chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles booster second shot killed my wife; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: shingles booster second shot killed my wife) (serious criteria death and GSK medically significant). The reported cause of death was unknown.   The reporter considered the unknown cause of death to be related to Shingles vaccine.     The company considered the unknown cause of death to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-JUL-2023 This case was reported by a patient via interactive digital media. The case was reported by patient's husband. The reporter stated that shingles booster second shot killed his wife and stated that everybody should be aware and be forewarned about it. The follow-up could not be possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Rigors, severe Headache, rapidly increasing temperature (102.5), pulse rose above 130, BP slightly elevated, chestbpressure (no pain).  Went to ER at 09:15pm.
Joint pains in both the shoulders and progressing to the hips; Pain at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) and ARTHRALGIA (Joint pains in both the shoulders and progressing to the hips) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 037B21A) for COVID-19 vaccination.     The patient's past medical history included Radical prostatectomy on 04-Oct-2004. Concurrent medical conditions included Bee sting, Drug allergy (Meloxicam and carry a epipen) and Prostate cancer since 14-Aug-2004.   On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 02-Aug-2021, the patient experienced ARTHRALGIA (Joint pains in both the shoulders and progressing to the hips). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) and ARTHRALGIA (Joint pains in both the shoulders and progressing to the hips) had not resolved.            No relevant concomitant medications were reported..   The patient had unbearable pain. He applied rubs which do not help and packs occasionally Patient had an appointment on 1st of July and he has been using salonpas on shoulders which lessens the soreness and also bio freeze on the hip areas to relieve the stiffness .   This case was linked to MOD-2021-359083 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: FU received on 20 Oct 2021 . Added patients demographics , past medical conditions, information regarding suspect product and outcome of events.
chronic hives/ he is still full of hives; some aches (second dose); little loopy for 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (chronic hives/ he is still full of hives), MYALGIA (some aches (second dose)) and FATIGUE (little loopy for 12 hours) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy and Hives.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (chronic hives/ he is still full of hives), MYALGIA (some aches (second dose)) and FATIGUE (little loopy for 12 hours). At the time of the report, URTICARIA (chronic hives/ he is still full of hives), MYALGIA (some aches (second dose)) and FATIGUE (little loopy for 12 hours) outcome was unknown.            No Concomitant medications were provided. No treatment medications were provided. It was reported that consumer called to report a chronic hives situation. Consumer works in the forest, so he was subjected to nettles. He thought the hives had to do with nettles, because he runs every day in the forest, and it looked like mosquito bites. Now, he said the nettle season was over, and he was still full of hives. He also thought he might have an egg allergy because he eats a lot of eggs.   This case was linked to MOD-2021-335282 (Patient Link).
I had mild arm pain after receiving the vaccine. I tested positive for COVID-19 on 02/11/2023.  I had a stuffy nose and a mild sore throat. I contacted a walk-in clinic and got a prescription for Paxlovid. I tolerated the medication without any complications. As of today, I feel good without any lingering symptoms of COVID-19.
hit a nerve in his shoulder; arm pain; This is spontaneous report from a contactable consumer. A 65 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route in shoulder on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided. Her husband felt a lot. The reporter thought they hit a nerve in his shoulder. The patient experienced arm pain. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Fever of 101; Extremely fatigued; Extreme lethargy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101), FATIGUE (Extremely fatigued) and LETHARGY (Extreme lethargy) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 101), FATIGUE (Extremely fatigued) and LETHARGY (Extreme lethargy). At the time of the report, PYREXIA (Fever of 101), FATIGUE (Extremely fatigued) and LETHARGY (Extreme lethargy) outcome was unknown.        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; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Pt recv vax on 12/8/98; on 12/9/98 pt exp irritable, unable to sleep, decreased appetite, lethargy; tx=Tylenol, cool compress
Ringing in her ears; Headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), HEADACHE (headache) and TINNITUS (ringing in her ears) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced MYALGIA (sore arm), HEADACHE (headache) and TINNITUS (ringing in her ears). On 21-Aug-2021, MYALGIA (sore arm), HEADACHE (headache) and TINNITUS (ringing in her ears) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.    This case was linked to MOD-2021-025089 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 09-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.    This case was linked to MOD-2021-025089 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Patient had a fever followed by a prolonged seizure for 20 minutes that required medication to stop the seizure. She was admitted to the hospital for observation. She continued to have seizure events for less than 20 minutes for two additional days. Patient was afebrile throughout the admission.
Post vax, the patient had a period of hypotonia, was overwrought and unconsolable and vomited frequently. She was seen 03/13/2001 and was better.
injection site was swollen/itching/red down to underside of arm; itching; bruising at site of injection (which patient states was administered very high up this time); severe neck pain on the left side; swollen glands; dizziness (preventing her from getting up); waking up sweating (just like when she had COVID; very high temperature of 103.5 F; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), VACCINATION SITE BRUISING (bruising at site of injection (which patient states was administered very high up this time)), NECK PAIN (severe neck pain on the left side), LYMPHADENOPATHY (swollen glands) and DIZZINESS (dizziness (preventing her from getting up)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 22-Mar-2021.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PRURITUS (itching), VACCINATION SITE BRUISING (bruising at site of injection (which patient states was administered very high up this time)), NECK PAIN (severe neck pain on the left side), LYMPHADENOPATHY (swollen glands), DIZZINESS (dizziness (preventing her from getting up)), HYPERHIDROSIS (waking up sweating (just like when she had COVID) and PYREXIA (very high temperature of 103.5 F). On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection site was swollen/itching/red down to underside of arm). At the time of the report, PRURITUS (itching), VACCINATION SITE BRUISING (bruising at site of injection (which patient states was administered very high up this time)), LYMPHADENOPATHY (swollen glands), DIZZINESS (dizziness (preventing her from getting up)), HYPERHIDROSIS (waking up sweating (just like when she had COVID) and VACCINATION SITE SWELLING (injection site was swollen/itching/red down to underside of arm) outcome was unknown, NECK PAIN (severe neck pain on the left side) had resolved and PYREXIA (very high temperature of 103.5 F) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Pyrexia: 103.5 (High) Fever. On 16-Apr-2021, Pyrexia: 100.1 (High) fever.         Patient took Ibuprofen and Tylenol for fever and also used ice packs. Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-079254 (E2B Linked Report). This case was linked to MOD-2021-079254 (Patient Link).; Sender's Comments:  MOD-2021-079254:Dose 1
One time shaking episode lasting approximately 30 seconds on day following vaccination. Also lethargy, decreased intake of food and liquids for 4 days following vaccines.
This spontaneous report as received from a registered nurse, refers to a patient of unknown age. On 09-SEP-2013 the patient was vaccinated with the dose of ZOSTAVAX (dose, route of administration and lot number were not reported). On 23-SEP-2013, the patient was vaccinated with the dose of Yellow Fever virus vaccine. The nurse states that the patient received two live vaccines within a little over a two week time period. No adverse effect reported. Additional information has been requested.
dizziness, SOB, nausea, local swelling & tenderness x 2d;epi given;
had sudden worsening of sinus congestion for about an hour, also tightness of throat for about 3 hours, then rash on upper body for about 3 days, head felt tingly and dizzy.  some redness and swelling of the injection site.
Dose 1 given 03/19/2021. Dose 2 due 04/16/2021 actual dose given 04/09/2021. Earliest dose could be given 04/12/2021.
Patient received Janssen vaccine on 3/14/21 according to her daughter. Patient is staying with daughter and family where some members tested positive. Patient herself tested positive on 5/15/21, she is completely asymptomatic.
This spontaneous case was initially received on 10-Nov-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication prevention of influenza on 09-Nov-2015- 09-Nov-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 09-Nov-2015, the patient experienced Did not get full dose because the needle came off the syringe/Partial administration of AFLURIA/Medication error (non serious, outcome: Unknown). The nurse confirmed the patient did not get the full dose. For relevant test results see appropriate report section.
This spontaneous case, initially received from a physician via pharmaceutical manufacturer (Merck) on 23-Oct-2018, concerns a 11-year-old, child, female patient. The patient's current condition included seasonal allergies. The patient's historical drug included NASONEX for seasonal allergies. It was unknown if the patient was taking NASONEX when the vaccines were administered. On 11-Oct-2018, the patient was administered influenza vaccine (batch number: U1982AC (as reported), anatomical location: left arm, dose, route of administration, expiry date, trade name and manufacturer: not reported). On the same day, the patient was also administered non-company suspect vaccines MENACTRA (anatomical location: right arm, batch number: U5986AA, dose, route of administration and expiry date: not reported), ADACEL (anatomical location: left arm, batch number: C5519BA, dose, route of administration and expiry date; not reported). The patient also received GARDASIL 9 (route of administration: intramuscular, anatomical location: right arm, batch number: R008163, dose and expiry date: not reported). On the same day, within minutes after receiving the four vaccines, the patient experienced a systemic bilateral rash on upper part of the body during an office visit. The rash was described as a red, blotchy shirt (as reported). The patient was given BENADRYL in the office and emergency services were called. The patient's blood pressure, oxygen level and temperature were monitored, and the vitals were reported as good. It was reported that, the patient was recovering, so the patient's parents declined the use of emergency services. The patient was taken home, after about an hour of vaccination. The field representative stated that, the emergency services had been contacted as a precaution, but the event was not life threatening. The reporter assessed the case as non-serious.
1-2 day hx fever, prior to outbreak. Saw with moderate case chicken pox. 3/21/06 In an immunized child with mild pharyngitis. Found multiple papules vesicles in different stages. Pruritic in nature. Started abd and spread to entire body.
Swollen painful lips on 4/14 On 5/2 lips swollen, stinging, cracked and bleeding
I received the vaccine on Friday March 19. I started to have flu like symptoms and intense fatigue the same day lasting until Sunday. Sunday I started to feel better. On Wednesday I started to feel fatigued and experience brain fog. On Thursday morning, I woke up with extreme pain in my arm pit and swollen lymph nodes. Since Friday I have been bed bound with debilitating fatigue and headache. Today is day 12 post vaccine and I still cant get out of bed, I have a headache, my arm pit aches and the site of injection is still sore.
Red, warm, tender raised area approximately 5cm x 3cm to back of right upper arm.  Benadryl every 6 hours PRN.
Patient arrives via EMS with complaint of shortness of breath.  Patient is at nursing home and staff noticed her pulse ox was low.  Patient is unable to provide history.  All history is obtained from nursing home records as well as husband who meets the patient in the emergency department.  Husband states the patient has been recently discharged home from the hospital and was placed in rehab for treatment.  States he saw her couple days ago and she was eating and was able to carry on a conversation.  States he was called today and told she was short of breath.  He states she appears more weak and is coughing more than she had been.  Patient does have a previous diagnosis of Covid.
This spontaneous report was received and was assigned case # 30121024484-WSC-52 refers to a female patient of unknown age. On an unspecified date in 2012, the patient was vaccinated with (lot # 671662/1160AA) ZOSTAVAX (route and dose were not reported, expiry date was 18-OCT-2012). No concomitant medications were reported. After administration of the vaccine the patient experienced swollen arm and redness (disability) on 03-OCT-2012. The patient did not want to seize and had called the pharmacist and was instructed as to what had to be done. On 14-OCT-2012, the patient was hospitalized since the patient could not move her arms or legs and the patient was diagnosed with Guillain-Barre Syndrome (disability). It was reported that at the time of the report, the patient was incapacitated and could not move her arms or legs. The patient's outcome for swollen arm and redness was unknown. This was originally reported by a consumer. Additional information has been requested.
Pt reported being nauseous and light-headed. BP remained 132/78, soon after she stated she felt a lot better and shortly thereafter, she stated she was ok. On 12/2/00 per telephone conversation with pt, she stated she is fine.
felling better than [he] ever did; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "felling better than [he] ever did".  Additional information: He however, explained that he did not receive a vaccination card and would like assistance on getting one. He explained having 10 different numbers and had been calling some with no success, including the Health Services and the CDC. He specified not having access to internet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Fairly severe localized reaction w/swelling, redness, discomfort. Localized to Right upper arm from shoulder to elbow.
I have had sudden hearing loss, the last dose given 8/26/21. I have had hearing aids and forgetting to wear them but before the holidays I noticed my hearing has become worse than my husband and he flew airplanes for 20 years. I took my aids in to have checked before the holiday and am due to go back to audiologist in March.
I suffer from lingering SOB with exertion  after COVID infection. On the night of 12/31/2020 I began to feel more SOB than usual and was unable to correct my SOB with rescue inhaler. Became more SOB with exacerbated tachycardia and tachypnea, My family had to call 911 because I became aphasic and showing signs of possible stroke. I was taken to the ER and admitted for respiratory recovery and to role out stroke. The stroke was ruled out and I recovered with IV prednisone therapy, twice daily and supplemental oxygen. Released after HR, BP, & respiratory effort returned to normal: 01/03/2021
Swelling at the injection site; Redness at the injection site; Underneath her armpit a really large lymph node; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE LYMPHADENOPATHY (Underneath her armpit a really large lymph node) in a female 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE LYMPHADENOPATHY (Underneath her armpit a really large lymph node). At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE LYMPHADENOPATHY (Underneath her armpit a really large lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was unknown. Treatment information was not provided.; Sender'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.