chrisvoncsefalvay/vaers-outcomes huggingface dataset:
drowsiness; general lack of stamina; extreme fatigue with minimal exertion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 (Lot number: EW0150) at the age of 79 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; GLUCOSAMINE; MUL-TAB; CHONDROITIN. Vaccination history included: Bnt162b2 (Lot number= en6204,, Dose number =1, Vaccine location =Left arm), administration date: 12Mar2021, when the patient was 79 years old, for Covid-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "drowsiness"; ASTHENIA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "general lack of stamina"; FATIGUE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "extreme fatigue with minimal exertion". The events "drowsiness", "general lack of stamina" and "extreme fatigue with minimal exertion" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of somnolence, asthenia, fatigue.  Additional information: The patient did not take any other vaccine in four weeks. The patient has led an active outdoor lifestyle and felt that he was in very good shape for his age. It was like he aged 15 years after that second shot.The patient was not tested for Covid prior vaccination and was not Covid tested post vaccination. The patient did not have any known allergies.  Follow-up attempts are completed. No further information is expected.
Patient was fully vaccinated Pfizer on 4/5/21, 4/26/21 and received booster on 12/22/21.  Facility received death abstract. confirmed Patient was admitted on 12/28/21 to Hospital.  Patient Died 12/31/21 at 00:20 due to Acute Hypoxic Respiratory failure and flash pulmonary edema. No further information provided to facility.
Arm pain, fever of 101 with chills and sweating, flu like symptoms lasting 24 hours. Tiredness.
Recurrent fever every afternoon up to 100.3 to 101 degree Fahrenheit Low energy, wheezing, tightness of my chest, coughing For more than 3 months, I have been experiencing fever-like symptoms.  I went to my PCP & family doctor. They recommended for me to see an Infectious disease doctor. I took a lot of tests. They stated I had an inflammation in my body, exaggerated immune response, and elevated atypical lymphocytes that the vaccine may have caused. Treatment: inhaler, steroids, antibiotics, antifungal medicine
pt recv vax & w/in 4hr devel an inj site rxn characterized by redness, swelling & itching;went to ER where auscultation of chest, scattered rhonchi were noted;tx w/IV DPH, Solumedrol & oral DPH;next day small amount of ecchymosis  @ site;
Today is January 8th, 2017, my daughter is still very ill with multiple symptoms including severe congestions, cough, fever, throbbing headache, lethargy, vomiting off and on (most recent 1/4/17) with blood in vomit, rapid pulse, tingling and numbness in hands, feet, and hip area, high irritability, mental confusion, mood swings, loss weight, loss of appetite, overly tired and sleeping many hours, blurred vision, recurring respiratory infection and flu like symptoms, soreness and weakness of muscles, weakness in climbing stairs and all other energy related functions, loss of interest in normal activities,  bleeding gums, trouble breathing during sleep, dislike of light, thermoregulation dysfunction.
Aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (On 25 or 26 Jan don't have clarity) and Knee surgery NOS on 04-Mar-2021.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (Aches) and PYREXIA (Fever). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Aches) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 101-101.2 (High) 101-101.2 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications includes painkillers and antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received on 23-Jul-2021 and does not contain any new information.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unspecified date in September 2014, the patient was vaccinated with a first dose of GARDASIL injection (dose, route of administration, lot# and expiration date were not provided). Then, on an unspecified date in September 2015, the patient received the second dose of GARDASIL 9 injection (dose, route of administration, lot# and expiration date were not provided). No adverse effect was reported. The outcome of the event and the causality assessment between the event and both the suspect vaccines were not reported. Additional information has been requested.
Patient broke out in rash took Benadryl Sunday morning went to walk in clinic md gave Depo-Medrol and valcyclovir.
This spontaneous report was received from a nurse and refers to a 6 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 05-OCT-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N009802, expiry date: 19-DEC-2019) and ROTATEQ (dosing details not reported) (lot # N009948, expiry date: 12-OCT-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
Discovered patient was pregnant after HPV vaccine given - patient was seen for family planning visit. Provider ordered HPV vaccine & flu vaccine "today". Vaccines were given at 3:05pm as ordered.
Throbbing in the left shoulder where the dose was received; Fever; Severe headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, fever and headache. On an unknown date, the outcome of the injection site pain, fever and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever and headache to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. The age at vaccination was not reported. The patient received Shingrix on left shoulder. Immediately after receiving Shingrix, the patient experienced throbbing in the left shoulder where the dose was received which lasted approximately 2 hours. Within 3 to 4 hours of receiving Shingrix, the patient experienced fever which lasted approximately 24 hours. The day after receiving Shingrix, the patient experienced severe headache which lasted approximately 48 hours and got progressively better as time passed. The reporter did not consent to follow-up.
This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction in both arms), DISCOMFORT (Uncomfortable) and PRURITUS (Itches) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 041B21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction in both arms), DISCOMFORT (Uncomfortable) and PRURITUS (Itches). At the time of the report, ALLERGY TO VACCINE (Allergic reaction in both arms), DISCOMFORT (Uncomfortable) and PRURITUS (Itches) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment with antihistamine pills and cream for itchiness taken to alleviate the symptoms experienced.
Since 12:00 AM pt states she has been vomiting, experiencing abdominal pain, headache and body aches. Pt denies fevers or redness to injection site.
RECEIVED A DOSE OF THE JANSSEN COVID-19  VACCINE 6 HOURS AND 52 MINUTES AFTER FIRST PUNCTURE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-SEP-2021, the patient experienced received a dose of the janssen covid-19 vaccine 6 hours and 52 minutes after first puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received a dose of the janssen covid-19 vaccine 6 hours and 52 minutes after first puncture was not reported. This report was non-serious.
This spontaneous report was received from a health professional (medical assistant) and refers to an unspecified number of patient of unknown age and sex. No pertinent medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ, via oral route. No adverse effects reported. The outcome of incorrect product storage was unknown. Additional information has been requested.
is on antibiotics; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (is on antibiotics) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (is on antibiotics). At the time of the report, VACCINATION COMPLICATION (is on antibiotics) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. No Concomitant medication was reported.
My psoriasis started to get worse when I had Covid vaccine (Moderna); This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (My psoriasis started to get worse when I had Covid vaccine (Moderna)) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Psoriasis. Concomitant products included APREMILAST (OTEZLA) for Psoriasis.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (My psoriasis started to get worse when I had Covid vaccine (Moderna)). At the time of the report, PSORIASIS (My psoriasis started to get worse when I had Covid vaccine (Moderna)) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Patient reported that, he was being considered for drug Llumya because he was treated for several years for psoriasis with Otezla and was working fine but last year psoriasis got worse.   Treatment information was not reported.   Reporter did not allow further contact
immediately after receiving her vaccination he developed lightheadedness. He  has an aversion to needles.
I was breaking down existing blood clot in my right leg  when after getting the 1st shot got a red rash &  my right leg  swelled up  producing  a blood clot in my right leg .
4 hours after vaccine was administered: Fatigue, Trouble Focusing 10 hours after vaccine was administered: temperature rose from 97.4 to 99.0, began experiencing full body ache and chills. 11-12 hours after vaccine was administered: Fever of 102.0°, extreme body ache,  headache, and slight nausea 19 hours after vaccine was administered: Fever broke, returned to temperature of 97.2°, intense headache and fatigue for the following hours. 28 hours after vaccine was administered: headache was reduced using ibuprofen, fatigue faded. At time of recording (31 hours after vaccine administration) Symptoms only consist of slight fatigue, slight headache, and pain at injection site.
Pt recvd vax & pt devel redness, swelling & warmth in the arm of inject;
I had a really bad reaction to my first shot; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (I had a really bad reaction to my first shot) 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 (I had a really bad reaction to my first shot). At the time of the report, VACCINATION COMPLICATION (I had a really bad reaction to my first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Patient describes reaction as a rash at the injection site and she experienced "pain all over" her body.
I felt perfectly fine after the shot at 8:30AM. Began to feel a bit tired & sluggish around 5PM. Was standing in the kitchen, moving my arm around as instructed, and became light headed & seeing stars. I took one step to sit down and the next thing I knew I woke up on the ground. I had fainted unexpectedly. I had to lay on the ground for about 10 minutes until I gained the strength to get myself off the ground. The day afterwards I was extremely weak & could not focus. Still a few days later I am not feeling 100%.
Patient began to feel nauseous approximately 15 min after her shot (1339), observation increase to 30 min and began to feel weakness as well as nauseated at 1359. The medics did evaluate the patient and gave ODT Zofran for the nausea. The nausea subsided and patient was released with no further issues.
hands and feet started itching uncontrollably; This is a spontaneous report from a contactable consumer (patient). A 53-year-old (age at the vaccination) non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was Ej1686 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm right on 28Jan2021 at 09:00 as 1st dose, single for COVID-19 immunisation. The patient medical history included thyroid disease from an unknown date and unknown if ongoing. The patient concomitant medication included levothyroxine, liothyronine, and vitamin D, all administered at an unknown dose for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. The patient experienced feet started itching uncontrollably on 28Jan2021 at 18:30. It was reported that at 18:30 at night, right after eating dinner her hands and feet started itching uncontrollably. She immediately took a Benadryl which helped stop the itching. She also had taken 3 Motrin about 1/2 prior to eating. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
redness at injection site; symptoms of swelling at the injection site and a ring around the injection site; This is a spontaneous report received from contactable reporter(s) (Nurse and Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GM9409, Expiration Date: 31Aug2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness at injection site"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "symptoms of swelling at the injection site and a ring around the injection site".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300185147 same drug and AE, different patient;
One week following administration of meningococcal vaccine patient developed an enlarged lymph node in her neck, same side (L) as vaccine was given. Pt was taken to a NP to be evaluated for any other infections etc that would cause an enlarged lymph node. Nothing found. Lymph node is fine now.
antibody test done and it was negative; This spontaneous report from a Pfizer sponsored program. A 72-year-old female consumer (patient) reported that she received the first and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both via an unspecified route of administration on unspecified dates as single dose for COVID-19 immunisation. Relevant medical history was not reported. Concomitant medication included hydroxychloroquine (PLAQUENIL) taken for an unspecified indication from 2000 and ongoing. On an unspecified date, after the two doses of the vaccine, the patient had an antibody test done and it was negative. The outcome of the event was unknown.   The information on the batch number has been requested.
Bump on her arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE CYST (Bump on her arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) 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 INJECTION SITE CYST (Bump on her arm). At the time of the report, INJECTION SITE CYST (Bump on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        No relevant concomitant medications were reported  Treatment details included Benadryl, it didn't help.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information regarding the patient's past medical history, concurrent conditions, or concomitant medication was provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 04-AUG-2015 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-JUN-2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed gabapentin and valacyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
I have a scratchy throat, a lot of nasal discharge, bad headache. I've been running 100- 102 fever. The severity is like having a really bad cold. They started on Monday June 18th and are about the same. My Dr prescribed me an antiviral Paxlovid which I started on Monday.
Swollen lymph node (left axillary); severe fatigue; muscle weakness; This is a spontaneous report from a contactable other health care professional, the patient. A 25-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264), via an unspecified route of administration in the left arm on 12Feb2021 (at the age of 25-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number:EN6206), via an unspecified route of administration in the left arm on 26Mar2021(at the age of 25-years-old); as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and metoclopramide (REGLAN); both on unknown dates for unspecified indications and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. On an unspecified date in 2021, the patient experienced swollen lymph node (left axillary), severe fatigue and muscle weakness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test and procedures which included COVID test (nasal swab) on 26Mar2021 and tested negative. The clinical outcome of the events swollen lymph node, severe fatigue and muscle weakness were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
I was very tired on the first day. The second day I was even more tired, and felt like I was getting a cold. I slept it off and felt better the next day.