chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stiff neck muscles, especially at base of skull accompanied by pain at the base of skull traveling up both sides of head into temples.  Painful temples when touched.  Headache was constant throughout the day (1-2) and would flare up 3-4 times a day (6-7).  Sometimes relived by Tylenol.  Often caused eye pain when severe.
Started with mild headaches about 14 days in. Noticed increase in tinnitus (already had tinnitus) around 17 days after. Tinnitus became  debilitating with addition of second tone, resulting in repeated panic attacks at night and anxiety throughout the day. Severe impairment of daily activities with huge disruption of sleep and work.  Saw ENT and then family doctor who had to prescribe anxiety medication to control anxiety.
I (she) started with chills and irritated temperature, at dawn the temperature increased to 39 degrees Celsius and without being able to control the movements of the (her) body, we gave her a dose of 2 aspirin and it helped control the temperature a little like at 6:30 am. After 8 in the morning the chills returned and  her temperature was 38 degrees Celsius and at this time she continues to have chills and has no desire to eat, she took her medications every day in the morning.
High fever 103.5 for about 15 hours then low grade fever 100+ for the next 24 hours with chills and shakes.  Headache for 5 days and fatigue for 4 days.
diarrhea; wheezing; cough; stomach issues; slept the whole day; tremendous amount to stomach pain; little bit of asthma; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), WHEEZING (wheezing), COUGH (cough), ABDOMINAL DISCOMFORT (stomach issues) and SOMNOLENCE (slept the whole day) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DILTIAZEM, HYDRALAZINE, OLMESARTAN, ROPINIROLE HYDROCHLORIDE (REQUIP), ALPRAZOLAM, FLUOXETINE and ZOLPIDEM for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DIARRHOEA (diarrhea), WHEEZING (wheezing), COUGH (cough), ABDOMINAL DISCOMFORT (stomach issues), SOMNOLENCE (slept the whole day), ABDOMINAL PAIN UPPER (tremendous amount to stomach pain), ASTHMA (little bit of asthma), NAUSEA (nausea) and FATIGUE (fatigue). The patient was treated with SALBUTAMOL (ALBUTEROL HFA) on 27-Feb-2021 at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), WHEEZING (wheezing), COUGH (cough), ABDOMINAL DISCOMFORT (stomach issues), SOMNOLENCE (slept the whole day), ABDOMINAL PAIN UPPER (tremendous amount to stomach pain), ASTHMA (little bit of asthma), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Information has been received from a licensed practical nurse referring to multiple patients of unknown ages and genders. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates in 2016 (reported as "between 01-MAR-2016 and 14-JUL-2016"), 2 doses of improperly stored GARDASIL 9 (lot# L048237, expiration date 08-MAY-2017, route not reported) were inadvertently administered to the patients. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
She noted bruising and redness in her left deltoid the day after receiving immunizations as well as body aches and also developed diarrhea 2/20. Local reaction was mild. GI symptoms and myalgias seem more likely related to a norovirus.
Swelling of arm from shoulder to elbow with extreme pain. As of 11/09/2009 the swelling has started to recede and there is just some light soreness.
Soreness in my upper right arm (arm the injection was received in); Slight discomfort; This spontaneous case was received on 10-Oct-2023 from a pharmacist (reference number: SEQW23-03201) with additional information received on the same date (being processed together) and concerned a 43-year-old male patient.  The patient's medical history included blood pressure and acid reflux. The patient's concomitant medications included amlodipine used for blood pressure, and pantoprazole used for acid reflux.  On 09-Oct-2023, at approximately 8:30 am, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; anatomical location: right arm, route of administration: not reported) for active immunization against influenza disease. The batch number was not reported.  On 10-Oct-2023, one day after receiving Flucelvax Quadrivalent, the patient experienced a very mild soreness in upper right arm (arm the injection was received in).  On an unspecified date in Oct-2023, the patient experienced slight discomfort.  On 10-Oct-2023, the patient recovered from event ' Painful R arm '.  At the time of reporting, on 10-Oct-2023, the outcome of event 'discomfort' was unknown.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 43-year-old patient experienced pain in upper right arm and discomfort within one day after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.; Sender's Comments: A 43-year-old patient experienced pain in upper right arm and discomfort within one day after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.
Positive COVID 19 test result when prescreening done for orthopedic surgery. ASYMPTOMATIC
Patient stated on 10/6/2011 she developed aching joints and muscles, nausea & vomiting and soreness at the injection site. Nausea/vomiting subsided in 2 days. Still experiencing joint pain today 11/2/2011. Had similar reaction to tetanus vaccine about 25 years ago.
t105, pc to MD, gave Pediaprophen; temp reduced w/med, sl rash neck & trunk next day, seen by MD rx ointment, relieved w/trt;
Patient reported itchy, red bumps to bilateral inner elbows. Patient reports having a similar reaction to the first does of Pfizer vaccine and patient's HCP  instructed him to take Benadryl. Administered diphenhydramine 25 mg PO liquid to patient at 1100. Red bumps and itchiness subsided after 25 minutes. Patient reports no other symptoms. Patient left facility at 1126.
Pt was a participant in Lyme study for 1994-1997. Post 2nd dose of vax, the pt could not walk more than 1/2 block; progressively worse.
Burning pain from spine up to the base of skull stayed that way for about 4 hours. Went to work, felt nauseated for about 15 mins. Broke out in face, neck and body rash. Headache on left side of head. the next morning, rash was gone. Nausea stayed off and on for about 7 days. Second shot scheduled on the 3/15.
Nauseated. BPs 133/97 (pulse 103); 136/97 (pulse 96). Given water, juice, crackers.
Went to bed with a sore arm, as expected, & woke up about 12:40am (a little over 13 hours after injection) shaking. Within 15 minutes I was shaking so hard that I could not stand straight to walk & needed assistance. I had to sit to scoot down the stairs to get to a tolerable position. The shaking continued to get worse to the point that I was hyperventilating. After a couple hours of shaking & being unable to take in full breaths I began to have tingling & some numbness in my feet & hands up to my elbows. This went on for about four hours then started to taper off where I could breathe better. It took an additional hour & a half to finally fall asleep. The next day was soreness & extreme exhaustion but no more shaking.
Information has been received from a vaccine specialist from another company concerning a patient in his customer's medical practice who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647271/1138N). Subsequently after vaccination, the patient developed a swollen throat, swollen tongue, and swollen face. The patient was treated in the emergency room, but was not hospitalized. The patient's outcome was unknown. There was no product quality complaint involved. Upon internal review, the patient's swollen throat, swollen tongue and swollen face were considered to be other important medical events. The reporter also indicated that another patient also had an adverse experience following exposure to pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Little bit soreness after the first dose at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN. At the time of the report, VACCINATION SITE PAIN outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.    Relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Upon returning the unused bottles of vaccine that we had left we realized that the vaccine was only good 30 days from the deep freeze.  We thought it was 10-30-2022 the date on the manufacter website when kept in the fridge.  We received this vaccine on 06-02-2022 and vaccinated on 08-02-2022.  We contacted the mfg which is going to do batch testing to see if we need to revaccinate.
Patient reported swelling, redness and lump (half-egg size) at injection site on Oct 5. She had mild cough too. Events have resolved today except for the lump.
Information has been received from a physician concerning a 2 year old patient (gender unknown) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The patient experienced a mild case of chickenpox. Attempts made to obtain additional identifying information to distinguish the individual patients mentioned in this report were unsuccessful. This is one of several reports received from the same source. The patient's sibling (WAES# 0705USA001187) had a similar experience following vaccination with varicella virus vaccine live (Oka/Merck). No additional information is expected.
PNEUMOVAX 23 was expired and given to the patient; This solicited report was received from a pharmacist, concerning a female patient of unknown age, who was enrolled in a Patient Support Program (PSP). The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies, and concomitant medications were unknown by the reporter.      On 28-JUN-2020, the patient was vaccinated with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot number R033079 with expiration date on 06-JUN-2020 as prophylaxis (strength, dose, frequency and anatomical location were not reported) (expired vaccine used).  Follow-up information was received in 08-JUL-2020.  It was reported that the call was deemed to be transferred from an internal group rather than a PSP. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R033079; expirationdate: 06-JUN-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Itching.; Random red rash appears  on numerous  parts of the body; feel headcrawling; This is a spontaneous report from contactable healthcare professional. A 28-year-old male patient received the second dose BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3249) via an unspecified route of administration in the left arm on 12Jan2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE: Lot number: EL0140) via an unspecified route of administration in the left arm on 23Dec2020 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 12Jan2021 the patient experienced itching, red rash and crawling sensation. The patient had itching, a random red rash appeared on numerous parts of the body one month after receiving the second dose of the vaccine. The patient also felt head crawling. The event resulted in a doctor or other healthcare professional office/clinic visit. On an unknown date, post-vaccination, the patient underwent a COVID-19 virus test (nasal swab test) and resulted negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events itching, red rash and crawling sensation were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Developed some swelling, erythema and pruritus at and around the site of her left arm. These symptoms began the next day after the injection. She did not have fever or chills. Treatment: Tylenol 500mg PO every 4 hours PM if the symptoms worsen notify MD.
Warm at site of injection (L) arm itchy, (L) hand swollen, (L) elbow red dorsal side, head itching all over.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: GJ5324) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "depression" (unspecified if ongoing); "c-PTSD" (unspecified if ongoing), notes: c-PTSD; "allergies" (unspecified if ongoing), notes: allergies; "asthma" (unspecified if ongoing); "overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
10OCT 7PM hives localized to thighs - generalized-took DPH; 11OCT rt arm pain began until 12OCT; lymph node swelling & pain noticed 12OCT94; 13OCT bilat wrist/hand pain; 14OCT noticed red areas; dx vasculitis/arthritis secondary to vax;
Information has been received from a physician concerning three patients (age and gender not reported) who on an unspecified date, in the morning, were vaccinated with GARDASIL vaccine. Subsequently, the patients fainted after receiving GARDASIL vaccine (date unknown).  It was reported that the patients had not eaten anything.  At the time of this report, the outcome of the events were unknown.  Additional information has been requested.
Patient was not of approved age for vaccine.  Follow-up with parent revealed no adverse effects from vaccine or no side effects immediately after receiving the vaccine.
General Fatigue  Muscle aches  Sore throat Loss of appetite  Headache  Scratchy throat Chest pressure  Going on five days now...
Headache for 1 week, fatigue for 1 week. Mood changes as well, felt more sluggish and depressed for 2 weeks since vaccine. Headaches were constant (bilateral) 4-10 in severity, unrelieved by NSAID.
generalized pruritus on arms, trunk, buttocks, thighs; progressed to hives-like patches w/intense itching;
This case was forwarded by Crucell, No: CVAE-027-2012 An initial report was received from a healthcare professional on 28.Jun.2012 and concerns a 48-year-old male patient who, on 25.Jun.2012, received the first administration of oral VIVOTIF (batch no: 3000132). The patient's medical history and concomitant medications were not reported. On 25.Jun.2012, at an unspecified time following the VIVOTIF administration, the patient experienced fever. The patient did not continue taking the VIVOTIF. The fever was still persisting four days later. No further information was available. At the time of reporting the patient was recovering. The event was considered non-serious.
Patient received flu vaccine on 10/11/2023 by myself into the left deltoid muscle of the arm. On 10/30/2023 patient reported experiencing "severe shoulder pain" since that time to District Pharmacy Manager. Patient did not report any issues on the day of the vaccination to myself and the vaccination was routine and uneventful. Patient was seen by orthopedic specialist who stated that the injury was likely was not SIRVA related but caused by some other reason.
patient's left arm became numb and her left arm became flushed and so did her neck and face area within a minute of receiving the vaccine
she experienced achiness; glands are swelling and achy; I just feel achy; I have this achiness, weakness; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FC3183) via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced as, she experienced achiness, glands are swelling and achy, i just feel achy; i have this achiness, weakness on 2021. Reported as, patient stated that after her first shot on 25Aug2021, she experienced achiness and her glands was swelling and achy. Patient stated that it will be two weeks tomorrow, that this started the day before she was to receive the second dose. Patient have achiness severe achiness. That could only last for one day, ok two weeks later, she got it was not severe but her glands were swollen and she just feel achy. Her glands was swollen like his ears and under his jaw. Outcome of all the events were not recovered.
This case involves an unknown age and unknown gender patient who experienced 2 worst flu season while receiving vaccine 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 (unknown formulation and strength)  produced by unknown manufacturer (lot number not reported ) via unknown route in unknown administration site. for immunization. On an unknown date the patient developed a non-serious 2 worst flu season (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported " I've had 2 flu shots - 2 worst flu season I ever had." Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (2 worst flu season ). At time of reporting, the outcome was Unknown for the event 2 worst flu season.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 13-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 13-Feb-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 13-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 13-Feb-2022) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.     On 13-Feb-2022 at 9:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Feb-2022 at 9:51 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 13-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 13-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 13-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 13-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. It was unknown if other vaccines were given on the same day or within one month prior to any dose of as Moderna COVID-19 Vaccine to the patient.  Patient received the booster dose.  It was reported that vaccines went into 2-8 C thaw state on or above 24-Dec-2021 and were administered up until t expiry date of 04-Apr-2022.  No treatment medications were provided.
Information has been received from a RN concerning a pt who was vaccinated (date unknown) with varicella virus vaccine live.  It was noted that on 12Apr2003 the pt's 7 month old younger brother who had not been vaccinated because of his age came down with chickenpox. Subsequently two weeks later, reported as 26Apr2003 the patient who had been vaccinated, "broke out with a moderate case of chicken pox".  Unspecified medical attention was sought. The reporter mentioned that two other siblings also "broke out with moderate cases of chicken pox" following vaccination with varicella virus vaccine live. No additional information is expected.