chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA182241, 2018SA182252, 2018SA182253, 2018SA182254, 2018SA182255. This case involves patient (age and gender not reported), who received a vaccine, which on 01-Jun-2018 reached to 52.8 degree F for 43 minutes and on 04-Jun-2018 product reached 48.2 degree F for more than 30 minutes, before he/she received a dose of vaccine IPOL lot N1K931M via intramuscular route. 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 incorrect product storage. It was not reported if the patient had any adverse event or not. 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. Documents held by sender: none.
Age: 7.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration
Clinical narrative: Initial information received on 06-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a seven-year-old patient (gender was not reported) who was vaccinated with a 0.5 ml single dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5325BA via intramuscular route in the left deltoid on 24-Mar-2018. The patient had no other vaccinations. It was reported that the patient visited a physician on 24-Mar-2018. It was a case of inappropriate schedule of vaccine administered. It was also a case of inappropriate age at vaccine administration. It is not known whether the patient had any untoward experiences after administration. 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.
Age: 79.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Initial unsolicited report received from a pharmacist on 13-Jul-2018. This case involves a 79-year-old male patient who had 0.5 ml dose of ADACEL lot number: C5541AA, expiration date: 13-Nov-2018 via unknown route in right deltoid on 09-Jul-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used and incorrect product storage as vaccine was 58.4 degrees F on July 6th at 12:00 AM until July 9th and was administered on July 9th at 8:30 AM. It was not known whether 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: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Bradycardia
Clinical narrative: Initial information received on 13-Jul-2018 regarding an unsolicited valid serious case received from a nurse. This case involves a 16 years old female patient who experienced anaphylaxis, while she received vaccine ADACEL. The patients past medical history, medical treatment, concomitant medication and family history were not provided. On an unknown date, the patient received injection of first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, two years ago, the patient developed a serious anaphylaxis with unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient was hospitalized for this event. On an unknown date, two years ago, the patient developed a serious bradycardia with unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient was hospitalized for this event. Hospitalization details not provided. Lab data was not provided. Final diagnosis was anaphylaxis. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for anaphylaxis and as Unknown for bradycardia. List of documents held by sender - none. Sender's Comments: This case concerns an adolescent patient who developed anaphylaxis after vaccination with ADACEL. The time to onset is unknown. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Initial information received on 16-Jul-2018 regarding an unsolicited valid non-serious case received from other health care professional (Medical assistant). This case is linked to case 2018SA196613 (same reporter). This case involves a 20 years old male patient who was given a third dose of MENACTRA instead of BEXSERO. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient was two doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. On 16-Jul-2018, the patient received a 0.5ml third dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5841AA, expiry date 08-Mar-2019 via intramuscular route in the right deltoid. 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 after the injection. 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: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is related to case 2018SA200797 for patient and 2018SA200800 for patient, from the same reporter. This case involves a 4 years old female patient who experienced hives, while she received vaccines PROQUAD and QUADRACEL. The patients past medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On 16-Jul-2018, the patient received a first dose 0.5ml of suspect QUADRACEL lot C5325BA, expiry date 14 Nov 2019 via unknown route in unknown administration site. On 16-Jul-2018, the patient received injection of a dose of suspect PROQUAD not produced by Sanofi Pasteur lot R002932, expiry date 29 Jul 2019 via unknown route in unknown administration site. On 16-Jul-2018, the patient developed a non-serious hives (urticaria) same day following the administration of QUADRACEL and following the administration of PROQUAD. Final diagnosis was hives. The patient received corrective treatment with BENADRYL which was given on 16-Jul-2018 and 17-Jul-2018. On 18-Jul-2018 HCP wanted the patient to take 15mg twice a day x 2 days, 15 mg once a day x 2 days and 7.5mg once a day x 2 days. The patient outcome is reported as Unknown for hives. List of documents held by sender- none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Rash erythematous, Rash papular, Urticaria
Clinical narrative: Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is related to case 2018SA200797 for patient and 2018SA200800 for patient, from the same reporter. This case involves a 4 years old female patient who experienced hives, while she received vaccines PROQUAD and QUADRACEL. The patients past medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On 16-Jul-2018, the patient received a first dose 0.5ml of suspect QUADRACEL lot C5325BA, expiry date 14 Nov 2019 via unknown route in unknown administration site. On 16-Jul-2018, the patient received injection of a dose of suspect PROQUAD not produced by Sanofi Pasteur lot R002932, expiry date 29 Jul 2019 via unknown route in unknown administration site. On 16-Jul-2018, the patient developed a non-serious hives (urticaria) same day following the administration of QUADRACEL and following the administration of PROQUAD. Final diagnosis was hives. The patient received corrective treatment with BENADRYL which was given on 16-Jul-2018 and 17-Jul-2018. On 18-Jul-2018 HCP wanted the patient to take 15mg twice a day x 2 days, 15 mg once a day x 2 days and 7.5mg once a day x 2 days. The patient outcome is reported as Unknown for hives. List of documents held by sender- none.
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 19 years old female patient who was vaccinated with an expired 0.5 ml single dose of TENIVAC (Batch number: U5411AA and expiry date: 30-Jun-2018) (dose in series were not reported) via intramuscular route in the right deltoid on 13-Jul-2018. The patient's past vaccination(s) included ADACEL in 2010. The patient's past medical history, medical treatment(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used because patient received a dose from 20 doses of TENIVAC that has expired. It was unknown if any adverse event was 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 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 the sender: None.
Age: 4.0
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked with Case ID 2018SA201498, 2018SA201512, 2018SA201514 and 2018SA183350 (same reporter). This case involves a four-years old patient (gender not reported) who received a IPOL from a IPOL shipment should be returned due to it being in transport a day longer than it should have, no adverse event. This is the case of actual medication error as the vaccine was administered to the patient, which was incorrectly stored. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On an unknown date, the patient received a dose 0.5 ml of suspect IPOL lot N1K92 via unknown route in unknown administration site. Caller reported that by the time they received notification that their IPOL shipment should be returned due to it being in transport a day longer than it should have, they had administered 5 doses to patients already. All of the patients were 4 years of age. It is unknown who administered each dose. There were no adverse reactions reported for any of the patients who received the doses. The doses were administered on June 8th, June 12th, June 13th, June 14th, June 18th and June 21st. Caller stated they were aware that the parents will have to be notified and the children will have to be re-vaccinated. Caller stated that she had already talked to someone about returning the shipment. Lab data and corrective treatment: not applicable. 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 sender: none.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked with Case ID 2018SA201498, 2018SA201512, 2018SA201513 and 2018SA183350 (same reporter). This case involves a four-years old patient (gender not reported) who received 0.5 ml dose of IPOL lot N1K92 via unknown route in unknown administration site on an unspecified date, from a IPOL shipment should be returned due to it being in transport a day longer than it should have, no adverse event. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. This is the case of actual medication error as the vaccine was administered to the patient, which was incorrectly stored. It was reported that the reported had reported that by the time they received notification that their IPOL shipment should be returned due to it being in transport a day longer than it should have, they had administered 5 doses to patients already. All of the patients were 4 years of age. It is unknown who administered each dose. There were no adverse reactions reported for any of the patients who received the doses. The doses were administered on June 8th, June 12th, June 13th, June 14th, June 18th and June 21st. Reporter stated they were aware that the parents will have to be notified and the children will have to be re-vaccinated. Reporter stated that she had already talked to someone about returning the shipment. It was unknown if the patient experience any adverse event. 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. Documents held by sender: none.
Sex: U
Vaccine: TYP
Symptoms: Pruritus generalised
Clinical narrative: Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves unknown demographic patient who experienced itching all over his body, while he/she received vaccine TYPHIM VI. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TYPHIM VI lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious itching all over his body (pruritus generalised) (Unknown latency) following the administration of TYPHIM VI. (Other relevant tests included No lab data.) Final diagnosis was itching all over his body. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for itching all over his body. List of documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site pain, Joint range of motion decreased, Neck pain, Pain in extremity
Clinical narrative: I had severe pain in left shoulder, down arm to hand and up to left side of neck; fever, limited range of motion of left arm and hand and headache for one week; now reduced pain one week later but still sore arm and less strength in left arm. Injection was in left arm.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: I had severe pain in left shoulder, down arm to hand and up to left side of neck; fever, limited range of motion of left arm and hand and headache for one week; now reduced pain one week later but still sore arm and less strength in left arm. Injection was in left arm.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Injection site swelling and redness, general rash on stomach.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Fever and sweating through the night, and fever and hot body upon rising in AM; stiff, sore neck starting about 5-6 hours after injection; headache upon waking in AM; significant shoulder pain. General lousy feeling upon rising day after injection. I did not experience these symptoms with my first injection 2-1/2  months ago. I did have mild pain in my arm.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Night sweats, Pyrexia, Skin warm
Clinical narrative: Fever and sweating through the night, and fever and hot body upon rising in AM; stiff, sore neck starting about 5-6 hours after injection; headache upon waking in AM; significant shoulder pain. General lousy feeling upon rising day after injection. I did not experience these symptoms with my first injection 2-1/2  months ago. I did have mild pain in my arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Muscle spasms
Clinical narrative: Muscle pain, muscle cramps, muscle spasms; headache; alternating shivering and fever; swelling at injection site, redness at injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle pain, muscle cramps, muscle spasms; headache; alternating shivering and fever; swelling at injection site, redness at injection site.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pain
Clinical narrative: All over Body ache, nausea pain at site.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Burning sensation, Inflammation, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: The site of the injection area was red, warm to touch and slightly swollen/inflamed. The patient mention that she has a burning sensation upon administering this vaccine. I massaged the area after the injection and told her to take Tylenol or ibuprofen. The patient came back on Sunday, July 22nd, 2018 and the area of the injection was still red and warm to touch. She mention she only took ibuprofen once a day so I mentioned to her that she had to take ibuprofen around the clock to decrease the inflammation and swollenness, ice the area, use hydrocortisone if it is itchy, and take a Benadryl. The patient came on Tuesday, July 24th, and the swelling and inflammation went down. The ibuprofen and icing suggestion worked and we gave her a tube of hydrocortisone cream since she was only complaining about the itching around the area of injection. She was told to take Benadryl just in case anything else happen.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Swelling
Clinical narrative: The site of the injection area was red, warm to touch and slightly swollen/inflamed. The patient mention that she has a burning sensation upon administering this vaccine. I massaged the area after the injection and told her to take Tylenol or ibuprofen. The patient came back on Sunday, July 22nd, 2018 and the area of the injection was still red and warm to touch. She mention she only took ibuprofen once a day so I mentioned to her that she had to take ibuprofen around the clock to decrease the inflammation and swollenness, ice the area, use hydrocortisone if it is itchy, and take a Benadryl. The patient came on Tuesday, July 24th, and the swelling and inflammation went down. The ibuprofen and icing suggestion worked and we gave her a tube of hydrocortisone cream since she was only complaining about the itching around the area of injection. She was told to take Benadryl just in case anything else happen.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: Muscle ache, low fever (100.2), headache, weakness, some dizziness.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Injection site pain, Malaise, Pain
Clinical narrative: Starting this morning, I feel lousy: aches, chills, malaise. Some tenderness at the injection site.  Same reaction as the first shot, received in late April 2018.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling, Pain in extremity, Vaccination site warmth
Clinical narrative: -Swelling of arm, shoulder to elbow. -Area of vaccination administration warm to touch. -Severe pain in arm of vaccine administration.
Age: 53.0
Sex: F
Vaccine: DT, HEP, HEPA, MMR, PPV, TYP, VARZOS
Symptoms: Confusional state, Dizziness, Fatigue, Headache, Lethargy
Clinical narrative: Night after vaccines were given patient had nausea, dizziness, headache, fever and confusion. Symptoms persisted with fatigue, nausea and fevers on Day 1 and 2. At this time also developed painful red rash and swelling to left upper arm. Day 3 fatigue and nausea improved but still had night sweats. Day 4 still lethargic but fevers are gone, large red swollen rash to left upper arm that is tender but not infected.
Age: 53.0
Sex: F
Vaccine: DT, HEP, HEPA, MMR, PPV, TYP, VARZOS
Symptoms: Nausea, Night sweats, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Night after vaccines were given patient had nausea, dizziness, headache, fever and confusion. Symptoms persisted with fatigue, nausea and fevers on Day 1 and 2. At this time also developed painful red rash and swelling to left upper arm. Day 3 fatigue and nausea improved but still had night sweats. Day 4 still lethargic but fevers are gone, large red swollen rash to left upper arm that is tender but not infected.
Age: 53.0
Sex: F
Vaccine: DT, HEP, HEPA, MMR, PPV, TYP, VARZOS
Symptoms: Rash erythematous, Tenderness
Clinical narrative: Night after vaccines were given patient had nausea, dizziness, headache, fever and confusion. Symptoms persisted with fatigue, nausea and fevers on Day 1 and 2. At this time also developed painful red rash and swelling to left upper arm. Day 3 fatigue and nausea improved but still had night sweats. Day 4 still lethargic but fevers are gone, large red swollen rash to left upper arm that is tender but not infected.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Exposure during pregnancy, Limb discomfort, Pain
Clinical narrative: Patient is 30.3 weeks pregnant. Received vaccine in LD IM. Called on 7-25-18 at 8:54 to report that left arm feels heavy and sore, had temp = 103 and chills. Feels achy all over. No meds taken. FNP recommended EXTRA STRENGTH TYLENOL as directed. Patient to call if no relief. Will check with patient 7-26-18 if no response from patient. To call HD or go to ER if worsens. Had MVA on 5-12-18.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient is 30.3 weeks pregnant. Received vaccine in LD IM. Called on 7-25-18 at 8:54 to report that left arm feels heavy and sore, had temp = 103 and chills. Feels achy all over. No meds taken. FNP recommended EXTRA STRENGTH TYLENOL as directed. Patient to call if no relief. Will check with patient 7-26-18 if no response from patient. To call HD or go to ER if worsens. Had MVA on 5-12-18.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Felt tired, had muscle pain, a headache, shivering.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Diarrhoea, Induration, Pain in extremity, Skin warm
Clinical narrative: Patient reported that on Friday 07/20/18 left arm was sore, warm to touch and hard. On Saturday morning 07/21/18 she experienced chills, vomiting and diarrhea. Patient drank water, ginger-ale and rested all day. Reported that she felt better late Saturday night. Patient notified PCP's office on 07/23/18.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Patient reported that on Friday 07/20/18 left arm was sore, warm to touch and hard. On Saturday morning 07/21/18 she experienced chills, vomiting and diarrhea. Patient drank water, ginger-ale and rested all day. Reported that she felt better late Saturday night. Patient notified PCP's office on 07/23/18.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient was given the SHINGRIX vaccine (dose 1) on Thursday July 19th, 2018. She felt some flu-like symptoms for 48 hours, and on Saturday, July 21, she experienced a red-hot area below the injection site (below deltoid muscle). She noted the area was red and about 2x2 inch in size at 3am on Monday July 23. The area grew to a 3x4 inch size by Tuesday morning and was red, hot, and itchy. She compared the signs to that of cellulitis. She took a dose of Levaquin, and the area was less red but still hot by Tuesday night. She noted that the area was much improved by Wednesday morning but looks more like a bruised area. Until the dose of Levaquin, the area had grown from the bottom of her deltoid to her elbow and was covering about 3/4 around the arm.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Wrong drug administered
Clinical narrative: MMRV given instead of MMR, no treatment, mother informed.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, muscle aches, fever, shivering, fatigue actually all listed 14 hrs after injection.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Pain in extremity, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 26-JUN-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route of administration, lot number and expiration date were not provided) in an unspecified arm for prophylaxis. On an unspecified day in June 2018, the patient experienced an injection site reaction that presented with swelling at the site down to the elbow. The arm was red and warm to the touch and painful. The patient contacted the pharmacist on an unspecified date in June 2018 and the pharmacist instructed the patient, to take an antihistamine drug (unspecified) and if the symptoms did not resolve to seek medical attention. The patient was not recovered from the events as of 28-JUN-2018. The causality assessment between the events and PNEUMOVAX 23 was not reported.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a female patient of unknown age. Information on patient's pertinent medical history and drug reactions/allergies were not reported. On 28-JUN-2018, the patient was vaccinated with one dose of Oka/Merck VARIVAX (strength, dose and route of administration were not reported) (lot # N026071 and expiry date: 20-SEP-2019) for prophylaxis (product storage error). The administered dose of Oka/Merck VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiry date were not reported) (concomitant therapy). The vaccine was stored in the range -9 °C (degree Celsius) to 8 °C (maximum -6.0 °C) for 9 hours 44 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1807USA007149.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information on patient's pertinent medical history and drug reactions/allergies were not reported. On 02-JUL-2018, the patient was vaccinated with one dose of VARIVAX (strength, dose and route of administration were not reported) (lot # N026071 and expiry date: 20-SEP-2019) for prophylaxis. The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (unknown manufacturer) (lot # and expiry date were not reported). The vaccine was stored in the range -9 °C (degrees Celsius) to 8 °C (maximum -6.0 C) for 9 hours 44 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1807USA006960.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2010, the patient was inoculated with ZOSTAVAX by a physician for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus that ZOSTAVAX is intended to prevent. On or about 23-JUN-2010, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 29-JAN-2010, the patient was inoculated with ZOSTAVAX by a physician for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus that ZOSTAVAX is intended to prevent. In 2015, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Laceration, Syncope
Clinical narrative: Pt Fainted. Pt left Pharmacy area and went up front bought a water at Front register and Fainted while ringing up. Pt cut back of head. Pt said he had not eaten or drank anything all day and was Prone to Fainting. Paramedic called Pt refused to go to Hospital.
Age: 1.17
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site papule
Clinical narrative: Subcutaneous nodules (x2 on (R) thigh) with overlying erythema and a few pinpoint papules, first noted by mother on 7/14/18 (vaccine given on 7/5/18). Non tender. Recommended topical steroid (HC 1%) BID x 1 wk and monitoring for increased redness, pain, swelling, fevers.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Influenza like illness, Nausea, Pain in extremity
Clinical narrative: Headache started after about 4 hrs increasing gradually becoming severe after about 8 hrs and continuing through the night.. restless night. Arm sore at night and through next day. Flu like symptoms next day, nausea, fever, pain in calf muscles and around hip? but still managed to get to work. No exercise. 10 hr sleep night of day-02. Body returned to normal day-03 around midday. No exercise.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Restlessness
Clinical narrative: Headache started after about 4 hrs increasing gradually becoming severe after about 8 hrs and continuing through the night.. restless night. Arm sore at night and through next day. Flu like symptoms next day, nausea, fever, pain in calf muscles and around hip? but still managed to get to work. No exercise. 10 hr sleep night of day-02. Body returned to normal day-03 around midday. No exercise.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Myalgia
Clinical narrative: Myalgia, joint aches.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Rash
Clinical narrative: Moderate discomfort; but, very annoying. Used a pain relief cream, at times, especially before bed. Rash got bigger and bigger. It is now the size, slightly larger than a silver dollar.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pt was given the vaccine. Within a couple of days, the patient noticed two bumps on the left arm - the same arm as the injection was given. A large area around the dots became swollen red, and warm. The patient applied ice and the swelling went down. 6 days after the vaccination there was still an area approximately 4-6 in diameter that was red and warm. The area started at the elbow and went midway up the upper arm - entirely below the injection site. Patient did not remember being bitten by anything. Benadryl did not help the rash at all. Patient was referred to doctor for follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Myalgia, Nausea
Clinical narrative: Patient came in for his second round of SHINGRIX vaccine. He said he had experienced the following side effects with the first dose: Fever, Chills, Nausea, Loss of Appetite, Muscle Pain, Weakness. All of this was experienced for 3 days. He went ahead and got his second injection. I called him 2 days later to check on his reaction to his round of the SHINGRIX vaccine. The patient stated he had the same reaction to the second dose. Fever, Chills, Loss of Appetite, Nausea, Muscle Pain, Weakness. He said it was not as bad this second time around. He feels better today and is on the road to recovery.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient came in for his second round of SHINGRIX vaccine. He said he had experienced the following side effects with the first dose: Fever, Chills, Nausea, Loss of Appetite, Muscle Pain, Weakness. All of this was experienced for 3 days. He went ahead and got his second injection. I called him 2 days later to check on his reaction to his round of the SHINGRIX vaccine. The patient stated he had the same reaction to the second dose. Fever, Chills, Loss of Appetite, Nausea, Muscle Pain, Weakness. He said it was not as bad this second time around. He feels better today and is on the road to recovery.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives present on both upper legs from hip to knee, First dose of Benadryl was given but some hives remained and after 4 hours a second dose of Benadryl was given and all hives went away.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on 12Jul2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. On 19Jul2018, the patient experienced redness, warmth and swelling at the injection site. The reporting physician wanted to know if there were reports of delayed local reactions since "he cannot rule out cellulitis". The outcome of the events was unknown. The information on the batch number has been requested. Sender's Comments: Based on the information currently available, it cannot be fully excluded that the vaccination with PREVNAR 13 might play a contributory role for the occurrence of cellulitis at vaccination site. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid oedema, Hypersensitivity, Pruritus, Rash generalised, Swelling face
Clinical narrative: Pt had allergic RXN. Left side of face swollen, ears itching, rash on body extensive. Sat. eyes swollen shut, vision blocked. Sun. itching and spreading to back and stomach. Pt went to Dr. 3 days later after trying to self medicate with BENADRYL and hydrocortisone cream. Pt received steroid shot from doc and the RX for steroid pack and ALLEGRA. Pt doing better today 7/20/18.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Pt had allergic RXN. Left side of face swollen, ears itching, rash on body extensive. Sat. eyes swollen shut, vision blocked. Sun. itching and spreading to back and stomach. Pt went to Dr. 3 days later after trying to self medicate with BENADRYL and hydrocortisone cream. Pt received steroid shot from doc and the RX for steroid pack and ALLEGRA. Pt doing better today 7/20/18.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dysstasia, Gait disturbance, Influenza like illness, Nausea
Clinical narrative: Fine through the day except sore arm. Arm sore at night, slightly restless night and through next day.  Severe flu like symptoms next day, nausea, fever, pain in calf muscles and around hip peaking in afternoon. In bed 4 hrs through afternoon; resisting to stand up and walk about! 10 hr sleep night of day-02. Body returned to normal when awake.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Restlessness
Clinical narrative: Fine through the day except sore arm. Arm sore at night, slightly restless night and through next day.  Severe flu like symptoms next day, nausea, fever, pain in calf muscles and around hip peaking in afternoon. In bed 4 hrs through afternoon; resisting to stand up and walk about! 10 hr sleep night of day-02. Body returned to normal when awake.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Influenza like illness, Nausea, Pain in extremity
Clinical narrative: Headache started after about 4 hrs increasing gradually becoming severe after about 8 hrs and continuing through the night.. restless night. Arm sore at night but less sore this time and subsided by dawn. Flu like symptoms next day, nausea, fever, pain in calf muscles and around hip. Mild exercise. 10 hr sleep night of day-02. Regular exercise. Body returned to normal when awake.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Restlessness
Clinical narrative: Headache started after about 4 hrs increasing gradually becoming severe after about 8 hrs and continuing through the night.. restless night. Arm sore at night but less sore this time and subsided by dawn. Flu like symptoms next day, nausea, fever, pain in calf muscles and around hip. Mild exercise. 10 hr sleep night of day-02. Regular exercise. Body returned to normal when awake.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fine through the day except sore arm. Less sore this time than first shot. Arm sore at night, slightly restless night, less sore this time and subsided by dawn. Mild flu like symptoms next day, nausea, fever, pain in calf muscles and around hip peaking in afternoon. In bed 2-3 hrs through afternoon; preferred not to move around. 10 hr sleep night of day-02. Body returned to normal when awake.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Restlessness
Clinical narrative: Fine through the day except sore arm. Less sore this time than first shot. Arm sore at night, slightly restless night, less sore this time and subsided by dawn. Mild flu like symptoms next day, nausea, fever, pain in calf muscles and around hip peaking in afternoon. In bed 2-3 hrs through afternoon; preferred not to move around. 10 hr sleep night of day-02. Body returned to normal when awake.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site haemorrhage, Injection site pain
Clinical narrative: The pt was given her first dose of SHINGRIX. She experienced bleeding at the time of injection but that resolved within 30 seconds. The patient reported bruising at the site as well as redness and tenderness. The patient came in to the pharmacy the next day to say that the symptoms were still present but improving.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Injection site erythema, Malaise, Myalgia
Clinical narrative: red face and arm below the injection site, nausea, ache in muscles, extreme fatigue, general feeling of malaise
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: red face and arm below the injection site, nausea, ache in muscles, extreme fatigue, general feeling of malaise
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Depressed level of consciousness, Dizziness, Eyelid function disorder, Feeling hot, Pallor
Clinical narrative: GAVE PT IMMUNIZATION, WITHIN 1-2 MIN PT STARTED TO FEEL LIGHTHEADED, FELT WARM. OFFERED PT WATER (ACCEPTED), FANNED PT TO KEEP COOL. STARTED TO PASS OUT. CALLED 911. OFFERED PT HAD ANOTHER WATER & CONTINUED TO FAN. EYES FLUTTERED AND HEAD SHOOK FOR A FEW SECONDS. LOSS OF COLOR. PT WAS COHERENT THE WHOLE TIME AND ABLE TO CONVERSE WITH ME. EMS ARRIVED, ADMINISTERED OXYGEN AND STARTED AN IV. TOOK PT TO HOSPITAL. FATHER CALLED AT APPOXIMATELY 1230PM, SAID PATIENT HAD BEEN DISCHARGED AND THEY WERE ON THEIR WAY HOME.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Tremor
Clinical narrative: GAVE PT IMMUNIZATION, WITHIN 1-2 MIN PT STARTED TO FEEL LIGHTHEADED, FELT WARM. OFFERED PT WATER (ACCEPTED), FANNED PT TO KEEP COOL. STARTED TO PASS OUT. CALLED 911. OFFERED PT HAD ANOTHER WATER & CONTINUED TO FAN. EYES FLUTTERED AND HEAD SHOOK FOR A FEW SECONDS. LOSS OF COLOR. PT WAS COHERENT THE WHOLE TIME AND ABLE TO CONVERSE WITH ME. EMS ARRIVED, ADMINISTERED OXYGEN AND STARTED AN IV. TOOK PT TO HOSPITAL. FATHER CALLED AT APPOXIMATELY 1230PM, SAID PATIENT HAD BEEN DISCHARGED AND THEY WERE ON THEIR WAY HOME.
Age: 1.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: 18 month old patient was given KINRIX.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Left upper muscular pain, constant since vaccine was given.
Age: 72.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Dizziness
Clinical narrative: Severe dizziness.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 02-JUL-2018, the patient was vaccinated with a improperly stored dose of ROTATEQ orally, lot # N030175, expiration date 16-JUN-2019 (strength and vaccination site were not provided) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion at of above 32 degrees Fahrenheit up to 35 degrees Fahrenheit for 84 hours. There was no previous temperature excursion. Information was received from a data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA010993: US-009507513-1807USA010994: US-009507513-1807USA010995.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report was received from a physician via company representative, concerning his 23 year old sister-in-law. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in 2006 (reported as "many years ago, when patients were first vaccinated"), the patient received three doses of GARDASIL, for prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date (reported as "shortly after third dose, within 10 months"), the patient started experiencing hair loss. On an unknown date, the patient's symptoms worsened, resulting in alopecia and loss of all body hair, which occurred over the course of four years. It was reported that on an unspecified date, the patient received an unspecified treatment from unspecified specialists, with no return of body hair. By the time of the reporting, the patient was not recovered from alopecia. The reporter did not provide the causal relationship between GARDASIL and the event.