chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID vaccine administered to patient. She began to have lightheadedness and dizziness. She disclosed she had not yet eaten for the day, except for a glass of milk. Writer brought her to an exam table and had her lay down. After 5-10 minutes, she was given a banana and two small apple juice boxes. She then laid back down. After another 5 minutes, she complained of headache and slight phlegm development in her throat. Dr. was called to evaluate- after an assessment, she asked for a BP. Writer completed the vitals and found her BP was 113/77. 5 more minutes passed. Dr. advised that since her situation was not improving and headache and phlegm appeared to be getting worse, patient should receive epi and go to the hospital. Writer administered 0.3mg/0.3mL of epi and drove patient to the Emergency Department of Hospital. She was there for about two hours before being discharged. Symptoms largely resolved by the evening.
itchiness; Negative rapid test and antigen test; rash started on feet and legs then moved to torso and the rest of body except the face; fever 101.5 F; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), SARS-COV-2 TEST NEGATIVE (Negative rapid test and antigen test), RASH (rash started on feet and legs then moved to torso and the rest of body except the face), PYREXIA (fever 101.5 F) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced PRURITUS (itchiness), SARS-COV-2 TEST NEGATIVE (Negative rapid test and antigen test), RASH (rash started on feet and legs then moved to torso and the rest of body except the face), PYREXIA (fever 101.5 F) and NAUSEA (nausea). At the time of the report, PRURITUS (itchiness), SARS-COV-2 TEST NEGATIVE (Negative rapid test and antigen test), RASH (rash started on feet and legs then moved to torso and the rest of body except the face), PYREXIA (fever 101.5 F) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment details included Benadryl, PREDNISONE .   Reporter did not allow further contact
1/15/21 -Fatigue, chills/hot flashes,  diarrhea, light-headedness,  rapid heart rate. 1/19/21 - EXTREME Fatigue, chills/hot flashes,  diarrhea, light-headedness,  rapid heart rate, Muscle weakness and shakiness, high blood pressure difficulty concentrating/remembering, headache , GI pain difficulty sleeping, vertigo, extreme mood swings, lower back pain, scalp tenderness .  These symptoms intensified through  April. 8/9/21-  The only symptoms that have lessened have been inability to concentrate (slightly better than before) , muscle body aches (slightly better)
Left Side Weakness with slurred speech.  Started Sunday. Send to hospital. Still in hospital as of this writing (4-12-2021 @ 15:00)  Charge nurse admittedly does not know if this is just a coincidence or cause by vaccine
Information has been received from a consumer concerning her 53 year old father with liver problems and no drug allergies who on 22-NOV-2006 inadvertently received HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 ml), orally. There was no concomitant medication.  Subsequently, "in late November" the patient experienced nausea, dizziness and weakness.  At the time of the report, the patient had not recovered.  There were no relevant diagnostic tests or laboratory data.  Additional information is not expected.
This spontaneous report as received from a health professional refers to an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date in approximately September 2014, (reported as within the past week and half), the patients were vaccinated with improperly stored GARDASIL (route, dose, lot number and expiration date not reported). No adverse effects were reported. Co-suspect and concomitant therapies were not reported. This is one of several reports from the same source. Additional information is not expected, since the reporter did not want to be contacted.
allergies turned to bronchitis with mucus; A spontaneous report (United States) was received from a consumer on 25-FEB-2021 concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a medically significant event of allergic bronchitis (reported as allergies turned to bronchitis with mucous).  The patient's medical history included asthma and allergy. Relevant concomitant medications were not provided.  On an unspecified date, the patient received Moderna COVID-19 Vaccine for COVID-19 vaccination. Tomorrow it´s being 5 weeks since her first shot. Some later, the patient developed allergies turned to bronchitis with mucus which started 3 or 4 weeks ago. She is going to receive her second shot the following week and will like not to miss it.   Treatment of the event included antibiotics and steroids.  Action taken with mRNA-1273 in response to the events was not reported.   The events, allergies turned to bronchitis was considered not recovered/not resolved at the time of reporting.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a physician concerning an 15 year old female with a history of polycystic ovary syndrome, who on 12-Sep-2006 was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#654540/0800F). Subsequently, shortly after receiving the vaccination the patient fainted. Subsequently, the patient recovered from the syncope. Unspecified medical attention was sought. Additional information has been requested.
Redness, heat, swelling at injection site; nausea and lightheadedness (not sure if related).
PAIN IN THE ARM; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported 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.  On an unspecified date, the subject experienced pain in the arm, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and pain in the arm was not reported. This report was non-serious.
Patient was initally a 15 minute observation period after his first vaccine. Around his 15 minute time, he started to complain of itching and nausea. His vitals were taken and were stable, but elevated Blood pressure of 160/98. Patient was given 50mg of PO Benadryl and monitored for an additional 2 hours with no resolve of symptoms. Denied complaints of chest pain or shortness of breath, but continued to have itching, nausea and appeared pale even after prolonged time to lay down. VSS. Sent to the ER for further evaluation via private vehicle after refusal for 911 to be called. Last BP: 130/78, RR=20, HR=90 and 95% on RA. Patient walked without assistance to his fathers vehicle and verbally commited to going straight to the ER.
Throbbing headache almost like a migraine; Throbbing headache almost like a migraine; light sensitivity; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: EL3247) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), MIGRAINE (non-serious), outcome "not recovered" and all described as "Throbbing headache almost like a migraine"; PHOTOPHOBIA (non-serious), outcome "not recovered", described as "light sensitivity"; FATIGUE (non-serious), outcome "not recovered", described as "tiredness".  Additional information: The patient did not receive other vaccine in four weeks. The patient did not covid prior vaccination. The patient did not have covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
itchy arm at injection site; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 39-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), administration time 10:30, administered in arm left (lot number EL9621) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (dose 1, lot number unknown), for covid-19 immunisation, reactions: "tired", "sore neck", "sore arm". The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 20Feb2021, outcome "recovered" (2021), described as "itchy arm at injection site". Therapeutic measures were not taken as a result of vaccination site pruritus.  Additional information: The event onset date was also reported as 21Feb2021. The vaccine was administered at a military facility.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093141 same patient/drug, different vaccine dose/event
Lower abdomen, waist line, approximated 4 days after vaccination. Spread across waistline, above waistline, below right breast, left shoulder.
DEC 15 2017 DR. VISIT -  RECEIVED PNEUMONIA SHOT PNEUMOVAX-23 Received Pneumonia shot and when returned home, immediately had to lay down, very ill feeling, with very red, swollen painful arm. I called back to the Dr office and they were closed. A friend was reassuring that it will get better and if not call Dr. I called Dr. on Monday Dec 18 regarding concern of continued poor shot reaction and pain. Jan9 I called Dr. again regarding continued pain and he assured me the reaction would go away.  Called Dr. again Dec19 with continued pain and decreasing mobility with increasing pain intensity. Got in to Dr.'s office and saw his nurse-practitioner on Jan22. Their office had multiple people look online at pharmaceutical sites regarding vaccine reactions and found that reactions were only to have lasted a week. As I was continuing to feel worse as time passed since the shot, and they really didn't know what to do, so I was prescribed Prednisone at the rate of 20mg for eighteen days. The prednisone ran out Feb13. Pain and joint stiffness intensified and by Feb17 I could not get out of bed. It took me two and a half hours to get out of bed, then I had to get changed and I was able to take myself to the Emergency Room where I was assisted into the building. At emergency I spoke with three doctors over an eight hour span. Tests included blood work and xrays after having shared my story since having the shot. They advised to stop Crestor as that can cause joint aches  I was to stop it for two weeks. I was put on a 10mg Prednisone twelve day taper-pack (60-40-30-20-10), which I finished Mar1. High dose of prednisone dose at the beginning was causing me to have jitters, heart palpitations and not sleeping. As the Prednisone tapered down, aches returned. So on Mar18 I started my CRESTOR again as pains were returning in spite of not taking it. No relief from muscle and joint aches was ever fully received. Later in March I had many more blood tests and Apr4 I was sent to a Rheumatologist and had many appointments where more blood work and prednisone given, without any relief. I saw Dr. May 1. On this date he had decided that what I had was something called Polymyalgia Rhumatica for the lack of knowing what else to call my situation. Needless to say, I was angry and upset to think that all these months knowing that this pneumonia shot did this to me and that the DRs. wouldn't even think about this having been caused by the pneumonia shot. I had to sell my home because I couldn't care for myself. Now in appointments have continued to this day. Other DRs. have encouraged me to report this because I am not the only one who has had had severe reactions from having vaccine shots. This summary does not include all of the appointments and blood tests I have had. And I continue to this day to seek medical help for this condition brought on by the pneumonia shot. I do not want others to go through what I have.
Information has been received from a third party administrator on behalf of a pharmacy concerning a female patient, who on 02NOV2013 was vaccinated with PNEUMOVAX vaccine with lot # H021941 and an expiration date of 11JUL2014. It was reported that the patient was diagnosed with pneumonia days after receiving the vaccine. Additional information has been requested.
Patient experienced a high fever (> 102*f), chills that cause chattering of the teeth, fatigue that has lasted up to 4 days, and pt states there is some blurriness in vision.
For 24 hours I had muscle spasms down the middle of my back and in my neck; severe malaise; This is a spontaneous report from a contactable nurse (patient). A 22-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1824; expiry date: unknown) via an unspecified route of administration in the right arm, on 20Jan2021 at 10:00, at a single dose, for Covid-19 immunization. Other medical history included depression, anxiety, and hypothyroidism. The patient had no known allergies. Concomitant medications included sertraline, prednicarbate (TOPIMAX), levothyroxine, and ethinylestradiol, norelgestromin (XULANE). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EI1284) in the right arm, on 26Dec2020 at 06:15 AM, for Covid-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. On 21Jan2021, at 12:00 AM, for 24 hours, the patient had muscle spasms down the middle of her back and in her neck, and severe malaise. The patient did not receive therapy for the events. Outcome of the events was recovered.
Report 20010245201 describes muscle tenderness of the lower back in a 22 year old female who received an injection of hep B vaccine recombinant (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not specified. On 08/09/2001, the pt received her first injection of Engerix-B in her left arm. Two hours post-immunization, the pt experienced muscle tenderness in the lower back that persisted for one week. She also experienced pain in her left elbow. The events resolved.
This spontaneous report was received from a healthcare worker refers to unknown number of patient of unknown age and gender. No medical history was reported. The healthcare worker reported that some of the improperly stored VAQTA, tetanus and diphtheria toxoids, absorbed, PNEUMOVAX23, GARDASIL and RECOMBIVAX HB might have been administered to unknown number of patients. The lot numbers and expiry dates of the vaccines were not reported. The vaccines were exposed to colder temperature excursion, temperatures ranging from 25-35 Fahrenheit (F) on multiple occasions. No adverse effects reported. Additional information has been requested.
Pt. states that he received covid Pzifzer vaccine at 11:17 am on 01/05/2021 to left deltoid IM. Around six to seven minutes  at 11:23 am post vaccination patient started having burning sensation at site, felt flushed, diaphoretic, light-headed, nauseated, and now he is experiencing tingling to bilateral feet. Pt. states that earlier post vaccination he was feeling anxious, but he is no longer feeling anxious. Pt. denies feeling this way post vaccination with other vaccines. Pt. states that he is still having bilateral  feet tingling up to both calves right greater than left.
Diarrhea; This is a spontaneous report from a non-contactable consumer reported for himself  A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea in Jan2021 with outcome of unknown. The action taken in was not applicable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient came into Health Clinic for 1st dose of COVID-19 Vaccine. Patient completed COVID-19 vaccine screening checklist for contraindications. Patient checked that she is allergic to peanuts with a reaction of mouth swelling and rash. Patient reports she takes gabapentin for neuropathy. Medical provider MD onsite, reviewed risks with patient, she made an educated decision to receive the vaccine. Patient received Moderna Lot # O11J20A in left deltoid administered by, RN at 0935. Patient observed in clinic for 15 minutes after vaccine given. No reactions reported at that time. Patient left clinic with husband but returned to clinic at 1030, reporting she had a hoarse cough and her throat felt tingly. MD assessed patient?s airway, and lung sounds.  RN obtained vital signs at 1045: temp 99.1 tympanic, BP 147/87, respiratory rate of 23, heart rate 72, O2 sats 100% on RA. Per MD verbal order with supervision and guidance from pharmacist, RN administered diphenhydramine 50mg/ml 1 ml in L. deltoid at 1050. Patient takes carvedilol for hypertension, reports she did not take this medication today. Pharmacist, RN, and MD in agreement to give medication closest to region of where reaction may have started from. Vital signs at 1103: 98.9F, 142/93, heart rate 72, O2 sats 100% and resp rate 22, slightly shallow breaths, though patient reports she is feeling some slight relief. 1109 per pharmacist request and with Drs approval/agreement, RN gave patient famotidine 20 mg tabs (2 tabs) oral. Patient tolerated well. 1120 vitals signs: 98.6F tympanic, BP 138/76, heart rate 74, O2 sats 98% and Respiratory rate 19. Patient reports she is feeling better at that time, RN observed patient?s shallow breathing getting to be less frequent and seemingly patient looked more comfortable. Patient having a conversation with pharmacist, no difficulty speaking, breathing, but voice does sound hoarse. Vital signs at 1140: 21 respiratory rate, 99.1 F tympanic, BP 123/88, 72 heart rate, and 98% O2 on RA. PHN listened to lungs and assessed breathing, lung sounds clear, patient reports she feels better though not completely back to normal. MD came in to assess patient, reports her exam is normal, cleared patient to go home and rest with strict instructions to go to the ER if symptoms of allergic reaction come back, get worse, or change. MD encouraged patient to reach out to allergist for further guidance on getting the 2nd dose of the vaccine. Patient escorted out of clinic by husband and RN.
This spontaneous report has been received from a nurse referring to a patient of unknown age and unknown gender. Information of concurrent condition, pertinent medical history and drug reactions/allergies was not provided. Concomitant medication included sterile diluent. On 07-JAN-2019, the patient was administered 1 dose of improperly stored PROQUAD (therapy type: recombinant Human albumin (rHA), two lot numbers and expiration dates (lot # R011214 with expiration date 15-OCT-2019; lot # R008203 with expiration date 16-SEP-2019) were provided, but which lot was administered to the patient was unknown; strength, dose detail and route were not reported) for prophylaxis. Two lots of PROQUAD were exposed to temperature excursion of 6 Fahrenheit degree to 14 Fahrenheit degree for 3 hours, 15 Fahrenheit degree to 46 Fahrenheit degree for 5 hours and 30 minutes and 47 Fahrenheit degree to 77 Fahrenheit degree (also reported as 49.6 Fahrenheit degree) for 30 minutes. No previous temperature excursion. No adverse effects was reported. Data logger was not involved. This is one of the four reports from a same reporter. Sender's Comments: US-009507513-1902USA004203: US-009507513-1901USA007256: US-009507513-1902USA004205.
ON 12/14/2022 PATIENT HAD COME IN FOR A COVID AND SHINGRIX #1 VACCINE. CONFIRMED WITH PATIENT THAT THIS WAS THEIR FIRST SHINGRIX. AFTER ADMINISTERING THE VACCINE AND DOCUMENTING IT IN DATABASE IT WAS DISCOVERED THAT THE PATIENT ALREADY HAD HIS SHINGLES VACCINATION SERIES DONE AND THIS WAS HIS 3RD DOSE.
Within 1 day: pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach. Still 5 weeks after 2nd shot, lump at injection site, very sore, pain travels into chest and up neck to temple causing headaches, sore to move arm, worse at night and effects getting to sleep.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 13-OCT-2014, the patient was inoculated (by an unspecified health care professional) at a pharmacy with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, and the male patient subsequently contracted a persistent strain condition of herpes zoster. On or about 04-JUL-2017, the male patient was treated by a physician at a clinic, for a blistering vesicular outbreak, which was diagnosed as herpes zoster. On or about 01-AUG-2017, he sought further treatment from a physician at a medical care group for treatment of continued and worsening herpes zoster outbreaks and an acute stroke. The patient has been prescribed valacyclovir (VALTREX), gabapentin and acyclovir for management of his painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. The event of acute stroke was determined to be medically significant. Additional information has been requested.
Patient-received (PENTACEL and HIB). so-patient received 2 doses of HIB.
pt recv vax 24APR96 &  2MAY96 pt exp nausea, vomiting, diarrhea;
Patient received vaccination 3pm on 11/4 and shopped in the store until 10pm.  She fell asleep in her car after shopping and did not wake up until 4:30am on 11/5.  When she went to start her car, her arm was so sore she had trouble starting the car and her hand was wrapped up tightly in a ball.  She has pain at the injection site, forearm, and wrist.  Most of the pain is in her forearm and wrist and complains of numbness/pain in her fingers as she is having trouble using them.  She also complains of a shooting pain that travels back up her arm at times.  Patient says there has been some improvement since evening of 11/5 and has gained some function in her hand.   She is able to move her entire arm above her head now as well.