chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Nausea, Syncope
Clinical narrative: Loss of consciousness (syncope) with urinary incontinence - occurred while standing - few minutes after HPV vaccinations. Regained consciousness about 1-2 minutes later when placed supine. Pt was diaphoretic and complained of feeling dizzy, sweaty and nauseous. Pt was observed for greater or equal 15 minutes. Orthostatics (P & BP) taken; drank water & was w/out clear Postictal signs.
Age: 19.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Urinary incontinence
Clinical narrative: Loss of consciousness (syncope) with urinary incontinence - occurred while standing - few minutes after HPV vaccinations. Regained consciousness about 1-2 minutes later when placed supine. Pt was diaphoretic and complained of feeling dizzy, sweaty and nauseous. Pt was observed for greater or equal 15 minutes. Orthostatics (P & BP) taken; drank water & was w/out clear Postictal signs.
Age: 5.0
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Injection site induration
Clinical narrative: Induration at (L) thigh injection site from DtaP. (about 4 x 6 inches): Site improving without meds or ice.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Muscle spasms, Nausea, Vomiting
Clinical narrative: Severe muscle cramps  Nausea and vomiting  Diarrhea
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: 4 cm x 4.25 cm red raised area, painful provider told mom to do BENADRYL and keep us informed of progress.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: 13.5 X 13.75 cm2 area of erythema and swelling surround vaccine puncture, non-tender, no fever, no wounds
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Deafness, Herpes zoster, Hypoaesthesia, Pain
Clinical narrative: Information has been received on 23-APR-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 11-AUG-2012, the patient was inoculated with ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). One week after receiving ZOSTAVAX, the patient suffered from a burning, prickling numb pain and a shingles rash on his right lower lateral ribs. The patient was diagnosed with shingles and also suffered from hearing loss. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to the resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Shingles and hearing loss were considered to be disabling. Upon internal review, hearing loss was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Information has been received on 23-APR-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 11-AUG-2012, the patient was inoculated with ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). One week after receiving ZOSTAVAX, the patient suffered from a burning, prickling numb pain and a shingles rash on his right lower lateral ribs. The patient was diagnosed with shingles and also suffered from hearing loss. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to the resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Shingles and hearing loss were considered to be disabling. Upon internal review, hearing loss was considered to be medically significant. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Migraine with aura
Clinical narrative: On 4/27, started getting ocular migraines (flashes of light) that lasted about 15 minutes. Did not take any medicine or followed-up with doctor because had similar problem after first dose. Another incident occurred on 4/29. Problems lasted 2-3 weeks, occurred sporadically.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Migraine with aura, Photopsia
Clinical narrative: On 4/27, started getting ocular migraines (flashes of light) that lasted about 15 minutes. Did not take any medicine or followed-up with doctor because had similar problem after first dose. Another incident occurred on 4/29. Problems lasted 2-3 weeks, occurred sporadically.
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Impaired driving ability, Somnolence
Clinical narrative: Patient had an extreme fatigue and fell asleep behind a wheel after the second dose of Shingrix on 3/29/2019.
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue
Clinical narrative: Patient had an extreme fatigue and fell asleep behind a wheel after the second dose of Shingrix on 3/29/2019.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Eye pain, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Burning in Palm of Hands; Upper Arm Pain; Second Finger Sensation / Middle Finger Sensation; Left Temporal Forehead Swelling; Left Arm Deltoid Swelling; Left eye pain; This case was reported by a consumer via call center representative and described the occurrence of extremities burning sensation of in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 2nd dose of Shingrix. On 22nd April 2019, less than a day after receiving Shingrix, the patient experienced extremities burning sensation of, pain in arm, tingling sensation, forehead swelling, injection site swelling and eye pain. On an unknown date, the outcome of the extremities burning sensation of, pain in arm, tingling sensation, forehead swelling, injection site swelling and eye pain were not recovered/not resolved.   It was unknown if the reporter considered the extremities burning sensation of, pain in arm, tingling sensation, forehead swelling, injection site swelling and eye pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix vaccine in the left deltoid. From evening of 22nd April 2019, the patient had burning in the palm of her hands, upper arm pain, second and middle finger sensations, left temporal forehead swelling, swelling in left arm deltoid region, and left eye pain.  This case had been linked to the case US2019073334, reported by same reporter. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Paraesthesia
Clinical narrative: Burning in Palm of Hands; Upper Arm Pain; Second Finger Sensation / Middle Finger Sensation; Left Temporal Forehead Swelling; Left Arm Deltoid Swelling; Left eye pain; This case was reported by a consumer via call center representative and described the occurrence of extremities burning sensation of in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 2nd dose of Shingrix. On 22nd April 2019, less than a day after receiving Shingrix, the patient experienced extremities burning sensation of, pain in arm, tingling sensation, forehead swelling, injection site swelling and eye pain. On an unknown date, the outcome of the extremities burning sensation of, pain in arm, tingling sensation, forehead swelling, injection site swelling and eye pain were not recovered/not resolved.   It was unknown if the reporter considered the extremities burning sensation of, pain in arm, tingling sensation, forehead swelling, injection site swelling and eye pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix vaccine in the left deltoid. From evening of 22nd April 2019, the patient had burning in the palm of her hands, upper arm pain, second and middle finger sensations, left temporal forehead swelling, swelling in left arm deltoid region, and left eye pain.  This case had been linked to the case US2019073334, reported by same reporter. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Photophobia
Clinical narrative: Burning in Palm of Hands; Upper Arm Pain; Second Finger Sensation / Middle Finger Sensation; Left Temporal Forehead Swelling; Left Arm Deltoid Swelling; Left eye pain; This case was reported by a consumer via call center representative and described the occurrence of extremities burning sensation of in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 2nd dose of Shingrix. On 22nd April 2019, less than a day after receiving Shingrix, the patient experienced extremities burning sensation of, pain in arm, tingling sensation, forehead swelling, injection site swelling and eye pain. On an unknown date, the outcome of the extremities burning sensation of, pain in arm, tingling sensation, forehead swelling, injection site swelling and eye pain were not recovered/not resolved.   It was unknown if the reporter considered the extremities burning sensation of, pain in arm, tingling sensation, forehead swelling, injection site swelling and eye pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix vaccine in the left deltoid. From evening of 22nd April 2019, the patient had burning in the palm of her hands, upper arm pain, second and middle finger sensations, left temporal forehead swelling, swelling in left arm deltoid region, and left eye pain.  This case had been linked to the case US2019073334, reported by same reporter. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Eye pain, Injection site swelling, Pain in extremity, Paraesthesia
Clinical narrative: Burning in Palm of Hands; Upper Arm Pain; Second Finger Sensation / Middle Finger Sensation; Left Temporal Forehead Swelling; Left Arm Deltoid Swelling; Left eye pain; This case was reported by a consumer via call center representative and described the occurrence of extremities burning sensation of in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 2nd dose of Shingrix. On 22nd April 2019, less than a day after receiving Shingrix, the patient experienced extremities burning sensation of, pain in arm, tingling sensation, forehead swelling, injection site swelling and eye pain. On an unknown date, the outcome of the extremities burning sensation of, pain in arm, tingling sensation, forehead swelling, injection site swelling and eye pain were not recovered/not resolved.   It was unknown if the reporter considered the extremities burning sensation of, pain in arm, tingling sensation, forehead swelling, injection site swelling and eye pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix vaccine in the left deltoid. From evening of 22nd April 2019, the patient had burning in the palm of her hands, upper arm pain, second and middle finger sensations, left temporal forehead swelling, swelling in left arm deltoid region, and left eye pain.  This case had been linked to the case US2019073334, reported by same reporter. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face
Clinical narrative: Burning in Palm of Hands; Upper Arm Pain; Second Finger Sensation / Middle Finger Sensation; Left Temporal Forehead Swelling; Left Arm Deltoid Swelling; Left eye pain; This case was reported by a consumer via call center representative and described the occurrence of extremities burning sensation of in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 2nd dose of Shingrix. On 22nd April 2019, less than a day after receiving Shingrix, the patient experienced extremities burning sensation of, pain in arm, tingling sensation, forehead swelling, injection site swelling and eye pain. On an unknown date, the outcome of the extremities burning sensation of, pain in arm, tingling sensation, forehead swelling, injection site swelling and eye pain were not recovered/not resolved.   It was unknown if the reporter considered the extremities burning sensation of, pain in arm, tingling sensation, forehead swelling, injection site swelling and eye pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix vaccine in the left deltoid. From evening of 22nd April 2019, the patient had burning in the palm of her hands, upper arm pain, second and middle finger sensations, left temporal forehead swelling, swelling in left arm deltoid region, and left eye pain.  This case had been linked to the case US2019073334, reported by same reporter. The reporter consented to follow up.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthritis, Pain in extremity, Spinal X-ray abnormal, Walking aid user, X-ray of pelvis and hip abnormal
Clinical narrative: Pain along the same nerves; patient is using a cane; This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2021) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix with an associated reaction of pain (localized pain after receiving 1st dose on 11th December 2018, see case US2019GSK079312).   On 29th March 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In April 2019, 7 days after receiving Shingrix, the patient experienced nerve pain and walking difficulty. On an unknown date, the outcome of the nerve pain and walking difficulty were unknown.   It was unknown if the reporter considered the nerve pain and walking difficulty to be related to Shingrix.  Additional details were provided as follows:  The pharmacist on the line who got a call from the patient who received their 2nd Shingrix dose in left deltoid about a month ago and approximately a week after started having pain along the same nerves he had a previous bout of shingles. It had progressively gotten worse over the past three weeks to the point the patient was using a cane.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Neuralgia, Walking aid user
Clinical narrative: Pain along the same nerves; patient is using a cane; This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2021) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix with an associated reaction of pain (localized pain after receiving 1st dose on 11th December 2018, see case US2019GSK079312).   On 29th March 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In April 2019, 7 days after receiving Shingrix, the patient experienced nerve pain and walking difficulty. On an unknown date, the outcome of the nerve pain and walking difficulty were unknown.   It was unknown if the reporter considered the nerve pain and walking difficulty to be related to Shingrix.  Additional details were provided as follows:  The pharmacist on the line who got a call from the patient who received their 2nd Shingrix dose in left deltoid about a month ago and approximately a week after started having pain along the same nerves he had a previous bout of shingles. It had progressively gotten worse over the past three weeks to the point the patient was using a cane.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anion gap, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: rash on wrists/rash on inner thighs/rash on sides of trunk/rash behind knees/rash on breasts.; itchy rash; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included osteoporosis. Previously experienced adverse reactions included gastrointestinal disorder (unspecified gastrointestinal issues).   On 18th April 2019 10:00, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 20 hrs 45 min after receiving Shingrix, the patient experienced generalized rash and itchy rash. The patient was treated with hydroxyzine hydrochloride (Atarax) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the generalized rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the generalized rash and itchy rash to be related to Shingrix.  Additional details were provided as follows:  The patient reported she received 1st dose of Shingrix in left arm at around 10 AM.  She reports the next morning, at around 6:45 AM, she had a rash on both wrists. The rash then spread to her inner legs, sides of her trunk, behind the knees, and breasts.  She went to urgent care and was prescribed Atarax and Benadryl. The rash still remains. The rash was itchy as well. The emergency room visit was required. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal, Carbon dioxide normal
Clinical narrative: rash on wrists/rash on inner thighs/rash on sides of trunk/rash behind knees/rash on breasts.; itchy rash; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included osteoporosis. Previously experienced adverse reactions included gastrointestinal disorder (unspecified gastrointestinal issues).   On 18th April 2019 10:00, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 20 hrs 45 min after receiving Shingrix, the patient experienced generalized rash and itchy rash. The patient was treated with hydroxyzine hydrochloride (Atarax) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the generalized rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the generalized rash and itchy rash to be related to Shingrix.  Additional details were provided as follows:  The patient reported she received 1st dose of Shingrix in left arm at around 10 AM.  She reports the next morning, at around 6:45 AM, she had a rash on both wrists. The rash then spread to her inner legs, sides of her trunk, behind the knees, and breasts.  She went to urgent care and was prescribed Atarax and Benadryl. The rash still remains. The rash was itchy as well. The emergency room visit was required. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fall, Glomerular filtration rate, Haematocrit normal, Haemoglobin normal, Mean cell haemoglobin concentration normal
Clinical narrative: rash on wrists/rash on inner thighs/rash on sides of trunk/rash behind knees/rash on breasts.; itchy rash; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included osteoporosis. Previously experienced adverse reactions included gastrointestinal disorder (unspecified gastrointestinal issues).   On 18th April 2019 10:00, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 20 hrs 45 min after receiving Shingrix, the patient experienced generalized rash and itchy rash. The patient was treated with hydroxyzine hydrochloride (Atarax) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the generalized rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the generalized rash and itchy rash to be related to Shingrix.  Additional details were provided as follows:  The patient reported she received 1st dose of Shingrix in left arm at around 10 AM.  She reports the next morning, at around 6:45 AM, she had a rash on both wrists. The rash then spread to her inner legs, sides of her trunk, behind the knees, and breasts.  She went to urgent care and was prescribed Atarax and Benadryl. The rash still remains. The rash was itchy as well. The emergency room visit was required. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Platelet count normal, Pruritus
Clinical narrative: rash on wrists/rash on inner thighs/rash on sides of trunk/rash behind knees/rash on breasts.; itchy rash; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included osteoporosis. Previously experienced adverse reactions included gastrointestinal disorder (unspecified gastrointestinal issues).   On 18th April 2019 10:00, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 20 hrs 45 min after receiving Shingrix, the patient experienced generalized rash and itchy rash. The patient was treated with hydroxyzine hydrochloride (Atarax) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the generalized rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the generalized rash and itchy rash to be related to Shingrix.  Additional details were provided as follows:  The patient reported she received 1st dose of Shingrix in left arm at around 10 AM.  She reports the next morning, at around 6:45 AM, she had a rash on both wrists. The rash then spread to her inner legs, sides of her trunk, behind the knees, and breasts.  She went to urgent care and was prescribed Atarax and Benadryl. The rash still remains. The rash was itchy as well. The emergency room visit was required. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Red blood cell count normal, Red cell distribution width normal, White blood cell count normal
Clinical narrative: rash on wrists/rash on inner thighs/rash on sides of trunk/rash behind knees/rash on breasts.; itchy rash; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included osteoporosis. Previously experienced adverse reactions included gastrointestinal disorder (unspecified gastrointestinal issues).   On 18th April 2019 10:00, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 20 hrs 45 min after receiving Shingrix, the patient experienced generalized rash and itchy rash. The patient was treated with hydroxyzine hydrochloride (Atarax) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the generalized rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the generalized rash and itchy rash to be related to Shingrix.  Additional details were provided as follows:  The patient reported she received 1st dose of Shingrix in left arm at around 10 AM.  She reports the next morning, at around 6:45 AM, she had a rash on both wrists. The rash then spread to her inner legs, sides of her trunk, behind the knees, and breasts.  She went to urgent care and was prescribed Atarax and Benadryl. The rash still remains. The rash was itchy as well. The emergency room visit was required. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: rash on wrists/rash on inner thighs/rash on sides of trunk/rash behind knees/rash on breasts.; itchy rash; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included osteoporosis. Previously experienced adverse reactions included gastrointestinal disorder (unspecified gastrointestinal issues).   On 18th April 2019 10:00, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 20 hrs 45 min after receiving Shingrix, the patient experienced generalized rash and itchy rash. The patient was treated with hydroxyzine hydrochloride (Atarax) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the generalized rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the generalized rash and itchy rash to be related to Shingrix.  Additional details were provided as follows:  The patient reported she received 1st dose of Shingrix in left arm at around 10 AM.  She reports the next morning, at around 6:45 AM, she had a rash on both wrists. The rash then spread to her inner legs, sides of her trunk, behind the knees, and breasts.  She went to urgent care and was prescribed Atarax and Benadryl. The rash still remains. The rash was itchy as well. The emergency room visit was required. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient returned to the pharmacy complaining of redness, fever and hardness at the injection site.  Patient will be seeing per primary care physician on Saturday 05/04/2019
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Headache, Nausea, Pain in extremity
Clinical narrative: Severe pain in arm, joint aches, nausea, headache
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: left shoulder pain few hours after immediately and more so a few hours after injection into the  next/present day.  Hurts to lift it in any direction.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chest discomfort, Cold sweat, Dry mouth, Headache
Clinical narrative: Woke up 4 am with dry mouth, headache, lethargic,  muscle pains throughout body, nausea, tight breathing,  and headache.  Stomach upset as well. Got worse throughout day so I left work at lunchtime and slept for 4 hours.  Started to feel better.  Slept fairly well but sweats throughout night.   In morning clammy, injection site still very sore,,,all condition there but 60% better than previous day.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy, Myalgia, Nausea, Night sweats
Clinical narrative: Woke up 4 am with dry mouth, headache, lethargic,  muscle pains throughout body, nausea, tight breathing,  and headache.  Stomach upset as well. Got worse throughout day so I left work at lunchtime and slept for 4 hours.  Started to feel better.  Slept fairly well but sweats throughout night.   In morning clammy, injection site still very sore,,,all condition there but 60% better than previous day.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received on 23-APR-2019 from a lawyer regarding a case in litigation concerning a female patient, age and medical history unknown. In or around 22-APR-2015 the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles. One day after received the vaccine, the patient suffered a rash on her upper left thoracic region and into her back and was diagnosed with shingles. As a direct and proximate result of ZOSTAVAX the patient symptoms have results in physical limitations not present prior to the vaccine.  The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patients condition. As a result the patient experienced severe and permanent personal injuries. Shingles was considered to be disabling. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 75 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 09-APR-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster and was treated by a physician. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Meningitis viral, Occipital neuralgia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 64 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 22-MAY-2017, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced occipital neuralgia and varicella meningitis. On an unspecified date, the patient was treated by a physician for occipital neuralgia and varicella meningitis. The outcome of the events occipital neuralgia and varicella meningitis was not reported. The reporter considered the events to be related to ZOSTAVAX. Upon internal review, the event varicella meningitis was determined to be medically significant. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: Patient who was pregnant was inadverdently administered a dose of GARDASIL 9; No adverse effect; Patient was supposed to be administered the influenza vaccine to prevent flu, but was administered with GARDASIL 9; This spontaneous prospective pregnancy report was received from a registered nurse refers to a 27-year-old female patient. The patient's concurrent conditions, medical history, historical drugs, drug allergies and concomitant medications were reported as none. On 18-MAR-2019, the pregnant patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose/frequency were unknown) (lot # 1581027, expire date: 03-JUN-2021, route: intramuscular) instead of a dose of influenza vaccine (manufacturer unspecified) for prophylaxis. The last menstrual period was reported as 34 weeks and estimated date of delivery was not known.The patient was supposed to be administered the influenza vaccine to prevent the flu, but was administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The reporter reported that this was not a product confusion. No adverse effects were reported. There was no treatment rendered for the events. No lab tests were performed. The pregnancy outcome was unknown. The patient did not seek medical attention.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect reported; one expired dose of ROTATEQ (N029868 3/12/2019) was inadvertently administered to one patient on 4/26/2019; This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.  On 26-APR-2019, the patient inadvertently received an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered orally for prophylaxis (dose, dose number and location of administration were not reported) (lot # N029868, expiration date 12-MAR-2019). No adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; the patient was inadvertently administered one dose of expired M-M-R II; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history and drug reactions/allergies was not provided. Concomitant therapy included sterile diluent.  On 26-APR-2019, the patient was inadvertently administered one dose of expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number N009799, expiration date 24-MAR-2019; strength and rote were not reported) for prophylaxis (Expired product administered). The nurse confirmed that the sterile diluent was not expired, although she did not have lot and expiration available. No adverse effects were reported.
Sex: F
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: patient received an MMRII injection, but was unaware that she was not supposed to take the medication if she was taking immunosuppressant medications; The patient was concerned but reported no adverse events; This spontaneous report was received from a female patient of unknown age regarding herself. The patient's medical history included renal transplant. Concomitant therapies included tacrolimus(PROGRAF) and mycophenolate sodium(MYFORTIC). Information about the patient's concurrent conditions and drug reactions or allergies was not provided.     On an unknown date, while the patient was on the above immunosuppressant medications, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided). At the time of the report, the patient was concerned but reported no adverse events.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper
Clinical narrative: stomach cramping; patient received a dose of recombivax HB after its labelled expiration date; This spontaneous report was received from medical assistant (also an office manager) regarding a 21-year-old Adult female patient. Patient's pertinent medical history, drug allergies/reactions, concurrent conditions and concomitant therapies were not reported.  On 17-APR-2019, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 10/1.0 mcrg/ml (microgram/milliliter) (strength) (lot # M039201, expiry date: November 2018) via intramuscular route for prophylaxis. Patient received hepatitis b vaccine (recombinant) (RECOMBIVAX HB) after its labelled expiration date (expired product administered). On 27-APR-2019, the patient experienced some stomach cramping (abdominal pain upper). The patient did not seek for any medical attention nor received any treatment. The outcome of abdominal pain upper was reported as resolved in April 2019. No product quality complaint was involved. Causality assessment was not provided by the reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; the patient was inadvertently administered a dose of expired MMR II; This spontaneous report has been received from a pharmacist referring to a patient of unknown age. The patient's concomitant therapy included sterile diluent. Pertinent medical history and drug reactions/allergies were not reported.  On 17-APR-2019, the patient was inadvertently vaccinated with a dose of expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # N009171, expiration date 20-MAR-2019; dose was unknown) subcutaneously for prophylaxis (expired vaccine used). No temperature excursion. No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) presented.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Myalgia
Clinical narrative: injection site redness; Injection site hot; muscle ache; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2019, the patient received Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced muscle pain, injection site erythema and injection site warmth. On an unknown date, the outcome of the muscle pain was recovered/resolved and the outcome of the injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received vaccine at reporters local pharmacy. Till the time of reporting, It had been a week and although the muscle aches went away after 4 to 5 days and the injection site remains red and hot. The patient asked whether they should be concerned.
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had headache for 3 days.  The reporter did not have additional information.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; rash on their back; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number H7JY4, expiry date 1st July 2021) for prophylaxis.   On 12th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 13th April 2019, 1 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.   Additional details were provided as follows: The medical assistant on the line reported that the patient developed a rash on their back and was unsure if it was just a rash.  On 15th April 2019, the reporter followed up on the morning with the doctor and are being treated for shingles. They were seen on 23rd April 2019 and are still being treated for shingles.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Injection site discomfort, Rash generalised
Clinical narrative: Discomfort at injection site; Dry skin; Rash on both legs, then traveling to buttocks, torso, and underarms; This case was reported by a physician via call center representative and described the occurrence of injection site discomfort in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th March 2019, the patient received the 1st dose of Shingrix. On 31st March 2019, 3 days after receiving Shingrix, the patient experienced widespread rash. In April 2019, the patient experienced injection site discomfort and dry skin. On an unknown date, the outcome of the injection site discomfort was unknown and the outcome of the widespread rash and dry skin were not recovered/not resolved.   It was unknown if the reporter considered the injection site discomfort, widespread rash and dry skin to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient experienced discomfort at injection site following dose 1 of Shingrix series. Three days later the patient experienced a rash on both legs. On 9th April 2019, the patient sought treatment from dermatologist for rash. The healthcare professional described rash as starting on both legs, then traveling to buttocks, torso and underarms. The reporter stated that the patient still has dry skin. The healthcare professional did not have lot number and expiration date for provider.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: unable to sleep at night; injection site swelling; injection site soreness; feeling tired; fever; chills; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site pain, tiredness, fever, chills and muscle pain. On 22nd April 2019, the patient experienced difficulty sleeping. On an unknown date, the outcome of the injection site swelling, injection site pain, tiredness, fever, chills, muscle pain and difficulty sleeping were unknown.   It was unknown if the reporter considered the injection site swelling, injection site pain, tiredness, fever, chills, muscle pain and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient who received Shingrix before the date of reporting. She was experiencing feeling tired, fever, chills, muscle pain, injection site swelling and soreness, and unable to sleep at night.  Did not consent to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: unable to sleep at night; injection site swelling; injection site soreness; feeling tired; fever; chills; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site pain, tiredness, fever, chills and muscle pain. On 22nd April 2019, the patient experienced difficulty sleeping. On an unknown date, the outcome of the injection site swelling, injection site pain, tiredness, fever, chills, muscle pain and difficulty sleeping were unknown.   It was unknown if the reporter considered the injection site swelling, injection site pain, tiredness, fever, chills, muscle pain and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient who received Shingrix before the date of reporting. She was experiencing feeling tired, fever, chills, muscle pain, injection site swelling and soreness, and unable to sleep at night.  Did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness; Swelling; Hot to the touch; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) (batch number G45LN, expiry date 30th November 2019) for prophylaxis.   On 1st April 2019, the patient received the 1st dose of Shingrix. On 1st April 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. In April 2019, the outcome of the injection site erythema, injection site swelling and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Later the same day after receiving Shingrix, the patient had large area of redness, swelling and hot to the touch, at the injection site. The reported reported that this was a pretty significant, severe reaction to vaccine which lasted for about 3 days to several days. The healthcare professional (HCP) did not want to provide the patient demographics without speaking to patient first. The HCP did not consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Pain, Product administered at inappropriate site
Clinical narrative: injection site pain, pain started within 20 minutes of the injection; swelling at the injection site; Pain in her left elbow which radiates down the top of her hand towards the wrist; Pain in her left elbow which radiates down the top of her hand towards the wrist; Wrong Injection Technique; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd April 2019, less than an hour after receiving Shingrix, the patient experienced injection site pain, injection site swelling, pain, arthralgia and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, pain and arthralgia were not recovered/not resolved and the outcome of the injection site swelling was recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, pain and arthralgia to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient received the Shingrix vaccine at a pharmacy (details not specified) and reported that the pain started within 20 minutes of the injection which was ongoing. The pharmacist injected the vaccine below the deltoid region in her left arm, which led to vaccine administered at inappropriate site. The patient reported that there was a swelling at the injection site, but it had resolved.  The patient also experienced pain in her left elbow which radiated down the top of her hand towards the wrist which was ongoing. The patient questioned the efficacy of the vaccine injected below the deltoid region.  The patient did not consent to follow up.