chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX
Symptoms: Gait disturbance, Malaise, Pallor
Clinical narrative: pale; limp; didn't look right; This case was reported by a physician via call center representative and described the occurrence of pallor in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 74FN7, expiry date 1st March 2021) for prophylaxis.   Co-suspect products included Rotavirus vaccine for prophylaxis, Hib UNK (Hib vaccine) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   On an unknown date, the patient received the 1st dose of Pediarix, Rotavirus vaccine (oral), Hib vaccine at an unknown dose and PREVNAR at an unknown dose. On an unknown date, 5 min after receiving Pediarix, Rotavirus vaccine and Hib vaccine, the patient experienced pallor, limping and feeling unwell. On an unknown date, the outcome of the pallor, limping and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the pallor, limping and feeling unwell to be related to Pediarix, Rotavirus vaccine and Hib vaccine.  Additional details were provided as follows: The patient received Pediarix, Rotavirus, Hib and Pneumococcal vaccine at the same time a couple of months ago and about 5 minutes later, the patient's father stuck his head out the door and asked the physician to come in. The patient was pale and did not look right. He was also limp. the patient's breathing was fine and there was no change to his heart rate but it took some time for him to come around. The reporter had concerns due to the warnings about pertussis-containing vaccines. The physician was transferred to medical information for additional assistance.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In August 2019, between 6 and 7 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the but did not come back for the 2nd dose within the recommended time frame, which led to incomplete course of vaccination. The patient developed shingles this month. Late dose was not due to vaccine shortage. The reporter did not give consent to follow up. The caller declined to leave additional information at this time.
Sex: M
Vaccine: FLUX
Symptoms: Acute febrile neutrophilic dermatosis, Arthralgia, Biopsy skin abnormal, Chest X-ray normal, Eczema
Clinical narrative: Sweet syndrome; This is a literature case, reported by health care professional (physician), initially received on 12-Aug-2019, concerning a 41-year-old, male patient.   The patient had no relevant medical history and drug reactions or allergies.  One day after receiving an influenza vaccination (batch number and expiration date were not reported), the patient's symptoms of painful rash on his left neck and arm began. Physical examination revealed erythematous papules and plaques on the lateral neck and left arm. Laboratory evaluation and chest X-ray were negative. A punch biopsy from the neck demonstrated slight epidermal spongiosis with papillary dermal edema and a diffuse dermal neutrophilic infiltrate. No vasculitis was identified and direct immunofluorescence was negative. The patient was treated with triamcinolone cream, minocycline, and niacinamide. His cutaneous manifestations significantly improved, but his arthralgias were still present. Rheumatology subsequently started him on diclofenac. The patient was diagnosed with Sweet syndrome (acute febrile neutrophilic dermatosis). The pathogenesis of Sweet syndrome remained unknown, but its association with underlying diseases suggested a hypersensitivity reaction. Preceding vaccination had been rarely described as a cause of Sweet syndrome. Only a few cases of influenza vaccine-induced Sweet syndrome had been reported in the literature. The drug-induced form of Sweet syndrome could be due to a variety of culprits, although the strongest association exists with granulocyte-colony stimulating factor. Reporter's Comments: The patient developed acute febrile neutrophilic dermatosis after administrating the suspect product, INN Flu Vaccine. Chronology is plausible. No information regarding medical history or concomitant drugs was provided. Based on this information, causal relationship between the suspect product and event is assessed as related.
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Hypersensitivity, Immunology test, Immunology test normal, Laboratory test normal
Clinical narrative: Sweet syndrome; This is a literature case, reported by health care professional (physician), initially received on 12-Aug-2019, concerning a 41-year-old, male patient.   The patient had no relevant medical history and drug reactions or allergies.  One day after receiving an influenza vaccination (batch number and expiration date were not reported), the patient's symptoms of painful rash on his left neck and arm began. Physical examination revealed erythematous papules and plaques on the lateral neck and left arm. Laboratory evaluation and chest X-ray were negative. A punch biopsy from the neck demonstrated slight epidermal spongiosis with papillary dermal edema and a diffuse dermal neutrophilic infiltrate. No vasculitis was identified and direct immunofluorescence was negative. The patient was treated with triamcinolone cream, minocycline, and niacinamide. His cutaneous manifestations significantly improved, but his arthralgias were still present. Rheumatology subsequently started him on diclofenac. The patient was diagnosed with Sweet syndrome (acute febrile neutrophilic dermatosis). The pathogenesis of Sweet syndrome remained unknown, but its association with underlying diseases suggested a hypersensitivity reaction. Preceding vaccination had been rarely described as a cause of Sweet syndrome. Only a few cases of influenza vaccine-induced Sweet syndrome had been reported in the literature. The drug-induced form of Sweet syndrome could be due to a variety of culprits, although the strongest association exists with granulocyte-colony stimulating factor. Reporter's Comments: The patient developed acute febrile neutrophilic dermatosis after administrating the suspect product, INN Flu Vaccine. Chronology is plausible. No information regarding medical history or concomitant drugs was provided. Based on this information, causal relationship between the suspect product and event is assessed as related.
Sex: M
Vaccine: FLUX
Symptoms: Papule, Rash, Skin disorder, Skin oedema, Skin plaque
Clinical narrative: Sweet syndrome; This is a literature case, reported by health care professional (physician), initially received on 12-Aug-2019, concerning a 41-year-old, male patient.   The patient had no relevant medical history and drug reactions or allergies.  One day after receiving an influenza vaccination (batch number and expiration date were not reported), the patient's symptoms of painful rash on his left neck and arm began. Physical examination revealed erythematous papules and plaques on the lateral neck and left arm. Laboratory evaluation and chest X-ray were negative. A punch biopsy from the neck demonstrated slight epidermal spongiosis with papillary dermal edema and a diffuse dermal neutrophilic infiltrate. No vasculitis was identified and direct immunofluorescence was negative. The patient was treated with triamcinolone cream, minocycline, and niacinamide. His cutaneous manifestations significantly improved, but his arthralgias were still present. Rheumatology subsequently started him on diclofenac. The patient was diagnosed with Sweet syndrome (acute febrile neutrophilic dermatosis). The pathogenesis of Sweet syndrome remained unknown, but its association with underlying diseases suggested a hypersensitivity reaction. Preceding vaccination had been rarely described as a cause of Sweet syndrome. Only a few cases of influenza vaccine-induced Sweet syndrome had been reported in the literature. The drug-induced form of Sweet syndrome could be due to a variety of culprits, although the strongest association exists with granulocyte-colony stimulating factor. Reporter's Comments: The patient developed acute febrile neutrophilic dermatosis after administrating the suspect product, INN Flu Vaccine. Chronology is plausible. No information regarding medical history or concomitant drugs was provided. Based on this information, causal relationship between the suspect product and event is assessed as related.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Insomnia, Malaise, Nausea, Pain
Clinical narrative: Shingrix vaccination shot. Caused fever, aches, exhaustion, general feeling of nauseousness.  Unable to sleep and unable to feel well
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Shingrix vaccination shot. Caused fever, aches, exhaustion, general feeling of nauseousness.  Unable to sleep and unable to feel well
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: EXPLOSIVE DIARRHEA OUT OF THE BLUE JUST THE 1 TIME AT HOME
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Starting the evening after administration the patient noticed dizziness and chills/shivering before going to bed.  When she woke up the following morning her temperature was 100.6.  She had arm soreness and muscle aches.  She took acetaminophen for soreness/aches/fever.
Age: 41.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal discomfort, Pain, Pyrexia
Clinical narrative: Fever, body aches, upset stomach for 24-36 hours
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Blister, Erythema, Photosensitivity reaction, Pruritus
Clinical narrative: Photosensitivity on skin covering zygomatic arch. Itchy, red pimples turned into small blisters. Would get irritated if re-exposed to sunlight. Slow to resolve. Still lingering as sensitive area at time of second shot on Aug 22, 2019.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin irritation
Clinical narrative: Photosensitivity on skin covering zygomatic arch. Itchy, red pimples turned into small blisters. Would get irritated if re-exposed to sunlight. Slow to resolve. Still lingering as sensitive area at time of second shot on Aug 22, 2019.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Blood glucose normal, Bradycardia, Consciousness fluctuating, Dizziness
Clinical narrative: 1005 - Patient passed out at check-out window. He stated that he felt like he was going to pass out so the receptionist told him to sit in the floor and came to get a nurse. He was pale and said he felt hot and weak. He was offered gatorade and crackers and while a staff member went to obtain them he passed out on the floor. CPNP assessed patient and said his heart rate was low. Ammonia pad used to awaken him. He drank the gatorade and ate a cracker., Pulse ox 99% HR 44 - jls 1005 1010 - Dr called to assess patient and while he was assessing him child awoke. He was assisted from the floor to a room and sat in a chair., Pulse ox 99% HR 45 BP 70/46 - jls 1010 Pulse ox 99% HR 53 - jls 1013 1015 - Dr still in room and patient passed out again but awoke slowly with difficulty answering questions directed at him., Pulse ox 98% HR 56 - jls 1015 1016 - Patient in and out of consciousness for an additional 5-8 minutes. Dr back to room to assess patient. Oxygen 15L via non-rebreather - jls 1020, Pulse ox 99% HR 61 BP 118/76 - jls 1020 1024 - Patient awake and groggy, Blood sugar 109, Pulse ox 100% HR 58. O2 stopped per Dr - jls 1024 1053 - Patient fully alert and talking. Texting on his phone., Pule ox 98% HR 64 BP 138/80 - jls 1053 Upon check out, patient walked to desk and went light headed sliding to the ground, no head injury, color was good but MS was slow to respond, He was moved to an exam room and pulse ox was placed. Transient bradycardia and hypotension were noted (and documented above). Patient was quite drowsy with fluctuating mental status during the observation period. There was no hypoglycemia or hypoxia. Patient was observed for and eventually mental status returned to baseline. Mom was at his side the entire time. We did apply blow-by O2 for stimulation, O2 sats remained high 90's throughout observation. He denies eating breakfast this am and did not take any meds this morning. This may represent a vagal response or vaccine reaction. I would hold gardisil for now. Mom will superhydrate him today with gatorade. He is asking to go to school as he has a biology test. Mom will call with any problems.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Feeling hot, Heart rate decreased, Hyporesponsive to stimuli, Hypotension, Loss of consciousness
Clinical narrative: 1005 - Patient passed out at check-out window. He stated that he felt like he was going to pass out so the receptionist told him to sit in the floor and came to get a nurse. He was pale and said he felt hot and weak. He was offered gatorade and crackers and while a staff member went to obtain them he passed out on the floor. CPNP assessed patient and said his heart rate was low. Ammonia pad used to awaken him. He drank the gatorade and ate a cracker., Pulse ox 99% HR 44 - jls 1005 1010 - Dr called to assess patient and while he was assessing him child awoke. He was assisted from the floor to a room and sat in a chair., Pulse ox 99% HR 45 BP 70/46 - jls 1010 Pulse ox 99% HR 53 - jls 1013 1015 - Dr still in room and patient passed out again but awoke slowly with difficulty answering questions directed at him., Pulse ox 98% HR 56 - jls 1015 1016 - Patient in and out of consciousness for an additional 5-8 minutes. Dr back to room to assess patient. Oxygen 15L via non-rebreather - jls 1020, Pulse ox 99% HR 61 BP 118/76 - jls 1020 1024 - Patient awake and groggy, Blood sugar 109, Pulse ox 100% HR 58. O2 stopped per Dr - jls 1024 1053 - Patient fully alert and talking. Texting on his phone., Pule ox 98% HR 64 BP 138/80 - jls 1053 Upon check out, patient walked to desk and went light headed sliding to the ground, no head injury, color was good but MS was slow to respond, He was moved to an exam room and pulse ox was placed. Transient bradycardia and hypotension were noted (and documented above). Patient was quite drowsy with fluctuating mental status during the observation period. There was no hypoglycemia or hypoxia. Patient was observed for and eventually mental status returned to baseline. Mom was at his side the entire time. We did apply blow-by O2 for stimulation, O2 sats remained high 90's throughout observation. He denies eating breakfast this am and did not take any meds this morning. This may represent a vagal response or vaccine reaction. I would hold gardisil for now. Mom will superhydrate him today with gatorade. He is asking to go to school as he has a biology test. Mom will call with any problems.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Pallor, Somnolence
Clinical narrative: 1005 - Patient passed out at check-out window. He stated that he felt like he was going to pass out so the receptionist told him to sit in the floor and came to get a nurse. He was pale and said he felt hot and weak. He was offered gatorade and crackers and while a staff member went to obtain them he passed out on the floor. CPNP assessed patient and said his heart rate was low. Ammonia pad used to awaken him. He drank the gatorade and ate a cracker., Pulse ox 99% HR 44 - jls 1005 1010 - Dr called to assess patient and while he was assessing him child awoke. He was assisted from the floor to a room and sat in a chair., Pulse ox 99% HR 45 BP 70/46 - jls 1010 Pulse ox 99% HR 53 - jls 1013 1015 - Dr still in room and patient passed out again but awoke slowly with difficulty answering questions directed at him., Pulse ox 98% HR 56 - jls 1015 1016 - Patient in and out of consciousness for an additional 5-8 minutes. Dr back to room to assess patient. Oxygen 15L via non-rebreather - jls 1020, Pulse ox 99% HR 61 BP 118/76 - jls 1020 1024 - Patient awake and groggy, Blood sugar 109, Pulse ox 100% HR 58. O2 stopped per Dr - jls 1024 1053 - Patient fully alert and talking. Texting on his phone., Pule ox 98% HR 64 BP 138/80 - jls 1053 Upon check out, patient walked to desk and went light headed sliding to the ground, no head injury, color was good but MS was slow to respond, He was moved to an exam room and pulse ox was placed. Transient bradycardia and hypotension were noted (and documented above). Patient was quite drowsy with fluctuating mental status during the observation period. There was no hypoglycemia or hypoxia. Patient was observed for and eventually mental status returned to baseline. Mom was at his side the entire time. We did apply blow-by O2 for stimulation, O2 sats remained high 90's throughout observation. He denies eating breakfast this am and did not take any meds this morning. This may represent a vagal response or vaccine reaction. I would hold gardisil for now. Mom will superhydrate him today with gatorade. He is asking to go to school as he has a biology test. Mom will call with any problems.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Inflammation, Pain in extremity, Paraesthesia, Pruritus
Clinical narrative: THE PATIENT WENT IN FOR HER 2ND DOSE OF MMR ON 08/07/19 AT URGENT CARE. SHE WAS GIVEN THE MRR VACCINE IN HER RIGHT DELTOID. THE PATIENT STATED HER ARM BECAME RED AND INFLAMED ABOUT 30 MINS AFTER RECEIVING THE INJECTION. THE REDNESS CONTINUED INTO DAY 5 POST INJECTION AND SHE BEGAN FEELING PAIN, ITCHING, AND TINGLING DOWN HER RIGHT ARM INTO HER HAND. THE PATIENT WENT TO AH MEDICAL CARE TO BE SEEN FOR HER SYMPTOMS. HER SYMPTOMS LASTED 2 WEEKS, BUT ARE NOW RESOLVED.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: Pt is a RN working in the department who had just received her yearly flu vaccination.   Had not had issues in previous years with these vaccinations.  Pt c/o feeling nauseated and sweaty approx. 7 min post injection.  by 1155a, c/o difficulty breathing.  Moved to exam room, pulse ox applied reading 100% on room air, and O2 mask at 6L/min offered to pt to aid with respirations.  At 1157a, received 50 mg Bendadryl IM L arm and maintained O2 Sat 100% on room air and with mask on occasionally.  At 12n, prepared to administer Epi pen when pt states was feeling better.  Continued to monitor over the next 30 minutes with O2 Sat remaining at 100% on room air and by 1220p, pt stated had no issues with breathing and was walking around the room.  Pt stayed in dept for 4 hours while being observed and then was able to go home without any respiratory issues (maintained 100% O2 Sat).
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: she stated she had arm pain that night, unable to sleep well due to arm pain, unable to lay on that side and it continued.  On 10/16/2018 she stated it was difficult to lift her arm above her head, and difficult to dress.  She was offered P.T., but declined.  Stated she has been taking Ibuprofen and doing stretches.
Age: 45.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site rash, Rash
Clinical narrative: Rash that started right upper arm and then went to left upper arm and down to bilateral LE. Rash gone one month later everywhere except right upper arm.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Urticaria
Clinical narrative: Received flu vaccination in a.m. of 11/19/2018, and went on to Café to eat breakfast.  Returned to Employee Health approx. 2.5 hours later with a very red face and a visible hive on her ant. neck.  Stated she felt warm.  Not sure if reaction from flu vaccination or something she ate.  No other signs of distress.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: She had flu like symptoms for 24 hours but no fever and a swollen, hot to the touch arm at the injection site. Her arm is less swollen and less painful but there still is pain (8/22).
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Pain
Clinical narrative: She received her flu vaccination on 10/04/18 approx. at 1300.  She called Employee Health on 10/05/18 stating she is sick, 'I've taken Ibuprofen all night long, I hurt so bad.'  She was reminded of the s/s listed on her VIS.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Menactra administered at 1458 into right deltoid. At 1510 patient began complaining of right arm pain below injection site, muscle spasms  and swelling in right upper arm. No signs of anaphylaxis. Right arm was not red or warm and patient able to move right arm/shoulder freely without pain, normal color and sensation of right upper arm. Symptoms improved with ice pack. Monitored patient for 30 minutes and red area noted below injection site. 25 mg of oral benadryl was administered at 1530. Patient remained stable without signs of anaphylaxis or distress. Continued to monitor patient. At 1545 patient developed chills, heart rate elevated but other vitals remained stable. Patient's mother requested the patient be transported to nearby ER for close monitoring, and she wished for EMS to transport patient as she did not feel comfortable driving him. (patient remained without distress, tachycardia present, no signs of anaphylaxis). EMS arrived at 1556 and transported patient to ER.Patient appeared stable upon leaving the clinic.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Muscle spasms
Clinical narrative: Menactra administered at 1458 into right deltoid. At 1510 patient began complaining of right arm pain below injection site, muscle spasms  and swelling in right upper arm. No signs of anaphylaxis. Right arm was not red or warm and patient able to move right arm/shoulder freely without pain, normal color and sensation of right upper arm. Symptoms improved with ice pack. Monitored patient for 30 minutes and red area noted below injection site. 25 mg of oral benadryl was administered at 1530. Patient remained stable without signs of anaphylaxis or distress. Continued to monitor patient. At 1545 patient developed chills, heart rate elevated but other vitals remained stable. Patient's mother requested the patient be transported to nearby ER for close monitoring, and she wished for EMS to transport patient as she did not feel comfortable driving him. (patient remained without distress, tachycardia present, no signs of anaphylaxis). EMS arrived at 1556 and transported patient to ER.Patient appeared stable upon leaving the clinic.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Flushing, Palpitations, Pruritus, Rash
Clinical narrative: Body , face, Rash Itch Palpitations Flushing Face
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site rash
Clinical narrative: Came to Employee Health on 11/19/19 and stated he had itching at site of vaccination as well as a rash and deep red coloration. Rash is gone now on 11/19/19, but still reddened in area of vaccination.  Not raised.  States not warm to touch, nor painful.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient had vaccines given at a different facility the day before presenting to the urgent care for the adverse reaction.  Patient is having left arm swelling and pain after receiving the Menactra, hepatitis A, and hepatitis B in her left arm and the Bexsero and Gardasill in her right arm.  I did call the administering facility that gave me the information but they did not give me any information about vaccine lot numbers or expiration dates.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: One day after flu vaccination, 10/10/18, she came to Employee Health to reveal a bright red circular area directly below the site of her flu vaccination, and it measured approx. 40 mm.  She states it does not hurt, nor itch, denies warmth.  It is not raised.  No c/o other s/s.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Rash started on trunk then spread to face, arms, & groin, days 7/11/19 thru 7/22/19 Apt. Fever 7/18/19 thru 7/21/19.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pregnancy test urine, Urine analysis, Vomiting
Clinical narrative: Nausea, vomiting experienced on 8/21/19
Sex: M
Vaccine: PPV
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: the patient developed "chills, shaking, flu-like symptoms, redness at injection site, swelling of arm from injection site to elbow, and pain in left arm."/The patient had significant disability as patient was having significant pain in his left arm.; the patient developed "chills, shaking, flu-like symptoms, redness at injection site, swelling of arm from injection site to elbow, and pain in left arm."; the patient developed "chills, shaking, flu-like symptoms, redness at injection site, swelling of arm from injection site to elbow, and pain in left arm."; the patient developed "chills, shaking, flu-like symptoms, redness at injection site, swelling of arm from injection site to elbow, and pain in left arm."; the patient developed "chills, shaking, flu-like symptoms, redness at injection site, swelling of arm from injection site to elbow, and pain in left arm."; the patient developed "chills, shaking, flu-like symptoms, redness at injection site, swelling of arm from injection site to elbow, and pain in left arm."; This spontaneous report was received from a pharmacist, referring to a 64-years-old male patient. The patient's concurrent conditions and historical condition were unknown by the reporter. It was reported that the patient did not have previously drug reactions or allergies. The patient's concomitant therapies included atorvastatin and losartan.     On 08-AUG-2019, the patient was vaccinated for first time with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, intramuscularly in his left arm (strength, and dose were not reported; lot number R034249 has been verified to be valid for pneumococcal vaccine, polyvalent (23-valent); expiration date 07-AUG-2020) as prevention of pneumonia..      On the same date a couple hours after receiving the vaccine, the patient developed chills, shaking (tremor), flu-like symptoms (Influenza like illness), redness at injection site (vaccination site erythema), swelling of arm from injection site to elbow (peripheral swelling), and pain in left arm (pain in extremity). Consequently, The patient sought for medical attention, he went to the pharmacy to reported the symptoms. The pharmacist reported that the patient had significant pain in his left arm. However, he did not received treatment for the events, and lab diagnostics/studies was not performed.   At the time of this report, the outcome of the aforementioned events was reported as resolving.        The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) and the events occurrence was not reported. The event pain in extremity was considered disability by the reporter.
Sex: M
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: the patient developed "chills, shaking, flu-like symptoms, redness at injection site, swelling of arm from injection site to elbow, and pain in left arm."/The patient had significant disability as patient was having significant pain in his left arm.; the patient developed "chills, shaking, flu-like symptoms, redness at injection site, swelling of arm from injection site to elbow, and pain in left arm."; the patient developed "chills, shaking, flu-like symptoms, redness at injection site, swelling of arm from injection site to elbow, and pain in left arm."; the patient developed "chills, shaking, flu-like symptoms, redness at injection site, swelling of arm from injection site to elbow, and pain in left arm."; the patient developed "chills, shaking, flu-like symptoms, redness at injection site, swelling of arm from injection site to elbow, and pain in left arm."; the patient developed "chills, shaking, flu-like symptoms, redness at injection site, swelling of arm from injection site to elbow, and pain in left arm."; This spontaneous report was received from a pharmacist, referring to a 64-years-old male patient. The patient's concurrent conditions and historical condition were unknown by the reporter. It was reported that the patient did not have previously drug reactions or allergies. The patient's concomitant therapies included atorvastatin and losartan.     On 08-AUG-2019, the patient was vaccinated for first time with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, intramuscularly in his left arm (strength, and dose were not reported; lot number R034249 has been verified to be valid for pneumococcal vaccine, polyvalent (23-valent); expiration date 07-AUG-2020) as prevention of pneumonia..      On the same date a couple hours after receiving the vaccine, the patient developed chills, shaking (tremor), flu-like symptoms (Influenza like illness), redness at injection site (vaccination site erythema), swelling of arm from injection site to elbow (peripheral swelling), and pain in left arm (pain in extremity). Consequently, The patient sought for medical attention, he went to the pharmacy to reported the symptoms. The pharmacist reported that the patient had significant pain in his left arm. However, he did not received treatment for the events, and lab diagnostics/studies was not performed.   At the time of this report, the outcome of the aforementioned events was reported as resolving.        The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) and the events occurrence was not reported. The event pain in extremity was considered disability by the reporter.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Feeling cold, Injection site swelling, Limb discomfort
Clinical narrative: Felt she was having a lupus flare up; Injection site swelling; arm hurt really bad; felt like arm was broken; body aches all over; felt cold; had chills; fever of 102.7; This case was reported by a consumer via call center representative and described the occurrence of systemic lupus erythematosus syndrome aggravated in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus.   On 17th May 2019, the patient received the 1st dose of Shingrix. In May 2019, 8 hrs after receiving Shingrix, the patient experienced systemic lupus erythematosus syndrome aggravated (serious criteria GSK medically significant), injection site swelling, pain in arm, arm discomfort, general body pain, feeling cold, chills and fever. On an unknown date, the outcome of the systemic lupus erythematosus syndrome aggravated, injection site swelling, pain in arm, arm discomfort, general body pain, feeling cold and chills were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the systemic lupus erythematosus syndrome aggravated, injection site swelling, pain in arm, arm discomfort, general body pain, feeling cold, chills and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and 8 hours later she developed swelling at the injection site, her arm hurt really bad and felt like it was broken. She felt she was having a lupus flare up, had body aches all over, felt cold and had chills. The patient also developed a fever of 102.7 degree F after 12th hour that lasted for two days. The reporter consented for follow up. For tolerance to the 2nd dose of Shingrix, refer case US2019AMR150026.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Systemic lupus erythematosus
Clinical narrative: Felt she was having a lupus flare up; Injection site swelling; arm hurt really bad; felt like arm was broken; body aches all over; felt cold; had chills; fever of 102.7; This case was reported by a consumer via call center representative and described the occurrence of systemic lupus erythematosus syndrome aggravated in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus.   On 17th May 2019, the patient received the 1st dose of Shingrix. In May 2019, 8 hrs after receiving Shingrix, the patient experienced systemic lupus erythematosus syndrome aggravated (serious criteria GSK medically significant), injection site swelling, pain in arm, arm discomfort, general body pain, feeling cold, chills and fever. On an unknown date, the outcome of the systemic lupus erythematosus syndrome aggravated, injection site swelling, pain in arm, arm discomfort, general body pain, feeling cold and chills were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the systemic lupus erythematosus syndrome aggravated, injection site swelling, pain in arm, arm discomfort, general body pain, feeling cold, chills and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and 8 hours later she developed swelling at the injection site, her arm hurt really bad and felt like it was broken. She felt she was having a lupus flare up, had body aches all over, felt cold and had chills. The patient also developed a fever of 102.7 degree F after 12th hour that lasted for two days. The reporter consented for follow up. For tolerance to the 2nd dose of Shingrix, refer case US2019AMR150026.
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness, Seizure
Clinical narrative: passed out; experienced first time seizure; This is a spontaneous report from a contactable physician.  A female patient of an unspecified age received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on 09Aug2019 at single dose for immunization. The patient's medical history and concomitant medications were not reported. Patient had first meningococcal group b rlp2086 vaccine on 09Aug2019, then experienced first time seizure, in emergency room currently. It was reported that the patient passed out and had what sounded possibly like a seizure. The outcome of the events was unknown. The patient was in a local emergency room being evaluated.; Sender's Comments: A possible causal association between administration of TRUMENBA and the onset of seizure/passed out cannot be excluded, assuming a plausible temporal association.  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: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Consciousness fluctuating, Electrocardiogram abnormal, Hypotension, Orthostatic hypotension, Sinus bradycardia
Clinical narrative: Syncopal episode lasting 5-10 seconds 3 minutes after vaccinations. Wavering consciousness for 8 minutes after waking up until EMS arrived. Hypotensive from EMS vitals. Sinus bradycardia on ECG in ER. Persistent orthostatic hypotension despite 1800 mL NS bolus led to peds admission. Diagnosis of vasovagal syncope.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncopal episode lasting 5-10 seconds 3 minutes after vaccinations. Wavering consciousness for 8 minutes after waking up until EMS arrived. Hypotensive from EMS vitals. Sinus bradycardia on ECG in ER. Persistent orthostatic hypotension despite 1800 mL NS bolus led to peds admission. Diagnosis of vasovagal syncope.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Deafness, Loss of consciousness, Nausea, Pallor, Seizure
Clinical narrative: Syncopal episode lasting 5-10 seconds 3 minutes after vaccinations. Wavering consciousness for 8 minutes after waking up until EMS arrived. Hypotensive from EMS vitals. Sinus bradycardia on ECG in ER. Persistent orthostatic hypotension despite 1800 mL NS bolus led to peds admission. Diagnosis of vasovagal syncope.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fall, Feeling cold, Feeling hot
Clinical narrative: For both doses (1 & 2), I had muscle pain, shivering, feeling hot, then cold.  These started in the late evening. The pain was much worse with the second dose.  Also with the second dose, upon waking following morning, I had severe nausea, was so weak I couldn't walk, fell when trying to get off the toilet.  I went back to bed and hours later I was able to get up but I was still very nauseous.  I almost called 911 but was too weak and nauseous to unlock my door.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: For both doses (1 & 2), I had muscle pain, shivering, feeling hot, then cold.  These started in the late evening. The pain was much worse with the second dose.  Also with the second dose, upon waking following morning, I had severe nausea, was so weak I couldn't walk, fell when trying to get off the toilet.  I went back to bed and hours later I was able to get up but I was still very nauseous.  I almost called 911 but was too weak and nauseous to unlock my door.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: Chills, shivering, Fever of 103 degrees fahreinheit, unable to open jaw due to shivering/chills, alleviated somewhat with Tylenol administration, rash and soreness around the injection, pain upon site.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events reported by the patient.  However, this was 3rd time the patient received Shingrix injection, instead of just 2 doses.  Previous doses were administered on 05/28/18, 07/31/18.  Third dose was given 1/8/19.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Injection given at approx.  10:30AM.  At 8 PM, pain/weakness in left arm/shoulder began and continues to date.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Pt complained of myalgia accompanied with a low temperature fever lasting over three days after administration of vaccination.
Age: 54.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash
Clinical narrative: Patient complaint of rash starting on neck down to chest
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Arteriogram coronary normal, Cardiac stress test normal, Chest discomfort, Chest pain, Computerised tomogram normal
Clinical narrative: I got the shot during the day, later that night I felt as if I was getting the flu, just sort of  icky feeling. By the next morning , after I was up and moving for a while, my chest felt heavy . By about 24 hours after I got the tdap it was becoming difficult to breathe. I didn?t have an appetite for about 5 days. It became more difficult to breath doing normal daily things. I never had a problem going up our stairs, now I have to stop. Before this shot I had been walking our new dog 5-7 days per week, we would do fast speed walking for a half mile, then walk another half mile. I was never out of breath or winded, only my heart would beat faster, as to be expected. Now walking short distances I get out of breath. If I talk in conversation about 30 minutes I am short of breath .If I do too much talking, and or walking I add to the heavy feeling in my chest/lungs and a burning feeling .It reminds me of having pneumonia. I have had PFT, stress treadmill test, CT scan, and heart angiogram, all tests have shown nothing. All of this started after the tdap shot. I am told by Dr. to build my endurance, I HAD endurance built up until I had the tdap shot. I am tired, feel like I?m going to get the flu, have more and more headaches daily. I  use to play WITH my grandchildren, now I sit and watch them play, after trying to play with them. I keep trying to build endurance back, it?s Not getting better. My chest hurts, it?s hard to breath. An inhaler didn?t help.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Dyspnoea, Fatigue, Headache, Influenza like illness
Clinical narrative: I got the shot during the day, later that night I felt as if I was getting the flu, just sort of  icky feeling. By the next morning , after I was up and moving for a while, my chest felt heavy . By about 24 hours after I got the tdap it was becoming difficult to breathe. I didn?t have an appetite for about 5 days. It became more difficult to breath doing normal daily things. I never had a problem going up our stairs, now I have to stop. Before this shot I had been walking our new dog 5-7 days per week, we would do fast speed walking for a half mile, then walk another half mile. I was never out of breath or winded, only my heart would beat faster, as to be expected. Now walking short distances I get out of breath. If I talk in conversation about 30 minutes I am short of breath .If I do too much talking, and or walking I add to the heavy feeling in my chest/lungs and a burning feeling .It reminds me of having pneumonia. I have had PFT, stress treadmill test, CT scan, and heart angiogram, all tests have shown nothing. All of this started after the tdap shot. I am told by Dr. to build my endurance, I HAD endurance built up until I had the tdap shot. I am tired, feel like I?m going to get the flu, have more and more headaches daily. I  use to play WITH my grandchildren, now I sit and watch them play, after trying to play with them. I keep trying to build endurance back, it?s Not getting better. My chest hurts, it?s hard to breath. An inhaler didn?t help.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pulmonary function test normal
Clinical narrative: I got the shot during the day, later that night I felt as if I was getting the flu, just sort of  icky feeling. By the next morning , after I was up and moving for a while, my chest felt heavy . By about 24 hours after I got the tdap it was becoming difficult to breathe. I didn?t have an appetite for about 5 days. It became more difficult to breath doing normal daily things. I never had a problem going up our stairs, now I have to stop. Before this shot I had been walking our new dog 5-7 days per week, we would do fast speed walking for a half mile, then walk another half mile. I was never out of breath or winded, only my heart would beat faster, as to be expected. Now walking short distances I get out of breath. If I talk in conversation about 30 minutes I am short of breath .If I do too much talking, and or walking I add to the heavy feeling in my chest/lungs and a burning feeling .It reminds me of having pneumonia. I have had PFT, stress treadmill test, CT scan, and heart angiogram, all tests have shown nothing. All of this started after the tdap shot. I am told by Dr. to build my endurance, I HAD endurance built up until I had the tdap shot. I am tired, feel like I?m going to get the flu, have more and more headaches daily. I  use to play WITH my grandchildren, now I sit and watch them play, after trying to play with them. I keep trying to build endurance back, it?s Not getting better. My chest hurts, it?s hard to breath. An inhaler didn?t help.
Age: 1.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: A rash of red blotchy patches popped up next day. The rash spread all over her body over the next 15 days. A fever was present for the next 15 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hypersomnia, Injection site erythema, Injection site pain, Pain
Clinical narrative: very tired, slept more than normal, achy all over, injection site sore day/night of injection,   injection site still  sore   8/22/2019  red area apx   1" x 2-1/2"   at injection site appeared 8/22/2019
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Sporadic, full body hives that lasted for 24 hours
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Chills, Depressed mood, Eye irritation, Feeling abnormal
Clinical narrative: started with fever/chills on 7/10/19, then spent number of weeks feeling low/eyes burning/miserable/brain fog, then hives started in clusters-would go away, then come back for about 3 weeks (very itchy), then strange large spot (2-3 inch) on left breast (skin textures stringy and molted, buns and aches).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Skin texture abnormal, Urticaria
Clinical narrative: started with fever/chills on 7/10/19, then spent number of weeks feeling low/eyes burning/miserable/brain fog, then hives started in clusters-would go away, then come back for about 3 weeks (very itchy), then strange large spot (2-3 inch) on left breast (skin textures stringy and molted, buns and aches).
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: perimeter marked with black sharpie, rec Tylenol and cold compress for now, let us know if anything worsens
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Secretion discharge, Skin hyperpigmentation, Skin lesion, Stomatitis
Clinical narrative: After patient received first dose of Shingrix, patient reports the development of lesions all over body approximately two to three days after injection.  Lesions were located bilaterally on back, legs, torso.  Lesions eventually produced a yellow secretion.  Lesions would disappear over a few days and then new lesions would appear.  At two months post injection, patient reports all lesions were mostly cleared with only a few areas of hyperpigmentation left.  Lesions did not appear at the injection site.  Pt reports having sores in mouth as well, which she is unsure if this was related or not.   Pt reported to urgent care and then was seen by PCP.  Pt was prescribed oral antibiotic and benadryl oral.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Arthralgia, Crying, Headache, Pain in extremity
Clinical narrative: TC from the mother. She reports that Patient had her vaccines at 1315 on 8-20-19.  At 1445 8-20-19, she was complaining of a severe headache and achenes in her legs and knees. She was crying. The mother gave  her 3 Tylenol and water and encouraged her to sleep. The symptoms were relieved and the client was able to play volleyball in the evening  of 8-20-19. The next day she felt fine. Today 8-22-19, she had a mild headache the mother contributed to not eating.  The mother was informed that the episode would be reported to VAERS.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: Erythema,, warmth and pain at injection sites.  Low grade fever.  Rash on trunk and legs
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Erythema,, warmth and pain at injection sites.  Low grade fever.  Rash on trunk and legs
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient was given MMRV instead of MMR, in error. He received Varicella in right thigh at same visit.  No symptoms at present. Immunization program advised. Parent advised of possible adverse effects.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: pt stated developed a lump under skin and redness over entire right upper arm, 10 days later lump remains but redness is subsiding