chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test normal, Erythema, Nausea, Pain, Skin burning sensation
Clinical narrative: head, neck, facial swelling and redness with burning skin.  Nausea, body aches.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling, Swelling face
Clinical narrative: head, neck, facial swelling and redness with burning skin.  Nausea, body aches.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Back pain
Clinical narrative: Assumed from Shingrix. Severe searing, superficial pain on back, left side only, immediately lateral to spine  approximately T-5 or T6. Intermittent, no rash or redness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: left deltoid swelling and erythema status post vaccine injection evaluated in ER 8/20/2019
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: erythema, swelling, pruritus, warm to touch, in appex 2.5 - 3 inches radius from injection site on left deltoid area
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Wife let us know that injection site was sore and warm to the touch, the day after vaccine. Recommended OTC analgesic and will contact tomorrow to see how they are doing. Called office (PCP) they will note in chart and let provider know  Followed up with pt on 8/17/19, everything is much better now, healing just fine. No further follow-up needed
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Patient came in to let us know that the injection site was sore and warm to the touch, the day after the vaccine. Recommended OTC analgesic and will contact tomorrow to see how they are doing. Called office (PCP) they will note in Chart & let provider know followed up with pt on 8/17/19, everything is much better now, healing just fine. no further follow-up needed
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Fatigue, Febrile convulsion, Feeling hot, Irritability, Pyrexia
Clinical narrative: Mom reports that patient had subjective Fever, then fever to 101.9. Gave Tylenol. Patient woke up at 330 on 8/21 Hot & Fussy. Tylenol given. Patient screaming at 0830, patient then started aggressively shaking x 15 sec, then unresponsive x 45 sec. Then tired. Went to ER. Dx febrile seizure. Patient taking scheduled antipyretic medications and doing well since. Playful.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Screaming, Tremor, Unresponsive to stimuli
Clinical narrative: Mom reports that patient had subjective Fever, then fever to 101.9. Gave Tylenol. Patient woke up at 330 on 8/21 Hot & Fussy. Tylenol given. Patient screaming at 0830, patient then started aggressively shaking x 15 sec, then unresponsive x 45 sec. Then tired. Went to ER. Dx febrile seizure. Patient taking scheduled antipyretic medications and doing well since. Playful.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Dyskinesia, Tic
Clinical narrative: Patient has Tics , elevation of eyebrows & involuntary smile & facial Tics 1 week after receiving DTaP, IPV & Hib
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dizziness
Clinical narrative: shortness of breath, weakness, nausea, vomiting, jaundice
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Blood bilirubin increased, Dyspnoea, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: shortness of breath, weakness, nausea, vomiting, jaundice
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Jaundice, Nausea, Vomiting
Clinical narrative: shortness of breath, weakness, nausea, vomiting, jaundice
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Malaise, Oedema, Pain, Pyrexia
Clinical narrative: Patient reported pain, redness, fever, malaise, edema. Needed to view camera to verify which arm received vaccine patient received shingrix in right deltoid and pneumovax 23 / fluad in left deltoid
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Chest pain, Injection site erythema, Injection site pain, Injection site swelling, Pain in jaw
Clinical narrative: Burning, redness, swelling, pain at the injection site. Chest pains (left), jaw pain (left)
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Hyperhidrosis, Malaise
Clinical narrative: I did not submit a report for the first dose, but had the exact same adverse symptoms.  Within a five hours started to feel very fatigued and week.  Overnight developed chills and sweats.  By morning had a fever of 102 degrees, extreme body aches, some nausea, and difficulty moving.  Very ill for another 6 hours or so and then gradually started to improve.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Nausea, Pain, Pyrexia
Clinical narrative: I did not submit a report for the first dose, but had the exact same adverse symptoms.  Within a five hours started to feel very fatigued and week.  Overnight developed chills and sweats.  By morning had a fever of 102 degrees, extreme body aches, some nausea, and difficulty moving.  Very ill for another 6 hours or so and then gradually started to improve.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: Woke up around 3:00 am with 'flu like' symptoms.  Basically body aches. Not Major. Tylenol has seemed to help and I was able to come to work.  No fever
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Eye irritation, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: localized reaction as expected - pain and swelling and redness at injection site - lowgrade fever and aching x 2 days   3rd night- severe hives and itching over torso, neck and arms - red and burning eyes and diminished vision - also some shortness of breath I am severely allergic to Sulfa drugs(including Neosporin ointment) - this is the exact reaction I have had to sulfa drugs - I have reviewed all the ingredients in this vaccine and do not see that sulfa is used - but I suspect otherwise - I am still having dramatic hives with new areas still forming and itching - making it difficult to maintain daily routine and wear clothing  - I will to back to emergency walk-in today to discuss additional treatments
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Ocular hyperaemia, Pain, Pruritus, Pyrexia
Clinical narrative: localized reaction as expected - pain and swelling and redness at injection site - lowgrade fever and aching x 2 days   3rd night- severe hives and itching over torso, neck and arms - red and burning eyes and diminished vision - also some shortness of breath I am severely allergic to Sulfa drugs(including Neosporin ointment) - this is the exact reaction I have had to sulfa drugs - I have reviewed all the ingredients in this vaccine and do not see that sulfa is used - but I suspect otherwise - I am still having dramatic hives with new areas still forming and itching - making it difficult to maintain daily routine and wear clothing  - I will to back to emergency walk-in today to discuss additional treatments
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria, Visual impairment
Clinical narrative: localized reaction as expected - pain and swelling and redness at injection site - lowgrade fever and aching x 2 days   3rd night- severe hives and itching over torso, neck and arms - red and burning eyes and diminished vision - also some shortness of breath I am severely allergic to Sulfa drugs(including Neosporin ointment) - this is the exact reaction I have had to sulfa drugs - I have reviewed all the ingredients in this vaccine and do not see that sulfa is used - but I suspect otherwise - I am still having dramatic hives with new areas still forming and itching - making it difficult to maintain daily routine and wear clothing  - I will to back to emergency walk-in today to discuss additional treatments
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: redness , swelling, bruising about 6 inches in diameter. painful and feverish to touch
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Malaise
Clinical narrative: Pt describes feeling very ill in the early morning hours. She felt very weak and sick.  This scared her.  She took some ibuprofen, felt better, and was able to go back to sleep.  She stated that she felt so bad that she considered waking her husband and going to the ER. After this there seemed to be resolution.  She said that the site of injection didn't appear to be the issue, yet just the ill episode in the early morning hours. She is 100% that it is from the vaccine, but believes it is the contributing factor to her feeling this way despite being her second and final dose.  Symptoms have resolved and no medical treatment has been pursued.  She stopped by to let me know of the matter, and I felt compelled to report.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adversed effects reported; MMR and Varivax were administered to patient by the intramuscular rather than the subcutaneous route; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 31-JUL-2019, the patient was vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) lot number R028004, expiration date 01-OCT-2020 (exact dose and site of administration were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) lot number R034398, expiration date 27-NOV-2020 (exact dose and site of administration were not reported), both for prophylaxis. The vaccines were administered by the intramuscular, rather than subcutaneous route. No adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was administered an improperly stored dose of Rotateq; No adverse effect; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported.  On an unknown date, the patient was administered an improperly stored dose  of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) injection for prophylaxis (lot # R033254, expiration date 04-JUL-2020; dose, frequency, route of administration were not reported).      The dose of vaccine experienced a temperature excursion of 34.8 degrees Fahrenheit for 31 hours. No previous temperature excursion was reported. Data logger was not involved in recording the excursion details. No adverse event was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: the patient suffered severe rash/shingles; This 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. On or around 15-AUG-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (the dosage regimen information was not reported). On an unspecified date (also reported as "shortly thereafter"), the patient suffered severe rash, then, the patient presented to a family clinic for this injury and he was diagnosed with shingles. As a direct and proximate result of the defective Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. The outcome of the events was considered as not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX). Shingles was considered to be disabling as the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported in the patient; a patient received a dose of VARIVAX following a temperature excursion; This spontaneous report has been received from an office manager, referring to a patient of unknown age.  The patient's relevant medical history, concurrent conditions, relevant past drugs reactions or allergies and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with a dose of Varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number N034553 has been verified to be valid for Varicella virus vaccine live (Oka/Merck); expiration date 05-DEC-2019, as prophylaxis, following a temperature excursion. The product storage error was first identified on 16-AUG-2019, with a temperature of 15° Fahrenheit to 46° Fahrenheit (-9°Celcius to 8°Celcius (39Fahrenheit). No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported; a dose of gardasil 9 was inadvertently administered to a 65 year old patient; This spontaneous report was received from a pharmacist, referring to a 65 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 19-AUG-2019, the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1621929, for prophylaxis (strength, dose, route, frequency and expiration date were not reported). No adverse effect reported.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient received a dose of Proquad following a temperature excursion; No adverse effects were reported; This spontaneous report has been received from a physician referring to a male patient of unknown age. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history.  On an unknown date, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, Lot# R013575, expiration date reported as 10-NOV-2019 (strength, dosage schedule, anatomical site and route of administration were not reported) for vaccination. (Product storage error)  The doses of vaccine were stored between 15 degrees Fahrenheit (°F) to 46 °F (-9 °C to 8 °C) (35.2 °F) for 20 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Cardiac murmur, Hypoaesthesia
Clinical narrative: numbness un an unspecified arm; heart murmur; This spontaneous report was received from a physician, via a company representative, regarding a female patient of unknown age. The patient's drug reactions/allergies, concomitant medications and pertinent medical history were not reported.   On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis  On an unknown date, the patient experienced numbness in the arm after receiving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). She went to the hospital after experiencing the numbness, where she was later diagnosed with a heart murmur. The outcome of the events was not reported.  The causality assessment between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the events was not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported.; The patient was vaccinated with improperly stored ROTATEQ; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.   On 20-AUG-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number R033255 and expiration date of 26-JUN-2020 orally for prophylaxis (dose was not provided). No adverse symptoms were reported.   The vaccine was exposed to a temperature excursion with a total time and lowest temperature below 36°F / 2°C FOR 6 hours. There was no previous temperature excursion. A "data logger" was involved.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects reported; she inadvertently administered both VARIVAX and PROQUAD to a six year old patient.; This spontaneous report was received from a physician concerning a 6 years old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 20-AUG-2019, the patient was vaccinated inadvertently (overdose) with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) and a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) both vaccines for prophylaxis (strength, dosage, frequency and route of administration, lot numbers and expiration dates were not reported). No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: A patient received an improperly stored PNEUMOVAX 23; Information has been received from a certified medical assistant, concerning a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, previously drug reactions, allergies and concomitant medications were not reported.   On 15-AUG-2019, the patient was vaccinated with one improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot number R025297 with expiration date on 08-JUN-2020 (strength, dose number, anatomical location and route of administration were not provided), for prophylaxis.   The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored at a temperature of 9 degrees Fahrenheit (°F) for the time frame of 5 days. There was no previous temperature excursion and the call was because of a data logger.
Age: 10.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effects; patient received 5 doses of gardasil 9; patient received 5 doses of gardasil 9/ received 2nd dose on 05-AUG-2016; This spontaneous report was received from a licensed practical nurse refers to a 12 year old patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 12-JAN-2015, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dosage information, route, anatomical location, lot# and expiration date were unknown) dose 1 for prophylaxis. On 05-AUG-2016, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 2 for prophylaxis (inappropriate schedule of product administration). On 11-OCT-2016, 02-MAY-2017 and 20-AUG-2019, the patient was vaccinated with dose 3rd, 4th and 5th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (incorrect dose administered). The lot number of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 5 was reported as R027577 and expiration date 23-JUN-2021. No adverse effects reported. The outcome of inappropriate schedule of product administration and incorrect dose administered was unknown. No product quality complaint reported.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: fever; flu like symptoms; This case was reported by a nurse via sales rep and described the occurrence of fever in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   In August 2019, the patient received the 1st dose of Bexsero. In August 2019, 2 hrs after receiving Bexsero, the patient experienced fever and influenza-like symptoms. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the fever and influenza-like symptoms to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero vaccine about a week ago from time of reporting. After about 2 hours the patient experienced fever, and flu like symptoms. The patient was given ibuprofen and fever, flu like symptoms went down right away. The nurse did not think it was serious enough to report, since side effects went away shortly after. Agreed to follow up if need be.
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Tremor
Clinical narrative: injection site pain; shaking; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA32AA, expiry date May 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, less than a day after receiving Bexsero, the patient experienced injection site pain and tremor. On an unknown date, the outcome of the injection site pain and tremor were unknown.   It was unknown if the reporter considered the injection site pain and tremor to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced injection site pain and shaking after arriving back at home.
Age: 76.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, Injection site reaction
Clinical narrative: injection site reaction; Inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 76-year-old female patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, unknown after receiving Twinrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated the patient was ten days late receiving dose 2nd of Twinrix, which led to incomplete course of vaccination . The pharmacist declined to answer additional questions at this follow up, stated the pharmacy was about to open.   Follow up information received from pharmacist on 12th August 2019: The patient's demographic details were updated. The patient received the 2nd dose of Twinrix via intramuscularly late by 10 days , which led to lengthening of vaccination schedule. The reporter considered the injection site reaction to be related to Twinrix. Possibly unknown if this was suspected transmission of an infectious agent via a medical product.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: sore arm at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix 4 months before the date of reporting. The patient experienced a sore arm at the injection site. The patient stated that the injection site pain had improved over the last 4 months, but that it had not completely resolved till the time of reporting. The patient went to see the doctor about the arm soreness. The patient consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspepsia, Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: Fever; Tiredness; pain at injection site; Nausea; Heartburn; not feel good; Headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, between 3 and 4 weeks after receiving Shingrix, the patient experienced feeling unwell. On 17th July 2019, the patient experienced nausea, heartburn, headache and injection site pain. On 18th July 2019, the patient experienced fever and tiredness. The patient was treated with omeprazole (Prilosec) and paracetamol (Tylenol). On 18th July 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the nausea, injection site pain, feeling unwell and tiredness were unknown and the outcome of the heartburn was not recovered/not resolved and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the fever, nausea, heartburn, headache, injection site pain, feeling unwell and tiredness to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient experienced a fever which started late afternoon on the following day after vaccination. Her fever was around 101 and it resolved that evening after taking Tylenol.  The patient reported nausea on the first day and tiredness on the 2nd and 3rd day and it stayed for the following week.  Her heartburn flared up the same day as the Shingrix vaccination later that night and now it was being controlled with Priolosec for a 14 day regime for heartburn.  The patient's headache started the first night or the second night and she has had a headache every day or every other day for the following week.  The patient also reported pain at the injection site which started later that evening of vaccination. The headache lasted for 1.5 weeks and patient did not feel good at all.  The patient reported that her body did not tolerate the Shingrix like she expected it to and she did not feel like doing much. The reporter gave permission to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever; Tiredness; pain at injection site; Nausea; Heartburn; not feel good; Headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, between 3 and 4 weeks after receiving Shingrix, the patient experienced feeling unwell. On 17th July 2019, the patient experienced nausea, heartburn, headache and injection site pain. On 18th July 2019, the patient experienced fever and tiredness. The patient was treated with omeprazole (Prilosec) and paracetamol (Tylenol). On 18th July 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the nausea, injection site pain, feeling unwell and tiredness were unknown and the outcome of the heartburn was not recovered/not resolved and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the fever, nausea, heartburn, headache, injection site pain, feeling unwell and tiredness to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient experienced a fever which started late afternoon on the following day after vaccination. Her fever was around 101 and it resolved that evening after taking Tylenol.  The patient reported nausea on the first day and tiredness on the 2nd and 3rd day and it stayed for the following week.  Her heartburn flared up the same day as the Shingrix vaccination later that night and now it was being controlled with Priolosec for a 14 day regime for heartburn.  The patient's headache started the first night or the second night and she has had a headache every day or every other day for the following week.  The patient also reported pain at the injection site which started later that evening of vaccination. The headache lasted for 1.5 weeks and patient did not feel good at all.  The patient reported that her body did not tolerate the Shingrix like she expected it to and she did not feel like doing much. The reporter gave permission to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Rash
Clinical narrative: headache; Felt really tired; Rash on arms neck and torso; This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix. On 15th May 2019, less than a day after receiving Shingrix, the patient experienced headache and tiredness. On 16th May 2019, the patient experienced widespread rash. On an unknown date, the outcome of the headache, tiredness and widespread rash were recovered/resolved.   It was unknown if the reporter considered the headache, tiredness and widespread rash to be related to Shingrix.  Additional case details were reported as follows: On 15th May 2019, evening the patient started getting a headache and felt really tired.  The next day she developed a rash on her arms neck and torso. The rash resolved after about 3 days.  The patient saw her healthcare professional for the rash and was referred to an allergist.  The allergist thought that the rash was probably due to an immune response, but the rash had already resolved by the time she saw him. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: flu like symptoms; redness at the injection site; swelling at the injection site; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, injection site erythema and injection site swelling. In August 2019, the outcome of the influenza-like symptoms, injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but the patient's age at vaccination could be 59 or 60 years. The patient experienced flu like symptoms and swelling and redness at the injection site. The symptoms lasted a couple of days. Reporter was willing to get contacted for further questions. This case had been linked with case US2019146761, reported by the same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Injection site reaction
Clinical narrative: Cramp; redness / redness at the injection site; soreness; vomiting; flu like symptoms; fever; chills; nausea; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle reaction in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 24th July 2019, immediately after receiving Shingrix, the patient experienced injection site muscle reaction, fever, chills, nausea, headache, injection site erythema, pain in arm, vomiting and influenza-like symptoms. On an unknown date, the outcome of the injection site muscle reaction, fever, chills, nausea, headache, injection site erythema, pain in arm, vomiting and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site muscle reaction, fever, chills, nausea, headache, injection site erythema, pain in arm, vomiting and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. Shortly after getting the vaccine the patient got a cramp feeling in the muscle where she received the vaccine. In the middle of the night patient started having fever, chills, nausea, headache and a sore arm and redness at the injection site.  The patient also vomited a couple times. The flu like symptoms lasted 5-6 days.  Around the time that the flu-like symptoms resolved, the redness started moving down her arm towards her elbow and her arm continued to be sore.  The redness eventually resolved a few days ago, but her arm was still sore, 19 days after getting the vaccine. The patient still having side effects from first Shingrix shot, and did not know what to do. The patient hesitant to get the second one, and did not know when the side effects would go away from the first one, and why did she get them so badly when average duration for side effects was two to three days. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Cramp; redness / redness at the injection site; soreness; vomiting; flu like symptoms; fever; chills; nausea; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle reaction in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 24th July 2019, immediately after receiving Shingrix, the patient experienced injection site muscle reaction, fever, chills, nausea, headache, injection site erythema, pain in arm, vomiting and influenza-like symptoms. On an unknown date, the outcome of the injection site muscle reaction, fever, chills, nausea, headache, injection site erythema, pain in arm, vomiting and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site muscle reaction, fever, chills, nausea, headache, injection site erythema, pain in arm, vomiting and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. Shortly after getting the vaccine the patient got a cramp feeling in the muscle where she received the vaccine. In the middle of the night patient started having fever, chills, nausea, headache and a sore arm and redness at the injection site.  The patient also vomited a couple times. The flu like symptoms lasted 5-6 days.  Around the time that the flu-like symptoms resolved, the redness started moving down her arm towards her elbow and her arm continued to be sore.  The redness eventually resolved a few days ago, but her arm was still sore, 19 days after getting the vaccine. The patient still having side effects from first Shingrix shot, and did not know what to do. The patient hesitant to get the second one, and did not know when the side effects would go away from the first one, and why did she get them so badly when average duration for side effects was two to three days. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: have pain when she lifts her arm/ Injection site pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) (batch number 7D9C3, expiry date 25th September 2021) for prophylaxis.   On 5th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 76 years or 77 years. The patient received Shingrix in the left arm. The patient's injected arm was sore and had pain when lift the arm. The pain had gotten better but continued to have pain when lift the arm. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Skin warm
Clinical narrative: Redness; Warmth on the injected arm; allergic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities, skin warm and allergic reaction. On an unknown date, the outcome of the erythema of extremities, skin warm and allergic reaction were unknown.   It was unknown if the reporter considered the erythema of extremities, skin warm and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient had an allergic reaction to the 1st dose of Shingrix, stated that the patient experienced redness and warmth on the injected arm that was spreading down the arm.  The reporter consented to follow up. No other details were provided.
Age: 1.67
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error, Pyrexia, Rash
Clinical narrative: low grade fever; rash that started on the forearms and progressed to entire body (not itchy); ActHib was administered with incorrect diluent; Initial information received on 12-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 20 months old male patient who experienced low grade fever and  rash that started on the forearms and progressed to entire body (not itchy), while he received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccines  included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and HEPATITIS A VACCINE INACT (VAQTA) for Immunisation on 31-Jul-2019.  On 31-Jul-2019, the patient received a 0.5 ml fourth dose of suspect HIB (PRP/T) VACCINE via intramuscular route in the right thigh (Carton Lot: U1950AAB Exp. date: 24/01/2020 and Diluent Lot U6111AA Exp. date: 24/01/2020).  On an unknown date, the patient developed low grade fever (pyrexia) and rash that started on the forearms and progressed to entire body (not itchy) (rash generalised) following the administration of HIB (PRP/T) VACCINE.  Also It was an actual medication error case due to wrong solution used in drug reconstitution as ActHib was administered with incorrect diluent, nurse found an extra vial of ActHib diluent.  Details of lab data not reported.  Final diagnosis was rash that started on the forearms and progressed to entire body (not itchy) and low grade fever.  The patient went to urgent care on Saturday on August 3rd and followed up with PCP the week after.  On an unknown date, the patient had recovered from events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Sex: M
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: ActHIB is accidentally given with sterile water; Initial information received on 14-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 15 months old male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] and reported that Act-Hib is accidentally given with sterile water.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  On 09-Aug-2019, the patient received a dose of suspect 0.5 ml HIB (PRP/T) VACCINE lot UJ079AAA and expiry date: 02-Oct-2020 via intramuscular route in the left thigh.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Sex: U
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Ipol was injection to a patient one week apart instead of the month that is recommended; Initial information received on 14-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 62 years old patient who was injected with a 0.5ml dose of IPV (VERO) [IPOL] one week apart instead of the month that is recommended lot PLE701M via intramuscular route in the right deltoid on 14-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate schedule of vaccine administered.  Adverse event was not reported.  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 document held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: the patient was only given the ActHIB portion of the vaccine, it was not reconstituted with the DTap/IPV portion when administered vaccine Pentacel; Initial information received on 14-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA229462 (same reporter).  This case involves a patient (demographics unknown) was only given the Acthib portion of the vaccine, it was not reconstituted with the dtap/ipv portion when administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5) /HIB(PRP/T) VACCINE [PENTACEL] lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Inappropriate reconstitution technique.  It was unknown if any adverse event occurred.  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.  Information on the batch number was requested.  List of document held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: vaccine into the posterior side of her left arm, in the fatty tissue in error. It was SC and not IM.; vaccine into the posterior side of her left arm, in the fatty tissue in error. It was SC and not IM.; Initial information received on 14-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 31 years old female patient who received 0.5 ml vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6273AA (Expiry date 24-Apr-2021) via subcutaneous route into the posterior side of her left arm, in the fatty tissue in error, on 09-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate route of vaccination and vaccine administered at inappropriate site.  It was reported that vaccine into the posterior side of her left arm, in the fatty tissue in error. It was SC and not IM.  At a time of reporting no adverse effect reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.