chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine (received in August 2018 (unknown manufacturer)). On 17th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th October 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, muscle pain, diarrhea, abdominal cramp and fatigue. On an unknown date, the outcome of the chills, fever, muscle pain, diarrhea, abdominal cramp and fatigue were not recovered/not resolved. It was unknown if the reporter considered the chills, fever, muscle pain, diarrhea, abdominal cramp and fatigue to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in left arm. The patient called her physician but did not go into the office for a visit. The patient had consented to follow up. The patient provided contact details of the physician.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine (received in August 2018 (unknown manufacturer)). On 17th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th October 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, muscle pain, diarrhea, abdominal cramp and fatigue. On an unknown date, the outcome of the chills, fever, muscle pain, diarrhea, abdominal cramp and fatigue were not recovered/not resolved. It was unknown if the reporter considered the chills, fever, muscle pain, diarrhea, abdominal cramp and fatigue to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in left arm. The patient called her physician but did not go into the office for a visit. The patient had consented to follow up. The patient provided contact details of the physician.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose was received on 11th July 2018). On 13th November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: On 13th November 2018, the patient received vaccine around 2 pm on right arm and noted just before midnight he had a fever. Not sure how high it was but noted it was worse than the morning of reporting date. On 14th November 2018, the patient noted his temperature was slightly over 100. The reporter was asked for healthcare professional information but never provided.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood immunoglobulin G decreased, Computerised tomogram thorax normal, Pneumonia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 84-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included chronic sinusitis, postnasal drip and cough. Concomitant products included dTpa vaccine, levofloxacin and PNEUMOVAX. On 30th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 10th August 2018, 11 days after receiving SHINGRIX, the patient experienced pneumonia (serious criteria hospitalization and GSK medically significant). In August 2018, the patient experienced immunoglobulin G decreased (serious criteria hospitalization). The patient was treated with antibiotics nos. On an unknown date, the outcome of the pneumonia was recovered/resolved and the outcome of the immunoglobulin G decreased was unknown. It was unknown if the reporter considered the pneumonia and immunoglobulin G decreased to be related to SHINGRIX. Additional details were provided as follows: The patient saw her pulmonologist the morning of her SHINGRIX vaccine for a standing 6 month appointment for chronic sinusitis with cough and postnasal drip which was a condition she has had for many years. The patient received the dose of SHINGRIX on the left arm around 1:40 PM and that she was not planning on getting her second dose after her reaction. The patient was recommended that she get the Tdap vaccine and PNEUMOVAX. The patient received PNEUMOVAX vaccine in August 2018. The patient claimed that she was admitted to the hospital on 10th August 2018 with pneumonia and she was discharged on 12th August 2018. Her pneumonia resolved after high doses of antibiotics with an intravenous and other antibiotic after her release from the hospital. She was diagnosed with Immunoglobulin G deficiency after blood work in August 2018. On 31st October 2018, the patient was recommended that she see an infectious disease doctor and they put her on an antibiotic Levofloxacin and her cough resolved. She had the cough with postnasal drip for months but it never amounted to anything. This was an ongoing condition that she has been treated for many years ago. The patient received the Tdap vaccine in September or October 2018. The patient had provided contact details of her treating physician.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Flushing
Clinical narrative: Pt's guardian was asked and counseled about vaccine: (ie No past vaccine complications, no allergies, not sick today) etc. Got vaccine. About 10 min later, returns to Pharmacy feeling faint, flushed. Sat in chair, rested about 10min.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Abnormal behaviour, Heart rate increased, Seizure like phenomena, Staring, Tremor
Clinical narrative: 11/16/2018 Patient started some odd behaviors. Shaking in arms and legs while lying on the floor around 6:15 pm. 11/17/2018 shaking arms and legs, eye staring increased and rapid heart beating. Lasted about 10 minutes 12 noon. 11/18/2018 same symptoms occurred shaking arms and legs, staring and increased heartbeat. Lasting 15 minutes. 11/19/2018 to 11/20/2018 same symptoms lasting 3-5 minutes. Wednesday 11/21/2018 called the Dr and they told me to take to ER. From then we went to Hospital, prescribed Topiramate 1.8 ML twice daily after being discharged still have seizure like activity. 11/24/2018 to 11/25/2018 small seizure like symptoms lasting a few minutes. 11/25/2018 seizure symptoms lasting 30 minutes went to Hospital was told to increase medicine to 3.5 ml twice a day. Came home about 6:30 pm he was given his medicine and 6:45 -7:30 seizure activity called ambulance took to ER told us to contact neurology.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: Third dose in series.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: This dose administered.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: Pt received an additional extra 3rd dose.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Malaise, Swelling
Clinical narrative: Patient stated after 3-4 hours of recieveing the vaccine she felt ill, and fatigue. The next day woke up with a red swollen deltoid area, x4 days.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site pain, Limb discomfort, Muscular weakness, Pain
Clinical narrative: Pt walked in today 11/26/2018, reporting that she had had the vaccine administered about 5 weeks ago and she was experiencing pain, around the injection site and traveling down her arm. Right after the injection she had a bruise and the pain started as if her arm was heavy and weak. Pt says she has been to her chiropractor and massage therapist and has seen some progress from her pain. It comes and goes but notices it when she wakes up if she sleeps on that side and when she is trying to take off her shirt, she is unable to pull her arm out. She repeatedly pointed to an area that showed the injection was given on the correct location. During our counseling session the patient moved her arm and raised, she did say if she put it across her body and tried lifting it up thats when she experienced pain and discomfort.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Pt walked in today 11/26/2018, reporting that she had had the vaccine administered about 5 weeks ago and she was experiencing pain, around the injection site and traveling down her arm. Right after the injection she had a bruise and the pain started as if her arm was heavy and weak. Pt says she has been to her chiropractor and massage therapist and has seen some progress from her pain. It comes and goes but notices it when she wakes up if she sleeps on that side and when she is trying to take off her shirt, she is unable to pull her arm out. She repeatedly pointed to an area that showed the injection was given on the correct location. During our counseling session the patient moved her arm and raised, she did say if she put it across her body and tried lifting it up thats when she experienced pain and discomfort.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain
Clinical narrative: Patient complained of pain immediately. Has been having trouble moving around and has seen the doctor.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Full blood count, Metabolic function test, Swollen tongue
Clinical narrative: Had flu shot at Health Department Monday, November 5, 2018. Presented to physician's office November 6,2018 10:03am with complaint of swollen tongue. Admitted for observation to Hospital. November 6, 2018 12:08 pm. Treatment: Solumedrol 80mg IV Q6 hours; Benadryl 25 mg po Q6 hours; Zantac 300mg po bid; Continuous  pulse ox; Oxygen if sat < 90; notify for respiratory distress; Continue home meds. Discharged improved on November 08,2018 9:30am on po prednisone.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Delirium, Dizziness, Heart rate increased
Clinical narrative: Patient contacts clinic 1 week after vaccination to report 2 hrs after getting the vaccines she developed fever, chills, delirium, nausea and vomiting, muscle aches and spasms, kidney pain, fast heart rate. No injection site swelling or tenderness, no swelling of the face or neck. No respiratory symptoms associated with fever. She did report weakness and dizziness.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Muscle spasms, Myalgia, Nausea
Clinical narrative: Patient contacts clinic 1 week after vaccination to report 2 hrs after getting the vaccines she developed fever, chills, delirium, nausea and vomiting, muscle aches and spasms, kidney pain, fast heart rate. No injection site swelling or tenderness, no swelling of the face or neck. No respiratory symptoms associated with fever. She did report weakness and dizziness.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Renal pain, Vomiting
Clinical narrative: Patient contacts clinic 1 week after vaccination to report 2 hrs after getting the vaccines she developed fever, chills, delirium, nausea and vomiting, muscle aches and spasms, kidney pain, fast heart rate. No injection site swelling or tenderness, no swelling of the face or neck. No respiratory symptoms associated with fever. She did report weakness and dizziness.
Age: 62.0
Sex: F
Vaccine: FLUA3
Symptoms: Inflammation, Joint injection, Middle insomnia, Mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: Severe arm pain. Unable to move arm away from body. Pain wakes me up at night.
Age: 62.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity, X-ray
Clinical narrative: Severe arm pain. Unable to move arm away from body. Pain wakes me up at night.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema
Clinical narrative: Pt went to MD on Monday with red puff areas that were spreading, MD diagnosed pt with cellulitis and wrote for Bactrim RS for 7 days.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation, from a lawyer, concerning a decedent patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-SEP-2012, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date, the decedent was diagnosed with herpes zoster ophtalmicus and postherpetic neuralgia and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine (vaccination failure). On 28-DEC-2016 and on 06-MAR-2017, the patient was treated for herpes zoster ophtalmicus and postherpetic neuralgia. On unknown date, the patient was diagnosed with shingles (herpes zoster) and/or other related injuries after and despite being inoculated with the ZOSTAVAX vaccine. It was also reported that, on unknown dates, the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life and diminished quality of life. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster ophtalmicus, postherpetic neuralgia, herpes zoster and quality of life decreased was unknown. The reporter considered the adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-treathening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 06-OCT-2009, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries as recommended by the healthcare professional. On an unknown date, the patient experienced shingles and on 22-FEB-2015, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages, as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered; extensive 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 included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and  the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On an unspecified date in 2013, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On an unknown date, the patient experienced shingles and in 2015, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages, as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered; extensive 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 included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and  the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: F
Vaccine: PNC13
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration in 2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received the shot 4 weeks ago and had an ongoing headache since unspecified date. Outcome of the event was not recovered.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Colonoscopy, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 65-year-old female patient received PREVNAR 13; (batch number unknown), via an unspecified route of administration on 15Nov2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had put ice on her arm because of site pain on 15Nov2018. The patient had a colonoscopy on an unspecified date. The outcome of the event was not recovered. Information on the batch number has been requested.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional reported that a 67-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (trade name and manufacturer were not reported), with route of administration and therapy dates unspecified, at a single dose for immunization; bacitracin (trade name and manufacturer were not reported), with route of administration, therapy dates, dose, frequency and indication unspecified; ibuprofen (trade name and manufacturer were not reported), with route of administration, therapy dates, dose, frequency and indication unspecified; NEOSPORIN, with route of administration, therapy dates, dose, frequency and indication unspecified; ASPIRIN, with route of administration, therapy dates, dose, frequency and indication unspecified; BENADRYL, with route of administration, therapy dates, dose, frequency and indication unspecified; SENOKOT, with route of administration, therapy dates, dose, frequency and indication unspecified; SUDAFED NON-DRYING SINUS, with route of administration, therapy dates, dose, frequency and indication unspecified; and VERSED, with route of administration, therapy dates, dose, frequency and indication unspecified. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had drug allergies with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), bacitracin, ibuprofen, gramicidin, neomycin sulfate, polymyxin b sulfate, acetylsalicylic acid, diphenhydramine hydrochloride, sennoside a+b, guaifenesin, pseudoephedrine hydrochloride, midazolam hydrochloride and cephalosporins (unspecified). The action taken in response to the event was not applicable for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein); and was unknown for bacitracin, ibuprofen, gramicidin, neomycin sulfate, polymyxin b sulfate, acetylsalicylic acid, diphenhydramine hydrochloride, sennoside a+b, guaifenesin, pseudoephedrine hydrochloride and midazolam hydrochloride. The outcome of the event was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), bacitracin and ibuprofen in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), bacitracin and ibuprofen has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Lethargy, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. This Pharmacist reported similar events for three patients. This is first of three reports. An elderly female patient (65-75 years) received PREVNAR 13, (lot number and expiration date were not reported), 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 pharmacist report that the patients complained of fever, sever lethargy, redness and soreness that lasts anywhere from 2 days to 7 days on an unspecified date. The outcome of the events was unknown. Information on lot number, batch number and expiration date has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018480405 same drug/event different patient; US-PFIZER INC-2018480406 same drug, event/different patient.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Lethargy, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. This Pharmacist reported similar events for three patients. This is second of three reports. An elderly female patient (65-75 years) received PREVNAR 13, (lot number and expiration date were not reported), 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 pharmacist report that the patients complained of fever, sever lethargy, redness and soreness that lasts anywhere from 2 days to 7 days on an unspecified date. The outcome of the events was unknown. Information on lot number, batch number and expiration date has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018480203 same drug/effect different patient; US-PFIZER INC-2018480406 same drug, event/different patient.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Lethargy, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported similar event for 3 patients. This is 3rd of 3 reports. A female patient of an unspecified age received PREVNAR 13, (lot number and expiration date: Unknown), 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 pharmacist reported that the patients complain of fever, severe lethargy, redness and soreness that lasts anywhere from 2 days to 7 days on an unspecified date. The outcome of the events was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2018480203 same reporter/drug/event, different patient; US-PFIZER INC-2018480405 same reporter/drug/event, different patient.
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer. An 82-year-old female patient received PREVNAR 13, (Lot number and expiration date were not reported), with route of administration and therapy dates unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had was sick; and had soreness all over (not just on her arm). The outcome of the events, 'sick' and 'soreness all over', was unknown.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Injection site reaction, Swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 17-year-old patient of an unspecified gender received TRUMENBA, (lot number: S58879), via an unspecified route of administration in Jun2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had an injection site reaction 2 days after getting the vaccine. The patient had redness and swelling and the child was put on an antibiotic in Jun2018. The pharmacist inquired if there was a recall of Lot S58879 and presumed that the office was given a bad batch. Outcome of the event was unknown.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Blood pressure increased, Dizziness, Hypoaesthesia, Staring, Tremor
Clinical narrative: This is a spontaneous report from a contactable healthcare professional received via a Pfizer sales representative. An 80-year-old female patient received PREVNAR 13, (lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history included anxiety, pace maker, congested heart failure, and high blood pressure. The patient's concomitant medications were not reported. On an unspecified date after the use of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), the 80-year-old female patient experienced a blank stare and almost fainted, trembling, both side of the face felt numb, and blood pressure elevated. Patient does have several comorbidities. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (medical assistant) received via a Pfizer sales representative. This consumer reported similar events for four patients. This is the first of four reports. An infant patient of an unspecified gender received PREVNAR 13, (batch/lot number and expiration date were not reported), 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. On an unspecified date, the patient experienced swelling and a little hardened area at the injection site. The reporter spoke to the doctor that said the swelling and a little hardened area at the injection site was okay and nothing serious. The outcome of the event was recovered within a few days on their own. The information on the batch/lot number and expiration date has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018482514 Same reporter, same drug, same events; different patient; US-PFIZER INC-2018482515 Same reporter, same drug, same events; different patient; US-PFIZER INC-2018482516 Same reporter, same drug, same events; different patient.
Sex: U
Vaccine: PNC13
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (medical assistant) received via a Pfizer sales representative. This consumer reported similar events for four patients. This is the second of four reports. An infant patient of an unspecified gender received PREVNAR 13, (batch/lot number and expiration date were not reported), 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. On an unspecified date, the patient experienced swelling and a little hardened area at the injection site. The reporter spoke to the doctor that said the swelling and a little hardened area at the injection site was okay and nothing serious. The outcome of the event was recovered within a few days on their own. The information on the batch/lot number and expiration date has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018482503, Same reporter/drug/AE, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (medical assistant) received via a Pfizer sales representative. This consumer reported similar events for four patients. This is the third of four reports. An infant patient of an unspecified gender received PREVNAR 13, batch/lot number and expiration date were not reported), 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. On an unspecified date, the patient experienced swelling and a little hardened area at the injection site. The reporter spoke to the doctor that said the swelling and a little hardened area at the injection site was okay and nothing serious. The outcome of the event was recovered within a few days on their own. The information on the batch/lot number and expiration date has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018482503 Same reporter, same drug, same events; different patient.
Sex: U
Vaccine: PNC13
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. This consumer reported similar events for four patients. This is the fourth of four reports. An infant patient of an unspecified gender received PREVNAR 13, (batch/lot number and expiration date were not reported), 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. On an unspecified date, the patient experienced swelling and a little hardened area at the injection site. The reporter spoke to the doctor that said the swelling and a little hardened area at the injection site was okay and nothing serious. The outcome of the events was recovered within a few days on their own. The information on the batch/lot number and expiration date has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018482503 Same reporter, same drug, same events; different patient.
Sex: U
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The reporter mentioned that he had seen and heard a lot of his older patients complain about redness and swelling. Some said it has become the size of a bug bite - some have seen their whole triceps get enlarged, some people have treated it like a skin infection and one (the patient) went to the hospital and was in the hospital for three days. The outcome was unknown. Sender's Comments: Current limited information does not allow a full medically meaningful assessment, especially lack of medical history, concomitant medications, concurrent illness and event details description including event location and time lag between the onset of the event and vaccination date of PREVENAR 13. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Bed rest, Fatigue, Injection site pain, Myalgia, Nausea
Clinical narrative: Pain at site of injection. Tinnitus - still present. Extreme fatigue requiring bedrest. Nausea. Myalgias - still present.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Tinnitus
Clinical narrative: Pain at site of injection. Tinnitus - still present. Extreme fatigue requiring bedrest. Nausea. Myalgias - still present.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Flu shot given in error.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a consumer regarding herself. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route, frequency and lot# were unknown) and an unspecified "flu" vaccine two nights ago for immunization. On an unknown date, soon after her arm from her elbow to the top of her shoulder became red and swollen and was still very painful (peripheral swelling, pain, erythema and joint swelling). She contacted her primary physician and he prescribed "BENADRYL". No further specifics or symptoms were provided. No further AE information was provided. The outcome of peripheral swelling, pain, erythema and joint swelling were not recovered. The causality assessment was not provided. No PQC was found for the case.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On or about 03-MAY-2012, the patient was inoculated with ZOSTAVAX (strength, dose, route, lot # and expiry date were not provided) by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions. On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 11-JUN-2015, the patient was treated for shingles. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2010, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, lot # and expiry date was not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 2016, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Outcome of the events was unknown. The lawyer assessed the causality was related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 08-SEP-2009, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On an unknown date, the patient experienced shingles (herpes zoster) and on October 2013, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages (emotional distress), as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (emotional distress, pain); extensive 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 included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and  the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX.  The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. In November 2012, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On an unknown date, the patient experienced shingles (herpes zoster) and on 10-DEC-2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages (emotional distress), as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (emotional distress, pain); extensive 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 included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-NOV-2015, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date, the patient experienced shingles (herpes zoster) and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine (vaccination failure). On an unspecified date in 2018, the patient was treated by a health care provider for shingles. It was also reported that, on unknown dates, the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), extensive 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 including 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 pre-existing conditions and activations of laten conditions, lost wages, loss of earning capacity and other losses and damages. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-treathening and medically significant.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Limb injury, Pain
Clinical narrative: Limited range of motion due to shoulder injury. Left shoulder has acute pain when reaching to full extension, removing and putting on shirt overhead. Will make appt. with general practitioner, probably physical therapy for treatment, initially.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Ecchymosis, Lymphadenitis
Clinical narrative: Swelling in right axilla and ecchymoses down right arm and right breast.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Chromosomal analysis, Cytogenetic analysis normal, Exposure during pregnancy, Foetal death
Clinical narrative: I received the flu vaccine when I was 14 weeks pregnant. I discovered at 16 weeks gestation that my babe had had a fetal demise around 15 weeks gestation. As of now, there is no indication to the cause. All genetic screenings were negative and the fetus appeared normal. We did do further chromosomal testing and the results are not back yet. We will do all possible testing to discover a cause. I am well aware that other factors may have played into this but if felt important to explore all possible causes.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Pain, Pyrexia, Tremor
Clinical narrative: FEVER OF 102 DEGREES, SHAKING, WEAKNESS, BODY ACHES.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Lasting pain in arm/shoulder region.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Facial paralysis
Clinical narrative: Patient developed Bells Palsy-right sided.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Pyrexia, Rash, Rash generalised
Clinical narrative: Symptoms start on day 11: rash starting at hairline and cheeks, then a gradual progression of rash over the torso and back and then waking on the 12th day with rash over entire body. Slight fever at highest of 101, diarrhea on the 11th day. And reduced appetite on the 12th day. After hours nurse called on the 11th day after shot. She suggested being seen the following day. Day 12 pediatrician saw her and dismissed the symptoms as occurring in reaction to the vaccine.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Aphonia, Cough, Dysphonia, Ear pruritus, Headache
Clinical narrative: Running nostrils; itching throat/ears; coughing and loss of voice; headache.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Rhinorrhoea, Throat irritation
Clinical narrative: Running nostrils; itching throat/ears; coughing and loss of voice; headache.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Vaccination injection site became red, swollen and painful. Pt reports swelling and redness to 15cm diameter over the course of 4 days. Pt SXs lessened with OTC BENADRYL.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Chills
Clinical narrative: Strong ache in knees and elbows, strong chills.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Mother called 11/13/2018 to inform PCP that at 3:30 am, she woke up vomiting and had vomiting episodes for 2 hours. She fell asleep for an hour and when she awoke she no longer had any symptoms. She had had the HPV vaccine on 11/12/2018 at 5:06 pm.