chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She woke up soaking wet; Fatigue; Fever; She had "normal reactions" after the first 2 shots/ Following the second dose, it totally knocked her out; She got it at 11:00 AM, and by 7:00 PM she felt she needed to go to bed; Aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She had "normal reactions" after the first 2 shots/ Following the second dose, it totally knocked her out), SOMNOLENCE (She got it at 11:00 AM, and by 7:00 PM she felt she needed to go to bed), PAIN (Aches), HYPERHIDROSIS (She woke up soaking wet) and FATIGUE (Fatigue) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced VACCINATION COMPLICATION (She had "normal reactions" after the first 2 shots/ Following the second dose, it totally knocked her out), SOMNOLENCE (She got it at 11:00 AM, and by 7:00 PM she felt she needed to go to bed), PAIN (Aches) and FATIGUE (Fatigue). 04-May-2021, the patient experienced PYREXIA (Fever). On 05-May-2021, the patient experienced HYPERHIDROSIS (She woke up soaking wet). At the time of the report, VACCINATION COMPLICATION (She had "normal reactions" after the first 2 shots/ Following the second dose, it totally knocked her out), SOMNOLENCE (She got it at 11:00 AM, and by 7:00 PM she felt she needed to go to bed), PAIN (Aches), HYPERHIDROSIS (She woke up soaking wet), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-405947, MOD-2021-406085 (Patient Link).
31DEC97 temp 100.6 (o) c/o achiness;3JAN98 hives started on back @ 530PM c/o nausea w/o emesis;hives on torso, arms, legs-spread to shoulders, head, hands & feet;5JAN98 saw MD dx urticaria of unk origin;rx DPH & claritin;
Patient present in office 3/12/04 with rash (quarter size) at injection site; itchy and sore.
This spontaneous report as received from a county health nurse/registered nurse refers to 3 patients of unknown age and gender, who on unspecified date were vaccinated by the physician with improperly stored RECOMBIVAX HB (route of administration, dose, frequency, lot # and expiry date were not reported). No adverse effect was reported at this time. This is one of several reports received from the same reporter. Additional information is not expected because there is no consent to contact the reporter.
INCREASE HEART RATE; FEELING ANXIOUS; UNWELL; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included COVID-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced increase heart rate. On 06-APR-2021, the subject experienced feeling anxious. On 06-APR-2021, the subject experienced unwell. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fever. Laboratory data included: Heart rate (NR: not provided) 120 and 158 (unit unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, increase heart rate, and fever, and the outcome of unwell and feeling anxious was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Information has been received from a physician concerning a 72 year old female with gamma globulin deficiency and chronic infection who on 4/28/05 was vaccinated with pneumococcal 23v polysaccharide vaccine. The physician reported that he did not expect the patient to seroconvert as the patient had a gamma globulin deficiency and considered this a lack of response. The physician further reported that as the patient did not respond to the pneumococcal 23v polysaccharide vaccine, he did not consider this to be an adverse experience. The patient sought unspecified medical attention. On 5/5/05, the patient underwent an enzyme-linked immunosorbent assay which was negative. At the time of this report, the outcome of the event was unknown. No further information is available.
Had the 2nd dose on april 10th  at 130 pm side effects started around 10 pm that night, body aches, chills, sweats, head to use my inhaler 3 times during the night as i felt I wasn't getting enough air. Woke up the next day April 11th less achy, but very tired, around 4 pm on the same day i started noticing swelling under my right eye. April 12th woke up in the morning with more swelling on the right side, under the eye and bottom lip with some numbness around the area. Contacted my doctor following her directions at the moment
one episode of blood tinged stool after 1st vaccine then 3 days of bloody stool following second dose
After receiving the second dose of the Pfizer COVID vaccine on 6/2/2021, the patient reported experiencing increased swelling of her knee for approximately 1.5 weeks. As of 6/17/2021, knee is swollen, red and hot to the touch. She also developed an acneiform rash on her back, feels lightheaded occasionally and had a fever that lasted for 2 days post-vaccination with a maximum of 102 degrees Fahrenheit.   Patient reported symptoms during a comprehensive medication management session that is offered as part of her benefits at work. Pharmacist advised the patient to report symptoms to her doctor immediately as it may indicate something more serious such as a DVT or infection. Patient made an appointment with her physician and showed her physical therapist the affected knee.
Not feeling well; This is a spontaneous report from a contactable consumer, the patient, via the sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient was not feeling well after the first vaccination. The patient wanted to confirm if this was an effect of the vaccine or if this was because she was exposed to her friend who felt COVID symptoms. The clinical outcome of not feeling well was unknown.  Information on the lot/batch number has been requested.
High fever of 103.2, chills, horrible body aches, swollen and painful lymph node
an expired pentacel vaccine was given to a patient during a visit, no AE; Initial information received on 17-Aug-2020 regarding an unsolicited valid non-serious case from other health professional in the United States.  This case involves a 14 months old male patient who was vaccinated with an expired dose  of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (first dose in series, lot number: UJ073AAA and expiration date: 13-Jun-2020), intramuscularly in the left thigh as prophylactic vaccination on 14-Aug-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination on the same visit that is on 14-Aug-2020.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Woke morning of 10/8/14 with severe rash on face. Both eyes almost swollen shut. Child spiked a temperature of 104 deg. Parent took to ER. Epinephrine given at ER. Dx:Delayed RN to FLUMIST.
Patient had COVID vaccine  May 2021 in state, unknown exact date put 5/14/2021.  Hospitalized with hypoxic respiratory failure needing HFNC.
After about 24 hours I felt effects from receiving my COVID booster and annual flu shot.  Symptoms presented on the right side of my head, mostly in the hairline.  The skin was painful without even touching my skin.  The pain periodically radiated into my right ear canal. On the fifth day of symptoms unabated and not improving, I sought care from local walk-in facility.  The PA quickly diagnosed my condition as shingles.  He stated that my shingles became active after my body had experienced stress, including my immune response to receiving two different vaccines. At this writing I am my first course of anti-viral caplets three pills a day for seven days.
3FEB97 t100.6 exp wheeze, rales in bilat lung fields;4FEB97 RVC positive influenza A; med given x 21 days 3FEB97;
Patient brought to the ED by EMS on 11/27/22 for worsening generalized weakness and cough that began 11/25. En route to the ED, patient found to have heartrate in 160-170s. COVID PCR test done in the ED on 11/27/22 resulted positive. Ultimately, patient admitted 11/27/22 for atrial fibrillation in RVR, acute respiratory failure with hypoxia, pneumonia due to COVID-19 virus, and suspected bacterial PNA/superinfection, among other problems. Per chart review, provider believed atrial fibrillation was likely triggered by COVID-19 sepsis. Patient discharged 12/3/22.
charlie horse / muscle cramps; stiff neck; nerve pain in neck area; This case was reported by a consumer via media and described the occurrence of charley horse in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix. In October 2020, 30 min after receiving Shingrix, the patient experienced charley horse, stiff neck and nerve pain. On an unknown date, the outcome of the charley horse, stiff neck and nerve pain were unknown.   It was unknown if the reporter considered the charley horse, stiff neck and nerve pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. 3 days before the date of reporting, the patient received Shingrix and experienced Charlie horse and stiff neck approximately 1/2 hours after injection. The reporter asked if any reports of muscle cramps or nerve pain in neck area after injection. The reporter also asked if any side effects reported of Charlie horse and stiff neck after first injection.
Re-dosing of moderna vaccine; Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Re-dosing of moderna vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Re-dosing of moderna vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (Re-dosing of moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  Time of vaccine administered is 10:15am
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD lot # R002934, expiration date 29-JUL-2019 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with a properly stored of sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit  for 35 hours 18 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 39 hours 57 minutes.
not experienced any AE; Received expired dose of vaccine; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 09-OCT-2020, the patient was vaccinated with the expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, one time, lot # R033342, expiration date 03-AUG-2020, (anatomical location and route of administration were not reported) for prophylaxis. The vaccine had not undergone a temperature excursion. Furthermore, the patient did not experience any adverse event from the administration of the expired vaccine. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R033342; expirationdate: 03-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Fever, vomiting, irritable 6/11/08 day after shots - now diarrhea.
-Woke up with rigors, fever 100.8 F, shaking cold x 6 hrs, mild-mod headache 3-6/10 for pain, extreme tiredness- slept except to go to the bathroom, no appetite, body aches- lasted about 60 hrs. -Then, low grade fever continued 99.8-100 F, and diarrhea x 24 hrs. Tired, but not as profound. -Then, low grade fever continued 99.2 - 99.8 F and sore throat x 48 hrs.   Symptoms treated with Tylenol and ibuprofen, throat lozenges.
COMPLETELY REGAINED SENSE OF SMELL AND ANY SENSE OF TASTE THAT HAD LOST AS A RESULT OF LACK OF SMELL; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included sinus infections, upper respiratory problems, parkinson's, phantosmia/parosmia, complete loss of smell, and loss of taste. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced completely regained sense of smell and any sense of taste that had lost as a result of lack of smell. The action taken with covid-19 vaccine  was not applicable. The outcome of the fatigue and completely regained sense of smell and any sense of taste that had lost as a result of lack of smell was not reported. This report was non-serious.
Neuropathy in lips and tongue and left side of face. Lasted about less than a minute.
Tdap administered 3/12/13. Present to office 3/14/13 with c/o swollen arm at site. Red, warm to touch at site. Temp 99.4 (TY).
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.   On 18-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
FELT LIKE ARM IS KILLING; INJECTION SITE HURTING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced felt like arm is killing, and injection site hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site hurting and felt like arm is killing was not reported. This report was non-serious.
6cm x 6cm warm erythematous swelling over the entire (L) deltoid area with subsequent abscess formation (+) significant soft tissue swelling. (L) upper arm cellulitis.
Immediate response noted in injection arm (L). - burning pain traveling to right foot.  Additional symptoms surfaced beginning 12/23. - tingling (pins & needles) in extremities; burning pain; itching of skin; prickly skin; muscle pain (often very intense) in back, neck, extremities; muscle cramping; muscle twitches; vibrating and humming in the arms and legs; cold sensations; fatigue; poor quality of sleep; pain along nerves in arms; tingling and tightness in face and scalp.  All symptoms are migratory and transient.
HYPOTENSION 4/22/2023 SUPERVISION NORMAL PREGNANCY, SROM CHECK, THIRD TRIMESTER
Given flu shot at 3:00pm on October 14, 2008. 24 hours later, severe drug reaction on face arms and chest.
pt recv vax 29FEB96 & 6MAR95 pt exp hypothalamus (encephalitis),fever of 104 & was hosp;tx Rocephil;CT scan revealed hypodense thalamus;LP nl;lab analysis revealed AST 4000;
Primary varicella infection; vaccine strain virus was the most likely etiology; This literature marketed report has been received from the authors of a published literature article and refers to a 61-year-old female patient with cirrhosis. The patient had been hospitalized the month previous for decompensated cirrhosis and underwent liver transplantation evaluation. She was found to have an undetectable varicella IgG antibody titer during routine pre-transplantation screening.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) first dose, (dose, frequency, route of administration, lot# and expiration date were not reported). On an unknown date, about 3 weeks later, the patient developed pruritic skin lesions involving her chest, back, arms, and legs. Dermatologic evaluation revealed disseminated vesicles and eroded papules on an erythematous base, without ocular or mucosal involvement. Direct fluorescent antibody (DFA) testing of a vesicle for varicella zoster virus (VZV) returned positive. The patient's classic skin lesions in multiple stages of evolution and positive DFA, were felt to be consistent with primary varicella infection, with which the patient presented 3 weeks after vaccination (also reported as 1 moth after the first dose of the vaccination). Based on the temporal relation of the patient's rash with the vaccination with varicella virus vaccine live (oka/merck) (manufacturer unknown), the authors felt that vaccine strain virus, rather than wild type, was the most likely etiology. The patient was started on intravenous acyclovir and was transitioned to oral valacyclovir for a total 10-day course. The event of the rash diagnosed as primary varicella infection resolved without complication on an unknown date. The outcome of the event of vaccination failure was unknown. The causality between the events and varicella virus vaccine live (oka/merck) (manufacturer unknown) was assessed to be related.
4 hours post administration: arm pain localized to upper deltoid 12-24 hr post: whole-body muscle/bone pain, chills, headache, fatigue 48-72hr post: mild diarrhea, upset stomach,  sore throat, congestion (previous symptoms resolved)
Injection sight is red, raised, and painful. Area is emitting heat. Also experiencing pain that is radiating from the injection site to the neck. Attempted to take 600mg of Motrin with no effect on pain or swelling.