chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Licensed Practical Nurse and a Registered Nurse referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient was not reported. On 07-DEC-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L000569, expiry date 13-JUL-2016) (dose unspecified) orally. Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from same source. Additional information has been requested.
Recv vax Aug 14, 1997. Same day exp fever which persisted till Aug. 16, 1997. Pt seen in ER dx w/OM  and tx w/Zithromax.Pt remained febrile until Aug 18,1997. Pt developed maculopapular rash.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 33 degree Fahrenheit (0.56 degrees Celsius) for 48 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
He has concern of hives which have been present directly following his 2nd COVID vaccine.  He reports that it started off as a little itching on his chest, but the hives are now on his chest, abdomen and back.  Reports that they are very itchy.  He has been using over-the-counter Benadryl with little relief.  Denies any shortness of breath, chest pain, tongue or neck swelling.  Or difficulty swallowing.
muscle pain in my left leg especially at hip, from hip to knee; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Sep2021 14:30 (Lot number: FC3183) at the age of 74 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "heart disease" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: MYALGIA (non-serious) with onset 25Sep2021, outcome "not recovered", described as "muscle pain in my left leg especially at hip, from hip to knee". Therapeutic measures were not taken as a result of myalgia. Additional Information-Patient had not received other vaccines in four weeks. Patient did not had covid prior vaccination. Patient did not tested covid post vaccination. No follow-up attempts are possible. No further information is expected.
tested positive and we were both boosted; tested positive and we were both boosted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 4 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive and we were both boosted". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested negative; Positive, notes: we both tested positive after eight days; Negative, notes: I tested negative on 14.  Clinical course: Both patient and her husband tested positive and they were both boosted (Unspecified vaccine), 2 boosters. Her husband was 84. He tested, since he was 84 his doctor recommended that he took Paxlovid but patient did not take it. Patient was fine and tested negative on day, they tested late because they both tested positive after eight days. So they decided to wait, so patient tested negative on 14 and her husband tested positive on 15. Today, her husband  was still positive on 19 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt c/o Nausea, light headiness 7 sweating profusely with heart palpitations. EKG per EMT.  Pt states better and refuses continued care & ER visit. States with f/u with her heart doctor. Staff spoke with her 4/14/2021@ 0853. States she is feeling fine. Not under doctor's care. Patient inquired about second dose. Advised to follow PMD guidance to receive though him/her , but not to receive second dose at drive through clinic.
Pt recv vax on 6/10/96; on 5/6/99 pt exp varicella &fever
2 days after vaccination patient had swollen lymph node in lower neck near collarbone and the area was hurting and tender Also armpit was sore .  Symptoms are slowly resolving.
MODERNA COVID-19 vaccine EUA 1st day after. arm swollen at inject. site, loose stool, food doesn't taste good 2nd 3x4" RED HOT Patch at inject site. Temp to 99 degrees (normal 97.6 degree) sour stomach, loose stools 3rd 4 am abdominal pains, loose stool- Day in Bed weak upset stomach. Arm less red 7th normal temp & energy, loose stools & gut rumbles
Tested positive for COVID-19 and experienced symptoms like a bad head cold and aches all over; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID-19 and experienced symptoms like a bad head cold and aches all over) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 012M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Oct-2022, the patient experienced COVID-19 (Tested positive for COVID-19 and experienced symptoms like a bad head cold and aches all over). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in October 2022 for COVID-19 treatment, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID-19 and experienced symptoms like a bad head cold and aches all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Oct-2022, SARS-CoV-2 test: Positive. On 12-Oct-2022, SARS-CoV-2 test: Negative. On 14-Oct-2022, SARS-CoV-2 test: Positive. In October 2022, SARS-CoV-2 test: (Negative) tested negative again multiple times. On 24-Oct-2022, SARS-CoV-2 test: Negative.   No concomitant medications were provided. Patient had a negative test on 12-Oct-2022, took Paxlovid, and tested positive for COVID-19 on 14-Oct-2022. Then tested negative again on 24-Oct-2022 and had tested negative again multiple times since then.  Patient had taken Tylenol for his symptoms.   This case was linked to MOD-2022-665337 (Patient Link).
Headache throughout the night on 5/12. Headache became more intense throughout the morning of 5/13. Fever started around 9:00 am on 5/13. Fever subsided around 6 pm. Felt achy, tired and had chills during that time.
Information has been received from a pharmacist reported that he received a call from a mother concerning a 14 female daughter who was vaccinated with a first dose of GARDASIL (date, dose, route and lot number unknown), laboratory performed were magnetic resonance imaging and blood work (date and results unknown). The mother reported her daughter, experienced adrenal insufficiency, curvature of her spine, bouts of intense abdominal cramps, nausea, vomiting and headache. The patient's symptoms began one week after administration. The patient sought specified medical attention a neurologist and gastroenterologist. The outcome was not recovered. The vaccine was administered with a different facility. Follow up has been received from a patient's mother who reported that in addition to the previous symptoms, the patient was experiencing insomnia, fever, joint pain, chronic cough, severe migraines, back pain. The patient was 15 years old (also reported by a pharmacist as 14 years old) and received her first dose of the vaccine on 17-OCT-2008 and the second dose on 19-DEC-2008. The patient had been tested for Lyme disease, mononucleosis, West Nile virus and rheumatoid arthritis with negative results. The patient was seeing a chiropractor and alternative medicine doctor. Follow up information his been received from a registered nurse which reported that on 17-OCT-2008 the patient received a dose of FLUZONE (lot no. U274AA) and on 19-DEC-2008. It was reported that the patient did not received any concomitant vaccinations. The nurse reported that the patient had 5 follow up visits with the physician since 19-DEC-2008. The patient was seen in the office on 05-JAN-2009. At this visit the patient had complained of headaches. The registered nurse refused to five additional information concerning the patient. Additional information has been requested.  5/28/09 Received vaccine records & PCP medical records for 11/5/2008-3/18/2009. FINAL DX: menstrual migraine, migraine, flu, bronochitis, viral syndrome. Records reveal patient experienced gen good health on 10/17/08 when received HPV#1 & Flu shot and on 12/19/08 when received HPV #2.  On 11/5/08 visit c/o LBP & dysmenorrhea x 10 days.  Tx w/NSAIDS.  RTC 1/5/09 w/intermittent HA, photophobia, cough, nasal discharge/stuffy nose x several mo w/increase in frequency x 2 wks.  Dx w/migraine w/possible sinus component.  Tx w/NSAIDS & Tylenol #3.  RTC 1/12/09 w/no improvement.  Labs & x-rays ordered.  Dx w/acute maxillary sinusitis & tx w/antibiotics.  RTC 2/20/09 w/fever, head congestion, cough, sore throat & migraine.  Dx w/influenza.  Tx w/cough syrup.  RTC 3/2 w/fatigue, nasal congestion, rhinitis, cough w/sputum production.  Dx w/bronchitis.  Tx w/antibiotics.  Neuro consult done 3/5/09 & reveals pt awakened daily w/HA, & had developed loose stools, sleep disrupted, bruxism.  Referred for head/neck MRI & tx w/meds. Dx w/menstrual migraines w/superimposed daily migraine.  Returned to PCP 3/18 w/chronic HA, LBP, fatigue, rash,  & recent abdominal pain w/n/v/d.  Dx w/prob viral abdominal pain.
RASH AND ITCHING ON FACE, TOP OF THE HEAD AND ALL OVER THE BODY; ALLERGIC REACTION; This spontaneous report received from a consumer concerned a 66 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient has allergies to unspecified medicine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the patient experienced rash and itching on face, top of the head and all over the body. On 16-MAR-2021, the patient experienced allergic reaction. Laboratory data (dates unspecified) included: Skin test (NR: not provided) Medicine allergy. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from allergic reaction, and rash and itching on face, top of the head and all over the body. This report was non-serious.
Covid positive after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid positive after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid positive after 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid positive after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the patient got 1st shot on 1Mar2021 and is Scheduled to get the 2nd shot on 29Mar2021 but on 17Mar2021 he tested positive for Covid 19. Consent for safety follow up denied.   Reporter did not allow further contact
I had a cold for about three weeks, so I had been testing myself regularly to make sure I didn't have COVID-19. On 12/22/2023, I was feeling really tired and dizzy at about 4:30 PM. When I went upstairs to shower, I felt winded. About an hour later at the grocery store, I felt out of it. At about 8:00 PM that night, I took a home antigen test and got a positive result. I didn't really get any other symptoms from the COVID-19. I had a residual cough from the cold I had had and some head and chest congestion. About two or three days later, I called my healthcare provider, and the doctor I spoke to didn't deem it necessary to prescribe me an antiviral, but I was prescribed an antibiotic to prevent bronchitis. I continued to test positive for COVID-19 for ten days. On 1/2/2023, I finally tested negative for COVID-19. At that point, the cough was almost gone, too.
Data base says the patient received a vaccine on 4/20/21. We documented it in the patient chart. When the group home bought the patient in they said that he never received a vaccine.   Pt chart has that pt received 1st vaccine from pharmacy on 4/20/21. Pt received dose of Pfizer on 5/14/21 at Covid vaccine clinic. Pt received 2nd dose at Covid vaccine clinic today, 6/4/2021. Pt and caregiver state this is patients second dose and received first dose here on 5/14/2021.
Patient received the vaccine even tho she is 16; A spontaneous report was received from a physician concerning a 16-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) even tho she is 16 product administered to patient of inappropriate age).  The patient's medical history was not provided. No relevant concomitant medications were provided.  On an unspecified date, prior to the onset of the event, the patient received a dose of mRNA-1273 (Lot number: not provided) for COVID-19 infection prophylaxis.    The physician stated that a pediatric patient had received the Moderna vaccine even though she was 16. No additional information was available at the time of this report. No treatment information was provided for the event.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event received Moderna's COVID-19 vaccine (mRNA-1273) even tho she is 16 (product administered to patient of inappropriate age) was considered resolved on an unspecified date.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
Welts on skin (abdomen & chest). Swollen upper lip. BENADRYL given.
Swollen lymph node in left armpit; pain in armpit; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL3247 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 01Apr2021 11:15 (at the age of 52-year-old), as dose 2, single, for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Patient had no allergies to medications, food, or other products. Medical history included lupus. Concomitant medications included hydroxychloroquine phosphate (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]); sumatriptan and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL3247 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 09Mar2021 13:15 (at the age of 52-year-old), as dose 1, single, for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced pain in armpit on 02Apr2021 and swollen lymph node in left armpit on 02Apr2021 at 20:00. Patient received no treatment for swollen lymph nodes. The outcome of swollen lymph node in left armpit was not recovered and the outcome of pain in armpit was unknown.  No follow-up attempts are possible. No further information is expected.
This case was reported by a healthcare professional (nurse) and described the occurrence of not responding to therapy in a 57-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included hepatitis B vaccine recombinant;GlaxoSmithKline;unknown;unknown given on 5 July 2012. On an unspecified date the subject received 1st dose, 2nd dose, 3rd dose of ENGERIX B (details unknown) and within weeks of vaccination with ENGERIX B, the subject experienced not responding to therapy. The nurse explained that the subject was administered 3 dose series of ENGERIX B and a "few weeks later upon testing did not have antibody titers to show a response to the vaccine". Therefore, on an unspecified date the subject received 4th dose of ENGERIX B (details unknown) and this time experienced decreased therapeutic response. The nurse stated the subject was tested after the 4th dose and the results showed low titer level and on 05 July 2012, the subject was administered a 5th dose of ENGERIX B.
mom called 24JUL reporting pt has sl fever on 19JUL;then on 20JUL devel [[name]] blister like areas on upper rt area w/a [[name]] white clot in the middle;by 21JUL it was one raspberry looking area sl bigger than 1/2 dollar x 2 days & gone, fussy
I woke up and was very achy so I took Tylenol every 6 hrs to keep the pain away.
Pfizer-BioNTech Covid 19 vaccine EUA. Sore at injection site
FELT MILD THROAT DISCOMFORT. RESOLVED IN 15 MINS. NO MEDS GIVEN.
This spontaneous report was received from a 64 years old female patient with high blood pressure and drug allergy to amoxicillin reporting on herself. On 15-MAY-2015, the patient was vaccinated with the first dose of RECOMBIVAX HB (manufacturer unknown) (dose, route of administration and lot # were not reported), reported that had to be vaccinated for a job requirement. Concomitant therapies included losartan (manufacturer unknown). On 16-MAY-2015 at approximately 3:00 AM or 4:00 AM, the patient woke up in a cold sweat and was shaking. At approximately 5:30 AM, she had a headache on the top part of her head. She was very weak and she threw up. She couldn't get out of bed because she was weak. She called the physician's office and the nurse thought she had a "stomach bug". Consumer did not have an office visit for her symptoms. No treatment was given for the events. No lab diagnostic tests have been performed. The patient had recovered by 4:30 PM on 16-MAY-2015. The patient would not receive any further doses of RECOMBIVAX HB (manufacturer unknown) because of this adverse events. Relatedness between the events and vaccination with RECOMBIVAX HB (manufacturer unknown) was not reported. Additional information has been requested.
Intense cramping during menstrual cycle. Awful, clumping discharge. Much longer and extremely heavy flow.  My typical cycles are 4 light days with no cramping.  Every month since they?ve been heavy, clumping, coagulated nightmares with cramping lastly at least 9 days. Each month has been the same since since may. Not decreasing in craziness.
mild pericarditis; anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Family history included: "heart problems" (unspecified if ongoing), notes: he also stated that her wife's family has had heart problems through the years. The patient's concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "mild pericarditis"; ANXIETY (non-serious), outcome "unknown", described as "anxiety".  Clinical course: The reporter called on behalf her wife that was administered with the Pfizer-BioNTech COVID 19 Vaccine a few months ago and now she was having some heart palpitations and racing hearts. He was wondering if that mild pericarditis that started with the vaccine could be triggered by the anxiety she was suffering right now. He also stated that her wife's family has had heart problems through the years.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Starting about 8 hours after the shot and for about 12 hours thereafter: fever, insomnia, fatigue, mild delirium, and aches/soreness. One instance of vomiting during this period. Symptoms gradually lessened after about 12 hours (around 8:30 am on April 2), and by that evening, or about 24 hours after onset, were entirely gone except for fatigue, which was itself gone by the morning of April 3.
The patient's arm swoll up to the size of a baseball, it was hot and red and patient stated difficulty moving arm up and down due to soreness.
This spontaneous report received from a consumer via a company representative concerned a 6 decade old female of unknown race and ethnicity. 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: Unknown, Expiry: UNKNOWN) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter reported that his mother was a healthy woman in her 50s. She got the vaccine in the spring. Reporter was so afraid for her. On 04-NOV-2021, patient had a stroke in the morning and was in the hospital (Number of days hospitalized not reported). Patient was just at doctors for yearly and was healthy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211112386-covid-19 vaccine ad26.cov2.s-stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
The patient called around 5:20PM on 06/23/2022 stating that she had left leg numbness and was having trouble walking.  She stated that she was dragging her foot around all day.  She stated that she had taken some Tylenol, but nothing was helping.  She received the shot around 5PM on 06/22/2022 and stated that her signs/symptoms began upon awakening on 06/23/2022.
Patient states "felt very tired all evening. The next morning dizzy upon rising, passed out".  Husband drove her to emergent care.  States they adm. Epipen and inst. to report if symptoms recurred.