chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received injection and complained about pain upon injection. Later that evening, patients arm swelled up and she complained of a burning pain that radiated to the tips of fingers. Pt. also complained of "dead arm" with lack of movement. Pt. was treated at ER.
Pt fell off chair and hit head on ground. EMS and 2 vaccinator RN's came to help. Pt lost consciousness for few seconds. Pt vitals and glucose were stable. Pt alert and oriented when awoke. Pt transported to hospital with EMS with mother.
Sister calls to report tennis ball sized hot, swollen, red area at vaccine site left deltoid.  No fever, streaking.  Has marked with pen.  Advised PHN or MD check available today.  If observing at home-bring in if fever, malaise, redness extends beyond marking, concerns.
mom called very upset over pt w/rash, sl fever & crankiness;told mom that rash was nl rxn;mom wanted incident documented;
pneumonia-like symptoms; lot of pain; A regulatory authority report was received from a consumer concerning a  female patient ( age unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia-like symptoms and was in a lot of pain.  Patient's medical history  was not provided by the reporter. Concomitant medications were not reported. Laboratory details was not given.  On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, prior to receiving mRNA-1273, the patient felt pneumonia-like symptoms and a lot of pain. pneumonia like symptoms with medically significant. Treatment for the events were not reported.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, pneumonia-like symptoms, a lot of pain were considered unknown.; Reporter's Comments: Although a temporal association exist, there is not enough information to assess the causal association as very limited information regarding this event has been provided at this time.  Further information has been requested.
Cold; This case was reported by a nurse via patient support programs and described the occurrence of cold in a 70-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for an unknown indication.   Co-suspect products included treprostinil (Orenitram) (batch number 2101407, expiry date 31st July 2020) and (batch number 2101408, expiry date 31st July 2020) for pulmonary arterial hypertension.   Concurrent medical conditions included pulmonary arterial hypertension (had primary pulmonary arterial hypertension). Concomitant products included amlodipine.   In October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On 26th March 2019, the patient started Orenitram 3.5 mg at an unknown dose 3 times daily. On 26th March 2019, the dose was changed to an unknown dose and frequency. On an unknown date, less than 3 weeks after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced cold. On an unknown date, the outcome of the cold was unknown.   It was unknown if the reporter considered the cold to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received dose of Flu vaccine 3 weeks ago from the date of reporting. At the time of reporting, the patient had cold. On 26th March 2019, the patient took 3.5 mg of Orenitram every 8 hours as tolerated three times a day orally for primary pulmonary arterial hypertension as a treatment medication. The patient received dose of Amlodipine as a treatment medication. No further details were provided.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 29-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
patient has received 1st dose / 10 months ago / did not come back to receive dose 2; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2020, 10 months ago from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not come back and receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. Details were reported for 1st dose. The batch number and expiration date was not provided. The reporter consented to follow up.
This case was reported by a physician via call center representative and described the occurrence of pallor in a 10-year-old male patient who received MENVEO (batch number M16164, expiry date 31st October 2018). Concomitant products included DTaP vaccine. On 16th August 2017, the patient received MENVEO .5 ml. On 16th August 2017, immediately after receiving MENVEO, the patient experienced pallor and vasovagal symptoms. On 16th August 2017, the outcome of the pallor and vasovagal symptoms were recovered/resolved. It was unknown if the reporter considered the pallor and vasovagal symptoms to be related to MENVEO. Additional details were provided as follows: The reporter administered the Dtap to the patient prior to MENVEO without an incident. On 16th August 2017 at 11:25 am, while being injected with the MENVEO the patient partially fainted. He did not lose completely consciousness but his eyes closed and his head fell to the side. It lasted for one second. He was also pale. The reporter said it happened when the needle was half inserted. The dose was administered. The reporter believed it might be a vasovagal because she vaccinated 3 others that day with the same lot without incidence. The patient was sent to the emergency room for monitoring and when the reporter checked on the patient last night, he was fine.
This is a spontaneous report from a contactable nurse (certified nurse practitioner, also the patient's daughter) via a Pfizer sales representative. A 94-year-old female patient of an unspecified ethnicity received PREVNAR 13, (lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at a single dose as pneumococcal vaccine. It was stated that the dose was the regular standard dose that was always given. The patient's medical history, other medical conditions and concomitant medications were unknown. The nurse stated that her 94 year old mother received the vaccine and had a local reaction to the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) on an unspecified date. She did not know when this happened other than it was within the last 6 months. Outcome was reported as unknown however the nurse reported that she thinks the reaction all went away. Investigations were unknown. Information on batch and lot numbers has been requested.
I received my second Shingrix shot on May 5th 2022. Within a week I started having numbness, burning pain and pins and needles feeling in both of my legs. I also experience whole body tremors that wake me up quite often as well as full body vibration. I have a hard time sleeping. I also experience muscle weakness in my arms and legs. I have been like this for several months now. I shake a lot just trying to take care of my son and home. Unfortunately I have a Dr. who after 3+ months and several appointments refused to do any testing to find out what is wrong. I have been to urgent cares and er with no answers. They always told me to talk to my Dr. I have had blood work done several times and it?s always perfect. I am not diabetic. I told my Dr. my symptoms every time I saw him. He never took me seriously. I am now in the process of finding a new Dr. I am a single older Mom of an 8 year old son and what happened after getting the shingles vaccine is debilitating. I am livid that I went from normal to this and May never be normal again. I now wish I had known about this horrible side effect. I would rather get shingles than what is happening to me now. I trusted my Dr when he said to get the shingles vaccine when I turned 50. I am the first person to advocate for vaccines. I have lost trust now. This vaccine is dangerous and debilitating. I wouldn?t wish this on anyone. I can?t do the things I love to do anymore. I highly regret getting this vaccine. I received my doses from a pharmacy. No one explained these worst case side effects. I feel hopeless.
Went to receive Moderna booster shot on October 26, 2021, at 5:30PM. I started having reactions later that night at 11PM, I was getting up freezing to walk around due to nonstop cramping in my foot. The next day I woke up in the hallway and nauseous with swelling around my head and partially my face. My husband had to dry me off multiple times because I kept sweating profusely. I also had a consistent throbbing migraine headache. I started taking Tylenol on that Wednesday night and Thursday morning. My eyes started turning black and blue by the weekend. I went to the hospital on October 31, 2021, after being recommend by family members. I received a head scan and EKG. Was told there was no internal bleeding and to take Advil which helped with the jabbing headache and swelling.
Fatigue that worsened over  3 week period, weakness in legs, arms that progressed over that time, dizzy foggy brain that progressed,  chest tightness/heaviness that became more frequent over time, ending in inability to stay active for normal activities, fever on & off - thought MS exacerbation - symptoms completely subsided by 4/7/21
Pt. states after receiving the 1st dose of Phizer 07/06/2021, started experiencing congesting flu-like symptoms, Chills (no fever), coughing up mucus 07/11/2021. Primary visit 07/13/2021 Antibiotics/Steroids  07/15/2021 Primary visit, steroid injections, Chest X-Ray 07/27/2021 Primary Visit diagnosed with Pneumonia, Up-drafts, antibiotics
Initial unsolicited report received from a non-healthcare professional on 11 Oct 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced bad reaction: neurological system shutdown. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. Upon medical review, the case was considered as serious due to important medical event: neurological impairment. List of documents held by sender: none.; Sender's Comments: This is poorly documented case where really bad reaction- the person's neurological system shut down reported after influeza vaccine. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
On the day of vaccination, the employee described pain and tenderness at the injection site 6 hours after receiving the vaccination. The next day (1/29/21), the employee became lethargic and had generalized aches in lower and mid-back. He reported taking Tylenol 1000 mg on 1/28/21 for the injection site pain, and again on 1/29/21 for the aches and pains.
Fever - broke fever Wednesday, April 14th around 3:00 PM CST Body Aches - April 12th - Sunday April 18th  Chills - April 12th - April 14th  Fatigue - April 12th - current Stomach Pain - April 12th - April 18th  Migraines - Both sides of my head - April 12th - currently - went to hospital on April 15th High Blood Pressure - April 12th - current - went to hospital April 15th - Called cardiologist, increased my blood pressure meds to twice a day on April 19th.
Dizziness, nausea, vomiting, fast heart rate, high blood pressure, weakness, fever, mild chest pain.
Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified) was vaccinated IM with a 0.5 ml dose of Gardasil vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite stinging" at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Pt. called into office reporting fever 100.4, no rash, could/chills. sore arm, no appetite or fatigue; pt. refused appt in office 2/19/16.
extreme dizziness, lower back pain - 36 hours solid but is still comes and goes a week later
Information has been received from an unpublished literature article. Varicella zoster virus (VZV) becomes latent in the dorsal root ganglia (DRG), cranial nerve ganglia (CNG), and enteric ganglia (EG) following chickenpox and vaccination. Children and adolescents who develop herpes zoster (HZ) may have transient decreases in cell mediated immunity (CMI) to VZV, possibly due to preceding viral infections that were asymptomatic, or to stress. In addition to being latent in CNG and DRG, RNA transcripts of wild type (WT) and Oka VZV and associated proteins have been demonstrated in enteric neurons in fresh surgical specimens removed from the intestines of children and adults. The demonstration of latency of VZV in EG is important because reactivation in intestinal ganglia may lead to a number of gastrointestinal diseases ascribed to VZV, such as achalasia, gastric ulcers and colonic pseudoobstruction, also known as Oglivie's syndrome. With the identification of latency of VZV in the ENS, and the potential for reactivation there, the pathogenesis of gastrointestinal disease due to VZV becomes clearer. Both WT and the Oka strain become latent in the ENS. The author recently identified an adolescent male with a severe gastric ulcer caused by Oka VZV, which must have been due to reactivation from latency, following 2 doses of varicella vaccine (manufacturer unknown). The demonstration of VZV RNA transcripts in fresh intestinal neuronal tissues avoids the confounding possibility of reactivation of VZV after death in autopsy specimens. The molecular capacity to differentiate between vaccine and wild type VZVs was an important aspect of studies on recipients of varicella vaccine in documenting reactivation and reinfection. Reactivation of VZV can occur following stress. VZV reactivation usually presents with rash, but rash may not invariably occur. When there is no rash, the virus may be demonstrated by the presence of VZV DNA in saliva or cerebrospinal fluid (CSF). Additional information is not expected.
The pt experienced a red, swollen area on the left thigh (about half dollar size). The child complained of pain or fever. Heat packs applied every 1-2 hours for 15 minutes for a 24 hour period.
difficulty breathing; severe sore throat; headache; At Injection felt woozie; This is a spontaneous report from a contactable consumer (patient reported herself). A 42-years-old female patient (non-pregnant) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm on 27Jan2021 at 1: 10 PM (at the age of 42 years 10 months, non-pregnant) as 0.3ML single dose for covid-19 immunisation. Medical history included polycystic ovaries, diabetes mellitus (ongoing), gastrooesophageal reflux disease, hypertension (HBP) and allergy to Red plums. Concomitant medications included Dienogest, estradiol valerate (NATAZIA), Metformin , Glimepiride,Insulin glargine (TOUJEO) for diabetes mellitus, Spironolactone , Lisinopril , Atorvastatin ,Omeprazole ,Amlodipine and vitamin D NOS for all the indication and medication dates were not reported except the indication for Insulin glargine (TOUJEO). The patient previously experienced allergy to Cipro [ciprofloxacin], Keflex [cefalexin] and Betadine [povidone-iodine]. There were no other illnesses reported at the time of vaccination and up to one month prior to the vaccination. On 27Jan2021, at 2:20 PM after the vaccination, the patient experienced At Injection felt woozie, thought just needed to eat 1 hr after injection, difficulty breathing, severe sore throat, headache. The patient visited Emergency room/department or urgent care due to the events. The patient was not resolved from the adverse events.    Follow-up attempts are completed. No further information is expected.
10/20/21 1610 patient comes into ED complaining for the past several days has had increasing shortness of breath mild cough back pain.  She has had lightheaded episodes.  Increasing leg pain after which she describes as possible fall.  No head injury.  No nausea no vomiting.  No cough no hemoptysis.  On arrival in the ED her room air pulse ox was between 85 and 88%.  Pulse rate was 120s.  Respiratory rate was in the 30 range.  Lungs were clear soft nontender right extremity has some tenderness in the calf and medial thigh.  Mild edema neuro intact.  Patient states she had her second Pfizer vaccine on Wednesday.  Symptoms started on Monday of gotten worse. Admitted for bilateral PE and right leg DVT. 10/21/21 AM taken to cath lab for pulmonary angiogram with measurement of central venous pressures, mechanical thrombectomy. Cardiac arrest at 0630 10/21/21 in cath lab during procedure. CPR performed for 45 minutes and while being transported to OR for emergent CABG. 10/21/21 1000 patient arrived to ICU with chest still cracked open and physician providing cardiac massage. Time of death called at 1005 10/21/21.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 12:34 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 12:34 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 88.66 for dose administered on 11-Jan-2021. No concomitant medications were reported.  Batch number 041L20A administered on 11-Jan-2021 underwent temperature excursion with temperature of 35 degrees Fahrenheit at 02:00 PM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 11-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Hot arm, fever, pain in my body, day 4 - shortness of breath with exhaustion, day 5 - shortness of breath.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 22-JUL-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K010522, expiration date 25-FEB-2016, dose and route not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
100.2 temperature; minor chills; stomach ache; mild headache; exhaustion/fatigue; exhaustion/fatigue; At 3 hours-sore arm only; This is a spontaneous report from a non-contactable consumer, the patient. A  52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 01May2021 at 10:30 as a single dose for COVID-19 immunisation. The medical history included asthma, multiple allergies, high blood pressure, high cholesterol, allergy to dust, pet, smoke and seasonal allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included daily vitamin (unspecified), ezetimibe (ZETIA), atorvastatin (MANUFACTURER UNKNOWN)  and hydrochlorothiazide (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 10Apr2021 at 10:00 as a single dose for COVID-19 immunisation. The patient also took previously codeine (MANUFACTURER UNKNOWN) and experienced allergy. On 01May2021 at 13:30, at 3 hours, the patient experienced sore arm. On 02May2021 at 10:30, at 24 hours, the patient experienced 100.2 temperature, minor chills, stomach ache, mild headache exhaustion and fatigue. On 02May2021, the patient underwent body temperature test and tested with a temperature of 100.2 (unspecified unit). The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event 100.2 temperature, minor chills, stomach ache, mild headache, exhaustion and fatigue was recovered on an unknown date in May2021, while that of sore arm was resolving at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I developed a blood clot in my left arm on a summer trip, showed symptoms of swelling arm, dizziness and sore muscle.  Same arm I received vaccine in.