chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm hurt so bad; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving 1st dose of Shingles vaccine, the patient's arm hurt so bad for a couple of weeks but stated it would be worth. The patient stated that, he/she needed the 2nd dose in a few more months.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness
Clinical narrative: the night I got the shot, got shingles; the night I got the second shot got sick; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 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, less than a day after receiving Shingles vaccine, the patient experienced shingles and sickness. On an unknown date, the outcome of the shingles and sickness were recovered/resolved.   It was unknown if the reporter considered the shingles and sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she got the vaccine and the night he/she got the second shot, got so sick and got shingles so bad, was sick for 2 months. The reporter suggested not to get the vaccine. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Injection site pain; rash at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and injection site rash. On an unknown date, the outcome of the injection site pain and injection site rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. Patient received the first Shingrix vaccine and initially had injection site pain, and then after several days she also developed a rash at the injection site. No other information reported. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: dose 3 years ago, not sure about receiving 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: Age at vaccination was not applicable for this report. The patient was not sure about receiving the 2nd dose yet. Patient did not recall receiving a 2nd dose. Till the time of reporting, patient did not receive the 2nd dose yet which led to incomplete course of vaccination. So far reporter requested information about possible late 2nd dose and what would happen in case of administration of a 3rd dose. No vaccine administered in current reporter facility at the moment. The reporter did not consent to follow-up.
Age: 2.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo reconstituted with non-approved diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 2-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA689A, expiry date 20th October 2022) for prophylaxis.   On 24th November 2021, the patient received the 1st dose of Menveo. On 24th November 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.  Additional details were provided as follows: The nurse reported that the patient received dose of Menveo vaccine that was reconstituted with a non-approved diluent, which led to wrong solution used in drug reconstitution. No further information reported. The reporter consented to follow-up.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Body temperature, Malaise, Pain, Physical examination, Pyrexia
Clinical narrative: CONVULSION; SPOTS ON LEFT LOWER ARM TOWARDS OUTSIDE/COVERED FROM HEAD TO TOE; PATIENT REACTED TO COVID19 VACCINE; ACHED ALL OVER; SHAKING; NOT FELT GOOD; HIGH FEVER; This spontaneous report received from a patient concerned a 56 year adult old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included abstained from alcohol. Patient had no known allergies and had no tobacco use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: UNKNOWN) dose was not reported, 1 total administered on an unspecified date in FEB-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: Skyrizi (risankizumab) (solution for injection, subcutaneous, batch number was not reported) dose was not reported, 1 time every 1 day, from 2020 for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date in 2021, the patient experienced convulsion, spots on left lower arm towards outside that covered from head to toe. The Skyrizi had cleared it all up. He had reacted to the Covid-19 vaccine and had convulsion, fever, ached all over and was unable to go to work as he did not felt good at all for about a day. He had missed a day at work due to shaking. The physician had advised to give a little bit of time about convulsions, just that the body was fighting at the time of reporting. He had missed a 150 milligram Skyrizi dose due to delivery issue. She had physical examination and everything was fine and normal. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) not reported, and Physical examination (NR: not provided) not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of risankizumab was not changed. The patient recovered from convulsion, spots on left lower arm towards outside/covered from head to toe, shaking, not felt good, and high fever, and the outcome of patient reacted to covid19 vaccine and ached all over was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211215241-COVID-19 VACCINE AD26.COV2.S-convulsion. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19, UNK
Symptoms: Seizure, Skin disorder, Tremor, Vaccination complication
Clinical narrative: CONVULSION; SPOTS ON LEFT LOWER ARM TOWARDS OUTSIDE/COVERED FROM HEAD TO TOE; PATIENT REACTED TO COVID19 VACCINE; ACHED ALL OVER; SHAKING; NOT FELT GOOD; HIGH FEVER; This spontaneous report received from a patient concerned a 56 year adult old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included abstained from alcohol. Patient had no known allergies and had no tobacco use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: UNKNOWN) dose was not reported, 1 total administered on an unspecified date in FEB-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: Skyrizi (risankizumab) (solution for injection, subcutaneous, batch number was not reported) dose was not reported, 1 time every 1 day, from 2020 for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date in 2021, the patient experienced convulsion, spots on left lower arm towards outside that covered from head to toe. The Skyrizi had cleared it all up. He had reacted to the Covid-19 vaccine and had convulsion, fever, ached all over and was unable to go to work as he did not felt good at all for about a day. He had missed a day at work due to shaking. The physician had advised to give a little bit of time about convulsions, just that the body was fighting at the time of reporting. He had missed a 150 milligram Skyrizi dose due to delivery issue. She had physical examination and everything was fine and normal. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) not reported, and Physical examination (NR: not provided) not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of risankizumab was not changed. The patient recovered from convulsion, spots on left lower arm towards outside/covered from head to toe, shaking, not felt good, and high fever, and the outcome of patient reacted to covid19 vaccine and ached all over was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211215241-COVID-19 VACCINE AD26.COV2.S-convulsion. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Pain in extremity, Pericarditis
Clinical narrative: PERICARDITIS; PAINS AND NEEDLES ON LEGS AND FEET; This spontaneous report received from a patient concerned a 28 year old male. The patient's weight was 165 pounds, and height was 73 inches. The patient's concurrent conditions included: alcohol use in moderation as there was no time to drink, and other pre-existing medical conditions included: The patient had no medical history, had no family history of heart issues, no medication and had no known allergies. The patient participated in activities related to martial arts, rugby. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: UNKNOWN) dose was not reported, 1 total administered on 02-OCT-2021 at around 09:00 for prophylactic vaccination (dose number in series 1) on right arm. No concomitant medications were reported.  On 02-OCT-2021, the patient experienced symptoms 8 hours post vaccination. The patient stayed at vaccination place for 10-15 minutes and biked back home and had dinner at a restaurant near house, while walking back to apartment the patient started to had extremely high heart rate. The patient went to apartment and then to hospital. At hospital the patient was diagnosed with pericarditis and was admitted there. The patient had complaints of pains and needles on legs and feet, palpitations with extraneous exercise, specifically cardio. As per consumer, the patient's resting heart rate was around 55 beats per minutes (bpm), and sometimes even in 40s, and in between 40s and 50s bpm, but post vaccination the heart rate was over 130 bpm and stayed over 100 bpm until 09:00-10:00, the day after vaccination, on 03-OCT-2021. The patient was being in follow up with cardiologist as the heart issues were not resolved. The patient was hospitalized for 2 days and was discharged on 03-OCT-2021. The patient had an emergency room visit for extremely high heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pericarditis, and the outcome of pains and needles on legs and feet was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211219890-covid-19 vaccine ad26.cov2.s-pericarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211219890-covid-19 vaccine ad26.cov2.s- pains and needles on legs and feet. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pharyngeal swelling, Vaccination site reaction
Clinical narrative: Swelling in this throat; Left hand started swelling up quite a bi/was still swollen/It became puffy/Hand is still swollen a month later; ER diagnosed him with COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swelling in this throat), PERIPHERAL SWELLING (Left hand started swelling up quite a bi/was still swollen/It became puffy/Hand is still swollen a month later) and VACCINATION SITE REACTION (ER diagnosed him with COVID arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 022M20A and 011M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included AMOXICILLIN for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced PHARYNGEAL SWELLING (Swelling in this throat), PERIPHERAL SWELLING (Left hand started swelling up quite a bi/was still swollen/It became puffy/Hand is still swollen a month later) and VACCINATION SITE REACTION (ER diagnosed him with COVID arm). The patient was treated with APAP for Hand swelling and Vaccination site reaction, at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (Swelling in this throat) outcome was unknown and PERIPHERAL SWELLING (Left hand started swelling up quite a bi/was still swollen/It became puffy/Hand is still swollen a month later) and VACCINATION SITE REACTION (ER diagnosed him with COVID arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The pharmacy told him to go to the emergency room. ER diagnosed him with COVID arm. They gave him a strong shot of APAP, iced his hand, and kept it elevated. They stated that if it did not get better, then go to the doctors. He went to the urgent care for swelling in this throat and the doctor gave him steroids to help with the swelling of throat and hand. Hand was still swollen a month later.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site movement impairment
Clinical narrative: Left Arm was sore; Could hardly move her left arm after receiving first vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could hardly move her left arm after receiving first vaccine.) and PAIN IN EXTREMITY (Left Arm was sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could hardly move her left arm after receiving first vaccine.). On an unknown date, the patient experienced PAIN IN EXTREMITY (Left Arm was sore). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could hardly move her left arm after receiving first vaccine.) and PAIN IN EXTREMITY (Left Arm was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient was receiving concomitant medicine which include high Blood Pressure Medication. No treatment medication was provided. It was reported that patient received her second  Moderna Covid-19 vaccine on 31MAR2021  lot number 025A21A. The patient received her second vaccine in her left arm. The patient had no side effects to her second Moderna covid-19 vaccine.   This case was linked to MOD-2021-402994 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive COVID-19 test/had my booster on Sunday and today I tested positive for Covid; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive COVID-19 test/had my booster on Sunday and today I tested positive for Covid) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: two doses were Pfizer (2 doses). Past adverse reactions to the above products included No adverse event with two doses were Pfizer.    On 05-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID-19 test/had my booster on Sunday and today I tested positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive COVID-19 test/had my booster on Sunday and today I tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.  This is a spontaneous case concerning a 51-year-old, female patient, who received the first two doses of  another brand of COVID-19 vaccine (Pfizer). The patient received booster dose of mRNA-1723 vaccine and two days later was positively tested for COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Follow up received contains - Reporter occupation and reporter type updated, updated event verbatim.; Sender's Comments: This is a spontaneous case concerning a 51-year-old, female patient, who received the first two doses of  another brand of COVID-19 vaccine (Pfizer). The patient received booster dose of mRNA-1723 vaccine and two days later was positively tested for COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes behind her knees/rashes besides her knees 1st dose; This spontaneous case was reported by a non-health professional and describes the occurrence of RASH (rashes behind her knees/rashes besides her knees 1st dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-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 RASH (rashes behind her knees/rashes besides her knees 1st dose). At the time of the report, RASH (rashes behind her knees/rashes besides her knees 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-407587 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 28-Nov-2021 The patient died on 28-Nov-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            Company Comment - This case concerns a 73 year old male patient with no relevant medical history, who experienced the serious unexpected event of death. The event occurred 9 months after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.  No concomitant medications were provided. Treatment for the event was not provided.; Sender's Comments: This case concerns a 73 year old male patient with no relevant medical history, who experienced the serious unexpected event of death. The event occurred 9 months after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Exercise tolerance decreased, Fatigue
Clinical narrative: Total fatigue. Played pickleball, one game and rested a half hour. Couldn't play another. Dizzy, lightheaded. Fine if I just laid around the house. Symptoms remained the same for close to a month, slowly improving. Took 3 months for symptoms to completely go away.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: Blister filled with liquid underarm
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Ocular hyperaemia
Clinical narrative: The white part of my eye has turned red. The intensity of red varies. The veins are NOT showing like typical blood shot eyes. My General Practitioner knows about it and has no given me advice other than to see the eye specialist. The Eye Specialist did not solve it. They tried different glaucoma eye drops nothing worked.  The eye drop Lumify give some and varying amount of comfort
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Disorientation, Dyspnoea, Hepatic enzyme abnormal, Hyperhidrosis
Clinical narrative: On 12/01/2021 I woke up with intense chest pain and short breath. I started sweating, felt nauseous, became disoriented and fainted. My partner called 911 and an ambulance took me to the ER. I saw a cardiologist on 12/10 &  it was seen through ultrasound that I have pericarditis. I am currently at home taking medication as prescribed; I am unable to work or do much physical activity.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Nausea, Pericarditis, Syncope
Clinical narrative: On 12/01/2021 I woke up with intense chest pain and short breath. I started sweating, felt nauseous, became disoriented and fainted. My partner called 911 and an ambulance took me to the ER. I saw a cardiologist on 12/10 &  it was seen through ultrasound that I have pericarditis. I am currently at home taking medication as prescribed; I am unable to work or do much physical activity.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Ipsilateral axillary lymph node swelling, fever, fatigue after day 1 of vaccination. Fever resolved, but lymph node  swelling still present and became tender to touch on day 2.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Presyncope, Vomiting
Clinical narrative: 1054 - Received vaccination. Asked to wait until 1109 for observation. 1103 - Pt ran to bathroom to vomit. Emerged to appear diaphoretic, distressed, and states that he "feels off".  Pt reports that he had COVID infection approx. 1 month prior to this date.  1105 - Placed in a reclining chair. Given apple juice. HR 75 bpm and regular. Monitored by on-site provider. 1110 - Pt states that he is "feeling better already" and appears improved. He wants to leave since his "time is up". Advised that it is best to stay for another 15 or so minutes to ensure he's recovered from probable vasovagal episode. Pt. declines. Advised to discuss this event with his PCP prior to 2nd dose and, if 2nd dose is advised, to ensure the staff are aware of this hx prior to vaccination. Pt. left site.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Muscle spasms, Pain, Pain in extremity
Clinical narrative: Excessive muscle cramps resulting in excessive leg pain, generalized pain and weakness, chills and fever. Tylenol taken. Symptoms resolving  on 12/12/2021
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Excessive muscle cramps resulting in excessive leg pain, generalized pain and weakness, chills and fever. Tylenol taken. Symptoms resolving  on 12/12/2021
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Diarrhoea haemorrhagic, Epistaxis, Full blood count, Headache
Clinical narrative: Patient developed headache, vomiting, epistaxis with vomiting and bloody diarrhea the day after the Pfizer injection. Symptoms lasted for 2 days. Mother brought to ED for nausea and was concerned symptoms would return and worsen.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: International normalised ratio, Lipase, Metabolic function test, Nausea, Vomiting
Clinical narrative: Patient developed headache, vomiting, epistaxis with vomiting and bloody diarrhea the day after the Pfizer injection. Symptoms lasted for 2 days. Mother brought to ED for nausea and was concerned symptoms would return and worsen.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: Skin writing Helps with I use cortizone-10 (1%) and allergy medicine (loratadine 10mg antihistamine)
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash erythematous
Clinical narrative: Periodic episodes of itchy skin in different parts of body.  Area of body such as arms, legs, neck will itch intensely for 10 minutes then will subside.  Occurs several times a day & night in various areas.  Sometimes accompanied by rashy/red skin but rash doesn't linger.   Has been occurring for 2 weeks.  Taking Benadryl and Claritin control the itching.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dyspnoea, Palpitations
Clinical narrative: Heart pounding heard, short of breath , arm pit pain
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Blood test abnormal, Cardiac discomfort, Electrocardiogram normal, Extra dose administered
Clinical narrative: Second shot made me tired and pain in the kidney areas, headache, and feeling of fever (went away after two days). Third shot (booster) made me really sick (high/strong pain and stretch/heavy feeling around the kidney area and heart, a lot of pain in the leg joints, left arm pain and stretch, headache).  Heart areas stretch and arm pain stayed for more than 10 days.  Feeling of tiredness and sleepiness stayed for 5 to 6 days.  As a precaution for heart, took 81 mg aspirin two times a day for a few days, doctor checked heart, EKG, blood test, everything was normal; one of the blood tests revealed some kind of inflammation (which doctor assumed could be due to one of the booster vaccine side effects). Doctor asked me to submit the vaccine side effect info for awareness.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Inflammation, Pain in extremity
Clinical narrative: Second shot made me tired and pain in the kidney areas, headache, and feeling of fever (went away after two days). Third shot (booster) made me really sick (high/strong pain and stretch/heavy feeling around the kidney area and heart, a lot of pain in the leg joints, left arm pain and stretch, headache).  Heart areas stretch and arm pain stayed for more than 10 days.  Feeling of tiredness and sleepiness stayed for 5 to 6 days.  As a precaution for heart, took 81 mg aspirin two times a day for a few days, doctor checked heart, EKG, blood test, everything was normal; one of the blood tests revealed some kind of inflammation (which doctor assumed could be due to one of the booster vaccine side effects). Doctor asked me to submit the vaccine side effect info for awareness.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Renal disorder, Renal pain, Somnolence
Clinical narrative: Second shot made me tired and pain in the kidney areas, headache, and feeling of fever (went away after two days). Third shot (booster) made me really sick (high/strong pain and stretch/heavy feeling around the kidney area and heart, a lot of pain in the leg joints, left arm pain and stretch, headache).  Heart areas stretch and arm pain stayed for more than 10 days.  Feeling of tiredness and sleepiness stayed for 5 to 6 days.  As a precaution for heart, took 81 mg aspirin two times a day for a few days, doctor checked heart, EKG, blood test, everything was normal; one of the blood tests revealed some kind of inflammation (which doctor assumed could be due to one of the booster vaccine side effects). Doctor asked me to submit the vaccine side effect info for awareness.
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site reaction, Joint swelling, Peripheral swelling, Pruritus
Clinical narrative: Moderna Vaccine EUA- Booster dose: At vaccine clinic, giving booster (3rd dose 0.25ml) Moderna vaccine to long term care employee at 8:10.  During requested 15 minute waiting period patient developed about 1/2 dollar round red area around injection site and was feeling something in her elbow.  She reports on her 1st dose she had a swollen red arm later in the day and the elbow was feeling similiar. Administered Benadryl dose at 8:26.  Continued to monitor patient for 20 minutes afterward.  At 8:50 patient reported she was still a little itchy.  Her red area was lighter in color.  I asked if she would like an Epi-pen dose and she refused.  I continued to check on her for 15 minutes and she left the facility on her own.  Went to ED 12/2/21 at 1904, where patient reported itchiness of throat and small papular rash noted. Patient received  IV Benadryl, Pepcid and Solu-Medrol, which improved her symptoms. Doubt anaphylaxis since not given epinephrine. Continued on a Medrol Dosepak and continue taking over-the-counter Benadryl and Pepcid.
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Rash papular, Throat irritation
Clinical narrative: Moderna Vaccine EUA- Booster dose: At vaccine clinic, giving booster (3rd dose 0.25ml) Moderna vaccine to long term care employee at 8:10.  During requested 15 minute waiting period patient developed about 1/2 dollar round red area around injection site and was feeling something in her elbow.  She reports on her 1st dose she had a swollen red arm later in the day and the elbow was feeling similiar. Administered Benadryl dose at 8:26.  Continued to monitor patient for 20 minutes afterward.  At 8:50 patient reported she was still a little itchy.  Her red area was lighter in color.  I asked if she would like an Epi-pen dose and she refused.  I continued to check on her for 15 minutes and she left the facility on her own.  Went to ED 12/2/21 at 1904, where patient reported itchiness of throat and small papular rash noted. Patient received  IV Benadryl, Pepcid and Solu-Medrol, which improved her symptoms. Doubt anaphylaxis since not given epinephrine. Continued on a Medrol Dosepak and continue taking over-the-counter Benadryl and Pepcid.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Vertigo and dizziness
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: VACCINATOR INJECTED 12 Y/O PATIENT WITH 0.2CC PFIZER PEDS DOSE RATHER THAN THE PFIZER 0.3CC 12 YRS AND UP DOSE
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata
Clinical narrative: Hair loss/ alopecia areata.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: VACCINATOR INJECTED PFIZER PEDS DOSE TO LEFT ARM AND RIGHT ARM INSTEAD OF 1 SHOT OF 12 Y/O AND ABOVE PFIZER COVID-19 VACCINE
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Constipation, Menstrual disorder
Clinical narrative: Since having the vaccination I have experienced strange progressive changes to my menstrual cycle which was up until the second vaccination a predictable 28 day cycle!! I am now experiencing a 21 day cycle. A month prior to the vaccine my hormones were checked via blood test and were perfect 'no perimenupause ' symptoms or signs.  I have also suffered a slowing of my bowel to the point of relying on laxative and fibre supplements otherwise the chronic constipation almost shuts the bowel down. I am seeing a gastroenterologist tomorrow! These symptoms are slow progressing and I am not alone 3 other women between 35-52 are experiencing similar menstrual and bowel changes since their pfizer!! This needs more research....
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Arthralgia, Blood test, Cardiac stress test, Chest X-ray
Clinical narrative: Cold lower legs (rest of body and head felt hot), shooting pain left leg, throbbing left knee (though had broke that patella 6 years ago). Lightheaded at times (bending over or exertion).  Joint pain. Tired.These symptoms lasted on and off for weeks and months and continued after 2nd shot and booster.  Especially cold lower legs. During August, For about 10 days, the pain in left leg was so bad at times I couldn't put weight on it.  Mild fever for very limited time (couple days at most) Chest pain (not excruciating, but unsettling) and slight short of breath...... these started end of July and continue, though chest pain happens less often now. Not sure of Diagnosis or cause. No treatment other than some testing. Moderna second vaccine (lot 039B21A) was ON 4/30/2021 And Booster Moderna (lot 029H21B) was on 12/07/2021 (with some reservation. because of the chest pains and leg issues). And again, still, cold lower legs.  Have had  a few episodes of the chest pains, and have had joint pain.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Electrocardiogram, Electrocardiogram Q waves
Clinical narrative: Cold lower legs (rest of body and head felt hot), shooting pain left leg, throbbing left knee (though had broke that patella 6 years ago). Lightheaded at times (bending over or exertion).  Joint pain. Tired.These symptoms lasted on and off for weeks and months and continued after 2nd shot and booster.  Especially cold lower legs. During August, For about 10 days, the pain in left leg was so bad at times I couldn't put weight on it.  Mild fever for very limited time (couple days at most) Chest pain (not excruciating, but unsettling) and slight short of breath...... these started end of July and continue, though chest pain happens less often now. Not sure of Diagnosis or cause. No treatment other than some testing. Moderna second vaccine (lot 039B21A) was ON 4/30/2021 And Booster Moderna (lot 029H21B) was on 12/07/2021 (with some reservation. because of the chest pains and leg issues). And again, still, cold lower legs.  Have had  a few episodes of the chest pains, and have had joint pain.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Pain, Pain in extremity, Peripheral coldness
Clinical narrative: Cold lower legs (rest of body and head felt hot), shooting pain left leg, throbbing left knee (though had broke that patella 6 years ago). Lightheaded at times (bending over or exertion).  Joint pain. Tired.These symptoms lasted on and off for weeks and months and continued after 2nd shot and booster.  Especially cold lower legs. During August, For about 10 days, the pain in left leg was so bad at times I couldn't put weight on it.  Mild fever for very limited time (couple days at most) Chest pain (not excruciating, but unsettling) and slight short of breath...... these started end of July and continue, though chest pain happens less often now. Not sure of Diagnosis or cause. No treatment other than some testing. Moderna second vaccine (lot 039B21A) was ON 4/30/2021 And Booster Moderna (lot 029H21B) was on 12/07/2021 (with some reservation. because of the chest pains and leg issues). And again, still, cold lower legs.  Have had  a few episodes of the chest pains, and have had joint pain.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Ultrasound Doppler, Weight bearing difficulty
Clinical narrative: Cold lower legs (rest of body and head felt hot), shooting pain left leg, throbbing left knee (though had broke that patella 6 years ago). Lightheaded at times (bending over or exertion).  Joint pain. Tired.These symptoms lasted on and off for weeks and months and continued after 2nd shot and booster.  Especially cold lower legs. During August, For about 10 days, the pain in left leg was so bad at times I couldn't put weight on it.  Mild fever for very limited time (couple days at most) Chest pain (not excruciating, but unsettling) and slight short of breath...... these started end of July and continue, though chest pain happens less often now. Not sure of Diagnosis or cause. No treatment other than some testing. Moderna second vaccine (lot 039B21A) was ON 4/30/2021 And Booster Moderna (lot 029H21B) was on 12/07/2021 (with some reservation. because of the chest pains and leg issues). And again, still, cold lower legs.  Have had  a few episodes of the chest pains, and have had joint pain.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no other issues; incorrect storage PROQUAD was administered; This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 23-NOV-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U019289 exp date 15-DEC-2022) (dose and route not reported) that was exposed to a temperature excursion of 29.9 F for a time frame of 3 hours and 2 minutes. The maximum temperature was -1.6 °C and had not back in range at the time of the report.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster, Ill-defined disorder
Clinical narrative: loss of vision; other zoster-related conditions; Shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 14-DEC-2015, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles (herpes zoster) and zoster-related conditions.  On an unspecified date, subsequent to the patient vaccination, the patient was treated by a physician for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) vaccination: shingles, Loss of vision and herpes zoster-related injuries (ill-defined disorder). As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, Plaintiff had and would be continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions. At the reporting time, the outcome of the event was unknown.  The reporter considered the events of shingles, loss of vision and herpes zoster-related injuries (ill-defined disorder) to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of loss of vision was considered as medically significant.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AE occurred/ No other AE; patient received a dose of MMRII on 11/19/2021 and product expired on 11/5/2021; This spontaneous report was received from a pharmacist referring to a patient of unreported age and gender. The patient's relevant medical history, drug reactions or allergies, and concomitant medications were not provided.  On 19-NOV-2021, the patient was vaccinated with one expired dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) for prophylaxis (lot number S035355, expiration date 05-NOV-2021; dose number, vaccination scheme, route of administration, and anatomical location were not reported).   The product did not have any known temperature excursions. The pharmacist confirmed no other adverse events (AE) occurred (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Vaccine positive rechallenge
Clinical narrative: itchy scalp / itchiness became worse / from head down to shoulders; itchiness became worse; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pruritus (received 1st dose on 17th June 2021, refer case US2021250207).   On 9th September 2021, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pruritus and condition aggravated. The patient was treated with gabapentin. On an unknown date, the outcome of the pruritus was not recovered/not resolved and the outcome of the condition aggravated was unknown.   It was unknown if the reporter considered the pruritus and condition aggravated to be related to Shingrix.  Additional details were provided as follows: This case was self-reported by the patient. The age at vaccination was not reported. The patient received dose of Shingrix and her itchiness became worse and experienced itchiness from head down to shoulders. The patient visited dermatologist and was put on Gabapentin. The patient still experienced itchiness. Medical Disclaimer was given and medical information phone number was provided. The patient was referred to the health care professional. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021250207:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the diluent portion of the Menveo; received only the diluent portion of the Menveo; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient received only the diluent portion of the Shingrix, which led to inappropriate preparation of medication and Inappropriate dose of vaccine administered. The reporter mentioned no symptoms were reported. The reporter stated no lot number, expiration date or administration date were provided. The reporter consented to follow up via email.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a consumer via social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination (dose number series 1). 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 reporter stated that the neighbor experienced stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211222253.; Sender's Comments: V0: 20211223284-Covid-19 vaccine ad26.cov2.s-Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 42.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 42-year-old patient. The patient's pertinent medical history, concomitant therapies, and previous drug reactions or allergies were not reported. On 30-NOV-2021, the 42-year-old patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (RHA) (PROQUAD) at a dose of 0.5 milliliters (ml) as prophylaxis (drug use in unapproved age group) (lot number T030760 has been verified to be valid, the expiration date was not reported but upon internal verification was established as 08-MAR-2022; vaccination scheme, route of administration, and anatomical location of vaccination were not reported). No additional adverse events (AE) were reported.