muscle ache; muscle weakness; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CHILLS (chills), MYALGIA (muscle ache), MUSCULAR WEAKNESS (muscle weakness), PAIN (body ache) and HEADACHE (headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced CHILLS (chills), MYALGIA (muscle ache) and MUSCULAR WEAKNESS (muscle weakness). On 28-Jan-2021, the patient experienced PAIN (body ache) and HEADACHE (headache). At the time of the report, CHILLS (chills), MYALGIA (muscle ache), MUSCULAR WEAKNESS (muscle weakness), PAIN (body ache) and HEADACHE (headache) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment details included OTC Ibuprofen for 2 days.
Information has been received from a licensed practical nurse (LPN) concerning a 26 year old female who was vaccinated with a dose of Gardasil.  Immediately after vaccination, the patient experienced numbness and tingling in the fingers on the hand of the arm the patient was vaccinated.  The numbness and tingling were of "fleeting duration," and subsequently, the patient recovered without sequelae.  No further information is available.  This is one of two reports received from the same reporter. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a licensed practical nurse (LPN) concerning a 26 year old female who on 27-DEC-2006 at 16:42 was vaccinated IM in the left arm with the first dose of the GARDASIL (Lot # 653736/0689F). Immediately after vaccination, the patient experienced tingling from the injection site in the left deltoid down to the fingertips for about 60 seconds, which then completely resolved. On 28-FEB-2007 at 14:55, the patient was vaccinated IM in the left arm with the second dose of the GARDASIL (Lot # 653736/0689F). After vaccination, the patient experienced tingling from the injection site in the left deltoid down to the fingertips for about 10 seconds, which then completely resolved. The third dose of the GARDASIL was administered on an unspecified date and the patient experienced no tingling or numbness. The patient recovered without sequelae. No further information is expected.
Scattered erythematous macules on chest, back, abdomen, arms, face, sparing legs.
09/03/2003: Mother stated child has not been the same since immunizations.  Mood swings, irritable, not sleeping, decrease appetite, temperature 101, went to ER 09/01/2003-otitis media diagnosed.
Patient reports "I  had MMR, Typhoid and Anthrax (think I was only one who got it). That evening my entire pointer finger and thumb on my right hand (dominant hand)burned (like a nerve burning pain); the next day my finger tips on those fingers burned but it would come and go.  Specifically when working (writing, gripping something, etc). Today they seem to be fine but I am monitoring."
pt recv vax 22OCT96 & mom reports pt came down w/chickenpox;3JAN97 devel approx 130 lesions all the lesions now crusted over;had not fever or other sx w/chickenpox;
High Fever 104 - 105 F x 48 hours, possible febrile seizure.
Patient reported that the sight of injection was red and itching. Redness had a diameter of about 4 inches from site of injection.
Approximately one month subsequent to receiving third dose of Lymerix, the pt was bitten by a black fly on the wrist and developed swelling and redness of the right hand. Pt was seen by a physician 24 hours later and was told that it appeared to be an allergic reaction. Pt was treated locally with ice and Benadryl. The reaction resolved within 48 hours. Approximately one month later, the pt experienced another insect bite on her right cheek. The area of the bite and the entire right side of her face swelled and continued for six days. The pt was seen by a physician and was diagnosed with an allergic reaction. Pt was treated with Cipro for seven days. After taking three doses the swelling started to abate. As of 09/12/2000 the outcome of the event is unknown.
diluted vaccine vaccine out of fridge 14Sep2022 at 8am it was given to patient 15Sep2022 at 3:49 pm, product was at room temperature; diluted vaccine vaccine out of fridge 14Sep2022 at 8am it was given to patient 15Sep2022 at 3:49 pm, product was at room temperature; Expired vaccine used/Expiration Date: 22Jan2022; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 15Sep2022 at 15:49 as dose number unknown (maroon cap), 3 ug single (Lot number: FT9142, Expiration Date: 22Jan2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 15Sep2022 at 15:49, outcome "unknown", described as "Expired vaccine used/Expiration Date: 22Jan2022"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 15Sep2022 at 15:49, outcome "unknown" and all described as "diluted vaccine vaccine out of fridge 14Sep2022 at 8am it was given to patient 15Sep2022 at 3:49 pm, product was at room temperature".  Additional information: The case reported as non-serious. Dose/Dosage Form: Maroon cap, Original(Monovalent)6 months to 4 years-3 mcg/dose, Dilute before use. RN asking about stability of pizer-BioNTech COVID-19 Vaccine per caller (burgundy cap) Maroon cap, 6 months to up to 05-years, diluted vaccine out of fridge 14Sep2022 at 8am it was given to patient 15Sep2022 at 3;49 pm, product was at room temperature, what to do in this situation Next steps also, on the vial expiry date is 22Jan2022 but expiry date. 31Dec2022 is noted in the chart, reporter wanted to know if we had any clear guidance on that Lot# FT9142 per safety reporter had a question regarding that as well but when reporter came on the line she stated that she had figured it out, no need to address that question, mentioned that NDC # on the box and actual vial were different last two digits were different that is why she was confused but she had figure it out ( per reporter she shared that with safety us well) no question to medical information about that either as per reporter he had figured it out as well. The only difference was the last two numbers one is the box is 04 and the vial is 01.
allergic reaction to Prevnar 13; whole arm swelled up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic reaction to Prevnar 13"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "whole arm swelled up".  Additional information: The patient had an allergic reaction to Prevnar 13 where her whole arm swelled up.  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Patient felt "funny" and collapsed over, when brought to our attention the patient was awake and alert, denied any injury, denied anaphylactic symptoms
Chills; Body Aches; Nausea; Vomiting; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (Chills), MYALGIA (Body Aches), NAUSEA (Nausea) and VOMITING (Vomiting) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced CHILLS (Chills), MYALGIA (Body Aches), NAUSEA (Nausea) and VOMITING (Vomiting). In February 2021, CHILLS (Chills), MYALGIA (Body Aches), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was Not Applicable. No concomitant information was reported.  No treatment information was reported.
I got my shot and got sick; Initial information was received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient with unknown demographics who got shot and got sick after being vaccinated with Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for prophylactic vaccination and got sick (illness) a few months later (unknown latency).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
He feels tense and he there's a bump on the nerves on between his neck and shoulder, and when you press on it hurts.
The pt developed a rash on the right 5th digit pad. Fever started on 8/17/00 and lasted until 8/18/00. On 8/26/00 blisters developed on the left thigh with redness and swelling. The pt also experienced swollen lymph nodes with worsening swelling, redness and pain.
medical history of asthma, obesity, and insulin-dependent type 2 diabetes with insulin pump who was admitted for COVID-19 pneumonia. He had received the JJ vaccine on March 16, but began having chills, cough and malaise on March 30th.
The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023; No adverse event; She states they administered the Moderna bivalent 2 days after the 30-day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She states they administered the Moderna bivalent 2 days after the 30-day BUD), PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 16-Aug-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (She states they administered the Moderna bivalent 2 days after the 30-day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She states they administered the Moderna bivalent 2 days after the 30-day BUD), PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023) and NO ADVERSE EVENT (No adverse 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 adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She states they administered the Moderna bivalent 2 days after the 30-day BUD) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 14-JUL-2023 and administered to patient on 16-AUG-2023).    The patient had Monovalent Moderna vaccine in 2021. It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  The vial did not undergo temperature excursions.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-737986 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737986:Same Reporter
The nurse was to give a Dtap to an 18 month old patient. Nurse accidentally pulled a PEDIARIX out of the fridge to give instead of an INFANRIX. Nurse gave vaccine and found error as putting them in NCIR.
Information has been received from a registered nurse concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). The registered nurse reported "somebody that works within the community health center's child received the dose of GARDASIL, at another office (which was not specified) and experienced a serious adverse event where she could not walk among other things which were unspecified". The registered nurse reported that the patient was hospitalized and the length of stay was unspecified. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Severe Headache. Pain from nose up throughout that half of the head from front, sides, and back of head. Excederin did not help. Nausea and eventually threw up everything in stomach. Went to ER, recieved fluids, toradol, Reglan by IV, and tylonal by mouth. After the ER visit, the pain went away.
Pfizer 3/5/21 and 3/26/21. Positive on 1/20/22
Patient received 0.3 ml from a pediatric vial, she received 15mcg instead of the 30mcg dose which she was suppoe.
Left arm pain when raising arm initially later that afternoon. Swelling under arm to the extent I could not lower arm, could not wear bra next morning. Area was hot and painful to the touch. Lasted three days. Generally did not feel well the entire week after receiving the booster.
p/vax pt was hosp w/Dx Intussusception reduced by barium enema & pt disch;  Per doc 198120, child is no longer a patient of this physician.
Developed cellulitis left upper extremity 1 day following Pneumovax. No organism identified. Pt treated with Clindamycin, Zocin. Pt is asplenic from trauma.
Pinkish in color; Warm to touch; Hardness at injection site; Sore; Clammy; Felt washed out; Pain across shoulder; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Clammy), SKIN DISCOLOURATION (Pinkish in color), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hardness at injection site) and ARTHRALGIA (Pain across shoulder) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028AZ1A and 025AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives (Chronic hives years ago.).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced ARTHRALGIA (Pain across shoulder) and FATIGUE (Felt washed out). On 29-Mar-2021, the patient experienced COLD SWEAT (Clammy). On 30-Mar-2021, the patient experienced SKIN DISCOLOURATION (Pinkish in color), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE PAIN (Sore). At the time of the report, COLD SWEAT (Clammy), SKIN DISCOLOURATION (Pinkish in color), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hardness at injection site), ARTHRALGIA (Pain across shoulder), VACCINATION SITE PAIN (Sore) and FATIGUE (Felt washed out) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
woke up at 7am and  fainted upon standing up (vaso-vagel event ) --NO HX OF VASO VEGAL EVENTS IN PAST , headaches, nausea , body aches
Approximately 10 minutes after receiving the COVID- 19 vaccine resident displayed seizure activity, staring straight ahead and strong allover muscle jerking of both the up and lower extremities, color became gray, activity lasted approximately 3 minutes, resident then became relaxed, color returned to normal, BP-140/80, 97.8, 60, 16, sleeping the remainder of the shift,. Resident continued to decline until resident CTB on 1/19/21
The pt experienced localized erythema at the site of injection 24 hours post vax. The pt also experienced pain at the injection site,, swelling of tissue with palpable nodule.
After flu shot was given, patient said he felt dizzy then fell off the chair unconscious. Patient was responsive after about 1 min. 911 team came and did further assessment. The emergency response team said he was ok and no further treatment was given.
Left arm 1st dose given at 12:39 pm. 15 mins post vaccination, patient began having a warms sensation on her left shoulder blade followed by itching in her extremities. She was brought to observation and reported urticaria all over, flushing of the face, and hives in her upper and lower extremities. Vitals taken and were stable. Benadryl 50mg was administered 15 mins post vaccination and immediately  patient reported decreasing symptoms of warmth sensation, itching, and hives. Patient reports she has recently developed hives with cortisone injections. Patient examined 20 mins post vaccination: S1,S2, CTA, hives noted on bilateral UE and LE. Hives resolved 25 mins post vaccination. Patient monitored for over 45mins and reported her symptoms were mild. She declined transportation to the ER. She left in stable condition with her husband.
a foggy feeling in my head that made it hard to think; woke up with my eyes crusted shut; my whole body aching so severely that I could barely move; my whole body aching so severely that I could barely move; a foggy feeling in my head that made it hard to think; severe dizziness that affected my ability to drive; severe dizziness that affected my ability to drive; loss of appetite; I also experienced some bruising at the injection site; I experienced a fever of 101.1; This is a spontaneous report from a contactable consumer, the patient.  A 17-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: FF2587), via an unspecified route of administration, in arm left on an unspecified date at 10:00 as dose 2, single for COVID-19 immunisation. The patient's medical history included IBS, asthma, cholecystectomy since an unknown date. The patient did not have covid prior to the vaccination. The patient did not have any known allergies. Concomitant medication(s) included dicycloverine hydrochloride (BENTYL) and ferrous sulphate since an unknown date. The patient previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: 30145BA), via an unspecified route of administration, in arm left on an unspecified date at 10:00 as dose 1, single for COVID-19 immunisation and experienced moderate dizziness, low grade fever, arm aches, and mild swelling at the injection site. No other vaccine was taken in in four weeks. The patient experienced her symptoms the day after the shot. She woke up with her eyes crusted shut, her whole body aching so severely that she could barely move, loss of appetite, a foggy feeling in her head that made it hard to think, and she experienced a fever of 101.1 and severe dizziness that affected her ability to drive. She also experienced some bruising at the injection site but that was to be expected. These adverse effects however only lasted 1 to 3 days and afterward she was fine. The patient did not take any treatment for the events. The patient underwent lab tests and procedures which included body temperature as 101.1 on an unknown date. The patient was not tested for COVID-19 post vaccination. The outcome of all the events was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a nurse and describes the occurrence of FLUSHING (Flushing in ears and face), PARAESTHESIA ORAL (Tingling on lips), ERYTHEMA (Redness in ears and face), HYPOAESTHESIA ORAL (Numbness on lips) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose/ second dose was not administered) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 14-Dec-2020.On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced FLUSHING (Flushing in ears and face), PARAESTHESIA ORAL (Tingling on lips), ERYTHEMA (Redness in ears and face) and HYPOAESTHESIA ORAL (Numbness on lips). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get second dose/ second dose was not administered). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 06-Jan-2021, FLUSHING (Flushing in ears and face), PARAESTHESIA ORAL (Tingling on lips), ERYTHEMA (Redness in ears and face) and HYPOAESTHESIA ORAL (Numbness on lips) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not get second dose/ second dose was not administered) had resolved.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. The symptoms went away in 1-2 hours post their onset.