chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; body aches; very lethargic and without much energy 13Mar; very lethargic and without much energy 13Mar/could not do anything except lie down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 09:30 (Lot number: EN6203) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: AMETHYST. Vaccination history included: Bnt162b2 (lot number: EL3247, administration date=19Feb2021,, administration time: 11:30 AM, vaccine location-Left arm, dose number: 1), administration date: 19Feb2021, when the patient was 46 years old, for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 13Mar2021, outcome "recovered" (13Mar2021), described as "headache"; PAIN (non-serious) with onset 13Mar2021, outcome "recovered" (14Mar2021), described as "body aches"; LETHARGY (non-serious) with onset 13Mar2021, outcome "recovered" (Mar2021), described as "very lethargic and without much energy 13Mar"; ASTHENIA (non-serious) with onset 13Mar2021, outcome "recovered" (Mar2021), described as "very lethargic and without much energy 13Mar/could not do anything except lie down". Therapeutic measures were not taken as a result of headache, pain, lethargy, asthenia. Additional information: The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination and was not tested covid post vaccination. Clinical course: It was reported that patient woke up a little before 2:30 am with a headache and body aches. The headache dissipated once she drank water. The body aches remained until 14Mar2021 late morning. She was very lethargic and without much energy 13Mar2021 and could not do anything except lie down. No follow-up attempts are possible. No further information is expected.
Had redness at injection site and progressive flu-like symptoms-achiness, fevers, malaise, hemolysis of RBC's with subsequent Hgb in 7's, elevated liver enzymes, bilateral pleural effusions and pericardial effusion hospitalized on 12/17 2008 for 4 days-CT, thoracentesis, echocardigram extensive work-up showing generalized inflammatory response.
This reporter also reported two other patients who experienced an event which is captured in case number 2014SA159410. Initial spontaneous report received on 17 November 2014 from a healthcare provider. An unidentified patient, gender, age and date of birth was not reported was vaccinated intramuscularly with INFLUENZA INTRADERMAL, batch, site and date of administration were not reported. The patient's concomitant medications were not reported. Pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as none, unknown. The patient was not ill at the time of vaccination. The patient experienced numbness and tingling in their arm with loss of grip strength. One of the patients that were reported required an emergency room/ doctor visit on an unspecified date. The patient was told that it was an injection site issue and was told to follow up in a few months. The patient outcome is not recovered. Documents held by sender: none.
Headache, insomnia, severe rash over bilateral upper extremities- itchy, raised.
lack of energy off and on; the duration is a lot longer; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (lack of energy off and on) and INCORRECT PRODUCT ADMINISTRATION DURATION (the duration is a lot longer) 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 25-Aug-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (lack of energy off and on) and INCORRECT PRODUCT ADMINISTRATION DURATION (the duration is a lot longer). At the time of the report, ASTHENIA (lack of energy off and on) outcome was unknown and INCORRECT PRODUCT ADMINISTRATION DURATION (the duration is a lot longer) had resolved.            The patient got 2 doses of vaccination and one of the doses was on 25th august 2021. Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.   This case was linked to MOD-2021-302152 (Patient Link).
Worsening tinnitus: louder and now both ears instead of just right ear. I have not gone to the doctor about this as there is no treatment or cure available.  Within approximately 2 weeks of vaccination, the "sound" was suddenly louder and in both ears. I did not have any other symptoms, aches,  pains, etc from either vaccination 1 or 2, or the booster (all pfizer).  In fact, in general I felt great .
Pt was given the shot and about a minute later started to faint in her chair. She regained consciousness in less than a minute. Paramedics were called and responded very quickly. Paramedics determined after gathering vitals and blood glucose that pt was alright, but should be seen by a physician tonight. Parents left pharmacy to take child to the hospital.
Not able to sleep; Back ache; I have been so worried; She doesn't feel well; Fatigue; Aching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 22May2022 at 15:00 as dose 3 (booster), single (Lot number: FM9992) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Johnson and johnson (Dose: 1), for COVID-19 immunization; Moderna (Dose: 2), for COVID-19 immunization. The following information was reported: PAIN (medically significant) with onset 22May2022, outcome "unknown", described as "Aching"; FATIGUE (non serious) with onset 22May2022, outcome "not recovered"; INSOMNIA (non serious), outcome "unknown", described as "Not able to sleep"; BACK PAIN (non serious ), outcome "unknown", described as "Back ache"; ANXIETY (non serious), outcome "unknown", described as "I have been so worried"; FEELING ABNORMAL (non serious), outcome "unknown", described as "She doesn't feel well". The events "not able to sleep", "back ache", "fatigue", "aching", "i have been so worried" and "she doesn't feel well" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: it was okay; SARS-CoV-2 test: Negative, notes: Tested her for Covid both times and both were negative. Therapeutic measures were taken as a result of insomnia, back pain, fatigue, pain, anxiety, feeling abnormal.  Clinical course: She had her Second booster shot (Clarified as Pfizer COVID 19 Vaccine) and after getting the vaccine she mentioned that she got side effects. She mentioned that when she went home she was not able to sleep and she had a back ache. It was primarily fatigue, aching and fatigue but mostly fatigue. I came home I was aching and then in the night got very little sleep but since then I have been so worried. I slept much the next day and I slept much of it next day since then for hours every day. I need to know how to get over it as quickly as possible, if there is anything I can do. Rest of my schedule, my appointments had been called off. I had taken an Ibuprofen and that was basically it and that has not helped much. It certainly did not. Started aching that night after about 3 in the afternoon when she got the vaccine. She had trouble sleeping because she was aching. Slept a lot the next day, 23May2022. Since, she's been having aches and fatigue that are intense. Can spend 4-5 hours a day doing what she normally does. The, the rest of the day she is aching too bad to function. By the time she went to bed on 22May2022 the aching was a problem. Had no side effects with the first two vaccines. Would hear people talking about side effects and didn't really know what they were talking about. She expected not to have side effects with this Pfizer booster because she didn't with the other two vaccines. Thought she would get better protection getting one vaccine from each manufacturer.
A few minutes after receiving Hep B vaccination, patient became ghost-white and extremely lethargic. Nurse brought back into office and O2 and pulse were low. Physician returned and monitored. After breastfeeding and a 10-15 minute waiting period color/responsiveness improved.
General symptoms: chills, headaches, joint pains, muscle pains, fatigue, diarrhea, injection site pain, burning, itching eyes, disturbed sleep Narrative
shortness of breath/difficulty breathing; loss of energy; next day experienced redness; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (shortness of breath/difficulty breathing), ASTHENIA (loss of energy) and ERYTHEMA (next day experienced redness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 053E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Sep-2021, the patient experienced DYSPNOEA (shortness of breath/difficulty breathing), ASTHENIA (loss of energy) and ERYTHEMA (next day experienced redness). At the time of the report, DYSPNOEA (shortness of breath/difficulty breathing), ASTHENIA (loss of energy) and ERYTHEMA (next day experienced redness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.  Patient had no reactions after receiving first dose and after the second shot had no reactions in the beginning. Patient experienced the symptoms the next day after the second dose.
Dizzy, pale became unresponsive, no pulse, no respirations. CPR started, administered 0.3 ml epi, EMS arrived provided O2, fluids and transported to ED.
Pain started in left arm near the injection; A very deep "joint" "nerve" pain; A very deep "joint" "nerve" pain; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 23Apr2021 at 16:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included secukinumab (COSENTYX) and methotrexate (MANUFACTURER UNKNOWN), both taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 at 10:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 00:00, the day after receiving the 2nd vaccine, the patient experienced pain which started in left arm near the injection site. Since then the patient had pain that came and went in the arm. The patient described it as a very deep "joint" "nerve" pain. On an unknown date in 2021, day 13, the patient was concerned and the pain was continuing to increase but not get better. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were 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 pain started in left arm near the injection site and a very deep "joint" "nerve" pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Decreased lung capacity.; Not able to exercise; getting short of breath after only one minute of any type of physical activity.; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient reported for himself that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration, administered in arm left on 26Feb2021 at 01:00 PM (age at vaccination was 47-year-old) as dose 2, single for COVID-19 immunisation at health clinic facility. No other vaccines were received within four weeks of vaccination. No other medications were received witFhin 2 weeks of vaccination. The patient's medical history was not reported. The patient had known allergies with Codein. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Batch/Lot Number: EL9265), via an unspecified route of administration, administered in arm left on 29Jan2021 at 05:30 PM (age at vaccination was 47-year-old) as dose 1, single for COVID-19 immunisation. On 10Mar2021 at 12:00 PM, the patient experienced decreased lung capacity. Not able to exercise without getting short of breath after only one minute of any type of physical activity. The events resulted in visit to doctor or other healthcare professional office/clinic visit. No treatment was received. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Left arm pit swelling, possibly the lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 15Apr2021 at 15:15, as a single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 25Mar2021 at 15:15, as a single dose for COVID-19 immunisation. On 16Apr2021 at 06:00, the patient experienced left arm pit swelling, possibly the lymph nodes. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left arm pit swelling, possibly the lymph nodes was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
She got her first dose of the Covid 19 vaccine on 14Apr2021/She was tested for the Covid 19 virus by the nurse at her school on 19Apr2021.; she had a headache, cough, and shortness of breath; she had a headache, cough, and shortness of breath; she had a headache, cough, and shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot# EW0162), via unspecified route of administration in right arm on 14Apr2021 09:00 at single dose for COVID-19 immunization. The patient was not administered with prior vaccine within four weeks. The Patient medical history and concomitant medications were not reported. There was no AE prior vaccination and no history of previous immunization with the Pfizer vaccine considered as suspect. She got her first dose of the Covid 19 vaccine on 14Apr2021 then she got the Covid 19 virus. She did her quarantine and all her symptoms have been gone for a while and she is all better now. Her second Covid 19 vaccine is scheduled for 05May2021. She enquired if she should get her second vaccine on 05May2021 or if she needs to reschedule it. She was tested for the Covid 19 virus by the nurse at her school on 19Apr2021. Her results came back positive for the Covid 19 virus on either the 21Apr2021 or 22Apr2021. She got tested for the Covid 19 virus because after she received the Covid 19 vaccine she had a headache, cough, and shortness of breath. Her symptoms started on the 15Apr2021. She started feeling better around the 18Apr2021. The patient did not require any Emergency Room/ Emergency Room due to adverse events. The patient was recovering from the event. NO PQC involved.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Chills, Headache, joint pains, muscle pains, fatigue Narrative:
Red, warm, indurated band of skin on L arm above elbow, measuring 6.5" x 3". Rash resolved within 72 hours. Stiff neck/limited ROM x 1 day after vaccinatino. Light-headed and stomach discomfort x 1 day. All symptoms resolved within 72 hours.
1st dose in 2019, needs his 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on April 2019 intramuscularly in an unknown deltoid).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 11 NOV 2022 Reporter's comment: The reporter was the patient. The reporter reported he needed to get his second Shingrix vaccine as the pharmacy never called to remind him. Reporter did not consent to follow up. The reporter does not give permission to contact HCP. Additional supportive information: Till the time of reporting the patient did not receive the second dose of Shingrix vaccine, which led to incomplete course of vaccination.
Patient developed runny nose, watery eyes, itching and bumpy rashes. Administered Benadryl 12.5 mg Po and symptoms subsided.
Was so ill after took the Covid shot; has been so ill and feeling so bad since taking it; Did not feel good; This is a spontaneous report form a contactable consumer (patient). A 69-year-old (also reported as 69 1/2 years old) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 69-years-old, via an unspecified route of administration, administered in Arm Left on 22Apr2021 11:00 (Batch/Lot Number: EW0171) as dose 1, single for COVID-19 immunization. Medical history included 2 unspecified cancers that was why his doctor told him to get vaccinated. No family history. There were no concomitant medications. The patient stated that he had gone back to the doctor and because he was so ill/ did not feel good after he took the Covid shot. He has been going back the doctor and they told him to call Pfizer because there was nothing else, they can do. Literally that shot just about killed him. He has been so ill/not feeling well and feeling so bad since taking it. His life was literally destroyed, and he does not know where to go or what to do. He has also sent an email to the website and has not heard anything back. Again, stated he does not know what to do because he has symptoms. Does not clarify symptoms had. Has had a CAT and PET scans and bloodwork and he knows his body. He was almost 70 years old and after taking this shot, he has been down for the count. Does not know what else to do and called to ask Pfizer what else he can do. His doctor advised him not to get the second dose. He had 2 cancers in past before Covid shots and with his immune system was told by doctor to get it. No other vaccines given the same day or 4 weeks prior. No history of problems with vaccines in past ever. The events resulted to a visit in a physician office. The outcome of the events was not recovered.
Body rash that was itchy for almost a week. Applied white vinegar until symptoms subsided.
On April 3, 2021 the patient received the first dose of the Moderna COVID vaccine. The patient's husband states that "crashed an hour and a half after she got the shot."  He defines this "crash" as decreased blood sugar, decreased responsiveness, and the seizures.  She presented to the Hospital for evaluation and was subsequently transferred to the Medical Center on April 4th for further workup. She was intubated on April 4th and subsequently self-extubated on April 8th. Nursing staff and documentation indicate that the patient has had no further seizures since her presentation to the medical center.  On April 14th she was found to have an acute lower extremity DVT. She was placed on a heparin drip and her platelet's dropped to 35. The heparin drip was discontinued, a HIT panel was ordered, and argatroban was started. Heamtology was consulted and the patient was found to have thrombotic thrombocytopenia. An MRI of the brain was ordered to rule out CNS thrombosis given recent seizures. The MRI has not been performed yet and the patient is still hospitalized.
Muscle pain on the right side, in the upper chest, right underneath the breast; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Muscle pain on the right side, in the upper chest, right underneath the breast) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced MYALGIA (Muscle pain on the right side, in the upper chest, right underneath the breast). On 07-Feb-2021, MYALGIA (Muscle pain on the right side, in the upper chest, right underneath the breast) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
After receiving the vaccine, during night had chills, fever and sore arm for 1 night. Reduced mostly next day. After that about 10 days later started feeling very itchy and soon got hives all over the body. Never had any food or allergy reactions before.  Started taking allegra for the last month and still did not completely go away.