chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Erythematous maculopapular rash  after 2nd dose, fever 12 hrs after 1st dose. Follow up states that: Do not have lot numbers for vaccine given
This spontaneous report as received from a registered nurse refers to 11 patients of unknown age and gender. On an unknown date 11 patients were inadvertently vaccinated with GARDASIL (dose, lot number and route was unknown) which was improperly stored. No adverse effects were reported. The outcome of the events was unknown. This case is linked to MARRS# 1410USA007761 and 1411USA003397 with the same reporter link. Additional information is not expected.
FACIAL TIGHTNESS, SHORTNESS OF BREATH, THROAT TIGHTNESS, DIZZINESS, RINGING IN EARS, LOSS OF FOCUS, SLIGHT CHEST PAIN
I felt nauseated within 5-10 minutes after the covid vaccine shot.  For 2-3 days I suffered from nausea, I broke out in a sweat, headache, fatigue and rashes all over my body. My left arm was painful and swelling for more than a week.   On May 31, 2021 I noticed my left arm was very itchy and saw a huge red  lesion  on the injection site.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 10 months old patient of unknown gender. On 06-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
CONTRACTED COVID, CONFIRMED 3/17/21, PATIENT DIED ON 3/23/21
First pt. starting c/o feeling funny, arms tingling, then lips started tingling, then got numb, tougue starting feeling funny, started coughing.
Patient given 0.2mL of adult formulation Pfizer COVID-19 vaccine. Correct dosage, incorrect formulation for age of patient. Mother of patient informed. No adverse reactions reported.
Information has been received from an office manager concerning a 62 year old female patient who on 08-NOV-2006 was vaccinated into the left deltoid with a first dose of Pneumovax 23 (lot# 651321/1036P).  On the morning of 09-NOV-2006, the patient experienced pain, swelling and hot to the touch (area unknown).  Subsequently, the patient developed cellulitis.  The location of the cellulitis and the patient's outcome were unknown.  The patient sought unspecified medical attention.  Additional information is not expected.
fever on and off all day for quite a while; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever on and off all day for quite a while) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever on and off all day for quite a while). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PYREXIA (fever on and off all day for quite a while) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with doses of improperly stored ROTATEQ (dose unknown, lot# M019706, expiration date: 24-OCT-2017) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had a seizure about 15 seconds after the second of two vaccinations. Had upper body tremors for approx. 10 hrs. Could not stand or walk for 7 hours (paralyzed).
Headache, couldn?t breathe, lung pain, chills, fever, went to local emergency room
TIREDNESS/FATIGUE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced tiredness/fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tiredness/fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210452621.
I had a sore arm on Thursday, which was consistent with getting the first dose.   Then around 8:30 am Friday I got hit with every symptom-chills, body ache, headache, nausea.  I slept all but about 2 hours between 9-5.  After 5 I was able to drink without immediately vomiting it right back up.  I did not sleep well last night, but I am sure that had more to do with sleeping all day yesterday.  10/10 would take the shot again because I want to hug my 97 year old grandpa again.  I just didn't get the link to report my reactions like it said in the rite Aide test (it told me I would be sent a link, but it wasn't in my texts or email)
mouth was itchy; lips were swelling; face, shoulder were blotchy, red and few hives, some of these blotches were raised; face, shoulder were blotchy, red, few hives/ blotchy all over his body, including neck, face, eyes, chest, back, some of these blotches were raised and some were not; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non healthcare professional (patient's mother) (Reference number- 00326392) and transmitted to Sanofi on 21-Oct-2020.  This case involves a 19 years old male patient who developed blotchy, red face, shoulder and few urticaria (urticaria), blotchy all over his body, including neck, face, eyes, chest, back (Rash macular), lips swelling (lip swelling) and itchy mouth (Oral pruritus), while he received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history included COVID-19 in SEP-2020, patient felt bad for 3 days, and was quarantined for 14 days.  The patient's past vaccination included flu shot late last flu season (reporter did not know which flu shot it was) in FEB-2020 which was tolerated by patient with no problem  Patient's past medical treatments and family history were not provided.  At the time of the event, the patient had ongoing coeliac disease three and half years ago and was completely gluten free now and Food allergy (allergic to melons and some random fruits), which would make his mouth itch.  Patient received no concomitant vaccines.   On 20-Oct-2020 at 3.30pm, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection prefilled syringes (lot number, expiration date was unknown) via intramuscular route in the left deltoid for prophylactic vaccination.  Patient took a shower very late on 20 Oct 2020 or else very early on 21 Oct 2020 after patient got out of the shower the patient developed blotchy, red face, shoulder and few urticaria (urticaria), blotchy all over his body, including neck, face, eyes, chest, back (Rash macular) 8 to 9 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported as some of these blotches were raised and some were not.  On 21-Oct-2020 midnight, patient called reporter and stated that he felt like his lips were swelling (lip swelling) and his mouth was itchy (Oral pruritus) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Reporter was on the phone with the patient until about 3 am.  Reporter spoke to the pediatric hotline and were advised against taking Benadryl, so the patient did not take it.  Patient was able to go to sleep after 3 am, and when he woke up in the morning, he had recovered.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  There will be no information available on the batch number for this case.
This spontaneous report as received from a physician referred to a 19 years old female patient. The patient was vaccinated with doses 1,2, and 3 GARDASIL on 10-APR-2007, on 05-AUG-2008 and on 18-JUN-2012, respectively. No adverse experience has been observed or reported. No treatment information was reported. Additional information has been requested.
Moderna COVID-19 Vaccine EUA: Major redness, irritated skin, warm to the touch on skin at injection site on shoulder. Swollen and painful lymph nodes in underarm on same side lasting for a week.
On 4-3 we administered an IM SHINGRIX: Pt stated on 6-27-18 difficulty moving her arm and decreased range of motion in the joint. No pain reported.
After 7 days, the whole body starts to itch. It was bad that bumps was everywhere on arms and legs. Got worse when taking warm bath and night time it was hard to sleep because it was very itchy.
She experienced a rapid heart beat with an onset of 20 minutes after vaccination lasting 1.5 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Jul2021 18:30 (Lot number: EW0186) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ventricular septal defect" (ongoing), notes: She was born with it.; "Heart murmur" (ongoing), notes: She was born with it.; "Diabetes" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Cancer " (unspecified if ongoing), notes: Cancer 2 generations ago. Family history included: "Heart cath" (unspecified if ongoing), notes: dad had a heart cath. The patient's concomitant medications were not reported. Vaccination history included: Flu shot, for Immunization, reaction(s): "she felt draggy", "Arm sore". The following information was reported: HEART RATE INCREASED (non-serious) with onset 27Jul2021 18:50, outcome "recovered" (27Jul2021 20:20), described as "She experienced a rapid heart beat with an onset of 20 minutes after vaccination lasting 1.5 hours". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. Receiving her first dose of the Pfizer covid 19 vaccine three weeks ago; after receiving the dose, she experienced a rapid heart beat with an onset of 20 minutes after vaccination lasting 1.5 hours. She has not had any more bouts of it like she did that day. Family medical history relevant to event were reported as diabetes, high cholesterol, high blood pressure and her dad had a heart cath.   No follow-up attempts are possible. No further information is expected.
Rash on left arm. Erythematous, swollen, hot, measuring appx. 6cm in diameter. Within 24h reaction started.
Fatigue, sore throat, chest tightness, headache, cough, irritated eyes
PT C/O WEAKNESS, SHAKING, AND NAUSEA. SX HAVE DECREASED AS OF 8/26/10. SX STILL PRESENT WHEN SPEAKING TO MOM @1:30 PM
Nerve pain in both arms starting in right arm but moving to left,  radiating from neck to fingers, acupuncture moved it to just tingling and numbness.  Similar but less intense tingling and numbness in legs.  Possibly unrelated (yet to be determined) sudden incident of hypertensive crisis on 11/7/2021 with chest pain.  Resolved 11/8/21 but no definitive diagnosis.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11-Jan-2023, lot numbers unknown to the HCP.  No concomitant medication reported. No treatment medication reported.  This case pertains to 37th of the total 100 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
This spontaneous case reported by a non-healthcare professional, describes the occurrence of chest pain (pain in chest, headaches, body aches), pyrexia (fever 101.8°F), headache (pain in chest, headaches, body aches), myalgia (pain in chest, headaches, body aches) and fatigue in a 71-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 2, 2021, patient experienced chest pain (pain in chest, headaches, body aches), pyrexia (fever 101.8°F), headache (pain in chest, headaches, body aches), myalgia (pain in chest, headaches, body aches) and fatigue. At the time of the report, chest pain (pain in chest, headaches, body aches), pyrexia (fever 101.8 °F), headache (pain in chest, headaches, body aches), myalgia (pain in chest, headaches, body aches) and fatigue outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No medical history, concomitant medications or treatment medications provided in source document. Reporter did not allow further contact. 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.
After receiving the Moderna COVID 19 vaccine the pt. (while walking around in the store with her husband) began to feel dizzy and weak. She came back to the pharmacy area and she was seated and had her blood pressure checked. It was high (194/84) but she reported that she does have high blood pressure and takes her med at night.  She was given a bottle of water, monitored and her blood pressure was checked twice again over the next 20 minutes. It read lower each time she was checked and when it read 156/84 she said she felt fine and was ready to leave with her husband. She also said she was diabetic and had eaten a small breakfast compared to normally. She will be contacted today to make sure she is still feeling ok.
Narrative: Patient contacted telephone triage nurse today requesting appt with provider for c/o, "I think I'm having a slight reaction to the Moderna vaccine." Patient states he received 2nd dose of vaccine on 4/5/21, "developed a rash at the injection site." States area is red, inflamed, "and slightly itchy." States concern because redness is worsening, "Getting worse, not better - spreading down the arm now." No fever/chills or vomiting. States that rash is at injection site, traveling down arm, yellow in areas "kind of like a bruise" admits to scratching at area, denies pain. Took Benedryl. Advised that this is a common side effect of the COVID vaccine. apply ice to area as needed, take Anti-histamine for itchm can apply Anti-itch cream to rash as needed, Tylenol or NSAIDS for pain if needed, denies any pain. Denies Drainage, blisters, fever, SOB or streaking. Patient advised to continue to monitor, Recommend home treatments.
Pt recvd vax 23SEP93; the next day pt devel peripheral neuropathy in the feet, hands & chest; neurologic exam revealed lack of sensation to pin prick;
VERTIGO; LETHARGY; FEELING SICK; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: prednisone ( form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 19-MAR-2021 for an unspecified indication. No concomitant medications were reported. On MAR-2021, the subject experienced vertigo. On MAR-2021, the subject experienced lethargy. On MAR-2021, the subject experienced feeling sick. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with prednisone was not reported. The outcome of the headache, nausea, vertigo, lethargy and feeling sick was not reported. This report was non-serious.
Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (Headache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient received Moderna COVID vaccine on 3/22/21 and 4/20/21. On 1/16/22, patient admitted to our inpatient CCU with hypernatremia, AKI, hyperglycemia, HONK with coma, and COVID-19 infection (asymptomatic, CXR w/minimal RML opacity,  respirations unlabored, lungs clear, oxygen normal). Patient transferred from CCU to med/surg unit on 1/17/22. As of today (1/19/22), patient is still admitted in the med/surg unit.
achy arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (achy arm). The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERINE) at a dose of 1 dosage form and MORPHINE at a dose of 1 dosage form. At the time of the report, MYALGIA (achy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.
Overall body aches, shivering, cold extremities, headache, tired feeling, fever.  Shivering began about eight hours after I received the vaccine.  It lasted about two hours.  Cold extremities and low-grade fever continued to 48 hours after the vaccine.  Took 600 mg at time of shivering/headache/body aches and 800mg of Advil about 42 hours in.
I experienced increasing abdominal pain and eating was very painful (hurt even if I drank a sip of water). I went to the hospital and the doctors could not diagnose anything. I went to my PCP, Internal Medicine, Gynecologists, Gastroenterologist, Herbalist and still they could not find anything. The Gastroenterologist suggested going on a low food mass diet and I started taking herbs from the Herbalist and started to eating foods that I normally eat which re-triggered all the pain. I'm really confused as to what's going on. I have been experienced the symptoms since March and am baffled as to why none of the doctors can diagnose my condition.
Patient became lightheaded, dizziness, nausea within 3 minutes of injection. Side effects diminished within 15 minutes and patient was discharged.
Dizziness 6 mins post vaccination. Patient has history of fibromyalgia and vasovagal reactions due to pain. Patient improved after laying down.  Vitals were taken, water and crackers given. Monitored for 30mins.  Had episode of dry heaving states, common occurrence with condition Discharged to home with caregiver
Patient started to not feel well about 2 minutes after injection, asked for water. I grabbed co-worker (my pharmacist as I am a student) and she stayed with him while I called 911. He passed out on here, came back to, EMTs arrived and he again passed out on them so they took him to ambulance on stretcher