chrisvoncsefalvay/vaers-outcomes huggingface dataset:
As I stated previously, I received the first shot on 01/05/2021.  One week after I got sick and had a covid test which came back negative.  Then  I got the second vaccine on 02/05/2021. On Feb 14,2021 I woke up at 1:00 am and had severe back pain.  Within about 10 mins the pain shot to my chest.  I went to the emergency room.  My troponin level continued to elevate and I was admitted for 2 days.  I had a cardiac catherization and all my arteries were completely clear.  It was later determined that I had a non stemi MI.  There was swelling around my pericardium of the heart.  Following this event I have also been having shortness of breath and also seeing a pulmonologist.  The pulmonologist believes the lung issue is related to my initial heart problem, from Feb 14,2021.  I am currently being treated for viral asthma.  I am on two inhalers, and a round of prednisone as of May 25,2021.  I have never had any health issues prior to these events.  I do not know for sure that the events are related to the vaccine but it certainly is a coincidence that everything started happening after I was vaccinated.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 01-DEC-2014, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-JUL-2016, the patient was seen at a hospital for a painful rash that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information was requested.
Within a few hours of receiving TDAP, developed nausea, dizziness and diarrhea. Also had chest tightness and blurry vision.
Initial report received on 21 October 2009 from a health care professional. A male patient (demographics not reported) had received a dose of H1N1 (lot number unknown) on the morning of 20 October 2009. It was unknown if the patient had any concurrent illnesses or pre-existing medical history. The same day after receiving the vaccination, the patient experienced shoulder pain (site not reported). It was not reported whether the patient was medically evaluated or received any treatment. It was unknown if the patient had any relevant diagnostic tests or laboratory data. The patient's recovery status was unknown. Documents held by sender: None.
Suspected Clinical Vaccination Failure; Suspected COVID-19 Infection; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. 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 expiry: Unknown) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  In late AUG-2021, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Unknown. Patient had a mild case but symptoms lasted 1 weeks longer although patient was not hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210952846.; Sender's Comments: V0. 20210953291-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
? PALPITATIONS     pt getting vaccine this afternoon. +palp post-injection, denies CP/SOB/dyspahagia, AOx4, fsbs=119   Patient was released after observation
Hives on day 2; Extreme fatigue; hypertension; tachycardia; This is a spontaneous report from a contactable other hcp (patient). A 50-year-old patient of an unspecified gender received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EJ16858, Expiration date was not reported), via an unspecified route of administration, in left deltoid on 22Dec2020 as single dose for covid-19 immunisation. Medical history included asthma and PCN allergy. Concomitant medication included albuterol [salbutamol] (ALBUTEROL) taken for an unspecified indication, start and stop date were not reported. The patient previously took naprosyn [naproxen] and experienced allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The patient experienced hives on day 2, extreme fatigue, hypertension and tachycardia on 23Dec2020. Therapeutic measures were taken as a result of hives on day 2, extreme fatigue, hypertension and tachycardia. The outcome of the event Hives was resolved on an unspecified date and not recovered for another events.
Nine days after the first dose of the vaccine on 02/01/2021 during the night I had a severe headache and I lost consciousness. I was taken to the hospital and I had had a stroke. I was hospitalized for four days and transferred to rehab on 02/05/2021 where I remained for 21 days. I was discharged from rehab on 02/26/2021. I also had in home therapy and continued to receive physical therapy until recently. I received the second dose of the vaccine in the hospital on 02/11/2021.
Tinnitus after second shot. Had third booster 11-20-21 at clinic, daily worsening tinnitus since.
Persistent pain, weakness, left deltoid muscle.  No pain or problem at time of injection.  2 weeks later he felt pain in deltoid region.  Some upper arm movements.  1-2 times a week now in last 2 weeks he has noted this pain 3-4 times a day with swelling, redness or lump.
FLUZONE QIV NP PFS, reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no reported adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA057733(CLUSTER) and 2023SA057309(CLUSTER).  This case involves Child patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.  It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  Action taken: not applicable.  Outcome:  Unknown for both the reported events   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 the 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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Pfizer COVID-19 vaccine (5-11yrs) manufacturer expiration date is 8/31/2022. However vaccine expiration date after being transferred from freezer to refrigerator is 5/17/22. Vaccine was administered on 5/27/22.
Pfizer Bivalent 5-11yr vaccine was given to patient as their first vaccine of the series rather than the Pfizer Monovalent 5-11yr vaccine.
Headache, chills, fatigue, slight nausea, dry mouth/dehydrated
Woke up w severe chills that night/next morning. Fever was 101.8. Took 50 mins in hot shower to get warm. Then had severe headache and body (back) aches. I began taking ibuprofen that night/morning. I remained in bed under 5 layers of covers for all of the 30th and until the afternoon of the 31st. My fever went down to 99.1 and then back to 100.8.  I have not had any chills since. I have no fever and no headache as of now, 1/1/2021.
Pt recv vax on 3/17/98; post vax pt exp hives on the vax site arm; tx=hydrocortisone cream
no further adverse event; Caller is Medical Assistant reporting administered dose of expired MMR II; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 09-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dose, lot #T016198, expiration date: 11-MAY-2022, administered as prophylaxis (strength, and route of administration were not provided). There was no history of temperature excursions and no further adverse events were reported.
Fever; Pain in arm; Tardiness in arms; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PAIN IN EXTREMITY (Pain in arm) and MUSCULAR WEAKNESS (Tardiness in arms) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (Fever), PAIN IN EXTREMITY (Pain in arm) and MUSCULAR WEAKNESS (Tardiness in arms). At the time of the report, PYREXIA (Fever), PAIN IN EXTREMITY (Pain in arm) and MUSCULAR WEAKNESS (Tardiness in arms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
Employee reports generalized arm pain after vaccine and then the morning after the vaccine reports pain in the shoulder when reaching above shoulder height or across her midline.
Initial healthcare professional report received on 27 Jul 2010: This patient received MENVEO (batch number: 029011) unknown dose intramuscularly on 13 Jul 2010. It was reported that on 13 Jul 2010, the patient was administered only the liquid Men CWY conjugate component of MENVEO instead of being reconstituted with Men A conjugate component. No adverse event had occurred due to this. The outcome and causality was not reported. Follow up report received health care professional on 09 Aug 2010: It was reported that the reporter was not sure if the patient received only MenCYW-135 liquid conjugate component of MENVEO. The titers of the patient were reported as A: 6.9, C: 6.5, Y: 15.2 and W: 0.5 on an unknown date. Follow up report received health care professional on 27 Aug 2010: The patient potentially received a partial dose of MENVEO, only liquid component. The titers were drawn but too early, only 10 days after the immunization to determine if the patient received the full dose of MENVEO. As the titers were drawn too early the results might be inconclusive. It was reported that, they would send titers and based on results of titers they would determine full dose of patient.
Symptoms of chills, body ache, headache, sore throat, nausea, diarrhea began 30min after receipt of vaccine.  All symptoms resolved within 24 hrs.
The evening of the day I had the shot ( in the morning), I had severe left rib and under the rib pain as well as pain on my left side and left lower back.  The pain was intermittent day and night from Aug 23 thru Aug 29 when it magically disappeared as quickly as it had come upon me. I had a video call Dr. Appt on 8/26 with a GP who thought it must be muscleoskeletal although I had no pother precipitating event besides the covid 19 shot.  I also saw a vascular doctor on 8/31 even though the pain was gone because there was also some swelling under the skin covering my rib which did not disappear and I wanted to make sure my situation was not related to my spleen issues
FOUR DAYS AFTER RECEIVING THE VACCINE I NOTICED A PAIN IN MY OPPOSITE ARM (LEFT ARM). I PUT ICE AND HEAT ON IT BUT NOTHING HELPED WITH THE PAIN. I FLEW OUT OF TOWN FOR THE WEEKEND OF 4/23/2021 AND RETURNED ON THE 26TH. I NOTICED MY ARM STARTED TO SWELL. I CALLED MY DOCTOR AND SHE TOLD ME TO GO TO THE WALK IN CLINIC.
Patient called pharmacy (3/10) and said she was not feeling well (headache, fever and tiredness). Explained these symptoms were common with vaccines and should lessen within 24-48 hours. Patient called back tonight (3/11) to say she is still tired and now has shortness of breath. Advise her to seek medical attention at urgent care or hospital.
Within 12 hours, post vax, developed fever to 103F-104F without other symptoms. About 30 hours, post vax, developed very large area of redness and swelling of left upper arm. Fever resolved within 24 hours.
Extremely painful menstrual cycle. Typically there is little to no pain but the night after the first shot, I was in so much pain I almost threw up.
Information has been received from a RN concerning a 18 month old male pt who on 12/09/02 was vaccinated with a dose of varicella virus vaccine live (Lot # 641983/0291M).  Concomitant vaccination included a dose of MMRII (Lot # 643500/0633M) and a dose of Hib conj vaccine (manufacturer unknown) (Lot # 480701).  On 05/19/03, the pt developed symptoms of chickenpox. Unspecified medical attention was sought and the pt was to be seen by the physician. Treatment was not required. A product quality complaint was not involved.  Additional information is not available.
Runny nose and eyes about 7 hours after vaccine was given. Lasted about 48 hours from when vaccine was given.  Redness, swelling and pain at injection site continues at 2 weeks post vaccine.
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, chills and fatigue. pain, redness and swelling at the injection site. Narrative:
she got the first dose of the pfizer covid vaccine on 05Apr2021 and a few days later she had covid 19, like 6-7 days after; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient stated that she got the first dose of the pfizer covid vaccine on 05Apr2021 and a few days later she had covid 19, like 6-7 days after(Apr2021). The outcome of event was unknown.  Information on the lot/batch number has been requested.
Patient experince SOB and racing heart after 1st dose.  Onsite EMS was called vitals BP 110/72. She recovered and she was released to go home.
8/19/21: presented to ED with cough, fever, body aches, HA and diarrhea for 5 days, COVID POS during stay started on steroids and remdesivir 8/20/21: discharged to home on night oxygen
Fatigue; weak; A spontaneous report was received from an other healthcare concerning a 75 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue and weak/asthenia.  The patient's medical history included multiple sclerosis and chemotherapy. Products known to have been used by the patient, within two weeks prior to the event, included Rituximab infusion.    The patient received their first of two planned doses of mRNA-1273 (Batch number: 006M20A) on 13 Feb 2021 intramuscularly in the unknown injection site for prophylaxis of COVID-19 infection.   The patient reports that he has been very fatigued and weak. Treatment for the event included Paracetamol.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events fatigue and weak was not reported.
Approximately 24 hours following vaccination developed malaise, arthralgia/myalgia, bad fatigue.  Feels he had a slight temperature, did not take his temperature.  The following morning, approximately 36 hours following vaccination awoke with swelling of upper lip and lower third of nose.  Denied difficulty breathing.  Day 4 improving.
had vax on 2NOV95; t103 on Sunday; temp 101 on Monday; temp 104 on Sunday noc; rash started on Monday
Extreme stomach pains with vomiting, body aches, lightheaded, generalized weakness, feverish.
Severe stabbing pain in abdominal area. Started approximately four hours after vaccine. More severe after consuming food or drinks.
sore throat, cough, headache, chills, body aches, loss of taste, loss of smell, sinus congestion, nasal congestion, post nasal drainage. starting 12/24/21
shingles; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 62-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 23Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced shingles on an unspecified date. She was due for the second dose on Wednesday, 14Apr2021. It was asked that if she can receive second dose of vaccine as scheduled. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total tie out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00 ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time ou of range of 10.5 hours. On 01-APR-2013, the patient was vaccinated with an out of rang dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
A non-serious spontaneous report of sore throat, temperature, fatigue, cough, runny nose and wheezing has been received from a consumer concerning a 10-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 27-Sep-2011. On 29-Sep-2011, the patient experienced temperature, fatigue, cough and runny nose, where coughing went to chest. The patient went to emergency room for wheezing, cough and sore throat and prescribed antibiotics and inhalers. Rest of the family also have similar symptoms. The outcome of events of sore throat, temperature, fatigue, cough, runny nose and wheezing was resolving.
Moderna COVID19 Vaccine EUA  Hospitalization after 1 week history of hyspnea on exertion. Found to have acute saddle pulmonary embolus along with multiple bilateral pulmonary emboli throughout both lungs
Local swelling and redness to left arm where received shot. Swelling and redness has increased with each day and is not covering from her shoulder to her elbow.
Patient reported severe pain in left arm the night after her injection. The pain has been decreasing each day. She took one dose of OTC ADVIL or ALEVE the night the pain started.
No patients reported any additional adverse experiences as a result of receiving the improperly stored vaccine; Since the receipt of the late shipment, the vaccine has been administered to 6 patients; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 03-NOV-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number T014309, expiration date: 24-APR-2022), as prophylaxis (product storage error). The patient did not report any additional adverse experiences as a result of receiving the improperly stored vaccine (no adverse event).  The reporter stated that they ordered the vaccines and they were supposed to come on 27-OCT-2020 but the product arrived on 29-OCT-2020. The caller stated that when she first received the vaccines, for some reason thought the current date of receipt was 27-OCT-2020 and not 29-OCT-2020 and that the product was received on time. The reporter immediately placed the product into the freezer. The product was received 2 days late.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2011USA013851: US-009507513-2011USA013379: US-009507513-2011USA013163: US-009507513-2011USA013620: US-009507513-2011USA013200:
pt recv vax 20OCT97 & devel wheezing, cough, vomiting & an inc temp to 99 4 days p/vax; tx w/med;
Patient came to the ED with symptoms of shortness of breath, generalized weakness, fatigue, and a dry cough.  Patient was admitted to the hosptial with Covid pneumonia.
Had the expected soreness at injection site, woke up the next morning with severe headache, nausea, & all over body ache. Headache is unrelieved by any OTC anti inflammatory.