chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient had already received Pfizer vaccine from another healthcare facility early in the year. She came in to pharmacy for a Covid test, but accidentally said Covid Vaccine. She filled out the screening questionnaire requesting the Moderna vaccine, which was then administered by the pharmacist on duty. Patient returned the next day and reported that she should not have been given the vaccine, rather a covid test.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: buzzing / ringing in the ears.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received Janssen Vaccine 03/05/21 from a different provider,  tried to get second pfizer 08/12/21
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: High fever for 24 hours, Nausea
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: No adverse reactions occurred. Patient was administered 1 dose of spoiled vaccine. Vial was an open vial left in cooler on 8/4/2021 and was not discarded at end of day. It was misidentified on 8/6/2021 as an active and good vial and used to vaccinate 3 patients with spoiled doses.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blister, Diarrhoea, Ear swelling
Clinical narrative: During the first 5 days after injection, had tiredness, headache, muscle pain, back ache, headache, joint pain, fever, nausea, felt unwell, swollen lymph nodes, diarrhea, arm pain. At 2pm on the 2nd day after the injection, had upper lip twitches, and right side of the face had 50% feeling. Had facial tingling, itching. This lasted 2 days, thought occasion lip twitches lasted several more days. Day 5 developed small blisters on right hand and left side of face, near the ear. This spread into more bumps, and swollen face, neck, ear (and eye lids one evening) with hives.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Lymphadenopathy, Malaise
Clinical narrative: During the first 5 days after injection, had tiredness, headache, muscle pain, back ache, headache, joint pain, fever, nausea, felt unwell, swollen lymph nodes, diarrhea, arm pain. At 2pm on the 2nd day after the injection, had upper lip twitches, and right side of the face had 50% feeling. Had facial tingling, itching. This lasted 2 days, thought occasion lip twitches lasted several more days. Day 5 developed small blisters on right hand and left side of face, near the ear. This spread into more bumps, and swollen face, neck, ear (and eye lids one evening) with hives.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Myalgia, Nausea, Pain in extremity, Pruritus
Clinical narrative: During the first 5 days after injection, had tiredness, headache, muscle pain, back ache, headache, joint pain, fever, nausea, felt unwell, swollen lymph nodes, diarrhea, arm pain. At 2pm on the 2nd day after the injection, had upper lip twitches, and right side of the face had 50% feeling. Had facial tingling, itching. This lasted 2 days, thought occasion lip twitches lasted several more days. Day 5 developed small blisters on right hand and left side of face, near the ear. This spread into more bumps, and swollen face, neck, ear (and eye lids one evening) with hives.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Swelling face, Swelling of eyelid, Urticaria
Clinical narrative: During the first 5 days after injection, had tiredness, headache, muscle pain, back ache, headache, joint pain, fever, nausea, felt unwell, swollen lymph nodes, diarrhea, arm pain. At 2pm on the 2nd day after the injection, had upper lip twitches, and right side of the face had 50% feeling. Had facial tingling, itching. This lasted 2 days, thought occasion lip twitches lasted several more days. Day 5 developed small blisters on right hand and left side of face, near the ear. This spread into more bumps, and swollen face, neck, ear (and eye lids one evening) with hives.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: Rash on arms and legs - raised, itches, no relief from over the counter medication.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Head injury, Tongue biting
Clinical narrative: Patient received vaccine and was seated in a chair waiting for 15 minute observation period, after about 5 to 10 minutes patient fell out of chair and hit head on ground and bit his tongue, 911 was called and he was taken via ambulance to hospital for further evaluation
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Blood test abnormal, Joint effusion, Joint swelling, Musculoskeletal stiffness
Clinical narrative: Stiffness and Pain,  all over body more in shoulders and knees. Also Body aches. Right ankle swelling
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Rheumatoid arthritis, X-ray abnormal
Clinical narrative: Stiffness and Pain,  all over body more in shoulders and knees. Also Body aches. Right ankle swelling
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient's mom mistakenly provided incorrect date of birth (12yo instead of 11yo) when patient received the first dose. When spoke with patient's doctor, she said patient is not experiencing any side effects and not to give 2nd dose until patient turns 12 yo
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Headache, Pain in extremity, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Patient's mom mistakenly provided incorrect date of birth (12yo instead of 11yo) when patient received the first dose. When spoke with patient's doctor, she said patient is not experiencing any side effects and not to give 2nd dose until patient turns 12 yo
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient's mom mistakenly provided incorrect date of birth (12yo instead of 11yo) when patient received the first dose. When spoke with patient's doctor, she said patient is not experiencing any side effects and not to give 2nd dose until patient turns 12 yo
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Night sweats, Pyrexia
Clinical narrative: bed was wet and his pillow/sweats at night have continued; Ran a temperature Sunday and Monday; really bad tired; no energy; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (really bad tired), ASTHENIA (no energy), DECREASED APPETITE (no appetite), NIGHT SWEATS (bed was wet and his pillow/sweats at night have continued) and PYREXIA (Ran a temperature Sunday and Monday) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO reported medical history).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Jan-2021, the patient experienced FATIGUE (really bad tired), ASTHENIA (no energy) and DECREASED APPETITE (no appetite). On 10-Jan-2021, the patient experienced NIGHT SWEATS (bed was wet and his pillow/sweats at night have continued) and PYREXIA (Ran a temperature Sunday and Monday). On 09-Jan-2021, FATIGUE (really bad tired), ASTHENIA (no energy) and DECREASED APPETITE (no appetite) had resolved. At the time of the report, NIGHT SWEATS (bed was wet and his pillow/sweats at night have continued) and PYREXIA (Ran a temperature Sunday and Monday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.   No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Feeling abnormal
Clinical narrative: significant light headedness; significant light headedness; little balance issue; mental fogginess; feel horrible; not feeling good; A spontaneous report was received from a health care professional(HCP) concerning a  46Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Dizziness, Confusion state, Balance disorder, Feeling abnormal, Feeling abnormal,    The patient's medical history was not provided.  On 09-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 10-JAN-2021, The patient experienced the events list significant light headedness, mental fogginess, little balance issue, feel horrible and not feeling good.   Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On date, the outcome of the events significant light headedness was unknown,mental fogginess was unknown,little balance issue was unknown,feel horrible was unknown and not feeling good was unknown.   The reporter assessed the events significant light headedness,mental fogginess,little balance issue,feel horrible and not feeling good related to study drug is unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: persistent, irritating runny nose; soreness in the arm; A spontaneous report was received from a consumer concerning a  Years-old male female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, persistent, irritating runny nose and soreness in the arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15/Jan/2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: or unknown) intramuscularly in the location for prophylaxis of COVID-19 infection.  On 16-JAN-2021, the patient experienced event, soreness in the arm and on  17-JAN-2021, the patient experienced event, persistent, irritating runny nose.  Treatment medications included neosynephrine and an antihistamine.  Action taken with mRNA-1273 in response to the events, persistent, irritating runny nose and soreness in the arm was not reported.   On 18-JAN-2021 the outcome of event, persistent, irritating runny nose was recovered and on an unknown date, the outcome of event, soreness in the arm was not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: Pain under her left arm; Lump under her arm, which she believes is a swollen lymph node; Felt like she was getting a cold; Ears hurt; Tired; Arm hurt at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Arm hurt at the injection site), FATIGUE (Tired), PAIN IN EXTREMITY (Pain under her left arm), LYMPHADENOPATHY (Lump under her arm, which she believes is a swollen lymph node) and CHILLS (Felt like she was getting a cold) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history found).    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt at the injection site). On 10-Jan-2021, the patient experienced FATIGUE (Tired). On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain under her left arm), LYMPHADENOPATHY (Lump under her arm, which she believes is a swollen lymph node), CHILLS (Felt like she was getting a cold) and EAR PAIN (Ears hurt). On 11-Jan-2021, VACCINATION SITE PAIN (Arm hurt at the injection site) had resolved. At the time of the report, FATIGUE (Tired), PAIN IN EXTREMITY (Pain under her left arm), LYMPHADENOPATHY (Lump under her arm, which she believes is a swollen lymph node), CHILLS (Felt like she was getting a cold) and EAR PAIN (Ears hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication and treatment provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain under her left arm; Lump under her arm, which she believes is a swollen lymph node; Felt like she was getting a cold; Ears hurt; Tired; Arm hurt at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Arm hurt at the injection site), FATIGUE (Tired), PAIN IN EXTREMITY (Pain under her left arm), LYMPHADENOPATHY (Lump under her arm, which she believes is a swollen lymph node) and CHILLS (Felt like she was getting a cold) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history found).    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt at the injection site). On 10-Jan-2021, the patient experienced FATIGUE (Tired). On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain under her left arm), LYMPHADENOPATHY (Lump under her arm, which she believes is a swollen lymph node), CHILLS (Felt like she was getting a cold) and EAR PAIN (Ears hurt). On 11-Jan-2021, VACCINATION SITE PAIN (Arm hurt at the injection site) had resolved. At the time of the report, FATIGUE (Tired), PAIN IN EXTREMITY (Pain under her left arm), LYMPHADENOPATHY (Lump under her arm, which she believes is a swollen lymph node), CHILLS (Felt like she was getting a cold) and EAR PAIN (Ears hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication and treatment provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: vaccine exposure during pregnancy; This spontaneous pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnant (Live, full -term child birth,  Son born with Cleft lip.) on 15-Apr-2019. Concurrent medical conditions included Asthma since 2010 and Alcohol use (ocasionally no until second trimester). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], TECHNETIUM TC 99M EXAMETAZIME (CERETEC [TECHNETIUM TC 99M EXAMETAZIME]) and PARACETAMOL (TYLENOL).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 31-May-2020 and the estimated date of delivery was 12-Mar-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 14-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2020, Pregnancy test: positive (Positive) Positive. On 20-Jul-2020, Ultrasound: unknown. On 12-Oct-2020, Ultrasound: unknown. On 02-Nov-2020, Ultrasound: unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reported estimated date of conception 16 JUN2020. No treatment related information has been reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: Internal review on 28-Jul-2021 resulted in updates to the pregnancy details.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Reaction to excipient
Clinical narrative: Diarrhea; vaccine has a laxative in it; 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 DIARRHOEA (Diarrhea) and REACTION TO EXCIPIENT (vaccine has a laxative in it) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-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 DIARRHOEA (Diarrhea) and REACTION TO EXCIPIENT (vaccine has a laxative in it). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company Comment: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Glucose tolerance test, Pregnancy test, Prenatal screening test, Ultrasound abdomen
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 35-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage (5 or 6 weeks) on 01-Feb-2020. Concurrent medical conditions included Low blood pressure (about the same) since 01-Jan-2006, Anemia (about the same, take iron medications) since 01-Jan-2006 and Drug allergy (Allergy to Sulfur). Concomitant products included IRON from 01-Sep-2020 to an unknown date for Anemia, Prenatal vitamins and supplements from 01-Jul-2020 to an unknown date for Pregnancy.   On 23-Jan-2021 at 7:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Jul-2020 and the estimated date of delivery was 07-Apr-2021. On 23-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy. The delivery occurred  on 30-Mar-2021, which was reported as Full-term. For neonate 1, The outcome was reported as Delivered NOS. Estimated date of conception: 14-Jul-2020. On 23-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2020, Glucose tolerance test: normal normal (normal) normal. On 15-Jan-2020, Prenatal screening test: normal normal (normal) Week 10- normal. On 15-Jan-2020, Ultrasound abdomen: normal normal (normal) week 20 and next is week 32. On 27-Jul-2020, Pregnancy test: positive positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Past pregnancy included: Live, full term birth on 28-May-2015; Live, full term birth on 16-Aug-2017.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Updated delivery date, and suspect product dose details.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Blood pressure increased, Blood pressure measurement, Dyspnoea, Headache
Clinical narrative: Intubated her because not breathing properly; Not talking; Threw up; headache; Blood pressure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Intubated her because not breathing properly), APHASIA (Not talking), BLOOD PRESSURE INCREASED (Blood pressure), VOMITING (Threw up) and HEADACHE (headache) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Sleep disorder, SODIUM BICARBONATE, VITAMIN B NOS, VITAMIN D [VITAMIN D NOS], ZINC and POTASSIUM for an unknown indication.  On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 24-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure) and HEADACHE (headache).   On 25-Jan-2021, the patient experienced DYSPNOEA (Intubated her because not breathing properly), APHASIA (Not talking) and VOMITING (Threw up).   At the time of the report, DYSPNOEA (Intubated her because not breathing properly) and APHASIA (Not talking) had not resolved and BLOOD PRESSURE INCREASED (Blood pressure), VOMITING (Threw up) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Blood pressure measurement: 210/100 High and 130/100 High. On 25-Jan-2021, Blood pressure measurement: 180 High.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Intubated her because not breathing properly; Not talking; Threw up; headache; Blood pressure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Intubated her because not breathing properly), APHASIA (Not talking), BLOOD PRESSURE INCREASED (Blood pressure), VOMITING (Threw up) and HEADACHE (headache) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Sleep disorder, SODIUM BICARBONATE, VITAMIN B NOS, VITAMIN D [VITAMIN D NOS], ZINC and POTASSIUM for an unknown indication.  On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 24-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure) and HEADACHE (headache).   On 25-Jan-2021, the patient experienced DYSPNOEA (Intubated her because not breathing properly), APHASIA (Not talking) and VOMITING (Threw up).   At the time of the report, DYSPNOEA (Intubated her because not breathing properly) and APHASIA (Not talking) had not resolved and BLOOD PRESSURE INCREASED (Blood pressure), VOMITING (Threw up) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Blood pressure measurement: 210/100 High and 130/100 High. On 25-Jan-2021, Blood pressure measurement: 180 High.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysaesthesia, Feeling abnormal, Flushing, Headache
Clinical narrative: full body hot flush; flushing; Hives; red with dots all over her stomach; Rash along her stomach; Rapid heart beat; Difficult to go to sleep; little rash on her stomach; felt weird; Residual weakness; Immediate sensation all over body; Tingling; Headache; This spontaneous case was reported by a physician and describes the occurrence of DYSAESTHESIA (Immediate sensation all over body), PARAESTHESIA (Tingling), FEELING ABNORMAL (felt weird), ASTHENIA (Residual weakness) and RASH ERYTHEMATOUS (Rash along her stomach) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergy to codeine). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, ROSUVASTATIN CALCIUM (ROSUVASTIN) for Hypercholesterolemia, ESTRADIOL (ESTROGEN) for Menopause.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced DYSAESTHESIA (Immediate sensation all over body), PARAESTHESIA (Tingling), FEELING ABNORMAL (felt weird), ASTHENIA (Residual weakness), HEART RATE INCREASED (Rapid heart beat), INSOMNIA (Difficult to go to sleep), RASH (little rash on her stomach) and HEADACHE (Headache). On 15-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Rash along her stomach). On an unknown date, the patient experienced HOT FLUSH (full body hot flush) and FLUSHING (flushing). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DYSAESTHESIA (Immediate sensation all over body), PARAESTHESIA (Tingling), FEELING ABNORMAL (felt weird), ASTHENIA (Residual weakness), RASH ERYTHEMATOUS (Rash along her stomach), HEART RATE INCREASED (Rapid heart beat), INSOMNIA (Difficult to go to sleep), RASH (little rash on her stomach), HEADACHE (Headache), HOT FLUSH (full body hot flush) and FLUSHING (flushing) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Tylenol was provided as treatment medication   This case was linked to MOD-2021-211651 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non significant follow up received on 07-jun-2021, Patient demographics updated, concomitant medications updated. 2nd dose details updated.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hot flush, Insomnia, Paraesthesia, Rash
Clinical narrative: full body hot flush; flushing; Hives; red with dots all over her stomach; Rash along her stomach; Rapid heart beat; Difficult to go to sleep; little rash on her stomach; felt weird; Residual weakness; Immediate sensation all over body; Tingling; Headache; This spontaneous case was reported by a physician and describes the occurrence of DYSAESTHESIA (Immediate sensation all over body), PARAESTHESIA (Tingling), FEELING ABNORMAL (felt weird), ASTHENIA (Residual weakness) and RASH ERYTHEMATOUS (Rash along her stomach) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergy to codeine). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, ROSUVASTATIN CALCIUM (ROSUVASTIN) for Hypercholesterolemia, ESTRADIOL (ESTROGEN) for Menopause.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced DYSAESTHESIA (Immediate sensation all over body), PARAESTHESIA (Tingling), FEELING ABNORMAL (felt weird), ASTHENIA (Residual weakness), HEART RATE INCREASED (Rapid heart beat), INSOMNIA (Difficult to go to sleep), RASH (little rash on her stomach) and HEADACHE (Headache). On 15-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Rash along her stomach). On an unknown date, the patient experienced HOT FLUSH (full body hot flush) and FLUSHING (flushing). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DYSAESTHESIA (Immediate sensation all over body), PARAESTHESIA (Tingling), FEELING ABNORMAL (felt weird), ASTHENIA (Residual weakness), RASH ERYTHEMATOUS (Rash along her stomach), HEART RATE INCREASED (Rapid heart beat), INSOMNIA (Difficult to go to sleep), RASH (little rash on her stomach), HEADACHE (Headache), HOT FLUSH (full body hot flush) and FLUSHING (flushing) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Tylenol was provided as treatment medication   This case was linked to MOD-2021-211651 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non significant follow up received on 07-jun-2021, Patient demographics updated, concomitant medications updated. 2nd dose details updated.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Urticaria
Clinical narrative: full body hot flush; flushing; Hives; red with dots all over her stomach; Rash along her stomach; Rapid heart beat; Difficult to go to sleep; little rash on her stomach; felt weird; Residual weakness; Immediate sensation all over body; Tingling; Headache; This spontaneous case was reported by a physician and describes the occurrence of DYSAESTHESIA (Immediate sensation all over body), PARAESTHESIA (Tingling), FEELING ABNORMAL (felt weird), ASTHENIA (Residual weakness) and RASH ERYTHEMATOUS (Rash along her stomach) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergy to codeine). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, ROSUVASTATIN CALCIUM (ROSUVASTIN) for Hypercholesterolemia, ESTRADIOL (ESTROGEN) for Menopause.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced DYSAESTHESIA (Immediate sensation all over body), PARAESTHESIA (Tingling), FEELING ABNORMAL (felt weird), ASTHENIA (Residual weakness), HEART RATE INCREASED (Rapid heart beat), INSOMNIA (Difficult to go to sleep), RASH (little rash on her stomach) and HEADACHE (Headache). On 15-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Rash along her stomach). On an unknown date, the patient experienced HOT FLUSH (full body hot flush) and FLUSHING (flushing). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DYSAESTHESIA (Immediate sensation all over body), PARAESTHESIA (Tingling), FEELING ABNORMAL (felt weird), ASTHENIA (Residual weakness), RASH ERYTHEMATOUS (Rash along her stomach), HEART RATE INCREASED (Rapid heart beat), INSOMNIA (Difficult to go to sleep), RASH (little rash on her stomach), HEADACHE (Headache), HOT FLUSH (full body hot flush) and FLUSHING (flushing) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Tylenol was provided as treatment medication   This case was linked to MOD-2021-211651 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non significant follow up received on 07-jun-2021, Patient demographics updated, concomitant medications updated. 2nd dose details updated.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: injection site soreness; This spontaneous case was reported by a non-health professional and describes the occurrence of INJECTION SITE PAIN (injection site soreness) in a patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (injection site soreness).   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was not reported.  At the time of the report, the outcome of injection site soreness outcome was not reported.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: whole body hurts; terrible headache; A spontaneous report was received from a consumer concerning a 80-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed headache and body pains.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not reported.  On 15 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 16 Jan 2021, the patient developed headache and body pains. Treatment for the event was not reported.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event, headache and body pains, was considered unknown.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Gait disturbance, Vertigo
Clinical narrative: dizzy with vertigo; could not walk; and slurred speech; This spontaneous case was reported by a consumer and describes the occurrence in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) and experienced events very dizzy with vertigo and could not walk and slurred speech.        The patient's medical history not provided.  On 14th JAN 2021, onset of the events, the patient received their one of two planned doses of mRNA-1273 intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.   The patient was treated with BARIUM SULFATE (FLUID) 14-Jan-2021 for Fluid and electrolyte imbalance in the emergency room.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.  On 14th JAN 2021, the outcome of the events dizziness, vertigo and speech resolved and  Walking difficulty not resolved.     Treatment given 1-bag of fluid and medicine for dizziness.  Upon in internal review on 21 May 2021, the age was corrected to unknown age.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: Upon internal review on 26 May 2021, it was discovered that the patient age was incorrectly captured as 121 years and DOB mentioned in source document was 01-Jan-1900, which was a MI error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Soreness at the injection site; A little bit swollen at the injection site; Injection site was pink like a rash; Arm is very itchy at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DISCOLOURATION (Injection site was pink like a rash), VACCINATION SITE PRURITUS (Arm is very itchy at the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE SWELLING (A little bit swollen at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). In January 2021, the patient experienced VACCINATION SITE DISCOLOURATION (Injection site was pink like a rash), VACCINATION SITE PRURITUS (Arm is very itchy at the injection site) and VACCINATION SITE SWELLING (A little bit swollen at the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Injection site was pink like a rash), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE SWELLING (A little bit swollen at the injection site) outcome was unknown and VACCINATION SITE PRURITUS (Arm is very itchy at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication included Diphenhydramine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Ear discomfort, Headache
Clinical narrative: Plugged ears; Arm hurts; Shoulder is soring; High fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (Plugged ears), VACCINATION SITE PAIN (Arm hurts), ARTHRALGIA (Shoulder is soring), PYREXIA (High fever) and CHILLS (Chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced EAR DISCOMFORT (Plugged ears), VACCINATION SITE PAIN (Arm hurts), ARTHRALGIA (Shoulder is soring), PYREXIA (High fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with IBUPROFEN at a dose of UNK UNK, q8h. At the time of the report, EAR DISCOMFORT (Plugged ears), VACCINATION SITE PAIN (Arm hurts), ARTHRALGIA (Shoulder is soring), PYREXIA (High fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Body temperature: 100 (High) 100 degree F to 101.9 degree F. On 17-Jan-2021, Body temperature: 101.9 (High) 100 degree F to 101.9 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up received on 25-Jun-2021 and contains no new information.; 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.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Plugged ears; Arm hurts; Shoulder is soring; High fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (Plugged ears), VACCINATION SITE PAIN (Arm hurts), ARTHRALGIA (Shoulder is soring), PYREXIA (High fever) and CHILLS (Chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced EAR DISCOMFORT (Plugged ears), VACCINATION SITE PAIN (Arm hurts), ARTHRALGIA (Shoulder is soring), PYREXIA (High fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with IBUPROFEN at a dose of UNK UNK, q8h. At the time of the report, EAR DISCOMFORT (Plugged ears), VACCINATION SITE PAIN (Arm hurts), ARTHRALGIA (Shoulder is soring), PYREXIA (High fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Body temperature: 100 (High) 100 degree F to 101.9 degree F. On 17-Jan-2021, Body temperature: 101.9 (High) 100 degree F to 101.9 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up received on 25-Jun-2021 and contains no new information.; 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.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: Very hard rash, 4 inches around, going up her neck; It was itchy; Arm hurt for 2 or 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (It was itchy), PAIN IN EXTREMITY (Arm hurt for 2 or 3 days) and RASH (Very hard rash, 4 inches around, going up her neck) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.    Co-suspect product included non-company product allergy for an unknown indication.    Concurrent medical conditions included Cholesterol. Concomitant products included Unkown.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started allergy (unknown route) at an unspecified dose. On 08-Jan-2021, the patient experienced PRURITUS (It was itchy) and PAIN IN EXTREMITY (Arm hurt for 2 or 3 days). On 11-Jan-2021, the patient experienced RASH (Very hard rash, 4 inches around, going up her neck). On 11-Jan-2021, PRURITUS (It was itchy) and PAIN IN EXTREMITY (Arm hurt for 2 or 3 days) outcome was unknown. At the time of the report, RASH (Very hard rash, 4 inches around, going up her neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Euphoric mood, Infection, Lymph node pain, Lymphadenopathy, Type IV hypersensitivity reaction
Clinical narrative: A little high from the vaccine; Redness of the injection site; Swelling of the injection site; Delayed hypersensitivity reaction; Infection; Lymph nodes tenderness; Lymph nodes swelling; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Delayed hypersensitivity reaction), INFECTION (Infection), EUPHORIC MOOD (A little high from the vaccine), VACCINATION SITE ERYTHEMA (Redness of the injection site) and VACCINATION SITE SWELLING (Swelling of the injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM LEVOMEFOLATE, DROSPIRENONE, ETHINYLESTRADIOL BETADEX CLATHRATE (BEYAZ), MINOXIDIL (ROGAINE), EPHEDRINE HYDROCHLORIDE (EPHEDRIN) and BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for Headache.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced LYMPH NODE PAIN (Lymph nodes tenderness) and LYMPHADENOPATHY (Lymph nodes swelling). On 13-Jan-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Delayed hypersensitivity reaction), INFECTION (Infection), VACCINATION SITE ERYTHEMA (Redness of the injection site) and VACCINATION SITE SWELLING (Swelling of the injection site). On 15-Jan-2021, the patient experienced EUPHORIC MOOD (A little high from the vaccine). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Delayed hypersensitivity reaction), INFECTION (Infection), EUPHORIC MOOD (A little high from the vaccine), VACCINATION SITE ERYTHEMA (Redness of the injection site), VACCINATION SITE SWELLING (Swelling of the injection site), LYMPH NODE PAIN (Lymph nodes tenderness) and LYMPHADENOPATHY (Lymph nodes swelling) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment were included Keflex, Zyrtec and Ice.; 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.