chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Injection site erythema, Pyrexia
Clinical narrative: injection site redness; Fever; chills; This is a spontaneous report from a contactable other healthcare professional (HCP). This Other HCP reported similar events for 2 patients on behalf of physician. This is 2nd of two reports.   A 15-year-old female patient started to receive meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on 25Apr2019 at a single dose for immunisation. The patient's medical history concomitant medications were not reported. The patient experienced fever, chills, and injection site redness on an unspecified date. The outcome of events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019337069 same reporter/drug different patients with similar events
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Patient experienced redness and at the injection site; This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history was not reported. Concomitant medication included influenza vaccine for immunization. The patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)and flu vaccine concomitantly in separate arms. The patient experienced redness and at the injection site. Outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: U
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Syncope; This is a spontaneous report from a contactable health care professional via Pfizer Sales Representative. This health care professional reported similar events for 3 patients. This is 1s of 3 reports.   A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced syncope on an unspecified date. Event took place after use of product. The outcome was unknown.  The information on the batch number has been requested.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 contributed to the development of the reported event syncope.,Linked Report(s) : US-PFIZER INC-2019341788 same drug/event/reporter, different patient;US-PFIZER INC-2019341787 same drug/event/reporter, different patient
Sex: U
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Syncope; This is a spontaneous report from a contactable health care professional via Pfizer Sales Representative. This health care professional reported similar events for 3 patients. This is 2nd of 3 reports.  A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced syncope on an unspecified date. Event took place after use of product. The outcome was unknown.  The information on the batch number has been requested.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 contributed to the development of the reported event syncope.,Linked Report(s) : US-PFIZER INC-2019341772 same drug/event/reporter, different patient;US-PFIZER INC-2019341788 same drug/event/reporter, different patient
Sex: F
Vaccine: FLUX, PPV
Symptoms: Allergy to vaccine, Drug hypersensitivity, Food allergy, Rubber sensitivity
Clinical narrative: allergic to pneumococcal vaccines, Avelox, Benadryl, codeine, Darvon, Demerol, erythromycin base, hydrocodone, Influenza vaccines, Lasix, Neosporin af, Novocain, prednisone, Robitussin (alcohol free); This is a spontaneous report from a Pfizer-sponsored program. A contactable prescribing physician reported that a 76-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (manufacturer unknown) at a single dose and influenza vaccine both administered via an unspecified route of administration for immunization; erythromycin, guaifenesin (ROBITUSSIN alcohol free), meperidine hcl (DEMEROL), moxifloxacin hydrochloride (AVELOX), diphenhydramine hydrochloride (BENADRYL), codeine, dextropropoxyphene hydrochloride (DARVON), hydrocodone, furosemide (LASIX), miconazole (NEOSPORIN AF), procaine (NOVOCAIN), and prednisone, all via unspecified routes of administration on unspecified dates at unknown doses for unspecified indications. The patient's medical history and concomitant medications were not reported. It was reported that the patient was allergic to pneumococcal vaccines, moxifloxacin (AVELOX), diphenhydramine (BENADRYL), codeine, propoxyphene (DARVON), meperidine (DEMEROL), erythromycin base, guaifenesin (ROBITUSSIN alcohol free), hydrocodone, Influenza vaccines, furosemide (LASIX), miconazole (NEOSPORIN AF), and procaine (NOVOCAIN), and prednisone on unspecified dates. The patient also had allergies with penicillins, latex, potassium-containing compounds, shellfish-derived products, sulfa antibiotics, and wheat. The action taken in response to the event for erythromycin, guaifenesin, meperidine hcl, moxifloxacin hydrochloride, diphenhydramine hydrochloride, codeine, dextropropoxyphene hydrochloride, hydrocodone, furosemide, miconazole, procaine, and prednisone and the outcome of the event were unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and erythromycin in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and erythromycin has submitted the same report to the regulatory authorities.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Wrong technique in product usage process
Clinical narrative: When administered the vaccine needle was too short (< 130 lb patient). We need to re immunize with proper needle Spoke to doctor, we will re-immunize.
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: Patient was immunized with a Pediatric needle She is closely with her doctor. If need to be reimmunized with adult needle. Patient will have to be reimmunized with an adult needle.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Fatigue, Lymph node pain
Clinical narrative: Pt awoke To pain concentrated around lymph nodes all along the Right side accompanied by severe fatigue. She presents today saying symptoms are less intense but has not fully resolved
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Pyrexia, Swelling of eyelid, Visual impairment, Vomiting
Clinical narrative: The husband said that within 24 hours of the vaccine the patient was having vomiting, diarrhea, a fever with a temp of over 101 and swelling of the eyelids that hindered her vision.  All of the symptoms lasted for over 7 days, except for the eye swelling which is still continuing.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Blepharospasm, Blood test normal, Chest X-ray normal, Chest pain, Dyskinesia
Clinical narrative: About 30 minutes after receiving the vaccine, client became syncopal. He was driving a motor vehicle. He pulled over and had his wife drive him to the local emergency room. Wife stated he had seizure like activity including head rolling back, eyes twitching, upper body movement. He also complained of chest pain. He was given an EKG, chest x-ray and blood work. All were normal. Client was given 2 liters of fluid. He had not eaten since 6 am that morning
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Electrocardiogram normal, Impaired driving ability, Posture abnormal, Seizure like phenomena, Syncope
Clinical narrative: About 30 minutes after receiving the vaccine, client became syncopal. He was driving a motor vehicle. He pulled over and had his wife drive him to the local emergency room. Wife stated he had seizure like activity including head rolling back, eyes twitching, upper body movement. He also complained of chest pain. He was given an EKG, chest x-ray and blood work. All were normal. Client was given 2 liters of fluid. He had not eaten since 6 am that morning
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Headache  swelling and pain at injection site about 3 to 4 hours  Chills and nausea  about 12 hours
Age: 29.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Injection site induration, Injection site paraesthesia, Injection site warmth
Clinical narrative: right upper arm induration, warmth, 9cm c/o headache once 8/12 and tingling at injection site 8/10 and 8/11
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Chills, Full blood count, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within 2 hours of vaccine administration patient began to experience body aches, chills, low grade fever, and injection site swelling , pain, and heat. About 4 hours after vaccine administration patient experienced several episodes of vomiting that resolved within two hours. Re-evaluated in office 7 hours after vaccine administration and given 50mg IM Benadryl. Blood work done to evaluate CBC and ESR.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Lymphocyte count, Neutrophil count, Pain, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: Within 2 hours of vaccine administration patient began to experience body aches, chills, low grade fever, and injection site swelling , pain, and heat. About 4 hours after vaccine administration patient experienced several episodes of vomiting that resolved within two hours. Re-evaluated in office 7 hours after vaccine administration and given 50mg IM Benadryl. Blood work done to evaluate CBC and ESR.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Within 2 hours of vaccine administration patient began to experience body aches, chills, low grade fever, and injection site swelling , pain, and heat. About 4 hours after vaccine administration patient experienced several episodes of vomiting that resolved within two hours. Re-evaluated in office 7 hours after vaccine administration and given 50mg IM Benadryl. Blood work done to evaluate CBC and ESR.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Chills, Injection site swelling, Lymphocyte count decreased, Neutrophil count increased, Pain
Clinical narrative: Within 2 hours of vaccine administration patient began to experience body aches, chills, low grade fever, and injection site swelling , pain, and heat. About 4 hours after vaccine administration patient experienced several episodes of vomiting that resolved within two hours. Re-evaluated in office 7 hours after vaccine administration and given 50mg IM Benadryl. Blood work done to evaluate CBC and ESR.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Pyrexia, Skin warm, Vomiting, White blood cell count increased
Clinical narrative: Within 2 hours of vaccine administration patient began to experience body aches, chills, low grade fever, and injection site swelling , pain, and heat. About 4 hours after vaccine administration patient experienced several episodes of vomiting that resolved within two hours. Re-evaluated in office 7 hours after vaccine administration and given 50mg IM Benadryl. Blood work done to evaluate CBC and ESR.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Chills, Fatigue, Injection site erythema, Injection site induration
Clinical narrative: In addition to hard red lump at injection site and tiredness and chills the next day, pt reports itchy rash on scalp from temple to facial hairline mostly on left side of head, but itchy all over head. She stated there were weeping sores in addition to the "pimply" rash. Head and Shoulders shampoo helped a bit. She has an appointment to see her Dr later this month (6 weeks after rash occurred.) Symptoms started a few days after second vaccination on 7/2/19, and she still has some symptoms today 8/13/19.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Pruritus, Rash, Rash pruritic, Skin weeping
Clinical narrative: In addition to hard red lump at injection site and tiredness and chills the next day, pt reports itchy rash on scalp from temple to facial hairline mostly on left side of head, but itchy all over head. She stated there were weeping sores in addition to the "pimply" rash. Head and Shoulders shampoo helped a bit. She has an appointment to see her Dr later this month (6 weeks after rash occurred.) Symptoms started a few days after second vaccination on 7/2/19, and she still has some symptoms today 8/13/19.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Biopsy skin, Discomfort, Full blood count, Hypoaesthesia, Peripheral swelling
Clinical narrative: The evening following flu vaccine in December 2017, my lower left leg became numb and swollen, with a red/black and blue band around entire calf.   This was a Friday.  By Sunday evening I was not able to weight bare on the left leg.  I returned to employee health Monday morning with the leg able to bare weight.  Dr., my primary care physician and employee health physician did not feel that it was caused by the flu vaccine.  I continued to have itching, swelling and discomfort.  Had a Doppler ultrasound which was negative.  Saw two separate dermatologist, primary care physicians who all stated that "this was not from the flu vaccine, but they could not tell me what it was".  I learned to live with the discomfort and the sore started to fade. In December of 2018, following my flu vaccine, the same sore became angry, swollen and much worse, with another sore now forming just above the first sore.   Following my own research, ( I am a registered nurse), I found that it seems to resemble "granuloma annulare".  There were several cases which this happened following the flu vaccine, but not a lot of research out there on this.  Once again several doctors looked at the sore, but no one can give answers.  In July of 2019 I saw Dr., Infectious Disease, who advised me never to take the flu vaccine again, as it seems to be an immunoreaction to the flu vaccine.  I still have yet to find a doctor or anyone who can tell me what to do for this.   It seems to be getting worse and more irritated.  I feel that this should be reported to the CDC so that maybe further research can be done or if I can be directed to someone who can help me.  I am convinced it is from the flu vaccine as it flared up following the second one last December.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Skin discolouration, Skin irritation, Skin ulcer, Swelling
Clinical narrative: The evening following flu vaccine in December 2017, my lower left leg became numb and swollen, with a red/black and blue band around entire calf.   This was a Friday.  By Sunday evening I was not able to weight bare on the left leg.  I returned to employee health Monday morning with the leg able to bare weight.  Dr., my primary care physician and employee health physician did not feel that it was caused by the flu vaccine.  I continued to have itching, swelling and discomfort.  Had a Doppler ultrasound which was negative.  Saw two separate dermatologist, primary care physicians who all stated that "this was not from the flu vaccine, but they could not tell me what it was".  I learned to live with the discomfort and the sore started to fade. In December of 2018, following my flu vaccine, the same sore became angry, swollen and much worse, with another sore now forming just above the first sore.   Following my own research, ( I am a registered nurse), I found that it seems to resemble "granuloma annulare".  There were several cases which this happened following the flu vaccine, but not a lot of research out there on this.  Once again several doctors looked at the sore, but no one can give answers.  In July of 2019 I saw Dr., Infectious Disease, who advised me never to take the flu vaccine again, as it seems to be an immunoreaction to the flu vaccine.  I still have yet to find a doctor or anyone who can tell me what to do for this.   It seems to be getting worse and more irritated.  I feel that this should be reported to the CDC so that maybe further research can be done or if I can be directed to someone who can help me.  I am convinced it is from the flu vaccine as it flared up following the second one last December.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound Doppler normal, Weight bearing difficulty
Clinical narrative: The evening following flu vaccine in December 2017, my lower left leg became numb and swollen, with a red/black and blue band around entire calf.   This was a Friday.  By Sunday evening I was not able to weight bare on the left leg.  I returned to employee health Monday morning with the leg able to bare weight.  Dr., my primary care physician and employee health physician did not feel that it was caused by the flu vaccine.  I continued to have itching, swelling and discomfort.  Had a Doppler ultrasound which was negative.  Saw two separate dermatologist, primary care physicians who all stated that "this was not from the flu vaccine, but they could not tell me what it was".  I learned to live with the discomfort and the sore started to fade. In December of 2018, following my flu vaccine, the same sore became angry, swollen and much worse, with another sore now forming just above the first sore.   Following my own research, ( I am a registered nurse), I found that it seems to resemble "granuloma annulare".  There were several cases which this happened following the flu vaccine, but not a lot of research out there on this.  Once again several doctors looked at the sore, but no one can give answers.  In July of 2019 I saw Dr., Infectious Disease, who advised me never to take the flu vaccine again, as it seems to be an immunoreaction to the flu vaccine.  I still have yet to find a doctor or anyone who can tell me what to do for this.   It seems to be getting worse and more irritated.  I feel that this should be reported to the CDC so that maybe further research can be done or if I can be directed to someone who can help me.  I am convinced it is from the flu vaccine as it flared up following the second one last December.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms. Joint pain fever
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Seizure, Syncope
Clinical narrative: Vaccines given @ 8:05pm. @ 8:15pm patient fainted and according to the secretary it looked like the patient was convulsing. Patient was transferred to ER.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: patient was treated for ocular shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were unknown) as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and zoster-related conditions (prophylaxis).   On an unspecified date, the patient experienced ocular shingles (ophthalmic herpes zoster), which led to hospitalization. On an unspecified date, the patient was treated by a healthcare provider for ocular shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  Upon internal review, ophthalmic herpes zoster was determined to be medically significant.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Pain, Rash, Visual impairment
Clinical narrative: diminished vision; vaccine did not prevent shingles, but rather caused patient to contract a persistent strain of herpes zoster; numbness in his legs; herpes zoster/persistent painful rash; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to  a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused patient to contract a persistent strain of herpes zoster accompanied by pain. On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient developed a persistent painful rash, numbness in his legs and feet and diminished vision. On an unknown date, patient presented to a physician and remained under their care. As a result, patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).     Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 84 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route were not reported) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster.  The outcome of herpes zoster was unknown.    The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71 year old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 16-JAN-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route were not reported) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster.  The outcome of herpes zoster was unknown.    The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route were not reported) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster.  The outcome of herpes zoster was unknown.    The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Musculoskeletal stiffness, Vomiting
Clinical narrative: Feeling bad; diarrhea; throwing up; stiffness; tired; This case was reported by a consumer via call center representative and described the occurrence of stiffness in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3-4 months ago and had redness at the injection site,refer case US2019AMR142864).   On 22nd July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 23rd July 2019, 1 days after receiving Shingrix, the patient experienced stiffness and tiredness. On 27th July 2019, the patient experienced diarrhea and vomiting. On 3rd August 2019, the patient experienced feeling bad. On an unknown date, the outcome of the stiffness, tiredness and vomiting were recovered/resolved and the outcome of the diarrhea and feeling bad were not recovered/not resolved.   It was unknown if the reporter considered the stiffness, tiredness, diarrhea, vomiting and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and the next day of reporting he was stiff and tired but he was fine.The patient got up and he had diarrhea and was throwing up on and then it all stopped. The patient started to feel bad again with diarrhea and it was currently not resolved. The reporter consented to follow up. There is discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovered with sequel). This is 1 of the 2 cases reported by the same reporter.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site reaction, Pain, Rash macular
Clinical narrative: Regular Pain; erythematous blotch on injection site; This case was reported by a physician via sales rep and described the occurrence of pain in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX794AZ, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero .5 ml. On 3rd August 2019, less than 6 months after receiving Bexsero, the patient experienced pain. In August 2019, the patient experienced injection site erythema. On an unknown date, the outcome of the pain and injection site erythema were unknown.   The reporter considered the pain and injection site erythema to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported but the patient could be 17 or 18 years old. On 3rd of August 2019, the patient had regular pain following her dose then erythematous blotch on injection site appeared on arm, 7 cm in size it was related to product. The reported batch ABS794A2 did not exist and was updated to ABX794AZ
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pain in extremity, Paraesthesia, Pruritus
Clinical narrative: Pain in hands; Hands Warm; Itchy hands; Pins in hands; This case was reported by a consumer via call center representative and described the occurrence of pain in hand in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced pain in hand, localized feeling of warmth, itching both hands and pins and needles. On an unknown date, the outcome of the pain in hand, localized feeling of warmth, itching both hands and pins and needles were not recovered/not resolved.   It was unknown if the reporter considered the pain in hand, localized feeling of warmth, itching both hands and pins and needles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm. The reporter received the Shingrix vaccine approximately 10 weeks ago before reporting.  A week after the vaccination, she began to experience pain and pins on the top of both hands, and both hands are warm and itchy. The reporter was still experiencing these symptoms. The reporter gave permission for her physician to be contacted. The reporter was unable to obtain additional information.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness at the injection site; injection site soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and saw a 3 inches wide and 1.5 inches long redness at the injection site. It was also sore and it did not get any better.  The reporter did not consent to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Fatigue, Herpes zoster, Loss of personal independence in daily activities
Clinical narrative: Very tired; The medication knocked him down; unable to do anything; Suspected vaccination failure; Shingles; Blisters; Shingles blisters were red; Shingles blisters were very itchy; Severe pain where the ribs touch the sternum; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 23rd February 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th May 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In June 2018, between 3 and 4 months after receiving Shingrix and less than 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister, erythema, pruritus and pain. On an unknown date, the patient experienced tiredness, feeling unwell and activities of daily living impaired. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, shingles, tiredness, erythema, pruritus, feeling unwell and activities of daily living impaired were unknown and the outcome of the blister was recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister, tiredness, erythema, pruritus and pain to be related to Shingrix and Shingrix. It was unknown if the reporter considered the feeling unwell and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and 2nd dose of Shingrix and was diagnosed with Shingles. The blisters were on the left chest under the breast and continued around under the arm to the left back.  The blisters stopped at the spine.  He was prescribed acyclovir 800mg three times a day for two weeks and acyclovir ointment twice daily on the blisters.  The medication knocked him out, making him very tired and unable to do anything.  The patient had had no life for six weeks.  The shingles blisters were red, and very itchy.  The only pain he felt was 10 days prior to the blisters appearing, he had severe pain where the ribs touch the sternum. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The reporter knew the manufacturer of the acyclovir - Camber pharmaceuticals, and will contact them to describe his experience with their product. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Non-cardiac chest pain, Pain, Pruritus, Vaccination failure
Clinical narrative: Very tired; The medication knocked him down; unable to do anything; Suspected vaccination failure; Shingles; Blisters; Shingles blisters were red; Shingles blisters were very itchy; Severe pain where the ribs touch the sternum; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 23rd February 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th May 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In June 2018, between 3 and 4 months after receiving Shingrix and less than 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister, erythema, pruritus and pain. On an unknown date, the patient experienced tiredness, feeling unwell and activities of daily living impaired. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, shingles, tiredness, erythema, pruritus, feeling unwell and activities of daily living impaired were unknown and the outcome of the blister was recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister, tiredness, erythema, pruritus and pain to be related to Shingrix and Shingrix. It was unknown if the reporter considered the feeling unwell and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and 2nd dose of Shingrix and was diagnosed with Shingles. The blisters were on the left chest under the breast and continued around under the arm to the left back.  The blisters stopped at the spine.  He was prescribed acyclovir 800mg three times a day for two weeks and acyclovir ointment twice daily on the blisters.  The medication knocked him out, making him very tired and unable to do anything.  The patient had had no life for six weeks.  The shingles blisters were red, and very itchy.  The only pain he felt was 10 days prior to the blisters appearing, he had severe pain where the ribs touch the sternum. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The reporter knew the manufacturer of the acyclovir - Camber pharmaceuticals, and will contact them to describe his experience with their product. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Rash, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Possible cellulitis; rash on entire arm/ Pain; rash symtpom-Itching; rash symptom-red; rash symptom -hot; This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), painful rash, itchy rash, red rash and skin warm. The patient was treated with lidocaine (Lidocaine Patch). On an unknown date, the outcome of the cellulitis, painful rash, itchy rash, red rash and skin warm were unknown.   It was unknown if the reporter considered the cellulitis, painful rash, itchy rash, red rash and skin warm to be related to Shingrix.  Additional details were received as follows: The reporter was a consulting pharmacist and was not in direct care of the patient but was given the information from the patient's physician. The age at vaccination was not reported but it could be 59 years or 60 years. Two days after receiving Shingrix, the patient developed a rash on arm on the side of injection.  It was initially 2 by 2 inches and then spread to the entire arm.  The rash symptoms included pain, itching, hot and red.  Pain was not relieved by lidocaine patch. The PCP (primary care provider) for the patient was investigating if it had developed into cellulitis. The reporter consented to follow up.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Mass, Pain, Tenderness
Clinical narrative: harden lump tender about 1 &1/2 inches in diameter. also was bumped at a meeting and hurt
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain, Pyrexia, Skin warm
Clinical narrative: Redness, spreading redness wrapping all around upper arm, Soreness, puffiness, warm. Headache, body ache. Fever of 102.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Redness, spreading redness wrapping all around upper arm, Soreness, puffiness, warm. Headache, body ache. Fever of 102.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Influenza like illness, Insomnia, Pain, Pain in extremity
Clinical narrative: Severe pain affected arm without rash or swelling, flu-like symptoms (body aches, feverishness), inability to sleep due to discomfort. After approximately 12 hours, began to improve.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe pain affected arm without rash or swelling, flu-like symptoms (body aches, feverishness), inability to sleep due to discomfort. After approximately 12 hours, began to improve.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: HAD A TEMP OF 100.2 STARTING ABOUT 3 PM ON 8-10-19.  WHOLE BODY ACHED  DID N'T THINK MUCH ABOUT IT.  8-11-19 STARTED RUNNING A FEVER OF AROUND 100 AGAIN AROUND 3 PM.   I HAVE HAD MANY VACCINES FOR FLU TO THE 1ST SHINGLES VACCINE AND HAVE NEVER HAD A REACTION LIKE THIS.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: I don't know for sure that this is related, but would be a very strange coincidence.  My healthy 13 year old son, (who had the chicken pox 1 week prior to his appointment to get the chicken pox vaccine at 51 weeks old) started getting a rash 2 days after we received the second Shingrix vacinne.  He was diagnosed toda, 7 days later, by his doctor with Shingles.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Erythema, Scab, Skin lesion
Clinical narrative: 13 days after Vaccine, 10 small pink red vesicular lesion, they scabbed over, cluster on legs/face and no fever
Age: 32.0
Sex: M
Vaccine: ANTH, MNQ, TYP
Symptoms: Generalised tonic-clonic seizure, Syncope
Clinical narrative: Patient experienced an episode of syncope followed by a full tonic-colonic seizure which lasted about 3 min. Patient was assisted to the floor, loosened all restrictive clothing ensuring not to cause further injury . Notified Ambulance services to transport to Emergency Department . Continued to treat and monitor until transport arrived.
Age: 1.17
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Asthenia, Eye movement disorder, Fatigue, Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: Patient received vaccines at about 0900 in the clinic.  Later in the evening, started looking more tired and less energy. At about 7pm that evening, dad noted eyes rolled back and had generalized tonic clonic seizure lasting for about 1.5 minutes.  911 contacted and taken to ER.  Noted fever of about 102 at that time.  No further work up.  No further symptoms, seizures or fevers since discharge from ER.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site discomfort, Rash, Rash pruritic
Clinical narrative: New onset rash of abdomen and back. States rash is very itchy but denies pain or fever.  Rash coincides with administration of Tdap 8/12/2019. Pt without rash at site of injection but with ongoing mild discomfort at injection site. No rash at site where silver sulfadiazine applied.  Zyrtec 10mg PO BID x 1-2 days  red flags reviewed for urgent f/u- SOB, tongue or lip swelling
Age: 15.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Face injury, Fall, Loss of consciousness, Neck pain, Syncope
Clinical narrative: Pt received shot. Several minutes later, pt was standing up in exam room and had syncopal episode. Hit face on exam table and then fell to floor. Pt was awake in <1 min. Vitals stable. Neck pain after event, so sent to ER.
Age: 15.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Syncope
Clinical narrative: Pt received shot. Several minutes later, pt was standing up in exam room and had syncopal episode. Hit face on exam table and then fell to floor. Pt was awake in <1 min. Vitals stable. Neck pain after event, so sent to ER.
Age: 61.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient is having residual pain in the arm which the Shingrix vaccine was given.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Patient is complaining of pain in her elbow crease since receiving the Shingrix vaccine.  No sign of redness, swelling or infection.  She reported it to the pharmacy 11 days after receiving the vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Pyrexia, Seizure like phenomena, Tremor
Clinical narrative: Pt stated that a few hours after her injection she started to experience shaking in her hands as she picked up objects and described it as seizure like shaking. Later on in the night she became cold and had a fever of 101-102 and tried using Tylenol initially for the fever when she first checked her temperature. she said that the fever resolved after 12 hours and there was no more shaking.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects; An unspecified 4 year old patient was inadvertently admininistered a third dose of PROQUAD on 8/8/2019; This spontaneous report was received from a nurse concerning to a 4 year old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On 08-AUG-2019, the patient was inadvertently vaccinated with the third dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (incorrect dose administered),  lot # R026350 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 15-MAR-2020, for prophylaxis (strength, dose and route of administration were not reported).          No adverse effects reported.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects reported.; a 18 year old patient received an adult dose of VAQTA; This spontaneous report was received from a Nurse Practitioner concerning to an 18 years old patient of unknown race and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 27-JUN-2019, the patient was vaccinated with an adult dose (product administered to patient of inappropriate age) of Hepatitis A Vaccine, Inactivated (VAQTA) 50/1.0 U/mL, lot number S001485 with expiration date on 12-MAY-2020 (dose number, frequency, and route of administration were not reported) for prophylaxis. No adverse effects reported.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: left arm edema with erythema around the deltoid  area , warm and tender with swelling extending towards elbow . No fever
Age: 27.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site paraesthesia, Injection site rash, Injection site swelling
Clinical narrative: bilateral sites- swelling redness  rash induration heat  LA only- some tingling from site  onward distally , intermittent x 4 days
Age: 27.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: bilateral sites- swelling redness  rash induration heat  LA only- some tingling from site  onward distally , intermittent x 4 days
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain in top of right arm. Could not move shoulder (5 hours later) to lift arm for a few hours. Started with ice packs and massaging shoulder to get some movement.  27 hours later can move arm up but pain in top arm and shoulder. Called doctor, alternating tylenol and motrin along with hot and cold packs.  Doctor said would schedule an appointment if not better on 8/14
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Feeling abnormal, Headache, Injection site rash, Pyrexia
Clinical narrative: PATIENT REPORTED RASH LIKE REACTION AT INJECTION SITE, ARM 'BURNING' SENSATION, FEVER, HEADACHE AND AN OVERALL "BAD" FEELING.  SHE STATED THAT THE REACTIONS BEGAN THE EVENING OF 8-8-19 AND PERSISTED TO VARYING DEGREES UNTIL AND INCLUDING 8-13-19.  THE RASH SEEMED TO CONTINUE TO GET LARGER (APPROX 5 X 4" ON 8-12-19) AND SHE FELT IT SHOULD BE ASSESSED.   SHE CALLED THE PHARMACY AND SAW HER MD ON 8-12-19 AND WAS PRESCRIBED CEPHALEXIN IN CASE IT WAS PROGRESSING TO CELLULITIS.  AS OF 8-12-19 ALL SYMPTOMS EXCEPT FOR THE RASH HAD RESOLVED PER PATIENT.
Age: 0.75
Sex: F
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: thigh induration, painful swelling, and erythema onset 5 days post vaccination, with sudden onset erythema with streaking prompting ER visit; exam reassuring, supportive treatment provided
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dehydration, Dizziness, Hypotension
Clinical narrative: PATIENT'S WIFE CALLED AND SAID HE EXPERIENCED FLU-LIKE SYMPTOMS (CHILLS & BODY ACHES). HE WENT FOR A WALK AND CAME BACK FEELING EXTREMELY WEAK, DIZZY AND NAUSEATED.  EMS WAS CALLED AND THEY TOOK HIS BLOOD PRESSURE AND IT WAS VERY LOW. THEY ATTRIBUTED HIS SYMPTOMS TO BE RELATED TO DEHYDRATION. HE WAS NOT TAKEN TO THE HOSPITAL BUT WAS TOLD TO REHYDRATE.  I ADVISED THAT THE PATIENT MAY HAVE AN ELECTROLYTE IMBALANCE AND TO REHYDRATE WITH AN ELECTROLYTE SOLUTION INSTEAD OF JUST WATER AND TO CALL THE PHARMACY OR HIS PRIMARY CARE PHYSICIAN IF HIS CONDITION WORSENS.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Pain
Clinical narrative: PATIENT'S WIFE CALLED AND SAID HE EXPERIENCED FLU-LIKE SYMPTOMS (CHILLS & BODY ACHES). HE WENT FOR A WALK AND CAME BACK FEELING EXTREMELY WEAK, DIZZY AND NAUSEATED.  EMS WAS CALLED AND THEY TOOK HIS BLOOD PRESSURE AND IT WAS VERY LOW. THEY ATTRIBUTED HIS SYMPTOMS TO BE RELATED TO DEHYDRATION. HE WAS NOT TAKEN TO THE HOSPITAL BUT WAS TOLD TO REHYDRATE.  I ADVISED THAT THE PATIENT MAY HAVE AN ELECTROLYTE IMBALANCE AND TO REHYDRATE WITH AN ELECTROLYTE SOLUTION INSTEAD OF JUST WATER AND TO CALL THE PHARMACY OR HIS PRIMARY CARE PHYSICIAN IF HIS CONDITION WORSENS.