chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Blood test, Burning sensation, Hallucination, Herpes zoster
Clinical narrative: This spontaneous report was received from a female consumer referring to herself currently 85 year old. The patient's concurrent conditions included, Bell palsy and hypersensitivity reaction to sulfa medications. There were no concomitant medications. On 05-NOV-2007, the patient was vaccinated with 1 dose of ZOSTAVAX (dosage, frequency, anatomical location, route of administration, lot# and expiration date were not reported) for prevent shingles. The patient reported that she developed shingles in April 2013, after receiving ZOSTAVAX. She further stated that she was admitted to the hospital in April 2014 to have her left knee replaced. The patient stated that currently she was dealing with a burning and itching feeling over her face, additionally, she stated that she had been diagnosed with post herpetic neuralgia (PHN). It was reported that on unspecified date she sought medical attention at the physician's office, also that a routine blood work was performed and no results were provided. The patient also mentioned that she had "issues" with oxycodone (unspecified). She stated that the medication gave her hallucinations. The patient stated that her nurse commented her that while on medication; she stated "there were dragons in her bed". The outcome of herpes zoster and post herpetic neuralgia was reported as not recovered. The outcome of knee arthroplasty was unknown. The relatedness between herpes zoster, hallucination, knee arthroplasty and post herpetic neuralgia with ZOSTAVAX was not reported. Upon internal review, the event of knee arthroplasty was considered to be a medically significant event.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Knee arthroplasty, Post herpetic neuralgia, Pruritus
Clinical narrative: This spontaneous report was received from a female consumer referring to herself currently 85 year old. The patient's concurrent conditions included, Bell palsy and hypersensitivity reaction to sulfa medications. There were no concomitant medications. On 05-NOV-2007, the patient was vaccinated with 1 dose of ZOSTAVAX (dosage, frequency, anatomical location, route of administration, lot# and expiration date were not reported) for prevent shingles. The patient reported that she developed shingles in April 2013, after receiving ZOSTAVAX. She further stated that she was admitted to the hospital in April 2014 to have her left knee replaced. The patient stated that currently she was dealing with a burning and itching feeling over her face, additionally, she stated that she had been diagnosed with post herpetic neuralgia (PHN). It was reported that on unspecified date she sought medical attention at the physician's office, also that a routine blood work was performed and no results were provided. The patient also mentioned that she had "issues" with oxycodone (unspecified). She stated that the medication gave her hallucinations. The patient stated that her nurse commented her that while on medication; she stated "there were dragons in her bed". The outcome of herpes zoster and post herpetic neuralgia was reported as not recovered. The outcome of knee arthroplasty was unknown. The relatedness between herpes zoster, hallucination, knee arthroplasty and post herpetic neuralgia with ZOSTAVAX was not reported. Upon internal review, the event of knee arthroplasty was considered to be a medically significant event.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist refers to a currently 40 years old female patient. The patient did not have any concomitant medication, drug reactions or allergies. The patient's historical drug included vaccination with a measles, mumps, and rubella vaccine (manufacturer unknown) as an infant. On an unknown date (reported as: "a few years ago"), the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiry date were not reported). On an unknown date (reported as: "a few weeks ago), the patient showed a low titer for Rubella. The outcome of the event was not reported. The causality assessment was not reported.
Age: 61.0
Sex: M
Vaccine: TD
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site paraesthesia, Product administered at inappropriate site
Clinical narrative: On January 12, 2017, a 61 year old man incorrectly received an intradermal injection of MassBiologics' Td vaccine (Lot # A092C) into the right side of his jaw instead of lidocaine; the lidocaine was intended to be used as anesthetic for a mole removal procedure that was subsequently cancelled. On the day of administration, the patient had taken his routine medications: hydrochlorothiazide, pravastatin, propranolol, and aspirin. The patient experienced same day onset of injection site erythema and one day following administration (01/13/17), the patient reported the development of an "eraser-sized" induration and paraesthesia at the injection site. The patient did not receive treatment for the adverse event. The reporter followed up with MassBiologics on January 20, 2017 and indicated that he had seen the patient on January 17, 2017 and that the patient's injection site erythema and induration had completely resolved. However, the patient was still experiencing slight tingling near the injection site and further follow-up would be required. On February 16, 2017, the reporter informed MassBiologics that during a follow-up the patient indicated that he was not experiencing any more symptoms from the adverse event; specifically, the continued injection site paraesthesia had completely resolved. During the investigation MassBiologics queried the reporter for a root cause for the administration error, the reporter explained that the Td was intended for a different patient and the syringes containing both drug products were misdirected to the wrong patients. The reporter further clarified that he had only administered approximately 0.25mL of the Td product before realizing the syringe did not contain the lidocaine product. Sender's Comments: MassBiologics assessed this adverse event as non-serious and contained both labeled reactions and unexpected reactions. The injection site reactions of local erythema and induration are listed in the package insert for Td; the injection site paraesthesia was assessed as unexpected. Due to the wrong drug being administered to the wrong patient, the route of administration for the Td vaccine was incorrect. MassBiologics' (Sender) attempted to obtain the manufacturer of the drug not administered (lidocaine) from the reporter, however the reporter could not be certain as to the specific drug not administered. The reporter provided the manufacturer of the lidocaine that his facility currently stocks (Fresenius Kabi) but could not provide assurances to the implicated product. The reporter confirmed that the event was not reported to the lidocaine manufacturer. MassBiologics sent a letter containing information regarding this event to Fresenius Kabi USA, LLC on August 25, 2017.
Age: 61.0
Sex: M
Vaccine: TD
Symptoms: Wrong drug administered
Clinical narrative: On January 12, 2017, a 61 year old man incorrectly received an intradermal injection of MassBiologics' Td vaccine (Lot # A092C) into the right side of his jaw instead of lidocaine; the lidocaine was intended to be used as anesthetic for a mole removal procedure that was subsequently cancelled. On the day of administration, the patient had taken his routine medications: hydrochlorothiazide, pravastatin, propranolol, and aspirin. The patient experienced same day onset of injection site erythema and one day following administration (01/13/17), the patient reported the development of an "eraser-sized" induration and paraesthesia at the injection site. The patient did not receive treatment for the adverse event. The reporter followed up with MassBiologics on January 20, 2017 and indicated that he had seen the patient on January 17, 2017 and that the patient's injection site erythema and induration had completely resolved. However, the patient was still experiencing slight tingling near the injection site and further follow-up would be required. On February 16, 2017, the reporter informed MassBiologics that during a follow-up the patient indicated that he was not experiencing any more symptoms from the adverse event; specifically, the continued injection site paraesthesia had completely resolved. During the investigation MassBiologics queried the reporter for a root cause for the administration error, the reporter explained that the Td was intended for a different patient and the syringes containing both drug products were misdirected to the wrong patients. The reporter further clarified that he had only administered approximately 0.25mL of the Td product before realizing the syringe did not contain the lidocaine product. Sender's Comments: MassBiologics assessed this adverse event as non-serious and contained both labeled reactions and unexpected reactions. The injection site reactions of local erythema and induration are listed in the package insert for Td; the injection site paraesthesia was assessed as unexpected. Due to the wrong drug being administered to the wrong patient, the route of administration for the Td vaccine was incorrect. MassBiologics' (Sender) attempted to obtain the manufacturer of the drug not administered (lidocaine) from the reporter, however the reporter could not be certain as to the specific drug not administered. The reporter provided the manufacturer of the lidocaine that his facility currently stocks (Fresenius Kabi) but could not provide assurances to the implicated product. The reporter confirmed that the event was not reported to the lidocaine manufacturer. MassBiologics sent a letter containing information regarding this event to Fresenius Kabi USA, LLC on August 25, 2017.
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Gait disturbance, Injection site joint pain, Insomnia, Joint stiffness
Clinical narrative: This is a spontaneous report from a contactable consumer. A 65-year-old female patient of an unspecified ethnicity started to receive PREVNAR 13, via an unspecified route of administration on12Dec2017 at single dose for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient developed reactions 14Dec2017. the reactions were her joints and knees got stiff and went through out her body until she couldn't walk without any assistance by her husband or walker, extreme pain on the thumb and shoulder joints as well on the injection site and had trouble sleeping but got better the next few days. Her doctor knows about this though and no medications were given. Last 12Jan, similar symptoms happened again. Wanted to know if there have been similar phenomenon's. The outcome of the events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Walking aid user
Clinical narrative: This is a spontaneous report from a contactable consumer. A 65-year-old female patient of an unspecified ethnicity started to receive PREVNAR 13, via an unspecified route of administration on12Dec2017 at single dose for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient developed reactions 14Dec2017. the reactions were her joints and knees got stiff and went through out her body until she couldn't walk without any assistance by her husband or walker, extreme pain on the thumb and shoulder joints as well on the injection site and had trouble sleeping but got better the next few days. Her doctor knows about this though and no medications were given. Last 12Jan, similar symptoms happened again. Wanted to know if there have been similar phenomenon's. The outcome of the events was unknown.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 70-year-old female patient received PREVNAR 13, via an unspecified route of administration, on an unspecified date around a year before report, at single dose, for immunisation. Medical history included ongoing diabetes mellitus, ongoing blood pressure abnormal, ongoing heart rate abnormal, food allergy (to eggs), latex allergy. Concomitant medication included CARDIZEM from an unspecified date and ongoing since 10 years for blood pressure and heart rate, metformin (unspecified trade name) from an unspecified date and ongoing since 15 years or longer for diabetes, glipizide (unspecified trade name) from many years for diabetes, labetalol (unspecified trade name) for blood pressure. The patient experienced fever for 3 days and severe headache for 3 days both the day after vaccination with outcome of recovered. On an unspecified date a year after the patient received PREVNAR 13 again and experienced severe headache for 3 or more days and fever for 3 or more days both with outcome of recovered. The information on the lot number has been requested.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Dizziness, Dyspnoea, Erythema, Fatigue
Clinical narrative: Patient is here because he had an adverse reaction after getting his influenza vaccine. He had dizziness, lightheadedness, and was red in the face. It got better after a few minutes and was allowed to leave the office. He went straight to bed, did not eat or drink much last night, and was told that patient had trouble breathing, looked hot, and did not look right. He had pulse of 112 at the time. He had temp of 103.2. He had a bad headache. He was given one BENADRYL, ibuprofen, and 2 puffs of his asthma rescue inhaler. He then took some bread and butter. He laid in bed with cool washcloths. The fever broke around 2-3 AM this morning. Patient says he feels tired and lethargic right now. He has not had any known sick contacts. He was examined today and appears normal now.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling hot, Headache, Lethargy
Clinical narrative: Patient is here because he had an adverse reaction after getting his influenza vaccine. He had dizziness, lightheadedness, and was red in the face. It got better after a few minutes and was allowed to leave the office. He went straight to bed, did not eat or drink much last night, and was told that patient had trouble breathing, looked hot, and did not look right. He had pulse of 112 at the time. He had temp of 103.2. He had a bad headache. He was given one BENADRYL, ibuprofen, and 2 puffs of his asthma rescue inhaler. He then took some bread and butter. He laid in bed with cool washcloths. The fever broke around 2-3 AM this morning. Patient says he feels tired and lethargic right now. He has not had any known sick contacts. He was examined today and appears normal now.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Injection site inflammation, Injection site irritation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, itchy, inflamed, hot, irritated skin around the injection site (shoulder), spreading out to neck/lower arm. (PENTACEL injection arm).
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood test normal, Lip swelling, Swelling face, Urticaria
Clinical narrative: I have a Band Aid mark on my arm where injection was given to this day. I started to get hives on my wrist. Next day woke up with swollen lips and 1/2 my face swollen. Next day my entire body was covered in hives. It has been almost 7 or 8 weeks that I am having an severe hives.
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Antinuclear antibody negative, Blood immunoglobulin E normal, Cold agglutinins negative, Cryoglobulins absent, Eye swelling
Clinical narrative: I have a Band Aid mark on my arm where injection was given to this day. I started to get hives on my wrist. Next day woke up with swollen lips and 1/2 my face swollen. Next day my entire body was covered in hives. It has been almost 7 or 8 weeks that I am having an severe hives.
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hepatitis A virus test, Hepatitis B surface antigen negative, Hepatitis B test negative, Hepatitis C test negative, Hepatitis viral test negative
Clinical narrative: I have a Band Aid mark on my arm where injection was given to this day. I started to get hives on my wrist. Next day woke up with swollen lips and 1/2 my face swollen. Next day my entire body was covered in hives. It has been almost 7 or 8 weeks that I am having an severe hives.
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Lip swelling, Metabolic function test normal, Mycobacterium tuberculosis complex test negative, Rheumatoid factor negative, Swelling face
Clinical narrative: I have a Band Aid mark on my arm where injection was given to this day. I started to get hives on my wrist. Next day woke up with swollen lips and 1/2 my face swollen. Next day my entire body was covered in hives. It has been almost 7 or 8 weeks that I am having an severe hives.
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Urticaria
Clinical narrative: I have a Band Aid mark on my arm where injection was given to this day. I started to get hives on my wrist. Next day woke up with swollen lips and 1/2 my face swollen. Next day my entire body was covered in hives. It has been almost 7 or 8 weeks that I am having an severe hives.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: Itching on right scapular area. Rash in scapula and axilla on right side appeared 1 day later. Rash is consistent with Zoster. Antiviral med prescribed.
Age: 18.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Pyrexia, Rash pustular, Vaccination site reaction
Clinical narrative: Patient developed a large pustular rash around the smallpox vaccination site. Patient also complained that during this timeframe he also developed a low grade fever. Doctor treated patient with Sulfamethoxazole + Trimethoprim, (SEPTRA DS), Tablet, Oral TAKE ONE TABLET BY MOUTH EVERY TWELVE HOURS TILL ALL TAKEN FOR INFECTION, Acetaminophen 325mg and Ibuprofen 400mg and instructed to follow up on 22 January 2018.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Alopecia areata
Clinical narrative: Developed Alopecia Areata. Twp large 5-6 cm. circular areas on top/side of head. Dermatologist injected  both areas and I am using minoxidil foam 5% daily since Jan. 10, 2018.  Too early for an outcome.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: Pain and tenderness in left deltoid area, increasing in severity on day 5. Very uncomfortable to lift left arm.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Anal incontinence, Asthenia, Discomfort, Dizziness, Dysstasia
Clinical narrative: By the evening of the shot my arm began to throb. (Pain level 6-7). By bedtime pain level was at 8. Around 12am I began to experience dizziness and nausea. This was followed by overall body discomfort of soreness and cramping. In an attempt to get to the bathroom I quickly found out that I was unable to stand or move without my wife's assistance in supporting me. By the time I got down a short hallway and into the bathroom my wife was no longer able to support me and I fell onto the bathroom floor. I lost bowel control. I was on the floor for 2 hrs unable to get up. Finally still dizzy and nauseous I got up with help to get back to the bed. I felt miserable for the next 6hrs and then started to get a feeling that I could possible stand. With help I again made it to the bathroom. The pain in the arm lasted for another 2 days along with the weakness and instability. Information was relayed to Dr and neurologist and followed up in letter to Dr on 12-17-2017.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Fall, Feeling abnormal, Gait disturbance, Muscle spasms, Nausea
Clinical narrative: By the evening of the shot my arm began to throb. (Pain level 6-7). By bedtime pain level was at 8. Around 12am I began to experience dizziness and nausea. This was followed by overall body discomfort of soreness and cramping. In an attempt to get to the bathroom I quickly found out that I was unable to stand or move without my wife's assistance in supporting me. By the time I got down a short hallway and into the bathroom my wife was no longer able to support me and I fell onto the bathroom floor. I lost bowel control. I was on the floor for 2 hrs unable to get up. Finally still dizzy and nauseous I got up with help to get back to the bed. I felt miserable for the next 6hrs and then started to get a feeling that I could possible stand. With help I again made it to the bathroom. The pain in the arm lasted for another 2 days along with the weakness and instability. Information was relayed to Dr and neurologist and followed up in letter to Dr on 12-17-2017.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: By the evening of the shot my arm began to throb. (Pain level 6-7). By bedtime pain level was at 8. Around 12am I began to experience dizziness and nausea. This was followed by overall body discomfort of soreness and cramping. In an attempt to get to the bathroom I quickly found out that I was unable to stand or move without my wife's assistance in supporting me. By the time I got down a short hallway and into the bathroom my wife was no longer able to support me and I fell onto the bathroom floor. I lost bowel control. I was on the floor for 2 hrs unable to get up. Finally still dizzy and nauseous I got up with help to get back to the bed. I felt miserable for the next 6hrs and then started to get a feeling that I could possible stand. With help I again made it to the bathroom. The pain in the arm lasted for another 2 days along with the weakness and instability. Information was relayed to Dr and neurologist and followed up in letter to Dr on 12-17-2017.
Age: 38.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain in extremity
Clinical narrative: Pain in arm right away after shot. Could not lift arm for two days after. Have loss of mobility now 3 weeks later.
Age: 38.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Pain in arm right away after shot. Could not lift arm for two days after. Have loss of mobility now 3 weeks later.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: Swollen right arm axilla area, reported enlarged "lymph node" on right clavicle area.
Sex: M
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 12 month old male patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. His concomitant therapies included Merck sterile diluent. On 11-DEC-2017, the patient was vaccinated with a dose of PROQUAD lot # N014633, expiration date: 07-NOV-2018, as prophylaxis. On 22-DEC-2017, the patient was vaccinated with a dose of VARIVAX lot # M045204, expiration date: 11-NOV-2018, as prophylaxis. No adverse effects were reported.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 25 year old female patient. The patient did not have concurrent conditions, any known allergies or reactions, medical history or concomitant medications. On approximately 22-NOV-2017 (reported as approximately one month ago), the patient was vaccinated with the first dose of GARDASIL 9, for prevention of diseases caused by Human Papillomavirus (dose, route of administration, lot number and expiration date were not reported). On an unspecified date, the patient became pregnant with last menstrual period (LMP) of 25-NOV-2017 and Estimated Date of Delivery (EDD) of 01-SEP-2018. Subsequently, on 22-DEC-2017, the patient received the second dose of GARDASIL 9, lot # N023952 with expiration date of 12-JUL-2020 (expiration date also reported as 17-NOV-2019), intramuscularly, for prevention of diseases caused by human papillomavirus, (dose was not reported). On the same date after receiving the second dose of GARDASIL 9, she was administered an unspecified type of pregnancy test in physician office which showed that the patient was pregnant; however, it was also reported that no laboratory tests were performed. That day was initial exposure to GARDASIL 9 was at 4 week(s). Due to the events, the patient went to a physician appointment. No treatment was given for the adverse events. No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection, Vaccination failure
Clinical narrative: This literature marketed report was received from the authors of a published article, and refers to a 23-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patient was vaccinated with a full series of ROTATEQ, orally (dose, lot # and expiration date were not reported). On an unknown date during 2014-2015 season, the patient experienced apparent vaccine failure and was infected with rotavirus. The outcome of the event was not reported. The authors considered the event to be related to ROTATEQ. This is one of two reports derived from the same literature article (cross-referenced in US-009507513-1801USA005735).
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection, Vaccination failure
Clinical narrative: This literature marketed report was received from the authors of a published article, and refers to a child of unknown gender and age. No information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patient was vaccinated with a full series of ROTATEQ, orally (dose, lot # and expiration date were not reported). On an unknown date in 2014-2015 season, the patient experienced apparent vaccine failure and was infected with rotavirus. The outcome of the event was not reported. The authors considered the event to be related to ROTATEQ. This is one of two reports derived from the same literature article (cross-referenced in US-009507513-1801USA005022).
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 16-JAN-2018 from a lawyer regarding a case in litigation concerning a male patient, age not reported. The patient was vaccinated with ZOSTAVAX on or about 16-APR-2014 at a pharmacy for general health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-SEP-2016 the patient was treated at a family practice for a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as herpes zoster or shingles. On or about 13-OCT-2016 the patient sought treatment at another clinic for ongoing and worsening symptoms of herpes zoster infections. As a direct and proximate result of these malfunctions the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further and proximate result the patient suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Outcome of herpes zoster and weakened immune symptoms was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 17-JAN-2018, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX subcutaneously, lot # M041085 and expiration date: 03-JAN-2018 (dose and frequency were not reported). No adverse effects were reported for the patient. No causality assessment was provided.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from the patient's mother and refers to a 1-month-old patient. No information regarding the patient's medical hstory, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of VAQTA injection (dose, route of administration, lot number and expiration date were not reported.
Sex: M
Vaccine: TD
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site pain, Injection site streaking
Clinical narrative: On July 20, 2017 a male patient received an intradermal injection of MassBiologics' Td vaccine (Lot #A090A) in his right arm instead of a PPD administration; the dose of Td administered was 0.1mL and not the 0.5mL labeled dose. The reporter would not disclose his date of birth but indicated he was in his mid to late 50's. The patient experienced same day onset of soreness around the injection site. The following day the patient experienced injection site induration (at least 10 mm in size), injection site erythema (~20cm x 8cm), and red streaks at the injection site but reported to not be cellulitis. The patient went to an Urgent Care facility on July 22, 2017 and was given a treatment plan of 500mg of KEFLEX for 10 days. At the time of the initial report, 7 days post-administration, the patient had recovered from all events except the injection site induration which had decreased to ~6mm. Follow up obtained on August 3, 2017 indicated that the induration was barely 6mm in size and was less-defined with minimal fine edges. Final follow up on August 15, 2017 indicated that all symptoms had completely resolved. The primary reporter indicated that the drug administration error occurred because the physical appearance of the Td vial label and the PPD vial label were very similar in color and pop top. In addition, the primary reporter said that "Tetanus" and "Tuberculin" look very similar when in a rush. Sender's Comments: All adverse events reported in this case were assessed as non-serious and labeled. MassBiologics sent a letter containing information regarding this event to the manufacturer of the PPD not administered, PAR Sterile Products, on August 25, 2017.
Sex: M
Vaccine: TD
Symptoms: Product label confusion, Wrong drug administered
Clinical narrative: On July 20, 2017 a male patient received an intradermal injection of MassBiologics' Td vaccine (Lot #A090A) in his right arm instead of a PPD administration; the dose of Td administered was 0.1mL and not the 0.5mL labeled dose. The reporter would not disclose his date of birth but indicated he was in his mid to late 50's. The patient experienced same day onset of soreness around the injection site. The following day the patient experienced injection site induration (at least 10 mm in size), injection site erythema (~20cm x 8cm), and red streaks at the injection site but reported to not be cellulitis. The patient went to an Urgent Care facility on July 22, 2017 and was given a treatment plan of 500mg of KEFLEX for 10 days. At the time of the initial report, 7 days post-administration, the patient had recovered from all events except the injection site induration which had decreased to ~6mm. Follow up obtained on August 3, 2017 indicated that the induration was barely 6mm in size and was less-defined with minimal fine edges. Final follow up on August 15, 2017 indicated that all symptoms had completely resolved. The primary reporter indicated that the drug administration error occurred because the physical appearance of the Td vial label and the PPD vial label were very similar in color and pop top. In addition, the primary reporter said that "Tetanus" and "Tuberculin" look very similar when in a rush. Sender's Comments: All adverse events reported in this case were assessed as non-serious and labeled. MassBiologics sent a letter containing information regarding this event to the manufacturer of the PPD not administered, PAR Sterile Products, on August 25, 2017.
Age: 35.0
Sex: F
Vaccine: MNQ, TYP, YF
Symptoms: Abdominal pain upper, Body temperature increased, Chills, Diarrhoea, Headache
Clinical narrative: Initial unsolicited report received from a nurse on 19-Dec-2017. This case involves a 35 years old female patient, who was vaccinated with a dose of 0.5 ml of TYPHIM VI (batch number: N1G102M, expiry date, dose in series and site of administration was not reported) via intramuscular route on 11-Dec-2017, and a dose of 0.5 ml of MENACTRA (batch number: U5514AC, expiry date, dose in series and site of administration was not reported) via intramuscular route on 11-Dec-2017 and also a dose of 0.5 ml of STAMARIL (batch number: M51761V, expiry date, dose in series and site of administration was not reported) via intramuscular route on 11-Dec-2017. The patient's medical history included allergies to latex, allergy to codeine, allergy to BENADRYL and allergy to ROBITUSSIN. Concomitant medications were not reported. On 12-Dec-2017, one day following the vaccination (reported as the day following the vaccination), the patient experienced temp of 100.8 oral, chills, diarrhea during the night, headache, stomach pain, felt like she was punched in the stomach, and a prickly feeling to her skin widespread over her body. The patient's laboratory data included body temperature of 100.8 (unit: unknown). Corrective treatment was not reported. On an unknown date, the patient was recovered from all the events. List of documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: MNQ, TYP, YF
Symptoms: Paraesthesia
Clinical narrative: Initial unsolicited report received from a nurse on 19-Dec-2017. This case involves a 35 years old female patient, who was vaccinated with a dose of 0.5 ml of TYPHIM VI (batch number: N1G102M, expiry date, dose in series and site of administration was not reported) via intramuscular route on 11-Dec-2017, and a dose of 0.5 ml of MENACTRA (batch number: U5514AC, expiry date, dose in series and site of administration was not reported) via intramuscular route on 11-Dec-2017 and also a dose of 0.5 ml of STAMARIL (batch number: M51761V, expiry date, dose in series and site of administration was not reported) via intramuscular route on 11-Dec-2017. The patient's medical history included allergies to latex, allergy to codeine, allergy to BENADRYL and allergy to ROBITUSSIN. Concomitant medications were not reported. On 12-Dec-2017, one day following the vaccination (reported as the day following the vaccination), the patient experienced temp of 100.8 oral, chills, diarrhea during the night, headache, stomach pain, felt like she was punched in the stomach, and a prickly feeling to her skin widespread over her body. The patient's laboratory data included body temperature of 100.8 (unit: unknown). Corrective treatment was not reported. On an unknown date, the patient was recovered from all the events. List of documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Eye swelling, Paraesthesia oral
Clinical narrative: Initial unsolicited report received from nurse on 05 Jan 2018. This case involves 52 years old female patient who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (batch number: UI852AB and expiry date was not reported) intramuscularly in deltoid once, on 15 Nov 2017. The patient's medical history and concomitant medication were not reported. On an unspecified date, 10 minutes post vaccination patient had developed right eye swelling and redness to right cheek along with tingling sensation around her mouth. Laboratory investigation was not reported. Patient was treated by the school nurse with 50 mg of oral DIPHENHYDRAMINE HYDROCHLORIDE (Benadryl) and was being evaluated by her pvt physician that day. On an unspecified date, patient was recovered from events. List of documents held by sender: none.
Sex: F
Vaccine: TYP, YF
Symptoms: Headache, New daily persistent headache
Clinical narrative: Initial unsolicited report received from consumer on 05 Jan 2018. This case involves 16 years old female patient who was vaccinated with dose of TYPHIM VI and YF-VAX (batch number, expiry date, route and site of administration were not reported) on an unspecified date in February 2017. The patient's medical history and concomitant medication were not reported. On an unspecified date in September or October 2017, post vaccination she experienced headaches and was diagnosed with daily persistent headache syndrome. Laboratory investigation and corrective treatment were not reported. Patient was not recovered from events. List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: TDAP, YF, YF, YF
Symptoms: Anxiety, Cold sweat, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Low grade fever first two days, then a near syncope episode on Tuesday night, sweating, clammy and nausea resulting in an ER visit. Since then I've been lightheaded, had sinus trouble, areas of cold and buzzing feelings which have traveled from my limbs to my back and to my head. Loss of appetite and increased feelings of anxiety. Muscle weakness and occasional loose stool.
Age: 40.0
Sex: F
Vaccine: TDAP, YF, YF, YF
Symptoms: Feeling cold, Hyperhidrosis, Muscular weakness, Nausea, Peripheral coldness
Clinical narrative: Low grade fever first two days, then a near syncope episode on Tuesday night, sweating, clammy and nausea resulting in an ER visit. Since then I've been lightheaded, had sinus trouble, areas of cold and buzzing feelings which have traveled from my limbs to my back and to my head. Loss of appetite and increased feelings of anxiety. Muscle weakness and occasional loose stool.
Age: 40.0
Sex: F
Vaccine: TDAP, YF, YF, YF
Symptoms: Presyncope, Pyrexia, Sinus disorder
Clinical narrative: Low grade fever first two days, then a near syncope episode on Tuesday night, sweating, clammy and nausea resulting in an ER visit. Since then I've been lightheaded, had sinus trouble, areas of cold and buzzing feelings which have traveled from my limbs to my back and to my head. Loss of appetite and increased feelings of anxiety. Muscle weakness and occasional loose stool.
Age: 40.0
Sex: F
Vaccine: TDAP, YF, YF, YF
Symptoms: Dizziness, Headache, Pyrexia, Syncope
Clinical narrative: Low grade fever first two days, then a near syncope episode on Tuesday night, sweating, clammy and nausea resulting in an ER visit. Since then I've been lightheaded, had sinus trouble, areas of cold and buzzing feelings which have traveled from my limbs to my back and to my head. Loss of appetite and increased feelings of anxiety. Muscle weakness and occasional loose stool.
Age: 40.0
Sex: F
Vaccine: TDAP, YF, YF, YF
Symptoms: Cold sweat, Decreased appetite, Headache, Hypotension, Muscular weakness
Clinical narrative: Low grade fever first two days, then a near syncope episode on Tuesday night, sweating, clammy and nausea resulting in an ER visit. Since then I've been lightheaded, had sinus trouble, areas of cold and buzzing feelings which have traveled from my limbs to my back and to my head. Loss of appetite and increased feelings of anxiety. Muscle weakness and occasional loose stool.
Age: 40.0
Sex: F
Vaccine: TDAP, YF, YF, YF
Symptoms: Nausea, Presyncope, Pyrexia, Sensory disturbance
Clinical narrative: Low grade fever first two days, then a near syncope episode on Tuesday night, sweating, clammy and nausea resulting in an ER visit. Since then I've been lightheaded, had sinus trouble, areas of cold and buzzing feelings which have traveled from my limbs to my back and to my head. Loss of appetite and increased feelings of anxiety. Muscle weakness and occasional loose stool.
Age: 42.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site urticaria, Swelling, Tenderness, Vaccination site pain
Clinical narrative: Area around vaccination site is swollen, red, and has a hives like appearance with radiated runners that look like welts. Area is warm to the touch and sore. Armpit of same arm is swollen and tender to the touch.
Age: 42.0
Sex: F
Vaccine: SMALL
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Area around vaccination site is swollen, red, and has a hives like appearance with radiated runners that look like welts. Area is warm to the touch and sore. Armpit of same arm is swollen and tender to the touch.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Complement factor C3, Contusion, Epistaxis, Haematuria, Immune thrombocytopenic purpura
Clinical narrative: Presented 12-29-17 wth 2 days of generalized petechial rash, nosebleeds X2. Labs 12-30-17 WBC 2.1, Pltt 30 ER 1-1-18 with bruising and hematuria, Admitted to medical Center. Dx  ITP. Given IVIG X2 , prednisone @ 70 mg. Discharged several days later on prednisone with ongoing FU with hematology.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immunoglobulin therapy, Inhibiting antibodies positive, Petechiae, Platelet count decreased, Rash generalised
Clinical narrative: Presented 12-29-17 wth 2 days of generalized petechial rash, nosebleeds X2. Labs 12-30-17 WBC 2.1, Pltt 30 ER 1-1-18 with bruising and hematuria, Admitted to medical Center. Dx  ITP. Given IVIG X2 , prednisone @ 70 mg. Discharged several days later on prednisone with ongoing FU with hematology.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: White blood cell count decreased
Clinical narrative: Presented 12-29-17 wth 2 days of generalized petechial rash, nosebleeds X2. Labs 12-30-17 WBC 2.1, Pltt 30 ER 1-1-18 with bruising and hematuria, Admitted to medical Center. Dx  ITP. Given IVIG X2 , prednisone @ 70 mg. Discharged several days later on prednisone with ongoing FU with hematology.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Sleep disorder
Clinical narrative: Patient reports pain in neck and upper shoulder but no rash. Pain affects her ability to sleep.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, MMRV, PNC13
Symptoms: Rash
Clinical narrative: Patient began developing rash to face and arms.
Age: 56.0
Sex: M
Vaccine: YF
Symptoms: Body temperature increased, Headache, Pain
Clinical narrative: Pt called this evening stating that since yesterday has had slight headache, slight body aches, and temperature of 99.8F. His doctor told him to call us to see if it was from YF vaccine. I told him that it is possible but we are in the flu season so he should see his doctor to be evaluated. He was thankful for the discussion.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Respiratory syncytial virus infection
Clinical narrative: This spontaneous report was received from a license practical nurse referring to currently 8 months old patient of unknown gender. The patient had no medical history, concurrent conditions or concomitant medications. On 12-JUL-2017, when the patient was 2 months old received the first dose of oral, ROTATEQ for prophylaxis lot N003970 and expiration date of 13-OCT-2018 (route of administration was not reported). On 14-SEP-2017, when the patient was 4 months old received the second dose of oral, ROTATEQ for prophylaxis lot N003970 and expiration date of 11-NOV-2018 (route of administration was not reported). On an unspecified date in 2017, (also reported as "on an unspecified date on or after 14-SEP-2017"), the patient developed respiratory syncytial virus infection (RSV). Furthermore, the patient sought medical attention and received treatment to the aforementioned event. The outcome of respiratory syncytial virus infection was unknown. Additionally, the reporter did not provide causality assessment between the event and therapy with ROTATEQ. Lot number N003970 is an invalid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent.
Sex: M
Vaccine: FLUX
Symptoms: Autism spectrum disorder, Learning disorder, Metal poisoning
Clinical narrative: Initial unsolicited report received from a consumer on 08-Jan-2018. This case involves a male patient (age not reported), who was vaccinated with INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, route and site of administration not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient seemed worse with his learning and he was diagnosed with mercury poisoning and heavy metal poisoning and he had autism diagnosis at the age of 11 (unit unspecified). Lab test and corrective treatment was not reported. Outcome of the events were unknown. Upon internal review the case was considered as serious because of important medical events. Documents held by sender: none. Sender's Comments: Time to onset was not known. No medical history or condition the time of vaccination was reported. Latency was also not reported. It is possible that the patient could have acquired heavy metal poisoning from alternate sources which should be investigated. Additional information regarding lab tests to confirm the diagnosis, medical history and name or lot number of the vaccine should also be requested to ascertain the causality with respect to the product. Based upon reported information the role of the vaccine cannot be assessed.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Infection, Pain, Skin ulcer
Clinical narrative: Pt noticed blisters next day after vaccination. Didn't hurt but was stinging. Pt came in on 12/23 or 12/24 and RPh told her to put ice pack on it and take BENADRYL. This became a sore/infected. Pt went to ER and has appt w/wound care on 1/19/18.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Swelling
Clinical narrative: Patient came complaining of soreness and swelling of her left side of her body (arm, side, and leg). When examining her arm, the location of the immunization was swollen and very warm. Patient's arm was also red from the area of the immunization given towards her arm. Referred patient to go to hospital or PCP to get it checked.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt called reporting that she had a fever after getting vaccinated. She also reported that the injection site was red and swollen and that area was "the size of her hand".
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site erythema, Pain
Clinical narrative: Redness around injection site, fist size. Felt tired and weak, aches lasting about 24 hours. Day naps and 8 hr night sleep.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reports that 1 day after injection he developed redness, soreness at the site, swelling, itching. He states this was on his left deltoid and spread up to his shoulder and into his left pectoral muscle on his chest. He states it lasted about 1 week before symptoms had fully resolved.