chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Coma
Clinical narrative: Coma; This case was reported by a consumer via call center representative and described the occurrence of coma in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced coma (serious criteria GSK medically significant). On an unknown date, the outcome of the coma was unknown.   The reporter considered the coma to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was considered as adult as per vaccine indication. The patient experience the symptoms (exact symptoms or patient identifiers not provided) but were in a coma due to Shingrix. This case has been linked with case US2019201127, reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number D924E, expiry date 8th March 2022) for prophylaxis.   On 22nd August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient after vaccination experienced some pain at the injection site. This case has been linked with case US2019202821, reported by the same reporter.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Product storage error, Pyrexia
Clinical narrative: Inadvertantly gave an adult dose of Havrix to a  12 month old child; Adult product administered to child; Incorrect storage of drug; Fever; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 12-month-old female patient who received HAV (Havrix adult) (batch number 4H37Y, expiry date 8th November 2020) for prophylaxis.   On 4th October 2019, the patient received Havrix adult. On 4th October 2019, unknown after receiving Havrix adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.  Additional case details were reported as follows: This case was report5ed by the medical assistant. The patient was inadvertently gave an adult dose of Havrix to a 12 month old child, accidental overdose and adult product administered to child. The reporter consented to follow up.   Follow up information was received from other healthcare professional on 6th November 2019: The patient's demographic details were updated. The patient received a dose of Havrix Adult on the lower right thigh via intramuscularly, which was incorrectly placed in the fridge. The reporter realized the mistake during administration. The patient's mother notified that, the patient was treating with Ibuprofen alternating with Tylenol for fever, which was for 12 hours. It was unknown if the reporter considered the fever to be related to Havrix adult. The VAERS details were updated. This case was considered as medication error with harm.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Developed shingles in his left eye; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2019, the patient received Shingrix (intramuscular). On 3rd November 2019, 6 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was not recovered/not resolved.   The reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provided as follows: The case is a legally significant case.  The patient received Shingrix in left arm. The patient experienced shingles in the left eye.  The patient saw more than one doctor about it and was told there was a good likelihood that he would lose vision in his eye because of the shingles. The patient believed Shingrix caused the shingles. The reporter consented to follow up. The reporter saw a junior doctor first. He then saw a senior doctor, but did not have the name available. He preferred to contact the senior doctor who diagnosed him with shingles. The reporter stated his attorney would be in touch with GSK.
Sex: U
Vaccine: VARZOS
Symptoms: Eye pain, Visual impairment
Clinical narrative: Left eye feels aching; Vision interference; This case was reported by a consumer via call center representative and described the occurrence of eye pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced eye pain and abnormal vision. On an unknown date, the outcome of the eye pain and abnormal vision were unknown.   It was unknown if the reporter considered the eye pain and abnormal vision to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that they had the shingles vaccine and their left eye felt aching vision interference. No further details captured, the patient was getting out of car and states they were calling in. Requested follow up, but contact did not give a response to question.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin discolouration
Clinical narrative: redness and bumps on both forearms, chest, lower back, and forehead; This case was reported by a pharmacist via call center representative and described the occurrence of red rash in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was recovering/resolving.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be between 67 or 68 years. The reporter stated that the patient few days after vaccination developed redness and bumps on both forearms, chest, lower back, and forehead. The bumps eventually turn from red to dark spots.   The bumps and dark spots were become less prevalent but still ongoing. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Agitation, Eye movement disorder, Head banging, Tic
Clinical narrative: Within an hour of  receiving his 3rd polio vaccine he began slamming his head side to side in his car seat . When he would stop his eyes would track and roll . He was extremely agitated and could not control head and eye movements . It became more infrequent by morning but he had developed a tic where here would roll his eyes back in his head and and he would cock his head to the side. This tic persisted for 5 years.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Severe pain couldn't touch arm or move. Red, warm to touch,tired, swelling went from top of shoulder down to elbow and had a golf ball shaped swelling by the inside of arm close to elbow. Lasted 3 days. Took ibuprofen and ice.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Severe pain couldn't touch arm or move. Red, warm to touch,tired, swelling went from top of shoulder down to elbow and had a golf ball shaped swelling by the inside of arm close to elbow. Lasted 3 days. Took ibuprofen and ice.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall
Clinical narrative: Patient reported lightheadedness after receiving flu shot and fell forward from her chair. Did not hit her head or have any other allergic reactions. No other symptoms and recovered after resting and drinking water. Patient has history of fainting and lightheadedness with shots/blood draws before due to fear of needles.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Erythema, Swelling
Clinical narrative: Stated vaccine burned with injection.  Became red swollen and itching approx. 45 min later.  Area not reddened, warm, Tender to palpation
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pruritus, Urticaria
Clinical narrative: Muscle soreness at injection site about 24 hours after injection.  After about 48 hours, itchy hives forming  on left arm,. Hives on arms mostly resolved within 5 days, but presently, about ~3 weeks post injection, observing uticaria/hives throughout the body; especially on torso.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Anger, Crying, Electrocardiogram abnormal, Fall, Head injury
Clinical narrative: Patient received vaccinations at approx 10:50 am.  PHN instructed her to remain sitting in her chair after receiving her vaccines.  She sat in the chair for approx 5-7 min, then patient and her mom left the nurse's office and walked out to the HD main lobby to schedule the next clinic appt.  They were in the lobby for approx 1-2 min. when PHN heard a "thud" and the admin asst shouted for PHN to come to the lobby.  PHN grabbed an ammonia inhalant and ran to the lobby.  PHN arrived in the lobby within 30 seconds of admin asst shouting for PHN.  Patient was laying face up on the floor in the HD lobby doorway.  Patient was responsive when PHN knelt beside her.  PHN Instructed her to remain laying down.  She was crying and upset and sat up.  PHN knelt behind her and supported her in the sitting position.  PHN waved the ammonia inhalant under her nose and told her to remain sitting.  Patient stated her head hurt, and wasn't sure what happened.  Patient's mom stated that patient was standing at the admn asst desk in the HD lobby and passed out and fell into the health dept entry way and hit her head on the floor of the building lobby.  PHN applied an icepack to the back of patient's head.  Another HD staff member called 911. HD police chief and HD fire capt. arrived on scene.  HD fire capt took over care of patient until FD EMS arrived.  FD asked mom if they wanted them to transport patient to the hospital.  Mom stated she would like her to be transported to hospital.  Transport to hospital by FD occurred at approx 1130-1145 am.  PHN followed up with mom on 11/6/19 at approx 2:30 pm.  Mom stated patient was home and resting. Mom stated that patient did not have a concussion, no CT scan was done.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient received vaccinations at approx 10:50 am.  PHN instructed her to remain sitting in her chair after receiving her vaccines.  She sat in the chair for approx 5-7 min, then patient and her mom left the nurse's office and walked out to the HD main lobby to schedule the next clinic appt.  They were in the lobby for approx 1-2 min. when PHN heard a "thud" and the admin asst shouted for PHN to come to the lobby.  PHN grabbed an ammonia inhalant and ran to the lobby.  PHN arrived in the lobby within 30 seconds of admin asst shouting for PHN.  Patient was laying face up on the floor in the HD lobby doorway.  Patient was responsive when PHN knelt beside her.  PHN Instructed her to remain laying down.  She was crying and upset and sat up.  PHN knelt behind her and supported her in the sitting position.  PHN waved the ammonia inhalant under her nose and told her to remain sitting.  Patient stated her head hurt, and wasn't sure what happened.  Patient's mom stated that patient was standing at the admn asst desk in the HD lobby and passed out and fell into the health dept entry way and hit her head on the floor of the building lobby.  PHN applied an icepack to the back of patient's head.  Another HD staff member called 911. HD police chief and HD fire capt. arrived on scene.  HD fire capt took over care of patient until FD EMS arrived.  FD asked mom if they wanted them to transport patient to the hospital.  Mom stated she would like her to be transported to hospital.  Transport to hospital by FD occurred at approx 1130-1145 am.  PHN followed up with mom on 11/6/19 at approx 2:30 pm.  Mom stated patient was home and resting. Mom stated that patient did not have a concussion, no CT scan was done.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient has redness and swelling that is warm to the touch on the interior or her arm from her arm pit down to her elbow.  She also states that it itches.  She says that it started about 2 hours after the injection and got worse over time.  There is no redness or swelling at the injection site of the left deltoid upon examination.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Erythema, Headache, Inflammation
Clinical narrative: My left arm immediately became very very sore and inflamed. I was unable to lift my arm, sleep on it. I had to sleep on my back and not move my left arm. My arm was hot to the touch and red to the elbow. This condition remained for several weeks. The muscle is still sore to the touch. I had high fever and chills for four days following the shot. Then I had diarrhea for at least 3 days. Then the fever and chills came again perhaps they did not leave me. I also had bad headaches. I was sick in my bed for a week, I could not get up. My friends brought me food, soup mostly and toast. It took about 3 weeks before I felt well enough to leave my house. It has been a while so I might not have included everything that happened to me. I was very ill. I filed a complaint with Pharmacy against the Manager wig gave me the shot as she was very rude and in my opinion no medical trained to administer shots. She just stabbed my arm then told me not to cry. She has since called me and apologized. I will never go there again. I saw my doctor she hasn't decided if I should have the booster shot however we are waiting for 6 months. I will she her prior to that time.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Malaise, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: My left arm immediately became very very sore and inflamed. I was unable to lift my arm, sleep on it. I had to sleep on my back and not move my left arm. My arm was hot to the touch and red to the elbow. This condition remained for several weeks. The muscle is still sore to the touch. I had high fever and chills for four days following the shot. Then I had diarrhea for at least 3 days. Then the fever and chills came again perhaps they did not leave me. I also had bad headaches. I was sick in my bed for a week, I could not get up. My friends brought me food, soup mostly and toast. It took about 3 weeks before I felt well enough to leave my house. It has been a while so I might not have included everything that happened to me. I was very ill. I filed a complaint with Pharmacy against the Manager wig gave me the shot as she was very rude and in my opinion no medical trained to administer shots. She just stabbed my arm then told me not to cry. She has since called me and apologized. I will never go there again. I saw my doctor she hasn't decided if I should have the booster shot however we are waiting for 6 months. I will she her prior to that time.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm, Sleep disorder
Clinical narrative: My left arm immediately became very very sore and inflamed. I was unable to lift my arm, sleep on it. I had to sleep on my back and not move my left arm. My arm was hot to the touch and red to the elbow. This condition remained for several weeks. The muscle is still sore to the touch. I had high fever and chills for four days following the shot. Then I had diarrhea for at least 3 days. Then the fever and chills came again perhaps they did not leave me. I also had bad headaches. I was sick in my bed for a week, I could not get up. My friends brought me food, soup mostly and toast. It took about 3 weeks before I felt well enough to leave my house. It has been a while so I might not have included everything that happened to me. I was very ill. I filed a complaint with Pharmacy against the Manager wig gave me the shot as she was very rude and in my opinion no medical trained to administer shots. She just stabbed my arm then told me not to cry. She has since called me and apologized. I will never go there again. I saw my doctor she hasn't decided if I should have the booster shot however we are waiting for 6 months. I will she her prior to that time.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; patient received an expired dose of VARlVAX; This spontaneous report was received from a medical assistant referring to a 34 years old female patient. There was no information about the patient's concurrent conditions, drug reactions, allergies and medical history provided.  On 24-OCT-2019, the patient received an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX)(dose and strength unknown; lot # N023961, expiration date was 01-SEP-2019) with sterile diluent (lot# N026288, expiration date 08-FEB-2020) subcutaneously for prophylaxis. Varicella virus vaccine live (oka/merck)(VARIVAX) was stored properly. No adverse effects were reported.  This is one of the two reports received form the same reporter.; Sender's Comments:  US-009507513-1910USA015487:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effect; patient received a dose of PROQUAD via the intramuscular route in error; This spontaneous report was received from a nurse practitioner, referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, concurrent conditions, previous drug reactions and allergies were not reported.     On 29-OCT-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) as prophylaxis. The dose was administered via intramuscular route (incorrect route of product administration), by error (strength, dose number and frequency were not provided; lot number S017240 and expiration date 01-DEC-2020). No adverse effects were reported.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; inadvertently administered an expired dose of Rotateq; This spontaneous report was received from a physician and refers to a 4 month old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 30-OCT-2019, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally,  for prophylaxis, lot # R003114, expiration date on 27-SEP-2019, (strength, dosage and frequency were not provided). No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; patient received an improperly stored ROTATEQ on 11/4/2019 or 11/5/2019. Exact date of administration unknown.; This spontaneous report was received from a medical assistant, and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On approximately November 2019 (reported as "11/4/2019 or 11/5/2019, exact date of administration unknown"), the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S004253 with an expiration date in 21-OCT-2020), orally, for prophylaxis (strength, dose and frequency were not provided), that underwent a temperature excursion with a lowest temperature of 1.3 degrees Celsius, during a time frame of two hours and eighteen minutes. No previous temperature excursion was reported, however, it was stated that the digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple unspecified patients were administered improperly stored VAQTA; No adverse effects; This spontaneous report was received from a nurse referring to multiple unspecified patients' of unknown age and gender. Information regarding the patients' concurrent conditions, medical history and concomitant medications were not provided. On multiple unspecified dates, unspecified number of patients were vaccinated with improperly stored Hepatitis A Vaccine, Inactivated (VAQTA) injection (strength, dose # and route of administration were not reported) (lot # S009943 and expiry date reported as 26-JUL-2020) (product storage error) for prophylaxis. No adverse effects were reported. Temperature reported as 32.4 Fahrenheit, total time and lowest temperature below 36 degree Fahrenheit per 2 degree Celsius. Multiple excursions timeframe reported as 50 hours. There were no previous temperature excursions. There was an involvement of digital data logger. There was no associated product quality complaint.   This is a non-valid case due to lack of patient identifiers.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: It was very sore at the site and surrounding area and then it became red hot, very itchy; It was very sore at the site and surrounding area and then it became red hot, very itchy; It was very sore at the site and surrounding area and then it became red hot, very itchy; swelling and then after about a week it moved to down the arm and then went to the wrist; This is a spontaneous report from a contactable pharmacist.  A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: X93809 and expiration date: 28Feb2021), 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.  Patient described the adverse events as very sore at the site and surrounding area and then it became red hot, very itchy. The patient added that she experienced swelling and then after about a week it moved to down the arm and then went to the wrist. It did not go to the hand on unknown date. The patient reported the events lasted for 3 weeks. The outcome of the events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: It was very sore at the site and surrounding area and then it became red hot, very itchy; It was very sore at the site and surrounding area and then it became red hot, very itchy; It was very sore at the site and surrounding area and then it became red hot, very itchy; swelling and then after about a week it moved to down the arm and then went to the wrist; This is a spontaneous report from a contactable pharmacist.  A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: X93809 and expiration date: 28Feb2021), 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.  Patient described the adverse events as very sore at the site and surrounding area and then it became red hot, very itchy. The patient added that she experienced swelling and then after about a week it moved to down the arm and then went to the wrist. It did not go to the hand on unknown date. The patient reported the events lasted for 3 weeks. The outcome of the events was unknown.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Swelling at the injection site/injection site looked puffy; injection site was also red; received the vaccine in his right arm 25Oct2019, he had a little pain; This is a spontaneous report from a Pfizer-sponsored program, Pfizer RXPathways received from a contactable consumer (patient's wife). A 73-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in the right arm on 25Oct2019 at about 14:00-14:30 at 0.5 ml, single for pneumonia shot, vaccinated on the pharmacy/drug store. The patient has no medical history. Concomitant medication included third dose of influenza vaccine (FLUZONE) on 25Oct2019, received the flu shot on the same day in the opposite arm (left) but didn't give a reaction; the first dose was in 2006 and the second dose in 2007. It was reported that the patient's arm was red and swollen and he had some type of reaction. The patient received the vaccine in his right arm 25Oct2019, he had a little pain on the day he received the shot. He still had a little pain if he moves his arm or touches the injection site. The injection site was also red on 26Oct2019, the day after he received the vaccine and was swollen on 27Oct2019, about 2 days after receiving the vaccine. At first, the reporter stated the swelling at the injection site was kind of expanding. She thought it has expanded since the day he received the vaccine but the patient stated that the swelling was about the same, maybe a little less. For the patient's wife, the area was scary looking, she stated "to me I thought the injection site looked puffy in the beginning and now it's less puffy". The  patient's wife wanted to know if there is anything the patient can do now to prevent the reaction from getting worse. She stated that the pharmacist suggested putting Hydrocortisone cream with aloe on the affected area. The cream was from a Pharmacy and it reads "Hydrocortisone cream with aloe; soothing relief for skin irration, rashes, redness and irritation". The patient asked if he could use Vicks Vapor Rub he bought the Vicks Vapor Rub asked the attendant could he use the product as treatment. Outcome of the event pain and redness was not recovered while recovering for other event.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swelling at the injection site/injection site looked puffy; injection site was also red; received the vaccine in his right arm 25Oct2019, he had a little pain; This is a spontaneous report from a Pfizer-sponsored program, Pfizer RXPathways received from a contactable consumer (patient's wife). A 73-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in the right arm on 25Oct2019 at about 14:00-14:30 at 0.5 ml, single for pneumonia shot, vaccinated on the pharmacy/drug store. The patient has no medical history. Concomitant medication included third dose of influenza vaccine (FLUZONE) on 25Oct2019, received the flu shot on the same day in the opposite arm (left) but didn't give a reaction; the first dose was in 2006 and the second dose in 2007. It was reported that the patient's arm was red and swollen and he had some type of reaction. The patient received the vaccine in his right arm 25Oct2019, he had a little pain on the day he received the shot. He still had a little pain if he moves his arm or touches the injection site. The injection site was also red on 26Oct2019, the day after he received the vaccine and was swollen on 27Oct2019, about 2 days after receiving the vaccine. At first, the reporter stated the swelling at the injection site was kind of expanding. She thought it has expanded since the day he received the vaccine but the patient stated that the swelling was about the same, maybe a little less. For the patient's wife, the area was scary looking, she stated "to me I thought the injection site looked puffy in the beginning and now it's less puffy". The  patient's wife wanted to know if there is anything the patient can do now to prevent the reaction from getting worse. She stated that the pharmacist suggested putting Hydrocortisone cream with aloe on the affected area. The cream was from a Pharmacy and it reads "Hydrocortisone cream with aloe; soothing relief for skin irration, rashes, redness and irritation". The patient asked if he could use Vicks Vapor Rub he bought the Vicks Vapor Rub asked the attendant could he use the product as treatment. Outcome of the event pain and redness was not recovered while recovering for other event.
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Vaccination complication
Clinical narrative: her appetite never fully recovered; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported a female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient had the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) shot years ago. The patient had about every side effect (unspecified) and her appetite never fully recovered. Outcome of the event was not recovered.  No follow-up attempts are possible; information on the batch number cannot be obtained.
Sex: U
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: Swollen at the injection site; This is a spontaneous report from a contactable pharmacist through a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Lot number and expiration date were not reported), with route of administration and therapy date unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was swollen at the injection site. The outcome of the event, 'swollen at the injection site', was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Hepatic cirrhosis, Malaise
Clinical narrative: Sick; Has cirrhosis of the liver; This is a spontaneous report from a Pfizer-sponsored program Pfizer RXPathways. A contactable consumer (Patient's mother) reported that a 52-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient was sick and was in the hospital, and had cirrhosis of the liver and it was getting ready to go on disability. The outcome of events was unknown.  Information on the batch number has been requested.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Pain in extremity
Clinical narrative: Both injections were done on the same arm; Slight soreness on left arm; This is a spontaneous report from a contactable consumer.   A female patient (66 / 67 years) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) and influenza vaccine (FLU), both via an unspecified route of administration at single dose in the same arm on 02Nov2019 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced that both injections were done on the same arm on 02Nov2019. The package insert indicates Prevnar 13 and flu vaccine in different injection site. She also developed slight soreness on left arm on an unspecified date in Nov2019 with outcome of unknown.  The information on the lot number has been requested.
Sex: M
Vaccine: MENB
Symptoms: Discomfort, Fatigue, Influenza like illness, Pain
Clinical narrative: flu-like symptoms; This is a spontaneous report from a contactable physician (Pediatrician) via Pfizer Sponsored Program, who reported similar events for three patient. This is 2nd of three reports.   A male patient of an unspecified age who attended the University received the 1st dose of meningococcal group b rlp2086 (TRUMENBA) at single dose on an unspecified date for immunization at college (not by the reporting physician). The reporter thought it happened around 5 years before this report but not sure.The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced flu-like symptoms.  2 days after vaccination patient came to the reporting physician (who was their pediatrician at home) complaining of flu-like symptoms (e.g., tired, heavy feeling, achy, maybe fever). Health care professional was not overly concerned and told him to take OTC products to remedy and the symptoms resolved in a couple of days. The outcome of the event was recovered on an unspecified date.No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019480953 Same reporter/ drug/ event for different patients;US-PFIZER INC-2019481020 Same reporter/ drug/ event for different patients
Sex: M
Vaccine: MENB
Symptoms: Discomfort, Fatigue, Influenza like illness, Pain
Clinical narrative: flu-like symptoms; This is a spontaneous report from a contactable physician (Pediatrician) via Pfizer Sponsored Program, who reported similar events for three patient. This is 3rd of three reports.   A male patient of an unspecified age who attended the University received the 1st dose of meningococcal group b rlp2086 (TRUMENBA) at single dose on an unspecified date for immunization at college (not by the reporting physician). The reporter thought it happened around 5 years before this report but not sure. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced flu-like symptoms. Two days after vaccination patient came to the reporting physician (who was their pediatrician at home) complaining of flu-like symptoms (e.g., tired, heavy feeling, achy, maybe fever). Health care professional was not overly concerned and told him to take OTC products to remedy and the symptoms resolved in a couple of days. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019481019 Same reporter/ drug/ event for different patients;US-PFIZER INC-2019480953 Same reporter/ drug/ event for different patients
Sex: U
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report from a contactable pharmacist based on the information received by Pfizer from Merck & Co., Inc.   A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced allergic reaction on an unspecified date with outcome of unknown.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: FLUX, PNC13, UNK
Symptoms: Immune system disorder, Stomatitis
Clinical narrative: Immunity issues; Mouth (oral) sores; This is a spontaneous report from a contactable pharmacist.   A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose, influenza vaccine and varicella zoster vaccine; all on an unspecified date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, 2 weeks after the vaccinations, the patient experienced immunity issues and mouth (oral) sores. Clinical outcome of the events was unknown at time of this report.   The information on the lot number has been requested.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Contusion, Nodule, Pain, Pruritus, Swelling
Clinical narrative: itching down to her elbow, toward the collar bone and into her chest; had a really big knot; This is a spontaneous report from a contactable pharmacist via a Pfizer Sponsored Program IBCC (Inbound Call Center for HCPs). A 69-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, NDC#: 00005197102), via an unspecified route of administration on an unspecified date at single dose in right arm for vaccination, influenza vaccine (FLU), via an unspecified route of administration on the same date at unknown dose in left arm for vaccination. The patient's medical history and concomitant medications were not reported.  The caller said she did not get the immunization from her pharmacy and said she did not come to them much and she just cams to them for acute care. The patient had received the pneumococcal 13-val conj vac (dipht crm197 protein) at another pharmacy. When the patient had the reaction she did not break out into hives but had itching down to her elbow, toward the collar bone and into her chest and she had a really big knot that felt like an egg but was quite a bit bigger and it was bruised but slightly sore but not overly painful. This was the patient's first year getting pneumococcal 13-val conj vac (dipht crm197 protein) and she was concerned about getting the pneumovax next year because of the reaction to the pneumococcal 13-val conj vac (dipht crm197 protein). The itching, swelling and knot size had gone down and some of the bruising was gone and it was still a little sore but not as sore. The outcome of itching was recovered, the other event was recovering. Reporter seriousness for the events was medically significant.; Sender's Comments: The association between the events itching and swelling with pneumococcal 13-valent conjugate vaccine can not be fully excluded.  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: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Visual impairment
Clinical narrative: Daughter instantly complained about her eyesight.  Within 6 weeks of hearing same complaint I took her to Eyecare.  Dr indicated he "rarely sees such abrupt changes in eyesight.  20/20 to 20/70 and it is possible she will not be able to drive as she gets older".   He emphasized the severity of the condition and referred us to Opthalmologist.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Chills, Pain, Pyrexia
Clinical narrative: Soreness and swelling began late in the evening which was expected. Began chills for several hours during the night. Early morning had a low grade temp of 100.2. On the next day about noon my arm felt on fire and I noted that some blistering such as seen with shingles had appeared on the medial aspect of the injection in my left upper deltoid. It was approximately 1/2 inch area involved. I did call pharmacy later in the day to see if this was a normal reaction and was told by the pharmacist that he had never heard of that problem before.  It took about 3 days for the blisters to decrease and then disappear. No further treatment was necessary.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Soreness and swelling began late in the evening which was expected. Began chills for several hours during the night. Early morning had a low grade temp of 100.2. On the next day about noon my arm felt on fire and I noted that some blistering such as seen with shingles had appeared on the medial aspect of the injection in my left upper deltoid. It was approximately 1/2 inch area involved. I did call pharmacy later in the day to see if this was a normal reaction and was told by the pharmacist that he had never heard of that problem before.  It took about 3 days for the blisters to decrease and then disappear. No further treatment was necessary.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscle swelling
Clinical narrative: Extreme pain in right sholder.  Can't lift arm above sholder or reach across body.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain
Clinical narrative: Patient came back to the pharmacy after about 15 minutes complaining of chest pain and asked us to call 911. I had him chew an aspirin and medics arrived on the scene. He had no reaction to the first shot and no past heart issues. He did not believe the symptoms to be from the vaccine.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Death
Clinical narrative: DEATH
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient states right arm  has been sore since immunization given. Patient states soreness is located in injection site area.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Very painful at injection site, severe chills, severe body aches and headache, low-grade fever (100)
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Headache, Injection site pain, Malaise, Nausea
Clinical narrative: Generalized hives, nausea, extreme malaise, headache, pain in left shoulder and neck, body aches involving multiple joints. This occurred within ten minutes of receiving the vaccination.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain, Urticaria
Clinical narrative: Generalized hives, nausea, extreme malaise, headache, pain in left shoulder and neck, body aches involving multiple joints. This occurred within ten minutes of receiving the vaccination.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Gait inability, Injection site reaction, Rash macular
Clinical narrative: Patient unable to walk on left leg after 1 day after injection,  developed a macular rash around injection site. Patient able to walk currently.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Muscular weakness, Pain in extremity
Clinical narrative: Patient states that her distal upper arm became weak and painful after the shot and hasn't gotten better a year later. She states she had a bruise that didn't go away for over a month at the injection site.
Age: 43.0
Sex: F
Vaccine: FLUR4
Symptoms: Chest pain, Pain in extremity, Pruritus, Rash, Skin irritation
Clinical narrative: Patient came into pharmacy on 11/11/19.  Patient stated she had pain in her left arm to fingertips and left side of chest for 4 days.  After the four days the pain subsided and she developed hives and rash on various parts of her body, very itch and irritating.
Age: 43.0
Sex: F
Vaccine: FLUR4
Symptoms: Urticaria
Clinical narrative: Patient came into pharmacy on 11/11/19.  Patient stated she had pain in her left arm to fingertips and left side of chest for 4 days.  After the four days the pain subsided and she developed hives and rash on various parts of her body, very itch and irritating.
Age: 23.0
Sex: F
Vaccine: FLUX, TDAP, TTOX
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: Ever since I got the tetnus shot in my right arm. I have had very bad pain every morning I wake up it just hurts so bad. I have to have to have help changing  my shirt because it hurts to lift my arm or bend it in certain ways. I even have issues lifting things at work with that arm or reaching for things up high. I just took a shower and pulled my scrunchie off the wall that was suctioned cupped to the wall with my right arm and it just hurt so bad. This is keeping me from doing things in my everyday life.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Dyspnoea
Clinical narrative: PATIENT WAS DIZZY RIGHT AFTER THE SHOT, ALMOST FAINTING , WAS BREATHING BUT MENTIONED DIFFICULTY BREATHING WITHIN A COUPLE OF MINUTES. IN 5- 10 MINUTES RECOVERED AND GOT UP BUT WAS TAKEN BY EMERGENCY RESPONDERS
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered
Clinical narrative: The float pharmacist that came in administered the shingrix vaccine to a couple but did not mix both vaccines, instead he injected one patient with diluent only and the other with the vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: C-reactive protein, Cellulitis, Full blood count, Red blood cell sedimentation rate, Ultrasound scan
Clinical narrative: Cellulitis to thigh-required ER visit, labs and ultrasound to r/o abscess. Treated with PO Clindamycin. Improving and afebrile on day 3 of abx.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered
Clinical narrative: The float pharmacist that came in administered the shingrix vaccine to a couple but did not mix both vaccines, instead he injected one patient with diluent only and the other with the vaccine.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Headache, Mouth ulceration, Myalgia, Oral disorder
Clinical narrative: Patient had initial Shingrix administered at her pharmacy 11/05/19. She relays onset of oral ulcers with associated headaches and myalgias on 11/08/19. Exam with 1 aphthous ulcer and 2 small superficial tongue ulcerations.  Oral lesions not listed as potential side effect/complication - unclear if correlation, but VAERS report being sent in case.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Tongue ulceration
Clinical narrative: Patient had initial Shingrix administered at her pharmacy 11/05/19. She relays onset of oral ulcers with associated headaches and myalgias on 11/08/19. Exam with 1 aphthous ulcer and 2 small superficial tongue ulcerations.  Oral lesions not listed as potential side effect/complication - unclear if correlation, but VAERS report being sent in case.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Chest pain, Pleuritic pain
Clinical narrative: The person started having right lateral chest aching about 2 days after flu shot and then sharp pleuritic type pain the next day radiating around to back.  She was started on antibiotic.  Pain gradually decreased.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: I received the Tdap vaccine on 8/15/2019 and on 8/18/2019, I could not physically move my right arm over my head or abduct my right arm from my body. It was 7/10 pain to move my arm and this lasted for 2.5 months. I then sought treatment during my Hospital Orientation. I completed 4 weeks of Physical Therapy. I am able to move my arm more freely but it is still often painful.
Age: 57.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site vesicles
Clinical narrative: Severe extensive erythema, edema, and blistering at site of injection
Age: 55.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site bruising, Injection site pain, Injection site paraesthesia, Injection site swelling
Clinical narrative: Pt had a small bump at administration site for 2 days then bruising for 2 weeks,. Now pt has a burning/tingling sensation in that area. He says it is not constant, but sporadic.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: Patient experienced 2-3 inches of swelling, redness, and infection at the site.   Patient presented to the ER for treatment on 11/9/19.  She was prescribed prednisone and cephalexin to treat the reaction.