chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 730198), concerning a 57-year-old, adult male patient. The patient had no medical history or current illness. The patient was allergic to Aspirin. The patient did not receive any concomitant medications. On 15-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date: not reported). On the same day, after vaccination, the patient had left shoulder pain when he raised it or tried to sleep on it. At the time of this report, the patient had not yet recovered from the event shoulder pain. The reporter assessed the event shoulder pain as non-serious.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: This is spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 730269), concerns a 26-year-old, adult female patient. The patient's historical condition included polysubstance abuse, bipolar disorder. The patient's current condition sepsis, hypertension, sulfa (as reported). The patient's concomitant medications included Vancomycin, ZOSYN, ATIVAN, Normal saline IV fluid, TYLENOL, PROZAC, LOVENOX, ESKALITH, VIBRAMYCIN, PROTONIX. It was reported that, the vaccine to be administered to patient was out of range (70 degrees Fahrenheit) due to maintenance issue with refrigerator. On 12-Dec-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, batch number: XF32708, anatomical location: left arm, route of administration: intramuscular). The dose was administered before the pharmacist discovered that the flu vaccine was in the refrigerator despite a note being placed on the refrigerator "not to use". She was the only patient that received a dose of the vaccine. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Malaise, Pain, Pyrexia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 730343), concerns a 50-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 28-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF30306, expiry date: not reported). On the same day, after administration of vaccine, the patient experienced extreme dizziness, malaise, low grade fever, body aches, chills, and rhinorrhea for two week. It was reported that, the patient visited her physician for the events. At the time of this report, the outcome of the events was not reported. The reporter considered this case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Rhinorrhoea
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 730343), concerns a 50-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 28-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF30306, expiry date: not reported). On the same day, after administration of vaccine, the patient experienced extreme dizziness, malaise, low grade fever, body aches, chills, and rhinorrhea for two week. It was reported that, the patient visited her physician for the events. At the time of this report, the outcome of the events was not reported. The reporter considered this case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Vaccination site bruising, Vaccination site inflammation
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 730500, concerns a 63-year-old, adult female patient. On 07-Dec-2017, the patient was administered with AFLURIA QUADRIVALENT (dose:0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On 08-Dec-2017, 1 day after vaccination, the patient stated that she had bruising and inflammation at the vaccination site. It was stated that, the patient also had bilateral numbness from waist to toes. The patient was advised to consult physician. The outcome of the events (injection site bruising and inflammation) was recovering and the event bilateral numbness was not recovered. The reporter assessed the case as non-serious.
Sex: M
Vaccine: FLU4
Symptoms: Blood urine present, Burning sensation, Fatigue, Headache, Irritability
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS (VAERS ID; 730502), concerns a 74-year-old, elderly, male patient. The patient's medical history was not reported. The concomitant medications included Acetaminophen, Amlodipine, Artificial tears, Atenolol, Azelaic acid, Vit D3, Vitamin D2, Lidocaine 5% extra, Lorazepam, Multivit, Ammonium lactate, and Camphor w/menthol. On 11-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: left arm, batch number and expiry date: not reported). On the same day, after flu vaccination, the patient had blood in urine. He had burning feeling and general body pain. The patient also experienced forgetful, irritable, joint stiffness, fatigue and frequent headaches. It was reported that, blood in urine was not continued and after 5 days, he noticed blood in his urine. On an unspecified date, urinalysis was performed, the results reported as normal. At the time of the report, the patient had not recovered from the events (blood in urine, general body pain, burning sensation, fatigue, irritable, joint stiffness, memory impairment and frequent headaches). The reporter assessed the case as non-serious.
Sex: M
Vaccine: FLU4
Symptoms: Joint stiffness, Memory impairment, Pain, Urine analysis normal
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS (VAERS ID; 730502), concerns a 74-year-old, elderly, male patient. The patient's medical history was not reported. The concomitant medications included Acetaminophen, Amlodipine, Artificial tears, Atenolol, Azelaic acid, Vit D3, Vitamin D2, Lidocaine 5% extra, Lorazepam, Multivit, Ammonium lactate, and Camphor w/menthol. On 11-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: left arm, batch number and expiry date: not reported). On the same day, after flu vaccination, the patient had blood in urine. He had burning feeling and general body pain. The patient also experienced forgetful, irritable, joint stiffness, fatigue and frequent headaches. It was reported that, blood in urine was not continued and after 5 days, he noticed blood in his urine. On an unspecified date, urinalysis was performed, the results reported as normal. At the time of the report, the patient had not recovered from the events (blood in urine, general body pain, burning sensation, fatigue, irritable, joint stiffness, memory impairment and frequent headaches). The reporter assessed the case as non-serious.
Sex: M
Vaccine: FLU4, PPV
Symptoms: Back pain, Cough, Headache, Musculoskeletal stiffness
Clinical narrative: This is spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 730577), concerns a 33-year-old, adult male patient. The patient's current condition hypertension (HTN as reported) and no known allergies. On 14-Dec-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, batch number: XF35309, anatomical location: left arm, route of administration: intramuscular). On the same day, the patient also received co-suspect PNEUMOVAX (dose: N/A as reported, batch number: N005597, anatomical location: right arm, route of administration: intramuscular). On the same day, after administration of the suspect vaccine, the patient experienced cough and headache. It was reported that, the patient's muscles went stiff and back hurt. The patient recovered from the events (cough, headache, musculoskeletal stiffness, back pain) on the same day. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Injection site reaction
Clinical narrative: This non-serious spontaneous case, initially received from other health professional on 14-Mar-2018 and concerns a female patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with influenza vaccine, dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date, the patient experienced injection site reaction. At the time of the report, the outcome of the event (injection site reaction) was not reported.
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-Mar-2018 by Seqirus from VAERS (VAERS ID: 731905), concerning a 38-year-old, adult male patient. The patient's medical history, current illness and concomitant medications were not reported. On 16-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number: XF35009, expiry date: not reported). On 18-Nov-2017, after 2 days of vaccination, the patient had constant pain in left shoulder where shot was administered. He could not move left arm above shoulder level due to constant pain. The patient could not sleep on left side due to pain, so had no sleep. The patient had not recovered from events. The reporter assessed this case as non-serious.
Age: 34.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site swelling, Vaccination site induration, Vaccination site nodule
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-Mar-2018 by Seqirus from VAERS (VAERS ID: 733810), concerning a 34-year-old, adult female patient. On 30-Apr-2013, the patient received tetanus vaccine and experienced injection site redness, injection site swelling, vaccination site induration and vaccination site nodule. Concomitant medications were not reported. On 01-Jan-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, anatomical location: left arm, route of administration: injection (reported as SYR), batch number, expiry date: not reported). On 12-Jan-2018, after 11 days of vaccination, the patient developed injection site redness and severe swelling at vaccination site. The site was greater than silver dollar, visibly raised from skin and hard knot at the vaccination site. The patient had not yet recovered from the events (severe swelling at vaccination site, vaccination site induration, injection site redness and vaccination site nodule). The reporter assessed the events as non-serious. Significant case correction received with IRD 11-Mar-2018: The as determined causality of the events (injection site redness and injection site swelling) was corrected from not related to related. The narrative and case comment were corrected.
Age: 34.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site nodule, Vaccination site swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-Mar-2018 by Seqirus from VAERS (VAERS ID: 733810), concerning a 34-year-old, adult female patient. On 30-Apr-2013, the patient received tetanus vaccine and experienced injection site redness, injection site swelling, vaccination site induration and vaccination site nodule. Concomitant medications were not reported. On 01-Jan-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, anatomical location: left arm, route of administration: injection (reported as SYR), batch number, expiry date: not reported). On 12-Jan-2018, after 11 days of vaccination, the patient developed injection site redness and severe swelling at vaccination site. The site was greater than silver dollar, visibly raised from skin and hard knot at the vaccination site. The patient had not yet recovered from the events (severe swelling at vaccination site, vaccination site induration, injection site redness and vaccination site nodule). The reporter assessed the events as non-serious. Significant case correction received with IRD 11-Mar-2018: The as determined causality of the events (injection site redness and injection site swelling) was corrected from not related to related. The narrative and case comment were corrected.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dizziness, Feeling hot, Flushing
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a female patient who received SHINGRIX for prophylaxis. On 24th May 2018, the patient received SHINGRIX. On 24th May 2018, less than an hour after receiving SHINGRIX, the patient experienced allergic reaction (serious criteria hospitalization), dizziness (serious criteria hospitalization) and feeling of hot flushes (serious criteria hospitalization). The patient was treated with EPIPEN (Nos). On an unknown date, the outcome of the allergic reaction, dizziness and feeling of hot flushes were not recovered/not resolved. It was unknown if the reporter considered the allergic reaction, dizziness and feeling of hot flushes to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via pharmacy claims management company. The age at vaccination was not reported. Allegedly patient came and requested to administer SHINGRIX. Within 5 minutes, after receiving SHINGRIX, the patient felt dizzy and warm flushing. The reporter grabbed EPI-PEN just in case and called the ambulance. The patient took into hospital. About an hour ago, the patient came back to got the prescription filled after she was discharged. The patient sustained the allergic reaction.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dizziness, Hot flush, Hypersensitivity
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a female patient who received SHINGRIX for prophylaxis. On 24th May 2018, the patient received SHINGRIX. On 24th May 2018, less than an hour after receiving SHINGRIX, the patient experienced allergic reaction (serious criteria hospitalization), dizziness (serious criteria hospitalization) and feeling of hot flushes (serious criteria hospitalization). The patient was treated with EPIPEN (Nos). On an unknown date, the outcome of the allergic reaction, dizziness and feeling of hot flushes were not recovered/not resolved. It was unknown if the reporter considered the allergic reaction, dizziness and feeling of hot flushes to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via pharmacy claims management company. The age at vaccination was not reported. Allegedly patient came and requested to administer SHINGRIX. Within 5 minutes, after receiving SHINGRIX, the patient felt dizzy and warm flushing. The reporter grabbed EPI-PEN just in case and called the ambulance. The patient took into hospital. About an hour ago, the patient came back to got the prescription filled after she was discharged. The patient sustained the allergic reaction.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Influenza like illness, Skin reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a female patient who received SHINGRIX for prophylaxis. On 24th May 2018, the patient received SHINGRIX. On 24th May 2018, less than an hour after receiving SHINGRIX, the patient experienced allergic reaction (serious criteria hospitalization), dizziness (serious criteria hospitalization) and feeling of hot flushes (serious criteria hospitalization). The patient was treated with EPIPEN (Nos). On an unknown date, the outcome of the allergic reaction, dizziness and feeling of hot flushes were not recovered/not resolved. It was unknown if the reporter considered the allergic reaction, dizziness and feeling of hot flushes to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via pharmacy claims management company. The age at vaccination was not reported. Allegedly patient came and requested to administer SHINGRIX. Within 5 minutes, after receiving SHINGRIX, the patient felt dizzy and warm flushing. The reporter grabbed EPI-PEN just in case and called the ambulance. The patient took into hospital. About an hour ago, the patient came back to got the prescription filled after she was discharged. The patient sustained the allergic reaction.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Erythema, Headache, Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 51-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included renal stone. Concomitant products included LIPITOR and triamterene. On 7th June 2018, the patient received the 1st dose of SHINGRIX. On 8th June 2018, 1 days after receiving SHINGRIX, the patient experienced shingles, headache, injection site pain and pain of skin. On 9th June 2018, the patient experienced blister. On 10th June 2018, the patient experienced swelling of eyelid and rash. On an unknown date, the outcome of the shingles and rash were unknown and the outcome of the headache, swelling of eyelid, blister, injection site pain and pain of skin were recovering/resolving. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. The reporter considered the headache, swelling of eyelid, blister, injection site pain and pain of skin to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient. The patient's concomitant medication included multivitamin. The patient received SHINGRIX on the left arm. The patient experienced arm pain at the site of injection and skin pain on her left side of her head which was prickly to the touch. Two days after vaccination, the patient woke up with a small blister on her left eyelid. Three days after vaccination, the patient woke with swollen left eye and rash on left side of her head. The patient reported this to her physician and was also seen by an eye doctor on 10th June 2018 and was diagnosed with shingles flare up.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ophthalmological examination, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 51-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included renal stone. Concomitant products included LIPITOR and triamterene. On 7th June 2018, the patient received the 1st dose of SHINGRIX. On 8th June 2018, 1 days after receiving SHINGRIX, the patient experienced shingles, headache, injection site pain and pain of skin. On 9th June 2018, the patient experienced blister. On 10th June 2018, the patient experienced swelling of eyelid and rash. On an unknown date, the outcome of the shingles and rash were unknown and the outcome of the headache, swelling of eyelid, blister, injection site pain and pain of skin were recovering/resolving. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. The reporter considered the headache, swelling of eyelid, blister, injection site pain and pain of skin to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient. The patient's concomitant medication included multivitamin. The patient received SHINGRIX on the left arm. The patient experienced arm pain at the site of injection and skin pain on her left side of her head which was prickly to the touch. Two days after vaccination, the patient woke up with a small blister on her left eyelid. Three days after vaccination, the patient woke with swollen left eye and rash on left side of her head. The patient reported this to her physician and was also seen by an eye doctor on 10th June 2018 and was diagnosed with shingles flare up.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Headache, Herpes zoster, Paraesthesia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 51-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included renal stone. Concomitant products included LIPITOR and triamterene. On 7th June 2018, the patient received the 1st dose of SHINGRIX. On 8th June 2018, 1 days after receiving SHINGRIX, the patient experienced shingles, headache, injection site pain and pain of skin. On 9th June 2018, the patient experienced blister. On 10th June 2018, the patient experienced swelling of eyelid and rash. On an unknown date, the outcome of the shingles and rash were unknown and the outcome of the headache, swelling of eyelid, blister, injection site pain and pain of skin were recovering/resolving. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. The reporter considered the headache, swelling of eyelid, blister, injection site pain and pain of skin to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient. The patient's concomitant medication included multivitamin. The patient received SHINGRIX on the left arm. The patient experienced arm pain at the site of injection and skin pain on her left side of her head which was prickly to the touch. Two days after vaccination, the patient woke up with a small blister on her left eyelid. Three days after vaccination, the patient woke with swollen left eye and rash on left side of her head. The patient reported this to her physician and was also seen by an eye doctor on 10th June 2018 and was diagnosed with shingles flare up.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 51-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included renal stone. Concomitant products included LIPITOR and triamterene. On 7th June 2018, the patient received the 1st dose of SHINGRIX. On 8th June 2018, 1 days after receiving SHINGRIX, the patient experienced shingles, headache, injection site pain and pain of skin. On 9th June 2018, the patient experienced blister. On 10th June 2018, the patient experienced swelling of eyelid and rash. On an unknown date, the outcome of the shingles and rash were unknown and the outcome of the headache, swelling of eyelid, blister, injection site pain and pain of skin were recovering/resolving. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. The reporter considered the headache, swelling of eyelid, blister, injection site pain and pain of skin to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient. The patient's concomitant medication included multivitamin. The patient received SHINGRIX on the left arm. The patient experienced arm pain at the site of injection and skin pain on her left side of her head which was prickly to the touch. Two days after vaccination, the patient woke up with a small blister on her left eyelid. Three days after vaccination, the patient woke with swollen left eye and rash on left side of her head. The patient reported this to her physician and was also seen by an eye doctor on 10th June 2018 and was diagnosed with shingles flare up.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Eyelid oedema, Headache, Herpes zoster, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 51-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included renal stone. Concomitant products included LIPITOR and triamterene. On 7th June 2018, the patient received the 1st dose of SHINGRIX. On 8th June 2018, 1 days after receiving SHINGRIX, the patient experienced shingles, headache, injection site pain and pain of skin. On 9th June 2018, the patient experienced blister. On 10th June 2018, the patient experienced swelling of eyelid and rash. On an unknown date, the outcome of the shingles and rash were unknown and the outcome of the headache, swelling of eyelid, blister, injection site pain and pain of skin were recovering/resolving. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. The reporter considered the headache, swelling of eyelid, blister, injection site pain and pain of skin to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient. The patient's concomitant medication included multivitamin. The patient received SHINGRIX on the left arm. The patient experienced arm pain at the site of injection and skin pain on her left side of her head which was prickly to the touch. Two days after vaccination, the patient woke up with a small blister on her left eyelid. Three days after vaccination, the patient woke with swollen left eye and rash on left side of her head. The patient reported this to her physician and was also seen by an eye doctor on 10th June 2018 and was diagnosed with shingles flare up.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain of skin, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 51-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included renal stone. Concomitant products included LIPITOR and triamterene. On 7th June 2018, the patient received the 1st dose of SHINGRIX. On 8th June 2018, 1 days after receiving SHINGRIX, the patient experienced shingles, headache, injection site pain and pain of skin. On 9th June 2018, the patient experienced blister. On 10th June 2018, the patient experienced swelling of eyelid and rash. On an unknown date, the outcome of the shingles and rash were unknown and the outcome of the headache, swelling of eyelid, blister, injection site pain and pain of skin were recovering/resolving. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. The reporter considered the headache, swelling of eyelid, blister, injection site pain and pain of skin to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient. The patient's concomitant medication included multivitamin. The patient received SHINGRIX on the left arm. The patient experienced arm pain at the site of injection and skin pain on her left side of her head which was prickly to the touch. Two days after vaccination, the patient woke up with a small blister on her left eyelid. Three days after vaccination, the patient woke with swollen left eye and rash on left side of her head. The patient reported this to her physician and was also seen by an eye doctor on 10th June 2018 and was diagnosed with shingles flare up.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 9th June 2018, the patient received SHINGRIX. On 10th June 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional stated that she already reported this event to VAERS, however, collected information anyway. The healthcare professional (HCP) called to ask about a local reaction one of her patients had with SHINGRIX. The patient was vaccinated with SHINGRIX on Saturday and the next day developed redness and extensive swelling of vaccinated limb that was 4 inches by 1 to 2 inches in diameter at the injection site. The HCP stated that the patient told her that her symptoms had now resolved and went away about 48 hours after getting vaccinated with SHINGRIX. No further information was provided.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 9th June 2018, the patient received SHINGRIX. On 10th June 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional stated that she already reported this event to VAERS, however, collected information anyway. The healthcare professional (HCP) called to ask about a local reaction one of her patients had with SHINGRIX. The patient was vaccinated with SHINGRIX on Saturday and the next day developed redness and extensive swelling of vaccinated limb that was 4 inches by 1 to 2 inches in diameter at the injection site. The HCP stated that the patient told her that her symptoms had now resolved and went away about 48 hours after getting vaccinated with SHINGRIX. No further information was provided.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Low birth weight baby
Clinical narrative: This is a spontaneous case, initially received on 19-Dec-2017 from other non-health professional, concerning a 29-year-old, adult, female pregnant patient of weight 202 lb and height 62.2 cm. The patient had no history of pregnancies and family history had no congenital malformations. The patient had no habit of tobacco, alcohol or illicit drug use. The patient's current condition included chronic hypertension and concomitant medication included VITAFOL-ONE for healthy pregnancy and Labetalol for chronic hypertension. The patient last menstrual period (LMP) was reported as 20-Jul-2017. On 17-Oct-2017, electrocardiogram (EKG) had performed and the result was normal (no major congenital malformations noted). On 17-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (batch number: 00644623A, dose, route of administration, anatomical location and expiry date: not reported), at 12th week of pregnancy. On 24-Oct-2017, cystic fibrosis mutation analysis was performed and the result was normal (no major congenital malformations noted). On 25-Oct-2017, 1st trimester screen was performed and the result was normal (no major congenital malformations noted). The nature of pregnancy was reported as singleton. The estimated date of delivery (EDD) on 26-Apr-2018. the reporter assessed this case as non-serious.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Electrocardiogram normal, Exposure during pregnancy, Prenatal screening test
Clinical narrative: This is a spontaneous case, initially received on 19-Dec-2017 from other non-health professional, concerning a 29-year-old, adult, female pregnant patient of weight 202 lb and height 62.2 cm. The patient had no history of pregnancies and family history had no congenital malformations. The patient had no habit of tobacco, alcohol or illicit drug use. The patient's current condition included chronic hypertension and concomitant medication included VITAFOL-ONE for healthy pregnancy and Labetalol for chronic hypertension. The patient last menstrual period (LMP) was reported as 20-Jul-2017. On 17-Oct-2017, electrocardiogram (EKG) had performed and the result was normal (no major congenital malformations noted). On 17-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (batch number: 00644623A, dose, route of administration, anatomical location and expiry date: not reported), at 12th week of pregnancy. On 24-Oct-2017, cystic fibrosis mutation analysis was performed and the result was normal (no major congenital malformations noted). On 25-Oct-2017, 1st trimester screen was performed and the result was normal (no major congenital malformations noted). The nature of pregnancy was reported as singleton. The estimated date of delivery (EDD) on 26-Apr-2018. the reporter assessed this case as non-serious.
Age: 73.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report has been received from a healthcare, concerning a 73 year old patient. The patient's concurrent conditions included an allergy to penicillin. The patient had no medical history and concomitant medications. On 13-JUN-2018, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, once, lot number N034525 and expiration date of 13-SEP-2019 (route was not provided) for  pneumococcal prevention. On 14-JUN-2018 (reported as 1 day later), the patient got back to the office with complains of swelling, "hot to touch" (injection site warmth) and, itching at injection site. The patient sought medical attention and was treated with diphenhydramine hydrochloride (BENADRYL) and, ice packs. There were no laboratory diagnostics or studies performed. At the time of the report, the outcome of swelling, injection site warmth and, itching at injection site was reported as recovering. The reporter did not provide causality assessment between the events and vaccination with PNEUMOVAX 23.
Age: 73.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site pruritus, Injection site warmth, Swelling
Clinical narrative: This spontaneous report has been received from a healthcare, concerning a 73 year old patient. The patient's concurrent conditions included an allergy to penicillin. The patient had no medical history and concomitant medications. On 13-JUN-2018, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, once, lot number N034525 and expiration date of 13-SEP-2019 (route was not provided) for  pneumococcal prevention. On 14-JUN-2018 (reported as 1 day later), the patient got back to the office with complains of swelling, "hot to touch" (injection site warmth) and, itching at injection site. The patient sought medical attention and was treated with diphenhydramine hydrochloride (BENADRYL) and, ice packs. There were no laboratory diagnostics or studies performed. At the time of the report, the outcome of swelling, injection site warmth and, itching at injection site was reported as recovering. The reporter did not provide causality assessment between the events and vaccination with PNEUMOVAX 23.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Lethargy, Pyrexia, Rash, Rash pustular
Clinical narrative: Severe flu symptoms: ache, lethargic, stomach upset, headache, fever, hives.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Headache, Influenza, Lethargy, Pain
Clinical narrative: Severe flu symptoms: ache, lethargic, stomach upset, headache, fever, hives.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: Severe flu symptoms: ache, lethargic, stomach upset, headache, fever, hives.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Eye swelling, Pruritus, Rash
Clinical narrative: Neck rash and itchy, swollen and burning eyes which lasted about 2 weeks since the vaccine. Pt saw her Primary Care Physician who recommended diphenhydramine oral caps for her eye symptoms and hydrocortisone cream for her neck rash. There was still evidence of swollen eyes and neck rash when she came in to the pharmacy a couple of days ago. Her Dr said it could be her allergies (seasonal or allergic rhinitis) or allergy to vaccine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Pyrexia, Vomiting
Clinical narrative: Fever of 104 degrees started afternoon of 6/16/18, gave her ibuprofen and temperature stayed 102 degrees until 6/18/18. Her temperature was normal the night of 6/19/18. She couldn't walk on her right leg on 6/15/18. Used a cool cloth on her thigh. Started to walk on it 6/16/18. Started to vomit 6/16/18 - 6/18/18. Not exactly sure which DTaP was given.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Patient complained of redness, pain, and swelling to entire upper left arm which has since subsided. Used ice and no longer painful but complaining of a lump "the size of a quarter" now in left deltoid where she received the vaccine. Instructed patient to go in to see PCP to have checked out.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Influenza like illness, Injection site pain
Clinical narrative: For the 24 hours after the injection, I felt like I had the flu--headache, bodyaches, chills, felt really bad. My left arm hurt from the injection site down to my fingertips.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: For the 24 hours after the injection, I felt like I had the flu--headache, bodyaches, chills, felt really bad. My left arm hurt from the injection site down to my fingertips.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site swelling
Clinical narrative: Small amt of swelling started the evening of the vaccine but when woke up the next morning it had progressed to below the elbow per great grandmother. She gave TYLENOL and used ice pack. She called and we discussed arthus reaction as listed on VIS sheets she had as possibility. Offered that she could bring him here to see a practitioner or take him to his doctor. Doctor told her to continue icing on and off and gave Hydroxyzine 10 mg 1 tsp 3 x day. She said he told her a child should never receive two vaccines in the same limb.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies, if any, were not provided. The office manager reported that, on 05-JUN-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX for prophylaxis (dose number, route and anatomical site of administration were not reported; lot number M024680, expiration date 18-MAY-2018). No adverse effects were reported, or product quality complaints involved. No additional information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a female patient reported as in her 60's. The patient's medical history included ciprofloxacin allergy. No other pertinent medical history, concurrent conditions or concomitant medication was provided. On 28-NOV-2014, the patient was vaccinated at a pharmacy with ZOSTAVAX 0.65mL, subcutaneously, for prevention of shingles (strength, frequency, lot# and expiration date were not reported). On the same date, the patient experienced injection site swelling and she was sore (injection site pain) for about 3 days. The patient did not sought medical attention. At the reporting time, the patient recovered from the events. The causal relationship between ZOSTAVAX and the events was not reported. No product quality complain was present.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with a dose ZOSTAVAX, lot # N025570, expiration date: 19-DEC-2018, for prophylaxis (drug administered to patient of inappropriate age). No adverse effects reported.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown. On an unknown date, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 for prophylaxis, lot # N024384 and expiration date 12-SEP-2019 or lot# N024384 and expiration date 18-MAY-2019 (dose, strength, route of administration, and frequency were unknown). On an unknown date, the vaccines experienced product storage error of 31°F or colder (26F) 15 cycles for 30 days. The vaccines had no previous temperature excursions. Data logger was involved.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 31 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 09-JUN-2018, the patient was vaccinated with M-M-R II 0.5mL, subcutaneously in the right upper arm, for prophylaxis, lot# M014902 and 22-MAR-2018 expiration date (strength and frequency were not reported). After the administration it was discovered that the expiration date was 22-MAR-2018. The patient had not experienced any adverse reactions.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. In 2016, the patient was treated at a health care facility for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the patient has suffered significant medical expenses and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-SEP-2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result the patient has suffered and will continue to suffer significant medical expenses and pain and suffering, and other damages.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2010, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) a health department (by an unspecified healthcare professional) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2010, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) at a clinic (by an unspecified healthcare professional) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2013, the patient was treated at the clinic (by an unspecified healthcare professional) for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.