chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was sitting in observation for about 10 minutes and complained of feeling dizzy and fuzzy. Pt was pale and sweating. This RN assisted patient to wheelchair and escorted patient to EMS room. Pt was lying on the cot; ice pack was applied to Pt forehead and neck.  BP 102/60, P 80.  Pt refused drink and snacks when RN offered.  Pt reported of feeling better after 15 minutes.  Patient's mother was with Pt at all times.  Pt and her mother left at 15:30 without any complications.
The morning after receiving the injection, patient experienced severe pain in the entire left arm, radiating to jaw and down to hand. Has also experienced "some chest pressure off and on". Visited MD on 12/8/10 who ruled out cardiac incident. Pt states there has been no improvement. No swelling of arm. Instructed to return to MD if no improvement or if worsens.
Patient presented to the pharmacy 4 days after receiving ZOSTAVAX with complaints of swelling, redness, and hot inflammation at the site of administration, extending around her tricep to her inner elbow area. She described this reaction occurred the day after she received the shot. She consulted her physician at a physical appointment, who at the time treated it as a bacterial infection and initiated antibiotic therapy. Follow-up call with the patient on day 5 revealed the swelling had improved and patient denied any other symptoms.
Patient woke up with a very sore arm. The site of the injection was swollen and tender. He complained of feeling overall weak and achy. He was running a low grade temp 100.6. Within an hour his temp went up to 101.8 and by 11:30am his temperature was 103.1. He took 800mg of Ibuprofen which did not bring down his fever.  At 3:30pm he took 1000mg of Aceteminaphen which started to bring down the fever to around 100. During the entire day he had to appetite and early evening he vomited.  The next day he seemed like himself with no fever or upset stomach.
Date of Admission  09/23/2021  Chief Complaint   Fall/Right hip pain   History of Present Illness     Patient is a 90-year-old white female comes to the ER with complaints of multiple falls.  Apparently she has had 6-7 falls this week.  At time my examination she appears to be somewhat confused.  She does know the day but is unable answer questions.  She states that she remembers falling yesterday but does not give any other history.  Unfortunately HPI is limited due to patient's mental acuity at this time.  Review of Systems  A 14 point review of systems attempted, difficult to obtain due to patient's mental acuity. Objective  Vitals & Measurements (Last Charted)  T: 97.6 °F  TMIN: 97.5 °F  TMAX: 97.6 °F  HR: 74  RR: 14  BP: 146/63  SpO2: 94%  WT: 46 kg  BMI: 17.97
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. Between 18-AUG-2015 and 21-AUG-2015, an unspecified number of patients wer4 vaccinated with unspecified doses in series of improperly stored RECOMBIVAX  HB (lot # L014418, expiry date 13-APR-2017, (dose, site and route of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received vaccine at 11:09AM on 7/10/2021.  The vaccine in my arm was burning rather badly within a few minutes of it being administered.  About 10PM the same day I started feeling dizzy, bad headache, muscles and joint started aching all over my body, joints were hurting, a few hives on my torso and I was experiencing chills.  Went to sleep that night and was very ill the entire next day with fever, chills, aching all over, swollen lymph notes in my neck, in my left arm pit, coughing out excessive phlem, headache, sore joints, and hives on my arms, legs and torso.  It is now 7/12/2021 at 4:34PM, I am still dealing with hives wheels all over my legs, several small hives on my right arm and several hives on my belly and sides.  My antihistamine is helping to keep the hives in check.  I am still quite sore all over and the arm I received the injection in hurts a lot.
This spontaneous report as received from a registered nurse via company representative refers to a 4 months old infant patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 16-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reaction or allergies, concurrent conditions and concomitant therapies were not reported. On 10-APR-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10PK 0.5 mcg/0.5 ml SDLLolCap Ped" and lot number K008986 with expiration date of 01-APR-2016 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 48 hours with a lowest recorded temperature of 32 Fahrenheit (F) (0 Celsius(C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as " in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse and 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 08-MAY-2017, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB injection, lot # M046373 with expiration date: 04-NOV-2018 ( dose, route and site of administration were not reported). The vaccine was stored in a nurse's unmonitored refrigerator and was exposed to temperature excursions of 47 to 77 degrees Fahrenheit for 46 hours and 32 to 35 degrees Fahrenheit for 46 hours. There were no previous temperature excursions and digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved in this case. This is one of five reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA011219: US-009507513-1705USA007715: US-009507513-1705USA011216: US-009507513-1705USA011217:
Fever x2d. Rash x 5d beginning 3 days after vaccines.
heart is poom, poom, poom, poom; can't breath; light headache; dizzy; don't feel good; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced heart is poom, poom, poom, poom, can't breath, light headache, dizzy and don't feel good. Outcome of the events were unknown.  QR Comment: Reporter type could not be probed hence captured by default as consumer or other non-health professional in tab.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Painful (whole arm - especially in area injection and arm-pit), swollen and red, size of tennis ball. Verified it is on the right arm.
no adverse effect noted after administration of 3rd dose. resident expired on 8/24/21 after long battle with Alzheimer's disease. death does not appear to vaccine related
Pt vaccinated with DTP/OPV experienced persistant inconsolable crying for 3 hrs.
No adverse effects; the patient was administered PROQUAD that may have been improperly stored; This spontaneous report was received from a registered nurse refers to a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 20-AUG-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S003169, expiry date:30-JUL-2020, anatomical location, route was not reported) for prophylaxis that may have been improperly stored (product storage error). The vaccine was reconstituted with sterile diluent(STERILE DILUENT) (lot# R022412 and expiry date:14-NOV-2019) that may have been improperly stored. The temperature, time frame was unknown by reporter. There was no previous temperature excursion noted and no data logger was involved. No adverse effects reported.
Patient was in the post-vaccination area seated after her shot.  About 10 minutes after receiving the vaccine, she stated that she started feeling lightheaded.  She fainted and fell out of her chair.  I  immediately went to her and found her conscious, but very disoriented.  She stated that she felt nauseated.  911 had been called;  I stayed with her until they arrived.  They fitted her with a cervical counter and raised her to  a seated position and took her vitals.  She was able to stand and get on the stretcher with their assistance.  The EMTs stayed with her and monitored her  vitals until her mother arrived to take her home.  I spoke with her by phone at 6PM.   She stated that she felt fine  now (except for a bump on her head).  She stated that she was afraid of needles and that anxiety probably caused the incident.
Weakness, facial swelling, neck pain, Central Nervous system damage, unable to move limbs or open eyelids, inflammatory reaction
This spontaneous report was received from a nurse prescriber via a Company representative referring to an 87 year old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2010, the patient was vaccinated with ZOSTAVAX (lot#, dose, frequency and route of administration were unspecified) for prophylaxis. On 13-SEP-2017, the patient was diagnosed with shingles. The patient was seen by a nurse practitioner and received an unspecified treatment for herpes zoster. No laboratory diagnostics were performed. No intervention to prevent serious criteria was necessary and herpes zoster was not significant disability or incapacity or life threatening. The patient was not hospitalized. No product quality complaint was involved. At the time of the report, the outcome of herpes zoster was reported as not recovered. The relatedness assessment between ZOSTAVAX and herpes zoster was not provided.
Irritability, possible seizure < 6 hours after vaccine. Hospitalization and neurology eval ongoing.
This spontaneous report was received from a Registered nurse regarding an 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
This spontaneous report was received from a consumer concerning her 18 year old son. Approximately on an unknown date in October 2011 (reported as October or November 2011), the patient was vaccinated with the first dose of 0.5 milliliter (ml) (reported as standard dose) of GARDASIL (lot number and expiry date unspecified), intramuscularly. Approximately on an unknown date in January 2012, the patient was vaccinated with the second dose of 0.5 ml (reported as standard dose) of GARDASIL (lot number and expiry date unspecified), intramuscularly. The patient did not receive his third dose of GARDASIL. No concomitant medications were reported. Additional information has been requested.
1.  Pt received IM injection on left deltoid and reported pain from injection 2.  4 hrs later developed numbness in the right hand/mid forearm, involving thumb and index.  Worse/present at night 3.  Symptoms persist, 12/06/2021.  Pt is concerned about adverse reaction directly related to this vaccine and is questioning future vaccines. 4.  Pt concerned about potential cost of work up for her symptoms.  Pt did not want vaccine to begin with but it was mandated with her job in Home Health. 5.  It is certainly possible that the vaccine contributed to an inflammatory response that may have triggered these symptoms.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 27th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were unknown. It was unknown if the reporter considered the pain in arm and tiredness to be related to SHINGRIX. Additional details were provided as follows: The day before reporting day, the patient received dose of SHINGRIX in the left arm. The reporter did not consent to follow up. No further details were provided.
A report has been received from a physician concerning, a 14 year old male patient. The patient's relevant history included cough and sore throat. The patient's concurrent disease and concomitant medication was not provided. The patient was received nasal FLUMIST of an unknown frequency was started on 25-Oct-2012 for an unknown indication. The physician reported that patient had flu like symptoms which was started on 26-Oct-2012. Patient also had fever and body aches which was started on 26-Oct-2012. At the time of reporting, the event of flu like symptoms was ongoing. The outcome of the events of fever and body aches was unknown. The company physician assessed the events of flu like symptoms, fever and body aches to be non serious. Summary of follow-up information received by AstraZeneca/MedImmune on 06-Aug-2012 from a HCP: Now non-serious events of fever and body aches added. Patients medical history added. Reporter's information updated. Patients height, weight and ethnic information added. Lot number added for the suspect drug.
Raised area at vaccine site of 50mm long X 40mm wide, red and warm with itching noted per patient.
Information has been received from a physician concerning a 21 year old female with no known drug allergies who on 03/03/1997 and 04/30/1997 was vaccinated with varicella vaccine. "Recently" in approximately 2001, the pt's titer was drawn and she was still susceptible. Additional information is not expected.
Clumsiness; This is a spontaneous report from a non-contactable consumer. An adult male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: unknown) via an unspecified route of administration on an unspecified date in Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccines within the 4 weeks prior to the COVID vaccine. On an unspecified date in Jan2021, the patient experienced clumsiness. There was no hospitalization for the event. The event was reported as non-serious. It was unknown if the patient received treatment for the adverse event. The clinical outcome of clumsiness was unknown.  No follow-up attempts are possible; information about lot number cannot be obtained.
Moderna COVID-19 Vaccine Exactly seven days after receiving the first dose of the vaccine I developed a rash that reserved a large hive near the site of injection. The skin was red with a wheal-like appearance and felt warm to the touch as well as swollen. I had no other symptoms and it was mildly itchy but not very bothersome. This rash improved by the next day, however the area was still red (less swelling and less redness overall) and now it is only very faintly noticeable.
LOCALIZED REDNESS TO LEFT ARM AT LOCATION OF IMMUNIZATION. AT OFFICE 2 1/2 INCHES LONG BY 3 INCHES WIDE REDNESS WHEN PATIENT LEFT OFFICE.
Information has been received from a pharm D. concerning a 46 year old male with HIV, penicillin allergy and drug hypersensitivity to sulfa and a history of herpes zoster prior to this episode who was vaccinated with VARIVAX (OKA/Merck). Concomitant therapy included SUSTIVA, lamivudine, COMBIVIR, and ZANAFLEX. The patient experienced zoster after exposure to a child who recently was administered VARIVAX (Oka/Merck) on 20-FEB-2009. The patient visited the child on 22-FEB-2009. On 23-FEB-2009 the patient experienced zoster-like lesions on his hands, pain and tingling in that area. The patient sough medical attention via phone. At this time of reporting, the patient's zoster-like lesions on his hands and pain in that area and tingling in that area persisted. Additional information has been requested.
Initial and follow-up information has been received through the Merck Pregnancy Registry from a registered nurse concerning a 21 year old female who on 05-JUL-2007 was vaccinated IM in the left deltoid with a 0.5 ml dose of GARDASIL (lot # 654741/1208F). Concomitant therapy included hormonal contraceptives (unspecified), ibuprofen, cough, cold, and flu therapies (unspecified). On an unspecified date the patient took herself off of these modification due to financial difficulty, albuterol, metformin, and WELLBUTRIN. On an unspecified date the patient went to the emergency room (unspecified reason) and found out she was 3 weeks pregnant. She had an OB/GYN appointment on 05-SEP-2007, results not reported. Her last menstrual period was 14-Aug-2007, with an estimated date of delivery was 20-MAY-2008. In September 2007 the patient experienced a miscarriage. Upon internal review the miscarriage was considered to be an other important medical event. Additional information has been requested.
Body aches, tiredness, nausea, diarrhea , headache, stiff neck
my daughter / developed RA after getting this vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant). On an unknown date, the outcome of the rheumatoid arthritis was unknown.   It was unknown if the reporter considered the rheumatoid arthritis to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by patient's parent. Age at vaccination was not reported. Parents reported that patient had experienced rheumatoid arthritis after taking this Meningococcal B vaccine. No further information was reported. Follow up was not possible as no contact details were provided.
Right Arm ache and Head Pressure and Headache.  Used icepack for right arm and used cool compress for headache.
Is painful leg swelling a side effect of the vaccine; Is painful leg swelling a side effect of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Is painful leg swelling a side effect of the vaccine) and PAIN IN EXTREMITY (Is painful leg swelling a side effect of the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Is painful leg swelling a side effect of the vaccine) and PAIN IN EXTREMITY (Is painful leg swelling a side effect of the vaccine). At the time of the report, PERIPHERAL SWELLING (Is painful leg swelling a side effect of the vaccine) and PAIN IN EXTREMITY (Is painful leg swelling a side effect of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
24 hours following administration of Moderna booster (after regular series of Pfizer vaccination x 2), hypopigmentation and increased swelling in axilla of arm of injection. increased fluid collection expanding after 48 hours. minor fever and headache at 24 hours post vaccine, none since
could not swallow; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 22Apr2021 at 08:30 (at the age of 63-years-old) as unknown, single for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included trazodone hydrochloride (TRAZADOL) taken for an unspecified indication, start and stop dates were not reported. After 30 minutes (22Apr2021 at 09:00), the patient felt that she could not swallow. The adverse event resulted in emergency room/department or urgent care. The patient was hospitalized for the event for 1 day.  Therapeutic measures were taken as a result of the event [Epi pen, diphenhydramine (BENADRYL), prednisone]. The outcome of the event was recovered on Apr2021.    Information about lot/batch number has been requested.
Had gotten mild version Corona virus a while back, got over it, was ok; Had gotten mild version Corona virus a while back, got over it, was ok; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) . The reporter is the patient.  A 63-year-old male patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown, Expiration Date: 31Jul2021), on 06Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 04Jan2022 as dose 3 (booster), single (Lot number: FD0809) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Broken hip" (unspecified if ongoing); "Anxiety" (unspecified if ongoing), notes: anti anxiety medication; "blood pressure" (unspecified if ongoing), notes: blood pressure medication. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had gotten mild version Corona virus a while back, got over it, was ok". Clinical course was reported as follows: reporter stated that he was unable to clarify if he had mild version Corona, as previously stated, before or after Corona virus shots, believed it was before the booster, has no way of getting that information.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Patient's left arm where she received the Pneumovax and Fluzone High Dose swelled post injection, became hot, and patient started itching on skin and eyes