chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: MENB, MNQ, PPV
Symptoms: Abdominal pain, Migraine, Product administered to patient of inappropriate age, Pyrexia, Tremor
Clinical narrative: High fever; Migraines; abdominal pain; shakes; inappropriate age at vaccination; This case was reported by a consumer via call center representative and described the occurrence of fever in a 34-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMOVAX) (batch number PPSV23, expiry date unknown) for prophylaxis.   Concurrent medical conditions included splenectomy.   On 22nd July 2019, the patient received Menveo, Bexsero and PNEUMOVAX. On 22nd July 2019, less than a day after receiving Menveo and Bexsero, the patient experienced fever (serious criteria hospitalization), migraine (serious criteria hospitalization), abdominal pain (serious criteria hospitalization), tremor (serious criteria hospitalization) and inappropriate age at vaccine administration. On an unknown date, the outcome of the fever, migraine, abdominal pain and tremor were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the fever, migraine, abdominal pain and tremor to be related to Menveo and Bexsero.  Additional details were provided as follows: The patient experienced high fever with shakes, migraines, and abdominal pain. The patient received Bexsero outside the recommended age, which led to inappropriate age at vaccine administration. On 24th July 2019, the patient was hospitalized. The reporter had to disconnect the call, so could not obtain additional information. The patient did not have a specific doctor and could not provide name of the health care professional to follow up. The reporter did not consent to follow-up. This case was medication error associated with adverse events. The outcome reported for all AES in the structured field of database is "recovered/resolved with sequel" instead of "recovered/resolved" (outcome uploaded in database).
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Peripheral swelling
Clinical narrative: Swelling on arm; Redness on arm; Wrong Route of Administration; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number F3D7H, expiry date 5th July 2021) for prophylaxis.   On 27th April 2019, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 27th April 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age of the patient could be 78 or 79 years old. The patient received dose of Shingrix in the left arm. The patient was a doctor and is adamant that vaccine was administered subcutaneously to him and his wife. The pharmacist reported that, the patient was adamant, who received dose of Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The reporter was from different pharmacy location in same town, who was notified of patient's events. The reporter was familiar with pharmacist who signed off on vaccination and believes that pharmacist knew what he was doing. This case was 1 of the 2 linked case. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (Recovered or resolved with sequel).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: shingles; itching; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 15th July 2019, 7 days after receiving Shingrix, the patient experienced shingles and pruritus. On an unknown date, the outcome of the shingles and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the shingles and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. After vaccination, the patient experienced shingles on her right side and left side of body. On an unknown date, the patient planned to continue follow up with her physician.  The reporter consented to follow up.
Age: 93.0
Sex: M
Vaccine: VARZOS
Symptoms: Housebound, Injection site inflammation, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Stiff/ stiffness extends up his neck and down into his elbow; Inflammed; Cannot sleep; felt like fluid under the skin; Swollen; Warm; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of stiffness in a 93-year-old male patient who received Herpes zoster (Shingrix) (batch number 7A55L, expiry date 16th April 2021) for prophylaxis.   On 29th April 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 1st May 2019, 2 days after receiving Shingrix, the patient experienced injection site swelling, injection site warmth and injection site pain. On an unknown date, the patient experienced stiffness, injection site inflammation, sleeplessness and injection site edema. On an unknown date, the outcome of the stiffness, injection site inflammation, sleeplessness, injection site swelling, injection site warmth and injection site pain were not recovered/not resolved and the outcome of the injection site edema was unknown.   It was unknown if the reporter considered the stiffness, injection site inflammation, sleeplessness, injection site swelling, injection site warmth, injection site pain and injection site edema to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter's father. The reporter and the patient both were on the call. The patient received dose of Shingrix in the left arm. Less than 3 months after vaccination, the patient experienced stiffness, injection site inflammation, sleeplessness and injection site edema. The patient stated that, at the time of reporting, he stil experienced injection site swelling, warmth and pain. The patient performed ultrasound with no findings. The patient stated that, when ge was not using his arm, the pain was mild, but when tried to use his arm it was very painful. The patient reported that, stiffness was extended up his neck and down into his elbow. The patient was normally very active but was now house bound. The patient was seen by three different physiacin and get conflicting treatment guidance. The patient has been told that, injection site was inflammed and that could lasted from three to six months. The patient's latest physician described that it felt like fluid under the skin, but he did not have a hematoma. The reporter have permission for his physician to be contacted. The reporter consented to follow up.      Lab Comments: lab test performed on an unknown date
Age: 93.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Insomnia, Musculoskeletal stiffness, Pain, Ultrasound scan normal
Clinical narrative: Stiff/ stiffness extends up his neck and down into his elbow; Inflammed; Cannot sleep; felt like fluid under the skin; Swollen; Warm; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of stiffness in a 93-year-old male patient who received Herpes zoster (Shingrix) (batch number 7A55L, expiry date 16th April 2021) for prophylaxis.   On 29th April 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 1st May 2019, 2 days after receiving Shingrix, the patient experienced injection site swelling, injection site warmth and injection site pain. On an unknown date, the patient experienced stiffness, injection site inflammation, sleeplessness and injection site edema. On an unknown date, the outcome of the stiffness, injection site inflammation, sleeplessness, injection site swelling, injection site warmth and injection site pain were not recovered/not resolved and the outcome of the injection site edema was unknown.   It was unknown if the reporter considered the stiffness, injection site inflammation, sleeplessness, injection site swelling, injection site warmth, injection site pain and injection site edema to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter's father. The reporter and the patient both were on the call. The patient received dose of Shingrix in the left arm. Less than 3 months after vaccination, the patient experienced stiffness, injection site inflammation, sleeplessness and injection site edema. The patient stated that, at the time of reporting, he stil experienced injection site swelling, warmth and pain. The patient performed ultrasound with no findings. The patient stated that, when ge was not using his arm, the pain was mild, but when tried to use his arm it was very painful. The patient reported that, stiffness was extended up his neck and down into his elbow. The patient was normally very active but was now house bound. The patient was seen by three different physiacin and get conflicting treatment guidance. The patient has been told that, injection site was inflammed and that could lasted from three to six months. The patient's latest physician described that it felt like fluid under the skin, but he did not have a hematoma. The reporter have permission for his physician to be contacted. The reporter consented to follow up.      Lab Comments: lab test performed on an unknown date
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number Z4359, expiry date 19th September 2021) for prophylaxis.   On 7th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In July 2019, less than a month after receiving Shingrix, the patient experienced shingles. The patient was treated with medication unknown. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The patient did not know date of onset of Shingles, but stated that, she went to a medical doctor and was starting on medication to treat the shingles today. The reporter did not consent to follow up.
Age: 84.0
Sex: M
Vaccine: MNQ
Symptoms: Bedridden, Erythema, Headache, Incorrect dose administered, Neck pain
Clinical narrative: fever; headache; body aches; neckpain; bedridden; swelling; off label use; he received a Menveo liquid portion only of the vaccination; Inappropriate dose of vaccine administered; Inappropriate age at vaccine administration; redness; This case was reported by a physician via call center representative and described the occurrence of fever in a 84-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 2nd May 2019, the patient received the 1st dose of Menveo (intramuscular). On 2nd May 2019, less than a day after receiving Menveo, the patient experienced erythema, off label use, inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration. On 3rd May 2019, the patient experienced fever, headache, general body pain, neck pain, bedridden and swelling. On an unknown date, the outcome of the fever, headache, general body pain, neck pain, bedridden, erythema and swelling were recovered/resolved and the outcome of the off label use, inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were unknown.   The reporter considered the fever, headache, general body pain, neck pain, bedridden, erythema and swelling to be unrelated to Menveo.  Additional information received were as follows: The physician reported that he received a Menveo liquid portion only of the vaccination. The physician called to report the side effects to the physician office and was told he only received the saline portion of the vaccine so the reactions were not vaccine related, which led to off label use, inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration  The physician noted that he went else where to have titres drawn and only the A portion was low and had not received another dose yet. 1 day after receiving Menveo, the patient experienced fever, headache, general body pain, neck pain, bedridden and swelling The physician reported the headache and body aches were extremely bad and continual fever. The physician noted that he was bedridden for about 48 hours. All issues resolved, but he was concerned about worse events if he repeated the vaccine to get the full dose. The healthcare professional was transferred to MIS for discussion.
Age: 84.0
Sex: M
Vaccine: MNQ
Symptoms: Off label use, Pain, Product administered to patient of inappropriate age, Product preparation issue, Pyrexia
Clinical narrative: fever; headache; body aches; neckpain; bedridden; swelling; off label use; he received a Menveo liquid portion only of the vaccination; Inappropriate dose of vaccine administered; Inappropriate age at vaccine administration; redness; This case was reported by a physician via call center representative and described the occurrence of fever in a 84-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 2nd May 2019, the patient received the 1st dose of Menveo (intramuscular). On 2nd May 2019, less than a day after receiving Menveo, the patient experienced erythema, off label use, inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration. On 3rd May 2019, the patient experienced fever, headache, general body pain, neck pain, bedridden and swelling. On an unknown date, the outcome of the fever, headache, general body pain, neck pain, bedridden, erythema and swelling were recovered/resolved and the outcome of the off label use, inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were unknown.   The reporter considered the fever, headache, general body pain, neck pain, bedridden, erythema and swelling to be unrelated to Menveo.  Additional information received were as follows: The physician reported that he received a Menveo liquid portion only of the vaccination. The physician called to report the side effects to the physician office and was told he only received the saline portion of the vaccine so the reactions were not vaccine related, which led to off label use, inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration  The physician noted that he went else where to have titres drawn and only the A portion was low and had not received another dose yet. 1 day after receiving Menveo, the patient experienced fever, headache, general body pain, neck pain, bedridden and swelling The physician reported the headache and body aches were extremely bad and continual fever. The physician noted that he was bedridden for about 48 hours. All issues resolved, but he was concerned about worse events if he repeated the vaccine to get the full dose. The healthcare professional was transferred to MIS for discussion.
Age: 84.0
Sex: M
Vaccine: MNQ
Symptoms: Swelling
Clinical narrative: fever; headache; body aches; neckpain; bedridden; swelling; off label use; he received a Menveo liquid portion only of the vaccination; Inappropriate dose of vaccine administered; Inappropriate age at vaccine administration; redness; This case was reported by a physician via call center representative and described the occurrence of fever in a 84-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 2nd May 2019, the patient received the 1st dose of Menveo (intramuscular). On 2nd May 2019, less than a day after receiving Menveo, the patient experienced erythema, off label use, inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration. On 3rd May 2019, the patient experienced fever, headache, general body pain, neck pain, bedridden and swelling. On an unknown date, the outcome of the fever, headache, general body pain, neck pain, bedridden, erythema and swelling were recovered/resolved and the outcome of the off label use, inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were unknown.   The reporter considered the fever, headache, general body pain, neck pain, bedridden, erythema and swelling to be unrelated to Menveo.  Additional information received were as follows: The physician reported that he received a Menveo liquid portion only of the vaccination. The physician called to report the side effects to the physician office and was told he only received the saline portion of the vaccine so the reactions were not vaccine related, which led to off label use, inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration  The physician noted that he went else where to have titres drawn and only the A portion was low and had not received another dose yet. 1 day after receiving Menveo, the patient experienced fever, headache, general body pain, neck pain, bedridden and swelling The physician reported the headache and body aches were extremely bad and continual fever. The physician noted that he was bedridden for about 48 hours. All issues resolved, but he was concerned about worse events if he repeated the vaccine to get the full dose. The healthcare professional was transferred to MIS for discussion.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Insomnia, Nausea
Clinical narrative: Redness, Swelling, Pain, Headache, Hot to touch, Fever, Chills, Unable to sleep, Unabletolay on the left side,  Nausea
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: Redness, Swelling, Pain, Headache, Hot to touch, Fever, Chills, Unable to sleep, Unabletolay on the left side,  Nausea
Age: 70.0
Sex: U
Vaccine: PPV
Symptoms: Arthralgia, Axillary pain, Erythema, Pain, Swelling
Clinical narrative: All the common side effects.  iced. Tylenol and ibufrophen  From nite of injection for first 2 days bad t=3rd day better. Soreness. Swelling. Red streaks down to elbow and under arm which were sore to the touch. Today is 8/2.  A little tender. Some swelling. Some red streaks showing. I did not seek medical treatment.
Age: 70.0
Sex: U
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: All the common side effects.  iced. Tylenol and ibufrophen  From nite of injection for first 2 days bad t=3rd day better. Soreness. Swelling. Red streaks down to elbow and under arm which were sore to the touch. Today is 8/2.  A little tender. Some swelling. Some red streaks showing. I did not seek medical treatment.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: Right arm at injection site day of and right T10 dermatome distribution vesicular rash over next 3 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Extreme fatigue, joint and muscle pain.  loss of appetite. generalized weakness and lightheadedness lasting 2-3 days
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Extreme fatigue, joint and muscle pain.  loss of appetite. generalized weakness and lightheadedness lasting 2-3 days
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site reaction, Local reaction
Clinical narrative: LOCALIZED REACTION TO INJECTION SITE NO  CELLULITIS PRESENT
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Urticaria
Clinical narrative: Mother called and stated that yesterday evening 7/31/2019 at around 7:00pm, he developed hives from head to toe on his body. Mother states he is out of town at this time and is not sure if this is from the vaccines that he received on 7/22/2019.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site swelling, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Significant swelling to R arm from Deltoid down to forearms. Erythema, warmth low grade fever.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: swelling; redness; soreness; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced swelling, erythema and pain. On an unknown date, the outcome of the swelling, erythema and pain were unknown.   It was unknown if the reporter considered the swelling, erythema and pain to be related to Shingrix.  Additional details were provided as follows: On 20th July 2019 Saturday, the patient received 1st dose of Shringrix and experienced swelling, redness and soreness. The patient was asked how long should the swelling, redness and soreness last. The patient was provided with the guidance of Shingrix package insert.
Age: 54.0
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: exrutiating pain in upper arms; not been able to raise arms; This case was reported by a consumer and described the occurrence of pain in arm in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm and mobility decreased. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had not been able to raise arms without excruciating pain in upper arms. The reporter just being put on pain medication. The reporter wants to know if this was permanent.
Sex: U
Vaccine: VARZOS
Symptoms: Gastroenteritis viral
Clinical narrative: side effects; This case was reported by a consumer via call center representative and described the occurrence of stomach flu in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, couple of weeks after receiving Shingrix, the patient experienced stomach flu. On an unknown date, the outcome of the stomach flu was unknown.   It was unknown if the reporter considered the stomach flu to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the Shingrix a couple of weeks ago experiencing those side effects. The reporter thought it might be a flu bug but then remembered the vaccine a couple of weeks ago.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: pain; numb; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix. On 24th July 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and numbness of upper extremities. On an unknown date, the outcome of the pain in arm and numbness of upper extremities were unknown.   It was unknown if the reporter considered the pain in arm and numbness of upper extremities to be related to Shingrix.  Additional details were provided as follows: The patient's husband is the reporter of the case. The patient received Shingrix and experienced severe pain and numbness from shoulders to finger.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, however the patient's age group could be elderly. The patient received Shingrix and experienced flu like symptoms. The reporter agreed to be followed up. This case has been linked with case US2019AMR140071, for same reporter.~
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Hyperaesthesia, Immediate post-injection reaction, Mass, Mobility decreased, Swelling
Clinical narrative: Swelling; sensitive to touch; Knot; decreased mobility to arm; Tenderness; This case was reported by a other health professional via sales rep and described the occurrence of swelling in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Bexsero. On an unknown date, less than a month after receiving Bexsero, the patient experienced swelling, touch sensitivity increased, mobility decreased, tenderness and mass. On an unknown date, the outcome of the swelling, touch sensitivity increased, mobility decreased, tenderness and mass were unknown.   The reporter considered the swelling, touch sensitivity increased, mobility decreased, tenderness and mass to be related to Bexsero.  Additional details were provided as follows: This case was reported by the Receptionist. The patient received Bexsero and had swelling, sensitive to touch, decreased mobility to arm for one week. Tenderness 2-3 weeks. Knot formed immediately following injection and still persist at the time of reporting. There was a discrepancy with respect to the primary reporter type, in ARGUS, the reporter type is reported as consumenr however in the source document the Reporter Credentials was reported as receptionist. It seems that the reporter was a receptionist at physician's office where the representative went.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Tenderness
Clinical narrative: Swelling; sensitive to touch; Knot; decreased mobility to arm; Tenderness; This case was reported by a other health professional via sales rep and described the occurrence of swelling in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Bexsero. On an unknown date, less than a month after receiving Bexsero, the patient experienced swelling, touch sensitivity increased, mobility decreased, tenderness and mass. On an unknown date, the outcome of the swelling, touch sensitivity increased, mobility decreased, tenderness and mass were unknown.   The reporter considered the swelling, touch sensitivity increased, mobility decreased, tenderness and mass to be related to Bexsero.  Additional details were provided as follows: This case was reported by the Receptionist. The patient received Bexsero and had swelling, sensitive to touch, decreased mobility to arm for one week. Tenderness 2-3 weeks. Knot formed immediately following injection and still persist at the time of reporting. There was a discrepancy with respect to the primary reporter type, in ARGUS, the reporter type is reported as consumenr however in the source document the Reporter Credentials was reported as receptionist. It seems that the reporter was a receptionist at physician's office where the representative went.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site rash, Injection site warmth, Pain in extremity
Clinical narrative: large rash on both sides of neck that wraps from front to back; sore arm; rash; injection site hard; injection site warm; This case was reported by a consumer and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (very mild case about 6 years ago located on one side of body around the bottom of bra line).   On 22nd July 2019, the patient received the 1st dose of Shingrix. On 22nd July 2019, immediately after receiving Shingrix, the patient experienced pain in arm, injection site rash, injection site induration and injection site warmth. On 25th July 2019, the patient experienced widespread rash. On an unknown date, the outcome of the pain in arm, injection site rash, injection site induration, injection site warmth and widespread rash were unknown.   It was unknown if the reporter considered the pain in arm, injection site rash, injection site induration, injection site warmth and widespread rash to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine at 4 pm, since then had expected sore arm, but the injection site continued to be rash-like, hard, warm, and about a golf ball size radius.  In the morning of the date of reporting, over 48 hours after her injection, the patient woke up with a large rash on both sides of her neck that wrapped from front to back.  The patient asked to advise if she should see her physician or avoid the 2nd dose of the vaccine. The patient was provided Shingrix package insert and as per the IAC (Immunization Action Coalition) was recommended to apply a cold compress to the injection site if localized reaction occured, such as soreness, redness, itching, or swelling at the injection site.  The patient was also asked to consider taking an analgesic (pain reliever) or antipruritic (anti-itch) medication and was informed that these were general recommendations from IAC and had not been evaluated with Shingrix. For the large rash on both sides of the neck the patient was asked to refer her doctor. The patient had scheduled an appointment with her physician.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash generalised
Clinical narrative: large rash on both sides of neck that wraps from front to back; sore arm; rash; injection site hard; injection site warm; This case was reported by a consumer and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (very mild case about 6 years ago located on one side of body around the bottom of bra line).   On 22nd July 2019, the patient received the 1st dose of Shingrix. On 22nd July 2019, immediately after receiving Shingrix, the patient experienced pain in arm, injection site rash, injection site induration and injection site warmth. On 25th July 2019, the patient experienced widespread rash. On an unknown date, the outcome of the pain in arm, injection site rash, injection site induration, injection site warmth and widespread rash were unknown.   It was unknown if the reporter considered the pain in arm, injection site rash, injection site induration, injection site warmth and widespread rash to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine at 4 pm, since then had expected sore arm, but the injection site continued to be rash-like, hard, warm, and about a golf ball size radius.  In the morning of the date of reporting, over 48 hours after her injection, the patient woke up with a large rash on both sides of her neck that wrapped from front to back.  The patient asked to advise if she should see her physician or avoid the 2nd dose of the vaccine. The patient was provided Shingrix package insert and as per the IAC (Immunization Action Coalition) was recommended to apply a cold compress to the injection site if localized reaction occured, such as soreness, redness, itching, or swelling at the injection site.  The patient was also asked to consider taking an analgesic (pain reliever) or antipruritic (anti-itch) medication and was informed that these were general recommendations from IAC and had not been evaluated with Shingrix. For the large rash on both sides of the neck the patient was asked to refer her doctor. The patient had scheduled an appointment with her physician.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Adverse event
Clinical narrative: adverse event; This case was reported by a other health professional via sales rep and described the occurrence of adverse event in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX749AA, expiry date unknown) for prophylaxis.   On 14th June 2019, the patient received the 1st dose of Bexsero. On an unknown date, between 1 and 2 months after receiving Bexsero, the patient experienced adverse event. Bexsero was discontinued. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Bexsero.  Additional details were provided as follows: This case was reported by the patient's mother who herself was a Medical Assistant (MA).  The patient received Bexsero and experienced a terrible reaction. The patient's mother decided to not to go with 2nd dose. The reporter agreed to be followed up.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Axillary mass, Pain
Clinical narrative: soreness; tiny knot under arm that dissolved within 2 weeks.; This case was reported by a other health professional via sales rep and described the occurrence of pain in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABX749AA, expiry date unknown) for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 9th July 2019, the patient received the 2nd dose of Bexsero. In July 2019, less than a month after receiving Bexsero, the patient experienced pain and axillary lump. On an unknown date, the outcome of the pain and axillary lump were recovered/resolved.   It was unknown if the reporter considered the pain and axillary lump to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero and experienced soreness, tiny knot under arm which dissolved within 2 weeks.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Axillary mass, Pain in extremity
Clinical narrative: sore arm; knot under arm; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABX749AA, expiry date unknown) for prophylaxis.   On 30th April 2019, the patient received the 1st dose of Bexsero. On an unknown date, 1 day after receiving Bexsero, the patient experienced pain in arm and axillary lump. On an unknown date, the outcome of the pain in arm and axillary lump were unknown.   It was unknown if the reporter considered the pain in arm and axillary lump to be related to Bexsero.  Additional details were provided as follows: The patient had sore arm, knot under arm. Started next day and knot did not go away. Soreness lasted several days.  No adverse events reported on 2nd dose. The reporter agreed to follow up with GlaxoSmithKline.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Malaise
Clinical narrative: got sick; inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the sickness and inappropriate schedule of vaccine administered were unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose of Shingrix. The age at vaccination was not applicable for 2nd dose of Shingrix. A female patient reported that she received 1st dose of Shingrix in August 2018 and till the time of reporting not received 2nd dose, which led to incomplete course of vaccine. The patient also reported that she got sick after the first dose, but did not elaborate.  The reporter was extremely upset and not very cooperative and also stated that what she said during the call.
Age: 28.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Nausea
Clinical narrative: Pt received po vivotif, started roughly on July 27 2019, prescribed by PCP, picked up at local pharmacy, in last 3-4 days, tmax 100.4, headache, nausea, better today. Of note, also started weekly mefloquine for malarial prophylaxis; pt was made aware to update PCP on current symptoms as well. Advised if tolerating, to complete entire vivotif at this time to ensure immunitycontinue antimalarial mefloquine to ensure prophylaxis. May take ibuprofen with food or tylenol prn. Patient to call her PCP who prescribed medications to update them as well and discuss alternative should pt not be tolerating SE. Rev worsened signs/symptoms, reactions and when to seek more emergent care
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue
Clinical narrative: It is NOT adverse event. When pharmacist was administering the 2nd dose of shingrix to customer, during injecting the vaccine into the skin, some leak out of the syringe (not sure amount)- had some drops on gloves.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Flatulence, Headache, Pain in extremity, Pyrexia
Clinical narrative: After client returned home, child stated to mother that his arms hurt and that he also had a headache. Child then was checked for fever by the mother and his fever was 103 F. Mother states she gave him Tylenol and Motrin in 4 hour increments with little relief of fever x 24 hrs. Child also had "very smelly flatulence" per mother and stomach pain. Mother came into our clinic on 08/01/19 and I spoke with her about the child's symptoms.  I asked if child had a pediatrician and that I advise that with a 103 F fever x 24 hrs that the child should be seen by a physician. Mother states that she will try and take him there and I said if you can't get him there now to take him to the ER.  Called mother today and she states that the fever did finally break but that he still has stomach pains but that he is feeling much better. Mother states she is holding off on taking him to the doctor unless his fever comes back.
Age: 1.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Blood test, Eye movement disorder, Musculoskeletal stiffness, Postictal state, Somnolence
Clinical narrative: on July 3rd, 2 days after vaccination , child had 10 second episode of stiffening up, and eyes rolling back followed by post ictal state for approximately 30 minutes ( drowsiness). Did not have any fever at the time, but had been more sleepy than usual for the previous 2 days. Mother brought child to be seen at  emergency room where reportedly he had some blood tests done which were normal. Mother was told to have him seen by a pediatric neurologist. He has an appointment coming up  next week at the neurologist, and has since otherwise been well. I saw him for follow up in office 07/31/2019.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; administered improperly stored dose; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided.  On 16-JUL-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S002736 with expiration date on 28-JAN-2021 (the exact dose and route of administration were not reported) for prophylaxis.  The suspect vaccine underwent a temperature excursion of 6 to 14 (7.7) degrees Fahrenheit for 305 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported. The sterile diluent used to reconstitute the vaccines was stored properly.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA011314:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; VARlVAX which was administered with expired DILUENT MRK JNJ; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.      On 07-JAN-2019, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot # N023961 with expiration date on 01-SEP-2019 that was diluted with an expired sterile diluent(MERCK STERILE DILUENT) with lot # L028663 that expired on 29-MAR-2018 for prophylaxis (dose and route of administration were not reported). On 28-FEB-2019, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) with the same aforementioned lot number for prophylaxis with an expired sterile diluent(MERCK STERILE DILUENT) with lot# L028663 that expired on 29-MAR-2018. However, no adverse effects were reported.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Injection site nodule, Injection site pain, Injection site pruritus, Musculoskeletal stiffness
Clinical narrative: Client called clinic on 08/01/2019 with complaints of soreness to injection site, states she has alternated "cold and hot" compresses to site.  Client also states she has a "knot" at the injection site and stiffness in her neck that started on Wednesday.  Clinical staff instructed client to continue to monitor and to gently massage site in a circular motion as well as application of cool and warm compresses.  Client also asked if she could apply "Benadryl cream" to site as there is some slight itching and was told by staff that would be fine. Follow up call from clinic on 8/2 9:30am states itching better, redness and soreness the same. Instructed to perform stretches, continue massage and alternating cold packs for no more than 20 minutes at a time.  Denies hives, mobility issues, fever or chills.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Injection site pain, Nausea, Pyrexia
Clinical narrative: Pain at site, nausea, weakness, fever
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Burning sensation, Exposure to toxic agent, Hypoaesthesia, Loss of personal independence in daily activities
Clinical narrative: Went to bed fine one night in August of 2008 and woke the next morning to not being able to straighten my right arm. Within 5 days my lower arm ( from my elbow to my wrist ) and 3 fingers on my hand going numb, weakness, tingling, burning. My 3 fingers are still numb, burning, tingling and have a very hard time doing certain tasks with my right arm / hand. My median nerve is swollen 3 times it's normal size in my right arm. These symptoms ( numbness, burning, tingling, weakness ) have since started in my left forearm / hand back in October of 2017. Treatments are too many too list here, I've been seeing "specialists" for the last 9 years and none of them can tell me what's wrong with me. My pain management doctor says I'm suffering from chemical exposure. He did his internship at the VA and he has seen my symptoms in many other veterans.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Mobility decreased, Muscular weakness, Paraesthesia, Swelling
Clinical narrative: Went to bed fine one night in August of 2008 and woke the next morning to not being able to straighten my right arm. Within 5 days my lower arm ( from my elbow to my wrist ) and 3 fingers on my hand going numb, weakness, tingling, burning. My 3 fingers are still numb, burning, tingling and have a very hard time doing certain tasks with my right arm / hand. My median nerve is swollen 3 times it's normal size in my right arm. These symptoms ( numbness, burning, tingling, weakness ) have since started in my left forearm / hand back in October of 2017. Treatments are too many too list here, I've been seeing "specialists" for the last 9 years and none of them can tell me what's wrong with me. My pain management doctor says I'm suffering from chemical exposure. He did his internship at the VA and he has seen my symptoms in many other veterans.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bronchospasm, Chest discomfort, Cough, Dyspnoea
Clinical narrative: Patient reported exhaustion, joint pain, chest tightness, bronchospasm, cough, rash, dull aching headache, and injection site soreness Treatment: prednisone 20 mg for 5 days, Benadryl 25 mg every 6 hours as needed, atenolol discontinued, and EpiPen given for emergent symptoms Outcome: As of 7/31, patient reported that chest tightness and shortness of breath remain but spasms have resolved
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Full blood count, Headache, Histamine level, Injection site pain
Clinical narrative: Patient reported exhaustion, joint pain, chest tightness, bronchospasm, cough, rash, dull aching headache, and injection site soreness Treatment: prednisone 20 mg for 5 days, Benadryl 25 mg every 6 hours as needed, atenolol discontinued, and EpiPen given for emergent symptoms Outcome: As of 7/31, patient reported that chest tightness and shortness of breath remain but spasms have resolved
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test, Rash, Tryptase
Clinical narrative: Patient reported exhaustion, joint pain, chest tightness, bronchospasm, cough, rash, dull aching headache, and injection site soreness Treatment: prednisone 20 mg for 5 days, Benadryl 25 mg every 6 hours as needed, atenolol discontinued, and EpiPen given for emergent symptoms Outcome: As of 7/31, patient reported that chest tightness and shortness of breath remain but spasms have resolved
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Migraine, Mobility decreased, Pain
Clinical narrative: Extreme body aches causing difficulty arising from bed Thursday morning. Very bad headache, similar to migraine which Tylenol helped with later in the day. Very low energy all day Thursday, the day after the vaccination. By Friday morning I felt much better and the symptoms were mainly gone except for a few sharp pains (not constant) in the head during the day. No treatment except the Tylenol and rest.