chrisvoncsefalvay/vaers-outcomes huggingface dataset:
waking up at 4am with aches and some nausea; waking up at 4am with aches and some nausea; experiencing some chills; This is a spontaneous report received from a contactable consumer. A 41-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 18Mar2021 at 12:00 (at the age of 41-year-old) as a single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. Previously, the patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021 at 04:00, the patient woke up with aches, some nausea and experiencing some chills. It was unknown if the patient received any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events aches, nausea and chills were resolved on an unspecified date.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Event ache, nausea description updated to waking up at 4am with aches and some nausea, Event chills description updated to experiencing some chills, Final sentence in analysis tab updated to No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This is a spontaneous report obtained from a contactable consumer. This 53 year-old male patient received PREVNAR 13 single dose, on 31May2013. Relevant medical history and concomitant medication were none. The patient had pain in left arm and arm pit since 31May2013. Then, on 01Jun2013, he experienced low grade fever, pain in rib cage, nausea, headache, some congestion and some collapse. Subsequently the patient reported he still felt bad and was having chest pains. Therapeutic measures taken in response to the adverse events were none. Clinical outcome of the events was unknown at the time of report. Follow-up (01Jun2013): New information reported from agency and was forwarded to Pfizer's agency includes: new events felt bad and chest pains. Follow-up - (26-JULY-2013) Follow-up attempts completed. No further information expected.
Severe Left Knee pain requiring rest, ice, anti-inflammatory drugs. Resolved in 6 weeks. Then reappeared in Right knee, only more severe and incapacitating. It lasted 9 weeks, then resolved.
I don't know if this event and the vaccine are related, but I had a menstrual period that started 8/7/21 and lasted about 10 days. This resulted in 6 months of cancer screening including 12 procedures over 6 months, including 3 biopsies.
Patient states voice higher, feels like sits in chest, started coughing and wheezing at 1350.  COVID Vaccine received at 1330.  Patient asked to walk outside to fresh air stating feels like something in old could be triggering reaction.  While outside, patient continued coughing and wheezing and use own inhaler.  Patient stated she called her work to have them come.  Patient is an EMS provider and works on ambulance. Patient continued to feel chest tight and decreased air entry along with coughing and states can't clear throat.  Patient escorted to emergency room of hospital by hospital administrator and vaccine clinic coordinator.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 01-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Case number PHEH2013US001614 is an initial spontaneous report received from a pharmacist on 15 Jan 2013. This report refers to a 56-year-old female patient. The patient received expired MENVEO (batch number: A10047, expiration date: Dec 2012) intramuscularly on 13 Jan 2013. No adverse events were reported. No other information was available at the time of this report.
Headaches, nausea, fever 101, body aches, felt like I had covid for a second time
Individual received the 1st dose of the Pfizer COVID vaccine on 12/ 22/20.On the first week of January 2021 she developed left neck and supraclavicular lymphadenopathy. CT scan on 1/13/21revealed multiple lymphadenopathy over the left supraclavicular area. Excisional biopsy of deep neck supraclavicular lymph nodes on 1/20/21. Surgical pathology revealed overall finding most consistent with a reactive lymphoid hyperplasia, etiology unknown. She received her 2nd Pfizer COVID vaccine on 1/12/21. She had slight redness/swelling of her left arm two to three days after vaccine. She developed red, raised itching rash on her trunk on 1/30/21. Rash continues as of today 2/5/21.
just diagnosed with shingles/suspected vaccination failure; shingles; Blisters around her eye, forehead and scalp; This case was reported by a nurse via interactive digital media and described the occurrence of vaccination failure in a 86-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blister. On an unknown date, the outcome of the vaccination failure, shingles and blister were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-MAR-2022 Reporter's Comment:  This case was reported by a patient's son/daughter via interactive digital media  The patient had shingles before and had also been vaccinated.  The patient was just diagnosed with shingles.  The patient experienced blisters around her eye, forehead and scalp.  The reporter stated that obviously, that was a waste of money, as this time it was worse than before. As a nurse it disgusts him/her to see how drugs, especially vaccines were pushed on people. Additional supportive information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
p/vax pt leg became red & swollen;next day broke out in a rash;ran dec grade fever & became very cranky;
Pt. received 3rd pneumococcal vaccine 12/13/01; developed rash which was later diagnosed as erythema multiforme. Unsure whether this was related to the vaccine. Pt. was treated with Orapred.
12 hours after my vaccination I had a 106 degree fever, and had chills (felt cold) and had extreme fatigue and had it for about 15 hours then it just went away after I woke up the next day.
Patient stated he was having hives that come and go that started about 5 days after vaccination. They come on with heat or sweat. he has been taking benadryl to keep them away.
Hives on arm and chest. Took diphenhyramine, resolved in two days.
Confusion, beginning the afternoon following the injection.   My mind became a complete and total blank, including not knowing my own name.  On 9/30/2031 I was hospitalized for 3 days.
tested positive for COVID-19 with a rapid test/asymptomatic at the time of the test and for the 10-day period of isolation; tested positive for COVID-19 with a rapid test/asymptomatic at the time of the test and for the 10-day period of isolation; This is a spontaneous report from a contactable pharmacist. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 27Dec2020 10:30 (Batch/Lot Number: EL1284) as a single dose for COVID-19 immunization. Medical history included hypertension, osteopenia, retinal pucker, high cholesterol, and coronary artery disease. Concomitant medications included spironolactone, hctz, atorvastatin, ezetimibe (ZETIA), and hydrochlorothiazide, lisinopril dihydrate (LISINOPLUS). Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. On 21Feb2021 11:00, patient underwent COVID-19 test (nasal swab; rapid test) with result positive in the ER at the hospital. Patient was asymptomatic at the time of the test and for the 10 day period of isolation. Patient recovered from the events on an unspecified date. No treatment received for the events. Case reported as non-serious. Seriousness criteria - results in death, life threatening, disabling/incapacitating, congenital anomaly/birth defect: no, caused/prolonged hospitalization: yes.; Sender's Comments: The reported positive Covid 19 test is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration. However, full immunity is expected 7 days after the 2nd dose.
pt brought to ED via EMS with dyspnea, diarrhea, hypoxia; O2 saturation 70% on RA; placed on NRB; found to be positive for COVID; pneumonia due to COVID; AHRF; treated with steroids, Remdesivir, Baricitinib; respiratory status worsened requiring BiPAP then intubation; transferred to ICU; AKI; was made DNR; pt's condition worsened and he expired in the hospital
Started as normal shot site soreness.  By 10/06/11 could barely lift left arm. Treated w/Advil. By day 3 stared applying hot compresses and taking prescription ibuprofen. 7 days later left arm is still sore, radiating to shoulder and neck, numbness in fingers, headache on left side of leftside. Stopped by pharmacy to ask, told to see own Dr. and report to VAERS.  Waiting on personal Dr. to return call as to course of treatment to resolve pain and numbness.
Withing 24 hours after 2nd Moderna COVID vaccine I started experiencing gastro intestinal issues, including uncontrollable diarrhea and extreme bloating and abdominal pain. This persisted for a period of 6 weeks to varying degrees of discomfort. The worst side effects came in the 4th week post injection to the point where I was not able to leave my house because of the pain in my abdomen and frequent diarrhea. At this point I sought medical attention and was referred to a gastroenterology and was told to report the side effects and to schedule a colon screening and colonoscopy. I had no GI issues prior to this vaccine but did experience similar issues within 24 hours after the first injection but those only lasted 3-4 days and were not as severe as after the end injection.
Experienced overall body aches, headaches, chills, fever, and pain at the injection site and throughout the whole arm for the first 48 hours. About 24 hours after receiving the shot, there was a large raised red area near the injection site, about the size of a golf ball and warm to the touch. After another 24 hours the red area has continued to expand to the size of a tennis ball and is very raised off the skin.
Pt developed inconsolable crying within 24 hours of receiving vaccines which lasted 3-4 hours.
Patient reported itching at injection site immediately after vaccine given. States it decreased while she was in the observation period. She states it has not resolved; she did have a bruise. Patient reported itching at injection site immediately after vaccine given. States it decreased while she was in the observation period. She states it has not resolved; she did have a bruise. She was not given any BENADRYL at the clinic and did not take anything for symptoms at home. Resolved by 2 days after injection. She denies: Feeling of impending doom, Skin symptoms present in 90% of people with anaphylaxis, including pruritus, flushing, angioedema, Confusion, disorientation, dizziness, lightheadedness, weakness, loss of consciousness, Shortness of breath, wheezing, bronchospasm, stridor, hypoxia, Hypotension, tachycardia, Nausea, vomiting, abdominal cramps, diarrhea.
64 y.o. female who presented with SOB. She has a history of CAD, diabetes, CHF, CKD and DVT presents to the ED in respiratory distress.  Patient was brought in by EMS from nursing home.  Patient had reported onset of shortness of breath and respiratory distress over the last 6-7 hours.  Patient has O2 sat of 90% on 6 L.  Patient only uses 2 L nasal cannula oxygen all day long.  Patient is coherent and initially was placed on BIPAP but then stated she wanted to go back, now after ER doc spoke to her she is ok with being admitted but does not want BIPAP or to be placed in the ICU. She is DNR/DNI. She is working hard to breathe currently. Patient is unsure if she is making urine at this time. Workup in the ER revealed AKI on CKD and covid + pneumonia.   Patient elected hospice and expired 5/20/2021.  It was reported that patient had received vaccines at Walmart.
S/p immunization update patient became nauseous with emesis x 1/ given BENADRYL 25mg and Promethazine 12.5mg/she responded with immediate resolution and discharged without symptoms and vital signs stable.
Patient reported tingling in lower lip and tongue starting at 2:00 pm with subjective fever and joint pain in both knees.  When he got home later in the day patient reported that his wife thought his face looked a little swollen.  Woke up on 10/24/14 with hives on his back and scalp, but fever, tingling and swelling had resolved.  Still has some pain in his knees.  Patient then called Health Services to report his symptoms on 10/24/2014 at approx. 1:30 pm.  Patient was referred to his private physician who treated him with Zyrtec with good effect.  Hives completely resolved by 10/25/2014.
Initial report received from a health care provider on 11 May 2010. A 3-year-old male patient, with no medical history and no known allergies, had received an .1 milliliter intradermal injection to the right forearm of ADACEL on 07 May 2010, lot number Sanofi Pasteur Ltd. C3246AA, and developed redness and a raised hardened area. The patient inadvertently received ADACEL instead of purified protein derivative (PPD). The area of redness was read as a positive test yesterday (date not provided). The patient had no adverse event following prior vaccinations. The outcome for the event was reported as not recovered.
Received 7th Anthrax vaccine. 24 hrs later pt noticed severe swelling 8 inches severe minimal pain at injection site. Sought medical attention, received Motrin.
Dizziness, fever, muscle pain, left arm sore, clamminess, fatigue, facial rash, headache, chills
Joint pain started about  3 hours after administration then the following day severe pain in arm where vaccine was given and severe muscle aches, fever, and headache. Today headache  and fever gone but muscles aches still present even though not as bad.
Two days after the patient received the vaccine, she had a burning sensation down the back of her neck that radiated to her lower chest. The burning sensation was accompanied by itching as well. The injection site was inflamed & sore as well. The patient went to ER for the reaction & was monitored, but no treatment was given. Dr. said it was reaction to the vaccine.
High pitched crying x 4 hrs 22AUG91 4PM-8PM; Also had vomiting & several loose stools on & off in PM 22AUG91, t101.4;
Pain in armpit, breast, and elbow; Pain in armpit, breast, and elbow; Pain in armpit, breast, and elbow; Numbness in fingers; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 20Dec2021 at 11:45 (Lot number: FH8027) at the age of 40 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Patient has taken unspecified concomitant medications. Past drug history included: Augmentin, reaction: "Drug allergy", notes: Known allergies: augmentin; Marcaine, reaction: "Drug allergy", notes: Known allergies: marcaine and Lidocaine, reaction: "Drug allergy", notes: Known allergies: lidocaine. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0176, Route of administration: Intramuscular), administration date: 12May2021, when the patient was 40 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE, Lot number: ER8731, Route of Administration: Intramuscular), administration date: 21Apr2021, when the patient was 40 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 at 11:45, outcome "unknown", described as "Dose number: 3"; AXILLARY PAIN (non-serious), BREAST PAIN (non-serious), ARTHRALGIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 21Dec2021, outcome "not recovered", and all described as "Pain in armpit, breast, and elbow". The events "Pain in armpit, breast, and elbow" and "Numbness in fingers" were evaluated at the physician office visit. Therapeutic measures taken as a result of pain in armpit, breast, and elbow, numbness in fingers increased was unknown.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit.
Fever that lasted through the night, woke up around noon after going to sleep at midnight and it was gone - I did not take medication for the fever. Body aches and chills before I went to sleep, headache like a hangover, stuffy nose.
This spontaneous report was received from a healthcare professional, referring to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unspecified date in October 2015, (reported as "between 05-OCT-2015 and 26-OCT-2015) the patients were vaccinated with improperly stored doses of PROQUAD (route, dosage, strength and lot# were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of two report received from the same reporter. Additional information has been requested.
Information has been received from a physician referring to a 15 month old male patient. The patient's medical history included exposure to herpes zoster. The patient didn't have drug reactions/allergies. On 17-APR-2015, the patient was administered MMR II, (lot number was reported as K012473, exp. was unknown), 0.5ml, subcutaneously in the left arm and (Merck) VARIVAX, (lot number was reported as K020761, exp. was unknown), 0.5 ml, subcutaneously in the right arm. The patient didn't have any concomitant medications. On 20-APR-2015, the patient developed a widespread vesicular rash. The patient sought medical attention by office visiting. On 23-APR-2015, the physician evaluated the patient in the office and noted the widespread rash, with a new vesicle on the patient's leg that erupted on that day. The physician diagnosed the patient with a varicella rash due to his exposure to herpes zoster. There was no treatment given to the event and no lab diagnostics studies performed. The outcome of the event was reported as not covered. The causality of the event was (Merck) VARIVAX or MMR II was reported as not related. Additional information has been requested.
All symptoms were present from 1/15/2021-1/16/2021.  Migraine: I took 1000 mg Tylenol every 8 hours; helped minimally, Cold pack. I continued to have a headache and migraine.  Fatigue: nothing helped. Joint pain: Severe pain all joints including wrist and finger joints. I took Ibuprofen every 8 hours. Hot pads to joints. Fever: low grade, see Tylenol above. Skin sensitivity: Sharp pain when I touched the skin over my joints, esp my hips.
Tingling of skin similar to getting a rash. Ongoing until going to Dr. office to determine cause. Anti viral tablets, 7 day supply, Calamine lotion and cream for the rash. Burning and itching of skin with lots of pain. Thermador for pain.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), BREAST SWELLING (their left breast was swollen), BREAST MASS, BREAST DISCHARGE and SKIN IRRITATION in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045LA2LLA) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced BREAST SWELLING (their left breast was swollen). On 23-Mar-2021, the patient experienced BREAST MASS, BREAST DISCHARGE and SKIN IRRITATION. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in the arm), BREAST SWELLING (their left breast was swollen), BREAST MASS, BREAST DISCHARGE and SKIN IRRITATION outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported.
25 yo AD E-5 received Vaccinia and anthrax #1 on 26Aug03. Vaccinia was L shoulder. That progressed properly with a jennerian pustule 7 days later and then the scab falling off approx 5Sep. He was well for the next 5 days and then, on 10Sep, began to notice lesions like acne in his L axilla. These doubled in # and size every day and then he began to notice them in his R arm pit, groin, and back. These were then evaluated by myself. The lesions were large (some 2-3cm across) placques with a red raised border, some central lichenification or scaling dermatiitis but no exudate or actual pustular appearance. These were biopsied that day with the appearance of spongiosis as well as a eosinophilic infiltration. Vaccinia PCR of one of the lesions was sent, under protocol, and that was negative. The lesions were itching and mildly painful. The lesions progressed, close to 50 new lesions developed in the ensuing 5 days. The distribution remained bilateral axilla, R back, and bilateral flanks, as well as bilateral groin. The lesions, once they stopped developing new, began to fade, the border first so that they became very uniform and then they began to fade altogether. The patient's symptoms were gone within three days and he only had the lesions without any symptoms. He complained twice about shortness of breath and PND type symptoms: CXR x2, Echocardiogram, EKG, Cardiac enzymes failed to show any abnormalities. Routine CBC did not show eosinophilia. The patient had a negative HIV test prior to the vaccination.