chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Hypokinesia, Illness, Induration
Clinical narrative: Could hardly touch her arm; Stayed in bed; Shivering; Shot was painful/achy; Really sick; Fever; Left arm was sore/slight soreness in her left arm; Left arm was rock hard; Post neuropathic itching; she couldn't sleep on that side due to the soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Patient had a bad case of shingles on her left arm last november). Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date and experienced sting and sore right arm , refer linked case US2020AMR213779) and Shingles vaccine with an associated reaction of herpes zoster (patient had shingles vaccine in past and had shingles).   On 20th October 2020, the patient received the 2nd dose of Shingrix. On 20th October 2020, the dose was an unknown dose. In October 2020, less than a day after receiving Shingrix, the patient experienced pain, sickness, fever, pain in arm, induration, pruritus and insomnia. On 20th October 2020, the patient experienced shivering. On 21st October 2020, the patient experienced weakness generalised. On 22nd October 2020, the patient experienced movements reduced. Rechallenge with Shingrix was positive. On 22nd October 2020, the outcome of the pain, sickness, shivering and weakness generalised were recovered/resolved. On an unknown date, the outcome of the movements reduced was unknown and the outcome of the fever, induration, pruritus and insomnia were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain, sickness, shivering, weakness generalised, movements reduced, fever, pain in arm, induration, pruritus and insomnia to be related to Shingrix.  Additional details were provided as follows: The reporter received the second dose in the right arm. After the vaccination, the patient claimed that the shot was painful and she was really sick.   On the night of vaccination date, she was shivering and achy. On 21st October 2020, she stayed in bed. On 22nd October 2020, she felt somewhat better but she could hardly touch her arm.  She had a fever and her left arm was sore and rock hard.  She also reported that she had post neuropathic itching that was reactivated during these days. She claimed that last November she had a bad case of shingles on her left arm but she had the previous shingles vaccine prior to the Shingrix.  She still has a slight soreness in her left arm till the time of reporting and further mentioned that previously she could not sleep on that side due to the soreness. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR213779:Same suspect, same reporter, different dose (1st dose)
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Nervous system disorder, Pain, Pain in extremity
Clinical narrative: Could hardly touch her arm; Stayed in bed; Shivering; Shot was painful/achy; Really sick; Fever; Left arm was sore/slight soreness in her left arm; Left arm was rock hard; Post neuropathic itching; she couldn't sleep on that side due to the soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Patient had a bad case of shingles on her left arm last november). Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date and experienced sting and sore right arm , refer linked case US2020AMR213779) and Shingles vaccine with an associated reaction of herpes zoster (patient had shingles vaccine in past and had shingles).   On 20th October 2020, the patient received the 2nd dose of Shingrix. On 20th October 2020, the dose was an unknown dose. In October 2020, less than a day after receiving Shingrix, the patient experienced pain, sickness, fever, pain in arm, induration, pruritus and insomnia. On 20th October 2020, the patient experienced shivering. On 21st October 2020, the patient experienced weakness generalised. On 22nd October 2020, the patient experienced movements reduced. Rechallenge with Shingrix was positive. On 22nd October 2020, the outcome of the pain, sickness, shivering and weakness generalised were recovered/resolved. On an unknown date, the outcome of the movements reduced was unknown and the outcome of the fever, induration, pruritus and insomnia were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain, sickness, shivering, weakness generalised, movements reduced, fever, pain in arm, induration, pruritus and insomnia to be related to Shingrix.  Additional details were provided as follows: The reporter received the second dose in the right arm. After the vaccination, the patient claimed that the shot was painful and she was really sick.   On the night of vaccination date, she was shivering and achy. On 21st October 2020, she stayed in bed. On 22nd October 2020, she felt somewhat better but she could hardly touch her arm.  She had a fever and her left arm was sore and rock hard.  She also reported that she had post neuropathic itching that was reactivated during these days. She claimed that last November she had a bad case of shingles on her left arm but she had the previous shingles vaccine prior to the Shingrix.  She still has a slight soreness in her left arm till the time of reporting and further mentioned that previously she could not sleep on that side due to the soreness. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR213779:Same suspect, same reporter, different dose (1st dose)
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Sleep disorder, Tenderness
Clinical narrative: Could hardly touch her arm; Stayed in bed; Shivering; Shot was painful/achy; Really sick; Fever; Left arm was sore/slight soreness in her left arm; Left arm was rock hard; Post neuropathic itching; she couldn't sleep on that side due to the soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Patient had a bad case of shingles on her left arm last november). Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date and experienced sting and sore right arm , refer linked case US2020AMR213779) and Shingles vaccine with an associated reaction of herpes zoster (patient had shingles vaccine in past and had shingles).   On 20th October 2020, the patient received the 2nd dose of Shingrix. On 20th October 2020, the dose was an unknown dose. In October 2020, less than a day after receiving Shingrix, the patient experienced pain, sickness, fever, pain in arm, induration, pruritus and insomnia. On 20th October 2020, the patient experienced shivering. On 21st October 2020, the patient experienced weakness generalised. On 22nd October 2020, the patient experienced movements reduced. Rechallenge with Shingrix was positive. On 22nd October 2020, the outcome of the pain, sickness, shivering and weakness generalised were recovered/resolved. On an unknown date, the outcome of the movements reduced was unknown and the outcome of the fever, induration, pruritus and insomnia were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain, sickness, shivering, weakness generalised, movements reduced, fever, pain in arm, induration, pruritus and insomnia to be related to Shingrix.  Additional details were provided as follows: The reporter received the second dose in the right arm. After the vaccination, the patient claimed that the shot was painful and she was really sick.   On the night of vaccination date, she was shivering and achy. On 21st October 2020, she stayed in bed. On 22nd October 2020, she felt somewhat better but she could hardly touch her arm.  She had a fever and her left arm was sore and rock hard.  She also reported that she had post neuropathic itching that was reactivated during these days. She claimed that last November she had a bad case of shingles on her left arm but she had the previous shingles vaccine prior to the Shingrix.  She still has a slight soreness in her left arm till the time of reporting and further mentioned that previously she could not sleep on that side due to the soreness. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR213779:Same suspect, same reporter, different dose (1st dose)
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Mobility decreased
Clinical narrative: fatigue; headaches; fever; chills; soreness; Flu-like symptoms; not being able to lift arm; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue 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 fatigue, headache, fever, chills, pain, influenza-like symptoms and mobility decreased. On an unknown date, the outcome of the fatigue, headache, fever, chills, pain, influenza-like symptoms and mobility decreased were unknown.   It was unknown if the reporter considered the fatigue, headache, fever, chills, pain, influenza-like symptoms and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned Flu-like symptoms such as chills, fever soreness, fatigue also complaints of not being able to lift arm and headaches. The patient noticed that if the patient did not experience an adverse event after 1st dose they may have a mild case after 2nd dose. And if they have an adverse event after 1st dose they have a mild case after 2nd dose.  The Health care professional mentioned it was all patients well over 10 patients, so no PII was captured nor lot/exp. date.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215857:same reporter US-GLAXOSMITHKLINE-US2020214762:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: fatigue; headaches; fever; chills; soreness; Flu-like symptoms; not being able to lift arm; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue 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 fatigue, headache, fever, chills, pain, influenza-like symptoms and mobility decreased. On an unknown date, the outcome of the fatigue, headache, fever, chills, pain, influenza-like symptoms and mobility decreased were unknown.   It was unknown if the reporter considered the fatigue, headache, fever, chills, pain, influenza-like symptoms and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned Flu-like symptoms such as chills, fever soreness, fatigue also complaints of not being able to lift arm and headaches. The patient noticed that if the patient did not experience an adverse event after 1st dose they may have a mild case after 2nd dose. And if they have an adverse event after 1st dose they have a mild case after 2nd dose.  The Health care professional mentioned it was all patients well over 10 patients, so no PII was captured nor lot/exp. date.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215857:same reporter US-GLAXOSMITHKLINE-US2020214762:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Head discomfort, Injection site erythema, Rash macular
Clinical narrative: Body warmth; left side of head "felt strange"; has "red blotches" on her face , left arm , and knees; injection site redness for 4 days; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 28th October 2020, unknown after receiving Shingrix, the patient experienced head discomfort and red blotches. On an unknown date, the patient experienced injection site erythema and feeling of warmth. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the head discomfort, red blotches and feeling of warmth were unknown.   It was unknown if the reporter considered the injection site erythema, head discomfort, red blotches and feeling of warmth to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced red injection site, red blotches on her face, left arm and knees and her left side face felt strange after receiving the dose of Shingrix. No additional details were provided. The reporter did not consent to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Alopecia, Blood test, Chills, Fatigue
Clinical narrative: warm feeling on her scalp; itching on her scalp; hair loss / in large quantities /falling out by the root on the top of the head / scalp can be seen on the top of her head; pain at the injection site; swelling; muscle pain; fatigue; headache; shivering; feverish; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th August 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, swelling, muscle pain, fatigue, headache, shivering, fever and upset stomach. On 24th September 2020, the patient experienced hair loss. On an unknown date, the patient experienced localized feeling of warmth and itchy scalp. On an unknown date, the outcome of the injection site pain, swelling, muscle pain, fatigue, headache, shivering, fever and upset stomach were recovered/resolved and the outcome of the localized feeling of warmth, itchy scalp and hair loss were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, swelling, muscle pain, fatigue, headache, shivering, fever, upset stomach, localized feeling of warmth, itchy scalp and hair loss to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix vaccine on 4th August 2020. The patient reported that same evening the patient experienced pain at the injection site, swelling, muscle pain, fatigue, headache, shivering, feverish, and upset stomach.  The events lasted for 3 days and then resolved. Caller reported she left work early a couple of times due to these events. The patient reported that she had hair loss and reported hair started falling out in large quantities and was falling out by the root on the top of the head. The patient reported hair has fallen out to the point where the scalp could be seen on the top of her head. The patient reported the hair loss was still ongoing at the time of reporting. Periodically the patient had  itching on her scalp and a warm feeling on her scalp but was not sure when this started.  The patient reported she was having blood work done because of the hair loss. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Injection site pain, Myalgia, Pruritus
Clinical narrative: warm feeling on her scalp; itching on her scalp; hair loss / in large quantities /falling out by the root on the top of the head / scalp can be seen on the top of her head; pain at the injection site; swelling; muscle pain; fatigue; headache; shivering; feverish; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th August 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, swelling, muscle pain, fatigue, headache, shivering, fever and upset stomach. On 24th September 2020, the patient experienced hair loss. On an unknown date, the patient experienced localized feeling of warmth and itchy scalp. On an unknown date, the outcome of the injection site pain, swelling, muscle pain, fatigue, headache, shivering, fever and upset stomach were recovered/resolved and the outcome of the localized feeling of warmth, itchy scalp and hair loss were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, swelling, muscle pain, fatigue, headache, shivering, fever, upset stomach, localized feeling of warmth, itchy scalp and hair loss to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix vaccine on 4th August 2020. The patient reported that same evening the patient experienced pain at the injection site, swelling, muscle pain, fatigue, headache, shivering, feverish, and upset stomach.  The events lasted for 3 days and then resolved. Caller reported she left work early a couple of times due to these events. The patient reported that she had hair loss and reported hair started falling out in large quantities and was falling out by the root on the top of the head. The patient reported hair has fallen out to the point where the scalp could be seen on the top of her head. The patient reported the hair loss was still ongoing at the time of reporting. Periodically the patient had  itching on her scalp and a warm feeling on her scalp but was not sure when this started.  The patient reported she was having blood work done because of the hair loss. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: warm feeling on her scalp; itching on her scalp; hair loss / in large quantities /falling out by the root on the top of the head / scalp can be seen on the top of her head; pain at the injection site; swelling; muscle pain; fatigue; headache; shivering; feverish; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th August 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, swelling, muscle pain, fatigue, headache, shivering, fever and upset stomach. On 24th September 2020, the patient experienced hair loss. On an unknown date, the patient experienced localized feeling of warmth and itchy scalp. On an unknown date, the outcome of the injection site pain, swelling, muscle pain, fatigue, headache, shivering, fever and upset stomach were recovered/resolved and the outcome of the localized feeling of warmth, itchy scalp and hair loss were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, swelling, muscle pain, fatigue, headache, shivering, fever, upset stomach, localized feeling of warmth, itchy scalp and hair loss to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix vaccine on 4th August 2020. The patient reported that same evening the patient experienced pain at the injection site, swelling, muscle pain, fatigue, headache, shivering, feverish, and upset stomach.  The events lasted for 3 days and then resolved. Caller reported she left work early a couple of times due to these events. The patient reported that she had hair loss and reported hair started falling out in large quantities and was falling out by the root on the top of the head. The patient reported hair has fallen out to the point where the scalp could be seen on the top of her head. The patient reported the hair loss was still ongoing at the time of reporting. Periodically the patient had  itching on her scalp and a warm feeling on her scalp but was not sure when this started.  The patient reported she was having blood work done because of the hair loss. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: injection site / painful; injection site / itchy; injection site / swollen lump; injection site was hot; injection site / red; injection site / lump; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received DTPa (DTaP vaccine) (batch number C5630AA ?, expiry date 21st November 2021; GSK Note: batch number did not match with sales data sheet) for prophylaxis.   On 23rd October 2020, the patient received DTaP vaccine. On 25th October 2020, 2 days after receiving DTaP vaccine, the patient experienced injection site pain, injection site itching, injection site swelling, injection site warmth, injection site erythema and injection site lump. On an unknown date, the outcome of the injection site pain, injection site itching, injection site swelling, injection site warmth, injection site erythema and injection site lump were unknown.   It was unknown if the reporter considered the injection site pain, injection site itching, injection site swelling, injection site warmth, injection site erythema and injection site lump to be related to DTaP vaccine.  Additional details were provided as follows: The patient received DTaP vaccine from by 25th October 2020 the patient noticed the injection site was hot, swollen lump, red, itchy, and painful.  The patient does not know the brand name of the vaccine.  The reporter consent to follow up.
Age: 75.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth
Clinical narrative: injection site / painful; injection site / itchy; injection site / swollen lump; injection site was hot; injection site / red; injection site / lump; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received DTPa (DTaP vaccine) (batch number C5630AA ?, expiry date 21st November 2021; GSK Note: batch number did not match with sales data sheet) for prophylaxis.   On 23rd October 2020, the patient received DTaP vaccine. On 25th October 2020, 2 days after receiving DTaP vaccine, the patient experienced injection site pain, injection site itching, injection site swelling, injection site warmth, injection site erythema and injection site lump. On an unknown date, the outcome of the injection site pain, injection site itching, injection site swelling, injection site warmth, injection site erythema and injection site lump were unknown.   It was unknown if the reporter considered the injection site pain, injection site itching, injection site swelling, injection site warmth, injection site erythema and injection site lump to be related to DTaP vaccine.  Additional details were provided as follows: The patient received DTaP vaccine from by 25th October 2020 the patient noticed the injection site was hot, swollen lump, red, itchy, and painful.  The patient does not know the brand name of the vaccine.  The reporter consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Injection site pain, Nausea, Neck pain
Clinical narrative: painful neck; dizziness; nausea; Pain at the injection site; painful neck and shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of neck pain in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number F4234, expiry date 30th April 2022) and (batch number 2S9CL, expiry date 29th August 2022) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. In August 2020, less than a week after receiving Shingrix, the patient experienced neck pain, dizziness, nausea, injection site pain and shoulder pain. On 27th August 2020, the outcome of the neck pain, dizziness, nausea, injection site pain and shoulder pain were recovered/resolved.   It was unknown if the reporter considered the neck pain, dizziness, nausea, injection site pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient who after receiving the first dose of Shingrix experienced pain at the injection site, nausea, dizziness, painful neck and shoulder, the symptoms lasted for 4 days after the vaccination that was on 27th August 2020. The reporter consent to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Erythema, Fatigue, Headache
Clinical narrative: Pain; Redness; Swelling; Muscle aches; Fatigue; Headache; Shivering; Little stomach upset; Sweating profusely at night; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced pain, erythema, swelling, muscle pain, fatigue, headache, shivering, upset stomach and excess sweating. In October 2020, the outcome of the pain, erythema, swelling, muscle pain, fatigue, headache, shivering and upset stomach were recovered/resolved. On an unknown date, the outcome of the excess sweating was not recovered/not resolved.   It was unknown if the reporter considered the pain, erythema, swelling, muscle pain, fatigue, headache, shivering, upset stomach and excess sweating to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for himself. On Wednesday, the patient received Shingrix on right arm. The patient experienced pain, redness, swelling, muscle aches, fatigue, headache, shivering and a little stomach upset. The patient also experienced sweating profusely at night which continues at the time of reporting. The reporter did not consent to follow-up. The reporter did not give permission to contact.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Myalgia, Night sweats, Pain, Swelling
Clinical narrative: Pain; Redness; Swelling; Muscle aches; Fatigue; Headache; Shivering; Little stomach upset; Sweating profusely at night; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced pain, erythema, swelling, muscle pain, fatigue, headache, shivering, upset stomach and excess sweating. In October 2020, the outcome of the pain, erythema, swelling, muscle pain, fatigue, headache, shivering and upset stomach were recovered/resolved. On an unknown date, the outcome of the excess sweating was not recovered/not resolved.   It was unknown if the reporter considered the pain, erythema, swelling, muscle pain, fatigue, headache, shivering, upset stomach and excess sweating to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for himself. On Wednesday, the patient received Shingrix on right arm. The patient experienced pain, redness, swelling, muscle aches, fatigue, headache, shivering and a little stomach upset. The patient also experienced sweating profusely at night which continues at the time of reporting. The reporter did not consent to follow-up. The reporter did not give permission to contact.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: became sick both times; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-heath care professional via social media.  This case a patient (demographics unknown) who became sick both times (malaise) after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. The patient had received 2 flu shots.  On an unknown date, the patient became sick both times (malaise) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE. The reporter reported that flu shots are not copacetic with immune system. The efficacy of the shots was usually less than 40 percent.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: It worked for me every year and i got the flu; Initial information was received on 18-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case is linked to case 2020SA295897 and 2020SA297164..  This case involves a female patient (unknown demography) who got the flu (influenza), while she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza), unknown latency following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.  It was reported that the vaccine work for patient every year.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown.  There will be no information on the batch number for this case.
Sex: U
Vaccine: DT
Symptoms: Allergy to vaccine
Clinical narrative: patient has allergy with tetanus and diphtheria toxoids; Initial information received on 19-Oct-2020 regarding an unsolicited valid non-serious courtesy case received from a consumer or non health care professional via Pfizer.    This case involves a patient who had allergy with DIPHTHERIA AND TETANUS TOXOIDS (allergy to vaccine).  The patient's medical history included lower respiratory tract infection, gastro esophageal reflux disease and gastrointestinal stromal tumor of stomach.  Patient also had lactose intolerance, milk allergy, chronic obstructive pulmonary disease and essential hypertension.  The patient's medical treatments, concomitant therapy, vaccinations and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had non-serious allergy with DIPHTHERIA AND TETANUS TOXOIDS (allergy to vaccine) (Unknown latency).  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: I got sick after every flu shot until I got the egg free one; Initial information received on 24-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves patient with unknown demography who got sick (illness), after receiving vaccine INFLUENZA VACCINE.  The patient's past vaccination included flu shot after which he/she turned sick.  Medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sickness (illness) (Unknown latency) following the administration of INFLUENZA VACCINE. It was reported that after every flu shot patient got sick until he/she got the egg free one.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was not reported for the event illness.  There will be no information on the batch number for this case.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: Fluzone High Dose Quadrivalent vaccine was administered in the dorsal, mid-forearm to a patient, no AE; Initial and additional information regarding an unsolicited valid non-serious case received from a pharmacist via agency (Reference number- 00303301) and transmitted to Sanofi on 06-Oct-2020 and 07-Oct-2020.  This case involves a 75-years-old female patient who received a 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number and expiry date not reported) via an unknown route in the dorsal, mid-forearm (product administered at inappropriate site) on 28-Sep-2020 for prophylactic vaccination.  The patient's medical history, past medical treatments, vaccinations and family history were not provided. Patient had no concomitant medications.  It was an actual medication error case due to vaccine administered at inappropriate site (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: his arm is sore for a few days; Initial information was received on 19-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or other nonprofessional.  This case involves a 65-year-old male patient who experienced his arm is sore for a few days (pain in extremity), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, concomitant medication, past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious his arm is sore for a few days (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported that, the patient was 70 years old and ever since he turned 65, he has been getting the Fluzone High-Dose vaccine (lot number: UJ516AA,expiration date :30-Jun-2021) via intramuscular route in the left deltoid. He reports that he went to a drive through flu-shot clinic this year on 17-Oct-2020 and reports that every year, after he receives the vaccine, his arm is sore for a few days. This year, it doesn't/ didn't hurt at all.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome was unknown for the event at the time of reporting.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant patient was given FLUZONE QUADRIVALENT, no AE; Initial information regarding an unsolicited valid non-serious case received from a pharmacist via Health Authority (Reference number- 00322387) and transmitted to Sanofi on 19-Oct-2020.  This case involves a female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] when she was pregnant (exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The gestation period during exposure was unknown. The date of last menstrual period was not reported. The estimated due date was not reported.  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  In Jul-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE batch number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy.  It was also reported that the nursing program she attends won't accept that as a viable vaccine because it was too early in the season.   It was not reported whether patient experienced any adverse reaction after the vaccination.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.  Information on the batch number was requested.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase increased, Chest pain, Chills, Dizziness, Malaise
Clinical narrative: The patient is a 63 yo male with a history of Afibb, HTN who received Fluarix brand vaccine  on 13 OCT 2020 (lot #LP9HK) to his left deltoid as a PAIVED study subject (vaccine is FDA approved,  not investigational)  and reports Shingrix receipt 1 week later ( I cannot retrieve record per Agency). He experienced CP day0 and near syncope day 15 (day 8 post shingrix),  both requiring ER visits. Per chart review he had a negative cardiac cath within the past 6 months.  On 28 OCT 20 (day 15) he reports he was again seen in Er for near syncope event. He experienced lightheadedness and racing heart. He was again seen in ER who put him on metoprolol, but he never took it per instructions of his cardiologist. These symptoms were present prior to vaccine receipt and he has current pending referral to ENT and neurology.   He also reports he received Shingrix vaccine 1 week after IIV (not in Agency records). He experienced no immediate adverse event. That evening he experienced chills, and malaise, but denies fever, rash, SOB, CP, dizziness. itching, urticaria. He reports symptoms were resolved by morning.  He was diagnosed with flu vaccine reaction by ER.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Palpitations, Syncope, Troponin T increased
Clinical narrative: The patient is a 63 yo male with a history of Afibb, HTN who received Fluarix brand vaccine  on 13 OCT 2020 (lot #LP9HK) to his left deltoid as a PAIVED study subject (vaccine is FDA approved,  not investigational)  and reports Shingrix receipt 1 week later ( I cannot retrieve record per Agency). He experienced CP day0 and near syncope day 15 (day 8 post shingrix),  both requiring ER visits. Per chart review he had a negative cardiac cath within the past 6 months.  On 28 OCT 20 (day 15) he reports he was again seen in Er for near syncope event. He experienced lightheadedness and racing heart. He was again seen in ER who put him on metoprolol, but he never took it per instructions of his cardiologist. These symptoms were present prior to vaccine receipt and he has current pending referral to ENT and neurology.   He also reports he received Shingrix vaccine 1 week after IIV (not in Agency records). He experienced no immediate adverse event. That evening he experienced chills, and malaise, but denies fever, rash, SOB, CP, dizziness. itching, urticaria. He reports symptoms were resolved by morning.  He was diagnosed with flu vaccine reaction by ER.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Presyncope
Clinical narrative: Pt has had vasovagal episodes after immunizations in past.  She had two again last night.  She recovered fine after resting and some juice and crackers.  Blood pressure checked twice and was at her normal range when leaving.  she was doing fine when she left
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Lymphadenopathy, Swelling face
Clinical narrative: Lymph nodes in neck swelled rapidly to include my face in front of my ears both sides but right side much worse
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Vomiting
Clinical narrative: violent chills, muscle / body aches, headache, vomiting, fatigue
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Limb discomfort, Myalgia, Pain
Clinical narrative: Sore arm, sore muscles, limited range of motion without pain
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Rash macular, Skin exfoliation
Clinical narrative: Rash started on day 4 after shingles vaccine. Red patch on neck, progressive and spread up her neck and onto the top part of her chest. She was seen in office on 11/3, rash had receded some. Per MD notes: on the midline of her neck there is a macular rash with just a faint overlying scale 5cm in width and 16cm in length. It is continuous. No other rash on any other distribution. No lesions.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Tremor
Clinical narrative: Pain in every joint.  Uncontrollable shaking of limbs. Chills.
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site discomfort, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: My daughter got her flu shot at school due to us not having insurance at this time.  This is not her first time getting a flu shot, but this is the first time she has had a reaction, the site of the shot is red, sore to touch and raised larger than golf ball size in diameter. The school nurse gave her ice for site due to pain, I gave her a Benadryl that night.  Now the 3rd day, site of injection has increased in size, redness and sore to touch.  We continue the ice & have notified doctor of this reaction.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain in arm continuing 4 weeks since shot. No hardness, warmth, redness or swelling. Can lift should and has range of motion. Pain extends down towards hand. Pain is relieved by ibuprofen.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu both times; Initial information received on 25-Oct-2020 regarding an unsolicited valid serious case received from a consumer via social media.  This case involves male patient (unknown age) who experienced flu both times (influenza), while he received two shots of INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a two dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious flu both times (influenza), (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not reported.  Information on the batch number was requested.; Sender's Comments: This case concerns a male patient (unknown age) who had influenza, after and despite vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, immune status and lab data excluding predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient was tested positive for Covid; Initial information received on 27-Oct-2020 regarding an unsolicited valid serious social media case received from a consumer (patient).  This case involves a male patient of unknown age who was tested positive for COVID (COVID-19), while he received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was tested positive for COVID (COVID-19), a week following the administration of INFLUENZA VACCINE. The patient was hospitalized for 3 weeks due to this event.  Other relevant laboratory data were not reported.  It was reported that the patient was back home taking treatments (not specified) and was on oxygen for COVID-19.   At the time of reporting, the patient was recovering from the event. He also reported that some of those folks that were in the Hospital did not make it.  Information on the batch number was requested.; Sender's Comments: This case involves a male patient of unknown age who was tested positive for COVID-19 after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset was compatible. However, patient's medical condition at time of vaccination was not reported. Based upon the reported information and considering the infectious nature of the event, the role of suspect vaccine cannot be assessed.