chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills and fever up to 101.5 for two days; Chills and fever up to 101.5 for two days; Swollen armpit/lymph nodes in left arm for several days; Digestive upset for 1 day; Head pressure ache when bending over for a few days.; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the arm left on 16Apr2021 at 15:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and the patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included calcium (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 15:15 as a single dose for COVID-19 immunisation. On 17Apr2021 at 02:00, the patient experienced chills and fever up to 101.5 for two days, swollen armpit/lymph nodes in left arm for several days, digestive upset for 1 day and head pressure ache when bending over for a few days. On the 17Apr2021, the patient underwent body temperature test and the result was found to be fever up to 101.5 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events digestive upset for 1 day was resolved on an 18Apr2021; and chills and fever up to 101.5 for two days was resolved on an 19Apr2021 whereas swollen armpit/lymph nodes in left arm for several days and head pressure ache when bending over for a few days were resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Lethargy; Flu-like symptoms; This is a spontaneous report received from a contactable consumer (patient's wife).  A male patient received BNT162B2 (BNT162B2), administration date 13Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LETHARGY (non-serious) with onset 13Mar2021, outcome "recovered" (15Mar2021), described as "Lethargy"; INFLUENZA LIKE ILLNESS (non-serious) with onset 13Mar2021, outcome "recovered" (15Mar2021), described as "Flu-like symptoms".  Additional Information: The patient's symptoms went away in 2 days.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Pt had mild headaches within 10 minutes of vaccine. He denies any other symptoms. He was sent home and instructed on home care. The following day, he continued to report headache that was progressively worsening with symptoms interfering with his ability to do his job. He spoke with his primary care provider and was excused from work, given home care instructions.
Initial and follow-up information has been received from a health professional concerning an 81 year old male with drug hypersensitivity to LORTAB and an unknown anesthetic who on 12-SEP-2007 was vaccinated intramuscularly into the left deltoid with a dose of PNEUMOVAX (Lot 655766/0038U).  There was no concomitant medication.  On 12-SEP-2007 the patient's injection site arm was swollen, red, and itchy.  The patient was instructed to take BENADRYL for the injection site reaction.  No laboratory or diagnostic tests were performed.  The patient called the office.  At the time of the report the patient had not recovered.  Follow-up information revealed that there was no further information to provide on this patient and that the physician "will not use the rest of the vaccine" from Lot # 655766/0038U.  The office requested a lot check.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  Additional information is not available.
This spontaneous report as received from a certified medical assistant refers to two patients of unknown age and gender. On 29-MAY-2014, the patients were vaccinated with PROQUAD lot # H020851, expiration date 26-MAY-2014, intramuscular. On 29-MAY-2014, 2 patients received expired PROQUAD via the intramuscular route. There was no known adverse effects. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. Additional information has been requested.
c/o febrile & vomiting on/off x1wk p/given vax;
On 8/10/21, woke up with extreme sensations of heat, dizziness, lightheaded, nausea, vomiting. Went to urgent care, saw PA, blood pressure was 182/96, shortly after the left side was checked (right side was checked first) 183/53. Pulse was 115 BPM, normal body temperature. Seemed like it was a panic attack, have not had a history of panic attacks, but have had anxiety many years ago. Propranolol was given, will help with high blood pressure as well. Have not had previous history of high blood pressure. On 8/18 after second shot, had same issues plus heart palpitations. Saw another HCP the second time. Blood pressure was 148/101. Had an EKG done, normal. Was the 45 second test. Ended up prescribing alprazolam for 3x/day (if needed). Started breaking out in rash on left side of stomach to front, worst area was back. On 8/20 was checked by a third HCP for palpitations and rash. Rash was confirmed as an allergic reaction to vaccine, given a steroid (methylprednisolone), back on original prescription 1/day and alprazolam as needed. Yesterday 8/23, had heart palpitations, went to ER. Had another EKG: ct w/ and w/o contrast, chest x-ray. At the end was tested for Covid, positive test. It appears that I had contracted Covid after the first dose, timeline not 100% clear.
vomiting; sick; lost 20+ pounds; have trouble with sleep; barely eat anything; GI flare up; got eh chest pressure; insomnia; nausea; diarrhea; This is a spontaneous report from a contactable consumer (Patient herself). A 35-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration, administered in Arm Right on 15-APR-2021 (at the age of 35-year-old non-pregnant) 10:30 A.M as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection for COVID-19 immunization. The patient previously took cephalexine, mucinex, nasonex. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient had not received other medications within 2 weeks of vaccination. It was reported that, on 28Apr2021 patient had experienced chest pressure and insomnia a few days after. Then, GI flare up. She was so sick and could not keep fluids down and ended up in the ER. She started to feel better week 3, then had to get my second dose. She got eh chest pressure and insomnia the first night. The nausea and diarrhea on on 28Apr2021 and vomiting came back a week and a half later, and now she was still so sick. She had lost 20 plus pounds and was only 145 to start. She still had trouble with sleep some nights like she jolt awake. She could barely eat anything. She was having an endoscopy and colonoscopy on Monday and a cardiology appointment on Wednesday. The adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had received treatment as all sorts of stomach medications. The patient's lab test included SARS-COV-2 test which was negative on 06May2021. The patient was not diagnosed prior and since the vaccination with COVID-19. The outcome of events, eh chest pressure, insomnia, nausea and diarrhea was not recovered while for other events was unknown.  information on batch and lot number is requested.
The evening on the day of my second vaccination I experienced mild side effects of body aches and fatigue. The following morning this was accompanied by a fever of 101 F and severe sharp chest pain. The chest pain lasted for several minutes at a time on and off throughout the day. When the chest pain was at its worst I also had shortness of breath and what felt like a fluttery heart beat and the pain radiated to my sternum and rib areas. The pain was severe enough that I could not sit or stand upright during these episodes, I cried, and asked not to be left alone in case something happened to me. It felt like sharp, knife-like pain not dull aching pain. Body aches and chills also continued throughout the entire day and evening. I used heat and cold packs, baths, and took Tylenol starting in the afternoon and again in the evening to help cope.
Measles-like rash covering body, most prominent on the arms and legs. No discomfort or itching. No treatment thus far.
THE INDIVIDUAL RECEIVED LESS THAN  0.5ML OF THE JANSSEN COVID-19  VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 77 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s  from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series 1), 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and batch number: 213D21A expiry: 11-APR-2022) dose was not reported, administered (dose number in series was 2) on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, the patient experienced the individual received less than 0.5ml of the janssen covid-19 vaccine as a booster dose. On 01-DEC-2021, the patient experienced off label use. (dose number in series was 2)  ''As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL."(dose number in series was 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the individual received less than 0.5ml of the janssen covid-19 vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211209976, 20211210549, 20211210588, 20211210112, 20211210610, 20211210733, 20211210409, 20211210555, 20211210408, 20211209880, 20211209816, 20211209782, 20211209775, 20211209798, 20211209874, 20211209884, 20211209679, 20211209706, 20211209740, 20211209843, 20211209912, 20211209921, 20211210019, 20211210058, 20211210067, 20211210106, 20211210133, 20211210141, 20211210143, 20211210159, 20211210160, 20211210165, 20211210180, 20211210334, 20211210350, 20211210385, 20211210585, 20211210588, 20211210590, 20211210662, 20211210670, 20211210684, 20211210824, 20211212082, 20211210107 and 20211213607.
l lost my friend; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 34-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "l lost my friend". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical Course: Reporter reported that, he lost his friend. He lost him at 34 years old, he was like a brother to him. (Caller would not let this agent speak, to find out if his friend had taken the Pfizer Covid 19 vaccine or not). Not sure this was related to Pfizer vaccine.    No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: l lost my friend
Started with sinus congestion on the 2nd. Then a bad headache - on the 3rd. Both continued and on the 4th I went to the Care Now Urgent Care COVID test.  No treatment except ibuprofen; Claritin; Tylenol - those helped some. I had the headache and sinus congestion until Wednesday - and then I felt pretty much back to normal except for some fatigue for next two days. I got the second dose of the vaccine - Monday, January 25th. I had a bad headache - and achy feeling - but after 24 hours I felt back to normal again.
no additional AE reported; expired MMR II was administered to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-MAY-202, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA) lot # R030812, expiration date: 24-OCT-2020 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis. No additional adverse event was reported.
Beginning about two weeks after my vaccine and continuing to the present day (about 4 months). I have had  red rashes, lumps, bumps or blisters on my ankles, lower and upper legs, back, and arms.  Some are the size of a pinhead, the largest are about an inch across.  I usually have about 5-10 at any one time. They itch about 25% of every day. Scratching them (which I rarely do) does NOT usually make them spread; it DOES make the itching more intense. Sometimes they go away and stay away. Sometimes they go and return. Some have stayed for the entire 4 months.
No adverse effects; the patient was administered an improperly stored dose of PEDVAXHIB; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 26-SEP-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot # S000356, expiration date 17-OCT-2021 (exact dose and route of administration was not reported) for prophylaxis. The administered dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion of 46.5 degrees Fahrenheit for 15 minutes. Data logger was not involved. There were no previous excursions reported. There was no adverse effect reported.
After patient received flu shot she had tissue damage, muscular atrophy and the loss of normal use of her left arm due to pain. Her doctors diagnosed that the injection site was too high in the rotary cuff causing destructive immune activity. She is undergoing extended physical therapy at this time.
injection site pain and left arm muscle achiness within 15 min of the injection; took one 500 mg Extra Strength Tylenol and 12.5 mg benyldryl (1/2 of a 25 mg tablet) taken at bed time (9 pm). Woke around 6 am with a general muscle stiffness, neck joint discomfort, chills, and malaise. Around 9 am took 200 mg Ibuprofen which relieved the symptoms except the injection site tenderness upon touch.
diarrhea; nausea; she was sick with a high fever; chills; felt deathly sick; couldn't get out of bed all day; headache; a little bit of a sore throat; This is a spontaneous report from a contactable consumer (patient).   A 50-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, lot # and expiration not available) intramuscular in left arm at single dose on 11Jan2021 09:30 for Covid-19 immunisation, for precaution because she worked in hospital, administered ad hospital. There was no prescriber. Medical history included asthma diagnosed 30 years before when she was in her 20's around 1990, hypothyroidism. Family medical history was none. Concomitant medication included only levothyroxine sodium (SYNTHROID) taking for 30 years for hypothyroidism. The patient received the 1st dose of bnt162b2 (BNT162B2, lot # and expiration not available) intramuscularly in left arm on 21Dec2020 09:30 (within 4 weeks prior to the 2nd dose of BNT162B2 suspect) Covid-19 immunisation and she was fine. No adverse events occurred following prior vaccinations. No additional vaccines administered on same date of BNT162B2 suspect.  On 12Jan2021, she was felt deathly sick at 15:00. On 11Jan2021 she experienced headache at 17:00. On 12Jan2021, at 17:00 she experienced high fever and chills and couldn't get out of bed all day. On 13Jan2021, she was fine during the day. On 13Jan2021 night, she had a fever that went past 100 degree F, she experienced diarrhea and nausea 02:00. The fever came and went. In Jan2021 she had a little bit of a sore throat. The patient underwent lab tests and procedures which included body temperature: a fever on 12Jan2021; wsa fien on 13-JAN-2021, fever went past 100 degree F, on 13Jan2021at night. No other relevant test performed. She has been out of work since 12Jan2021. On 14Jan2021 she still has diarrhea and nausea with a little bit of a sore throat as well. No ER or physician's office was required. The outcome of felt deathly sick and chills was recovering, of headache, high fever, diarrhea and nausea was not recovered, of couldn't get out of bed all day and a little bit of a sore throat was unknown. She was not sure if her new symptoms meant she should get COVID testing and would like to find out.   Information on lot number/batch number was requested.
Soreness throughout injected arm; Soreness throughout injected arm including joints of wrist, elbow, and shoulder; Nausea; GI upset; 99.5F fever; Chills.; Fatigue.; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the left arm on 04May2021 at 14:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included exercise induced asthma. Concomitant medications included ascorbic acid (VITAMIN C) and colecalciferol (VITAMIN D3). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0158) via an unspecified route of administration in the left arm on 13Apr2021 at 11:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not 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 05May2021 at 13:30, the patient experienced soreness throughout injected arm including joints of wrist, elbow and shoulder, nausea, GI upset, 99.5F fever, chills and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events of soreness throughout injected arm including joints of wrist, elbow and shoulder, nausea, GI upset, 99.5F fever, chills and fatigue were recovered on unknown date in May2021.  No follow-up attempts are possible. No further information is expected.
anemia Hb12.4 HCT - 37 on 8/4/2022 H/H 11-8/37 on 4/25/2022 immature granulocytes - present on both labs; lymphopenia - 0.6 on 8/4/2022; 0.6 on 4/25/2022 monocytosis - 15% on 8/4/2022;  high RDW - 17.2 on 8/4/2022 leukopenia 3.5K on 8/4/2022
This case meets criteria for vaccine breakthrough review. SxS of 3 days PTA generalized weakness, sore throat, fever, cough.
Loud ringing in left ear feel left side of neck. Treatment: Nothing Cannot do daily function.
Patient complained to heart palpitations and shakiness.  HR ranged from 100-130 BPM with increasing tremors over 30 minutes.  Took Benadryl 25 mg PO and symptoms subsided.
Received telephone call at 9A on day following vaccinations. Client reports severe pain in (R) upper arm and difficulty moving arm. Also reported "stiffness" and "numbness" in jaw below (R) ear. Advised to call primary care provider. Telephoned client at 230P on 03-23-16 as f/u. She states she took a nap after call with me on 03/22 and arm pain was gone when she woke up, so she did not call Dr. States jaw discomf. lasted approx. two hrs. outside doing yardwork yesterday.
@ 1300HR mom noticed pts hands & feet were purplish, pt was shaking, moaning not crying & appeared limp x 10min; pt examined & MD who felt had febrile seizure recommended ped DT in future; highest temp recorded 100.3 ax; pt given APAP;
CHEST PAIN; short sharp pains; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (CHEST PAIN) and PAIN (short sharp pains) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced CHEST PAIN (CHEST PAIN) and PAIN (short sharp pains). At the time of the report, CHEST PAIN (CHEST PAIN) and PAIN (short sharp pains) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.
Arm swollen from elbow up to injection site, warm to the touch and  pain in arm (on 1-10 scale a 5).  Tenderness on arm lasted 5 days.   Could not lay on that side while sleeping.  Currently still have a purple bruise at the vaccine site.   Moderate chills for over 36 hours with fatigue.
This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (had some symptoms that went away in two weeks) and lymphoedema/the lymphatic system (the back of her head was swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; at an unspecified dose. On an unknown date, patient experienced vaccination complication (had some symptoms that went away in two weeks) and lymphoedema/the lymphatic system (the back of her head was swollen). At the time of the report, vaccination complication (had some symptoms that went away in two weeks) resolved; and lymphoedema/the lymphatic system (the back of her head was swollen) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. This case linked to MOD-2021-320633 (patient link).