chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness started at the injection site; moved into this joints in the elbow and shoulder area; This is an initial spontaneous report from a contactable nurse (patient). An 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number; NDC number; Expiry Date: Unknown) via an unspecified route of administration, administered in right arm on 03Feb2021 14:15 as single dose for COVID-19 immunization (at hospital). The patient medical history was none. The concomitant medications were not reported. History of all previous immunization reported none. Patient not provided the family medical history. Patient reported that both she and her husband received their first Pfizer COVID-19 vaccine shots 8 days ago (clarified as 03Feb2021). She said her arm was sore for 3 days, and then the arm soreness was gone. She said her husband's arm has been sore for 8 days, clarifying it was 8 days ago that her husband got the COVID-19 vaccine. She said her husband has tried Advil, Tylenol, hot packs, cold packs, and nothing seems to help his pain. Reported that she and her husband both received their first COVID-19 Vaccines on the same day and time, and the COVID-19 Vaccines were administered at the same facility. Treatment declined due to the reported stated that she did not need to take anything for her COVID-19 Vaccine injection site pain, saying the vaccine injection site pain went away on its own after 3 days. On 03Feb2021 the patient reported that she experienced soreness started at the injection site, moved into this joints in the elbow and shoulder area. The reaction of duration reaction/event: 03 days. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The term highlighted by the reporter. The reporter classified the event as Non-serious and assessed the causality between the event and the vaccines as Related. The outcome of the events was recovered on 06Feb2021.  Information about lot and batch number was requested.
I had a slight fever and I had like some sniffles. It wasn't anything major. Pregnancy was 10-11 weeks long before I miscarried. Between the 2nd and 3rd month after receiving the Moderna booster, we have not had any successful attempts with conceiving again.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unknown dates the patients received doses of (Oka/Merck) VARIVAX (dose, route of administration, lot# and expiration dates not reported), that were exposed to temperatures outside of the proper storage range. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Patient had a 30mm diameter red, slightly raised mark around the injection site for 2 weeks after immunization.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 09-AUG-2016, the patient was vaccinated with a dose of improperly stored M-M-R II lot # L029266 (dose and route of administration were not reported). Additional information has been requested.
she experienced what she thought was a rash and was diagnosed as having Shingles.; This is a spontaneous report from a contactable 46-year-old female consumer(reporter). A 46 year old female patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 13Aug2021 as DOSE 1, SINGLE for covid-19 immunization( at age of 46 years).The patient medical history and concomitant medications were not reported. On 13Aug2021 the patient had experienced what she thought was a rash and was diagnosed as having Shingles  The clinical outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
1.  Approx 24 hours after injection: lower back stiffness. Lasted approx 18 hours. 2. Approx 36 hours after injection: hot/cold flashes. Lasted approx 12 hours.
Pt received pneumococcal 23 on 2-20-07. Pt called out office on 2-21-07 complaining of left arm soreness, slightly red, swollen, itchy.  Pt seen by pcp 2-21-07-subjective data=erythema overlying left elbow; tender in deltoid region but no fluctuance warmth or erythema with pt supine. Treatment cellulitis vs reaction to vaccine, placed on Dicloxacillin sodium cap 500 mg
Dizziness and vertigo, when I make certain move; Dizziness and vertigo, when I make certain move; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administration date 10Feb2021 (Lot number: EL3302) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE1, SINGLE , Lot Number : EL1238), administration date: 20Jan2021, when the patient was 70 years old, for covid-19 vaccination. The following information was reported: DIZZINESS POSTURAL (non-serious), VERTIGO POSITIONAL (non-serious) all with onset 11Feb2021, outcome "not recovered" and all described as "Dizziness and vertigo, when I make certain move". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness postural, vertigo positional.  Additional information: On 11Feb2021, the patient started having some kind of dizziness and vertigo, when she made certain move. The patient was still experiencing but not often, only when she did some sudden movement. The patient underwent some lab test. She did some test, for physical. Not 2 weeks. That was not 2 weeks. 3-4 weeks. May be 3 weeks.  No follow-up attempts are needed. No further information is expected.
Fever: 101*F,  Fever reducing meds, Family member of staff is self monitoring for 2-3 days. If fever doesn't resolve then family member of the staff will report to his PCP.
Information has been received from a health professional concerning 5-7 patients who on 12-NOV-2007 were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot# 658200/0804U). On 12-NOV-2007, the patients experienced cellulitis like reaction. The patient's entire upper arm from shoulder to elbow was red and hot to touch. Unknown medical attention was sought. At the time of report the patients had not recovered. No product quality complaint was involved. This is one of multiple patient report from the same source. Additional information has been requested.
Due date: May 14, 2021 My water broke less than 24 hours after my second dose of the Pfizer vaccination. I started leaking amniotic fluid in the morning of 4/17/21 and went to the hospital around 1 pm the same day. It was diagnosed as Premature Rupture of Membranes and my son was delivered on 4/18/21.  Birth weight was 6 lbs, 14 ounces.
runny nose; sinuse tightness; I tested negative on 01May2022 and again 05May2022/Morning of 09May2022 tested twice showed faint positive lines; I tested negative on 01May2022 and again 05May2022/Morning of 09May2022 tested twice showed faint positive lines; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "low thyroid" (unspecified if ongoing), notes: other medical history: low thyroid; "high cholesterol" (unspecified if ongoing), notes: stopped pravastatin for 6 days. There were no concomitant medications. The following information was reported: RHINORRHOEA (non-serious) with onset Apr2022, outcome "recovering", described as "runny nose"; PARANASAL SINUS DISCOMFORT (non-serious) with onset Apr2022, outcome "recovering", described as "sinuse tightness"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "I tested negative on 01May2022 and again 05May2022/Morning of 09May2022 tested twice showed faint positive lines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive, notes: faint positive; (01May2022) Negative; (05May2022) Negative; (09May2022) Positive, notes: faint positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included treatment for COVID-19 with Paxlovid (lot number fw6343) from 26Apr2022 to 01May2022. On the evening of 08May2022 runny nose began again. This seems beyond the 9 days from onset of symptoms suggested for rebound, and beyond the 2 days post Paxlovid. No other medications the patient received within 2 weeks of vaccination. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Painful, swelling from above the right elbow to 4 inches below the elbow in iner arm.
severe body aches and physical pain; severe body aches and physical pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe body aches and physical pain) and MYALGIA (severe body aches and physical pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003a21a and 025b21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVETIRACETAM (KEPPRA), LAMOTRIGINE (LAMICTAL), PHENOBARBITAL, OMEPRAZOLE, LOSARTAN, ROSUVASTATIN, TAMSULOSIN, VITAMINS NOS, METFORMIN HYDROCHLORIDE, SAXAGLIPTIN HYDROCHLORIDE (KOMBIGLYZE XR [METFORMIN HYDROCHLORIDE;SAXAGLIPTIN HYDROCHLORIDE]) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (severe body aches and physical pain) and MYALGIA (severe body aches and physical pain). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 04-Apr-2021, PAIN (severe body aches and physical pain) and MYALGIA (severe body aches and physical pain) had resolved. Not Provided
Pt recvd HIB vax & it was noted that pt had devel a small nodule @ inject site;
chest pain; chills; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), CHILLS (chills) and MYALGIA (muscle pain) 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 CHEST PAIN (chest pain), CHILLS (chills) and MYALGIA (muscle pain). At the time of the report, CHEST PAIN (chest pain), CHILLS (chills) and MYALGIA (muscle pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No concomitant medication was provided. Patient received vaccination a week ago but as of 3 days ago.
Also, May of 2021 after the 2nd dose, Moderna, I noticed that I had tinnitus in my ears. It has gradually gotten worse. There is a continual high pitched buzzing. Hearing aids now. I have a mild loss of hearing. Loss of hearing is hereditary. Hearing tested at a facility. In addition to the tinnitus, I was extremely fatigued and had trouble sleeping. My PCP, lowered thyroid meds from 125 to 112 July 1, 2021. Lowered 112-100 in September 2021 then 100-88 in March 2022. I was not satisfied with this treatment so I went to my natural path doctor for further treatment. The results from her care will be listed on report for booster shot.
she developed hives on both forearms.  she is taking Benadryl for her symptoms but will contact PCP if they get worse.
62 YO female with recurrent cervical cancer on cisplatin/pembro and concurrent radiation. PMH significant for T2DM, HLD, HTN, CAD, depression, GERD, chronic nausea, and neuropathy. She is s/p full Pfizer COVID-19 vaccination: first dose on 3/4 and second dose on 3/25. On 5/17 pt calls this institution to explain that she had been exposed to someone COVID-19 positive. Only symptom reported was fatigue. Nasopharyngeal swab obtained from pt on 5/17 and resulted positive. Pt opted to discontinue upcoming radiation appt and continue on systemic therapy alone for her cancer.
The patient experienced the following reaction(s) during the immediate   of observation: 0900- pt stated she was not feeling well.  Pt stated she became nauseated, dizzy, and diaphoretic.  Pt was placed in wheelchair and taken to post-vac area.  BP: 141/70 P: 70 R: 18 Sp02 99% RA. 0903- pt advised dizziness has almost resolved and she is starting to feel better.  0907- vitals retaken BP: 120/60 P: 85 R: 18 Sp02 100%.  Pt states symptoms are improving.  Pt drinking water A&O x4.  0916: Repeat vitals BP: 110/64 P: 64 R: 18 Sp02 98%. 0920- pt stated she normally carries an epi pen with her, but forgot it today.  BP: 110/60 P: 63 R:18 Sp02: 99% 0920- pt ambulated with no issues, pt taken home.
This was dose #2; I had not had a reaction to dose #1, which was 6 months earlier. The shot was at about 7 pm. The shot hurt just slightly for a few seconds and then was fine. The BENADRYL was making me drowsy as expected, but about an hour later, I just kept getting more and more drowsy until I fell asleep in my chair. (That might have still just been the BENADRYL although it hasn't made me THAT drowsy before.) I trudged upstairs and collapsed in the bed. I tried to get up the next morning and just couldn't because I was so out of it, had just a little congestion, and tried getting up for real about 11 am feeling tired. I took a shower hoping that would help, went downstairs and tried eating a few bites of a banana, and started spiraling downhill: chills, sweating, weakness, tingling skin, aches in general, and then started feeling like I was about to black out. I went upstairs and almost threw up, felt like blacking out again, had a little chest tightness. I fell into bed again, slept until about 1:30 pm, got up and felt a little better but very weak. Over the next 2 hours, it pretty much completely went away; I was just a little lacking in motivation for the rest of the day. Then I was pretty much back to normal, so that was not a real flu that I just happened to get by coincidence.
This spontaneous report was received from the patient's mother via a company representative and refers to her daughter, a currently 30 year old female patient. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. In approximately 2008 (reported as 8-9 years ago), the patient was vaccinated with a dose of GARDASIL, for prophylaxis (dose, route, lot number and expiration date were not provided). On an unknown date (reported as a couple of months after administration of GARDASIL, it was reported that the patient developed "symptoms of Multiple Sclerosis". Subsequently on an unspecified date, the patient had a brain scan that revealed lesions indicative of multiple sclerosis. As a result, the patient was diagnosed with multiple sclerosis and was prescribed with an unspecified medication. No product quality complaint (PQC) was involved. At the time of reporting, the outcome of multiple sclerosis was unknown. The causal relationship between GARDASIL and multiple sclerosis was not provided. Upon internal review, multiple sclerosis was determined to be a medically significant event. Additional information is not expected as no contact details to contact the physician were provided.
fever; headache; body aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, headache and general body pain. On an unknown date, the outcome of the fever, headache and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, headache and general body pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and experienced adverse events for 24 hours included fever, headache and pain. The patient was unable to get off the couch for a day due to the adverse events. This is one of 3 cases reported.
Shaky Malaise Swelling/erythema/induration at site ( 6x8 cm) Lymph node swelling/tenderness ( 2 cm) brachial/axillary
NO ADVERSE REACTION- Misadministration of vaccine.  Vaccine expired 5 June 2012.
occasionally shortness of breathe; lost smell and taste; lost smell and taste; "flu like aches"; fatigue; nausea; fever 102 degrees Fahrenheit; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (occasionally shortness of breathe), ANOSMIA (lost smell and taste), AGEUSIA (lost smell and taste), MYALGIA ("flu like aches") and FATIGUE (fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in August 2020. Concomitant products included ALPRAZOLAM, ACETYLSALICYLIC ACID (ASPIRIN 81), CLONAZEPAM, CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE 600 + D), CETIRIZINE, CLONIDINE, CYCLOBENZAPRINE, FLUOXETINE, FLUTICASONE, GABAPENTIN, INSULIN LISPRO (HUMALOG), SITAGLIPTIN (JANUVIA [SITAGLIPTIN]), EMPAGLIFLOZIN (JARDIANCE), LANSOPRAZOLE, LISINOPRIL and MELOXICAM for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced DYSPNOEA (occasionally shortness of breathe), ANOSMIA (lost smell and taste), AGEUSIA (lost smell and taste), MYALGIA ("flu like aches"), FATIGUE (fatigue), NAUSEA (nausea), PYREXIA (fever 102 degrees Fahrenheit) and HEADACHE (bad headache). On 24-Mar-2021, DYSPNOEA (occasionally shortness of breathe), ANOSMIA (lost smell and taste), AGEUSIA (lost smell and taste), MYALGIA ("flu like aches"), FATIGUE (fatigue), NAUSEA (nausea), PYREXIA (fever 102 degrees Fahrenheit) and HEADACHE (bad headache) had resolved.      No treatment of symptoms for Dose 1 was provided. Additional concomitant medication was Vitamin D 50000 twice a week.   This case was linked to US-MODERNATX, INC.-MOD-2021-081412 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081412:Case for dose 2
27OCT93 chills, fever (had cold 3 wks, earlier, sl cough); 1NOV93 walking pneumonia-rx Cipro-seen by MD;
Loss of smell, taste, and appetite. Unusual bowel movements. Future date will make a month of these occurring symptoms.
Approximately 20 mins after receiving a COVID-19 vaccine the patient complained of dizziness and blurry vision.
Incorrect Administration Procedure; This case was reported by a other health professional via call center representative and described the occurrence of wrong injection technique in a 61-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th April 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 14th April 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong injection technique. On an unknown date, the outcome of the wrong injection technique was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-APR-2022 Reporter's Comments: Pharmacy Intern reported that, the syringe plunger for Boostrix was jammed and she was not able to push the plunger when administering the vaccine to the patient. The patient did not receive the vaccine and she withdrew the needle and replaced the syringe with another needle, then was able to administer the vaccine. It was given in left deltoid. She used a 25g safety needle and therefore, product complaint ruled out. The agent informed the intern to use the LUER Lok needle going forward. Additional Supportive Information: Since the reporter used 25g safety needle instead of Luer lok needle, it led to wrong injection technique.
high fever 104, swollen glands, sleeping all the time, listless;APAP given & tepid bath-cold foods;
Patient presents to the ED with myocarditis s/p dose #2 of Pfizer COVID-19 vaccine.    From note: Patient is 13 yo M who was in his usual state of health prior to getting his Pzifer COVID-19 vaccine #2 on Saturday morning (6/5). Saturday night he began to feel fatigued with fevers as high as 102.8 F. These symptoms continued through the night and into Sunday morning when he had episodes of NBNB emesis. Sunday night he was actually feeling somewhat better and was able to sleep through the night. He stayed home from school on Monday due to fatigue. At 3 am this morning (6/8), he woke up with aching parasternal non-radiating chest pain that he describes as an 8/10 and worse while lying down. Denies SOB and heart palpitations. His parents took him to a hospital where he was found to have an elevated troponin (reported 5.84 - unknown scale) and Hct 28.8. There was also question of an abnormal EKG (?p wave inversion). He got a bedside echo which showed no pericardial effusion. Additional labs included: WBC nml, plt nml, MBCK 16.   In the ED, his vital signs have been stable. EKG was normal sinus. Trop elevated to 0.43 and echo was normal. Reassuringly his echo was normal, he has had no arrhythmias (after nearly 24hrs of continuous monitoring), his chest pain has largely resolved and his troponin has remained stable.
Pain in the injection site radiating to the shoulder lower arm and fingers up to behind the ear, started 2 days after pt. received Seasonal influenza vaccine on his Right arm. Also c/o tingling in the same extremity on and off. Pain also worsens with movement of arm.
blood test : HSV-1 Virus high; This case was reported by a consumer via call center representative and described the occurrence of herpes simplex type i in a 35-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced herpes simplex type i. On an unknown date, the outcome of the herpes simplex type i was unknown.   It was unknown if the reporter considered the herpes simplex type i to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-DEC-2022 Reporter's Comment: The case was self reported by the patient. The patient received a dose of Shingrix vaccine and reported recently got a blood test back with the HSV-1 virus high. No further information reported to the agent by the patient. The reporter ended call before any further information could be collected. The reporter did not consent to follow up.