chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Neuropathy in the finger / Neuropathy in the right arm; chills; Nausea; Headache; A spontaneous report  received from a consumer concerning a 73-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced chills, nausea, headache, neuropathy in the finger and right arm.  The patient's medical history was not provided. Concomitant medications reported included rosuvastatin and eye drop.  On 16 Jan 2021, approximately 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number 041L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 16 Jan 2021, the patient experienced chills, nausea and headache, all of which resolved within 36 hours on 18 Jan 2021. She took 3 Tylenol, and a Zomig to help with the symptoms.  On 24 Jan 2021, the patient began to experience neuropathy in her finger and right arm, which she reported as it was getting worse.    Action taken with mRNA-1273 in response to the events was not reported.  The events, chills, nausea and headache, were considered resolved on 18 Jan 2021. The outcomes of the events, neuropathy in the finger / neuropathy in the right arm  were unknown.; Reporter's Comments: This spontaneous report concerns a 73-year-old female patient who experienced a serious event of neuropathy in the right finger and non-serious events of chills, nausea and headache. The events of chills, nausea and headache occurred on the same day after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: Unknown, expiration date-Unknown). Neuropathy occurred 8 days after the administration of mRNA-1273 vaccine. Treatment administered included Tylenol and Zomig for chills, nausea and headache with resolution.  The events of chills, nausea and headache are consistent with the safety profile for mRNA-1273 vaccine.  Based on the information provided, including temporal association and in the absence of any other etiology, a causal association cannot be excluded for all reported events. Causality for the event of neuropathy is also confounded by the patient's advanced age.  Main field defaults to possibly related'
Screaming for hours, fatigue, seizure activity (hear turning from side to side repeatedly for 5-10 seconds), loss of vocalization (cooing) for one week.
Nurse spoke to mother @10:00 AM on 08/14/2018: mother reports  pain at injection site with large local reaction; pain and sensation of pressure in sternum resulting in "trouble breathing".  Afebrile and no other signs of illness. Mother giving Acetaminophen. Dr.consulted and concerned about possible pneumothorax. Mother spoke with doctor to discuss option of ER and/or Chest X-ray and mutually decided for Chest X-ray.  Dr. also advised giving 600mg of ibuprofen. Pt received Chest X-ray at 11:30 with normal results. Dr. advised to continue with ibuprofen and follow up if symptoms worsen. Mother reported on 08-15-2018: pt continues having symptoms but with lessening severity.
Dizziness approx. 30 minutes after vaccination, spinning sensation 1hr after vaccination. Chills and shivering approx. 5 hrs after-- nausea-vomiting-102 fever, severe muscle, joint and headache. 5 1/2 hrs later. 36 hrs after shot side effects lessen.  72 hrs later weakness and fatigue. Day 4 these symptoms resolve. Five days after vaccine dizziness and muffled hearing in left ear which is unresolved.
nauseous; Dizzy; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received Shingrix. On 3rd December 2019, 1 days after receiving Shingrix, the patient experienced nausea and dizziness. On an unknown date, the outcome of the nausea and dizziness were unknown.   It was unknown if the reporter considered the nausea and dizziness to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's husband. The age at vaccination was not reported. The reporter stated that the patient had nausea and dizziness after vaccination.
The patient was admitted to the Pediatric Intensive care Unit for acute vaccine related myocarditis.  He began to have fever the evening after his vaccine with chest pain developing the following night. his chest pain progressed prompting evaluation in the ED where abnormal ECG prompted further workup. He was treated with Solumedrol, IVIG x 2, Pepcid, Tylenol, aspirin x 1, benadryl with a good response. He was monitored in the PICU for risk of arrythmia or shock but did not ever demonstrate either of these conditions. He improved and his labs and echo, ecg normalized. he was discharged home on prednisone and pepcid to follow up with cardiology the following week to discuss steroid taper pending further lab analysis.
11y male given Moderna Bivalent. There was no adverse event status post vaccine. Mother called today by provider (day after vaccine) and she reported he has had no side effects and is doing well.
Patient reported to PCP  on 03/04/2022 with loss of appeitite, fatigue/weakness, nausea, and headache for 5 days.  Patient tested positive for Covid-19.  Patient received antibodies on 03/04/2022, since then patient has been in bed.  Patient was admitted to home hospice services.  Patient expired on 05/03/2022.
Shingles outbreak involving dermatomes T10-12 on right side. Began two days after vaccination with deep pain and hives initially, resulting in typical herpes zoster rash about 6 days later. On the third day of the rash, began Valacyclovir 1gm PO TID. Is still symptomatic; rash has not yet resolved.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (developed a large lump on arm), SOMNOLENCE (Felt sleepy), SLUGGISHNESS (sluggish), VACCINATION SITE PRURITUS (Arm was itchy) and VACCINATION SITE RASH (Arm has a rash) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 043B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE MASS (developed a large lump on arm), SOMNOLENCE (Felt sleepy), SLUGGISHNESS (sluggish), VACCINATION SITE PRURITUS (Arm was itchy) and VACCINATION SITE RASH (Arm has a rash). At the time of the report, VACCINATION SITE MASS (developed a large lump on arm), SOMNOLENCE (Felt sleepy), SLUGGISHNESS (sluggish), VACCINATION SITE PRURITUS (Arm was itchy) and VACCINATION SITE RASH (Arm has a rash) outcome was unknown. Treatment information not provided. Concomitant medications were not provided.
Reduced range of motion in injection arm-left continuing still Headaches 1-2 per day still Fall at 3am 12 hours after vaccine. Very serious. Bruised ribs
he was calling to report an administration error, not an adverse event.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (he was calling to report an administration error, not an adverse event.) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender 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 an unknown date, 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 an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (he was calling to report an administration error, not an adverse event.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (he was calling to report an administration error, not an adverse event.) 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 assessment was provided for PRODUCT ADMINISTRATION ERROR (he was calling to report an administration error, not an adverse event.).    No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact
leukemia; This spontaneous case was reported by a pharmacist and describes the occurrence of LEUKAEMIA (leukemia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041M20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 24-Mar-2021, the patient experienced LEUKAEMIA (leukemia) (seriousness criterion medically significant). The patient was treated with Transplant (Bone marrow transplant) for Leukaemia. At the time of the report, LEUKAEMIA (leukemia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.  On 24-Mar-2021, the patient was diagnosed with leukemia.  On 02-Aug-2021, the patient underwent bone marrow transplant and hospitalization was required for the same.  On 20-Dec-2021, the patient took third dose, lot number 067H21A.; Sender's Comments: This case concerns a 67-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Leukemia. The event occurred approximately 2 months after a reported second dose of mRNA-1273 (Moderna covid-19 vaccine); though it's unclear if it was the second or third dose. The rechallenge was not applicable as event occurred after second dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
I have my left ear that has started to itch. Soon it became red and inflated to double volume. Then she turned green for half a day before returning to normal.
First seen in office on 8/19/23 dx adverse vaccine reaction, prescribed ibuprofen Seen again on 8/20/23 Adverse vaccine reaction and later that night prescribed course of keflex for worsening sx. telemed appt on 08/21/2023 , came for nurse visit for ceftriaxone injection for Dx Cellulitis.
On Feb 8, 6 days after dose 1 of the phizer vaccine, I developed a small patch of itchy bumps on my chest, very slightly to the left of center.  On February 14, I developed three more patches of itchy, painful vessicles on my left arm, along a single dermasone.  My doctor and I suspected shingles, and the diagnosis was confirmed by a blood test.  As of March 9, the patches are still visible but much improved, nearly gone but still a bit red and mildly itchy.
About five hours after receiving the vaccine, I had a bright red spot on my shoulder for a day or two. It didn't hurt but it was very hot. On 04/24/2021, I noticed a strange rash or bruising on my right thigh that came out of nowhere. From then I would randomly have this rash or bruising on my legs. I found out that it was petechiae rash and it was these round spots that would randomly appear without any reason. I saw my doctor and was referred to a hematologist. I have had several blood tests ran over the last year and it was determined that I am having an autoimmune reaction to something in the vaccine. I have been referred to another hematologist and I have an appointment on 12/21/2022.
Going on 5 months extreme fatigue in mornings; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: FEXOFENADINE; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]. Past drug history included: Prednisone, reaction(s): "Allergy". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered with sequelae", described as "Going on 5 months extreme fatigue in mornings". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue.  Additional Information: The patient did not receive any other vaccines within four weeks. Probiotics used for the treatment of adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 on an unknown date, result was negative (have had over 70 negative rapid tests and 1 negative antibody) and through nasal swab result was negative on Nov2021. The patient had recovered from fatigue with lasting effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nausea,   Diarrhea, chills, stomach cramps, tired, sore arm. Lasted from 8am 3/18/21 until 3PM on 3/20/21.
Information has been received from a nurse concerning an approximately 29 month old male patient with an allergy to gelatin who in December 2001 (reported as "10 years ago"), was vaccinated with the first dose of MMR II (dose, route and lot number not reported). Subsequently in December 2001 (reported as "10 years ago"), the patient had an anaphylactic reaction and was rushed to the emergency room. At the time of the report the patient's outcome was recovered (date unknown). Upon internal review, anaphylactic reaction was determined to be an other important medical event. Additional information has been requested.
The bottom of her face is swollen; Area where the band-aid was applied is inflamed and risen; Risen area; Knocked out; This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient experienced shingles in November 2018). Concomitant products included Herpes zoster (Shingrix).   On 27th October 2019, the patient received the 2nd dose of Shingrix. On 28th October 2019, 1 days after receiving Shingrix, the patient experienced loss of consciousness (serious criteria GSK medically significant). On 29th October 2019, the patient experienced facial swelling, injection site inflammation and injection site swelling. On an unknown date, the outcome of the loss of consciousness and facial swelling were unknown and the outcome of the injection site inflammation and injection site swelling were not recovered/not resolved.   The reporter considered the loss of consciousness, facial swelling, injection site inflammation and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient could not remember the date of her first dose but guesses three months. The patient received 2nd dose of Shingrix which knocked her out. Next morning, the bottom of her face is swollen. The area where the band-aid was applied is inflamed and risen. The reporter did not consent to follow-up.
"Chest pain, throat swelling, fever, chills, nausea, muscle weakness, dizziness..etc".  Pt is health care provider and self treated with "Benadryl, Ibuprofen, Tylenol, and Zofran."  Lasted >24 hours.  Resolved without further incident.
Pt had cardiac arrest at nursing home, found pulseless, apenic; received cpr, 7.5 et tube, 3 epi, 1 bicarb; pt arrived to the ER via ems unresponsive, in asystole, without spontaneous respirations, no pulses, no apical heart sounds and no signs of life; pt pronounced doa due to COVID 19 related infection PMH: acute COVID-19, anxiety, depression, atrial flutter, coronary artery disease, congestive heart failure, dementia, diabetes, emphysema, GERD, hyperlipidemia, hypertension; Allergies: amiodarone, contrast media (iodine-based), penicillian
Severe pain started approximately 24 hours after immunization in left side of head in neck.  Pain is centered in joint of jaw and radiates to top of head, through upper and lower teeth, back through and behind ear area, and down into neck to the shoulder.  Jaw and neck are stiff on left side.  Dizzy spells started approximately the same time as severe pain.  Symptons persist at this time, 1400 June 15, 2005.
Exactly 14 days (Oct.29)after receiving my COVID booster injection, I started having a burning and prickling sensation on the left side of my abdomen. It continued to get worse over the weekend, with spasms or "electric shocks" on the left side of my abdomen and the left side of my back. On Nov. 1, I noticed the beginning of a red rash starting in the same area of the pain. I called my PCP and described the symptoms. He prescribed Valtrex and Lyrica, and I took the first two doses that day. The  red pustular rash continued to spread over my entire left side of my abdomen and left side of my back. I continued with the Valtrex until I completed the prescription today (Nov. 8). I still have the rash and the pain, but it doesn't appear to be spreading. Note: On October 29, I received a Pneumovax 23 injection IM in my left arm at 9:00 am.
cannot walk or exercise; cannot sit/cannot walk or exercise; I had arthritis before the shots, but this pain is worse than I have ever felt; can't sleep; This is a spontaneous report from a contactable consumer.   A non-pregnant 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 14Jan2021 10:00 (Batch/Lot Number: EL3249) as dose 1, single (at the age o 42 years old) for COVID-19 immunisation.  Medical history included ongoing arthritis before the shots. No known allergies. The patient's concomitant medications were not reported.  The patient stated, "I had arthritis before the shots, but this pain is worse than I have ever felt. I cannot sleep. I cannot sit. I cannot walk or exercise". AE treatment: Cortisone shot for hip. Covid test type post vaccination: Nasal Swab on 21Feb2021 and the result is negative. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
temperature of 100.3°F; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), CHILLS (chills) and PYREXIA (temperature of 100.3°F) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), AMLODIPINE, ATORVASTATIN, HYDROCHLOROTHIAZIDE, METOPROLOL (METOPROLOL ER) and TIMOLOL for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced NAUSEA (nausea) and CHILLS (chills). On 27-Mar-2021, the patient experienced PYREXIA (temperature of 100.3°F). At the time of the report, NAUSEA (nausea), CHILLS (chills) and PYREXIA (temperature of 100.3°F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took Tylenol (Acetaminophen) and within an hour, the symptoms subsided.   This case was linked to INC.-MOD-2021-067156 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-067156:
This spontaneous report as received from a consumer through a webpage, refers to a 17 year old (also reported as 15 year old) female patient. The reporter described the patient to be healthy, active and academically gifted. On September 2012, the patient received dose 1 of GARDASIL. In February 2013, the patient received dose 2 of GARDASIL. On an unknown date in 2013, approximately a week after the patient received dose 2 of GARDASIL, she developed cold symptoms and a barking cough. The patient went on to develop repeated lung spasms. Reporter did not think these events were related to the vaccine. In July 2013, the patient was vaccinated with the third dose of GARDASIL. No concomitant medication was reported. On an unknown date in 2013, after the patient received dose 3 of GARDASIL, she experienced dizziness, loss of balance, weakness, anxiety, ear pain, abdominal pain and nausea. Reporter did not associate patient's new symptoms with the vaccine. On an unknown date in December 2014, the patient was diagnosed with a simple sinus infection and was prescribed a "z-pack" which she has had many times before with no problems. Approximately 15 minutes after administration of the first dose of the "z-pack", reporter was frantically working to keep the patient alive until the ambulance arrived. Patient was diagnosed with severe unexplained hypokalemia (life threatening low potassium) and a cardiac condition called electrocardiogram QT prolonged. Patient was treated with intravenous (IV) potassium and magnesium, then released. On an unknown date, the patient was diagnosed with familial periodic paralysis with outlying symptoms of Hashimoto's, autoimmune disorder, hair loss, nerve damage; as per an Electromyography (EMG) test, weakness, tremors, exercise intolerance, heat/cold intolerance, air hunger, chest pain, abdominal pain, nausea and vomiting, brain fog, allodynia, nystagmus and non-epileptic seizures. The outcomes of all the events were unknown. The reporter stated that GARDASIL had devastatingly injured the patient and hence causality assessment was considered related. The reporter considered hypokalemia to be life-threatening. Upon internal review, hypokalemia, prolonged QT interval, Hashimoto's, autoimmune disorder and non epileptic seizure were considered to be medically significant. This is one of the two reports from the same source (linked to MARRS # 1607USA012465). Additional information has been requested.
High Fever (greater than 101); Chills Shakes, Coughing.  OTC medication to moderate symptoms. Not finished as of 11.5.2016 PM
This study case was received from the investigator in a trial on 19 August 2011. A 25-year-old male subject who had a past history of palpitations/pounding heart without exercise, chest pain, congestive heart failure, cardiomyopathy, shortness of breath, asthma, psychiatric illness and abnormal ECG (electrocardiogram), had received ACAM2000 (lot number not reported) on 29 November 2010. The subject had previously received vaccination with Influenza, live intranasal (other manufacturer, lot number not reported) on 22 November 2011. On 03 December 2010, laboratory and diagnostic findings consisted of an abnormal ECG and abnormal Echocardiogram. Troponin I results were not available. On 16 December 2010, the subject was diagnosed with "Other primary cardiomyopathies". Outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.