chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was having a hard time breathing and swallowing water. Felt that his throat was hurting. Pt was given epinephrine 0.3mg and EMS was called. Pt left site and went to the hospital via ambulance.
Rash on neck, both forearms extending to thumb, both, underarms, severe itching and burning. Had video appointment with NP at Neurology the following Monday and she prescribed Benadryl every 4 hours, it got worse for several days and gets worse in sunlight but today is much better so have reduced Benadryl to every 8 hours.
Dizziness, severe headache, abdominal pain,  diarrhea, nausea, fatigue, and muscle pain
Patient received moderna vaccine on 3/16/21 and 4/13/21. Presented to ER on 7/14/22 and found to be covid positive. Evaluation in the ED did reveal a temperature of 97.9° initial pulse was 93 blood pressure 170/94 98% on room air, was placed on 2 L for comfort.  Incidentally her COVID was positive potassium 5.5 BUN creatinine of 75 and 12.90 INR 1.3 BNP 6-6 white count within normal limits at 5.31 H and H of 7.3/23.5 platelets of 164 x-ray of the chest did reveal cardiomegaly with interstitial pulmonary edema and small bilateral pleural effusions suggestive of volume overload. Patient was admitted. Received no specific COVID19 medications. Discharged on 7/18/22
Redness, swelling and pain Rt buttock injection site noted of onset several hours after immunization given at that night.
mumps parotitis; vaccination failure; This literature marketed report has been received from authors of published article. The incidence of parotitis and mumps in children was increasing nationwide. Retrospective chart reviews were conducted using ICD9/10-codes for parotitis and mumps from January 2007 to December 2017. Data on demographics, vaccination status, labs, management and disposition were collected. The patients had mumps immunoglobulin (IgM) and/or buccal swab for mumps reverse transcription polymerase chain reaction (RT-PCR) or viral culture to test mumps. 1017 parotitis cases were diagnosed, an upward trend in incidence occurred over time. Of the 1017 children with parotitis evaluated over the decade in emergency departments (EDs), 47 (4.6%) were tested for mumps and 9 (19%) of those tested were positive for mumps either by serology and/or PCR. Five of those cases were considered probable mumps and 4 were confirmed mumps. Of the 9 patients identified with probable or confirmed mumps, 7 (78%) were fully immunized, one was incompletely immunized (one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)) and 1 child was unvaccinated. The most likely explanation for mumps cases in previously immunized persons may be secondary vaccine failure, or waning immunity.  This report referring to a 7 years old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On unknown dates, the patient was vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose detial, route, lot #, expiration date and anatomical location were not provided).   In 2017, the patient was tested mumps IgM and RT-PCR at buccal and urine. The results were postive for mumps at left buccal. It was confirmed that the patient experienced mumps parotitis. The patient required admission to the ward. The patient had fever with body temperature more than 38 degree Celsius. On an unknown date, the patient experienced vaccination failure. The outcome of the events was unknown. The reporter considered the events to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown).   Literature report:   This is one of several reports received from the same literature. Sender's Comments:  US-009507513-2011USA009173:
injection site sore; 3 inch diameter red spot, like a bruise; like a bruise; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a 53-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's mother had it several years ago from the date of reporting).   On 5th October 2022, the patient received the 2nd dose of Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced injection site pain, localized erythema and contusion. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the localized erythema and contusion were unknown.   It was unknown if the reporter considered the injection site pain, localized erythema and contusion to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient just got Shingles vaccine on Wednesday morning and his/her arm remained sore at the injection site and a 3 inch diameter red spot kinda like a bruise or something. The patient stated that since his/her mom had it several years ago and it was not something he/she wanted to get. The patient did not get flu shots or any other vaccines but did get this one. Additional supportive information: The follow-up would not possible, as no contact, details were available.
About 10 minutes after vaccination, patient began to complain of abdominal fullness, nausea, shortness of breath, anxiety. No dizziness or chest pain. BP & glucose monitored until EMTs arrived.
Information has been received from a certificated medical assistant referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 09-JUL-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006117, expiration date 14-JAN-2017, dose and route were not reported). Concomitant drug was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Received shot at 3/4 PM, left arm started hurting at 6 AM and throat felt extremely parched. At 10 o'clock started dry coughing periodically throughout the day. Symptoms disappeared 2 days after receiving the COVID injection.
This 9 month old patient was given covid 12+, waited for 45 minutes no adverse reaction noted/observed. Parent notified, manufacturer notified, physician notified
9 days post MMR vaccine - had seizure with fever - lasted 20 min & longer. Was intubated, transferred to Hospital by helicopter.
rapid heart rate and racing thoughts; rapid heart rate and racing thoughts; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EL3246), via an unspecified route of administration on 14Jan2021 08:00 at single dose in the left arm for COVID-19 immunization. Medical history included peptic ulcers and acid reflux. Concomitant medication included sucralfate (CARAFATE) and esomeprazole sodium (NEXIUM). On 14Jan2021 09:00, the patient experienced rapid heart rate and racing thoughts. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the 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. Therapeutic measures were taken as a result of rapid heart rate and racing thoughts includes Benadryl. The outcome of the events was unknown.
Pain in her bones \ bones ache in an impressive way; Pain in her skin (she fell it as hot); Back is hot; Headache; Chills; As if she had a fever; Arm is hard; Arm is swollen; Like she couldn't breathe.; Arm is in pain; Felt fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm is hard), PERIPHERAL SWELLING (Arm is swollen), DYSPNOEA (Like she couldn't breathe.), BONE PAIN (Pain in her bones \ bones ache in an impressive way) and PAIN OF SKIN (Pain in her skin (she fell it as hot)) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025c21a and 04b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included CENTRUM ACTIVE, VITAMIN D NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm is hard), PERIPHERAL SWELLING (Arm is swollen), DYSPNOEA (Like she couldn't breathe.), MYALGIA (Arm is in pain) and FATIGUE (Felt fatigue). On 13-May-2021, the patient experienced BONE PAIN (Pain in her bones \ bones ache in an impressive way), PAIN OF SKIN (Pain in her skin (she fell it as hot)), FEELING HOT (Back is hot), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (As if she had a fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, q6h. At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm is hard), PERIPHERAL SWELLING (Arm is swollen), DYSPNOEA (Like she couldn't breathe.), BONE PAIN (Pain in her bones \ bones ache in an impressive way), PAIN OF SKIN (Pain in her skin (she fell it as hot)), FEELING HOT (Back is hot), MYALGIA (Arm is in pain), FATIGUE (Felt fatigue), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (As if she had a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
1/6/21 Cough, loss of taste and smell, congestion, runny nose, HA, fatigue, wheesing
Menstrual period started 5 days after 2nd Covid vaccination. It was MUCH heavier then normal and it lasted for 11 days.  Previous periods last about 7 days. The period after that started on the 20th day after the above mentioned period started (only 9 period free days between cycles). Will wait to see if cycles return to normal
Pt received Prevnar booster #2 on 12/01/00. The next day, his upper arm was swollen and red. The family was advised to use Motrin  and cool compresses. On the morning of 12/3/00, pt awoke with swelling around face and lips. Redness had spread around his arm to his shoulder. Went to ER and got Benadryl and Keflex.
On approximately 08/31/2022, in the afternoon, we saw blood and mucous in her stool in small amounts. It has been intermittent since then. We are in between follow-up appointments. We will see a gastrointestinal pediatric internist soon.
Mother noticed swelling, intense heat around injection site in child's left deltoid.  Child complained about severe discomfort.  Child was sent to school on May 16 and Mom called the nurse at school and asked her to please check her childs arm.  School nurse checked arm and stated that left arm was about twice the size as the right arm with warmth and suggested that Mom take child to MD.
pt recv vax 9OCT96 + facial swelling & localized wheat @ inj site noted w/in 15min of inj;also recv
At 9:30 pm teeth chattering, joint pain, fatigue, headache, chills. I was exp nausea however I have that anyway with my pregnancy.(estimated date of delivery 8/3/2021).
Patient notified of temperature monitory event of this vaccine prior to its arrival at the clinic.  CDC recommendation is to repeat this vaccination.  Patient came in on 10/13/22 to repeat vaccine.
Almost immediately after the vaccine patient went the bathroom with explosive diarrhea that lasted about 30 minutes.  Then she left for home and had a 2nd episode on the way.   She stated that the diarrhea continued at home for an undetermined amount of time and that the stool contained bright red blood.  She contacted her physician and the physician is investigating a high bleeding hemorrhoid.
Pain in left upper arm; pain radiating to left side of neck; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and neck pain. The patient was treated with oxycodone and non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the injection site pain and neck pain were not recovered/not resolved.   The reporter considered the injection site pain and neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 89 years or 90 years. The patient received Shingrix in her left upper arm at the local pharmacy. Within 24 hours of receiving the vaccine, the patient started to experience this pain. The patient had been suffering from excruciating pain in her left upper arm which radiated up the left side of her neck on occasion.  The patient had been seen by her physician several times since the initial vaccine and her physician prescribed Oxycodone for the pain which helped but she was concerned about taking the medication long term. Her physician recently prescribed a round of physical therapy to help with her pain.  The patient reported that, she would definitely not getting the 2nd vaccine and also would not obtained the 1st one if she knew, she would be at an increased risk for this type of pain.  On the day of reporting, the patient was following up with her physician. She consented to follow up and provided details of her physician. In source document, the outcome was reported as recovering/ resolving for all the symptoms, however as per narrative description it was not recovered/ not resolved.
Tested positive for COVID19 on 5/17/21. Symptoms began on 5/15/21 and include headache, cough, sneezing, and a subjective fever. A 2nd swab was obtained and has been sent to the state lab for genome sequencing.
pt recvd vax;devel red to purple patches throughout trunk,legs,back & face;dx of urticaria & had fever between 101 and 102;to er;
2:37 pm 10 minutes after receiving vaccine pt reports feeling dizzy and nervous. She has a history of anxiety and has been seen before for anxiety attacks. Pt denies chest pain, shortness of breath or pain. 2:45 pm pt evaluated by EMS BP 138/78, Pulse 98. pt reports feeling better. 2:55 pm pt declined transport to ED, signed out AMA. Pt was escorted out to car.
sinus headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 09:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sinus troubles" (unspecified if ongoing); "high blood pressure" (not ongoing). Family history included: "Environmental allergy" (unspecified if ongoing), notes: She said allergies run on both sides of her family; "Drug allergy" (unspecified if ongoing), notes: She said allergies run on both sides of her family. The patient took concomitant medications. The following information was reported: SINUS HEADACHE (non-serious) with onset 23Mar2021, outcome "not recovered", described as "sinus headache". The event "sinus headache" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of sinus headache.  Additional information: There were no additional vaccines administered on the same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported she took approximately 2 weeks before (or maybe longer) "Organic Smooth Move" herbal supplement (UPC Number: 3291700200, Lot Number: MB0004783, Expiration Date: Sep2022) to help clean her colon. Patient further reported that she had been having a sinus headache for 4 days straight now. She said she believed the headache started on 23Mar2021, and she still had the headache today (26Mar2021). She called her doctor today (26Mar2021) and told her doctor about the headache. She said she hadn't taken anything because she had read not to take any medications, like paracetamol (TYLENOL) or anti-inflammatories. She said she read certain medications could mask allergy symptoms to the COVID-19 Vaccine. Event did not result to emergency room visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a office manager and refers to a 75-year-old male patient. The patient's concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unknown date in September 2015, the patient was first time vaccinated with ZOSTAVAX, subcutaneously, for prophylaxis (lot #, expiration date, dosage were unknown).  On an unknown date in October 2017, the patient was second time vaccinated with the ZOSTAVAX, subcutaneously, for prophylaxis (lot #, expiration date, dosage were unknown).
Slight burning sensation at time of injection; Roughly 16 hours later onset of headache and nausea; Roughly 16 hours later onset of headache and nausea; This is a spontaneous report from a non-contactable consumer reporting for herself. A 24-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 23Feb2021 14:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.   The patient's medical history and concomitant medications were not reported.  The patient previously took bnt162b2 for covid-19 immunisation, amoxicillin and experienced known allergies: amoxicillin.    Historical vaccine information included BNT162B2 on 02Feb2021 02:30 PM, in the left arm, dose number 1 at the age of 24 years old. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Feb2021 06:30, the patient experienced slight burning sensation at time of injection.  Roughly 16 hours later onset of headache and nausea In Feb2021. Headache and nausea lasted roughly 14 hours in Feb2021. No treatment was received for the events. Outcome of the event was recovered in 2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
11-3-14 mom noticed pt left deltoid was red, swollen, itching, pain when scratching, warm to touch.
MD rpt pt recv vax on 9/24/97 & in 5/98 pt devel chickenpox. described as ``severe case w/lesions all over his body. MD seen
Headache, fever 104, unable to stand, unable to walk, muscle pain, delirium. September 29 2PM Received Tdap vaccine 4PM fever 102, headache, not feeling well. September 30 1AM fever 104, severe headache, muscle ache 8AM fever 104, unable to stand, walk unaided, severe headache, muscle pain 10AM call ambulance, delirium, high fever, severe headache etc. Hospital care: IV fluids, pain meds, fever meds, Spinal tap CAT Scan Blood culture testing Test for brain bleed, aneurism, blood clot Test for Lyme disease, plague, meningitis. All test negative except for slightly elevated white count. Per ER MD - probably reaction to vaccine. Follow up with family care MD on Wednesday. Discharged from ER ~ 5PM. October 3 Saw Family MD Concurred with ER MD - probably severe reaction to vaccine. Recommended - rest, self care - return to work Oct 10. Missed 1 1/2 weeks work. ER visit costs, ambulance costs, medication costs. October 12 Still having back pain, fatigue.
Information regarding Prevenar was received from a consumer regarding a 2 month old male patient who developed a fever, became fussy, was not eating and is experiencing developmental delay. At 2 months of age, the patient received the first dose on 11/12/2004. The patient also received the first dose of Tripacel, the first dose of Comvax and the first dose of Ipol on 11/12/2004. Relevant medical history was not provided. Product was administered on 11/12/2004. Concomitant medications were not reported. On 11/12/2004 the patient developed a fever after receiving his vaccinations. Two weeks later, he stopped eating and was unable to keep his head up. The child became fussy. He was subsequently hospitalized for four nights and treated with unspecified antibiotics. The fever resolved. The mother reported that a physician informed her that the baby was developmental delay (medically important) (OMIC), which included symptoms of hypotonia low muscle tone. Additionally, the baby was not sitting up, walking or talking. Currently, the child can hold his head up. He has a nutritionist and feeding therapist to assist with eating. On 6/30/2006 the patient weight 20 pounds, 10 ounce. Outcome of the child's irritability and developmental delay is unknown. Caller noted that her doctor wanted her to ask the different manufacturers of the vaccines for information concerning adverse events such as these reported. No additional information was available at the time of this report.
hearing loss; other serious neurological problems; postherpetic neuralgia; vision problems; balance issues; multiple outbreaks of herpes zoster; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. The pt's medical history, concurrent conditions or concomitant medications were not provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, vision problems, hearing loss, balance issues and other serious neurological problems. As a result of these symptoms, the pt was seen and treated by medical providers and at the time of report was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all events was not recovered/not resolved. The reporter considered all events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss was determined to be medically significant. The lawyer reported all events as disabling, and the event of neurological problems to be serious (medically significant).