chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Bronchial secretion retention, Computerised tomogram thorax abnormal, Pneumonia, Scan with contrast abnormal, Sinusitis
Clinical narrative: showed Bilateral Pneumonia; a sinus infection; out mucus from my lungs; This case was reported by a consumer via call center representative and described the occurrence of bilateral pneumonia in a 65-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) unknown (batch number Unknown, expiry date unknown) for an unknown indication.   The patient's past medical history included ex-smoker. Previously administered products included Nucala (started Nucala 9 moths ago). Concurrent medical conditions included sinus disorder.   On 29th January 2020, the patient received the 2nd dose of Shingles vaccine. In January 2020, the patient started Nucala at an unknown dose and frequency. On 30th January 2020, 1 days after receiving Shingles vaccine and less than a month after starting Nucala, the patient experienced bilateral pneumonia (serious criteria hospitalization and GSK medically significant), sinus infection and bronchial mucus plug. The patient was treated with prednisone and levofloxacin (Levaquin). On an unknown date, the outcome of the bilateral pneumonia, sinus infection and bronchial mucus plug were recovering/resolving.   It was unknown if the reporter considered the bilateral pneumonia, sinus infection and bronchial mucus plug to be related to Shingles vaccine and Nucala.  Additional details were provided as follows: The reporter stated that, the patient had statrted Nucala 9 months ago and got it once a month at doctor's office. The patient received Nucala between 10th and 15th january 2020. The reporter stated that, next day after vaccination with dose of Shingrix, the patient experienced Pneumonia symptoms. The reporter reported that, the patient's primary health care professional first diagnosed it as sinus infection since, the patient always had sinuses problems. The patient had CT scan  with contrast, and it showed bilateral pneumonia. The patient was prescribed Levaquin 750 and Prednisone. The patient was hospitalised for 1 day, as an ambulatory patient to get a bronchial flush. The reporter stated that, till the time of reporting, the patient was recovering. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: swelling injection site for 2 days
Sex: U
Vaccine: HEPA, HIBV, HPV9, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; a patient was administered an improperly stored dose of either VAQTA, PEDVAX HIB, or GARDASIL9; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant medication and drug reactions/allergies were not provided.  On 19-DEC-2019, the patient was administered an improperly stored dose of either hepatitis a vaccine, inactivated (VAQTA) (lot# S010727, expiration date 26-JUL-2020, dose detail, strength and route were not provided), haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot# S006471, expiration date 22-JAN-2022, dose detail, strength and route were not provided) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# 1621926, expiration date 28-NOV-2021, dose detail, strength and route were not provided) for prophylaxis (product storage error). The temperature excursions included 34.9 Fahrenheit degree for 7 minutes and 48.2 Fahrenheit degree for 5 hours. There was no temperature previously excursion. There was a data logger involved. The medical assistant could not confirm during the call which of these products the patient received. No additional adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history.   In 2014, the patient was vaccinated with a dose of the zoster vaccine live (ZOSTAVAX) (lot number, expiration date, anatomical location and administration route were not reported) at a clinic, for the long-term prevention of shingles and/or zoster-related conditions. On an unspecified date, subsequent to the patient's zoster vaccine live (ZOSTAVAX inoculation, patient was treated by a physician for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization (on unknown dates), physician care, monitoring, treatment, medications, and supplies. By the time of the report, the patient did not recover from shingles. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 30-JUL-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for herpes zoster. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2015, the patient was inoculated with zoster vaccine live ZOSTAVAX (dose, anatomical location, route of administration, lot # and expiry date were not provided), as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's inoculation, the patient was treated by nurse practitioner for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was considered to be not recovered. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Myelitis transverse
Clinical narrative: Transverse Myelitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or around 09-DEC-2012 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after the vaccination, unsure it's in December 2012 or 2013), the patient suffered from and was diagnosed with transverse myelitis. As the result of vaccine live(ZOSTAVAX), the patient suffered serious, progressive, severe, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of transverse myelitis was considered as not recovered. The lawyer considered it to be related to zoster vaccine live(ZOSTAVAX).  Upon internal review, transverse myelitis was determined to be medically significant. Transverse myelitis was considered as disable by reporting lawyer.
Sex: M
Vaccine: VARZOS
Symptoms: Myelitis transverse
Clinical narrative: Myasthenia gravis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or around 20-DEC-2016 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after the vaccination, unsure it's in December 2016 or 2017), the patient suffered from and was diagnosed with transverse myelitis. As the result of vaccine live(ZOSTAVAX), the patient suffered serious, progressive, severe, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of transverse myelitis was considered as not recovered. The lawyer considered it to be related to zoster vaccine live(ZOSTAVAX).  Upon internal review, transverse myelitis was determined to be medically significant. Transverse myelitis was considered as disable by reporting lawyer.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Pregnancy test positive, Seroconversion test negative
Clinical narrative: she had received the MMR II vaccine (unspecified date) as a child but a recent test revealed that she had not seroconverted; she tested positive to a pregnancy test after receiving the MMR II vaccine; Information has been received from a female patient of unknown age, referring to herself. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. The patient had received the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine (strength, dose, route, lot # and expiration date were not reported) for prophylaxis on an unspecified date as a child. The patient was pregnant.  On an unknown date (reported as recently), the patient performed a test, which revealed that she had not seroconverted. Subsequently, the patient received a booster shot (one dosage form) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine (strength, dose detail, route, lot # and expiration date were not reported) for prophylaxis on 21-FEB-2020.   On the same date, after receiving the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine, the patient tested positive to a pregnancy test (exposure during pregnancy). The last menstrual period (LMP) and the estimated date of delivery (EDD) were unknown. The pregnancy outcome was outcome pending. The fetal outcome was unknown. There was no treatment received. The patient had sought medical attention. The outcome of seroconversion test negative was unknown. The causality assessment was not provided.
Age: 4.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Seroconversion test negative
Clinical narrative: she had not seroconverted after receiving the first VARlVAX shot; Information has been received from a currently 25 years old female patient, referring to herself. The patient had no concomitant medications, no pertinent medical history and no drug reactions/allergies. The patient was not pregnant.  On 25-FEB-1998, the patient received her first varicella virus vaccine live (oka/merck) (VARIVAX) shot (one dosage form) (strength, route, lot # and expiration date were not reported) through upper arm for chickenpox.  On 14-JAN-2019, the patient performed a routine blood work with the result of her titer test indicated that she had not seroconverted (seroconversion test negative). The patient had sought medical attention by visiting the physician. On 10-FEB-2020, treatment was received by giving a booster shot of varicella virus vaccine live (oka/merck) (VARIVAX) (one dosage form; strength and route were not reported) (lot # S006017, expiration date was not reported, but upon internal validation established as 27-FEB-2021) and sterile diluent (STERILE DILUENT) in the upper arm for chickenpox. Therapy with the varicella virus vaccine live (oka/merck) (VARIVAX) was reported as continued. The outcome of the seroconversion test negative was unknown. The causality assessment was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Gait disturbance, Mobility decreased, Ocular discomfort
Clinical narrative: My entire upper arm is swollen /Each day the swelling is more than the previous day; My entire upper arm is red; My entire upper arm is hot; Im having difficulty waking since the shot; I wake up but have to fight to open my eyes; I wake up but have to fight to move; This case was reported by a consumer and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm, erythema of extremities, extremities hot feeling of, walking difficulty, eye discomfort and mobility decreased. On an unknown date, the outcome of the swelling arm, erythema of extremities, extremities hot feeling of, walking difficulty, eye discomfort and mobility decreased were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, extremities hot feeling of, walking difficulty, eye discomfort and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient's entire upper arm was swollen, red and hot.  On day by day the swelling was increased. The patient had difficulty in waking since the shot.  After wake up the patient had to fight to open eyes and to move the patient never had this before this could not be normal.  The patient was afraid to go to sleep.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: My entire upper arm is swollen /Each day the swelling is more than the previous day; My entire upper arm is red; My entire upper arm is hot; Im having difficulty waking since the shot; I wake up but have to fight to open my eyes; I wake up but have to fight to move; This case was reported by a consumer and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm, erythema of extremities, extremities hot feeling of, walking difficulty, eye discomfort and mobility decreased. On an unknown date, the outcome of the swelling arm, erythema of extremities, extremities hot feeling of, walking difficulty, eye discomfort and mobility decreased were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, extremities hot feeling of, walking difficulty, eye discomfort and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient's entire upper arm was swollen, red and hot.  On day by day the swelling was increased. The patient had difficulty in waking since the shot.  After wake up the patient had to fight to open eyes and to move the patient never had this before this could not be normal.  The patient was afraid to go to sleep.
Sex: F
Vaccine: VARZOS
Symptoms: Ill-defined disorder, Joint swelling, Limb discomfort, Myalgia, Neuralgia
Clinical narrative: Nerve pain; Muscle pain; swollen joints; facial symptoms; heavy legs; shouting pain in the legs; This case was reported by a other health professional via call center representative and described the occurrence of nerve pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pruritus (1st dose received in August 2019, refer the case US2020032209 ).   In November 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced nerve pain, myalgia, swollen joints, ill-defined disorder, heaviness in leg and leg pain. On an unknown date, the outcome of the nerve pain, myalgia, swollen joints, ill-defined disorder, heaviness in leg and leg pain were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain, myalgia, swollen joints, ill-defined disorder, heaviness in leg and leg pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After 2nd dose the patient experienced nerve pain, muscle pain, swollen joints,facial symptoms that had never had before, heavy legs and shouting pain in the legs. The patient still had these symptoms.  The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Nerve pain; Muscle pain; swollen joints; facial symptoms; heavy legs; shouting pain in the legs; This case was reported by a other health professional via call center representative and described the occurrence of nerve pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pruritus (1st dose received in August 2019, refer the case US2020032209 ).   In November 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced nerve pain, myalgia, swollen joints, ill-defined disorder, heaviness in leg and leg pain. On an unknown date, the outcome of the nerve pain, myalgia, swollen joints, ill-defined disorder, heaviness in leg and leg pain were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain, myalgia, swollen joints, ill-defined disorder, heaviness in leg and leg pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After 2nd dose the patient experienced nerve pain, muscle pain, swollen joints,facial symptoms that had never had before, heavy legs and shouting pain in the legs. The patient still had these symptoms.  The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Induration, Limb mass
Clinical narrative: arm now has a hard lump under the skin; arm now has a hard lump under the skin; This case was reported by a other health professional via interactive digital media and described the occurrence of upper extremity mass in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received Shingrix. In February 2020, 3 days after receiving Shingrix, the patient experienced upper extremity mass and induration. On an unknown date, the outcome of the upper extremity mass and induration were unknown.   It was unknown if the reporter considered the upper extremity mass and induration to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient had Shingrix shot three days before the time of reporting. The patient's arm had a hard lump under the skin. The patient wanted to knowif this was a normal side effect.
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Iodine dye (Dye). Concurrent medical conditions included autoimmune disorder.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovered/resolved.   It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced side effects from an unspecified flu vaccine, that only lasted a day or two. The patient would see her hematologist on Wednesday. This case had been linked to the case US2020033027, reported for same patient by same reporter. The reporter consented to follow up.
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Malaise, Rash, Rash pruritic
Clinical narrative: Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Iodine dye (Dye). Concurrent medical conditions included autoimmune disorder.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovered/resolved.   It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced side effects from an unspecified flu vaccine, that only lasted a day or two. The patient would see her hematologist on Wednesday. This case had been linked to the case US2020033027, reported for same patient by same reporter. The reporter consented to follow up.
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Burning sensation, Eye infection, Feeding disorder
Clinical narrative: Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Iodine dye (Dye). Concurrent medical conditions included autoimmune disorder.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovered/resolved.   It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced side effects from an unspecified flu vaccine, that only lasted a day or two. The patient would see her hematologist on Wednesday. This case had been linked to the case US2020033027, reported for same patient by same reporter. The reporter consented to follow up.
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Hepatitis, Herpes zoster, Insomnia, Pain, Pruritus
Clinical narrative: Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Iodine dye (Dye). Concurrent medical conditions included autoimmune disorder.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovered/resolved.   It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced side effects from an unspecified flu vaccine, that only lasted a day or two. The patient would see her hematologist on Wednesday. This case had been linked to the case US2020033027, reported for same patient by same reporter. The reporter consented to follow up.
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Rash, Skin lesion
Clinical narrative: Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Iodine dye (Dye). Concurrent medical conditions included autoimmune disorder.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovered/resolved.   It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced side effects from an unspecified flu vaccine, that only lasted a day or two. The patient would see her hematologist on Wednesday. This case had been linked to the case US2020033027, reported for same patient by same reporter. The reporter consented to follow up.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Ectopic pregnancy, Exposure during pregnancy, Human chorionic gonadotropin increased, Mass, Muscle spasms
Clinical narrative: I obviously didn't know I was just a few days pregnant at the time of my work-required flu shot. (Date of last period was Sept. 15, conception somewhere the first week of October.) In late October I found out I was pregnant. Just days after finding out, I started spotting and cramping. I spotted a little with my first child so I wasn?t immediately alarmed. I just kept my 8-week appointment as scheduled. The bleeding increased so I called Dr. who ordered a blood test that day and ultrasound the next morning. Blood test showed an HCG level of around 4,000 and we were planning a follow-up blood draw at the end the next day. I went to the ultrasound the next morning and within 20 minutes my doctor called to have me come in right away. The ultrasound showed a small mass in my tube. The doctor was willing to let me wait for the follow-up blood test, but said if I had any pain, to go to the emergency department because if the tube ruptured, I was at high risk of bleeding to death. That night the pain became severe so my husband and I headed to the ED. Within an hour I was in surgery to remove the ectopic pregnancy.   My first pregnancy had no complications whatsoever and I had no risk factors for having an ectopic pregnancy. Even in line to get the flu shot I told I co-worker I was nervous to get the shot because I had seen the study where you are more likely to miscarry if you get consecutive flu shots, which I?m required to do for work. She knew we were trying for our second child.  I know it?s hard to prove that the shot caused the loss, but the dates work out and I have no other reason to have had complications.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Surgery, Ultrasound antenatal screen abnormal, Vaginal haemorrhage
Clinical narrative: I obviously didn't know I was just a few days pregnant at the time of my work-required flu shot. (Date of last period was Sept. 15, conception somewhere the first week of October.) In late October I found out I was pregnant. Just days after finding out, I started spotting and cramping. I spotted a little with my first child so I wasn?t immediately alarmed. I just kept my 8-week appointment as scheduled. The bleeding increased so I called Dr. who ordered a blood test that day and ultrasound the next morning. Blood test showed an HCG level of around 4,000 and we were planning a follow-up blood draw at the end the next day. I went to the ultrasound the next morning and within 20 minutes my doctor called to have me come in right away. The ultrasound showed a small mass in my tube. The doctor was willing to let me wait for the follow-up blood test, but said if I had any pain, to go to the emergency department because if the tube ruptured, I was at high risk of bleeding to death. That night the pain became severe so my husband and I headed to the ED. Within an hour I was in surgery to remove the ectopic pregnancy.   My first pregnancy had no complications whatsoever and I had no risk factors for having an ectopic pregnancy. Even in line to get the flu shot I told I co-worker I was nervous to get the shot because I had seen the study where you are more likely to miscarry if you get consecutive flu shots, which I?m required to do for work. She knew we were trying for our second child.  I know it?s hard to prove that the shot caused the loss, but the dates work out and I have no other reason to have had complications.
Age: 87.0
Sex: F
Vaccine: UNK
Symptoms: Computerised tomogram normal, Feeling hot, Head injury, Hyperhidrosis, Loss of consciousness
Clinical narrative: I had the shot at Pharmacy the afternoon of March 6.  Sat. morning soon after I got up I felt hot and sweaty.  I sat down for awhile, then got up to continue what I was doing in the kitchen.  I passed out and struck my head on the floor.  Neighbors took me to the emergency where I had a CAT scan and xray.  All were okay.  The dr. put stitches in the back of my head.  I was stiff and sore, took tyanol for 2-3 days and visited the PA at my family dr.'s office.
Age: 87.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal stiffness, Pain, Suture insertion, X-ray normal
Clinical narrative: I had the shot at Pharmacy the afternoon of March 6.  Sat. morning soon after I got up I felt hot and sweaty.  I sat down for awhile, then got up to continue what I was doing in the kitchen.  I passed out and struck my head on the floor.  Neighbors took me to the emergency where I had a CAT scan and xray.  All were okay.  The dr. put stitches in the back of my head.  I was stiff and sore, took tyanol for 2-3 days and visited the PA at my family dr.'s office.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date not provided) as prescribed and/or administered by a health care provider at the physician office for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, on an unknown date, the patient was treated by health care provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event shingles (Herpes zoster) was unknown. Causality assessment between the event and zoster vaccine live (ZOSTAVAX) was considered related.  {Additional information has been requested. / Additional information is not expected.}
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster oticus
Clinical narrative: Herpes zoster oticus/Ramsay-Hunt syndrome; Information has been received regarding a case in litigation from a lawyer and consumer, to a patient of unknown age and gender. Information about concurrent condition, historical condition and concomitant medication was unknown.   On or about 24-SEP-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency and route unknown) for the long-term prevention of shingles and/or zoster-related conditions, by the pharmacist at a pharmacy.   On an unknown date, the patient was treated for herpes zoster oticus and Ramsay Hunt Syndrome. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster oticus and Ramsay Hunt Syndrome was considered as not recovered/not resolved. The herpes zoster oticus was considered to be related to zoster vaccine live (ZOSTAVAX).     Upon internal review, herpes zoster oticus and Ramsay Hunt Syndrome was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer and consumer, referring to a patient of unknown age and gender. Information about concurrent condition, historical condition and concomitant medication was unknown.   On or about 25-NOV-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency and route unknown) for the long-term prevention of shingles and/or zoster-related conditions, by a healthcare provider.   On an unknown date, the patient was treated for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of event was considered as not recovered/not resolved. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: pain; heat at injection site, mostly when exercising; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABX797AB, expiry date 29th February 2020) for prophylaxis.   On 7th January 2020, the patient received the 1st dose of Bexsero. On an unknown date, less than a month after receiving Bexsero, the patient experienced injection site pain and injection site warmth. On an unknown date, the outcome of the injection site pain and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site warmth to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero and had pain and heat at injection site, mostly when exercising.  The event has resolved. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Formication, Musculoskeletal stiffness
Clinical narrative: feel like things were crawling through her body; stiffness in her right arm; This case was reported by a consumer via call center representative and described the occurrence of crawling sensation in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th November 2019, 1 days after receiving Shingrix, the patient experienced crawling sensation and limbs stiffness. On an unknown date, the outcome of the crawling sensation and limbs stiffness were unknown.   It was unknown if the reporter considered the crawling sensation and limbs stiffness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and it caused her to felt like things were crawling through her body.   The patient also reported that she experienced stiffness in her right arm although she got the vaccine in her left arm. The reporter did not consent to follow up. This case linked with US2020031415, reported by same reporter.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: did not develop immunity against the Hepatitis B virus; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine.  Additional details were provided as follows: No patients date of birth or vaccine data was provided. The registered nurse reported that the patient who received a full series of unknown brand of hepatitis B vaccine, and did not develop immunity against the Hepatitis B virus. The reporter consented to follow up. This case linked with US2020036858, reported by same reporter.      Lab Comments: lab test performed on unknown date
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: Concussion, Fall, Head injury, Presyncope
Clinical narrative: vasovagal episode lasting 5-10 seconds with patient falling to floor and hit head of floor.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Malaise, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: March 4, went very well.  I received my first PCV13 vaccine at that appointment.  The nurse did a wonderful job of administering the vaccine-it did not hurt!  Unfortunately, starting that evening I did start experiencing all the classic side effects of a reaction-sore arm, body aches, low grade temperature....general yuk.  All those symptoms continued thru Saturday.   Also, starting on Thursday, my arm became very sore, red, swollen and very warm to the touch.  Took Tylenol and applied ice pack occasionally.  The redness, swelling and itching seemed to grow and be traveling down my arm towards my elbow and to the underside of my arm.   Starting Sunday my temperature returned to normal and the redness and swelling has lightened but I can still feel the itchy feeling in my arm.  It is definitely getting better.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Pyrexia, Skin warm
Clinical narrative: March 4, went very well.  I received my first PCV13 vaccine at that appointment.  The nurse did a wonderful job of administering the vaccine-it did not hurt!  Unfortunately, starting that evening I did start experiencing all the classic side effects of a reaction-sore arm, body aches, low grade temperature....general yuk.  All those symptoms continued thru Saturday.   Also, starting on Thursday, my arm became very sore, red, swollen and very warm to the touch.  Took Tylenol and applied ice pack occasionally.  The redness, swelling and itching seemed to grow and be traveling down my arm towards my elbow and to the underside of my arm.   Starting Sunday my temperature returned to normal and the redness and swelling has lightened but I can still feel the itchy feeling in my arm.  It is definitely getting better.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Cough, Decreased appetite, Hyperhidrosis, Nasal congestion
Clinical narrative: & Chill; Nasal congestion; Cough; Loss of appetite; Diaphoresis
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Muscle spasms, Nocturia
Clinical narrative: Patient awoke with dizziness and muscle spasms originating at the soles of her feet and radiating upwards throughout her body.  She also reported that she had to urinate an unusually high number of times throughout the night.  These events resolved on their own.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Arm pain, fever, chills
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Given at age 64
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer and consumer, referring to the currently 66 years old patient of unknown gender. Information about concurrent condition, historical condition and concomitant medication was unknown.   The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 14-AUG-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency and route unknown) at a medical office.   The patient was treated by a healthcare provider at a clinic for the following injuries resulting from zoster vaccine live (ZOSTAVAX): shingles. The outcome of the event was unknown. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: polymyalgia rheumatica; Information has been received regarding a case in litigation from a lawyer and consumer, referring to the 60 year old patient of unknown gender. Information about concurrent condition, historical condition and concomitant medication was unknown.   The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 24-FEB-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency and route unknown) by a pharmacist at a pharmacy.   The patient suffered the following injuries and was diagnosed on the following dates: as a result of the zoster vaccine live (ZOSTAVAX), patient was diagnosed with polymyalgia rheumatica on 09-SEP-2014. The outcome of the event was unknown. The event was considered to be related to zoster vaccine live (ZOSTAVAX).     Upon internal review, polymyalgia rheumatica was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a healthcare provided for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the patient was treated by medical providers for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the shingles was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).