chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Skin irritation, Skin warm, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (in January 2016). Previously administered products included ZOSTAVAX (received in October 2016) and SHINGRIX with an associated reaction of pyrexia (1st dose received on 26th September 2018 (refer case US2019GSK030794). On 18th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 18th January 2019, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills and sweating. On 9th February 2019, the patient experienced shingles, blister and pruritus. In February 2019, the patient experienced skin red, skin warm, skin irritation and scab. On an unknown date, the patient experienced exhaustion. The patient was treated with acyclovir. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shingles, skin red, exhaustion, skin warm, blister and skin irritation were not recovered/not resolved and the outcome of the influenza-like symptoms, fever, chills, sweating and pruritus were recovered/resolved and the outcome of the scab was unknown. It was unknown if the reporter considered the shingles, influenza-like symptoms, fever, skin red, chills, exhaustion, sweating, skin warm, blister, skin irritation, pruritus and scab to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in the left arm. Less than a day after vaccination with SHINGRIX, at 9:00 pm, the patient experienced flu-like symptoms which included sweating, fever and chills. Less than a month after vaccination, the patient was feeling exhausted after all of the other symptoms resolved but only for an evening. On 9th February 2019 on Sunday, 22 days after vaccination, the shingles blisters started appearing on chest and spread to both sides of neck over the next couple of days. On 10th February 2019 on Monday, the patient was diagnosed with shingles. The patient was prescribed with Acyclovir. The patient reported that, the itching was insane on the first day. At the time of reporting, she had the episodes of itching and then it stopped. Less than a month after vaccination, some of the blisters had scabbed over; some looked like white pustules and the skin around the blister were red, hot and irritated. The reporter consented to follow up. This case was linked with case US2019027673 (husband's case), reported by the same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Injection site induration, Injection site warmth, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th February 2019, several hours after receiving SHINGRIX, the patient experienced pain in arm and headache. On 14th February 2019, the patient experienced muscle pain, injection site induration, injection site warmth, appetite absent and fever. In February 2019, the patient experienced insomnia and blurred vision. On an unknown date, the outcome of the pain in arm, blurred vision, muscle pain, injection site induration, injection site warmth and appetite absent were not recovered/not resolved and the outcome of the insomnia, fever and headache were unknown. It was unknown if the reporter considered the pain in arm, insomnia, blurred vision, muscle pain, injection site induration, injection site warmth, appetite absent, fever and headache to be related to SHINGRIX. Additional details were received as follows: At about 4 pm, the patient received SHINGRIX in an unknown arm. In the evening of vaccination day, the patient experienced sore arm and she had a headache. In the night at 1 am, 9 hours after vaccination, the patient woke up with insomnia and found that she couldn't read because her vision was blurry. One day after vaccination, the patient experienced fever, muscle aches, pain from the top of her arm down to her hand, blurry vision and hardness and warmth at the injection site with no appetite. The reporter did not consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia, Vision blurred
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th February 2019, several hours after receiving SHINGRIX, the patient experienced pain in arm and headache. On 14th February 2019, the patient experienced muscle pain, injection site induration, injection site warmth, appetite absent and fever. In February 2019, the patient experienced insomnia and blurred vision. On an unknown date, the outcome of the pain in arm, blurred vision, muscle pain, injection site induration, injection site warmth and appetite absent were not recovered/not resolved and the outcome of the insomnia, fever and headache were unknown. It was unknown if the reporter considered the pain in arm, insomnia, blurred vision, muscle pain, injection site induration, injection site warmth, appetite absent, fever and headache to be related to SHINGRIX. Additional details were received as follows: At about 4 pm, the patient received SHINGRIX in an unknown arm. In the evening of vaccination day, the patient experienced sore arm and she had a headache. In the night at 1 am, 9 hours after vaccination, the patient woke up with insomnia and found that she couldn't read because her vision was blurry. One day after vaccination, the patient experienced fever, muscle aches, pain from the top of her arm down to her hand, blurry vision and hardness and warmth at the injection site with no appetite. The reporter did not consent to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of appetite absent in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 12th February 2019, the patient received SHINGRIX (intramuscular). On 12th February 2019, less than a day after receiving SHINGRIX, the patient experienced appetite absent, headache, chills and injection site pain. On an unknown date, the outcome of the appetite absent, headache, chills and injection site pain were recovering/resolving. It was unknown if the reporter considered the appetite absent, headache, chills and injection site pain to be related to SHINGRIX. Additional details were received as follows: This case was reported by the patient's wife. On the day of vaccination, the patient was feeling bad which was described as no appetite, chills, headache and pain at the injection site, but felt worse on 13th February 2019. At the time of reporting, the patient was feeling better though it was not 100 percent. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On 11th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site lump, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site lump, injection site erythema and injection site itching were recovering/resolving. It was unknown if the reporter considered the injection site swelling, injection site lump, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Impaired work ability, Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain at injection site for 5 days. Fever, shivering, fatigue muscle aches several hours after injection for 22 hours (stayed home from work because I felt so sleepy). This was my 2nd injection. The only side effects I experienced from the first injection were soreness and swelling at the injection site for about a week.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Somnolence
Clinical narrative: Swelling and pain at injection site for 5 days. Fever, shivering, fatigue muscle aches several hours after injection for 22 hours (stayed home from work because I felt so sleepy). This was my 2nd injection. The only side effects I experienced from the first injection were soreness and swelling at the injection site for about a week.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling redness and slightly warm measuring 4.6" x 4".
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 12/2018.
Age: 19.0
Sex: M
Vaccine: FLU4, HEPA, MNQ, TDAP
Symptoms: Body temperature decreased, Dizziness, Hypertonia, Loss of consciousness, Snoring
Clinical narrative: Pt recieved ADACEL, FLUZONE, MENVEO starting at 1150 in the left deltoid. Nurse then moved to the rt side and administered HAVRIX in the rt deltoid. At this point, 1153, pt stated that he was beginning to feel lightheaded and asked if he could take a minute. He then immediately stated that he was feeling extremely lightheaded at which point he passed out. Pt went completely limp and was observed to begin to snore. At this point this nurse was joined by BSN and another BSN. Pt was moved from the chair to the bed, legs were elevated. Vital signs were 96.7, 61 bpm, RR 23 100/60 left arm, 100/62 rt arm. 1157 HOB was raised to 30 degrees BP 90/48, temp 96.4. 1200 cool cloth was applied to the forehead and HOB was lowered back down 1206 BP 100/70. 1213 BP 120/70, 70 BPM, 98% RA. 1219 HOB was raised to 30 degrees, BP 124/74. 1224 HOB was raised to 75 degrees BP 118/68 rt arm, 83 BPM, 98% RA. 1230 Pt at 90%, dangled legs, sips of water. 1234 BP 94/60, Pt reported to be feeling lightheaded, granola bar was given and HOB was returned to 30 degrees. 1240 BP 118/70. 1245 HOB 90 degrees, dangled legs BP 120/76 on LT arm 80 bpm, 97% RA. 1250 BP 118/80 rt arm. 1302 BP 118/82, 62 BPM, pt standing leaning on bed. 1305 91% RA, 81 BPM, 1308 BP 100/76, pt is standing and walks. 1310 BP 118/76, 67 BPM, and 91% RA. 1312 Pt states he feels well enough to leave, he is able to walk on his own. He is escorted by his mother.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Diarrhoea, Insomnia, Musculoskeletal stiffness, Nausea
Clinical narrative: She experienced serious body aches to the point that she could not bend her fingers. She did not sleep that night and experienced nausea, vomiting, and diarrhea. It's been four days and all of the symptoms have cleared except pain. She still feels pain in her arm and underneath her arm.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: She experienced serious body aches to the point that she could not bend her fingers. She did not sleep that night and experienced nausea, vomiting, and diarrhea. It's been four days and all of the symptoms have cleared except pain. She still feels pain in her arm and underneath her arm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Impaired driving ability, Joint range of motion decreased, Loss of personal independence in daily activities, Musculoskeletal pain
Clinical narrative: Pt reports ongoing shoulder pain and pain in other joints, particularly in her left wrist and hand. Her range of motion has been affected and it is difficult for her to drive or do some other ADLs. She denies fever. Pain unrelieved by acetaminophen. It has now been 7 days since the vaccine and pain is persisting. Not getting better or worse.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pt reports ongoing shoulder pain and pain in other joints, particularly in her left wrist and hand. Her range of motion has been affected and it is difficult for her to drive or do some other ADLs. She denies fever. Pain unrelieved by acetaminophen. It has now been 7 days since the vaccine and pain is persisting. Not getting better or worse.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient developed a red rash in area below the injection site, patient reports no inflammation or swelling.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Patient had received Flu vaccination in 10/2018 but did not report any adverse reaction until 12/2018. Pt stated that he has soreness in his Arm. Initially patient was showing different area of the upper arm (not Deltoid muscle) but when Rph said it would not be because of Vaccination, pt had switched the area and said pain goes lower and upper arm at different times, Rph has advised patient to go see PCP for evaluation first and then let Rph know of outcome. Patient returns in Feb 2019 and still has not seen PCP and said he was taking Ibuprofen to see if it goes away. Rph advised again to go see Doctor for evaluation. Patient shows different areas of upper arm for pain every time.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Erythema, Headache, Malaise
Clinical narrative: After receiving above vaccine on 2-19-19 about 2:34 PM, as I was getting ready to go to bed, I noted a headache, soreness of arm but went on to bed. Headache continued during night, along with soreness and muscle pain. When I got up the next morning, I took two TYLENOL, got ready to go to Mass but just wasn't feeling well at all, so made decision to stay home. I continued with headache, muscle aches, chills. Temperature was 100. I took two more TYLENOL about 10:00 AM. Now I have redness and swelling. (Time has run out).
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Swelling
Clinical narrative: After receiving above vaccine on 2-19-19 about 2:34 PM, as I was getting ready to go to bed, I noted a headache, soreness of arm but went on to bed. Headache continued during night, along with soreness and muscle pain. When I got up the next morning, I took two TYLENOL, got ready to go to Mass but just wasn't feeling well at all, so made decision to stay home. I continued with headache, muscle aches, chills. Temperature was 100. I took two more TYLENOL about 10:00 AM. Now I have redness and swelling. (Time has run out).
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: The patient received the first dose on 10/20/18. On 11/03/2018, patient came to the pharmacy to receive a VALTREX script to treat the shingles virus. Patient experienced the shingles virus in the middle of his forehead. After speaking with the patient, he stated that the virus lasted for about 10 days until it was clear.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to two patients in their 60's of unknown gender. The patients' pertinent medical history, concomitant medications, drug reactions and allergies were unknown by the reporter. In approximately January 2019, the patients were vaccinated with PNEUMOVAX 23 (strength, dose, route of administration, anatomical location, lot #, and expiration date were not reported) indicated for prevention of pneumococcal disease. In approximately January 2019, the patients experienced extreme swelling and redness following vaccination with PNEUMOVAX 23. It was unknown if a treatment was given for the events and if laboratory diagnostics and studies were performed. In addition, it was unknown if the patients sought medical attention. The outcome of swelling and erythema was unknown and its causal relationship with PNEUMOVAX 23 was not reported.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2016, at approximately 68 years old, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy. On an unknown date, the patient was treated by a healthcare provider at a hospital for the following injury resulting from her ZOSTAVAX use: Bell's palsy. The outcome of the Bell's palsy is unknown. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. Upon internal review, Bell's palsy was determined to be medically significant. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, an approximately 60 year old female patient, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 08-FEB-2010, at age 58, the patient was administered the ZOSTAVAX by a healthcare provider. On an unknown date in 2013, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a 77 year old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 01-JUL-2009, at age 69, the patient was administered the ZOSTAVAX by a healthcare provider at a physician's office. On or about 01-MAR-2017, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a elderly male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2015, at approximately 68 years of age, the patient was administered the ZOSTAVAX by a healthcare provider. On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning an approximately 66 year old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 07-NOV-2011, at age 64, the patient was administered the ZOSTAVAX by a healthcare provider. On an unknown date in 2012, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to herself and economic losses. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a 65 year old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 21-MAR-2015, at age 62, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a pharmacist at a pharmacy. In December 2017, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to herself and economic losses. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2019SA036637 (same reporter). This case involves a seven years old patient who was vaccinated with a dose of DAPTACEL (lot number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported seven years patient received TDaP. It was unknown whether patient experienced any adverse reaction. 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be 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: 66.0
Sex: F
Vaccine: TD, TYP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 06-Feb-2019 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 66 years old female patient who received a dose of 0.5ml dose TENIVAC, pre filled syringe, batch number: U5525AA, expiration Date: 07-Jan-2019 via intramuscular route in the right deltoid on 06-Feb-2019. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included TYPHOID VACCINE for Immunisation. It was an actual medication error due to expired vaccine used. A patient was administered a expired TENIVAC vaccine. It was unknown whether patient experienced any adverse event following 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.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 11-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (office staff). This case involves a patient of unknown demographics who was accidentally administered with product which expired on 12-Jan-2019, while he/she received vaccine TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 11-Feb-2019, the patient received a once dose of 0.5 ml suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot number: U5541AA and expiry date: 12-Jan-2019) (dose in series, route and site of administration was not reported). It was a case of actual medication error due to expired vaccine used. No adverse event was 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.
Age: 9.0
Sex: F
Vaccine: DTAPIPV, FLUX, HEPA, IPV, TDAP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 9 years old female patient who was vaccinated with a dose of IPOL, ADACEL and 0.5 ml dose of QUADRACEL (expiry date 17-Jul-2020 lot number C5497AA) instead of PROQUAD (route and site of administration was not reported), On 01-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE and INFLUENZA VACCINE. It was a case of actual medication error due to wrong vaccine administered and extra dose administered. It was unknown whether patient experienced any adverse reaction. 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 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: 0.5
Sex: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid non-serious case received from a physician by phone. This case involves a 6 months old patient who was vaccinated with an expired third dose of IPOL (Batch number, expiry date, dose, route and site of administration were not reported) on 11-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event occurred or not following the 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 and Module VI of the 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. Documents held by the sender: none.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 11-Feb-2019 regarding an unsolicited valid non-serious case received from non-healthcare professional. This case involves a patient with unknown demographics who received once an expired IPOL (Exp. Date 09-Feb-2019) vaccine, on 11-Feb-2019 (route, site, batch number not reported). Patient medical history and concomitant were not reported. It was a case of actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse reaction. 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.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non healthcare professional (office staff) by phone. This case involves a 4 months old female patient who was vaccinated with a one time dose (also reported as 0.5 ml) of PENTACEL (Batch number: UJ065AA, expiry date: 16-Oct-2020) via intramuscular route in the left thigh on 12-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because PENTACEL had undergone a temp excursion during delivery. It was unknown if any adverse event occurred or not following the 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 and Module VI of the 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. Documents held by the sender: none.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (office staff). It was reported that five week old male patient receiving MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to inappropriate age at vaccine administration. Other relevant tests included: On 06-Jan-2019 the five week old male patient has received one skin integrity check which he passed and is scheduled for his second skin integrity check on 12-Feb-2019. No adverse event was 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.
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 13-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves Adult female patient who was vaccinated with ADACEL lot number U6202BA Expiry date 26-FEB-2021 via intramuscular route in the right thigh, instead of ADACEL, On 14- Jan-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 wrong vaccine administered and Inappropriate age at vaccine administration (It was reported that 2 years old child who received ADACEL instead of DAPTACEL). It was unknown whether adverse event occurred. 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 and Module VI of the 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: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a two years old patient who was vaccinated with ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that reporter gave a ADACEL to a 2yrs old and is looking to see what to worry about with side effects. It was unknown whether patient experienced any adverse reaction. 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. Documents held by sender: none.
Sex: F
Vaccine: DTAP, DTAPIPVHIB, PNC, RVX
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Initial information received on 13-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a four months old female patient who had a fever, while she received vaccines PENTACEL, ROTAVIRUS VACCINE SHANTHA, DAPTACEL and PREVNAR. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Jan-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, ROTAVIRUS VACCINE SHANTHA (lot number and Expiry date unknown) via unknown route in unknown administration site). On 11-Feb-2019 DAPTACEL and PREVNAR  (lot number and Expiry date unknown) via unknown route in unknown administration site). On an unknown date, the patient developed a non-serious running a fever (pyrexia) (Unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, ROTAVIRUS VACCINE SHANTHA, DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE and PREVNAR. It was an actual medication case error due inappropriate schedule of vaccine administered. (Other relevant tests included no lab data.) Final diagnosis was fever. It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown. 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: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Pyrexia, Rash erythematous, Rash macular, Swelling
Clinical narrative: Rash around vaccine area on arm started the next afternoon after vaccine. (Also had upset stomach and low grade fever). The 2nd day after vaccine (2/20) rash/splotchiness started from arm to upper torso, stomach, groin, arms and neck. By end of day, rash area was red (like a sunburn) and swollen, covering same areas as mentioned. Went to Urgent Care that night, they prescribed Prednisone, which I didn't take. They said since I wasn't having difficulty breathing or having other severe effects, I could continue with BENADRYL and Loratadine, over the counter. On 2/21 the rash had decreased by about 30%, on 2/22 rash had decreased by 80%, continuing BENADRYL and Loratadine.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site rash
Clinical narrative: Rash around vaccine area on arm started the next afternoon after vaccine. (Also had upset stomach and low grade fever). The 2nd day after vaccine (2/20) rash/splotchiness started from arm to upper torso, stomach, groin, arms and neck. By end of day, rash area was red (like a sunburn) and swollen, covering same areas as mentioned. Went to Urgent Care that night, they prescribed Prednisone, which I didn't take. They said since I wasn't having difficulty breathing or having other severe effects, I could continue with BENADRYL and Loratadine, over the counter. On 2/21 the rash had decreased by about 30%, on 2/22 rash had decreased by 80%, continuing BENADRYL and Loratadine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Approximately 1 month following vaccine administration, patient was hospitalized with shingles. Patient reports not ever having shingles before this event. Patient has MS and is not sure if prolonged illness is due to MS or result of vaccine.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chest discomfort, Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Swelling of the left arm associated with pain/tenderness. Swelling with erythema is about 5x3in in size, slight left sided chest discomfort. Treatment, antihistamine, ibuprofen and prednisone.
Age: 19.0
Sex: M
Vaccine: FLU4, HEPA, TD, TDAP, TYP
Symptoms: Extra dose administered
Clinical narrative: Student inadvertently received both Tdap and TD vaccines during a travel clinic. He should have received only the Tdap vaccine. The error was discovered 3 days later. Attempts to contact the student have been unsuccessful. He is not reading secure message sent and unable to leave voice message on his phone.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Feeling hot, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Within approximately 36 hours the left deltoid area became red, swollen and mildly painful. By 48 hours the redness spread to a length of 6-8 inches surrounded by a red rash. The redness and swelling continued for almost two weeks. The left arm rash slowly resolved in 3 weeks. Within 6-7 days, I experienced the same sort of hot and prickly sensation I had with active shingles 10 years ago on the right axilla and back. The symptoms of axillary and back discomfort have continued intermittently with some mild overall lessening in the past two days. My concern is why was the post-herpetic neuralgia stimulated by the vaccine?
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Musculoskeletal discomfort, Paraesthesia, Post herpetic neuralgia, Rash erythematous
Clinical narrative: Within approximately 36 hours the left deltoid area became red, swollen and mildly painful. By 48 hours the redness spread to a length of 6-8 inches surrounded by a red rash. The redness and swelling continued for almost two weeks. The left arm rash slowly resolved in 3 weeks. Within 6-7 days, I experienced the same sort of hot and prickly sensation I had with active shingles 10 years ago on the right axilla and back. The symptoms of axillary and back discomfort have continued intermittently with some mild overall lessening in the past two days. My concern is why was the post-herpetic neuralgia stimulated by the vaccine?
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Pain in extremity, Peripheral coldness
Clinical narrative: Arm: intense local soreness lasting 3 full days, minor residual soreness 4th day. Fatigue; intense feeling of cold including ice cold hands and cold feet despite warm indoor temp and full assemblage of layered clothing (my body temp measured 98.4º; and chills (the risk advisory form refers to "shivering", a term I've never used). These lasted 3 full days, then abated on the 4th day.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: PT CAME IN DAYS AFTER VACCINE AND SHOWED LEFT ARM. WAS RED AROUND INJECTION SITE AND WARM TO TOUCH, MILDLY ITCHY. I RECOMMENDED PT TAKE BENADRYL OR CLARITIN TO TREAT AND FOLLOW UP WITH MD.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Hot flush, Impaired work ability
Clinical narrative: Nausea 2/21 at 12:45 am, headache 2/21 at 5:00 am, severe hotflash followed by severe weakness and passing out 2/21 at 7:15 am. I was extremely weak and could barely move, unable to get up off the floor for about 20 minutes after passing out. Then weak and and extremely fatigued for the remainder of the day (stayed home from work). Felt fine the following day.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Nausea
Clinical narrative: Nausea 2/21 at 12:45 am, headache 2/21 at 5:00 am, severe hotflash followed by severe weakness and passing out 2/21 at 7:15 am. I was extremely weak and could barely move, unable to get up off the floor for about 20 minutes after passing out. Then weak and and extremely fatigued for the remainder of the day (stayed home from work). Felt fine the following day.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, Ear, nose and throat examination, Injection site pain, Injection site swelling, Nasal congestion
Clinical narrative: Day one - moderate pain and swelling at injection. Day 2 - injection site ache, mild diffuse aches, nasal congestion. Day 6 - brief vertigo. Day10- recurrent vertigo, brief but lingers though the day. Day11 - worsening persistent vertigo with persistent lateral nystagmus Nausea and vomiting. Seen acutely by ENT physician and diagnosed with vestibular neuritis after negative head CT scan.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Nystagmus, Vertigo, Vestibular neuronitis, Vomiting
Clinical narrative: Day one - moderate pain and swelling at injection. Day 2 - injection site ache, mild diffuse aches, nasal congestion. Day 6 - brief vertigo. Day10- recurrent vertigo, brief but lingers though the day. Day11 - worsening persistent vertigo with persistent lateral nystagmus Nausea and vomiting. Seen acutely by ENT physician and diagnosed with vestibular neuritis after negative head CT scan.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Myalgia
Clinical narrative: Severe muscle aches throughout body, recurring headache, upset GI. Resolved approximately 3 days after injection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site vesicles
Clinical narrative: On day following the vaccine no adverse effect noted at site of Kinrix (R thigh). But on 2/22/19 pt awoke c/o pain on R thigh, with a 14 cm area of erythema and induration on R thigh, with central blisters present at injection site. L thigh had less than 5 cm of erythema and mild induration only.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Patient had swelling and redness at the injection site, immediately following injection of the vaccine.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site reaction with knot, warmth, itching, redness, tenderness.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Abnormal behaviour, Diet refusal, Lethargy, Motor dysfunction, Poor sucking reflex
Clinical narrative: High pitched screaming for 4 hours, refused food for 9 hours, the next day she was lethargic, lost motor control, couldn't suck to eat or use pacifier. Took her to the docs at 2. Her motor control had returned and they found nothing definitive, only that she was not herself.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Screaming
Clinical narrative: High pitched screaming for 4 hours, refused food for 9 hours, the next day she was lethargic, lost motor control, couldn't suck to eat or use pacifier. Took her to the docs at 2. Her motor control had returned and they found nothing definitive, only that she was not herself.
Age: 89.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus, Peripheral swelling
Clinical narrative: PATIENT RECEIVED VACCINE ON 02/01/2019. ON THE MORNING OF 02/02/2019, PATIENT'S UPPER ARM WAS SWOLLEN AND RED. THE FOLLOWING DAY PATIENT'S ARM WAS "PINK AND SLIGHTLY SWOLLEN". PATIENT DENIED ANY RASH/FEVER, BUT DID CONFIRM THERE WAS SOME MILD ITCHING AT THE SITE. ON THE THIRD DAY POST VACCINE, PATIENT REPORTS ADR WAS RESOLVED: NO MORE ITCHING, REDNESS, OR SWELLING.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Crying, Disorientation, Inflammation, Injection site erythema, Pyrexia
Clinical narrative: Fever, severe rash, inflamed right nipple, red at injection site, running nose, disoriented, constant crying.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Rash, Rhinorrhoea
Clinical narrative: Fever, severe rash, inflamed right nipple, red at injection site, running nose, disoriented, constant crying.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site inflammation, Injection site swelling, Pain
Clinical narrative: Patient has swelling and hardness in his right arm from the injection. The inflammation was creeping down the arm. The pain level was described as a 6 out of 10. Patient went to the ER where he was given prednisone 20 mg daily x 4 days, PEPCID 20 mg daily x 7 days, and ZYRTEC 10 mg daily x 7 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Pain in extremity, Pruritus
Clinical narrative: Redness, itching, sore arm, softball size redness around injection site.