chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever and fast heart rate. Fever broke and elevated heart rate still ongoing felt very weak. Any time I moved around it was a big effort. And my heart rate would elevate to 130-140. I took some more Tylenol and stayed in bed. I had a lot of inflammation in my lymph nodes in my armpit. I took some Advil 800mg and went back to bed, and I felt a bit better after being in bed. When moving around, my heart rate would increase, and I would start to get chest pain. And then on Saturday I went to the urgent care, and I still felt like crap. And anything I did would result in the elevated heart rate and chest pain. The chest pain was under my left breast, and it radiated around to the back. It did mess with more of my stomach since last time. And even nausea was present but that also went away. At urgent care, ECG was done and came back normal. Was told to just keep doing what I was doing at home and take Advil as it was a side effect of the vaccination.
Horrible headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 34 years old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration on 15Mar2021 (at the age of 34 years old) as single dose for COVID 19 immunisation. Medical history and Concomitant medications of the patient were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any allergy towards medications, food, or other products. Prior to vaccination the patient had not been diagnosed with COVID-19. On an unknown date patient experienced horrible headache and fatigue. Therapeutic measures were not taken for the events. Advil did not help. Since the vaccination, the patient had not tested positive for COVID 19. The clinical outcome of the events headache and fatigue was recovered. No follow-up attempts are possible; information about lot number cannot be obtained.
First week in September, started feeling fatigued and sluggish. Gradually getting worse to the point of being winded when walking to the car at work. Sunday, September 19th taken to the emergency room for shortness of breath, heart rate at 40.  4:30 am on Monday, September 20th, code blue called for heart stopping. Rushed into CCU for a pacemaker, had to be transported to put in a temporary pacemaker due to vitals being unstable.  Tuesday, September 21st, had pacemaker installed.
Based on the additional information received on 27-Jul-2015, this case initially considered as non-serious was upgraded to serious as the patient was hospitalized on an unspecified date. Initial unsolicited report received from a nurse on 30-Jun-2015. A four months old patient (gender not reported), had received a dose of PENTACEL (batch number: C4759AA, expiry date: 22-Mar-2016, dose details, route of administration and site of administration were not provided) and a dose of PREVNAR (dose details, batch number, route of administration and site of administration were not provided) both on an unspecified date. The patient had received PENTACEL and PREVNAR vaccines previously at 2 months of age. There were no issues. On an unspecified date, one hour post-vaccination, the patient went limp and eyes rolled back. Laboratory investigations and corrective treatment were not provided. At the time of this report, the outcome of the event was not reported. Documents held by sender: none. Follow up information received from a nurse on 27-Jul-2015. The gender of the patient was reported as female. The patient was approximately nine months of age at the time of this report and was in good health. The lot number for PENTACEL vaccine was 4759AA and the vaccine was administered in the right thigh. It was reported that on an unspecified date, the patient had a possible seizure in the evening hours after receiving the PENTACEL vaccine. She also had 102 temperature (units not provided) prior to the seizure. On an unspecified date, she was admitted overnight for observation in the hospital. Laboratory tests included RSV (Respiratory Syncytial Virus), Flu, UA (Urinalysis) and Chest X-ray, the results of which were negative for all the tests. Results of CBC (Complete Blood Count) and urine culture also showed no abnormalities. She was discharged home and had no further events after that time. It was reported that the future doses of vaccine were given individually to avoid PENTACEL. At the time of this report, the patient had recovered from the above mentioned events. Documents held by sender: none.
heart rate shot up; was getting sluggish; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (heart rate shot up), SLUGGISHNESS (was getting sluggish) and PYREXIA (Fever) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 002B21A) for COVID-19 vaccination.     The patient's past medical history included Stroke on 30-Mar-2021. Concurrent medical conditions included Polycythemia. Concomitant products included IBUPROFEN for Hip fracture, SIMVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN), LISINOPRIL and METOPROLOL for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced TACHYCARDIA (heart rate shot up), SLUGGISHNESS (was getting sluggish) and PYREXIA (Fever). At the time of the report, TACHYCARDIA (heart rate shot up), SLUGGISHNESS (was getting sluggish) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Heart rate: (High) increased. On 21-Apr-2021, Oxygen saturation: (abnormal) oxygen level was bumping up and down.         The reporter mentioned that the patient was in ER for 12 hours. They ran every test they can to make sure he didn't have UTI that was causing the fever. The ER is attributing the fever to the shot.  Concomitant medication also included clot busters.  No treatment information was provided   This case was linked to US-MODERNATX, INC.-MOD-2021-086386, US-MODERNATX, INC.-MOD-2021-086668 (Linked Report). This case was linked to MOD-2021-086137 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086386:case for dose 1 US-MODERNATX, INC.-MOD-2021-086668:case for dose 2
Shingrix second underdose; There were a few drops on patient´s arm; There were a few drops on patient´s arm; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number DC434, expiry date 3rd June 2027) for prophylaxis.   On 23rd March 2022, the patient received the 2nd dose of Shingrix. On 23rd March 2022, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.       Additional Information: GSK Receipt Date: 25th March 2022 Reporter's Comments: The pharmacist reported that patient received Shingrix second dose but there were a few drops (probably 5) on patient´s arm. Her doctor indicated a third Shingrix shot. The possible third shot was not given at the time of reporting. The reporter consented to follow up by Fax. Additional Supportive Information: Few drops of vaccine (probably 5) leaked on patient´s arm which led to accidental underdose and exposure via skin contact and inadvertent exposure to vaccine.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. In 2012, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for the onset of a severe, painful vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine and/or because of the tenuous efficacy of the vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. Further, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Nausea; Fever; Chills; Fatigue; Headache; This is a spontaneous report from a contactable consumer. An unspecified aged adult female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Mar2021 as a single dose for COVID-19 immunisation. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. On 12Apr2021, the patient experienced fever, chills, fatigue, headache, nausea. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of event fever, chills, fatigue, headache, nausea were recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
MMR given on 2/20/08. On 2/26/08, Pt reports that she starting experiencing sinus drainage, sore throat, swollen eyelids, and an itchy rash that spread all over her trunk, arms, and thighs starting evening of 2/25/08. She states that she took Benadryl 50mg PO for tightness in throat. Denies fever. She stated that her airway was "fine." Informed Pt that she needed to emergency treatment if problems with airway developed. Pt states that she will see her private physician. On 2/26/08 she provides documentation from her medical provider that states that she "has hives" and is "not contagious." The doctor prescribes Allegra 180mg/day and Prednisone 60mg x3 days, 40mg x3 days, then 20mg/day until gone.
12 days following my second Moderna vaccination I woke with dizziness, increased tinnitus, decreased hearing, fever and chills, nausea, and headache. After 2 1/2 days, the fever and chills, headache, and nausea had subsided. The tinnitus is the same as it's been since 3/17 (meaning worse than it's been over the past several decades), dizziness is mostly okay, some hearing loss is still noticeable when I am speaking with people who are wearing masks.
Gastrointestinal - Persistent Bloating not related to diet.   Nausea - 1 instance of Severe Vomiting (on April 14) - Not related to Alph-Gal
BLOOD PRESSURE WENT UP; TOO MUCH HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced blood pressure went up, and too much headache. Laboratory data (dates unspecified) included: Cardiac monitoring (NR: not provided) not reported, EKG (NR: not provided) cardio doctor saw something in it, normal, Echocardiogram (NR: not provided) not reported, and Stress test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the too much headache and blood pressure went up was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Information has been received from a physician concerning an 18 year old female student who on 26-MAR-2007 was vaccinated IM with her first dose of Gardasil, lot #657622/0388U. Five minutes after the injection, the patient had an episode of syncope. She had normal vitals and improved after lying flat for approximately 15-20 minutes. The patient recovered and received a second dose of Gardasil on an unspecified date. It was reported that "we made her lie flat after the injection. No syncope on 2nd injection. Additional information is not expected.
Febrile seizure. Taken by ambulance to the medical center. After the blood test and x-ray the pt was treated and released.  Follow up:  A few hours prior to seizure, the child was diagnosed with bilateral otitis media and prescribed Augmentin.  "Patient is delayed" refers to Autistic spectrum disorder.
Headache, Myalgia, Arthralgia, NauseaVomiting, body aches, headaches, stomach ache, nausea, joint pain, left arm/shoulder pain Narrative:
Information has been received from a licensed practical nurse concerning a patient (age and gender not reported) who, on an unspecified date, was vaccinated with a dose of MMR (lot # not reported). Subsequently, on an unspecified date, the patient developed autism. It was reported that the patient sought unspecified medical attention. There was no product quality complaint involved. The patient's autism is considered an important medical event (OMIC). Additional information has been requested.
Mammogram found slightly enlarged large lymph nodes on the left side; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Mammogram found slightly enlarged large lymph nodes on the left side ) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Mammogram found slightly enlarged large lymph nodes on the left side ). At the time of the report, LYMPHADENOPATHY (Mammogram found slightly enlarged large lymph nodes on the left side ) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: negative (Negative) 3 months post-vaccine: Negative. On an unknown date, Mammogram: inconclusive (Inconclusive) 3 weeks post vaccine: Large lymph nodes noted and inconclusive (Inconclusive) 3 months post vaccine: Still slightly enlarged lymph nodes noted.         Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow up received contains no new information. Patient declined consent for further follow-up.
@ first numbness throughout arm-returned to nl 24hr;rash on inside of arms 2 days later, itching 1 day later;
patient wanted extreme soreness in vaccinated arm reported stated she "could not willingly pick it up because it hurt so bad".
3 days after I noticed on opposite arm of vaccine looks like either spot of shingles doesn't itch, doesn't hurt; its little bit lower than where you get the vaccine but on the other arm; raised spot towards the back of the arm; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (3 days after I noticed on opposite arm of vaccine looks like either spot of shingles doesn't itch, doesn't hurt), VACCINATION SITE REACTION (its little bit lower than where you get the vaccine but on the other arm) and RASH MACULAR (raised spot towards the back of the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HERPES ZOSTER (3 days after I noticed on opposite arm of vaccine looks like either spot of shingles doesn't itch, doesn't hurt), VACCINATION SITE REACTION (its little bit lower than where you get the vaccine but on the other arm) and RASH MACULAR (raised spot towards the back of the arm). At the time of the report, HERPES ZOSTER (3 days after I noticed on opposite arm of vaccine looks like either spot of shingles doesn't itch, doesn't hurt), VACCINATION SITE REACTION (its little bit lower than where you get the vaccine but on the other arm) and RASH MACULAR (raised spot towards the back of the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Lymph node; arm hurting; vomiting; so tired; hard to breathe in; cannot move arm with injection site; numb; giant lumps; cannot jog; cannot see; sweating; back hurts; back of throat is not normal; constantly dehydrated; bumps on tongue; cannot think; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (hard to breathe in), INJECTION SITE MOVEMENT IMPAIRMENT (cannot move arm with injection site), HYPOAESTHESIA (numb), SWELLING (giant lumps) and MOBILITY DECREASED (cannot jog) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney disorder (PATIENT REPORTED AS KIDNEY PROBLEM.) and Heart murmur. Concurrent medical conditions included Sinusitis and Penicillin allergy.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced DYSPNOEA (hard to breathe in), INJECTION SITE MOVEMENT IMPAIRMENT (cannot move arm with injection site), HYPOAESTHESIA (numb), SWELLING (giant lumps), MOBILITY DECREASED (cannot jog), VISUAL IMPAIRMENT (cannot see), HYPERHIDROSIS (sweating), BACK PAIN (back hurts), OROPHARYNGEAL DISCOMFORT (back of throat is not normal), DEHYDRATION (constantly dehydrated), TONGUE ERUPTION (bumps on tongue), THINKING ABNORMAL (cannot think), MYALGIA (arm hurting), VOMITING (vomiting) and FATIGUE (so tired). On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph node). At the time of the report, DYSPNOEA (hard to breathe in), INJECTION SITE MOVEMENT IMPAIRMENT (cannot move arm with injection site), HYPOAESTHESIA (numb), SWELLING (giant lumps), MOBILITY DECREASED (cannot jog), VISUAL IMPAIRMENT (cannot see), HYPERHIDROSIS (sweating), BACK PAIN (back hurts), OROPHARYNGEAL DISCOMFORT (back of throat is not normal), DEHYDRATION (constantly dehydrated), TONGUE ERUPTION (bumps on tongue), THINKING ABNORMAL (cannot think), LYMPHADENOPATHY (Lymph node), MYALGIA (arm hurting), VOMITING (vomiting) and FATIGUE (so tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs include Vitamins and supplements. No treatment details were provided.
neuritis, myocytis in the lt deltoid; treated w/physicial therapy & non steroidals;
No symptoms reported; patient received unspecified dose of either a VARIVAX or a PROQUAD dose that was improperly stored; Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 07-FEB-2020, the patient received unspecified dose of either a varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were unknown; lot # S025610, expiration date 18-AUG-2021) or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose and route were unknown; lot # S017250, expiration date 01-DEC-2020) for prophylaxis, that was improperly stored. sterile diluent was properly stored. The vaccine was exposed to temperature excursion at 7.5 degrees Fahrenheit for 15 minutes (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No symptoms were reported.
Patient received 2 doses of Fluad vaccine 4 weeks apart. Did not report any adverse effects.
3.5 x 5cm area of erythema and .5cm area of induration. This persisted for at least 1 week after vaccination.
102.5 sudden fever, chills, could not get warm, myalgia (intense contraction of leg/calf muscle for 2 hours), nausea, achy all over entire body, could not move from bed, profuse sweating, no sore arm -typically i have a sore arm for 3 days
This spontaneous report was received from a licensed practical nurse refers to an unknown number of patients of unknown ages who from 27-AUG-2012 to 06-SEP-2012, were vaccinated with a dose of GARDASIL (dose, route and lot number not reported) that was stored at 30F for 264 hours and then 31F for 840 hours. The unknown number of patients were not experiencing any known symptoms. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
12 hours after receiving my 2nd dose of the Pfizer COVID-19 vaccine, I experienced the following: Severe body aches  Fever (100.4 average throughout the day, highest was 101.7) Chills No appetite Nausea  Diarrhea  Severe fatigue Severe joint pain Muscle Weakness Sore Throat Racing heart Confusion Sore arm from injection site  These symptoms lasted the entire day of April 1, 2021. My symptoms on April 2, 2021 are not as severe and I do not have a fever.
No additional AE/no PQC; missed dose of GARDASIL 9. received first dose on 05/24/22, forgot to return for second dose, and returned on 05/20/23 for second dose; This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 24-MAY-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot number W014479 has been determined to be valid forhpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Expiration date has been established as 16-DEC-2024), administered for prophylaxis (strength, and anatomical site of administration were not provided); the patient returned on 20-MAY-2023 for the second dose after forgetting to have it administered before (inappropriate schedule of product administration). No additional adverse events were reported.