chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in her upper arm/shoulder/ pain in her left arm/tender and hurts at night; Pain in her upper arm/shoulder/ pain in her left arm/ tender and hurts at night; Pain in her upper arm/shoulder/ pain in her left arm/ tender and hurts at night; This spontaneous case from the  was received on 07-Dec-2020 from other non-health professional (consumer) via The agency (reference number: SEQW20-05636) and concerned an 84-year-old female patient.  The patient's medical history included blood pressure abnormal, blood cholesterol abnormal and fibroid. The patient's concomitant medications included blood pressure, cholesterol medications and fibroid pill. The patient's historical vaccine included influenza vaccines, after which her arm was sore and painful, but not for long period of time as in this report.   On 08-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml; anatomical location: left arm; route of administration: not reported) for prevention of seasonal influenza. The batch number was not reported.   On 10-Sep-2020, two days after receiving Fluad Quadrivalent, the patient experienced pain in her upper arm and shoulder, it was tender and hurt at night. The patient also had difficulty dressing.     On an unknown date in 2020, the patient went to doctor, and was provided a prescription for meloxicam, but she was still experiencing pain and soreness in her arm.  At the time of initial reporting on 07-Dec-2020, the patient had not recovered from the events, as she was still experiencing pain in her left arm three months after the injection.  The reporter did not provide a causality assessment.  This case is linked with case 202007548 (the same patient and reporter).  Company comment: A 84-year-old patient was vaccinated with Fluad Quadrivalent. Two days after receiving Fluad Quadrivalent, the patient experienced pain in extremity, arthralgia and tenderness. Causality is assessed as possibly related for all events.; Sender's Comments: A 84-year-old patient was vaccinated with Fluad Quadrivalent. Two days after receiving Fluad Quadrivalent, the patient experienced pain in extremity, arthralgia and tenderness. Causality is assessed as possibly related for all events.
My first symptoms started 18APR2023 I tested positive for COVID-19 with a home test on 19APR2023. On 22APR2023 I had a consistent feeling of lightheadedness that would not go away and my heart was racing so I called EMS and the paramedics came and hooked me up to an EKG machine and I was transported to the local hospital ER. I stayed six hours felt better and went home.
This spontaneous report as received from a nurse refers to an unspecified number of patients. The patients medical histories were not reported. On an unknown date, the patients received improperly stored VAQTA, (lot #, dose, route and site of administration were not reported). No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
I also have covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I also have covid) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (I also have covid). At the time of the report, COVID-19 (I also have covid) had not resolved.            No concomitant medications were reported. Patient stated that he was a anti vaccine person. Patient had two shots and both were Moderna. Patient stated that this stuff was bad and was prescribed to different medications, going on for 7 days.  Company comment: This Spontaneous case reported by patient concerns a male patient of unknown age, with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19, unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient had previously received the Moderna vaccine on an unknown date. No other information regarding comorbidities, risk factors, symptoms, labs, diagnostic procedures, concomitant medications and treatment was available in the report. Ongoing Covid 19 pandemia is a confounder. The event had not resolved.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This Spontaneous case reported by patient concerns a male patient of unknown age, with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19, unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient had previously received the Moderna vaccine on an unknown date. No other information regarding comorbidities, risk factors, symptoms, labs, diagnostic procedures, concomitant medications and treatment was available in the report. Ongoing Covid 19 pandemia is a confounder. The event had not resolved.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Reports "tongue swelling" in Evening.  R/O Food. - Resolved w/ Benadryl.
Hives began on back on evening of 03/08/2012.  Worsened throughout the evening with urticaria with soft tissue involvement on 03/09/2012.
Dizziness; sickness; Achiness,pain; fever; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (Dizziness), ILLNESS (sickness), PAIN (Achiness,pain) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DENOSUMAB (PROLIA) injection for Osteoporosis postmenopausal.    The patient's past medical history included Sinus operation (for dilation) on 12-Aug-2020, Stapedectomy (stapes surgery) on 27-Aug-2021 and Arthroscopic surgery (calcified bone removal and an implant was put in and was intubated.). Previously administered products included for Product used for unknown indication: Boniva. Family history included Deafness (Hearing aid user in both ears, no hearing in right ear from 15 years) since an unknown date. Concurrent medical conditions included Hypertension, Blood cholesterol (Blood cholesterol abnormal), Osteoporosis postmenopausal, Carcinoid tumour since 2010 and Hearing aid user (Hearing aid user in both ears). Concomitant products included HYDROCHLOROTHIAZIDE, ZOLPIDEM TARTRATE (AMBIEN), ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]), CALCIUM, MONTELUKAST, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ROSUVASTATIN CALCIUM (CRESTOR), METOPROLOL SUCCINATE (TOPROL) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   In 2008, the patient started DENOSUMAB (PROLIA) (Subcutaneous) 60 milligram every six months. On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced ILLNESS (sickness), PAIN (Achiness,pain) and PYREXIA (fever). In September 2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) and PAIN (Achiness,pain) was resolving, ILLNESS (sickness) had resolved and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Bone densitometry: high (High) seven percent increase in bone.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported. Patient had underwent urine analysis and laboratory test and results were unknown.
headache brain fog pressure on eyes  rash on stomach including inside of belly button - treatment = hydrocortisone cream , still present 11 days after vaccination
temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's pertinent medical history and concomitant medications.  On 08-APR-2021 the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) with dose reported as 1 administered subcutaneously(lot number T028303 and expiration date 20-AUG-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002751:
Got COVID-19 after their first vaccination but before their second one; Got COVID-19 after their first vaccination but before their second one; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient got COVID-19 after first vaccination but before the second one. Event took place after use of product. Event outcome was unknown.    Information on the lot/batch number has been requested.
Swollen, painful, red, hot site, pt bedridden x 48 hours.
Pt c/o 3 X3 red, rash area, very warm to touch, whole upper arm aches. Advised oral Benadryl-topical hydrocortisone.
Face/neck sl raised non papular rash began 3/2. Infant was scratching it. Low grade fever, rash completely gone by Saturday 3/5/05. With interpreter, parent explained baby had rash nowhere else on body. States she had not changed soaps, lotions, etc. Fever was 99.6 rectal. Suggested Tylenol before next appt. Child received no sequelae.
COVID-19 vaccine given. Second day heart and chest felt funny. Can?t describe.  Third day had vertigo, nausea,  and chills.  Fourth day pretty good. Fifth day had vertigo, nausea and chills again. Sixth day, today, doing pretty good. Started ginger for vertigo yesterday and sprite.
Undetermined category II SIDS. 3/20/07 Received Autopsy Report which reveals COD as Undertermined (Category II SIDS).  Following were findings at Autopsy: hx of recent cough hx of cosleeping w/parent bloody fluid about nasal orifices pulmonary congestion & edema No evidence of trauma, natural disease, toxicological findings or metabolic disorder. Patent ductus arteriosus. Meckels diverticulum.
3:00 pm face got puffy, got flush & lasted about an hour.  By 8:00 pm I had extreme pain when I tried to walk. Right leg. It got a little better, I could walk but couldn?t lift my leg without a lot of pain for 1 week. I consulted my doctor & she said to take Advil. I took it for several days & symptoms went away.  2nd vaccination- within 5 minutes I had a cold sensation throughout my limbs. Then my blood pressure went very high & was erratic for several hours. I was advised to go to emergency hospital .
This is a spontaneous report from a contactable Consumer(patient). This consumer reported similar events for the patient. This is the first of two reports. A 67-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration at Arm Right on 14-JAN-2021 at the 67 years old at single dose for COVID-19 immunization.  The medical history included breast cancer survivor, allergies to strawberries, bananas, lobster, mahi, whiting fish. The concomitant medications were cholecalciferol (VITAMIN D), ascorbic acid(VITAMIN C), collagen, curcuma longa(TURMERIC) , olive oil.  The patient previously took VALIUM and experienced allergy. The patient got hives near her left eye with the first Pfizer shot in 2021 but wasn't sure if that was the cause as she did have food allergies. Her arm was a little stiff but not significantly and she did not have any other side effects in 2021. There was not treatment received for all the events. The patient had no Covid prior vaccination. There was no Covid tested post vaccination.  The outcome of the events was recovered in 2021. The information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148988 same patient, same product( different dose), similar events
chronic joint pain and muscle aches with elevated inflammatory markers, began around 12/01/2022- present
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 20-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Felt dizzy/lightheaded for the first few days after vaccine.  4/9 he noticed the development of petechiae.  4/10 he went to the ER about it and his labs came back normal. He said it continued to spread after his ER visit. I reviewed with him there isn't a treatment option and it should clear on its own, but if it still continues to spread or spots get bigger, if he develops a fever, increased heart rate, or pulse changes to contact his doctor or go back to the ER and followup with us as well.
red plaque-like papular rash over entire body, including sole of feet, palm of hands, etc; t97.4 ax;
Gran mal seizure lasting 2 minutes with incontinence. Temp of 99 taken by squad. Transported to Hospital ER and fever 101. Non coherent for 25 minutes; then communicative normally.
This spontaneous case, was initially received on 09-Oct-2017, reported by other non-health professional and concerns a 47-year-old female patient. Patient's medical history was not reported. The patient's concomitant medications included trazodone. On 19-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, anatomical location: deltoid, left arm, route of administration: intramuscular, batch number: 195218, expiry date: 30-Apr-2018). It was reported that, administration by nurse was too high up reaching tendon (as stated by patient's physician). A week after receiving vaccine (FLUCELVAX QIV) the patient had a limited range of motion, was unable to lift arm and described pain in upper shoulder. The patient's treatment medications included ALEVE, naproxen. It was reported that, the patient was still struggling with shoulder arm issues in the left arm, despite consulting many doctors. An MRI (magnetic resonance imaging) was scheduled on 23-Oct-17, the patient was on physical therapy. It was stated that, it has been very challenging for her, the pain was quite intense and her range of motion was limited. She struggled with day to day activities such as clothing herself and even to put on socks she has to take help of her son. She was not able to carry heavy objects. The patient felt constant probing pain in shoulder and cannot easily get out of the bathtub. The outcome of the events was not recovered. The reporter assessed this case as non-serious. Follow-up report received on 20-Oct-2017: It was reported that, the patient was still struggling with shoulder arm issues in the left arm, despite consulting many doctors. An MRI (magnetic resonance imaging) was scheduled on 23-Oct-17, the patient was on physical therapy. It was stated that, it has been very challenging for her, the pain was quite intense and her range of motion was limited. She struggled with day to day activities such as clothing herself and even to put on socks she has to take help of her son. She was not able to carry heavy objects. The patient felt constant probing pain in shoulder and cannot easily get out of the bathtub. Event "activities of daily living impaired" was added. Amended narrative accordingly. Non-significant case correction received with IRD 09-Oct-2017: Batch number (195218) was captured in the case form and narrative was amended accordingly.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated on 03/19/21 and has since received dose 2  on 04/09/21
It was so bad that he could hardly sleep; warm; night the area started itching; It's a large red circle around the injection site; it was just a little bit sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (It's a large red circle around the injection site), PAIN (it was just a little bit sore), PRURITUS (night the area started itching), INSOMNIA (It was so bad that he could hardly sleep) and FEELING HOT (warm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 immunisation.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN (it was just a little bit sore). On 05-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (It's a large red circle around the injection site). On 08-Feb-2021, the patient experienced PRURITUS (night the area started itching). On 09-Feb-2021, the patient experienced INSOMNIA (It was so bad that he could hardly sleep) and FEELING HOT (warm). At the time of the report, VACCINATION SITE ERYTHEMA (It's a large red circle around the injection site), PAIN (it was just a little bit sore), PRURITUS (night the area started itching), INSOMNIA (It was so bad that he could hardly sleep) and FEELING HOT (warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided. Treatment details Ice,Mosquito bite medication,Topical antihistamine
I was given the vaccine in my left shoulder while at work. A few hours into my shift, I noticed that my shoulder began to hurt, more then the other times I received the vaccine. Everyday after, the pain became more intense until it was unbearable. I can not move my shoulder without sharp shooting pain. I went to the Dr. at Occupational health, at my work, on Oct 21, 2015. The Dr prescribed naproxen and tramadol. I was told to return in a week. I returned on Oct 27th. I saw a different Dr this time. He ordered a shoulder Xray, which he said was negative. He said to continue taking the anti-inflammatories, showed me some exercises to do and said to return in 10 days. He also stated that if my shoulder wasn't better then, I could do physical therapy. My shoulder is still in a lot of pain. I am not able to use my arm because of the pain.
The patient, who is 16 years old, received the vaccine when the vaccine is EUA approved for 18 years of age or older.
Rash on back of hands (on-going, started 9 days after injection)   Swollen lymph nodes under arm (three days, started 5 days after injection)
I had celiac disease for 11 years, and after receiving my first dose I am now able to eat gluten with no issue.
Patient tested negative for blood work/titer from MD office post getting their first series of Pfizer from another facility and was advised by their provider to get another series of the COVID vaccine. Patient received their first dose Moderna without informing the pharmacy that they previously completed the 2-dose series for Pfizer.  Patient  returned for their second dose of Moderna on 7-8-21. Upon screening for the second dose, patient then informed the pharmacy for the 1st time about previous Pfizer doses. Patient was informed at this time that pharmacy can not complete 2 dose Moderna series.
Fever, body aches, dizziness, palpitations Pt has contacted her PCP for advise and evaluaiton
On 4th day - I started feeling dizzy  and weak and it is still persistent. I continuously feel off balance .   I also felt nausea on 29th April,2021 (4 days from the date of vaccination) but it has not been since then.
Arm is like bright red in that area and it's warm; arm is like bright red in that area and it's warm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6204), via an unspecified route of administration on 27Feb2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On an unspecified date (a week since vaccination), patient still had her arm was like bright red in that area and it's warm. Patient saw it was even listed as one of the side effects and she was wondering whether this was okay and how long that would last. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
102 fever for 36 hours, low grade 99-99.5 fever for another 24 hours, massive headache for 72 hours, arm pain for 5 days, tired for the first 24 hours after the 102 fever started.
11/11/22 - Patient presents for diffuse rash to bilateral arms s/p 2nd dose of novavax vaccine yesterday. She states she had the same reaction after the first vaccine and the meds from UC worked well for her. She after the shot yesterday she felt swollen in her arms, had ear itching, itching on her feet as well. She took a left over cetirizine last night which helped and rash is improved today. She denies any SOB, cough, itching mouth, swelling in face or lips, or wheezing.  11/14/22 - Patient presents for acute worsening of rash and now with chest tightness. She states she did now do well on the 40mg of prednisone and when she tapered to 1 yesterday, all her sx came back with associated chest tightness. No wheezing, SOB, itching to mouth, cough, swelling, etc.
Patient was given monovalent instead of bivalent as the booster dose. this was the 1st day after the new recommendations came out to no longer give monovalent as a booster and before the pharmacy protocol was updated. also, before bivalent was in stores yet. No actual adverse reaction from pt.
The patient's boss called into the pharmacy to state that her employee received her flu and Tdap shot at the pharmacy on Sunday 10/23/16 and still has a red, sore, warm and painful arm where the vaccine was administered.