chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Urticaria, White blood cell count normal
Clinical narrative: Patient got a welt distal to the vaccine sites and subsequently developed swelling and redness in her upper extremity to level of elbow. Still had symptoms 10/31/18.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Aphthous ulcer, Asthenia, Chest discomfort, Dyspnoea, Epistaxis
Clinical narrative: Acute onset evening of shot: sudden profuse SOB, runny nose, nasal itching, tongue and oral mucosa burning, (R) side headache, sneezing. Lethargy, nasal sores, and continued Sx with blood when blow nose. Lasted 9 days. Took Inhale-BENADRYL 25mg every 6 hours and Loratadine 10mg daily. Spent 5/9 days in bed. This was a first time experience. Suddenly got clear runny nose, short of breath, chest felt heavy, nose very itchy and had a pink circle around shot site. Mouth and tongue burning and tongue swollen. Then a headache on the right side of head and pressure. When blowing nose, had blood and very sore nares. Got one sore inside mouth, like a canker sore on inside lip area. Felt weak and general malaise and spent 5 days in bed - Kept on BENADRYL and Loratadine 9 days. Afraid to get one next year!
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Head discomfort, Headache, Injection site erythema, Lethargy, Malaise
Clinical narrative: Acute onset evening of shot: sudden profuse SOB, runny nose, nasal itching, tongue and oral mucosa burning, (R) side headache, sneezing. Lethargy, nasal sores, and continued Sx with blood when blow nose. Lasted 9 days. Took Inhale-BENADRYL 25mg every 6 hours and Loratadine 10mg daily. Spent 5/9 days in bed. This was a first time experience. Suddenly got clear runny nose, short of breath, chest felt heavy, nose very itchy and had a pink circle around shot site. Mouth and tongue burning and tongue swollen. Then a headache on the right side of head and pressure. When blowing nose, had blood and very sore nares. Got one sore inside mouth, like a canker sore on inside lip area. Felt weak and general malaise and spent 5 days in bed - Kept on BENADRYL and Loratadine 9 days. Afraid to get one next year!
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Nasal discomfort, Nasal pruritus, Nasal ulcer, Oral discomfort, Rhinorrhoea
Clinical narrative: Acute onset evening of shot: sudden profuse SOB, runny nose, nasal itching, tongue and oral mucosa burning, (R) side headache, sneezing. Lethargy, nasal sores, and continued Sx with blood when blow nose. Lasted 9 days. Took Inhale-BENADRYL 25mg every 6 hours and Loratadine 10mg daily. Spent 5/9 days in bed. This was a first time experience. Suddenly got clear runny nose, short of breath, chest felt heavy, nose very itchy and had a pink circle around shot site. Mouth and tongue burning and tongue swollen. Then a headache on the right side of head and pressure. When blowing nose, had blood and very sore nares. Got one sore inside mouth, like a canker sore on inside lip area. Felt weak and general malaise and spent 5 days in bed - Kept on BENADRYL and Loratadine 9 days. Afraid to get one next year!
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Sneezing, Swollen tongue, Tongue discomfort
Clinical narrative: Acute onset evening of shot: sudden profuse SOB, runny nose, nasal itching, tongue and oral mucosa burning, (R) side headache, sneezing. Lethargy, nasal sores, and continued Sx with blood when blow nose. Lasted 9 days. Took Inhale-BENADRYL 25mg every 6 hours and Loratadine 10mg daily. Spent 5/9 days in bed. This was a first time experience. Suddenly got clear runny nose, short of breath, chest felt heavy, nose very itchy and had a pink circle around shot site. Mouth and tongue burning and tongue swollen. Then a headache on the right side of head and pressure. When blowing nose, had blood and very sore nares. Got one sore inside mouth, like a canker sore on inside lip area. Felt weak and general malaise and spent 5 days in bed - Kept on BENADRYL and Loratadine 9 days. Afraid to get one next year!
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure measurement, Bursitis, Condition aggravated, Injection site erythema, Injection site inflammation
Clinical narrative: 10/31/2018 the patient's daughter let us know that the patient had pain, inflammation, redness and warmth at the vaccination site. We recommended to take some analgesics, use ice compresses, and go to the doctor if there is no improvement. On 11/1/18 patient doesn't feel good so went to the doctor for pain, fever, erythema, inflammation at the vaccination site and having high blood pressure. Doctor refers patient to the ER where they administer medicine, mark the affected erythema and inflammation area. They recommend cold compresses, to check the marked area and to go back to the doctor if it expands. Per daughter, according to what doctor explained was bursitis. Patient was released on the same day 11/01/2018 with monitoring instructions.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth, Pain, Pyrexia
Clinical narrative: 10/31/2018 the patient's daughter let us know that the patient had pain, inflammation, redness and warmth at the vaccination site. We recommended to take some analgesics, use ice compresses, and go to the doctor if there is no improvement. On 11/1/18 patient doesn't feel good so went to the doctor for pain, fever, erythema, inflammation at the vaccination site and having high blood pressure. Doctor refers patient to the ER where they administer medicine, mark the affected erythema and inflammation area. They recommend cold compresses, to check the marked area and to go back to the doctor if it expands. Per daughter, according to what doctor explained was bursitis. Patient was released on the same day 11/01/2018 with monitoring instructions.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Abnormal faeces, Bone pain, Dysgeusia, Eye pruritus, Injection site erythema
Clinical narrative: Patient had swelling 1 inch below injection site the size of a pear. A few hours after the injection she couldn't move her legs. Her eyes were itchy and her bones felt sore. She had a metallic taste in her mouth and metallic odor from her urine and bowel movement on Sunday October 29th. The swelling the size of a pear lasted until Monday Oct 29th. The swelling is down now but the injection site is still red and itchy.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pruritus, Injection site swelling, Mobility decreased, Urine odour abnormal
Clinical narrative: Patient had swelling 1 inch below injection site the size of a pear. A few hours after the injection she couldn't move her legs. Her eyes were itchy and her bones felt sore. She had a metallic taste in her mouth and metallic odor from her urine and bowel movement on Sunday October 29th. The swelling the size of a pear lasted until Monday Oct 29th. The swelling is down now but the injection site is still red and itchy.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: UrticariaPruritus.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Mom reports red and raised around injection site. Lasted for 2 days post injection. Went away day 3, Patient went to pediatrician who deemed it an allergic reaction to a component of the FLUZONE vaccine.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Muscular weakness
Clinical narrative: 2 days after shot severe muscle aches/weakness mild HA.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Myalgia
Clinical narrative: 2 days after shot severe muscle aches/weakness mild HA.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: 5-7 mm circular red itch rash. Took BENADRYL and hydrocortisone cream, treatment last a few hours. Rash last 2 weeks.
Age: 19.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dehydration, Erythema, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Pt came to office next day - Redness on arm, painful Fever 103, vomiting, dehydration - Came in 12/31 - arm worse, area of redness doubled in size.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Feeling cold, Influenza like illness, Injection site erythema
Clinical narrative: Pt Received her first dose of SHINGRIX vaccine on 10/19. Pt is reporting that same evening she began feeling: muscle weakness, joint/muscle soreness, swelling and reddening at the injection site, also a "flu" like condition of being cold. She also reported vomiting. Says she was too weak to get out of bed for 3 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Muscular weakness, Myalgia, Vomiting
Clinical narrative: Pt Received her first dose of SHINGRIX vaccine on 10/19. Pt is reporting that same evening she began feeling: muscle weakness, joint/muscle soreness, swelling and reddening at the injection site, also a "flu" like condition of being cold. She also reported vomiting. Says she was too weak to get out of bed for 3 days.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Post flu shot - mild skin reaction including hardness at injection site with redness, mild swelling and mild pain.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient received SHINGRIX on 10/17/2018. Reported shingles symptoms on 10/30/2018. Patient went to doctor's office and diagnosed with mild case of shingles and being treated with VALTREX.
Age: 64.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Blood test, Erythema, Nausea, Pain, Skin warm
Clinical narrative: 10/28/18 Arm red, warm to touch, aching, nausea. Went to see MD 10/31/2018. Dr. - seen 10/31/2018.
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Fatigue, Headache, Influenza like illness, Lethargy, Myalgia
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of influenza like illness in a male patient who received FLULAVAL QUADRIVALENT 2018-2019 season) (batch number TA422, expiry date 30th June 2019) for prophylaxis. On 16th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season .5 ml. In October 2018, less than a week after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced influenza like illness, fever, headache, runny nose, muscle pain and lethargy. On an unknown date, the outcome of the influenza like illness, fever, headache, runny nose, muscle pain and lethargy were unknown. It was unknown if the reporter considered the influenza like illness, fever, headache, runny nose, muscle pain and lethargy to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were received as follows: The age at vaccination was not reported. The reporter had been informed that they have reported an experience with a GlaxoSmithKline product that needs to be shared with GSK. The patient developed Influenza-Like Illness, fever showed 101.5 degree F, severe headaches, runny nose, muscular aches, acute lethargy. This event did not include a product complaint. The reporter agreed to be contacted for follow up.
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of influenza like illness in a male patient who received FLULAVAL QUADRIVALENT 2018-2019 season) (batch number TA422, expiry date 30th June 2019) for prophylaxis. On 16th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season .5 ml. In October 2018, less than a week after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced influenza like illness, fever, headache, runny nose, muscle pain and lethargy. On an unknown date, the outcome of the influenza like illness, fever, headache, runny nose, muscle pain and lethargy were unknown. It was unknown if the reporter considered the influenza like illness, fever, headache, runny nose, muscle pain and lethargy to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were received as follows: The age at vaccination was not reported. The reporter had been informed that they have reported an experience with a GlaxoSmithKline product that needs to be shared with GSK. The patient developed Influenza-Like Illness, fever showed 101.5 degree F, severe headaches, runny nose, muscular aches, acute lethargy. This event did not include a product complaint. The reporter agreed to be contacted for follow up.
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Headache, Influenza like illness, Lethargy, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of influenza like illness in a male patient who received FLULAVAL QUADRIVALENT 2018-2019 season) (batch number TA422, expiry date 30th June 2019) for prophylaxis. On 16th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season .5 ml. In October 2018, less than a week after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced influenza like illness, fever, headache, runny nose, muscle pain and lethargy. On an unknown date, the outcome of the influenza like illness, fever, headache, runny nose, muscle pain and lethargy were unknown. It was unknown if the reporter considered the influenza like illness, fever, headache, runny nose, muscle pain and lethargy to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were received as follows: The age at vaccination was not reported. The reporter had been informed that they have reported an experience with a GlaxoSmithKline product that needs to be shared with GSK. The patient developed Influenza-Like Illness, fever showed 101.5 degree F, severe headaches, runny nose, muscular aches, acute lethargy. This event did not include a product complaint. The reporter agreed to be contacted for follow up.
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Rhinorrhoea
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of influenza like illness in a male patient who received FLULAVAL QUADRIVALENT 2018-2019 season) (batch number TA422, expiry date 30th June 2019) for prophylaxis. On 16th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season .5 ml. In October 2018, less than a week after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced influenza like illness, fever, headache, runny nose, muscle pain and lethargy. On an unknown date, the outcome of the influenza like illness, fever, headache, runny nose, muscle pain and lethargy were unknown. It was unknown if the reporter considered the influenza like illness, fever, headache, runny nose, muscle pain and lethargy to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were received as follows: The age at vaccination was not reported. The reporter had been informed that they have reported an experience with a GlaxoSmithKline product that needs to be shared with GSK. The patient developed Influenza-Like Illness, fever showed 101.5 degree F, severe headaches, runny nose, muscular aches, acute lethargy. This event did not include a product complaint. The reporter agreed to be contacted for follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 58-year-old male patient who received SHINGRIX (batch number C7B9P, expiry date unknown) for prophylaxis. On 11th October 2018, the patient received SHINGRIX (intramuscular). On 16th October 2018, 5 days after receiving SHINGRIX, the patient experienced shingles and painful rash. On an unknown date, the outcome of the shingles and painful rash were not recovered/not resolved. It was unknown if the reporter considered the shingles and painful rash to be related to SHINGRIX. Additional details were provided as follows: On 16th October 2018, the patient started developing a painful rash and he saw his physician on 19th October 2018 where he was diagnosed with shingles.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 58-year-old male patient who received SHINGRIX (batch number C7B9P, expiry date unknown) for prophylaxis. On 11th October 2018, the patient received SHINGRIX (intramuscular). On 16th October 2018, 5 days after receiving SHINGRIX, the patient experienced shingles and painful rash. On an unknown date, the outcome of the shingles and painful rash were not recovered/not resolved. It was unknown if the reporter considered the shingles and painful rash to be related to SHINGRIX. Additional details were provided as follows: On 16th October 2018, the patient started developing a painful rash and he saw his physician on 19th October 2018 where he was diagnosed with shingles.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Pain of skin, Paraesthesia, Swelling
Clinical narrative: Patient diagnosed with Shingles 10/29/2018 by Dr. 10/25/2018 she was vaccinated with SHINGRIX, 10 minutes later while driving, she began to feel irritation and general malaise. Over the weekend, her pain was severe 9/10 ameliorated with ibuprofen. Monday, 10/29/2018, Dr. prescribed valacyclovir HCL and amitriptyline.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Irritability, Malaise
Clinical narrative: Patient diagnosed with Shingles 10/29/2018 by Dr. 10/25/2018 she was vaccinated with SHINGRIX, 10 minutes later while driving, she began to feel irritation and general malaise. Over the weekend, her pain was severe 9/10 ameliorated with ibuprofen. Monday, 10/29/2018, Dr. prescribed valacyclovir HCL and amitriptyline.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash erythematous
Clinical narrative: Patient diagnosed with Shingles 10/29/2018 by Dr. 10/25/2018 she was vaccinated with SHINGRIX, 10 minutes later while driving, she began to feel irritation and general malaise. Over the weekend, her pain was severe 9/10 ameliorated with ibuprofen. Monday, 10/29/2018, Dr. prescribed valacyclovir HCL and amitriptyline.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Immediate pain in left arm. Started chills and being tired in about 3 hours. Later fever approx. 101, chills, and muscle aches all over.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Immediate pain in left arm. Started chills and being tired in about 3 hours. Later fever approx. 101, chills, and muscle aches all over.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site haemorrhage, Injection site mass, Injection site rash, Injection site urticaria, Pruritus
Clinical narrative: Developed a lump, ecchymosis, rash/hives at injection site day of shot. Also developed hives/rash/itching on  both arms and back.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Urticaria
Clinical narrative: Developed a lump, ecchymosis, rash/hives at injection site day of shot. Also developed hives/rash/itching on  both arms and back.
Sex: F
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report was received from the patient's step mother and refers to her 17 year old daughter. The patient's pertinent medical history included back surgery and an unspecified extensive medical history. No information was reported about her concomitant medications, concurrent conditions and drug reactions/allergies. On an unknown date in 2012, the patient was vaccinated with GARDASIL 9, "1 x 0.5-mL dose at 0, 2 and 6 months", intramuscularly, for prevention of HPV (lot # and expiration date were not reported). On an unspecified date, the patient experienced warts on her toes (skin papilloma) after receiving her first dose of GARDASIL 9. At the time of reporting, the outcome of the event was reported as recovered (date unspecified). The causality assessment between warts on her toes (skin papilloma) with GARDASIL 9 was not provided. This one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA006397; US-009507513-1810USA006562.
Age: 7.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from medical resident and refers to a 7-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported. On 16-OCT-2018, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis (drug administered to patient of inappropriate age). The reported stated that the patient has experienced no adverse effects.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacy intern to a 22 year old female patient. The patient's relevant medical history, past drug history and concomitant medications are unknown. On 21-OCT-2018 the patient was vaccinated with expired dose of VARIVAX (dose, frequency and route were not reported) (lot # M033906, expiry date: 20-JUL-2018) for prophylaxis (expired product administered). Laboratory data was unknown. As of 21-OCT-2018, the patient had not received another vaccine.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Induration, Limb mass, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a consumer and refers to herself, a 71 years old, female patient. The patient's medical history included Klebsiella pneumonia and the concomitant's medication included NITROFURANTOIN MONOHYD MACRO, also reported as NITROFURANTOIN MCR. The patient did not have pertinent drug reactions or allergies. On 20-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 for prevent pneumonia, single 0.5 ml dose, intramuscularly (anatomical site of injection, lot # and expiration date were not reported). On the same date, the patient started experienced joint pain and swelling down past her elbow and the area was warm to the touch. Also the patient reported that she had developed a hard lump size of a marble in the area between her neck and shoulder. The patient did not received treatment for the adverse events. The laboratory test of urine for bladder infection was performed (no results were provided). The patient did not seek medical attention. The outcome for the events was reported as not recovered. The causality assessment between PNEUMOVAX 23 and the events were not reported.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Urine analysis
Clinical narrative: This spontaneous report was received from a consumer and refers to herself, a 71 years old, female patient. The patient's medical history included Klebsiella pneumonia and the concomitant's medication included NITROFURANTOIN MONOHYD MACRO, also reported as NITROFURANTOIN MCR. The patient did not have pertinent drug reactions or allergies. On 20-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 for prevent pneumonia, single 0.5 ml dose, intramuscularly (anatomical site of injection, lot # and expiration date were not reported). On the same date, the patient started experienced joint pain and swelling down past her elbow and the area was warm to the touch. Also the patient reported that she had developed a hard lump size of a marble in the area between her neck and shoulder. The patient did not received treatment for the adverse events. The laboratory test of urine for bladder infection was performed (no results were provided). The patient did not seek medical attention. The outcome for the events was reported as not recovered. The causality assessment between PNEUMOVAX 23 and the events were not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Ophthalmic herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's husband reported that on or about December 2015, the patient received the ZOSTAVAX, (lot# and route unknown) vaccine for its intended purpose: the prevention of shingles. Shortly thereafter, the patient suffered multiple outbreaks of shingles around her left eye. She passed away from an unrelated medical condition on 27-OCT-2016.  As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using this product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Upon internal review multiple outbreaks of shingles around her left eye and passed away were considered medically significant events. Additional information has been requested.; Reported Cause(s) of Death: passed away.
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Arthralgia, Asthma, Condition aggravated, Headache, Laryngoscopy
Clinical narrative: This spontaneous report was received from a physician referring to a 11 year old female patient with asthma and penicillin allergy. Concomitant therapy included MENACTRA. Information about relevant history condition was not provided. On 19-JUL-2018, the patient was vaccinated with a dose of VAQTA (strength, dose detail, lot # and expiration date were not reported) intramuscularly for prophylaxis. In September 2018 (reported as beginning 2 months after injection), the patient experienced hives, uticaria, occasional flares of asthma, hip pain, headache and paresthesia. On 25-SEP-2018, the patient made a visit to a hospital emergency room and received unspecified treatment for headache. On 27-SEP-2018, patient made a visit to the emergency room again and received unspecified treatment for allergies. The patient had laryngoscopy on an unspecified date without any result provided. The outcome of the events was reported as not recovered/not resolved. The causality assessment was not provided. The reporter considered all the events to be serious for the following reason: potentially life threatening.
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Paraesthesia, Urticaria
Clinical narrative: This spontaneous report was received from a physician referring to a 11 year old female patient with asthma and penicillin allergy. Concomitant therapy included MENACTRA. Information about relevant history condition was not provided. On 19-JUL-2018, the patient was vaccinated with a dose of VAQTA (strength, dose detail, lot # and expiration date were not reported) intramuscularly for prophylaxis. In September 2018 (reported as beginning 2 months after injection), the patient experienced hives, uticaria, occasional flares of asthma, hip pain, headache and paresthesia. On 25-SEP-2018, the patient made a visit to a hospital emergency room and received unspecified treatment for headache. On 27-SEP-2018, patient made a visit to the emergency room again and received unspecified treatment for allergies. The patient had laryngoscopy on an unspecified date without any result provided. The outcome of the events was reported as not recovered/not resolved. The causality assessment was not provided. The reporter considered all the events to be serious for the following reason: potentially life threatening.
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a consumer concerning her daughter of 6 months. Concurrent conditions, medical history, concomitant medication and drug reactions/allergies were not reported. It was reported that on an unspecified date, the patient was vaccinated with either improperly stored or expired dose of ROTATEQ (strength, dose, unit, frequency, lot number and expiration date not reported) for prophylaxis. No adverse effects were reported. Temperature and timeframe of the vaccine were not reported. There was no product quality complaint (PQC) reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's physician recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-SEP-2012, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 19-SEP-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 20-JUN-2007 the patient was vaccinated with ZOSTAVAX. On or about 31-OCT-2016, the patient was treated by healthcare providers for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages as a result of shingles and other zoster-related injuries. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 31-JAN-2011, a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2011, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2006, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 17-SEP-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the zoster vaccine live (ZOSTAVAX) vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2012, a healthcare provider at a physician's office administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2009, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2009, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 2011, the patient was administered ZOSTAVAX at a hospital (dose, route, and lot # not provided).  The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In or about 2013, the patient was treated by his healthcare provider at the same hospital for shingles.  He was diagnosed with shingles and/or other zoster-related injuries after and despite being vaccinated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries.  As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events were unknown.  Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (dose, route, and lot # not provided). The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions.  In or about November 2016, the patient was treated by a physician for shingles.  He was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries.  As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages.  The outcome of the events were unknown.  Causality assessment was related. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Nausea, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse received via a sales representative. A 67-year-old female patient received PREVNAR 13, via intramuscular in the arm on an unspecified date in 2017 at single dose for immunisation. The patient medical history was not reported. Concomitant medication included Lisinopril and atorvastatin (ATORVASTATIN). The patient received the pneumococcal 13-val conj vac (dipht crm197 protein) at her doctor's appointment last year (in 2017) and within a couple of hours of getting the vaccine, her mother had a 103 degrees Fahrenheit fever, had vomiting, nausea, and was weak. This lasted for 2 to 3 days and everything was fine after. The arm that had received the vaccine was swollen and her mother was immunocompromised. The outcome of the events, 103 degrees Fahrenheit fever, vomiting, nausea, and weak, was recovered in 2017. The outcome of the other events was unknown.; Sender's Comments: Being immunocompromised is the patient's underlying medical condition unrelated to the vaccination with PREVENAR 13.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was administered this above influenza injection on 11/1/2018 before provider and MA administering the vaccine acknolwedged that the patient had already received a flu shot this season on 09/29/2018. No adverse effects were noted and patient was informed of medication error by provider,  PA.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Tdap Dose given in error. She had come in before school started for  the Tdap on 9/14/18.
Age: 73.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Extra dose administered, Injection site discolouration
Clinical narrative: Patient presented with his upper arm black and blue (slight black and blue around the site of injection, more black and blue leading to the elbow). It appears he may have suffered a hematoma from the shot. He stated that it didn't hurt and it appears to be resolving because of the yellowing color. The patient was reluctant to see the doctor but I suggested that he still go see his doctor to have it evaluated. He has an appointment with his physician on Monday Nov 5th to evaluate it.
Age: 75.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Insomnia, Pyrexia
Clinical narrative: Chills for over two hours followed by fever for two hours. Could not sleep. Kept waking up every half hour. Some chills during the following day. Slept very well the next night.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 24hrs after vaccination, injection site noted to be hot to touch, red, and hard 1.5in diameter around site, painful to touch. No change for next 24hrs (48hrs after vaccine).
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pruritus
Clinical narrative: Patient reported yesterday Nov. 1, 2018 that she has been having itching on her right arm for the past 6 days after receiving her flu shot on Sat. Oct. 27th. She reported that the itching feeling has been happening 2-3 times per day at the site of the injection and that the itching feeling progresses down her upper arm to her elbow.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: Parents concerned about localized cellulitis not at administration site, but on the same leg as injection.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Chest pain, Dyspnoea, Electrocardiogram, Flushing
Clinical narrative: Employee complained of left neck and left back burning pain, shortness of breath, tachycardia, face flushed, weak knees- felt like jello, pain in chest.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Neck pain, Pain, Tachycardia
Clinical narrative: Employee complained of left neck and left back burning pain, shortness of breath, tachycardia, face flushed, weak knees- felt like jello, pain in chest.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pyrexia
Clinical narrative: Fever, could not sleep.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Decreased appetite, Eyelid pain, Feeling cold, Myalgia
Clinical narrative: After having the flu shot AFLURIA QUAD PF injected at pharmacy at 12:45 PM on October 30, 2018, five hours later, my body was shaking so bad I was freezing and could not get warm, had low-grade fever 99.2. The following day I have very sore muscles, even my eyelids ache. I have never experienced the uncontrollable shaking. This was not just a chill where you would get a random tremor this was so bad I could not even hold a spoon to eat. Was weak and had no appetite until 24 hours later. I contacted the pharmacy the next day and they told me that there had been another case of this exact thing two weeks prior. I'm just wondering how many people actually call the pharmacy after they go through something like this perhaps the amount of people affected is much greater than is thought.