chrisvoncsefalvay/vaers-outcomes huggingface dataset:
breathing issues; back of hand swelling; Ankle swelling; knuckle swelling; Headache; Muscle pain; Joint pain; chills; This is a spontaneous report from a contactable consumer (Patient). An unspecified age of male patient received first dose of bnt162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 27Jan2021 as a single dose COVID-19 immunization. The patient medical history and concomitant medications were not reported. He had the first shot on the 27Jan2021, and then starting on the 28Jan2021, he started getting Headache, muscle pains, chills, and joint pains in all joints in his body. Then, he started having breathing issues. He couldn't breathe very well. He came out of that. He has back of the hand and ankle swelling. His knuckles are swelled up. He is supposed to get the second dose 21Feb2021. He would prefer just to get over to Medical Information. The outcome of the events was unknown.   Information on the Batch/Lot number has been requested.  Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
Dizziness, Headache, Fever,  fatigue, injection site pain Narrative: missed a day of work
I had chills and muscle aches which lasted about 24 hours starting about 9 hours after receiving the vaccine. I just rested the next day and wore more layers to feel warm. No additional medication aside from my prescription of 3mg of melatonin at bedtime was taken. Symptoms were gone after awakening from a full night sleep, roughly 43 hours after vaccination.
This case was reported by a consumer and described the occurrence of not responding to therapy in an adult male subject who was vaccinated with Hepatitis a + b vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received 3rd dose of Hepatitis a + b vaccine (unknown). After vaccination with Hepatitis a + b vaccine, the subject felt that he had not developed antibodies to the vaccine. He felt that he had not responded to therapy. No adverse events were noted at the time of reporting.
Information has been received from a physician via a field representative referring to a 19 years old female patient. The patient's concurrent condition included attention-deficit hyperactivity disorder (ADHD). The patient's medical history included dizziness and syncope. The patient was not pregnant. Concomitant medication was not provided. On 24-OCT-2007, 02-JAN-2008 and 15-SEP-2008, the patient was vaccinated with the first, second and third doses of GARDASIL, intramuscularly (lot number, expiration date, dose unknown). On an unspecified date in 2013, the patient's mother took the patient to an emergency room which "triggered visits to the gynecology and fertility institution for evaluations". On an unknown date, the patient's mother reported the patient has been diagnosed with premature ovarian failure, and she "believes is the result of the GARDASIL vaccination". The patient had visited a reproductive specialist on an unspecified date and reported by the mother to have extremely high hormone levels. The outcome of premature ovarian failure was unknown. No product quality issue involved. The causal relationship between premature ovarian failure and GARDAIL was reported as related. Additional information has been requested.
A report recved concerning a pt who devel hives over a 2-3 wk period following admin of hep B vax. No further details provided.
pt recv vax 9NOV95 & lab eval on 10MAY96 revealed elevated liver enzymes (prev liver enzyme levels in SEP95 were nl);alk phos was 80, ASt was 156 & LDH was 201;repeat eval on 11MAY revealed alkaline phos 70, AST 80, ALT 133, LDH 207;
I do that and I still got it/Suspected vaccination failure; still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I do that and I still got it/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 The case was received from the patient via interactive digital media. The patient got the shot and still got them. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Heart inflammation (myocarditis). Chest pain, tightness, occasional shortness of breath.
significantly heavier menstrual cycle after receiving the moderna shot. I've been on nuvaring since I was 15 (so 15 years total) and i have never experienced heavy menstrual bleeding or spotting in between periods. After receiving the vaccine both started.
a lot of pain; not feeling well; This is a spontaneous report from Pfizer sponsored program. A contactable consumer (patient) reported a female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on 24Mar2021. No medical history and concomitant medication was not reported. The patient was in a lot of pain and was not feeling good today. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
13 days after receiving Hepatitis A, Tdap and Typhoid injection (10/23/2018) patient showed a significant increase in LFT's. Patient denied any symptoms during that time. Was having routine labs drawn, repeat labs drawn 11/7 showed a significant decrease in LFT's.
Fever of 102.6 degrees for two days.  Severe abdominal muscle pain.  Unable to sit, stand, or lay down without being in severe pain.  Abdomen was soar to the touch across entire lower area, encompassing entire left to right side areas.
Patient described severe pain over entire body, including bones/joints/muscles not relieved by Tylenol or Ibuprofen. Patient took Tramadol and pain was somewhat relieved.
Headache; Gradual tingling down the arm to fingers; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 06Apr2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included smoker and penicillin allergy. The patient did not receive any other medications within two weeks of vaccination. 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 COVID vaccine. On 06Apr2021 at 10:15, fifteen minutes after injection, the patient experienced gradual tingling down the arm to fingers which lasted half hour and then went away (at 10:45). The patient experienced sore arm on first (06Apr2021) and second (07Apr2021) day. The patient experienced headache on second day (07Apr2021). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event tingling was resolved on 06Apr2021 after half hour while sore arm and headache were resolved on 07Apr2021.   No follow-up attempts are needed. No further information is expected.
Child experienced rapid onset of fever followed by unconsciousness and 1 minute seizure over a 15 minute time period with no preceding symptoms of illness or fever. ER discharge diagnosis was febrile seizure of possible viral origin although lab results of WBC and viral load were unremarkable. Physician suspected that the event was preceding an illness that had not reached detectable levels by CBC and viral load tests. The febrile event was followed by 2 days of persistent fever above 102 and approximately two weeks of general malaise and lethargy with no overt symptoms of rhinitis, cough, otitis media, or cold.
Patient received the Pfizer COVID vaccine (Lot EW0150, exp 7/2021) dose 1 at 1400. At 1405, EMT approached patient who appeared pale and diaphoretic with his eyes closed. PHN approached to assess, patient had slow speech and pulse felt thready. Vital signs: O2 99%, pulse 56, respirations 24. Patient had thick sweatshirt on EMT had difficulty obtaining blood pressure. Paramedic approached to assist. At 1410, PHN, EMT, and paramedic transfered patient to zero gravity chair and placed in reclining position. Patient was offered water and he verbalized feeling better. Patient denied allergies, medical conditions, or medications. PHN assisted patient in removing sweatshirt partially to obtain blood pressure. Vital signs: O2 99%, pulse 51, blood pressure 92/60, respirations 24. PHN offered Benadryl but patient declined. PHN advised on when to call 911. At 1422, patient reported light sensitivity and blurry vision. At 1425, vital signs: pulse 52, respirations 18, O2 99%, blood pressure 118/84. At 1535, vital signs: O2 99%, pulse 58, respirations 18, blood pressure 110/66. Patient reported continued improvement in symptoms, only feeling tired. Patient reported working out, only sleeping 2 hours that night, and not eating before coming in. PHN called family member at patient's request to drive patient home. At 1439, patient assisted to seated position in zero-gravity chair by PHN and EMT. Patient reported symptoms had resolved and he felt back to baseline. At 1445, patient stood up, monitored closely by PHN and EMT. At 1449, patient left walking with steady gait to parking lot where family member was waiting to drive patient home.
Information has been received from a consumer concerning her daughter with no past medical history, and no none allergies who on 5/19/00 was vaccinated with MMR II. On 5/25/00, the sixth day following vaccination, the pt complained that her eye was hurting. The mother indicated that the daughter's eye teared and she developed a fever. The eye then became swollen and that's when the mother called the healthcare provider. The doctor indicated to watch her and if it gets worse to bring her in. After a few days, the pt started getting better and her eye was fine. Unspecified medical attention was sought. Additional info has been requested.
Information has been received from a physician concerning an 11 yr old male who on 05Nov96 was vaccinated with a dose of varicella virus vaccine live. On 25Jan06 the pt broke out with red, vesicular lesions on his back, arms and buttocks. Unspecified medical attention was sought. He did not have a fever and he was treated with diphenhydramine hydrochloride (Benadryl). Subsequently, the pt recovered. The physician also noted that there was a wild varicella outbreak at his school. No product quality complaint was involved. Additional information has been requested.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Additional Details: Patient stated injection was given too high. 2 hrs after injection he said pain was so intense it took him to his knees. He took ibu and APAP around the clock for 4 days and iced it. He still has a lot of pain, especially when he lays down. Went to a massage therapist who has given him stretches to do. he also has an appt with an MD
Very Sore Right Arm where PPV23 Vaccine administered, followed by flu like achy muscles throughout whole body while sleeping. Swelling of right arm & redness to noticed when waking on morning of 19 Jun 15. Flu like achiness, moderate swelling of right, upper arm, and moderate fatigue continue through day. Right upper arm muscle very sore. Symptoms started to improve on 20 Jun 15, with swelling of right upper arm shifting down. Swelling continue to drift down to slightly below right elbow (with redness) for several days. All symptoms continued with time, and where completely gone on morning of 24 Jun 15.
Happened 4 hours after shot, Face swelled, throat closing, rash hives and rash
Presented with acute chest pain, awakening him from sleep, elevated troponin, cardiac arrhythmia. CMRI confirms myocarditis. Treated with lidocaine for ventricular arrhythmia, IVIG given, noted to have HTN discharged home on lisinopril. Troponin I peak 14.3, last level 9/8 0.83.
Information has been received from a certified medical assistant (CMA) referring to a patient (8) of unknown age and gender. No information regarding patient's relevant medical history, current condition and concomitant medications was provided. On 20-JAN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013206, expiration date 29-JAN-2017, dose and route were unknown. The vaccines were stored under 34.5 F (min) and 37.9 F (Max) for 24 hours. There was no previous temperatures excursion. It was called because of a "data logger". No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient was diagnosed with cellulitis at injection site, the day after injection. Treatment: oral Keflex 500mg three times per day for 7 days.
Pt reported upper arm pain and small lump fored at injection site after levaing. Pt called that same evening to report sx. RPh recommened OTC pain relief and f/u with PCP. Pt took Tylenol at 3 AM on 9/10 pt could not sleep due to severe arm soreness and difficulty moving arm - prompted ER visit. Per pt ER administered Percocet and two injections. Later recovered. Pt had received Pneumovax in the past and did not experience this reaction.
sick as a dog; Initial information received on 28-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-HCP (healthcare professional).  This case involves an unknown age female patient who experienced sick after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2006, the patient received a dose of suspect INFLUENZA VACCINE (dose, formulation, brand name, batch lot details: unknown) produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination.  Patient states she is 67 years old, reported she got sick as a dog  (illness) in 2006 after receiving a flu shot (unknown latency) . Patient was unable to verify during the call, if it was a Sanofi flu vaccine she had a reaction to.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (sick as a dog).  At time of reporting, the outcome was Unknown for the event sick as a dog.
Night of  vaccine (about 6hrs after) : bad headache , chills throughout the night, tiredness, heartburn, nausea.  Last until about 3 pm the next day.   Slight rash /blotchiness on skin 2-3 days after. Non itchy, non raised.
Recv'd vax on 2/8/00. Foster mom found infant dead Sunday am on 2/13/00. Pt autopsied. Preliminary COD is SIDS.
FLU SHOT ADMINISTERED FRIDAY AFTERNOON.  SATURDAY MORNING DEVELOPED EYE SWELLING AND IN AFTERNOON DEVELOPED RASH AND ICTHING CHEST AND KNEE
Myalgia, Fever, sore arm, chills Narrative:  Other Relevant History:
HIGH PULSE RATE, RAGING HEART RATE; CLINCHING PRESSURE ON TEMPLE FOREHEAD, HEAD PRESSURE; SENSITIVE NARES, PRESSURE FEELING; SLEEP LOSS; SHAKING; CHILLS; FEVER; EXCRUCIATING HEADACHE; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced high pulse rate, raging heart rate, clinching pressure on temple forehead, head pressure, sensitive nares, pressure feeling, sleep loss, shaking, chills, fever, and excruciating headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F, and Heart rate (NR: not provided) 100-112 {beats}/min. Treatment medications (dates unspecified) included: zolpidem tartrate, paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, chills, and fever, had not recovered from sleep loss, and the outcome of high pulse rate, raging heart rate, clinching pressure on temple forehead, head pressure, sensitive nares, pressure feeling and excruciating headache was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Patient reported increased blood pressure and 103 degree temperature 3 days after vaccine administration which sent him to ER.
I had some of the normal side effects: Nausea, body aches, headache, HOWEVER!! the very strange side effect was this: I received the vaccine in my right arm since I am left handed. The following day, the entire right side of my head (the scalp) was burning and painful like a had gotten a bad sunburn. This lasted for three days, with improvement on the third day and my left side of the head being very sensitive. There was absolutely NO pain or burning on the right side of my head (scalp).
pt devel a total body rash beginning on the rt arm @ the site of the pneumovax;pt came in for the rash 3 days p/vax;pt was given DPH 25-50mg PRN for itching;
serious discomfort in my lymph nodes; It is causing serious discomfort; bad reaction to the 2nd dose; started after the first shot and got worse after the second; numbness in my left thigh; tingling/pain in my left leg; tingling/pain in my left leg; This is a spontaneous report from a contactable consumer or other non-health care professional (patient reported for self). A 51-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, administered in arm left (reported as left arm) on 02Apr2021 16:00 (at the age of 51-year-old) as dose 2, single for covid-19 immunization administered in other facility (Reason why batch/lot is Unknown: Unknown). Patient's relevant medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included lamotrigine (LAMICTAL) and buspirone hydrochloride (BUSPAR), both taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with covid-19. Patient had earlier received, first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration, administered in arm left on 12Mar2021 16:00 as dose 1, single for covid-19 immunization and experienced "tingling/pain in my left leg" (Paraesthesia, Pain in extremity) on 12Mar2021 23:30. The patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Patient reported that, patient was having tingling/pain in the left leg (thigh) on unspecified date in 2021. It mostly occurred when patient was laying down. It started after the 1st shot and now after the 2nd had gotten worse. Patient had a bad reaction to the 2nd dose (Apr 2021) and it's been a week and patient was still having serious discomfort in the lymph nodes (03Apr2021). Patient also reported that patient was having numbness in the left thigh. It started after the first shot and got worse after the second (condition aggravated on unspecified date in Apr 2021). It was causing serious discomfort on 03Apr2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included covid test (sars-cov-2 test) resulted as negative on 05Apr2021 and nasal swab (sars-cov-2 test) resulted as negative on 27Apr2021. The patient did not receive any treatment for the adverse events. Device date noted as 11May2021. Outcome of the event "bad reaction" was unknown; outcome of all the other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Having rebound after taking paxlovid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Having rebound after taking paxlovid) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Having rebound after taking paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Having rebound after taking paxlovid) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that the co-suspect Pfizer drug was taken for the treatment of COVID-19 from 19 May 2022 to 23 May 2022.Patient had experienced having rebound after taking paxlovidon 28 May 2022, and had not recovered.  Device Date was reported as 01Jun2022  Company comment: This spontaneous case concerns a 50-years-old male patient, with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Having rebound after taking paxlovid) which occurred on unspecified day after the third dose of mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 23-May-2022 for COVID-19 treatment. Patient had experienced having rebound after taking paxlovidon 28 May 2022 and had not recovered. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 50-years-old male patient, with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Having rebound after taking paxlovid) which occurred on unspecified day after the third dose of mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 23-May-2022 for COVID-19 treatment. Patient had experienced having rebound after taking paxlovidon 28 May 2022 and had not recovered. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Mother reported on 1/20/15 that child had redness and swelling to (L) arm and 2 day later (1/18/15) also had redness and swelling to (R) arm. This was when she took the child to ER. He was treated with BENADRYl and "steroid" and was released.