chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dies suddenly and mysteriously in her room; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received via consumer/non-hcp.  This case involves a 24 years old adult female patient who died suddenly and mysteriously in her room while receiving vaccine influenza vaccine.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received suspect influenza vaccine (strength, formulation, dose, frequency: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  The consumer commented that the list went on and on, and on and it was happening everywhere and was not normal. On an unknown date the patient developed a serious dies suddenly and mysteriously in her room (sudden death) (unknown latency) following the administration of Influenza Vaccine. This event was assessed as medically significant and was leading to death.  Final diagnosis was (fatal) dies suddenly and mysteriously in her room.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (dies suddenly and mysteriously in her room).  At time of reporting, the outcome was Fatal for the event dies suddenly and mysteriously in her room. No autopsy was done. The cause of death was reported as Death NOS.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case concerns a 24 year old adult female patient who died suddenly and mysteriously in her room, after vaccination with vaccine Influenza Vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, medical history, concomitant medication, autopsy findings would be needed to rule out the alternative etiology. Based on the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: not provided
Large tender indurated area on right deltoid 7 days post vaccination 10 cm induration 3 cm erythema 1 1/2 cm bubble.
Aunt said that during night following day of vax child made "strange breathing sounds," became unresponsive & had sz; fever to 104.2R & did not really respond to APAP; 15OCT91 aunt says no further szs or problems;
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feels a little bit dizzy), NAUSEA (little bit nauseous) and VOMITING (vomited a little bit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history.). On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIZZINESS (feels a little bit dizzy), NAUSEA (little bit nauseous) and VOMITING (vomited a little bit). At the time of the report, DIZZINESS (feels a little bit dizzy), NAUSEA (little bit nauseous) and VOMITING (vomited a little bit) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment and concomitant medications were not provided by reporter. Reporter did not allow further contact.
his left upper arm/shoulder, he got a severe pain when he was just doing normal things and he had never had that problem before; his left upper arm/shoulder, he got a severe pain when he was just doing normal things and he had never had that problem before/Both shoulders are pretty sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EN6199, Expiration Date: 28Feb2022) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rotator Cuff surgery", start date: 2010 (unspecified if ongoing), notes: on right side; they replaced the joint; "blood pressure" (ongoing), notes: takes medication for blood pressure; "cholesterol" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single; Lot number: EN9581; Anatomical site: right arm), administration date: 12Feb2021, when the patient was 80 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jul2021, outcome "not recovered", described as "his left upper arm/shoulder, he got a severe pain when he was just doing normal things and he had never had that problem before"; ARTHRALGIA (non-serious) with onset Jul2021, outcome "not recovered", described as "his left upper arm/shoulder, he got a severe pain when he was just doing normal things and he had never had that problem before/Both shoulders are pretty sore".  Additional information: States that he has something going on with his upper arms where he got the vaccinations. It didn't start immediately. He got his 1st dose on 12Feb2021, 2nd dose on 05Mar2021, and booster dose on 22Oct2021. The symptoms started around mid-July; his left upper arm/shoulder, he got a severe pain when he was just doing normal things and he had never had that problem before. Then after the booster he had an intense pain from that one and it was still painful in the shoulder joint. His right arm, in 2010, he had surgery for the rotator cuff where they replaced the joint, and it was doing very good with no problems, but all the sudden about 2 weeks ago he was throwing something for his dog and he pulled something loose in there and now it was very painful. States that he was going to try to see an orthopedic surgeon. He was reading all that he was supposed to do within a year of getting the vaccines to report this stuff, so he was starting by reporting it to Pfizer. Something has changed since he had these shots. Both shoulders were pretty sore, but he was most worried about the right one; he cannot hardly use this right arm right now because he has really intense pain in his shoulder. It was reported as he did get a flu shot but he thinks it was more than 4 weeks before the booster dose.   No follow-up attempts are possible. No further information is expected.
hives; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient stated that the 2nd dose of the Covid vaccine gave her hives because it contains preservatives. They advised that the vaccine does not contain preservatives and she told that was wrong and that it says differently on the Pfizer website. The outcome of event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
5/12 Admitted to medical center with new dysphagia and slurred speech.    5/17 Acute Hypercarbic respiratory failure; Neuromuscular dysfunction -  5/19 -CONCERN FOR GBS.  Patient on BiPAP (no history of pulmonary disease)
Writer and witnessed arrived to patient home at 1500. Patient asked if this is here first covid vaccine, and patient stated yes this is my first shot. Writer implemented teaching on answering the consent form correctly pt verbalized understanding and signed consent. vaccine given appropriately. .  during observation  patients friend walked in and stated i got my vaccine card where is yours, patient stated i cant find it, writer re asked patient did you receive a covid vaccine shot and patient stated "oh ya i did i forgot i did it in February at the hospital. teaching implemented to patient, doctor notified in a timely manner, no adverse reaction noted, supervisor notified timely manner.
Headache; chills; myalgia; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2020, the patient received Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache, chills and myalgia. On an unknown date, the outcome of the headache, chills and myalgia were not recovered/not resolved.   It was unknown if the reporter considered the headache, chills and myalgia to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had headache, chills and myalgia. Ptient ask can take acetaminophen aspirin or ibuprofen as tratment becuse patient do not want to interfere with the vaccine.
Patient is a 89 years old female with a past medical history significant for hypothyroidism and hypertension. She was in her normal state of health prior to receiving her first dose of the COVID-19 vaccine (Pfizer). She has no known documented allergies. After her routine 15-minute wait., she was walking to her car with her son when she become short of breath. She was brought back into facility via wheelchair. She appeared to have labored breathing with use of accessory muscles. Vital signs showed BP185/88, HR 78, 93% room air. Her heart rate was regular, lung sounds with expiatory wheezing in all fields. She was given Epi 0.3 mg IM and neb treatment. Transported to ED via EMS.
Red rash/hives on breasts and abdomen. Burning/itching. Not relieved with Benadryl. Lasted for 48 hours.
Pt returned to clinic on 9/21/12 with runny nose x 3 days, fever (101) and congested cough onset 9/20/12 worsening. MD assessment found (+) wheezes, clear runny nose, and resp rate 25. Dx with pneumonitis and Rx albuterol sulfate 0.083% neb tx q 4-6 hrs. and Children's BENADRYL.
Mom states child's left arm became red with swelling. The child complained of pain at injection site. 1/1/17 seen in the ER, was given liq prednisone. Swelling improved by AM of 1/2/17.
On 5/17/01 the pt was achy all over, warm and tire, in the afternoon, increased pain, hot, red, firm to the touch at the injection site. On 5/18/01 the pt was unable to lift injected arm more than 90 degrees from torso. Pain, hot red, firmness continues. On 5/19/01 and 5/20/01 decrease in symptoms and increase in ROM. Treated with Tylenol, Aleve OTC medication.
Spoke to Pt who states rcvd J&J vaccine 4/1/2021 through the County. Pt reports transient facial numbness 4/12/2021 in am. Pt concerned of possible embolism given family h/o strokes. Father died of stroke and siblings have had prior stroke episodes. Pt advised to go to ER given recent information regarding women and potential strokes post-J&J vaccination.
Became pale and nauseated after vaccines were given. Vomited a small amount clear mucus. Appeared to faint, then would not respond. Vitals normal. Paramedics called. After 20 minutes he was responding (stood up and talking).Mother decided not to seek treatment at hospital and signed release.
Information has been received from the authors in a published literature article, concerning a healthy 15-year-old female developed new onset dizziness and headache 4 weeks after receiving the first injection with HPV vaccine. In the following 2 months she began to experience syncope and presyncope, along with dizziness, shaking, muscle twitching, hyperventilation and generalized weakness. Nuclear magnetic resonance imaging (MRI) of the brain and magnetic resonance angiography of the head and neck, as well as Electroencephalogram (EEG), were unremarkable. A tilt table test demonstrated an increase in heart rate from 75 bpm supine to 112 bpm within 1 min of tilt without orthostatic hypotension. After 7 min of tilt, the heart rate decreased to 60 bpm with an unobtainable blood pressure, at which time the patient became unresponsive. She regained consciousness and her vital signs stabilized on assuming a supine position. The tilt table test was consistent with Postural orthostatic tachycardia syndrome (POTS) and neurocardiogenic syncope (NCS). With pharmacotherapy consisting of a selective serotonin reuptake inhibitor (sertraline), which can be helpful in patients with POTS and NCS, her symptoms improved but persisted over the following 2 years. She was able to attend school 4 hours per day with pre-syncope occurring between one and four times per month. The reporter stated that nevertheless, none of the patients experienced complete resolution of symptoms, and all patients continued to experience some residual symptoms. Possible pathogenesis of the new onset POTS after vaccination may include the mechanism of molecular mimicry, whereas Human papillomavirus (HPV) vaccine epitopes may induce formation of cross-reacting antibodies against potential targets of the autonomic ganglia, neurons, cardiac proteins or 31 /2-adrenergic and M2/3 muscarinic receptors. Additionally, induction of bystander lymphocyte activation and a broad spectrum of cytokine responses elicited by the HPV vaccine may also be involved. The reporter stated that the temporal association between vaccination with GARDASIL and the onset of symptoms of POTS in healthy young women is significant and deserves further investigation for assessment of a possible causal relationship. Upon internal review patient became unresponsive. She regained consciousness and her vital signs stabilized was considered medically significant. This is one of several reports from the same literature article: 1310USA000643, 1007USA02012, 1310USA003785, 1310USA003799, 1310USA003819. Additional information has been requested.
No other AE or PQC reported; temperature excursion and was administered; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On an unknown date in August 2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was not reported, 1 time dose, lot# 1707487, expiration date: 23-MAR-2022) orally for prophylaxis.  It was reported that, on 25-AUG-2021, the suspect vaccine was exposed to a temperature of  50.5 Fahrenheit (F) for a time frame of 1 hour. No digital data logger was reported. There were no previous temperature excursions. No other adverse event (AE) information was provided. It was also reported that Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot# T012806, expiration date: 14-APR-2022; lot# T016198, expiration date: 11-MAY-2022) was involved in the temperature excursion, but not administrated.   This is one of the two report from the same reporter.; Sender's Comments:  US-009507513-2108USA007439:
Biceps tendon rupture; This spontaneous case was reported by a patient and describes the occurrence of TENDON RUPTURE (Biceps tendon rupture) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced TENDON RUPTURE (Biceps tendon rupture). At the time of the report, TENDON RUPTURE (Biceps tendon rupture) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Magnetic resonance imaging: results not reported Results not reported.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Humira, Action taken was unknown, dechallenge was not applicable for event Bicep's tendon rupture. The reporter's causality for co-suspect Humira for the event Biceps tendon rupture was probable.  No concomitant drug reported. No treatment information was provided by the reporter.
Although I am 53 I have still been menstruating every month.  I had all the symptoms for begins my menses and after receiving my first shot, all symptoms disappeared and I never bled.  I was due to start my next cycle 3 days prior to the second vaccine and I have now missed two cycles.   This may seem normal given my age, however I didn?t start my period till 16 years of age ( just like my mother and also my daughter) and have still never missed a period.
Information has been received from a health professional concerning a 61 year old white female with hypertension, "hyperlipids", allergies to bee stings and penicillin who on 09 Nov 2006 at 10:00 was vaccinated in the left deltoid with a first dose of Zostavax (lot # 652965/0622F). Concomitant therapy included influenza virus vaccine (unspecified). There was no illness at the time of vaccination. On 10 Nov 2006 at 12:00 am, the patient developed a lump in her muscle the size of a tennis ball which was red, raised and hot to touch. The patient had shortness of breath and rapid pulse rate. The patient is allergic to bee stings and she described her reaction as such. Unspecified medical attention was sought. No epinephrine was given. One week post vaccination, the lum was gone and some redness and itching were noted. The patient recovered on 18 Nov 2006. Additional information has been requested.
13 days after vaccine, left arm at vaccine injection site began to itch. Local circular red rash appeared, approximately 2 inches by 3.5 inches. Resolved after 36 hours. After searching internet, it looks like a rare type 4 delayed hypersensitivity reaction from the Moderna vaccine.
Patient received a Monovalent Pediatrict Pfizer instead of of Bivalent Pediatrict Pfizer booster.
Woke up with a 101.5 fever and really bad headache on 9/19/18 (the day after the shot). Had chills and fever all day. Fever that night still 100.5. Was fine on the Thursday 9/20/18 like as if nothing happened.
took the needle out of her arm, she noticed several big drops of blood that came out.; vaccine may have leaked and she may not have gotten the full dose; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site haemorrhage, and accidental underdose.  The patient's medical history, was not provided by the reporter.  No Concomitant medications were reported.  On 01 Mar 2021, the patient received their one of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   When the nurse took the needle out of her arm, the patient noticed several big drops of blood that came out. The patient felt that the vaccine may have leaked and she may not have gotten the full dose.  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, were recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a consumer refers to a her 5 years old son who on an unknown date was vaccinated with a dose of ROTATEQ (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The patient's mother stated that while on ROTATEQ her son did not eat eggs any longer. He also had unspecified bowel issues. No treatment was given for the experience. At the time of the report, the patient had not recovered. The relatedness for patient did not eat eggs any longer and patient had unspecified bowel issues was unknown for ROTATEQ. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from a 37 year old male consumer with no pertinent medical history and no drug reactions or allergies reporting on himself. On 02-NOV-2015, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (dose, route and lot # not reported) the left arm. There was no concomitant medication. The consumer reported that on 02-NOV-2015, right after he received the vaccine, he experienced a burning sensation. His shoulder felt like "Charlie horse" or cramp. The consumer reported that he could not sleep through the night because his left arm was aching. His left peck was also in pain and he believed that this would affect his heart. There was a constant cramp in his chest area. TYLENOL was given as treatment for the adverse events. On an unspecified date the patient underwent a blood work for a wellness check (results were not provided). At the time of the report, the patient had not recovered. Additional information has been requested.
diagnosed with covid 19 less than 1 week later; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (diagnosed with covid 19 less than 1 week later) 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 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (diagnosed with covid 19 less than 1 week later). At the time of the report, COVID-19 (diagnosed with covid 19 less than 1 week later) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported  no treatment medication was reported
At 11:25 gave MMR in this child's right arm sq and IPV in his left arm sq. Approximately  2-5 minutes later the child had 2-3 mm hive like welts 1 cm above the injection site. Over the next 2 minutes the welts joined and became approximately 1 cm raised red area. Redness 5 cm around injection site. No hives anywhere else, no respiratory distress, Benadryl given. Patient was observed for 20 minutes. Discharged. Advised to return if SOB, wheezing, more hives or redness lasting longer than 1-3 days.
Possibly inadvertently injected with empty syringe with J&J vaccine and ml vanish point syringe.
Last night she was up all night vomiting; Last night she was up all night vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DEFICIT (Last night she was up all night vomiting) and VOMITING (Last night she was up all night vomiting) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, the patient experienced SLEEP DEFICIT (Last night she was up all night vomiting). 14-Dec-2021, the patient experienced VOMITING (Last night she was up all night vomiting). At the time of the report, SLEEP DEFICIT (Last night she was up all night vomiting) and VOMITING (Last night she was up all night vomiting) outcome was unknown. No Concomitant product use was reported. No treatment information was provided.