chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Hyperaesthesia, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Patient came in at 9am 5/30/2018 to report arm tenderness and swelling due to PPSV23 vaccination from yesterday. She showed me her arm, which presented a significant inflammatory reaction (redness/flushed, tenderness, swollen, painful/sensitive to touch, very warm) that involved the upper left arm, shoulder, and the top of the forearm. She stated it was so painful she couldn't sleep all night. She also stated she had a bad headache and just didn't feel good so she would go to her doctor to follow up. Considering it may have been an allergic reaction, I recommended patient take BENADRYL to reduce the inflammatory/allergy response. I also recommended for her to drink plenty of fluids, ice the area on/off for 10 minute intervals to reduce acute swelling and pain. I recommended TYLENOL for the headache. I asked if she has any GI or stomach problems and she said she just had an endoscopy and colonoscopy to diagnose some stomach pains. I recommended she talk to her doctor first before taking any anti-inflammatories (ie, ibuprofen) for that matter. The patient thanked me for taking the time and attention to address her concerns before leaving the store. I called her primary care physician's office and spoke with nurse @930am shortly after the patient left. I informed them of patient's symptoms and gave them advanced notice that patient would be coming in to be seen for treatment without an appointment scheduled. We will follow up with the patient.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Insomnia, Peripheral swelling
Clinical narrative: Patient came in at 9am 5/30/2018 to report arm tenderness and swelling due to PPSV23 vaccination from yesterday. She showed me her arm, which presented a significant inflammatory reaction (redness/flushed, tenderness, swollen, painful/sensitive to touch, very warm) that involved the upper left arm, shoulder, and the top of the forearm. She stated it was so painful she couldn't sleep all night. She also stated she had a bad headache and just didn't feel good so she would go to her doctor to follow up. Considering it may have been an allergic reaction, I recommended patient take BENADRYL to reduce the inflammatory/allergy response. I also recommended for her to drink plenty of fluids, ice the area on/off for 10 minute intervals to reduce acute swelling and pain. I recommended TYLENOL for the headache. I asked if she has any GI or stomach problems and she said she just had an endoscopy and colonoscopy to diagnose some stomach pains. I recommended she talk to her doctor first before taking any anti-inflammatories (ie, ibuprofen) for that matter. The patient thanked me for taking the time and attention to address her concerns before leaving the store. I called her primary care physician's office and spoke with nurse @930am shortly after the patient left. I informed them of patient's symptoms and gave them advanced notice that patient would be coming in to be seen for treatment without an appointment scheduled. We will follow up with the patient.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Patient came in at 9am 5/30/2018 to report arm tenderness and swelling due to PPSV23 vaccination from yesterday. She showed me her arm, which presented a significant inflammatory reaction (redness/flushed, tenderness, swollen, painful/sensitive to touch, very warm) that involved the upper left arm, shoulder, and the top of the forearm. She stated it was so painful she couldn't sleep all night. She also stated she had a bad headache and just didn't feel good so she would go to her doctor to follow up. Considering it may have been an allergic reaction, I recommended patient take BENADRYL to reduce the inflammatory/allergy response. I also recommended for her to drink plenty of fluids, ice the area on/off for 10 minute intervals to reduce acute swelling and pain. I recommended TYLENOL for the headache. I asked if she has any GI or stomach problems and she said she just had an endoscopy and colonoscopy to diagnose some stomach pains. I recommended she talk to her doctor first before taking any anti-inflammatories (ie, ibuprofen) for that matter. The patient thanked me for taking the time and attention to address her concerns before leaving the store. I called her primary care physician's office and spoke with nurse @930am shortly after the patient left. I informed them of patient's symptoms and gave them advanced notice that patient would be coming in to be seen for treatment without an appointment scheduled. We will follow up with the patient.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a clinical lead refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 08-MAY-2018, the patient was inadvertently vaccinated with both PROQUAD lot # N025719, expiration date 17-MAR-2019 (dose and route of administration were not reported) and VARIVAX lot # N012131, expiration date 17-APR-2019 (dose and route of administration were not reported). No adverse effects were reported in the patient at  time of the report.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-MAY-2018, the patient was vaccinated with an expired dose of ROTATEQ oral liquid, orally, lot # M038846, expiration date 26-APR-2018 (exact dose was not reported). Used ROTATEQ did not have any temperature excursions prior to administration. No adverse symptoms were reported. Lot number M038846 has been verified to be a valid lot number for ROTATEQ.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Administration site induration, Administration site inflammation, Incorrect route of drug administration, Local reaction, Pain
Clinical narrative: This spontaneous report was received from a physician and refers to a 15-year-old female patient with no pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter mentioned that on 14-MAY-2018, the patient was supposed to receive a dose of tuberculin purified protein derivative (PPD); however, instead of that, she received mistakenly a dose of GARDASIL 9 intradermal instead of intramuscularly (strength, dose, frequency, anatomical location, lot number, and expiration date were not reported) for an unspecified reason. On the same date, the patient began to have a "local reaction" which was described as an 1 centimeter area of induration surrounded by a 4x4 area of inflammation on the left forearm at the administration site; additionally, the patient mentioned that the local reaction was also painful. It was reported that the patient sought for medical attention but laboratory tests or diagnostic procedures were not performed. The patient was treated with cephalexin (KEFLEX) and consequently, on an unknown date, the patient recovered from the adverse events.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician and refers to a 15-year-old female patient with no pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter mentioned that on 14-MAY-2018, the patient was supposed to receive a dose of tuberculin purified protein derivative (PPD); however, instead of that, she received mistakenly a dose of GARDASIL 9 intradermal instead of intramuscularly (strength, dose, frequency, anatomical location, lot number, and expiration date were not reported) for an unspecified reason. On the same date, the patient began to have a "local reaction" which was described as an 1 centimeter area of induration surrounded by a 4x4 area of inflammation on the left forearm at the administration site; additionally, the patient mentioned that the local reaction was also painful. It was reported that the patient sought for medical attention but laboratory tests or diagnostic procedures were not performed. The patient was treated with cephalexin (KEFLEX) and consequently, on an unknown date, the patient recovered from the adverse events.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report has been received from a pharmacist and referring to a currently 48-year-old female patient with no pertinent medical history, concurrent conditions, concomitant medications, and drug reaction or allergies. On 16-MAY-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly (IM) in the left deltoid muscle, lot number R002085, expiration date 26-OCT-2019 (strength, dose, and frequency were not reported) for prophylaxis also reported as "pneumococcal". On an unspecified date, the patient experienced redness, swelling and rash at the injection site and consequently she was advised to go to an emergency room (ER) and being there, the patient was placed on treatment with BENADRYL. No laboratory tests or diagnostic procedures were performed. At the reporting time, it was unknown whether the patient recovered or not from the adverse events. The causal relationship between the adverse events and the therapy with PNEUMOVAX 23 was not provided.
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 31 year old female patient. Pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 23-MAY-2018, the patient was vaccinated with a dose of PROQUAD lot # N020010, expiry date: 13-JAN-2019, for prophylaxis (strength, dose, route, dosage schedule and anatomical location were not provided). No adverse effects reported.
Sex: F
Vaccine: VARCEL
Symptoms: Mouth swelling, Oral pruritus, Pruritus, Swelling face
Clinical narrative: This spontaneous report was received from a company representative's son via a company representative and refers to an 18-year-old female patient with allergy to gelatin. No information regarding her medical history or concomitant medications was provided. On 24-MAY-2018, the patient was vaccinated with a dose of Oka/Merck VARIVAX injection (dose, route of administration, lot number and expiration date were not reported) as a part of vaccinations for school. On the same day, 10 minutes after the administration of the vaccine, the patient experienced facial and mouth itching and swelling. She was treated with an epinephrine injection and was subsequently sent to an emergency room. The outcome of the events was unknown. The relatedness between the events and Oka/Merck VARIVAX was not reported. Upon internal review, the events of itching and swelling face and mouth were considered to be medically significant due to treatment with epinephrine.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: This spontaneous report was received from a company representative and refers to her 18 year old son. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient's injection site was red and inflamed (injection site inflammation and injection site erythema). The outcome of injection site inflammation and injection site erythema and the causal relationship between the aforementioned events and therapy with GARDASIL 9 was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 23-MAY-2018, the patient was vaccinated with the first dose of GARDASIL 9 (lot number N010497 with expiration date on 15-JAN-2020) (strength and anatomical location were not provided), administered intramuscularly for prophylaxis. After vaccination, she had a pregnancy test which showed that she was pregnant. No adverse effect was reported. Her last menstrual period (LMP), estimated date of delivery (EDD), gestational age and trimester of exposure were not provided. At the time of this report, the pregnancy outcome was pending.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a consumer, concerning a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with one dose of VAQTA (lot #, expiration date, strength, anatomical location or route of administration were not provided), for prophylaxis; but it was expired by 1 month. No adverse effects were reported.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Red inflammation around injection site. Patient does have a latex allergy, but band aid was latex free.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, RV5
Symptoms: Respiratory tract congestion, Sleep apnoea syndrome, Vomiting
Clinical narrative: I'm not sure which series of shots caused but at 7 months we finally brought our son in due to sleep apnea which started somewhere after he was 6 months after his vaccinations. He started having vomiting; Congestion; And sleep apnea.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Swelling face
Clinical narrative: Swelling to cheeks (worse to left cheek), swelling to right upper arm, erythema to right upper arm.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Injury associated with device, Scratch
Clinical narrative: When RN attempted to administer Varicella, child kicked and dislodged needle from injection site, causing two small needle scratches the size of pin points. RN changed needle, re-cleaned area, and reinserted and injected varicella vaccination without incident on second attempt.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 7 year old male patient. On an unknown date, at 12 months of age, the patient was vaccinated with a dose of VARIVAX for prophylaxis (lot #, dose, route and site of administration were not reported). On an unknown date, approximately 6 years after vaccination, the patient was diagnosed with shingles. The outcome of shingles was unknown. Causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a adult female patient who received SHINGRIX. Concurrent medical conditions included Crohn's disease (Crohn's disease and is on medications which suppress my immune system). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, muscle pain, influenza-like symptoms and adverse event. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the chills, muscle pain, influenza-like symptoms and adverse event were unknown. It was unknown if the reporter considered the fever, chills, muscle pain, influenza-like symptoms and adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had a fairly bad reaction to the SHIGRIX vaccine, she had all of the possible side effects that were listed, including fever, chills, muscle aches, flu-like symptoms, etc. The fever lasted on an off for about 3 days. The patient has Crohn's disease and she was on medications which suppressed her immune system. The patient's doctor told her to contact to see what the company's recommendation was for people like her as far as getting the 2nd dose of the vaccine. The patient questioned about recommendation of the 2nd dose even if people had a bad reaction, the patient also want to know if the 2nd dose usually cause as bad of a reaction as the 1st dose.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Injection site nodule, Malaise, Nausea
Clinical narrative: Day 1: Swollen arm, malaise Day 2: Swollen arm, hives, itching, headache, nausea, diarrhea, aches Day 3:  knot at injection sight.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Day 1: Swollen arm, malaise Day 2: Swollen arm, hives, itching, headache, nausea, diarrhea, aches Day 3:  knot at injection sight.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Eructation, Fatigue, Feeling abnormal
Clinical narrative: The morning after the vaccine, woke feeling tired, some nausea and returned to bed without breakfast. Remained in bad all day with severe shaking and chills about  2:30 PM. Pharmacist suggested Tylenol so took one then to bed. Cold and shivering. Temperature by digital thermometer 101 but steadily increased to 103 deg F by 3:30 PM. Tired, in bed, nauseous, slight head ache and temperature began to decrease at 4 PM down to and holding at 101.2 by 6 PM. Not able to complete supper and back to bed at 6:20 PM. More minor chills, feeling poorly , tired with some burping and no energy. This morning, 7:30 AM feeling some better but tired and temperature  99.5.  My vaccine results were minor but gave tired feeling beyond normal for one day after the vaccine.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Nausea, Tremor
Clinical narrative: The morning after the vaccine, woke feeling tired, some nausea and returned to bed without breakfast. Remained in bad all day with severe shaking and chills about  2:30 PM. Pharmacist suggested Tylenol so took one then to bed. Cold and shivering. Temperature by digital thermometer 101 but steadily increased to 103 deg F by 3:30 PM. Tired, in bed, nauseous, slight head ache and temperature began to decrease at 4 PM down to and holding at 101.2 by 6 PM. Not able to complete supper and back to bed at 6:20 PM. More minor chills, feeling poorly , tired with some burping and no energy. This morning, 7:30 AM feeling some better but tired and temperature  99.5.  My vaccine results were minor but gave tired feeling beyond normal for one day after the vaccine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Ear congestion, Fatigue, Headache, Injection site erythema
Clinical narrative: Fever, chills, body aches, headache, plugged right ear, exhaustion, 3 x 5" redness at injection site, pain at injection site. This has been going on for 3 days -- I don't know when it will end. I have never had an adverse reaction to a shot before, except for a sore arm for a few days. I am a very healthy woman. This reaction has been a bizarre experience for me.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, headache, plugged right ear, exhaustion, 3 x 5" redness at injection site, pain at injection site. This has been going on for 3 days -- I don't know when it will end. I have never had an adverse reaction to a shot before, except for a sore arm for a few days. I am a very healthy woman. This reaction has been a bizarre experience for me.
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: C-reactive protein increased, Protein total increased
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of serum total protein increased in a male patient who received SHINGRIX. Co-suspect products included PREVENAR 13. On an unknown date, the patient received SHINGRIX at an unknown dose and PREVENAR 13 at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced serum total protein increased. On an unknown date, the outcome of the serum total protein increased was unknown. It was unknown if the reporter considered the serum total protein increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter refused to provide full demographics of the patient. The patient declined to participate in the adverse event report. The reporter was the patient's wife who reported that the patient experienced a high unspecified active protein count when getting blood work done after taking SHINGRIX and PREVENAR 13. It was unknown if the reporter considered the serum total protein increased to be related to PREVENAR 13. No product quality complaint was reported. No additional adverse event information was provided.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Mouth swelling
Clinical narrative: Patient's mouth started to swell along with getting lumps on the roof of her mouth and back of her throat. Patient was given BENADRYL which brought down swelling.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Patient has complained of red welt just below injection site that is red and tender. Patient contacted pharmacy about this reaction 48 hours after the injection. Advised patient to apply some topical hydrocortisone 1 percent cream and monitor for signs and symptoms of infection including worsening of the area and streaking.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Myalgia, Pyrexia
Clinical narrative: Muscle ache, chills, 102 fever, lethargic-lasted 2-3 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Pain/warmth/redness at injection site, aches/flu symptoms.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in in an unspecified number of patients who received BEXSERO. On an unknown date, the patients received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patients experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional information were provided as follows: The age at vaccination was not applicable. The medical assistant stated that she had observed a sore arm for up to 10 days in some cases.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a 55-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and pain. On an unknown date, the outcome of the influenza-like symptoms and pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and pain to be related to SHINGRIX. Additional details were provided as follows: The patient felt pain for a day but severe flu like symptoms below the waist for 2 days.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin warm, Swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in upper extremities in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in upper extremities, local swelling and skin warm. On an unknown date, the outcome of the pain in upper extremities, local swelling and skin warm were unknown. It was unknown if the reporter considered the pain in upper extremities, local swelling and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patients arm had a pretty good size lump larger than a quarter and it was warm and it was really hurting. The patient asked whether it was normal.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Drug administered to patient of inappropriate age, Herpes zoster, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of shingles in a 44-year-old female patient who received SHINGRIX. The patient's past medical history included shingles. Previously administered products included ZOVIRAX (had a history of shingles and had been taking ZOVIRAX for suppression up to 22nd April). Concomitant products included Levothyroxine. On 23rd April 2018, the patient received the 1st dose of SHINGRIX. On 23rd April 2018, unknown after receiving SHINGRIX, the patient experienced inappropriate age at vaccine administration. On 24th April 2018, the patient experienced pain, chills and fever. On 14th May 2018, the patient experienced shingles. On an unknown date, the outcome of the shingles was unchanged and the outcome of the pain, chills and fever were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown. The reporter considered the shingles to be possibly related to SHINGRIX. It was unknown if the reporter considered the pain, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. This case was previously reported to the doctor. The patient reported that since 2007, she had averages 6 to 8 shingles outbreaks per year. A 44 year old age at vaccine administration. The patient also reported fever, achy, and chills the next day of vaccination, which resolved in 3 days. The patient reported that this last case of shingles was the worse she ever experienced. The case was reported after hours reporter was received voice mail at 6:27 PM. The reporter heard the message and called back and spoke to the patient. The patient was driving, but consented to received a Safety letter for specific doctor information and lot number.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX. Previously experienced adverse reactions included injection site swelling, injection site erythema, injection site rash and discomfort (see case US2018GSK011692). Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received in January 2018). Concomitant products included ADVIL and BENADRYL. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovered/resolved. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The reporter was the husband of the patient. The age at vaccination was not reported. The reporter declined to answer any follow-up questions during the call. The reporter wanted to relay information to GSK about what the healthcare professional directed in order to be shared with other future consumers. The patient received second dose in the SHINGRIX series a couple of weeks before the date of reporting. Her healthcare professional told her to take an over the counter BENADRYL about 30 minutes to 1 hour prior to having the 2nd dose in the series. Then after having the 2nd dose of the series, her physician told her to take another BENADRYL 2 to 3 hours afterwards and then, if needed to take another in 4 hours. Also, the patient was instructed to take two 2 over the counter ADVIL along with the BENADRYL 2 to 3 hours after having had the 2nd dose of SHINGRIX. The patient followed the physician's instructions and had only a minor reaction for a couple of days after the 2nd dose in the series. The reporter declined to address any questions or to be further contacted, so there was no further related information beyond what was documented. The reporter declined to provide his specific mailing address beyond zip code or his phone number. The reporter said his wife had already contacted GSK to report her reactions after the 1st dose in the series.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: Area of erythema 7cm x 8cm, firm to the tough and tender to palpation.
Age: 63.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient received two vaccines in our pharmacy on 5/30/18. Engerix B (NDC 58160-0821-43) in her left arm and SHINGRIX (NDC 58160-0829-03) in her right arm. Patient came in on 5/31/18 stating that her right arm had swelling, redness and was itchy. She stated she had already taken Ibuprofen which seemed to be helping and was directed to continue that as well as OTC hydrocortisone if the itching continued. She was also told to follow up with her PCP if the reaction got any worse. Patient was satisfied with this information.
Age: 56.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise, Middle insomnia
Clinical narrative: Pt describes waking up in the middle of the night with a fever of 102. Continued fever throughout the next day. Feeling of Malaise continuing through today. Sore arm. Erythema and swelling and heat detectable to the touch at and around the injection site from 2 inches above the injection and going down the arm to the elbow. The approximate width of the visible rash is 2 - 3 inches.
Age: 56.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: Pt describes waking up in the middle of the night with a fever of 102. Continued fever throughout the next day. Feeling of Malaise continuing through today. Sore arm. Erythema and swelling and heat detectable to the touch at and around the injection site from 2 inches above the injection and going down the arm to the elbow. The approximate width of the visible rash is 2 - 3 inches.
Age: 0.25
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Was informed by,CMA that wrong vaccine was given to patient. VFC Tdap was given in place of Required Dtap. Called CDC and spoke to person at CDC. Per CDC there is no contraindication for the patient to have received Tdap but that Dtap should be administer as soon as possible to patient. Verfied with CDC that patient had immunizations 10 days ago and it is ok for patient to have Dtap administered tomorrow. CDC states that patient can receive Dtap immunization as soon as possible. Called and spoke to patient's mother regarding Wrong Vaccine given to patient. Verified identification with Last name and Date of Birth. Patient's Mother was informed accidentally patient received wrong immunization 10 days ago. Mother was informed that CDC was called and that there are no issues or should not Be any problems with patient receiving Tdap and that Dtap needs to be administered as soon as possible to patient. Mother scheduled for DTap Immunization on 06/01/2018. Patient has no further questions at this time.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 74-year-old male patient who received SHINGRIX. On 21st May 2018, the patient received the 1st dose of SHINGRIX. On 21st May 2018, less than a day after receiving SHINGRIX, the patient experienced fever, muscle pain, upset stomach and headache. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever, muscle pain, upset stomach and headache were not recovered/not resolved. The reporter considered the fever, muscle pain, upset stomach and headache to be related to SHINGRIX. Additional details were provided as follows: The patient declined to provided concomitant medications. The patient was administered SHINGRIX in the right arm in the evening. Around 9 pm, the patient developed fever and the body temperature was recorded as 100 degree F, headache, muscle aches and upset stomach. The patient was unable to provide full pharmacy demographics. The patient took TYLENOL to treat the fever. The patient had denied permission to contact their physician.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Dizziness, Headache, Laboratory test normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 82-year-old female patient who received SHINGRIX. The patient's past medical history included back surgery (has rods and screws in her back). Concomitant products included simvastatin, lisinopril and PROCARDIA. On 10th April 2018, the patient received the 1st dose of SHINGRIX. On 12th April 2018, 2 days after receiving SHINGRIX, the patient experienced fever and chills. On 14th April 2018, the patient experienced vomiting. In April 2018, the patient experienced dizziness and headache. In May 2018, the patient experienced back pain. On an unknown date, the patient experienced activities of daily living impaired. The patient was treated with Meclizine and NOS Steroids. On an unknown date, the outcome of the fever, chills and vomiting were recovered/resolved and the outcome of the back pain, dizziness and headache were not recovered/not resolved and the outcome of the activities of daily living impaired was unknown. It was unknown if the reporter considered the fever, back pain, dizziness, headache, chills, vomiting and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: In the morning, the patient received SHINGRIX on left arm. Four days after receiving SHINGRIX, the patient started to vomit at 11:00 at night, which lasted until 3:00 am the next morning. The dizziness and headache started at end of April (less than a month after vaccination). The dizziness had improved but it was still slightly present. The headache was on the top of the patient's head. On 5th May 2018, the patient had a steroid shot to help relieve symptoms and was prescribed meclizine and that did not work. The patient also had Magnetic resonance imaging (MRI) in the week before reporting and other tests were done a day before reporting and the test results were clean. There was no presence of crystals in her ears. The patient was not hospitalized due to the symptoms. The patient said she was immobilized by them because she could not got out and could not get her regular physical therapy treatments and exercise her back hurts.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Nuclear magnetic resonance imaging normal, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 82-year-old female patient who received SHINGRIX. The patient's past medical history included back surgery (has rods and screws in her back). Concomitant products included simvastatin, lisinopril and PROCARDIA. On 10th April 2018, the patient received the 1st dose of SHINGRIX. On 12th April 2018, 2 days after receiving SHINGRIX, the patient experienced fever and chills. On 14th April 2018, the patient experienced vomiting. In April 2018, the patient experienced dizziness and headache. In May 2018, the patient experienced back pain. On an unknown date, the patient experienced activities of daily living impaired. The patient was treated with Meclizine and NOS Steroids. On an unknown date, the outcome of the fever, chills and vomiting were recovered/resolved and the outcome of the back pain, dizziness and headache were not recovered/not resolved and the outcome of the activities of daily living impaired was unknown. It was unknown if the reporter considered the fever, back pain, dizziness, headache, chills, vomiting and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: In the morning, the patient received SHINGRIX on left arm. Four days after receiving SHINGRIX, the patient started to vomit at 11:00 at night, which lasted until 3:00 am the next morning. The dizziness and headache started at end of April (less than a month after vaccination). The dizziness had improved but it was still slightly present. The headache was on the top of the patient's head. On 5th May 2018, the patient had a steroid shot to help relieve symptoms and was prescribed meclizine and that did not work. The patient also had Magnetic resonance imaging (MRI) in the week before reporting and other tests were done a day before reporting and the test results were clean. There was no presence of crystals in her ears. The patient was not hospitalized due to the symptoms. The patient said she was immobilized by them because she could not got out and could not get her regular physical therapy treatments and exercise her back hurts.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Eye inflammation, Gait disturbance, Injection site erythema, Photophobia, Vision blurred
Clinical narrative: This is a spontaneous report from a contactable consumer. The 74-year-old female consumer received PREVNAR 13 on 22May2018 at single dose for immunisation. Medical history included glaucoma. The concomitant medications were not reported. The consumer developed localized redness on arm at injection site. It was a little better but still red. She also reported blurred vision and "bubbly vision" in left eye since the shot. She reported blurred vision in both eyes but left eye was much worse. She also saw floaters; had sensitivity to bright light. When she went outside it's like someone poured a "shaker full of bubbles" in her left eye. She need to wear sunglasses outside and inside. She had difficulty reading and trouble walking. She was very concerned about losing her eyesight. She went to eye Doctor the day before for assessment. Her eye doctor said he's never seen so much inflammation in her eyes before. She stated blurriness and 'bubbles' appeared the next day and had not improved at all. She reported having allergies which she took allergy shots for. Outcome of the blurred vision much worse was not recovered, localized redness was recovering, other events was unknown.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Visual impairment, Vitreous floaters
Clinical narrative: This is a spontaneous report from a contactable consumer. The 74-year-old female consumer received PREVNAR 13 on 22May2018 at single dose for immunisation. Medical history included glaucoma. The concomitant medications were not reported. The consumer developed localized redness on arm at injection site. It was a little better but still red. She also reported blurred vision and "bubbly vision" in left eye since the shot. She reported blurred vision in both eyes but left eye was much worse. She also saw floaters; had sensitivity to bright light. When she went outside it's like someone poured a "shaker full of bubbles" in her left eye. She need to wear sunglasses outside and inside. She had difficulty reading and trouble walking. She was very concerned about losing her eyesight. She went to eye Doctor the day before for assessment. Her eye doctor said he's never seen so much inflammation in her eyes before. She stated blurriness and 'bubbles' appeared the next day and had not improved at all. She reported having allergies which she took allergy shots for. Outcome of the blurred vision much worse was not recovered, localized redness was recovering, other events was unknown.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Intraocular lens implant, Ophthalmological examination abnormal, Visual impairment, Vitreous floaters
Clinical narrative: This is a spontaneous report from a contactable consumer. The 74-year-old female consumer received PREVNAR 13 on 22May2018 at single dose for immunisation. Medical history included glaucoma. The concomitant medications were not reported. The consumer developed localized redness on arm at injection site. It was a little better but still red. She also reported blurred vision and "bubbly vision" in left eye since the shot. She reported blurred vision in both eyes but left eye was much worse. She also saw floaters; had sensitivity to bright light. When she went outside it's like someone poured a "shaker full of bubbles" in her left eye. She need to wear sunglasses outside and inside. She had difficulty reading and trouble walking. She was very concerned about losing her eyesight. She went to eye Doctor the day before for assessment. Her eye doctor said he's never seen so much inflammation in her eyes before. She stated blurriness and 'bubbles' appeared the next day and had not improved at all. She reported having allergies which she took allergy shots for. Outcome of the blurred vision much worse was not recovered, localized redness was recovering, other events was unknown.
Sex: M
Vaccine: PNC13
Symptoms: Injection site irritation, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer-sales representative. This pharmacist reported similar events for two patients. This is the first of two reports. A 7-decade-old (reported as sixties) male patient received PREVNAR 13, via an unspecified route of administration, on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe rash and irritation at injection site on an unspecified date. The outcome of the events, severe rash and irritation at injection site was unknown. Information on batch number has been requested. Sender's Comments: Linked Report(s): PFIZER INC-2018223202 same reporter, events, drug, and different patients.
Age: 8.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site irritation, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported similar events for two patients. This is 2nd of two reports. An 8-decade-old (seventies) female patient started to receive PREVNAR 13 (lot number and expiration date not provided), via an unspecified route of administration from an unspecified date a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe rash and irritation at injection site. Outcome of the events were unknown. Information on batch number has been requested. Sender's Comments: Linked Report(s): PFIZER INC-2018223185 Same reporter/product/event, different patient.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Crying, Hyperventilation, Hypoaesthesia, Posture abnormal, Respiratory rate increased
Clinical narrative: Following administration of the HPV vaccine, patient fell back on the exam table-started shaking. She was breathing very fast and crying. Then patient stated that her arm/hands felt numb. She was treated for hyperventilation with paper bag rebreathing. Pt regained sensation in her arms/hands and was able to leave clinic about 30 mins following vaccinations.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Tremor
Clinical narrative: Following administration of the HPV vaccine, patient fell back on the exam table-started shaking. She was breathing very fast and crying. Then patient stated that her arm/hands felt numb. She was treated for hyperventilation with paper bag rebreathing. Pt regained sensation in her arms/hands and was able to leave clinic about 30 mins following vaccinations.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction, Axillary pain, Body temperature increased, Contusion, Erythema
Clinical narrative: Shot given on 4/14/18. Pain at site and underarm with swelling by early evening. Brief nausea and profuse sweating 4/15/18 with brief mild temp of 99.4 degrees. On 4/16 swelling spread to collar bone, arms and hands; plus bruising under arm. On 4/18 even more bruising from side of body with red stripes. Saw doctor who prescribed 3 days of prednisone. Bruising and swelling gone around 5/27/18.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site pain, Nausea, Peripheral swelling, Swelling
Clinical narrative: Shot given on 4/14/18. Pain at site and underarm with swelling by early evening. Brief nausea and profuse sweating 4/15/18 with brief mild temp of 99.4 degrees. On 4/16 swelling spread to collar bone, arms and hands; plus bruising under arm. On 4/18 even more bruising from side of body with red stripes. Saw doctor who prescribed 3 days of prednisone. Bruising and swelling gone around 5/27/18.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Ultrasound Doppler
Clinical narrative: (R) deltoid swelling, tenderness, multiple spreading areas of erythema, LOM to RUE. Recovering with ABX and steroid.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: This case was reported by a other health professional and described the occurrence of injection site rash in a 82-year-old female patient who received SHINGRIX (batch number 32GR4 ?, expiry date unknown). On 10th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a month after receiving SHINGRIX, the patient experienced injection site rash, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site rash, injection site warmth and injection site itching were not recovered/not resolved. The reporter considered the injection site rash, injection site warmth and injection site itching to be probably related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy intern. The age at vaccination was not reported. The reporter did not know how soon the events were started after the vaccination. The pharmacist recommended BENADRYL for the patient.
Age: 45.0
Sex: F
Vaccine: HIBV, MEN, PPV
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site nodule, Injection site pain, Limb discomfort
Clinical narrative: My pain starts same day of these vaccines and is getting worse. My both arms are weak, can't even raised them for one minute because I feel heaviness and pain right where the shots was given. I feel nodules on shot site and my joints are painful.
Age: 45.0
Sex: F
Vaccine: HIBV, MEN, PPV
Symptoms: Muscular weakness, Pain
Clinical narrative: My pain starts same day of these vaccines and is getting worse. My both arms are weak, can't even raised them for one minute because I feel heaviness and pain right where the shots was given. I feel nodules on shot site and my joints are painful.