chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Injected limb mobility decreased, Injection site pain, Limb discomfort, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (Refer case US2018GSK144869). On 31st July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 1st August 2018, 1 days after receiving SHINGRIX, the patient experienced sleepiness. On 2nd August 2018, the patient experienced headache. On 3rd August 2018, the patient experienced fever. On an unknown date, the patient experienced pain, heaviness in limbs, swelling arm, chills, injection site pain, feels awful, multiple allergies and injected limb mobility decreased. On an unknown date, the outcome of the headache, chills, feels awful, sleepiness and injected limb mobility decreased were unknown and the outcome of the pain, heaviness in limbs, swelling arm and multiple allergies were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the fever was recovering/resolving. It was unknown if the reporter considered the headache, pain, heaviness in limbs, swelling arm, chills, injection site pain, feels awful, multiple allergies, sleepiness, injected limb mobility decreased and fever to be related to SHINGRIX. Additional details were provided as follows: The reporter was unable to provided batch number or expiry date. NDC number was provided as 58160-0823-11. The patient received her 1st dose of SHINGRIX on 20th April 2018 and 2nd dose on 31st July 2018 around 12.30 pm at her local Pharmacy, in her left arm and within 14 to 16 hours of the 2nd dose she experienced cold chills although she did not feel sick. The patient slept most of the day on 1st August 2018 and when she woke up that morning, she had horrible headache, she was uncertain if it was allergy related but it resolved that morning, she overall felt horrible with aches and pains that are not normal. The reporter stated that her left arm felt heavy, almost lead like and it hurt to lift the arm, and that her arm was swollen and she had ongoing pain or soreness around injection site. The patient woke up on the day of reporting with a slight fever. Permission was given to contact Pharmacy and primary health care professional. No further information was provided. This case has been linked with case US2018GSK144869 reported by the same reporter for the same patient.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (Refer case US2018GSK144869). On 31st July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 1st August 2018, 1 days after receiving SHINGRIX, the patient experienced sleepiness. On 2nd August 2018, the patient experienced headache. On 3rd August 2018, the patient experienced fever. On an unknown date, the patient experienced pain, heaviness in limbs, swelling arm, chills, injection site pain, feels awful, multiple allergies and injected limb mobility decreased. On an unknown date, the outcome of the headache, chills, feels awful, sleepiness and injected limb mobility decreased were unknown and the outcome of the pain, heaviness in limbs, swelling arm and multiple allergies were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the fever was recovering/resolving. It was unknown if the reporter considered the headache, pain, heaviness in limbs, swelling arm, chills, injection site pain, feels awful, multiple allergies, sleepiness, injected limb mobility decreased and fever to be related to SHINGRIX. Additional details were provided as follows: The reporter was unable to provided batch number or expiry date. NDC number was provided as 58160-0823-11. The patient received her 1st dose of SHINGRIX on 20th April 2018 and 2nd dose on 31st July 2018 around 12.30 pm at her local Pharmacy, in her left arm and within 14 to 16 hours of the 2nd dose she experienced cold chills although she did not feel sick. The patient slept most of the day on 1st August 2018 and when she woke up that morning, she had horrible headache, she was uncertain if it was allergy related but it resolved that morning, she overall felt horrible with aches and pains that are not normal. The reporter stated that her left arm felt heavy, almost lead like and it hurt to lift the arm, and that her arm was swollen and she had ongoing pain or soreness around injection site. The patient woke up on the day of reporting with a slight fever. Permission was given to contact Pharmacy and primary health care professional. No further information was provided. This case has been linked with case US2018GSK144869 reported by the same reporter for the same patient.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Back pain, Fatigue, Headache, Muscle fatigue, Myalgia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of tiredness in a 18-year-old male patient who received MENVEO for prophylaxis. On 26th July 2018, the patient received the 1st dose of MENVEO (intramuscular). In July 2018, less than a day after receiving MENVEO, the patient experienced pain in arm. On 28th July 2018, the patient experienced tiredness, muscle pain, headache, back pain and muscle fatigue. On an unknown date, the outcome of the tiredness, muscle pain, headache, back pain and muscle fatigue were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the tiredness, muscle pain, headache, pain in arm, back pain and muscle fatigue to be related to MENVEO. Additional details were provided as follows: This case was reported by the patient's father, who was a neuroscientist. The patient was an athlete and had been training so much and has been very active lately. The patient received MENVEO in an unknown deltoid. The patient came home and said that his arm was hurt but then it went away. The patient had been a bit tired following the injection in his deltoid. 2 days after receiving MENVEO, the patient's back was also hurt and he had complained about fatigue, muscle pain, muscle fatigue, and headache. Two to three days after injection the patient did began talking about how tired he was. About 4 to 5 days after the injection, the patient started talking about being extraordinarily tired, as a different thing. The patient said that he was been training and should felt like he was getting in better shape but felt like he was in worse shape. He was been complaining about this for about 5 days at the time of reporting. No lot or expiration date was available.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of tiredness in a 18-year-old male patient who received MENVEO for prophylaxis. On 26th July 2018, the patient received the 1st dose of MENVEO (intramuscular). In July 2018, less than a day after receiving MENVEO, the patient experienced pain in arm. On 28th July 2018, the patient experienced tiredness, muscle pain, headache, back pain and muscle fatigue. On an unknown date, the outcome of the tiredness, muscle pain, headache, back pain and muscle fatigue were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the tiredness, muscle pain, headache, pain in arm, back pain and muscle fatigue to be related to MENVEO. Additional details were provided as follows: This case was reported by the patient's father, who was a neuroscientist. The patient was an athlete and had been training so much and has been very active lately. The patient received MENVEO in an unknown deltoid. The patient came home and said that his arm was hurt but then it went away. The patient had been a bit tired following the injection in his deltoid. 2 days after receiving MENVEO, the patient's back was also hurt and he had complained about fatigue, muscle pain, muscle fatigue, and headache. Two to three days after injection the patient did began talking about how tired he was. About 4 to 5 days after the injection, the patient started talking about being extraordinarily tired, as a different thing. The patient said that he was been training and should felt like he was getting in better shape but felt like he was in worse shape. He was been complaining about this for about 5 days at the time of reporting. No lot or expiration date was available.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Ear pain, Ear pruritus, Eye pain, Eye pruritus, Eye swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 28th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th July 2018, 1 days after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), eye pain, eye pruritus, ear pruritus, multiple allergies, ear pain and shingles. On 3rd August 2018, the patient experienced eye swelling and rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and ophthalmologicals (Eye Drop). On an unknown date, the outcome of the ophthalmic herpes zoster, eye swelling, rash, eye pain, eye pruritus and shingles were not recovered/not resolved and the outcome of the ear pruritus and ear pain were recovered/resolved and the outcome of the multiple allergies was unknown. It was unknown if the reporter considered the ophthalmic herpes zoster, eye swelling, rash, eye pain, eye pruritus, ear pruritus, multiple allergies, ear pain and shingles to be related to SHINGRIX. Additional details were provided as follows: At approximately 11:00 am, the patient received the Shingles vaccine a week ago in the left arm. The following day the patient experienced pain and itching in his eye and ear and his symptoms were similar to allergies. The patient's ear symptoms had resolved but he had the classic face shingles including a rash on his forehead and his right eye was swollen shut. Six days after receiving vaccination, the patient's eye started to swell and had gotten worse. The patient received Valacyclovir and eye drops which he started yesterday. The patient was officially diagnosed with shingles at an urgent care a day before reporting date but his symptoms started the day after the vaccination.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Multiple allergies, Ophthalmic herpes zoster, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 28th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th July 2018, 1 days after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), eye pain, eye pruritus, ear pruritus, multiple allergies, ear pain and shingles. On 3rd August 2018, the patient experienced eye swelling and rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and ophthalmologicals (Eye Drop). On an unknown date, the outcome of the ophthalmic herpes zoster, eye swelling, rash, eye pain, eye pruritus and shingles were not recovered/not resolved and the outcome of the ear pruritus and ear pain were recovered/resolved and the outcome of the multiple allergies was unknown. It was unknown if the reporter considered the ophthalmic herpes zoster, eye swelling, rash, eye pain, eye pruritus, ear pruritus, multiple allergies, ear pain and shingles to be related to SHINGRIX. Additional details were provided as follows: At approximately 11:00 am, the patient received the Shingles vaccine a week ago in the left arm. The following day the patient experienced pain and itching in his eye and ear and his symptoms were similar to allergies. The patient's ear symptoms had resolved but he had the classic face shingles including a rash on his forehead and his right eye was swollen shut. Six days after receiving vaccination, the patient's eye started to swell and had gotten worse. The patient received Valacyclovir and eye drops which he started yesterday. The patient was officially diagnosed with shingles at an urgent care a day before reporting date but his symptoms started the day after the vaccination.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 28th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th July 2018, 1 days after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), eye pain, eye pruritus, ear pruritus, multiple allergies, ear pain and shingles. On 3rd August 2018, the patient experienced eye swelling and rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and ophthalmologicals (Eye Drop). On an unknown date, the outcome of the ophthalmic herpes zoster, eye swelling, rash, eye pain, eye pruritus and shingles were not recovered/not resolved and the outcome of the ear pruritus and ear pain were recovered/resolved and the outcome of the multiple allergies was unknown. It was unknown if the reporter considered the ophthalmic herpes zoster, eye swelling, rash, eye pain, eye pruritus, ear pruritus, multiple allergies, ear pain and shingles to be related to SHINGRIX. Additional details were provided as follows: At approximately 11:00 am, the patient received the Shingles vaccine a week ago in the left arm. The following day the patient experienced pain and itching in his eye and ear and his symptoms were similar to allergies. The patient's ear symptoms had resolved but he had the classic face shingles including a rash on his forehead and his right eye was swollen shut. Six days after receiving vaccination, the patient's eye started to swell and had gotten worse. The patient received Valacyclovir and eye drops which he started yesterday. The patient was officially diagnosed with shingles at an urgent care a day before reporting date but his symptoms started the day after the vaccination.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Drug administered to patient of inappropriate age, Herpes zoster, Inappropriate schedule of drug administration, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 48-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th June 2018, the patient received the 2nd dose of SHINGRIX. On 27th April 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced inappropriate age at vaccine administration. On 20th June 2018, the patient experienced drug dose administration interval too short and inappropriate age at vaccine administration. On 1st August 2018, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and arthralgia. On an unknown date, the outcome of the vaccination failure, shingles, arthralgia, drug dose administration interval too short, inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the vaccination failure, shingles and arthralgia to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The patient was administered the second dose of the SHINGRIX vaccine 7 days early than the recommended interval, which led to shortening of vaccination schedule. On 1st August 2018, 96 days after receiving 1st dose of SHINGRIX and 42 days after receiving 2nd dose of SHINGRIX, the patient presented to physician's office with moderate Shingles rash and severe pain on her right ankle and right upper lateral hip. The patient paid cash at the pharmacy to get the vaccine. No further details were provided.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 48-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th June 2018, the patient received the 2nd dose of SHINGRIX. On 27th April 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced inappropriate age at vaccine administration. On 20th June 2018, the patient experienced drug dose administration interval too short and inappropriate age at vaccine administration. On 1st August 2018, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and arthralgia. On an unknown date, the outcome of the vaccination failure, shingles, arthralgia, drug dose administration interval too short, inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the vaccination failure, shingles and arthralgia to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The patient was administered the second dose of the SHINGRIX vaccine 7 days early than the recommended interval, which led to shortening of vaccination schedule. On 1st August 2018, 96 days after receiving 1st dose of SHINGRIX and 42 days after receiving 2nd dose of SHINGRIX, the patient presented to physician's office with moderate Shingles rash and severe pain on her right ankle and right upper lateral hip. The patient paid cash at the pharmacy to get the vaccine. No further details were provided.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Back disorder, Osteoporosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of osteoporosis in a elderly female patient who received SHINGRIX for prophylaxis. In January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced osteoporosis (serious criteria hospitalization) and back disorder (serious criteria hospitalization). On an unknown date, the outcome of the osteoporosis was unknown and the outcome of the back disorder was recovering/resolving. The reporter considered the osteoporosis and back disorder to be unrelated to SHINGRIX. Additional information was received as follows: The patient stated that she presented back to the pharmacy to receive the second shot and the pharmacist denied stating that she was beyond the timeframe. The patient stated that the cutoff date he noted was 22nd July 2018. The patient noted the reason for the delay was due to medical reasons. She noted that about 3 months before the reporting date, she began having back problems. She was hospitalized twice and seen in the emergency room. She noted that the first hospitalization was for 2 days and the second was for 3 days. The patient stated it was due to osteoporosis and she denied any relationship to the SHINGRIX vaccination. The patient would have the pharmacist call back to GlaxoSmithKline for discussion on the delayed time. This case has been linked to the case US2018142991 (husband's case), reported by the same reporter.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hyperaesthesia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 7th August 2018 19:00, the patient received SHINGRIX. On 7th August 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 8th August 2018, the patient experienced headache and hypersensation skin. On an unknown date, the outcome of the headache, hypersensation skin and pain in arm were unknown. It was unknown if the reporter considered the headache, hypersensation skin and pain in arm to be related to SHINGRIX. Additional information was reported as follows: On the day and in the evening of the vaccination, the patient's arm became painful. The next day after vaccination, the patient developed headache and his skin felt sensitive to touch but the patient did not experience any rash or swelling on the skin. The patient did not specify where the skin sentivity was present.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site atrophy, Injection site pruritus, Injection site rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site indentation in a 83-year-old female patient who received SHINGRIX for prophylaxis.  On an unknown date, the patient received SHINGRIX at an unknown dose. In June 2018, less than a year after receiving SHINGRIX, the patient experienced injection site indentation, rash and pruritus. On an unknown date, the outcome of the injection site indentation, rash and pruritus were not recovered/not resolved. It was unknown if the reporter considered the injection site indentation, rash and pruritus to be related to SHINGRIX. Additional details were received as follows: The reporter was the patient's physician. Six weeks before the date of reporting, the patient experienced rash and itching and indentation at site of SHINGRIX vaccination. No vaccination date was provided. The health care professional (HCP) stated the patient inquired if she need to take 2nd dose of SHINGRIX.
Age: 18.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient given HPV, Hepatitis B-Child, and PPD during office visit at 07:49. Patient sat down while receiving all vaccines and reported no complaints. Patient proceeded to stand up with no difficulty and walked out of clinic. Patient arrived at another clinic 10 minutes later at 07:59 and had a vasovagal syncope. Patient immediately regained consciousness and was seen by family health provider and cleared of all concerns. Patient reported history of vasovagal episodes but not with receiving immunizations.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient developed rash 6 days post vaccination. Onset was sudden. Rash was spotted and red, spots were not raised or have any abnormality to note. Area of coverage for rash included the backside of both arms and legs and across lower back. There was no apparent local reaction at site of injection. Patient reported no other distress (pain, itch) associated with rash other than it being unsightly and mildly uncomfortable. Patient had already contacted a relative health care professional who instructed them it could be due to allergy and to take BENADRYL to see if that helped it clear up and as the pharmacist patient reported to I concurred. Patient has been using BENADRYL and Calamine lotion with no resolution for approximately 4 days. Rash as of 8/13 during follow up call to patient had not remarkably improved, but patient stated it was not getting any worse. Patient noted at this time they are very active and usually upon rest it seemed the rash was less uncomfortable. They plan to follow up with primary care provider within the next week if it does not resolve. As an additional note patient did want it reported she was not sure if this could be related to her adverse reaction as she feels it does predispose her to other adverse reactions to medications.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abnormal behaviour, Affect lability, Aphasia, Blood test normal, Computerised tomogram head normal
Clinical narrative: Patient was given second vaccination on 12/28/2017. On 12/31/2017 she was at a friend's house and had a pressure headache. According to friend's father she was not acting like her normal self she was very lethargic. She is an athlete and is never tired. She went to the kitchen and was standing in line for a pancake and passed out, hit her head on tile floor. She was unconscious for a little less than 1 min. She was unable talk or form a sentence. After about 30 min she could say her name but took a lot of thought and could not walk. She was taken to the ED and starting throwing up. She had a CT scan, Labs, Urine sample, EKG, given 2 L fluids and monitored for 6 hours. All testing come back normal. Except her EKG was bradycardic at 49 BPM. Her heart rate has been fluctuating for the last month between 40s to 115s, it changes by the minute (even with no activity). She recovered from the concussion 2 weeks later and no other symptoms for 3 days. However, she then came down with strep throat and had headaches and dizziness again. She has never had strep and has never really been sick. This was her first time ever missing school for an illness. She recovered from strep after a round of amoxicillin. Her breakout on her forehead has not healed even after a month and half of topical clindamycin. She can't seem to get her immune system back in check. 1 month to the day later she started having fatigue in her legs and they feel heavy and weak, this comes and goes. She also seems to be more emotional about a month after getting the vaccination. Her appetite seems to be normal thus far. 8/14/2018 - update: 7 months post 2nd vaccination. Has a headache every day for 3 weeks, fatigue, head is still not cleared up after being on antibiotics and RETIN A. She has insomnia and cannot fall asleep. At times she has numbness or tingling in her feet. She seems to be feeling worse not better.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Concussion, Dehydration, Dizziness, Electrocardiogram abnormal, Fall
Clinical narrative: Patient was given second vaccination on 12/28/2017. On 12/31/2017 she was at a friend's house and had a pressure headache. According to friend's father she was not acting like her normal self she was very lethargic. She is an athlete and is never tired. She went to the kitchen and was standing in line for a pancake and passed out, hit her head on tile floor. She was unconscious for a little less than 1 min. She was unable talk or form a sentence. After about 30 min she could say her name but took a lot of thought and could not walk. She was taken to the ED and starting throwing up. She had a CT scan, Labs, Urine sample, EKG, given 2 L fluids and monitored for 6 hours. All testing come back normal. Except her EKG was bradycardic at 49 BPM. Her heart rate has been fluctuating for the last month between 40s to 115s, it changes by the minute (even with no activity). She recovered from the concussion 2 weeks later and no other symptoms for 3 days. However, she then came down with strep throat and had headaches and dizziness again. She has never had strep and has never really been sick. This was her first time ever missing school for an illness. She recovered from strep after a round of amoxicillin. Her breakout on her forehead has not healed even after a month and half of topical clindamycin. She can't seem to get her immune system back in check. 1 month to the day later she started having fatigue in her legs and they feel heavy and weak, this comes and goes. She also seems to be more emotional about a month after getting the vaccination. Her appetite seems to be normal thus far. 8/14/2018 - update: 7 months post 2nd vaccination. Has a headache every day for 3 weeks, fatigue, head is still not cleared up after being on antibiotics and RETIN A. She has insomnia and cannot fall asleep. At times she has numbness or tingling in her feet. She seems to be feeling worse not better.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Gait inability, Head discomfort, Head injury, Headache
Clinical narrative: Patient was given second vaccination on 12/28/2017. On 12/31/2017 she was at a friend's house and had a pressure headache. According to friend's father she was not acting like her normal self she was very lethargic. She is an athlete and is never tired. She went to the kitchen and was standing in line for a pancake and passed out, hit her head on tile floor. She was unconscious for a little less than 1 min. She was unable talk or form a sentence. After about 30 min she could say her name but took a lot of thought and could not walk. She was taken to the ED and starting throwing up. She had a CT scan, Labs, Urine sample, EKG, given 2 L fluids and monitored for 6 hours. All testing come back normal. Except her EKG was bradycardic at 49 BPM. Her heart rate has been fluctuating for the last month between 40s to 115s, it changes by the minute (even with no activity). She recovered from the concussion 2 weeks later and no other symptoms for 3 days. However, she then came down with strep throat and had headaches and dizziness again. She has never had strep and has never really been sick. This was her first time ever missing school for an illness. She recovered from strep after a round of amoxicillin. Her breakout on her forehead has not healed even after a month and half of topical clindamycin. She can't seem to get her immune system back in check. 1 month to the day later she started having fatigue in her legs and they feel heavy and weak, this comes and goes. She also seems to be more emotional about a month after getting the vaccination. Her appetite seems to be normal thus far. 8/14/2018 - update: 7 months post 2nd vaccination. Has a headache every day for 3 weeks, fatigue, head is still not cleared up after being on antibiotics and RETIN A. She has insomnia and cannot fall asleep. At times she has numbness or tingling in her feet. She seems to be feeling worse not better.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Heart rate irregular, Hypoaesthesia, Immune system disorder, Insomnia, Laboratory test normal
Clinical narrative: Patient was given second vaccination on 12/28/2017. On 12/31/2017 she was at a friend's house and had a pressure headache. According to friend's father she was not acting like her normal self she was very lethargic. She is an athlete and is never tired. She went to the kitchen and was standing in line for a pancake and passed out, hit her head on tile floor. She was unconscious for a little less than 1 min. She was unable talk or form a sentence. After about 30 min she could say her name but took a lot of thought and could not walk. She was taken to the ED and starting throwing up. She had a CT scan, Labs, Urine sample, EKG, given 2 L fluids and monitored for 6 hours. All testing come back normal. Except her EKG was bradycardic at 49 BPM. Her heart rate has been fluctuating for the last month between 40s to 115s, it changes by the minute (even with no activity). She recovered from the concussion 2 weeks later and no other symptoms for 3 days. However, she then came down with strep throat and had headaches and dizziness again. She has never had strep and has never really been sick. This was her first time ever missing school for an illness. She recovered from strep after a round of amoxicillin. Her breakout on her forehead has not healed even after a month and half of topical clindamycin. She can't seem to get her immune system back in check. 1 month to the day later she started having fatigue in her legs and they feel heavy and weak, this comes and goes. She also seems to be more emotional about a month after getting the vaccination. Her appetite seems to be normal thus far. 8/14/2018 - update: 7 months post 2nd vaccination. Has a headache every day for 3 weeks, fatigue, head is still not cleared up after being on antibiotics and RETIN A. She has insomnia and cannot fall asleep. At times she has numbness or tingling in her feet. She seems to be feeling worse not better.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Lethargy, Limb discomfort, Loss of consciousness, Muscular weakness, Paraesthesia
Clinical narrative: Patient was given second vaccination on 12/28/2017. On 12/31/2017 she was at a friend's house and had a pressure headache. According to friend's father she was not acting like her normal self she was very lethargic. She is an athlete and is never tired. She went to the kitchen and was standing in line for a pancake and passed out, hit her head on tile floor. She was unconscious for a little less than 1 min. She was unable talk or form a sentence. After about 30 min she could say her name but took a lot of thought and could not walk. She was taken to the ED and starting throwing up. She had a CT scan, Labs, Urine sample, EKG, given 2 L fluids and monitored for 6 hours. All testing come back normal. Except her EKG was bradycardic at 49 BPM. Her heart rate has been fluctuating for the last month between 40s to 115s, it changes by the minute (even with no activity). She recovered from the concussion 2 weeks later and no other symptoms for 3 days. However, she then came down with strep throat and had headaches and dizziness again. She has never had strep and has never really been sick. This was her first time ever missing school for an illness. She recovered from strep after a round of amoxicillin. Her breakout on her forehead has not healed even after a month and half of topical clindamycin. She can't seem to get her immune system back in check. 1 month to the day later she started having fatigue in her legs and they feel heavy and weak, this comes and goes. She also seems to be more emotional about a month after getting the vaccination. Her appetite seems to be normal thus far. 8/14/2018 - update: 7 months post 2nd vaccination. Has a headache every day for 3 weeks, fatigue, head is still not cleared up after being on antibiotics and RETIN A. She has insomnia and cannot fall asleep. At times she has numbness or tingling in her feet. She seems to be feeling worse not better.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pharyngitis streptococcal, Sinus bradycardia, Urine analysis, Vomiting
Clinical narrative: Patient was given second vaccination on 12/28/2017. On 12/31/2017 she was at a friend's house and had a pressure headache. According to friend's father she was not acting like her normal self she was very lethargic. She is an athlete and is never tired. She went to the kitchen and was standing in line for a pancake and passed out, hit her head on tile floor. She was unconscious for a little less than 1 min. She was unable talk or form a sentence. After about 30 min she could say her name but took a lot of thought and could not walk. She was taken to the ED and starting throwing up. She had a CT scan, Labs, Urine sample, EKG, given 2 L fluids and monitored for 6 hours. All testing come back normal. Except her EKG was bradycardic at 49 BPM. Her heart rate has been fluctuating for the last month between 40s to 115s, it changes by the minute (even with no activity). She recovered from the concussion 2 weeks later and no other symptoms for 3 days. However, she then came down with strep throat and had headaches and dizziness again. She has never had strep and has never really been sick. This was her first time ever missing school for an illness. She recovered from strep after a round of amoxicillin. Her breakout on her forehead has not healed even after a month and half of topical clindamycin. She can't seem to get her immune system back in check. 1 month to the day later she started having fatigue in her legs and they feel heavy and weak, this comes and goes. She also seems to be more emotional about a month after getting the vaccination. Her appetite seems to be normal thus far. 8/14/2018 - update: 7 months post 2nd vaccination. Has a headache every day for 3 weeks, fatigue, head is still not cleared up after being on antibiotics and RETIN A. She has insomnia and cannot fall asleep. At times she has numbness or tingling in her feet. She seems to be feeling worse not better.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: No reaction just received 2 doses of the same vaccines within a 2 month time frame. Was mistakenly given these  8/13/18 after receiving them 6/1/18.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product reconstitution quality issue
Clinical narrative: Dose was not reconstituted, only the dilatant was given, mother notified via phone and contracted to return for re admin.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site macule, Injection site pain
Clinical narrative: 2 raised, red spots each measuring approximately 2x3 cm per patient report located immediate adjacent to the injection site at the 2 o'clock and 6 o'clock position in relationship to the vaccination site on the upper left arm. Patient reports significant pain in his deltoid and describes it as if he 'were punched really hard on the shoulder.' Symptoms lasted for approximately two weeks but did not seek care.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Axillary pain, Local reaction, Pain in extremity, Peripheral swelling
Clinical narrative: Mom called on 8/11, two days after the injection to report the initial swelling. The progression/regression of the swelling where it went to ant chest wall/breast happened Sunday. Mom reports that after the vaccine in the right arm which we recorded as the MENACTRA, he had swelling in his upper arm and shoulder with extension to the axilla with no lymphadenopathy. He complained of pain in the arm and axilla but no itch. The following day the swelling in the shoulder had decreased and the swelling had fallen to the level of the breast. I told mom that it sounded like a local reaction and not an allergic reaction because there was no pain. I told mom we would do  a VAERS report.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Computerised tomogram normal, Electrocardiogram normal, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Seizure, admission to hospital on July 3, 2018. After performing multiple tests, no anomalies were found. Gabapentin 100mg 3 times per day prescribed. I was discharged on July 4, 2018.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Seizure, Urine analysis normal
Clinical narrative: Seizure, admission to hospital on July 3, 2018. After performing multiple tests, no anomalies were found. Gabapentin 100mg 3 times per day prescribed. I was discharged on July 4, 2018.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: I inadvertently gave patient a partial dose (a few drops) of the Rotavirus vaccine, but she wasn't due for it because she was 20 weeks old and had not had any previous doses. As soon as I realized I did not need to give her the dose, I removed the syringe from her mouth and wasted the remainder and explained to parents why she did not need it. They asked what "Rotavirus" was and I explained how the virus affects the body and since she technically is past the age of receiving the vaccine, I gave them the symptoms to watch for, and to call our office if she should come down with them.  They verbalized understanding.
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a nurse via field representative refers to a 15 year old female patient. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 16-JAN-2018, the patient was vaccinated with first dose of  GARDASIL 9) (strength, dose, lot # and expiration date were not reported), via intramuscular route for prophylaxis. On 30-JUN-2018, the patient was vaccinated with second dose of GARDASIL 9. On 30-JUN-2018, the patient developed a 'weird rash' (not clarified further) and had since been seen by an unknown dermatologist and an unknown infectious disease specialist on unknown dates (sought medical attention), where she received treatment (unknown). It was unknown whether any lab diagnostics/studies were performed. Outcome of rash was unknown. The reporter's causality assessment was not reported. There was no product quality complaint (PQC) reported.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an adult patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-JUL-2018, the patient was inadvertently administered a pediatric/adolescent dose of RECOMBIVAX HB, lot # M033334, expiry date 11-AUG-2018, intramuscularly for prophylaxis. No adverse effects were reported in the patient.
Sex: U
Vaccine: RAB
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 02-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 39 years old patient (gender not reported) who was vaccinated once with a 1.0 ml dose of IMOVAX RABIES (Batch number: N1L383M, expiration date: 26-Feb-2019) via intramuscular route in the right deltoid on 28-Jul-2018. This was a case of syringe issue and vaccine underdose as after drawing from the vial IMOVAX VACCINE started leaking between the needle during injection which was provided by company in kit. It was not reported whether the patient experienced adverse effects post vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Balance disorder, Biopsy, Biopsy peripheral nerve abnormal, Blood test, Burning sensation
Clinical narrative: This was a pre-exposure vaccine booster because of low titer. The original series was in 83. Severe headache with nausea within 45 minutes. Fingers and toes became tingly within 5 hours and progressed until both hands and feet felt numb over several days. Hands and feet felt like pins and needles- sensory deficit in feet on neurology exam 14 days post-vaccination. 19 days post vaccination rash on side of face and both arms that was itchy. Day 21 imbalance, tremors, and twitches in fingers, 2nd ER visit for severe headache and new symptom. Legs began to burn and sensation to touch at 29 days post exposure. Muscle weakness concurrent. 5/28/17 legs and feet are burning. Tremor and twitches are still present on 8/14/18.
Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Computerised tomogram normal, Headache, Hypoaesthesia, Lumbar puncture, Lumbar puncture normal
Clinical narrative: This was a pre-exposure vaccine booster because of low titer. The original series was in 83. Severe headache with nausea within 45 minutes. Fingers and toes became tingly within 5 hours and progressed until both hands and feet felt numb over several days. Hands and feet felt like pins and needles- sensory deficit in feet on neurology exam 14 days post-vaccination. 19 days post vaccination rash on side of face and both arms that was itchy. Day 21 imbalance, tremors, and twitches in fingers, 2nd ER visit for severe headache and new symptom. Legs began to burn and sensation to touch at 29 days post exposure. Muscle weakness concurrent. 5/28/17 legs and feet are burning. Tremor and twitches are still present on 8/14/18.
Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Muscle twitching, Muscular weakness, Nausea, Nerve conduction studies normal, Neurological examination abnormal
Clinical narrative: This was a pre-exposure vaccine booster because of low titer. The original series was in 83. Severe headache with nausea within 45 minutes. Fingers and toes became tingly within 5 hours and progressed until both hands and feet felt numb over several days. Hands and feet felt like pins and needles- sensory deficit in feet on neurology exam 14 days post-vaccination. 19 days post vaccination rash on side of face and both arms that was itchy. Day 21 imbalance, tremors, and twitches in fingers, 2nd ER visit for severe headache and new symptom. Legs began to burn and sensation to touch at 29 days post exposure. Muscle weakness concurrent. 5/28/17 legs and feet are burning. Tremor and twitches are still present on 8/14/18.
Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Nuclear magnetic resonance imaging brain normal, Paraesthesia, Pruritus, Rash, Rash pruritic
Clinical narrative: This was a pre-exposure vaccine booster because of low titer. The original series was in 83. Severe headache with nausea within 45 minutes. Fingers and toes became tingly within 5 hours and progressed until both hands and feet felt numb over several days. Hands and feet felt like pins and needles- sensory deficit in feet on neurology exam 14 days post-vaccination. 19 days post vaccination rash on side of face and both arms that was itchy. Day 21 imbalance, tremors, and twitches in fingers, 2nd ER visit for severe headache and new symptom. Legs began to burn and sensation to touch at 29 days post exposure. Muscle weakness concurrent. 5/28/17 legs and feet are burning. Tremor and twitches are still present on 8/14/18.
Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Sensory loss, Small fibre neuropathy, Tremor, Vitamin D deficiency
Clinical narrative: This was a pre-exposure vaccine booster because of low titer. The original series was in 83. Severe headache with nausea within 45 minutes. Fingers and toes became tingly within 5 hours and progressed until both hands and feet felt numb over several days. Hands and feet felt like pins and needles- sensory deficit in feet on neurology exam 14 days post-vaccination. 19 days post vaccination rash on side of face and both arms that was itchy. Day 21 imbalance, tremors, and twitches in fingers, 2nd ER visit for severe headache and new symptom. Legs began to burn and sensation to touch at 29 days post exposure. Muscle weakness concurrent. 5/28/17 legs and feet are burning. Tremor and twitches are still present on 8/14/18.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pain and swelling at injection site (could move arm only with severe discomfort); fever and chills.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Patient is experiencing, itchiness and rash over entire body which commenced on the evening after administration of immunization. Pt states putting lotion to soothe itchiness but refused any other treatment.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Hemiplegia, Injected limb mobility decreased, Loss of personal independence in daily activities, Pain
Clinical narrative: Patient reported she left pharmacy following 2nd SHINGRIX vaccination, and started walking back to home approximately 4 miles from store. She reported she started having severe pain/paralysis on left side of body, to the point where she said she needed assistance from family members to dress/eat/use restroom/etc. She reported this went on between Friday (day of vaccination) and Monday. She did not call her doctor or call any medical professional during this time period. She did not go to an urgent care location or an ED, nor call an ambulance. She stated by Monday she was able to freely lift her arm again and ambulate as she could before.