chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Nasty rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient nasty rash after 2nd Shingrix shot.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Nasty rash after second Shingrix vac; This case was reported by a consumer and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient nasty rash after 2nd Shingrix shot. The patient asked the duration that the rash might last..
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site rash, Malaise, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Rash at site / symptoms / not as severe this time; Fever for 3 days / symptoms / not as severe this time; Tired / symptoms / not as severe this time; Not feeling my best / symptoms / not as severe this time; This case was reported by a consumer and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site rash (1st dose received in 30th November 2020 and the patient experienced Injection site rash,injection site pain, injection site swelling, fever, chills and fatigue refer case US2021030909).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site rash, fever, fatigue and feeling unwell. Rechallenge with Shingrix was positive. On 3rd December 2020, the outcome of the feeling unwell was recovered/resolved. On an unknown date, the outcome of the injection site rash, fever and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site rash, fever, fatigue and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that second vaccination still had side effects; fever for 3 days, rash at injection site, tired and not feeling her best. The patient reported that the symptoms were not as severe this time and recovery was about 7 days this time. The patient did not go to doctor regarding the side effects.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021030909:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash, Vaccination failure
Clinical narrative: we end up giving the shingles to ourselves/ suspected vaccination failure; We end up giving the shingles to ourselves; Had a rash then; Still having burning in my back and face; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster Shingles vaccine.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. In January 2021, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and burning sensation. On an unknown date, the outcome of the vaccination failure, shingles, rash and burning sensation were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and burning sensation to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. After receiving 2nd dose of shingles vaccine, 2 months before the date of reporting, the patient had a rash then and still having burning in back and face. The patient was taking all kinds of medicine too. The patient stated what a big mistake the patient made here was that the patient thought that the vaccine was going to protect from the shingles and end up giving the shingles to the patient. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and exact time to onset were unknown. This case has been linked with the case US2021AMR063255, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063255:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: felt like I had a bad case of the flu; Chills; High temperature; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling abnormal (1st dose received on an unknown date, refer link case US2021AMR064339)).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms, chills and high temperature. On an unknown date, the outcome of the influenza-like symptoms, chills and high temperature were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, chills and high temperature to be related to Shingles vaccine.  Additional details were provided as follows:  This case was reported by patient himself/herself. The age at vaccination was not reported.  The age group was not reported but was selected as an adult as per vaccine indication. The patient received 2nd dose of Shingles vaccine and felt like he/she had a bad case of the flu with chills and high temperature for 2 days. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR064339:same reporter
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Lip swelling, Malaise, Oral herpes, Pain in extremity
Clinical narrative: Headache; Sinus issues; Fullness and pulsing in / left ear; Puffy Lips; Vision changes; Palpitations; Pain in teeth; Arm pain; Not feeling good / All / symptoms have resolved / except for not feeling good; Cold sore; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th December 2020, 12 days after receiving Shingrix, the patient experienced cold sores. On an unknown date, the patient experienced headache, sinus disorder, ear feels clogged, lip swelling, visual disturbance, palpitation, toothache, pain in arm and feeling unwell. The patient was treated with acyclovir and medication unknown (Otc Medicines (Medication Unknown)). In December 2020, the outcome of the cold sores was recovered/resolved. On an unknown date, the outcome of the headache, sinus disorder, ear feels clogged, lip swelling, visual disturbance, palpitation, toothache and pain in arm were recovered/resolved and the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the cold sores, headache, sinus disorder, ear feels clogged, lip swelling, visual disturbance, palpitation, toothache, pain in arm and feeling unwell to be related to Shingrix.  Additional details were reported as follows: On 16th December 2020, the patient recieved Acyclovir.  The patient reported that the cold sore returned in January 2021 and she again treated with Acyclovir and it resolved (unknown date).  The patient also had headache, sinus issues, fullness and pulsing in her left ear, puffy lips, arm pain, pain in teeth vision changes, palpitations and she was not feeling good. No Lot number or expiration date for vaccine was provided.  The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Sinus disorder, Toothache, Visual impairment
Clinical narrative: Headache; Sinus issues; Fullness and pulsing in / left ear; Puffy Lips; Vision changes; Palpitations; Pain in teeth; Arm pain; Not feeling good / All / symptoms have resolved / except for not feeling good; Cold sore; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th December 2020, 12 days after receiving Shingrix, the patient experienced cold sores. On an unknown date, the patient experienced headache, sinus disorder, ear feels clogged, lip swelling, visual disturbance, palpitation, toothache, pain in arm and feeling unwell. The patient was treated with acyclovir and medication unknown (Otc Medicines (Medication Unknown)). In December 2020, the outcome of the cold sores was recovered/resolved. On an unknown date, the outcome of the headache, sinus disorder, ear feels clogged, lip swelling, visual disturbance, palpitation, toothache and pain in arm were recovered/resolved and the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the cold sores, headache, sinus disorder, ear feels clogged, lip swelling, visual disturbance, palpitation, toothache, pain in arm and feeling unwell to be related to Shingrix.  Additional details were reported as follows: On 16th December 2020, the patient recieved Acyclovir.  The patient reported that the cold sore returned in January 2021 and she again treated with Acyclovir and it resolved (unknown date).  The patient also had headache, sinus issues, fullness and pulsing in her left ear, puffy lips, arm pain, pain in teeth vision changes, palpitations and she was not feeling good. No Lot number or expiration date for vaccine was provided.  The reporter did not consent to follow-up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Pain
Clinical narrative: body aches in back and sides; fatigue; chills; body aches in back and sides; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced general body pain, fatigue, chills and back pain. On an unknown date, the outcome of the general body pain, fatigue, chills and back pain were recovered/resolved.   It was unknown if the reporter considered the general body pain, fatigue, chills and back pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after 1st dose vaccination, the patient had body aches in back and sides, some chills and fatigue. The symptoms were recovered in 2 days. The reporter consented to follow up. For the tolerence of dose 2 refer case US2021AMR032160, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR032160:same reporter
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: red, itchy swollen injection site reaction on her left arm; red, itchy swollen injection site reaction on her left arm; red, itchy swollen injection site reaction on her left arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 38-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) (batch number FX77G, expiry date 30th June 2020) for prophylaxis.   On 2nd April 2020, the patient received Fluarix Tetra 2019-2020 season (intramuscular). On 2nd April 2020, less than a day after receiving Fluarix Tetra 2019-2020 season, the patient experienced injection site erythema, injection site itching and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching and injection site swelling to be related to Fluarix Tetra 2019-2020 season.  Additional details were provided as follows: The patient received vaccine in left arm. It was reported that the patient was still having red, itchy swollen injection site reaction on her left arm. The  reaction was still persists at the time of reporting. The reporter did not consent to follow-up.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Malaise
Clinical narrative: He did feel unwell next day; On 07Feb2021, the patient inadvertently received two doses of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 7th February 2021, the patient received Shingrix. On 7th February 2021, unknown after receiving Shingrix, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.  Additional details were provided as follows:  The pharmacist calling regarding the patient inadvertently received two doses of Shingrix at the same time, which led to accidental overdose. The lot, expiration date and injection sites unknown at time of call. The reporter consent to follow up.   Follow up information received from a pharmacist on 10th March 2021: The patient received 2 doses of Shingrix on the same day on different arms.  The patient did feel unwell next day but was good now at the time of reporting.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Mobility decreased, Pain in extremity
Clinical narrative: Certain position, like put jacket on /stretches, can't do that anymore /unable to do certain things/ if it hangs it bothers me; I have a bit of a knot there; left arm pain / doesn't hurt all the time; shooting pain / It is so painful.; this is very upsetting to me; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injected limb mobility decreased, injection site mass, pain in arm, pain and emotional distress. On an unknown date, the outcome of the injected limb mobility decreased, injection site mass, pain in arm, pain and emotional distress were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, injection site mass, pain in arm, pain and emotional distress to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient herself. The patient share her email address but did not have the personal fax number. The patient received 1st dose of Shingrix in her left deltoid and thinks that it was given in the muscle. The patient provided her pharmacy's contact information since she was unable to locate the lot number or expiration date on the paperwork. The patient was reported left arm pain and it did not hurt all the time. It was just in certain positions, like when she put the jacket on. The patient used to be able to do these stretches, but she could not do that anymore. The patient was concerned that she would not be able to to her recreational activities like kayaking, river tubing anymore. The patient was really active and she like to enjoy the activities on the lake. The patient used to be able to do these things and she did not know if she would be able to anymore. It was just certain positions, it was like the shooting pain and it was so painful. Sometimes if it hangs it bothers her and she think she had the bit knot there on left arm. The patient had using the heating pad on it and that was  the big inconvenience. The patient felt great before the shot and that was very upsetting to her. The patient stated that she did not think that she was going to received 2nd dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: pain at the injection site; swelling / at the injection site; redness / at the injection site; injected arm was sore; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema and pain in arm. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received shingrix and experienced redness, swelling and pain at the injection site, which was resolved. The patient also mentioned that the injected arm was sore for about a week, and then resolved.  The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: headache; dizziness; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced headache and dizziness. On an unknown date, the outcome of the headache and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the headache and dizziness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported to having headache and dizziness two days after receiving the second dose of Shingrix vaccine three months ago. The symptoms had not resolved.  The patient wanted to know if the symptoms were related to the second dose of Shingrix vaccine. The reporter did not consent to follow-up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: she currently has shingles although she was vaccinated only last year; she currently has shingles although she was vaccinated only last year; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. In July 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received Shingrix both doses and currently had shingles although was vaccinated only last year.  The reporter consented for contact with HCP, but did not know any other information other that HCP name.  The patient called back to requested to retract consent and permission for follow up with her HCP.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pyrexia, Rash
Clinical narrative: fever; rash all over her body; muscle pains; Extra dose administered; First dose / on July2018, second dose on Dec2018 / third dose was given on Feb2019 / fourth dose on 08Mar2021; This case was reported by a pharmacist via and described the occurrence of muscle pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in July 2018) and Shingrix (received 2nd dose in December 2018).   On 8th March 2021, the patient received the 4th dose of Shingrix (intramuscular). On 1st February 2019, the patient received the 3rd dose of Shingrix (intramuscular). On 1st February 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced extra dose administered. On 8th March 2021, the patient experienced muscle pain, extra dose administered and drug dose administration interval too long. On 9th March 2021, the patient experienced rash. On an unknown date, the patient experienced fever. The patient was treated with prednisone, paracetamol (Tylenol) and hydroxyzine. On an unknown date, the outcome of the muscle pain, rash, fever, extra dose administered, extra dose administered and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the muscle pain, rash and fever to be related to Shingrix.  Additional details were provided as follows: The patient received 3rd dose of Shingrix, which led to extra dose administered. The patient received 4th dose of Shingrix and on same day experienced fever and muscle pain. The next day, patient experienced rash. The patient received 4th dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number X7Z52, expiry date 5th November 2022) for prophylaxis.   On 25th February 2021, the patient received the 1st dose of Shingrix. On 8th March 2021, 11 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details provided as follow: The patient developed shingles after the 1st dose of Shingrix. No further information was provided. The reporter consented to follow-up. The reported batch number X7Z58 was not available in sales data sheet, hence updated to X7Z52.
Sex: M
Vaccine: VARZOS
Symptoms: Disorientation, Hypoaesthesia, Syncope
Clinical narrative: fainted and continued to feel lost; hands and knee went numb; felt lost and disoriented; This case was reported by a consumer via call center representative and described the occurrence of faint in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), numbness in hand and disorientation. On an unknown date, the outcome of the faint, numbness in hand and disorientation were recovered/resolved.   It was unknown if the reporter considered the faint, numbness in hand and disorientation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. While driving, the patient felt lost and disoriented. When he arrived home his hands and knee went numb. He fainted and continued to feel lost. The reporter did not consent to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Disorientation, Gait disturbance, Loss of consciousness, Mobility decreased
Clinical narrative: TEMPORARILY BLACKING OUT / unsure if he was unconscious or just sleeping; LOSING SENSE OF WHERE THEY WERE / became unaware of time and is unsure how he drove home; he was unsteady on his feet/crawl into house as was unsteady on his feet.; This case was reported by a consumer via call center representative and described the occurrence of blackout in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced blackout (serious criteria GSK medically significant), disorientation and balance disorder. On an unknown date, the outcome of the blackout, disorientation and balance disorder were recovered/resolved.   It was unknown if the reporter considered the blackout, disorientation and balance disorder to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and within a matter of minutes, became unaware of time and was unsure how drove home.  The patient had a bad reaction of losing sense of where they were. When he got home, he had to crawl into his house as he was unsteady on his feet. After getting through the door, the patient laid on the floor and was unsure if was unconscious or just sleeping.  The patient reported temporarily blacking out. The patient did not get the 2nd dose due to the bad reaction and asked if the patient could get the COVID-19 vaccine. These symptoms resolved after 2 to 3 hours and was able to get up. Lot and expiration date of vaccine were unknown.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021062754:same reporter
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood blister, Rash, Rash erythematous
Clinical narrative: red raised bumps on her chest and arms / bumps with blood in them\ rash; red raised bumps on her chest and arms / bumps with blood in them; Can leave scars; This case was reported by a consumer via call center representative and described the occurrence of papular rash in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced papular rash, blood blister and scar. On an unknown date, the outcome of the papular rash and blood blister were not recovered/not resolved and the outcome of the scar was unknown.   It was unknown if the reporter considered the papular rash, blood blister and scar to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix shots in February and April 2019. Since then occasionally develop small red bumps with blood and could leave scars. The patient began having red raised bumps on her chest and arms. They did not itch. The adverse event was not resolved. The physician did not know anything about, what was causing this? was immunity compromised? Did need to see a specialist who can determine what it was? Also, was Shingrix one a lifetime coverage, or was a new shot required every year? The reporter did not want to provide health care professional information.  The reporter did not consent to follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea haemorrhagic, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Body aches; Had blood in diarrhea; Throwing up bile; Patient got super dizzy; Congestion; Swelling; Feeling tired; Headache; A spontaneous report was received from a Consumer concerning a 56-years-old female patient who experienced blood in diarrhea, throwing up bile (bilious vomiting), body aches (myalgia), felt congestion (nasal congestion), headache, felt tired (fatigue), swelling, and super dizzy (dizziness).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot : 007M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced swelling, headache, and tiredness shortly after receiving the vaccine.   On 02 Feb 201 the patient felt congestion.   On 03 Feb 2021, the patient experienced diarrhea which was bloody, throwing up bile, and having body aches but no fever. The patient also was super dizzy.    Treatment details included bismuth subsalicylate, Ibuprofen  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, blood in diarrhea, throwing up bile (bilious vomiting), body aches (myalgia), felt congestion (nasal congestion), headache, felt tired (fatigue), swelling, and super dizzy (dizziness) were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Swelling, Vomiting
Clinical narrative: Body aches; Had blood in diarrhea; Throwing up bile; Patient got super dizzy; Congestion; Swelling; Feeling tired; Headache; A spontaneous report was received from a Consumer concerning a 56-years-old female patient who experienced blood in diarrhea, throwing up bile (bilious vomiting), body aches (myalgia), felt congestion (nasal congestion), headache, felt tired (fatigue), swelling, and super dizzy (dizziness).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot : 007M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced swelling, headache, and tiredness shortly after receiving the vaccine.   On 02 Feb 201 the patient felt congestion.   On 03 Feb 2021, the patient experienced diarrhea which was bloody, throwing up bile, and having body aches but no fever. The patient also was super dizzy.    Treatment details included bismuth subsalicylate, Ibuprofen  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, blood in diarrhea, throwing up bile (bilious vomiting), body aches (myalgia), felt congestion (nasal congestion), headache, felt tired (fatigue), swelling, and super dizzy (dizziness) were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Colon cancer
Clinical narrative: Colon cancer; A spontaneous report was received from a consumer concerning a 75-year old female patient who found to have colon cancer (colon cancer).  The patient's medical history was not reported. Concomitant product use was not reported.  On 18 Feb 2021, the patient received their first of two planned doses of mRNA-1273  intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 19 Feb 2021, next day of receiving vaccine, the patient found out she had colon cancer and needed surgery.   Treatment information was not reported.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, colon cancer (colon cancer). was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Colon cancer could have been an existing medical condition  prior to vaccination. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Altered state of consciousness, Blood pressure diastolic decreased, Dizziness, Fatigue, Heart rate
Clinical narrative: Dizzy/dizziness; Nausea; Fatigue; first day after administration of the vaccination the patient fainted; Diastolic in the 40s; Heart squeezing; Unresponsive for 30 seconds; A spontaneous report was received from a consumer concerning a female patient who experienced unresponsiveness for 30 seconds/altered state of consciousness, dizzy/dizziness, diastolic in the 40s/blood pressure diastolic decreased, heart squeezing/palpitations, dizziness, fainting/syncope, nausea and fatigue.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 10 Feb 2021, approximately 10 days prior to the onset of the symptoms, the patient received second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.    On 10 Feb 2021, the patient reports she received the second dose of the vaccine. On day one was unresponsive for 30 seconds and has been dizzy since. The next day she fainted after administration of the vaccine. The first 5 days after receiving the vaccination, patient felt like her heart was being squeezed. Diastolic dropped to 40s and heart rate has not been higher than 70. On following up, she reports having nausea and fatigue now along with dizzy feelings. Treatment information was not provided/unknown.    The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, unresponsiveness for 30 seconds/altered state of consciousness, diastolic in the 40s/blood pressure diastolic decreased, heart squeezing/palpitations and fainting/syncope, were considered resolved.  The outcome of the events, dizzy/dizziness, nausea and fatigue, were considered unknown.   Follow-up received on 19 Feb 2021 included that the patient now has nausea, fatigue and dizziness.; Reporter'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: Nausea, Palpitations, Syncope
Clinical narrative: Dizzy/dizziness; Nausea; Fatigue; first day after administration of the vaccination the patient fainted; Diastolic in the 40s; Heart squeezing; Unresponsive for 30 seconds; A spontaneous report was received from a consumer concerning a female patient who experienced unresponsiveness for 30 seconds/altered state of consciousness, dizzy/dizziness, diastolic in the 40s/blood pressure diastolic decreased, heart squeezing/palpitations, dizziness, fainting/syncope, nausea and fatigue.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 10 Feb 2021, approximately 10 days prior to the onset of the symptoms, the patient received second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.    On 10 Feb 2021, the patient reports she received the second dose of the vaccine. On day one was unresponsive for 30 seconds and has been dizzy since. The next day she fainted after administration of the vaccine. The first 5 days after receiving the vaccination, patient felt like her heart was being squeezed. Diastolic dropped to 40s and heart rate has not been higher than 70. On following up, she reports having nausea and fatigue now along with dizzy feelings. Treatment information was not provided/unknown.    The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, unresponsiveness for 30 seconds/altered state of consciousness, diastolic in the 40s/blood pressure diastolic decreased, heart squeezing/palpitations and fainting/syncope, were considered resolved.  The outcome of the events, dizzy/dizziness, nausea and fatigue, were considered unknown.   Follow-up received on 19 Feb 2021 included that the patient now has nausea, fatigue and dizziness.; Reporter'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: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to 17 year old; A spontaneous report  was received from a health care professional (Nurse) concerning 17-years old male patient who got mRNA-1273 vaccine at the inappropriate age.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On 20 Feb 2021, the patient received first dose of mRNA-1273 (Batch number: 023M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  The reporter reported that the patient is completely fine and has no symptoms.  Action taken with the drug in response to the event was not applicable.  The outcome of the event was considered as recovered on 20 Feb 2021.; Reporter's Comments: This case concerns a 17-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Sjogren's syndrome, Vaccination complication
Clinical narrative: a flare in their immune system; severe symptoms happening 12 hours after receiving the Moderna vaccine; A spontaneous report was received from a consumer concerning 20 people (age and gender unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a flare in their immune system (Sjogren's syndrome) and severe symptoms (vaccine adverse reaction).  The patients medical history included Sjogren's disease. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patients received their dose of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.  Consumer reported that she is in a social group and 20 people with a medical history of autoimmune disease Sjogren's experienced a flare in their immune system and severe symptoms happening 12 hours after receiving the Moderna vaccine.    On an unknown date, the patients experienced the events: a flare in their immune system (Sjogren's syndrome) and severe symptoms (vaccine adverse reaction).   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), a flare in their immune system, severe symptoms was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Pruritus, Rash macular, Vaccination site erythema
Clinical narrative: Itchy; Patient states her HCP stated the injection was given below the muscle and not in the muscle; Red spot has turned pink and seems to be clearing up; Big red circle on her arm; A spontaneous report was received from a consumer concerning an  83-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and  experienced big red circle on her arm, itchy, red spot has turned pink and seems to be clearing up, and injection was given below the muscle not in the muscle.  The patient's medical history, was not provided by the reporter, and included no known allergies. No relevant concomitant medications were included.   On 11 Jan  2021, the patient received their  first  of two planned doses of mRNA-1273 (lot number  unknown) intramuscularly  for prophylaxis of COVID-19 infection.  On 15 Jan  2021, the patient noticed big red circle on her arm.  On an unknown date, the patient reported feeling itchy and also noticed that her arm turned pink and had seemed to cleared up.  On 25 Jan 2021, the patient visited her health care professional and was informed that the injection was given below the muscle and not in the muscle.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events   red spot has turned pink and seems to be clearing up, itchy, big red circle on her arm were unknown. The outcome of the event injection was given below the the muscle not in the muscle was resolved .; Reporter's Comments: This case concerns an 83-year-old female with Product administration error for mRNA-1273 (lot # unknown) with associated adverse events of NS expected vaccination site erythema and NS unexpected rash macular, pruritus.  Adverse event onset 5 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on the current available information and temporal association between use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Herpes zoster, Pruritus
Clinical narrative: Developed Shingles; This morning had a lot more burning; Itching and Burning; A spontaneous report  was received from a consumer concerning a 91 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Shingles, itching and burning, this morning had a lot more burning and it was running down the leg.  The patient's medical history was provided not by the reporter. No concomitant medications were reported.   On 28 Jan 2021, about seven days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: probably 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, a week later, the patient developed shingles and an itching and burning. On 05 Feb 2021, this morning had a lot more burning and it was running down the leg. Treatment included anti viral drug for shingles and lidocaine for itch and burning and pain. Lab details were not provided.  The seriousness criterion for all the events was reported as other without a rationale. The event is serious meeting Medical Significant criteria due to the necessity of treatment.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, developed shingles, itching and burning, this morning had a lot more burning and it was running down the leg was considered as unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity vasculitis, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Allergic vasculitis along the legs, thigs, and buttocks; Itchiness at injection site; Redness at injection site, red circles; A spontaneous report was received from a consumer concerning a 73-years-old female patient who experienced allergic vasculitis along the legs, thigs, and buttocks (hypersensitivity vasculitis), itchiness at injection site (vaccination site pruritus), and redness at injection site, red circles (vaccination site erythema).  The patient's medical history was not provided. Concomitant product use was unknown.  On 04 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  It was reported that the injection site became itchy immediately upon injection and red circle developed afterwards (04 Feb 2021). Injection site reactions cleared up.  On 9 Feb 2021, about 5 to 7 days later, the patient experienced allergic vasculitis along the legs, thighs, and buttocks.(The diagnosis was from her doctor). Treatment for the events was unknown.  Action taken with mRNA-1273 in response to the events was unknown.   The event of allergic vasculitis along the legs, thigs, and buttocks (hypersensitivity vasculitis) recovered on 02 March 2021.  The events, itchiness at injection site (vaccination site pruritus) and redness at injection site, red circles (vaccination site erythema), were considered recovered.; Reporter'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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Cellulitis; Pain; Swelling; Heat at the injection site; A spontaneous report was received from a consumer who was also a 68-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced cellulitis at the injection site.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Aspirin, Metformin, Vivo, Thyroxine, Metoprolol, Omeprazole, Singulair, Oxygen, B12 Injection, Flaxseed Oil, Cocu10, Libutrin, Evox, Alogliptin, calcium Citrate and Vitamin B/C/D nonspecific.  The patient received both of two planned doses of mRNA-1273 first dose (Batch number: 027620A) on 19-Jan-2021 and second dose (Batch Number 002A219A) on 24Feb2021 intramuscularly in the hip for prophylaxis of COVID-19 infection.    On unspecified dates, following second dose the patient developed cellulitis with heat, pain and swelling at the injection site, the swelling was 6 inhes by 2 inches in size. Treatment for the event included Keflex and heat pad.  The action taken is not applicable.  The outcome of the events were considered resolving.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells palsy; A spontaneous report was received from a consumer, concerning a 70-year-old, male who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's Palsy/ facial paralysis.  The patient's medical history was not provided. Concomitant product was not provided.   On 01 Feb 2021, approximately 31 days prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 (batch number: 012M20A) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.  On 03 Mar 2021, post vaccination, the patient experienced Bell's Palsy.    Treatment included prednisone 20 mg once daily and valacyclovir 1g TID 7 days.  The outcome of the event, Bell's Palsy was unknown.; Reporter'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.