chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Gastrointestinal disorder, Injection site erythema, Injection site pain
Clinical narrative: pain, redness, and swelling at the injection site; pain, redness, and swelling at the injection site; swelling at the injection site; fever; muscle pain,; tiredness; upset stomach; GI problem is the worst; This case was reported by a consumer and described the occurrence of injection site pain in a 65-year-old 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, injection site erythema, injection site swelling, fever, muscle pain, tiredness, upset stomach and gastrointestinal disorder. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, fever, muscle pain, tiredness, upset stomach and gastrointestinal disorder were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, fever, muscle pain, tiredness, upset stomach and gastrointestinal disorder to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had most common side effects after vaccination. The patient experinced pain, redness, and swelling at the injection site, muscle pain, tiredness, fever, and upset stomach. According to patient gastrointestinal problem was worst but also had other events.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: pain, redness, and swelling at the injection site; pain, redness, and swelling at the injection site; swelling at the injection site; fever; muscle pain,; tiredness; upset stomach; GI problem is the worst; This case was reported by a consumer and described the occurrence of injection site pain in a 65-year-old 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, injection site erythema, injection site swelling, fever, muscle pain, tiredness, upset stomach and gastrointestinal disorder. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, fever, muscle pain, tiredness, upset stomach and gastrointestinal disorder were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, fever, muscle pain, tiredness, upset stomach and gastrointestinal disorder to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had most common side effects after vaccination. The patient experinced pain, redness, and swelling at the injection site, muscle pain, tiredness, fever, and upset stomach. According to patient gastrointestinal problem was worst but also had other events.
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: fever of 100.0; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 2nd dose of Shingrix. In January 2021, 28 hrs after receiving Shingrix, the patient experienced fever. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient received the vaccine 28 hours ago from date of reporting and ran into a fever of 100 degree F. The patient took some Tylenol.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: sore arms at the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (mild case of shingles experienced in 2008).   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows:     The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had sore arms at the injection site. The patient commented that patient was glad to receive the dose. For tolerance of 2nd dose, refer case US2021AMR025883. This case has been linked with US2021AMR025887 and US2021AMR025893, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR025887:same reporter US-GLAXOSMITHKLINE-US2021AMR025893:same reporter US-GLAXOSMITHKLINE-US2021AMR025883:same patient, same reporter, 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: sore arms at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (mild case of shingles in 2008). Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in October 2020, refer case US2021AMR025865).   In December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows:     The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had sore arms at the injection site. The patient commented that patient was glad to receive the dose. This case has been linked with US2021AMR025887 and US2021AMR025893, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR025887:same reporter US-GLAXOSMITHKLINE-US2021AMR025893:same reporter US-GLAXOSMITHKLINE-US2021AMR025865:same patient, same reporter, 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: arm is red and swollen at the injection site; arm is red and swollen at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2021, the patient received Shingrix. In February 2021, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient's arm was red and swollen at the injection site.  The patient asked if an ice pack can be put on arm to help the swelling go down.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: sore arm; pain / at injection site; swelling at injection site; shivering; fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-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 pain in arm, injection site pain, injection site swelling, shivering and fatigue. On an unknown date, the outcome of the pain in arm, injection site pain, injection site swelling, shivering and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injection site pain, injection site swelling, shivering and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix recently and at the time of reporting the patient experienced sore arm, pain and swelling at injection site, shivering, and fatigue. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 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 diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was mother-in-law of patient.  The patient experienced diarrhea after receiving what they believe was the Shingrix vaccine. The reporter did not consent to followup. This case linked with US2021005930 and US2021005937, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021005930:Same reporter US-GLAXOSMITHKLINE-US2021005937:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Vomiting
Clinical narrative: vomiting; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd October 2020).   On 7th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, 12 hrs after receiving Shingrix, the patient experienced vomiting and diarrhea. On an unknown date, the outcome of the vomiting and diarrhea were recovered/resolved.   It was unknown if the reporter considered the vomiting and diarrhea to be related to Shingrix.  Additional information was provided as follows: The case was reported by member of public (patient). The age at vaccination was not reported. The patient experienced gastrointestinal symptoms (diarrhea and vomiting) The symptoms during night. The reporter did not consent to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: First dose on 06-Nov-2020 / diagnosed with COVID-19 later December; This case was reported by a pharmacist via and described the occurrence of covid-19 in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th November 2020, the patient received the 1st dose of Shingrix. In December 2020, less than 2 months after receiving Shingrix, the patient experienced covid-19. The patient was treated with monoclonal antibody (nos) (Monoclonal Antibodies). On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and in later December 2020, the patient was diagnosed with COVID-19, which was treated with monoclonal antibodies. There was no other problem with 1st dose. The pharmacist wanted to know that could this patient receive the 2nd dose of Shingrix. No further information provided. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: injection site / redness; pain in the injection site; injection site, swelling; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2020, the patient received the 1st dose of Shingrix. On 23rd October 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site pain and injection site swelling. On 26th October 2020, the outcome of the injection site erythema, injection site pain and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose in left arm and the day after she had pain in the injection site, swelling and redness that lasted for 3 days. The vaccines lot number and expiration date was not provided. The reporter consented to follow-up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Feeling hot, Rhinorrhoea
Clinical narrative: Feeling hot, with no temperature / events have not resolved; Sniffles and runny nose / events have not resolved; Stomach discomfort / events have not resolved; Experienced chills and shivering; This case was reported by a consumer via call center representative and described the occurrence of chills in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 28th December 2020, the patient received the 2nd dose of Shingrix. On 28th December 2020, 12 hrs after receiving Shingrix, the patient experienced chills. On 13th January 2021, the patient experienced feeling hot, sniffles and stomach discomfort. On 29th December 2020, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the feeling hot, sniffles and stomach discomfort were not recovered/not resolved.   It was unknown if the reporter considered the chills, feeling hot, sniffles and stomach discomfort to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient stated that there were no events after 1st dose.  The patient received the 2nd dose and about 12 hours after the patient experienced chills and shivering, which resolved on the next day.  The patient reported that 2 weeks later, she began to experience feeling hot, with no temperature.  The patient reported sniffles and runny nose.  The patient also experienced stomach discomfort.  These events were not resolved.  The reporter did not consent to followup.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: erythema on upper half of injected extremity (left arm).; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient who was a radiologist reported the case for himself. The age at vaccination was not reported but could be 53 or 54 years. Lot and expiry date were not provided.  The patient developed erythema on the upper half of the injected extremity (left arm).  The reporter did not consent to follow-up.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Urticaria
Clinical narrative: First dose July 2018 and never received her second dose; Severe hives from her neck to her waist; This case was reported by a consumer and described the occurrence of hives in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In July 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced hives and incomplete course of vaccination. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the hives was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received the 1st dose of Shingrix on right arm. The patient experienced severe hives from her neck to her waist that lasted about a week.   The patient did not receive the 2nd dose till the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Insomnia, Pain in extremity
Clinical narrative: Right arm / have been hurting severely; Shoulder have been hurting severely; She is unable to sleep on it (right arm); This case was reported by a consumer and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, immediately after receiving Shingrix, the patient experienced pain in arm, shoulder pain and difficulty sleeping. On an unknown date, the outcome of the pain in arm, shoulder pain and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, shoulder pain and difficulty sleeping to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The patient stated that since receiving the vaccine, her right arm and shoulder had been hurting severely, to the point that she was unable to sleep on it. The reporter consented to follow-up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Underdose, Vaccination site discharge
Clinical narrative: Liquid began leaking down arm; Liquid leaked down arm; Shot was given in top layer of skin; A spontaneous report was received from a consumer, concerning a 61-years-old, female patient who was administered Moderna's COVID-19 vaccine and reported that Liquid began leaking down arm (Vaccination site discharge), Liquid leaked down arm (Underdose) and Shot was given in top layer of skin (Incorrect route of product administration).  The patient's medical history included asthma. Concomitant medications were not provided.  On 10-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.  Patient reported that the shot did not feel intramuscular, patient thinks the shot was given in the top layer of skin. After patient received the dose immediately liquid began leaking down her arm, which the patient believes was the Moderna Dose that should have gone in her arm.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, Liquid began leaking down arm, Liquid leaked down arm and Shot was given in top layer of skin was considered as resolved; Reporter's Comments: This report refers to a case of vaccination site discharge, underdose, and incorrect route of product administration for mRNA-1273 (lot # unknown), with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: A lot of leakage as dose was being administered/ dripped up to her fingers; Syringe was cracked; A spontaneous report was received from a consumer, concerning 32-year-old of old female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and where a lot of leakage as dose was being administered/ dripped up to her fingers as syringe was cracked.  The patient medical history was not reported. Concomitant medication was not reported.  On an unspecified date, prior to onset of events the patient received first of two planned doses of vaccine (batch: unknown) for prophylaxis of COVID-19 infection. On17-Feb-2021, the patient received second of two planned doses of vaccine (batch no unknown) for prophylaxis of COVID-19 infection.  On 17-Feb-2021 the patient experienced a lot of leakage happened in second dose. It dripped up to her fingers as syringe was cracked. Treatment taken information was not reported.  Action taken in to (mRNA-1273) COVID-19 in response to events were not reported.  The outcome of events a lot of leakage as dose was being administered/ dripped up to her fingers as syringe was cracked were considered resolved on 170-Feb-2021.; Reporter's Comments: This report refers to a case of Product administration error - Incorrect dose administered and Syringe issue for mRNA-1273, lot # unknown,  with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old and was mistakenly given the Moderna vaccine; A spontaneous report was received from a consumer, concerning a 17 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced product administered to patient of inappropriate age.  The patient's medical history was not provided. No concomitant medications were reported.  On 28 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown), in left non-dominant arm for prophylaxis of COVID-19 infection  Caregiver said that daughter got the vaccine at her workplace and now they refusing to give her the second dose because she is under 18 years old. The workplace had the second dose on 25Jan2021.  Action taken with second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event, product administered to patient of inappropriate age, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 17-year-old female who experienced nonserious unexpected event of Product administered to patient of inappropriate age for mRNA-1273 (lot # unknown) without associated adverse events.  The event occurred the same day as the first dose of mRNA-1273. Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 Year old boy accidentally got Moderna shot; A spontaneous report was received from consumer, concerning her son, a 16 years old male patient who accidentally received Moderna's covid-19 vaccine (mRNA-1273).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 22 Feb 2021, the patient received first of two planned doses of mRNA-1273 (lot no:024M20A) intramuscularly for prophylaxis of covid-19 infection.  On 22 Feb 2021, a 16-year-old boy accidentally got Moderna vaccine shot.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event 16-Year-old boy accidentally got Moderna shot was considered recovered on 22 Feb 2021.; Reporter's Comments: This report refers to a case of a 16-year old male patient who accidentally received Moderna's covid-19 vaccine (mRNA-1273) lot # 024M20A with no associated AEs.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccination card says use the vaccine by 2/18/2021; A spontaneous report was received from a consumer concerning a 33-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and vaccination card says use the vaccine by 18 Feb 2021.  No relevant concomitant medications were reported.   On 19 Feb 2021, approximately 1 day prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (007M20A) intramuscularly for prophylaxis of COVID-19 infection.  Vaccination card says use the vaccine by 18 Feb 2021 (expired vaccine used).  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event vaccination card says use the vaccine by 18 Feb 2021 was considered resolved.; Reporter's Comments: This report refers to a case of Expired product administered for mRNA-1273 (lot # 007M20A), with no associated AEs.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Contraindicated product administered, Nausea
Clinical narrative: nausea; takes an anticoagulant; A spontaneous report was received from a consumer concerning a 94-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea and contraindicated product administered.  The patient's medical history was not provided.  Concomitant medications included warfarin.  On 24-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot unknown)  in the right arm for prophylaxis of COVID-19 infection.  On 25-Jan-2021, the patient experienced nausea.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, nausea, was unknown.  The outcome of the event, contraindicated product administered, was considered recovered/resolved.; Reporter's Comments: This case concerns a 94-year old female patient who received mRNA-1273 and experienced non-serious event nausea and contraindicated product administered. Based on the current available information and temporal association between the use of the product and the start date of nausea, a causal relationship cannot be excluded. The event contraindicated product administered is assessed as not applicable.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Feeling cold, Hypothermia, Immediate post-injection reaction, Malaise
Clinical narrative: patient had hypothermia, with a temperature of 92.1 degrees Fahrenheit; trouble in breathing; she was freezing inside out; immediately got sick; Based on information previously received, the following information [Event hypothermia upgraded to serious from non-serious (Medically significant as per important medical event (IME) list)] has been amended.  Initial information received on 15-Feb-2021 regarding an unsolicited valid serious case from non-healthcare professional.  This case involves a 78 years elderly female patient who got immediately sick (illness), hypothermia, with a temperature of 92. 1 degrees Fahrenheit (hypothermia), trouble in breathing (dyspnoea) and was freezing inside (feeling cold), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date in December 2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed hypothermia, with a temperature of 92. 1 degrees fahrenheit (hypothermia) (serious event), immediately got sick (illness) (on the same day), trouble in breathing (dyspnoea) and was freezing inside (feeling cold) (non-serious events) (exact latency unknown), following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Hypothermia was assessed as medically significant.  Other relevant laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome is unknown for the reported events.; Sender's Comments: This case involves a 78 years elderly female patient who had hypothermia, illness, dyspnoea and feeling cold after receiving FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset was compatible. However, concomitant medication, family history, patient's medical condition at the time of vaccination and other relevant laboratory tests were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site warmth, Rash
Clinical narrative: Eight days after receiving the Moderna vaccine, I developed a rash on my left arm, and it remained for 6 days.  It encircled the arm, was hot to the touch, and tender at the injection site.  The rash grew from a circular (approx 1.5 inch diameter) rash at first, to a band approximately 2-2.5 inches wide, encircling the arm.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Sleep disorder
Clinical narrative: Very bad headache, body chills, achy all over, could not sleep.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Internal chills, shivering but not cold, arm soreness. Still shivering on 02/26/2021, but seems improved.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pt. was lightheaded at observation lane.  paramedics assessed pt. once pt. was stable paramedics released her to leave.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Headache, fever, body aches and pain
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Dyspnoea, Hypoaesthesia, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: FACE.THROAT NUMBNESS AND TINGLING-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia, Throat tightness
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: FACE.THROAT NUMBNESS AND TINGLING-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: FACE.THROAT NUMBNESS AND TINGLING-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: 7 days post shot; itchy arm at injection site; raised, hive-like area approximately 2 inches in diameter; warm to touch
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Pharyngeal swelling, Swollen tongue
Clinical narrative: Anaphylactic reaction....swelling of throat and tongue
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: mild shooting pains in my right testicle it also happened after my 2nd covid shot
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Urinary incontinence
Clinical narrative: On day 1-2: severe fatigue and lethargy. On day 10: sudden nighttime urinary incontinence - this has never happened before but both my husband and I have both now had this side effect
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Client verbalized feeling lightheaded after receiving the vaccine.  Client was then evaluated by Paramedic onsite.  Client was released to go home at 9:13 am by paramedic after symptom was resolved.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Injection site reaction, Pain, Rash macular, Skin warm
Clinical narrative: Red blotchy spot at injection site approx. 3 x 6 inches, hot to the touch.  Never grew larger from original sighting.  Stayed warm to the touch for several days later.  General soreness and discomfort.  Kept a photo.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Fall, Headache, Vertigo
Clinical narrative: Severe headache and vertigo. With vertigo: spinning sensation, falling sensation and rapid eye movement.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Injection was administered to a 16 year old, even though it is only approved for ages 18+.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: very lethargic on 1/22, 1/23, 1/24
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pharyngeal swelling, Pruritus, Rash, Swollen tongue
Clinical narrative: At approx 7:45 received FIRST dose of Moderna IM. Approx 15 min. after injection reported that tongue was swelling first dose Epi 0.3mg given @ 08:04; then complained of throat swelling and reported difficutly breathing second dose Epi 0.3mg given @ 08:09 - initially reported that breathing was getting better however third dose of Epi 0.3 mg given 08:19 due to complaints of increased difficulty breathing - he was able to in one word statements but was needing to sit forward. Oxygen saturations ranged:97-99%. Returned from ER approx 5 hours later. Continued with body rash, itching, tongue feeling thick. Medicated with Benadryl 25-50mg QID; Prednisone 50 mg daily; Pepcid 20mg BID all of these for 5 days.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: At approx 7:45 received FIRST dose of Moderna IM. Approx 15 min. after injection reported that tongue was swelling first dose Epi 0.3mg given @ 08:04; then complained of throat swelling and reported difficutly breathing second dose Epi 0.3mg given @ 08:09 - initially reported that breathing was getting better however third dose of Epi 0.3 mg given 08:19 due to complaints of increased difficulty breathing - he was able to in one word statements but was needing to sit forward. Oxygen saturations ranged:97-99%. Returned from ER approx 5 hours later. Continued with body rash, itching, tongue feeling thick. Medicated with Benadryl 25-50mg QID; Prednisone 50 mg daily; Pepcid 20mg BID all of these for 5 days.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test abnormal, Dizziness, Feeling abnormal, Headache
Clinical narrative: First dose.. had weird couple days of feeling like I was unable to breath correctly. Tired .. swollen red round arm.   Second dose. Felt loopy couple hours later, about 8 hours later started vomiting with the worse stomach ache. Slept 12 hours, felt off, had an obgyn appointment, took blood levels and hormone levels were off the chart, still not well ended up in ER, STOMACH PAIN, FOUND Enlarged nediatiatioal lymph nodes. Headaches Been in and out of the docs, now need scans, bloodwork and tons of medical .  Blood pressure off the roof high.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Hormone level abnormal, Hypertension, Lymphadenopathy, Lymphadenopathy mediastinal, Magnetic resonance imaging
Clinical narrative: First dose.. had weird couple days of feeling like I was unable to breath correctly. Tired .. swollen red round arm.   Second dose. Felt loopy couple hours later, about 8 hours later started vomiting with the worse stomach ache. Slept 12 hours, felt off, had an obgyn appointment, took blood levels and hormone levels were off the chart, still not well ended up in ER, STOMACH PAIN, FOUND Enlarged nediatiatioal lymph nodes. Headaches Been in and out of the docs, now need scans, bloodwork and tons of medical .  Blood pressure off the roof high.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Positron emission tomogram, Vomiting
Clinical narrative: First dose.. had weird couple days of feeling like I was unable to breath correctly. Tired .. swollen red round arm.   Second dose. Felt loopy couple hours later, about 8 hours later started vomiting with the worse stomach ache. Slept 12 hours, felt off, had an obgyn appointment, took blood levels and hormone levels were off the chart, still not well ended up in ER, STOMACH PAIN, FOUND Enlarged nediatiatioal lymph nodes. Headaches Been in and out of the docs, now need scans, bloodwork and tons of medical .  Blood pressure off the roof high.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Impaired work ability, Influenza like illness, Malaise, Oropharyngeal pain
Clinical narrative: Made me fell sick for about 36hours, low grade fever 101.5, flu like symptoms - body aches, chills, had sore throat as well.  Was sick enough to call in sick to work next day after shot.  All symptoms completely gone after about 36hrs.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Made me fell sick for about 36hours, low grade fever 101.5, flu like symptoms - body aches, chills, had sore throat as well.  Was sick enough to call in sick to work next day after shot.  All symptoms completely gone after about 36hrs.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Severe headache, chills,  fever, achey, nausea fatigue     Received the vaccine at 1:30 pm and symptoms started at 7:30 the following morning,   I still have symptoms 2 days later.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: The day after the shot, I had nausea, fatigue and a slight fever. This lasted 24 hours. I fell much better 2 days after the shot but still have slight nausea.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: 47-year-old female complained of allergic type reaction. On-site team responded. vital below. She refused additional evaluation and care.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Headache, Lip pain, Paraesthesia
Clinical narrative: Flushing upper torso and face, tingling pins and needles skin on face and arms (more left side of face) and behind ears, lips stinging (this started first) tongue tingling, felt lightheaded or unsteady (pulse was up), and headache
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Flushing upper torso and face, tingling pins and needles skin on face and arms (more left side of face) and behind ears, lips stinging (this started first) tongue tingling, felt lightheaded or unsteady (pulse was up), and headache
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash erythematous, Rash papular
Clinical narrative: Large irregular shaped rash at injection site.  It is red, raised, and slightly itchy.  It is about 5 inches high and about 4 inches across.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Sore arm and swollen, red and rash around injection site. Didn't start until 6 days after injection
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity
Clinical narrative: I have a big oval shaped bruise that will not go away. It doesn't hurt but some times I get aches in that same arm.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: Covid- Arm- Red splotchy itchy arm several days after injection
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Injection site pain, Limb discomfort, Musculoskeletal chest pain
Clinical narrative: Started with pain in left arm and then the pain increased  around 5pm on saturday. At midnight the pain increased and went down the left arm and across the shoulder and neck , down the right arm, down the back and ribs and into the legs. His hands and knuckles swelled up. From 1am to 5am he couldn't hardly walk, he felt almost paralyed. Around 6am(Sunday) he was starting to move more but the swelling in his hands lasted into Tuesday.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Started with pain in left arm and then the pain increased  around 5pm on saturday. At midnight the pain increased and went down the left arm and across the shoulder and neck , down the right arm, down the back and ribs and into the legs. His hands and knuckles swelled up. From 1am to 5am he couldn't hardly walk, he felt almost paralyed. Around 6am(Sunday) he was starting to move more but the swelling in his hands lasted into Tuesday.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Dysphagia, Eye swelling, Injection site pain
Clinical narrative: chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped.  Limited range of motion noted on L arm, could not lift arm ROM more than  30 degrees   12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching.   Took Benadryl 25mg and feel asleep.  hives and itching was gone by the time she woke up.  Severe fever and body aches 22 hours after vaccine administration.  Temperature was 101.8.  Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg  and Vit C 2000mg and Vit D 10,000 IU  and Zinc 100mg.   Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Oropharyngeal pain, Pain, Periorbital swelling, Pruritus
Clinical narrative: chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped.  Limited range of motion noted on L arm, could not lift arm ROM more than  30 degrees   12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching.   Took Benadryl 25mg and feel asleep.  hives and itching was gone by the time she woke up.  Severe fever and body aches 22 hours after vaccine administration.  Temperature was 101.8.  Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg  and Vit C 2000mg and Vit D 10,000 IU  and Zinc 100mg.   Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling of eyelid, Urticaria
Clinical narrative: chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped.  Limited range of motion noted on L arm, could not lift arm ROM more than  30 degrees   12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching.   Took Benadryl 25mg and feel asleep.  hives and itching was gone by the time she woke up.  Severe fever and body aches 22 hours after vaccine administration.  Temperature was 101.8.  Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg  and Vit C 2000mg and Vit D 10,000 IU  and Zinc 100mg.   Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: On Feb. 24.2021, my left arm at the vaccine site started to itch.  It now has a red patch about 5 inches long and 3 inches wide which itches and is sensitive to my touch.  I tried putting anti-itch cream on it but that had no effect/  It itches and is sensitive to my touch, not pain but  bothersome
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Needle hub separated from the syringe body while attempting to administer the vaccine. The dose was wasted while attempting the injection. No adverse symptoms.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Client stated she felt lightheaded after receiving her vaccine.  Vital signs obtained: BP 117/81, HR 74, O2 sat 98%.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Body aches, fever (102.1F), headache, chills. Took Advil once fever hit 102.1 and used ice packs and fever reduced. Ongoing symptoms have not resolved yet.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Paranasal sinus discomfort
Clinical narrative: the sinus pressure started the 1st two days then this week about 10 days after vaccine the symptoms were getting worst saw my GP and was told i had an ear infection and given 2 antibiotics. ear drops which i have started to take  and Zithromax but have not used it yet.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm, Swelling
Clinical narrative: It started to itch  about Tuesday the 23rd. My daughter said Mom look at your arm. It is red, warm and itching. It is the size of a baseball. The side of necks also seems a little puffy. I have took Benadryl  and put ice on it. Today the redness and warmness is still these but it is not itching.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Fever, chills, nausea
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Chills, Headache, Immediate post-injection reaction
Clinical narrative: Almost immediately, sore injection site, later becoming sore shoulder muscle. Around 10 pm began feeling like onset of flu. Woke up around 3 am with temperature of 98, chills, cramps, muscle ache, headache. Temperature rose to 99.1 around 4 am. Woke up around 7 am still feeling same. Temp at 98.8 as of 8:45 pm.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pain, Mitral valve prolapse, Muscle spasms, Myalgia
Clinical narrative: Almost immediately, sore injection site, later becoming sore shoulder muscle. Around 10 pm began feeling like onset of flu. Woke up around 3 am with temperature of 98, chills, cramps, muscle ache, headache. Temperature rose to 99.1 around 4 am. Woke up around 7 am still feeling same. Temp at 98.8 as of 8:45 pm.