chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharged. Patient is a 71 y.o. female with COPD, type 2 DM, CAD, OSA, bilateral carotid artery stenosis, HTN, TIA, tobacco use, hypothyroidism, GERD who presents today with multiple complaints but primarily shortness of breath and cough. She was admitted for acute hypoxemic respiratory failure from COVID pneumonia. She was vaccinated, but had not received a booster. She was placed on dexamethasone and Remdesivir. Her oxygen requirements decreased during admission and she did not require any oxygen at rest on the day of discharge. She was discharged with 7 more days of dexamethasone to complete a 10 day course. She was prescribed benzonatate, guaifenasin as needed for cough. Hydroxyzine as needed for anxiety/restless leg syndrome. She was also having some heartburn symptoms which simethicone helped with during her stay, will prescribe simethicone at discharge. Patient was instructed to follow up with her PCP within 1 week of discharge to follow up on the above as well as for further workup/management of possible restless leg syndrome. Pulm rehab arranged for 2L of oxygen with exertion and at night for home use prior to discharge.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male patient of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, 1 total administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. In AUG-2021, the patient used the (IgG antibody test) to assess his IgG and the result was negative (confirmed immunological vaccine failure). He stated that other patients who received an mRNA vaccine get a positive test for IgG when this test was used. Laboratory data included: SARS-CoV-2 rapid antibody test (NR: not provided) Negative for IgM IgG. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210832350-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
This spontaneous report as received from a Registered Nurse refers to multiple unspecified patients. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number and expiration date unknown), RECOMBIVAX HB (lot number and expiration date unknown) and M-M-R II (lot number and expiration date unknown) for prophylaxis. Nurse also reports it is not certain if the sterile diluent (lot number & expiration date unknown) used to reconstitute M-M-R II underwent a temperature excursion. Temperature and time frame was unknown by reporter. There was no previous temperature excursion involved. No adverse effects reported in any patients. No further information provided. The call was because of a data logger. Follow up information has been received from the Registered Nurse on 19-FEB-2018 regarding the case mentioned above. The reporter called back and mentioned that the M-M-R II that was administered had been maintained in recommended temperature, and had not experienced a temperature excursion. Therefore, the vaccines that underwent a temperature excursion were GARDASIL 9 and RECOMBIVAX HB. The temperature excursion and time frame for both vaccines was between 32F to 35F for a cumulative time of 111 hours.
Pt fainted after receiving 2 vaccines. Pt stood up then fainted recovered quickly waited 15 min in clinic.
This spontaneous report as received from a medical assistant refers a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding a 16 years old, male patient with no pertinent medical history reported. On 15-NOV-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). Concomitant medications included Hepatitis A Vaccine (manufacturer unknown) (intramuscular in the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. This is an amended report the adverse event codification was updated. Additional information is not expected.
swollen, itchy, red arm .... chills, fever, increased heart rate (118) ... extreme headache
Information has been received from a nurse referring to an adult (exact age unknown) patient of unknown gender. The patient's current conditions, medical history and concomitant medication were not reported. On 30-AUG-2016, the patient was vaccinated 2 pediatric doses of VAQTA (strength, exact dose, frequency, route, lot number and expiration date were unknown). No adverse effects were reported. Additional information has been requested.
Syncope post vaccine. Dizziness, nausea, jerking motions upon event last few seconds, incontinence,  Vomited.  Pt left with girlfriend at 2:45. symptoms resolved
Pain at injection site, feeling of weakness, Dizziness on the 24th lasting all day. Was ok next morning.
This spontaneous report was received from a nurse referring to patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. The nurse reported that an unknown number of doses of PEDVAXHIB (lot# K008679; expiration date: 05-MAR-2017 experienced a temperature excursion of >46F - <77F for 6 hours 30 minutes. Data logger was involved. There was no previous temperature excursion. On multiple unspecified dates, multiple unspecified patients were administered these improperly stored doses of vaccines. No adverse effects reported. This report is one of the reports from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA011416.
FEVER., GENERALIZED BODY ACHES, CHEST PAIN/PRESSURE/TIGHNESS
SUDDEN ONSET LOW GRADE FEVER (99.3), MALAISE, WEAKNESS, MUSCLE ACHES, DIZZINESS, THROBBING SENSATION IN RIGHT SIDE, HEADACHE, INCREASED BLOOD PRESSURE, PULSE AND RESPIRATION, CHILLS
seven cm of erythema; t103; temp lasting from 9AUG-14AUG;
Brain fog,forgetfulness; Brain fog,forgetfulness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergy Shrimp" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose number 1, vaccine location: Left arm.), administration date: 02Feb2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: MEMORY IMPAIRMENT (non-serious), FEELING ABNORMAL (non-serious) all with onset 26Feb2021, outcome "unknown" and all described as "Brain fog,forgetfulness". Therapeutic measures were not taken as a result of memory impairment, feeling abnormal.  Additional Information: This consumer reported similar events for 2 patients. This is 1st of 2 reports. The patient had no other medical history. The patient received no other vaccine in four weeks. The patient reported that "Both my husband (who is also vaccinated) noticed yesterday that we were forgetting simple things." The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021254036 same reporter/drug/event, different patient
Covid on 27Jul2022, in between the 2nd dose and the bivalent dose which she got on 01Mar2023; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid on 27Jul2022, in between the 2nd dose and the bivalent dose which she got on 01Mar2023) in a 69-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypothyroidism, High cholesterol and Disorder gastrointestinal. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN CALCIUM (CRESTOR), OMEPRAZOLE, URSODIOL, RIFAXIMIN, LIOTHYRONINE SODIUM (CYTOMEL), LORAZEPAM, COLECALCIFEROL (VIT D [COLECALCIFEROL]), CYANOCOBALAMIN (VIT B12) and PARACETAMOL (TYLENOL) for an unknown indication.   On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, the patient experienced COVID-19 (Covid on 27Jul2022, in between the 2nd dose and the bivalent dose which she got on 01Mar2023). At the time of the report, COVID-19 (Covid on 27Jul2022, in between the 2nd dose and the bivalent dose which she got on 01Mar2023) outcome was unknown. Not Provided      For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.   This case was linked to MOD-2023-739850 (Patient Link).
Was sick and numb for a few days and now metallic items are sticking to the site of the injection.
The pt experienced a low grade fever,  a rash that started the night of the injection. The pt continued to breakout over the weekend and began to scab over. The pt complained of itching but otherwise feels ok. MD feels it was chicken pox induced by varicella injection.
Red raised, rash over body, denied itch, afebrile. Dx w/ V.Z.
34 community firemen recvd 3 doses of Engerix-B; titers drawn 27OCT91 & 4 of these firemen were not protected; these 4 recvd a 4th dose of Engerix-B & 2nd titer was drawn 9MAR92& these 4 pts were still not protected; recvd 5th dose still ne
Pt has had reactions to his Dtap vaccines since he was an infant.  Pt has always had some swelling and redness that lasts about 3-4 days.  Mother was very reluctant to give this immunization, but scheduled him to have it done after speaking to doctor.  He had swelling and redness to the site right away, overnight it worsened and she contacted the office - cool compresses and tylenol/motrin were given to the patient along with benadaryl.  On 1/18/23 pt was seen in an urgent care for possible cellulitis - the area was red, tight, warm to the touch and augmentin was prescribed which mother did not start.  In clinic on 1/19/23 around 4:50pm pt arm continued to be warm, swollen, mother had drawn a line around the redness and it has now spread beyond that line. Cephalexin was prescribed and started. Mother is very concerned about pt getting this immunization in the future
The first three shots I received successfully, with no adverse outcome, had been Pfizer, which was not available in my town for the second booster, so I had the Moderna shot instead at the Pharmacy. The day after the shot, I developed raging tinnitus in my right ear. I have had some tinnitus in the past, but nothing like this, that would prevent my being able to sleep. The reason I know it was caused by the shot is that the same thing has happened to a friend, who never had tinnitus before, and is now afraid to have her second booster. I am equally afraid to have the next one, now that my hearing is involved.
Booster; Sore arm at the injection site location; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administration date 07Dec2021 (Lot number: EW0196) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Sore arm at the injection site location". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Seriousness criteria was life threatening, results in death, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect: No. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to a 16 year old female patient. Patient had no drug reaction reported. On 05-SEP-2013 the patient was vaccinated with a dose 1 of GARDASIL (lot # J005679, expiry: 27-NOV-2015). On 05-SEP-2013, the patient experienced syncopal episode after receiving the first dose in the GARDASIL series. The patient was instructed to stay seated in the examination room for 15 minutes after she received the GARDASIL dose. The patient did not follow the instructions and upon trying to exit the room, experienced a syncopal episode and fell to the floor hitting her head on the floor. The patient was sent to the emergency room to have a CAT scan of her head on 05-SEP-2013. The medical assistant was unsure of the results of the CAT scan or if the patient was admitted. The medical assistant believed that the patient had the emergency room visit and returned home on the same day. The outcome of syncopal episode was reported as recovered (September 2013). Additional information has been requested.
Swollen right eyelid; Painful right eyelid at times; Fever of 101.7; Grape-size swollen lymph node under left armpit; Headache; Body aches; This case was reported by a consumer via call center representative and described the occurrence of axillary lymph nodes enlarged in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 30th August 2021, less than a day after receiving Shingrix, the patient experienced axillary lymph nodes enlarged, headache and general body pain. On 31st August 2021, the patient experienced fever. On 1st September 2021, the patient experienced swelling of eyelid and eyelid pain. On 1st September 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the axillary lymph nodes enlarged, headache and general body pain were recovered/resolved and the outcome of the swelling of eyelid and eyelid pain were not recovered/not resolved.   It was unknown if the reporter considered the axillary lymph nodes enlarged, headache, general body pain, fever, swelling of eyelid and eyelid pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The patient received Shingrix on the left arm and she felt a grape-size swollen lymph node under left armpit, a headache and body aches on the evening of the vaccination day which had recovered. On the next day after vaccination, the patient stated that she had a fever of 101.7 that went away the next morning.  Two days after the vaccination, the patient stated that she woke up with a swollen and at times painful right eyelid which had not recovered till the time of reporting.  The reporter consented to follow-up.
R leg 8cm area of erythema, slight swelling. Slight increase warmth around puncture site.
I received my flu shot and there was pain instantly. The pain in my left arm increased and was so intense that I couldn't lift my arm. That Friday morning I woke up with nausea, vomiting, fever, abdominal pain and the pain in my arm which continued to get worse. I was ill for 3 days, missing one day of work. Today is day 6 and still have arm pain but not as severe as well as some nausea and abdominal pain. I feel it was all related to the flu shot.
THROAT TIGHTNESS/CHEST TIGHTNESS/ITCHINESS/LIGHTHEADEDNESS THE DAY OF AND TREATED IN EMERGENCY ROOM 3 DAYS LATER, DEVELOPED BRONCHOSPASMS DX LATER WITH ALLERGIST TO BE ASTHMA.
PT REPORTED SHORTNESS OF BREATH THAT RESOLVED THEN SHE BROKE OUT IN HIVES
Had Shingrix in 2021, still need to get 2nd dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 68-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (had a 1st shingles shot in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: Had Shingrix in 2021, still need to get 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient had a shingles shot in 2021 and still need to get the 2nd one shingle shot.  The reporter stated that at this age, we could not get a live virus.  The reporter further stated that please let people knew this or, at least people liked him/her with autoimmune diseases. Till the time of reporting , the patient did not receive the 2nd dose of shingles vaccine, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
Client given Hep B (Pediatric/Adolescent) vaccine too early; Vaccination was not due until 12/20/2016.
Terrible Migraine like headache from 8:30pm 3am. Repeated every 5 minutes to 20 minutes vomiting from 10:30 to 3am. Both stopped only with IV medications.
The patient came to the Pharmacy on January 12 2019 and told the me (pharmacist) that the vaccine SHINGRIX given to him on 11/17/2018 gave him some reactions, ten hours after the shot was given. He complained about shortness of breath, narrowing of his trachea, fever and body pain. He went to the Dr and the Dr. told him to take a BENADRYL 50 mg capsule and not to take the second dose.
Rec'd DTP on 1MAR91 in LA; 3MAR91 child c/o soreness in lt arm; On exam, mom found hard tender lump in lt axilla;
flu; Initial information received on 15-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer.  This case involves a adult patient (gender and age: unknown) who experienced flu while receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (formulation, strength, dose, route, lot and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event flu (influenza) (latency: unknown) following the administration of Influenza vaccine.  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event influenza.  At time of reporting, the outcome was unknown for the event influenza.
Patient received Pfizer COVID vaccine for first dose, and received 2nd dose Moderna. Was supposed to receive Pfizer. Patient had a fever that same night.
Numbness/tingling in left hand.  I?m 33weeks and 3days pregnant . Expecting due date 10/06,2021
Pt c/o  mild blurred vision, "tingly" on head and feeling "jittery." EMS and RN assessed pt. BP was in the 150's/80's. PT states she has a hx of DM, has not eaten yet for the day, has a hx of getting a reaction from Tetanus shot. Blood sugar was 126. Pt was given a snack and water. Reassessed after 10 minutes and pt still "feels the same." After another 15 minutes, Pt and husband decided to leave but recommended to stay and be checked for a few minutes but pt insisted they want to go home. Was advised to go the hospital if symptoms persist. Pt and husband verbalized understanding. Upon leaving, pt had steady gait, denies dizziness and blurred vision at this time.
This spontaneous report was received from a Medical Assistant via a company representative, referring to a male patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions and known allergies was not reported. The patient's concomitant vaccinations included influenza virus vaccine inactivated (unspecified). On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (anatomical route of vaccination, lot number and expiration date were not provided) as immunization for the prevention of pneumococcal disease (prophylaxis). On an unknown date, the patient developed severe redness (injection site erythema) and swelling (injection site swelling) at the injection site after being vaccinated with PNEUMOVAX 23. It was also reported that, it was not specified if the patient received the flu shot in the same arm as the PNEUMOVAX 23. Furthermore, the patient was advised by the physician to go to an urgent care for the above reported symptoms, but it was unknown if the patient went to an urgent care. No product quality issue was involved. At the time of the report, the outcome of injection site erythema and injection site swelling was unknown. Additionally, the reporter did not provide for causality between the adverse events and vaccination with PNEUMOVAX 23. Additional information has been requested.
This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 673029/0616AE, expiration date and dose not reported) on 16-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.