chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Chills; Fatigue; Exhaustion; Trouble concentrating; feel run over; like flu; Extreme arm pain; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Apr2021 at 13:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies, anxiety, polycystic ovarian syndrome (PCOS) and COVID-19. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 22:00, the patient experienced extreme arm pain in evening of vaccine day, then day after on 09Apr2021, around 11:00, the patient experienced fever, chills, fatigue and exhaustion, trouble concentrating, feel run over, like flu. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme arm pain, fever, chills, fatigue, exhaustion, trouble concentrating and feel run over, like flu were not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sore throat, fever 103, chills, headache, body aches, dizzy, congestion. From 11/20 afternoon to 11/25/2003 complete bed rest, liquids, Advil.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Sweaty palms-Mild, Additional Details: Symptoms started approximately 10 minutes after Covid vaccine and lasted approximately 30 min. Declined
Patient stated on 04/08/2011 that she experienced the following-dizzy symptoms on morning following the infection but has decrease since. Feverish symptoms on evening following injection. Patient took apap and symptoms resolved. No rash or swelling at immunization site.
This spontaneous report has been received from a pharmacist (also reported as a nurse) referring to unspecified patients of unknown age and gender. There was not information regarding pertinent medical history, drug reaction or concomitant therapies. On 30-DEC-2016,  the patients were vaccinated with doses of an improperly stored GARDASIL 9, with lot # M017983, expiration date 30-MAY-2018 and lot# M024261, expiration date 30-JUL-2018 (route of administration, dose and frequency were not provided) for prophylaxis. The reporter stated that the temperature range of the vaccine was 1.4 Celsius (C) and the time frame was 46 minutes, also she stated that the previous temperature excursion was 9.4 Celsius (C) during 1 hour and 35 minutes, this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007904: US-009507513-1701USA007902: US-009507513-1701USA007903.
started feeling numbness and tingling to hands/arms/ foot/ leg.  Developed into weakness and went to hospital and dx as Guillan Barre
Manufacturing malfunction. The glass of the syringe at the end was damaged. As the vaccinator pushed, the fluid squirted out. Patient's skin was already penetrated by the needle. "20%" of the fluid may have gone in.
w/in 1-2 minutes of receiving MMR vax lt deltoid became weak, pale, unconscious w/shallow resp, sweaty (shocky); given Ammonia; laid supine; recvd O2 via face mask;
03/15/2021: Presented to the emergency department with worsening lower extremity edema and dyspnea on exertion. The patient was admitted for a congestive heart failure exacerbation for IV diuretics. Patient currently still admitted and now having lower GI bleeding on a heparin infusion.
Patient reported a pain that spread over her lower back that started within 15 min of receiving vaccines. Did not take any medications to relieve the pain. Patient states the pain went away the same day.
Non-itchy slighlty raised rash that appeared about 24 hours after vaccine at location of shot that extended up to shoulder and down to elbow. It went away after another 24 hours.    1 week after vaccine, developed lip twitch on side of body that vaccine was administered. Still persists 1 week later, but is not as intense
Started to run 100.4 fever; lymph node under left arm where I had the injection site was EXTREMELY swollen, severe headache
The first evening with problem, (6/1/10), arm with injection became very sore and somewhat painful to move. By that night around 10:15PM arm pain was very severe. Next day (6/2/10), I could not move my arm because of severe pain. I could not do any of the following: lift my arm, move arm in any direction, hold something that weighed more than 2 pounds or even make any quick movement without feeling robust severe pain in that arm. The pain at times when trying to dress was so severe, I cried out. I got little sleep because lying down caused pain which moved from my arm to my neck and back shoulder. This pain has lasted so far four days. Today is day four and I am finally feeling less pain. I can finally touch my face without pain but, I still can not raise my arm without feeling pain.
Ten vesicular & papular rash both arms & chest wall on 4/26/08.  ? post vaccination dermatitis.  ? chicken pox.
lymphadenopathy neck; lymphadenopathy neck and axillary area; Achiness; This spontaneous case was reported by a nurse and describes the occurrence of LYMPHADENOPATHY (lymphadenopathy neck), LYMPHADENOPATHY (lymphadenopathy neck and axillary area) and MYALGIA (Achiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (lymphadenopathy neck), LYMPHADENOPATHY (lymphadenopathy neck and axillary area) and MYALGIA (Achiness). At the time of the report, LYMPHADENOPATHY (lymphadenopathy neck), LYMPHADENOPATHY (lymphadenopathy neck and axillary area) and MYALGIA (Achiness) was resolving.        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.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: case was not valid until 22-Jan-2021; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Hard to the touch; Red area under the site of the injection sensible to the touch; Red area that is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard to the touch), VACCINATION SITE ERYTHEMA (Red area under the site of the injection sensible to the touch) and VACCINATION SITE PAIN (Red area that is sore) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Hard to the touch), VACCINATION SITE ERYTHEMA (Red area under the site of the injection sensible to the touch) and VACCINATION SITE PAIN (Red area that is sore). At the time of the report, VACCINATION SITE INDURATION (Hard to the touch), VACCINATION SITE ERYTHEMA (Red area under the site of the injection sensible to the touch) and VACCINATION SITE PAIN (Red area that is sore) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Immunization received 08/10/2005 that night the left upper arm swelled, turned red and hot from shoulder to elbow.
sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (sick) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (sick). At the time of the report, VACCINATION COMPLICATION (sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
Patient received vaccine at 11:15 ten minutes later she passed out in a sweat, hot, dizzy, nauseous.
This spontaneous report as received from a medical assistant refers to 14 month old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Client was administered season flu vaccine (FLUVIRIN) on 10-5-10. Returned to pharmacy on Sunday (10-10-10) and reported had muscle and joint pain with onset the evening of injection. Felt relief from movement but reported that it was restricted. Also reported fluid retention. Reported improvement by Sat. and better on Sunday.
Band around arm that was swollen, hot and red.  Arm was also very sore.  Symptoms have decreased and a little soreness and itching is now remaining.
Breathlessness; TIREDNESS; BODY ACHE; Joint pain; Vaccination site redness; Lots of shivering; Fever is 101.2; Back ache; Headache; Aggravated Cough; Stomach ache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Aggravated Cough), ABDOMINAL PAIN UPPER (Stomach ache), DYSPNOEA (Breathlessness), BACK PAIN (Back ache) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma (Recent change in status of chronic condition: after taking the vaccine for a couple of weeks.) in 2004.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced COUGH (Aggravated Cough), ABDOMINAL PAIN UPPER (Stomach ache), BACK PAIN (Back ache), HEADACHE (Headache), ARTHRALGIA (Joint pain), VACCINATION SITE ERYTHEMA (Vaccination site redness), CHILLS (Lots of shivering) and PYREXIA (Fever is 101.2). On an unknown date, the patient experienced DYSPNOEA (Breathlessness), FATIGUE (TIREDNESS) and MYALGIA (BODY ACHE). The patient was treated with Physical therapy for Back pain. At the time of the report, COUGH (Aggravated Cough), ABDOMINAL PAIN UPPER (Stomach ache), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Vaccination site redness), CHILLS (Lots of shivering) and PYREXIA (Fever is 101.2) had resolved, DYSPNOEA (Breathlessness), FATIGUE (TIREDNESS) and MYALGIA (BODY ACHE) outcome was unknown and BACK PAIN (Back ache) and ARTHRALGIA (Joint pain) had resolved with sequelae.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   This case was linked to MOD-2021-009476 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant FU : AE details provided; Sender's Comments:  MOD-2021-009476:Dose 1
New onset left sided tinnitus without associated hearing loss shortly after vaccination.  Of note patient was diagnosed with prostate cancer 2 months ago and was started on hormone therapy 1 week prior to our clinic visit. He was also vaccinated with Pfizer vaccine ( about 2 weeks prior) and the tinnitus may have started around the time of second vaccine.
Patient reported loss of use of his legs on Friday 9/22/17, was seen at Hospital Emergency Room. Patient came to clinic on 9/25/17 with continued leg weakness, leg swelling and ecchymosis of legs.  Patient collapsed in clinic and was unable to stand, bear weight or move legs.  Was transported to  Hospital ER.  Patient was then transported from ER to Hospital where he remains hospitalized without a definitive diagnosis as of this date. Hospital was notified of immunization status.
This patient may have received less than the standard 0.5mL dose. The vaccinator who administered the vaccine to this patient obtained over the expected 11 doses from a single vial. This was noted on reconciliation of vials and consents.  Patient informed (or attempts are being made to contact  them to inform them).  Plan on second dose as scheduled as per guidance from CDC and Moderna.
This spontaneous report as received from a licensed nurse practitioner refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9 (dosing details were not reported). On an unknown date, the patient was vaccinated with second dose of GARDASIL 9, intramuscularly six months after receiving her first dose. No adverse reactions were reported. No product quality complaint (PQC) was reported for GARDASIL 9. Additional information has been requested.
Patient reported that she the right side of her face was swollen and had bump on her right eye....
Consumer reports pt in good hlth recvd DTP; Shortly following immun, pt exp vomiting, lethargy, & difficulty breathing; Previous rxn to an earlier DTP;
Information has been received from a health professional concerning a female patient between 11-18 years who on an unspecified date was vaccinated with the fist dose of GARDASIL (lot number, site and route not reported). On an unspecified date, the patient's menstrual cycle was interrupted. She stopped the vaccine series because her MD recommended it. Additional information has been requested.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and drug allergies were not reported. On unknown dates, the patients received either one or tow doses of GARDASIL (dose, strength and route unknown). On unspecified dates, the patients were administered either one or two doses of GARDASIL 9 (dose, strength and route unknown) to complete their three-dose HPV vaccination series. These patients had an extended vaccination interval (more than 2 or 6 months, depending on which dose in the series for which they were due) between the administration of the two doses of GARDASIL or GARDASIL 9. No adverse effect reported. This is one of the two cases received from the same reporter. Additional information has been requested.
fever; received the booster shot; received the booster shot; This is a spontaneous report from a contactable consumer (wife) reported for a 78-year-old male patient (husband). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), dose 3 via an unspecified route of administration on 02Sep2021 (at the age of 78 years old) as DOSE 3, SINGLE for covid-19 immunisation. Medical history included ongoing spinocerebellar ataxia. When asking for medical conditions, medications, testing labs and treatment, the reporter referred to the facility where he lives. Confirms he has had Spinocerebellar ataxia for 20 years. She noted he had Covid in Apr2020 and after he had Covid he had a flare up of prostatitis which was something he never had before. This was prior to getting the vaccines. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on Dec2020 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on Jan2021 (at the age of 77 years old) for covid-19 immunisation and after the first 2 doses he was lethargic and weak, patient was diagnosed with colon cancer was diagnosed in May2021, after the first 2 vaccines. Reporter, a wife calling for her husband regarding the Pfizer Covid booster vaccine and who explained her husband received the booster shot last Thursday on 02Sep2021. The booster shot was given on 02Sep2021, the first shot was given in Dec2020 and the second was in Jan2021. He has a rare neurological condition Spinocerebellar ataxia. Currently he was getting chemotherapy for colon cancer. He has had 2 treatments of chemo and did wonderful after both. A week after the second dose of chemotherapy he had his booster shot and has tanked, he has not been the same and it has been hard for him to crawl back out of this. His labs and vitals are fine though he did have a little fever the day after vaccine on 03Sep2021, but he was not back to where he was the day before he got the vaccine. The reporter was looking for to evaluate his specific situation. She wonders if due to the neurological condition he should have gotten the booster shot. She was very concerned and though the doctors are telling her he has a lot of other things going on she felt she should take it a step further and question what was going on. She explained he got the first dose of the Covid vaccine in Dec2020 and the second dose in Jan2021. After the first 2 doses he was lethargic and weak but nothing like what he was experiencing now. She understands that now the booster shot has been compounded with the chemotherapy he was also taking but there was not an issues with the first and second dose of the Chemotherapy. The outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Soreness in left arm (which is the arm that received the shot); fatigue; mild body aches; short-term diarrhea; nasal congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 10:00 (Lot number: EP6955) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Date:22Mar2021 10:00, Lot:EP9655, Location: arm left), administration date: 22Mar2021, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Apr2021 12:00, outcome "recovered" (Apr2021), described as "Soreness in left arm (which is the arm that received the shot)"; FATIGUE (non-serious) with onset 13Apr2021 12:00, outcome "recovered" (Apr2021), described as "fatigue"; PAIN (non-serious) with onset 13Apr2021 12:00, outcome "recovered" (Apr2021), described as "mild body aches"; DIARRHOEA (non-serious) with onset 13Apr2021 12:00, outcome "recovered" (Apr2021), described as "short-term diarrhea"; NASAL CONGESTION (non-serious) with onset 13Apr2021 12:00, outcome "recovered" (Apr2021), described as "nasal congestion". Therapeutic measures were not taken as a result of pain in extremity, fatigue, pain, diarrhoea, nasal congestion.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Patient had no known allergies. Patient other medical history was none. Patient was not pregnant at the time of vaccination. Yes, Pfizer have permission to contact you about this report. No, Pfizer have permission to contact your the patient's healthcare provider about this report. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. No, treatment received for the adverse event. Patient did not had allergies to medications, food, or other products. Vaccine Facility information was available. He was the primary reporter (patient's husband). The patient was his wife. He first became aware of the occurrence of the reported events on Tuesday, 13Apr.  No follow-up attempts are possible. No further information is expected.
Approximately 5 minutes post-vaccination patient called for staff saying she felt lightheaded.  Staff arrived and moved patient to floor,  head supported by patient's jacket.  We placed her feet above head (in a chair).  Upon questioning patient about her history with vaccines, patient stated she had had a similar reaction with blood draws, but not with a vaccine.  Patient also stated she is borderline diabetic and had only eaten a small bowl of cereal this morning and not had lunch yet.  Patient stated she was feeling better, we sat her up and she drank a bottle of orange juice.  Patient monitored for another 15 minutes, felt well and was escorted to her to her apartment and she claimed she felt well.  Patient instructed to call her PCP, 911, or go to the nearest emergency emergency room for any additional issues.
My daughter was diagnosed with COVID-19 infection on 08/08/2022. She had slight cough, runny nose, and headaches. I thought she probably caught cold, and she also had rashes on both of her thighs so, I took her to the urgent care on the same day. At the ER they tested her for COVID-19 which turned out to be positive. They didn't prescribe her any medications but suggested to take over the counter medications. I gave her TYLENOL later that day for headaches.
19 Jul 2000 - Received Anthrax vaccination at deployed location.  For 24 hours after, experienced aching and stiffness of joint in middle finger on left hand.  Same arm that injection was given.  Symptom subsided and returned to normal. Since the completion of 5 shots, have experienced more frequent headaches, have been diagnosed with acid reflux, additionally have been considerably more tired most of the time requiring greater amounts of sleep and longer recovery times.  When discussed with the immunization clinic, was told to seek guidance from physicians.  Have been tested for sleep apnea, one night sleep study inconclusive.  Still experiencing difficulty maintaining active lifestyle and work without requiring abnormally greater amounts of rest and sleep.
Fever in 3 hours after shot. Began having severe headache, fever up to 102. I took Tylenol but did not bring fever down for 2 1/2 days. My arm swelled and was red from armpit to below elbow. I put ice on it and finally went down in 5 days. I had to lift my arm with my left hand. Still having runny nose and headaches.