chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, an approximately 62 year old male patient, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2013, at approximately 61 years of age, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a healthcare provider. On an unknown date in 2014, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ 1 dose, orally, lot number N021308, expiration date 05-MAR-2019 (exact dose was not reported) for prophylaxis. The vaccine had been stored improperly in temperature of 10.58 degrees Celsius for 52 minutes. It was not reported if there were any previous temperature excursions. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the office manager referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 06-FEB-2019 the patient was inadvertently administered M-M-R II (rHA) lot number R025335 and expiration date of 06-APR-2020 and lot number R001659 with expiration date of 17-JAN-2020 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 60°F for 60 minutes while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved.; Sender's Comments: US-009507513-1902USA011926: US-009507513-1902USA011925: US-009507513-1902USA011924: US-009507513-1902USA011927: US-009507513-1902USA007818:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the office manager referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 06-FEB-2019 the patient was inadvertently administered M-M-R II (rHA) lot number R025335 and expiration date of 06-APR-2020 and lot number R001659 with expiration date of 17-JAN-2020 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 60°F for 60 minutes while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved.; Sender's Comments: US-009507513-1902USA011926: US-009507513-1902USA011925: US-009507513-1902USA007818: US-009507513-1902USA011927: US-009507513-1902USA011923:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the office manager referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 06-FEB-2019 the patient was inadvertently administered M-M-R II (rHA) lot number R025335 and expiration date of 06-APR-2020 and lot number R001659 with expiration date of 17-JAN-2020 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 60°F for 60 minutes while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved.; Sender's Comments: US-009507513-1902USA011926: US-009507513-1902USA007818: US-009507513-1902USA011924: US-009507513-1902USA011927: US-009507513-1902USA011923:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the office manager referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 07-FEB-2019 the patient was inadvertently administered M-M-R II (rHA) lot number R025335 and expiration date of 06-APR-2020 and lot number R001659 with expiration date of 17-JAN-2020 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 60°F for 60 minutes while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved. Sender's Comments: US-009507513-1902USA007818: US-009507513-1902USA011925: US-009507513-1902USA011924: US-009507513-1902USA011927: US-009507513-1902USA011923.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the office manager referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 14-FEB-2019 the patient was inadvertently administered M-M-R II (rHA) lot number R025335 and expiration date of 06-APR-2020 and lot number R001659 with expiration date of 17-JAN-2020 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 60°F for 60 minutes while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved.; Sender's Comments: US-009507513-1902USA011926: US-009507513-1902USA011925: US-009507513-1902USA011924: US-009507513-1902USA007818: US-009507513-1902USA011923.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Therapy non-responder, Underdose
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of therapy non-responder in a 17-year-old female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and HBV (ENGERIX B) for prophylaxis. Concurrent medical conditions included lung transplant (patient on list for lung transplant.). On an unknown date, the patient received Hepatitis B vaccine at an unknown dose, Hepatitis B vaccine at an unknown dose and Hepatitis B vaccine at an unknown dose. On 30th January 2019, the patient received ENGERIX B 1 ml. On 30th January 2019, not applicable after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine and unknown after receiving ENGERIX B, the patient experienced underdose. On an unknown date, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and underdose were unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and ENGERIX B. Additional details were provided as follows: The patient was on list for lung transplant. The patient received a complete Hep B series as an infant. On 30th January 2019, the patient received ENGERIX B 20mcg/ml, 1 ml since, office could not verify doses given as an infant, which led to an underdose. The Anti-HBs titer was drawn and was not detectable or less than 10 mIU/ml, which led to therapy non-responder. Recommendations do not support the dose given to this patient (IDSA Clinical Practice Guidelines for vaccination of the Immunocompromised Host) state the patient should have received a 40mcg dose. The reporter did not agree to be followed up.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned one of the doctors in his assisted living facility had the dose of SHINGRIX and he did not feel well after. The reporter did not know the name of the patient. The reporter did not give consent to follow up. The reporter repeatedly asked for more specifics regarding not feeling well and he kept repeating that he just did not feel well. This case was 2 of the 3 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned one of the doctors in his assisted living facility had the dose of SHINGRIX and he did not feel well after. The reporter did not know the name of the patient. The reporter did not give consent to follow up. The reporter was asked repeatedly for more specifics regarding not feeling well and he kept repeating that he just did not feel well. This case was 3 of the 3 cases, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Skin burning sensation
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX (batch number B37G7, expiry date 23rd May 2021) for prophylaxis. On 23rd January 2019, the patient received SHINGRIX (intramuscular). On 23rd January 2019, 1 sec after receiving SHINGRIX, the patient experienced injection site pain and pain in arm. On 28th January 2019, the patient experienced burning skin. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved and the outcome of the burning skin was not recovered/not resolved. It was unknown if the reporter considered the injection site pain, pain in arm and burning skin to be related to SHINGRIX. Additional details were provided as follows: This case was reported by other healthcare professional for herself. The patient received SHINGRIX on left deltoid. The patient immediately felt the pain of the needle in her left upper arm. 2 hours after receiving SHINGRIX, the patient's arm was sore for about 5 days and then resolved. 5 days after receiving SHINGRIX, the patient began to experience skin burning beginning in the anterior upper arms and face. The burning was spreading to other unspecified parts. At time of reporting, the burning has become worse. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Hallucination, Pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 64-year-old male patient who received SHINGRIX (batch number 5MG5E, expiry date 21st May 2021) for prophylaxis. On 11th January 2019, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, pain and hallucination. On an unknown date, the outcome of the fever, pain and hallucination were recovered/resolved. It was unknown if the reporter considered the fever, pain and hallucination to be related to SHINGRIX. Additional details were provided as follows: This case was reported by an Office Manager. The patient experienced fever, achiness and a hallucination after receiving SHINGRIX.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site warmth, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 78-year-old male patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX (1st dose received on 25th October 2018). On 1st February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 1st February 2019, immediately after receiving SHINGRIX, the patient experienced injection site erythema, injection site induration and injection site warmth. In February 2019, the patient experienced hives and erythromacular rash. On an unknown date, the outcome of the injection site erythema, injection site induration and injection site warmth were recovered/resolved and the outcome of the hives was not recovered/not resolved and the outcome of the erythromacular rash was unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site warmth, hives and erythromacular rash to be related to SHINGRIX. Additional details were provided as follows: The reporter indicated that her husband had the 1st dose of the SHINGRIX via intramuscularly 0.5 ml, in left arm vaccine and had no issues. Immediately after receiving the 2nd dose of the SHINGRIX vaccine and he developed a hard, red, hot area at the injection site. This resolved within 6 or 7 days. Approximately five days after receiving the vaccine, he developed hives in between his fingers, on both hands, and both wrists. The hives then developed under both of his arms, and then moved to his groan. Two days ago he developed hives on his chest and around his abdomen. Now there are just red dots on his chest, not hives but he still has the hives on his wrist. The reporter indicated that the hives had resolved on the other parts of his body. However, she stated that the hives come on one location, resolve, and then appear somewhere else. The reporter given permission for his physician to be contacted. The reporter gave consent to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 78-year-old male patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX (1st dose received on 25th October 2018). On 1st February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 1st February 2019, immediately after receiving SHINGRIX, the patient experienced injection site erythema, injection site induration and injection site warmth. In February 2019, the patient experienced hives and erythromacular rash. On an unknown date, the outcome of the injection site erythema, injection site induration and injection site warmth were recovered/resolved and the outcome of the hives was not recovered/not resolved and the outcome of the erythromacular rash was unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site warmth, hives and erythromacular rash to be related to SHINGRIX. Additional details were provided as follows: The reporter indicated that her husband had the 1st dose of the SHINGRIX via intramuscularly 0.5 ml, in left arm vaccine and had no issues. Immediately after receiving the 2nd dose of the SHINGRIX vaccine and he developed a hard, red, hot area at the injection site. This resolved within 6 or 7 days. Approximately five days after receiving the vaccine, he developed hives in between his fingers, on both hands, and both wrists. The hives then developed under both of his arms, and then moved to his groan. Two days ago he developed hives on his chest and around his abdomen. Now there are just red dots on his chest, not hives but he still has the hives on his wrist. The reporter indicated that the hives had resolved on the other parts of his body. However, she stated that the hives come on one location, resolve, and then appear somewhere else. The reporter given permission for his physician to be contacted. The reporter gave consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a male patient who received SHINGIRX for prophylaxis. On 13th February 2019, the patient received the 1st dose of SHINGIRX. On 13th February 2019, several hours after receiving SHINGIRX, the patient experienced hives. On 14th February 2019, the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the hives to be related to SHINGIRX. Additional details were provided as follows: The age at vaccination was not reported. The patient date of birth, batch number and expiration date were not reported. Around 3:00 to 4:00 pm (exact time was not reported), the patient received SHINGIRX. The patient contacted Pharmacist around 08:00 to 8:30 pm (exact time was not reported), to advise that he had broken out in hives on his back. The pharmacist followed up with the patient on the next day and patient reported the hives had completely resolved. This case had been linked with case US2019GSK036497, reported by same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 14th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th February 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 15th February 2019, the patient experienced fever, feeling bad and headache. On an unknown date, the outcome of the fever, feeling bad and headache were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the fever, pain in arm, feeling bad and headache to be related to SHINGRIX. dditional details were provided as follows: 1 day after receiving SHINGRIX, the patient experienced fever, headache and has felt lousy. The patient's arm was also sore for a long timeafter receiving SHINGRIX. The patient went to urgent care and it was found that she does not have any sinus infection or congestion to explain the headache or fever. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Injection site pain, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of bedridden in a female patient who received 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 bedridden, pain, fever and injection site pain. On an unknown date, the outcome of the bedridden was recovered/resolved and the outcome of the pain, fever and injection site pain were unknown. It was unknown if the reporter considered the bedridden, pain, fever and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was very petite and weighs barely 100 pounds. The patient experienced several side effects after receiving a SHINGRIX vaccine. The patient experienced severe injection site pain.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Incomplete course of vaccination, Pyrexia, Rash erythematous, Rash papular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythropapular rash in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced erythropapular rash, fever, chills and incomplete course of vaccination. On an unknown date, the outcome of the erythropapular rash and incomplete course of vaccination were unknown and the outcome of the fever and chills were recovered/resolved. It was unknown if the reporter considered the erythropapular rash, fever and chills to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporting pharmacist was the concerned patient.   The patient reported that a day later, she had red bumps appear on different body areas, fever, and chills. Events resolved after 5 days. Till the time of reporting, the patient did not receive the 2nd dose of SHINGRIX, which led to incomplete course of vaccination. The reporter did not give consent to follow up.
Sex: F
Vaccine: PPV
Symptoms: Interchange of vaccine products, Wrong product administered
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer regarding to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient who was supposed to receive PREVNAR 13 but instead of that, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, lot# and expiry were not reported) for prophylaxis (wrong product administered and interchange of vaccine products). It was reported that, the physician wants the patient to get the PREVNAR 13 now, 2 months later instead of waiting for a year.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Dizziness, Fall, Fatigue, Headache
Clinical narrative: Only felt tired and then a slight headache several hours after vaccination. Next morning, still had headache, but feeling nauseous. Just sipped water occasionally for a few hours. Just sat on couch for little while. When I started feeling a stronger nausea, I went to kitchen sink. I soon felt dizzy, next thing, I woke up on the kitchen floor with a bruise on my head! This has never happened to me in all of my life! By lunchtime (11:00 a.m.), ate some plain yogurt, 20 min. later I threw it up. I sat down for a while, then laid down for an hour. Just sipped water all day and evening. Nauseous headache continued. Feeling a little better Thursday morning.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Only felt tired and then a slight headache several hours after vaccination. Next morning, still had headache, but feeling nauseous. Just sipped water occasionally for a few hours. Just sat on couch for little while. When I started feeling a stronger nausea, I went to kitchen sink. I soon felt dizzy, next thing, I woke up on the kitchen floor with a bruise on my head! This has never happened to me in all of my life! By lunchtime (11:00 a.m.), ate some plain yogurt, 20 min. later I threw it up. I sat down for a while, then laid down for an hour. Just sipped water all day and evening. Nauseous headache continued. Feeling a little better Thursday morning.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray, Cough, Diarrhoea, Ear congestion, Ear discomfort
Clinical narrative: I became very sick with flu symptoms after receiving the vaccine, but at first I thought it was just a coincidence as I have had the flu vaccine before without issue. By 02/19, I had a fever, body aches, a terrible cough, diarrhea, a headache, and I was feeling terrible. So I left work to go to the urgent care. They had me try a phone appointment first, where I was recommended to see the doctor - so then I waited in the urgent care facility to be seen by Dr. They tested me for the flu, pregnancy, even though she said the test was inaccurate and high chance I had the flu even if it gets a negative, and they x-rayed my lungs to check for pneumonia. I was prescribed Tamiflu 75 mg twice a day and Benzonatate 100 mg three times a day. I also took over the counter ibuprofen as needed. I tried to go back to work the next Friday 02/22, even though I was still feeling very ill - all of my symptoms persisted except fever (though possibly masked by ibuprofen), diarrhea, and body aches. But I ended up leaving again early as my left ear was ringing, felt clogged (loss of hearing), and I just didn't feel right. I did a phone appointment with Dr. who prescribed me 500 mg Amoxicillin twice a day. I had high hopes this was going to be it and I would get better. But by Monday 02/26, my ear was worse and my left eye was also red with discharge. My other flu symptoms had lightened up quite a bit though, as I was not coughing like I had been. I went back to the urgent care and saw Dr. again, who confirmed my left ear was infected and then said my throat was red and it appeared I'd had post-nasal drip for a long time, so she also recommended a variety of over-the-counter allergy treatments such as a saline nose rinse three times a day, allergy medicine once a day (like Zyrtec - I bought generic version), flonase spray two sprays in each nostril twice a day, and a warm salt water rinse three times a day. I was also prescribed Polymyxin B - Tremethoprim 1 mg/ml for my eyes, 1 drop in each eye four times a day. It is now 02/28 and my eyes are more red than they were yesterday, and my hearing in my left ear is more muffled. There is also a constant ringing in my left ear since 02/22. I do not feel congestion at all besides my eye and ear. My other flu symptoms seem to have cured. I'm very concerned as all of this began directly after I received the vaccine. I know it's possible it is a coincidence and that I had been carrying the flu when I was vaccinated, but it seems like too much of a coincidence.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Ear infection, Eye discharge, Feeling abnormal, Hypoacusis, Impaired work ability
Clinical narrative: I became very sick with flu symptoms after receiving the vaccine, but at first I thought it was just a coincidence as I have had the flu vaccine before without issue. By 02/19, I had a fever, body aches, a terrible cough, diarrhea, a headache, and I was feeling terrible. So I left work to go to the urgent care. They had me try a phone appointment first, where I was recommended to see the doctor - so then I waited in the urgent care facility to be seen by Dr. They tested me for the flu, pregnancy, even though she said the test was inaccurate and high chance I had the flu even if it gets a negative, and they x-rayed my lungs to check for pneumonia. I was prescribed Tamiflu 75 mg twice a day and Benzonatate 100 mg three times a day. I also took over the counter ibuprofen as needed. I tried to go back to work the next Friday 02/22, even though I was still feeling very ill - all of my symptoms persisted except fever (though possibly masked by ibuprofen), diarrhea, and body aches. But I ended up leaving again early as my left ear was ringing, felt clogged (loss of hearing), and I just didn't feel right. I did a phone appointment with Dr. who prescribed me 500 mg Amoxicillin twice a day. I had high hopes this was going to be it and I would get better. But by Monday 02/26, my ear was worse and my left eye was also red with discharge. My other flu symptoms had lightened up quite a bit though, as I was not coughing like I had been. I went back to the urgent care and saw Dr. again, who confirmed my left ear was infected and then said my throat was red and it appeared I'd had post-nasal drip for a long time, so she also recommended a variety of over-the-counter allergy treatments such as a saline nose rinse three times a day, allergy medicine once a day (like Zyrtec - I bought generic version), flonase spray two sprays in each nostril twice a day, and a warm salt water rinse three times a day. I was also prescribed Polymyxin B - Tremethoprim 1 mg/ml for my eyes, 1 drop in each eye four times a day. It is now 02/28 and my eyes are more red than they were yesterday, and my hearing in my left ear is more muffled. There is also a constant ringing in my left ear since 02/22. I do not feel congestion at all besides my eye and ear. My other flu symptoms seem to have cured. I'm very concerned as all of this began directly after I received the vaccine. I know it's possible it is a coincidence and that I had been carrying the flu when I was vaccinated, but it seems like too much of a coincidence.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Influenza virus test, Malaise, Ocular hyperaemia, Pain
Clinical narrative: I became very sick with flu symptoms after receiving the vaccine, but at first I thought it was just a coincidence as I have had the flu vaccine before without issue. By 02/19, I had a fever, body aches, a terrible cough, diarrhea, a headache, and I was feeling terrible. So I left work to go to the urgent care. They had me try a phone appointment first, where I was recommended to see the doctor - so then I waited in the urgent care facility to be seen by Dr. They tested me for the flu, pregnancy, even though she said the test was inaccurate and high chance I had the flu even if it gets a negative, and they x-rayed my lungs to check for pneumonia. I was prescribed Tamiflu 75 mg twice a day and Benzonatate 100 mg three times a day. I also took over the counter ibuprofen as needed. I tried to go back to work the next Friday 02/22, even though I was still feeling very ill - all of my symptoms persisted except fever (though possibly masked by ibuprofen), diarrhea, and body aches. But I ended up leaving again early as my left ear was ringing, felt clogged (loss of hearing), and I just didn't feel right. I did a phone appointment with Dr. who prescribed me 500 mg Amoxicillin twice a day. I had high hopes this was going to be it and I would get better. But by Monday 02/26, my ear was worse and my left eye was also red with discharge. My other flu symptoms had lightened up quite a bit though, as I was not coughing like I had been. I went back to the urgent care and saw Dr. again, who confirmed my left ear was infected and then said my throat was red and it appeared I'd had post-nasal drip for a long time, so she also recommended a variety of over-the-counter allergy treatments such as a saline nose rinse three times a day, allergy medicine once a day (like Zyrtec - I bought generic version), flonase spray two sprays in each nostril twice a day, and a warm salt water rinse three times a day. I was also prescribed Polymyxin B - Tremethoprim 1 mg/ml for my eyes, 1 drop in each eye four times a day. It is now 02/28 and my eyes are more red than they were yesterday, and my hearing in my left ear is more muffled. There is also a constant ringing in my left ear since 02/22. I do not feel congestion at all besides my eye and ear. My other flu symptoms seem to have cured. I'm very concerned as all of this began directly after I received the vaccine. I know it's possible it is a coincidence and that I had been carrying the flu when I was vaccinated, but it seems like too much of a coincidence.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal erythema, Pregnancy test, Pyrexia, Tinnitus, Upper-airway cough syndrome
Clinical narrative: I became very sick with flu symptoms after receiving the vaccine, but at first I thought it was just a coincidence as I have had the flu vaccine before without issue. By 02/19, I had a fever, body aches, a terrible cough, diarrhea, a headache, and I was feeling terrible. So I left work to go to the urgent care. They had me try a phone appointment first, where I was recommended to see the doctor - so then I waited in the urgent care facility to be seen by Dr. They tested me for the flu, pregnancy, even though she said the test was inaccurate and high chance I had the flu even if it gets a negative, and they x-rayed my lungs to check for pneumonia. I was prescribed Tamiflu 75 mg twice a day and Benzonatate 100 mg three times a day. I also took over the counter ibuprofen as needed. I tried to go back to work the next Friday 02/22, even though I was still feeling very ill - all of my symptoms persisted except fever (though possibly masked by ibuprofen), diarrhea, and body aches. But I ended up leaving again early as my left ear was ringing, felt clogged (loss of hearing), and I just didn't feel right. I did a phone appointment with Dr. who prescribed me 500 mg Amoxicillin twice a day. I had high hopes this was going to be it and I would get better. But by Monday 02/26, my ear was worse and my left eye was also red with discharge. My other flu symptoms had lightened up quite a bit though, as I was not coughing like I had been. I went back to the urgent care and saw Dr. again, who confirmed my left ear was infected and then said my throat was red and it appeared I'd had post-nasal drip for a long time, so she also recommended a variety of over-the-counter allergy treatments such as a saline nose rinse three times a day, allergy medicine once a day (like Zyrtec - I bought generic version), flonase spray two sprays in each nostril twice a day, and a warm salt water rinse three times a day. I was also prescribed Polymyxin B - Tremethoprim 1 mg/ml for my eyes, 1 drop in each eye four times a day. It is now 02/28 and my eyes are more red than they were yesterday, and my hearing in my left ear is more muffled. There is also a constant ringing in my left ear since 02/22. I do not feel congestion at all besides my eye and ear. My other flu symptoms seem to have cured. I'm very concerned as all of this began directly after I received the vaccine. I know it's possible it is a coincidence and that I had been carrying the flu when I was vaccinated, but it seems like too much of a coincidence.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy
Clinical narrative: Posterior cervical/ preauricular lymphadenopathy.
Age: 1.75
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: Fever over 104 within 24 hours of administration.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Insomnia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: My right arm has been sore since the shot, sometimes pain makes it hard to sleep, can barely reach to tuck my shirt in, my arm hurts that much.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Altered state of consciousness, Asthenia, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: A few minutes after receiving the vaccination, I became extremely dizzy and sweaty, had blurred vision, and came extremely close to passing out (the only reason I did not pass out is because I laid down and focused very carefully on my breathing, having had practice doing this after blood tests I've received in the past and had syncope from). However, in the past when I have passed out or come close to it, I have never felt the way I did this time. This time, I felt extremely ill and had a very difficult time breathing. Throughout the next week after the vaccine I was extraordinarily weak and felt constantly ill, barely able to get myself out of bed. I also had pain and swelling at the injection site. My vision has been blurred since then, I have had a hard time seeing clearly beyond about 10-15 feet ahead of me.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Malaise, Vision blurred
Clinical narrative: A few minutes after receiving the vaccination, I became extremely dizzy and sweaty, had blurred vision, and came extremely close to passing out (the only reason I did not pass out is because I laid down and focused very carefully on my breathing, having had practice doing this after blood tests I've received in the past and had syncope from). However, in the past when I have passed out or come close to it, I have never felt the way I did this time. This time, I felt extremely ill and had a very difficult time breathing. Throughout the next week after the vaccine I was extraordinarily weak and felt constantly ill, barely able to get myself out of bed. I also had pain and swelling at the injection site. My vision has been blurred since then, I have had a hard time seeing clearly beyond about 10-15 feet ahead of me.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Skin induration, Swelling
Clinical narrative: Hardness of skin. Itching. Growing redness. Pain. Swelling. Started within a few hours of time of injection in Monday. Symptoms are worse today on Friday.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Cold sweat, Confusional state, Dyskinesia, Eye movement disorder, Heart rate decreased
Clinical narrative: The client was given his shots today at 14:12 & I asked him to remain seated until we made appointments for next visit. At 14:15 he started to turn pale & leaned his head back. I asked if he felt OK & he said "I'm going to faint". I went to hold him in the chair while I called for help in getting the cot & some juice. His eyes rolled back, his hands clenched with arms stiff & outstretched, both legs stiffened & stretched out straight in front, both feet plantar flexed. He began rhythmically jerking his whole body & I put my hand behind his head to keep it from hitting the wall. The jerking & posturing lasted 45 seconds during which time I kept him in the chair. After it ended, he lost consciousness for 30 seconds. Once he regained consciousness we gave him juice & moved him to the cot with two person assist. We had him lie down & elevated his legs. His color remained pale-yellow, he was clammy & his pulse was 38 bpm. He was somewhat confused about what happened but was able to drink the whole juice box while lying down. He started saying "I had a dream while I was gone". His family & I asked what he meant by that & he said that he couldn't explain it but he knew he had had a dream & had "left" himself for awhile. He went on to say "I didn't get that spinny looking thing but I new I was leaving". His mom said that he had an episode of near-syncope when she checked his blood sugar one time & that he had seen "spinning" when it happened. She said that he's never fully fainted like today. I reassured that this can happen with adolescents & vaccinations. The client sat unassisted on the side of the cot for 5 minutes, during which time his pulse increased in rate to 58 bpm. He asked if they could leave & I made sure that he was steady on his feet. He left in the care of his mother & sister at 14:30 without further incident.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Pallor, Posturing, Syncope
Clinical narrative: The client was given his shots today at 14:12 & I asked him to remain seated until we made appointments for next visit. At 14:15 he started to turn pale & leaned his head back. I asked if he felt OK & he said "I'm going to faint". I went to hold him in the chair while I called for help in getting the cot & some juice. His eyes rolled back, his hands clenched with arms stiff & outstretched, both legs stiffened & stretched out straight in front, both feet plantar flexed. He began rhythmically jerking his whole body & I put my hand behind his head to keep it from hitting the wall. The jerking & posturing lasted 45 seconds during which time I kept him in the chair. After it ended, he lost consciousness for 30 seconds. Once he regained consciousness we gave him juice & moved him to the cot with two person assist. We had him lie down & elevated his legs. His color remained pale-yellow, he was clammy & his pulse was 38 bpm. He was somewhat confused about what happened but was able to drink the whole juice box while lying down. He started saying "I had a dream while I was gone". His family & I asked what he meant by that & he said that he couldn't explain it but he knew he had had a dream & had "left" himself for awhile. He went on to say "I didn't get that spinny looking thing but I new I was leaving". His mom said that he had an episode of near-syncope when she checked his blood sugar one time & that he had seen "spinning" when it happened. She said that he's never fully fainted like today. I reassured that this can happen with adolescents & vaccinations. The client sat unassisted on the side of the cot for 5 minutes, during which time his pulse increased in rate to 58 bpm. He asked if they could leave & I made sure that he was steady on his feet. He left in the care of his mother & sister at 14:30 without further incident.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: HIVES 24 HOURS AFTER VACCINATIONS, APPEARED ON LEFT THIGH THEN TO RIGHT THIGH THEN SPREAD TO OTHER PARTS OF BODY. TREATED WITH OVER THE COUNTER BENADRYL.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 26-FEB-2019, the patient was inadvertently vaccinated with expired dose of M-M-R II lot # N005774, expiration date 17-FEB-2019 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site swelling, Lymphadenopathy, Muscle spasms, Myalgia
Clinical narrative: This case was reported by a consumer via facebook interactive digital media and described the occurrence of shivering in a 57-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (when patient was young). On an unknown date, the patient received SHINGRIX. On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced shivering, injection site swelling, axillary lymph nodes enlarged, tremor, muscle spasm, general body pain and muscle pain. On an unknown date, the outcome of the shivering and general body pain were recovering/resolving and the outcome of the injection site swelling, axillary lymph nodes enlarged, tremor, muscle spasm and muscle pain were unknown. It was unknown if the reporter considered the shivering, injection site swelling, axillary lymph nodes enlarged, tremor, muscle spasm, general body pain and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm. The side effects the patient experienced after receiveing SHINGRIX were extreme swelling of the shot area (left arm), extreme swelling in the lymph nodes in her left armpit. Twelve hours after the vaccination while trying to sleep, the patient entire body temperature was just above freezing, entire body shaking uncontrollably. The patient teeth were even chattering. The patient wanted to get out of bed to get a couple wool blankets but she could not even move from all the muscle spasms.  Eventually, she forced herself to. Even after covering with two very heavy wool blankets, she was still shivered. After about an hour with the blankets on, it held in enough eat providing minor relief. In the morning, the patient body was so sore. It felt as though the patient ran a marathon. Every muscle ached beyond belief. The patient was certain it was from the shivering from hours. The patient was now 24 hours from when the shivering started and some of the pain was starting to subside. This was the worst of her shot experience. The patient stated that the GlaxoSmithKline should know while they kept track of side effects. If patients did not report, then how would GlaxoSmithKline know.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Tremor
Clinical narrative: This case was reported by a consumer via facebook interactive digital media and described the occurrence of shivering in a 57-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (when patient was young). On an unknown date, the patient received SHINGRIX. On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced shivering, injection site swelling, axillary lymph nodes enlarged, tremor, muscle spasm, general body pain and muscle pain. On an unknown date, the outcome of the shivering and general body pain were recovering/resolving and the outcome of the injection site swelling, axillary lymph nodes enlarged, tremor, muscle spasm and muscle pain were unknown. It was unknown if the reporter considered the shivering, injection site swelling, axillary lymph nodes enlarged, tremor, muscle spasm, general body pain and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm. The side effects the patient experienced after receiveing SHINGRIX were extreme swelling of the shot area (left arm), extreme swelling in the lymph nodes in her left armpit. Twelve hours after the vaccination while trying to sleep, the patient entire body temperature was just above freezing, entire body shaking uncontrollably. The patient teeth were even chattering. The patient wanted to get out of bed to get a couple wool blankets but she could not even move from all the muscle spasms.  Eventually, she forced herself to. Even after covering with two very heavy wool blankets, she was still shivered. After about an hour with the blankets on, it held in enough eat providing minor relief. In the morning, the patient body was so sore. It felt as though the patient ran a marathon. Every muscle ached beyond belief. The patient was certain it was from the shivering from hours. The patient was now 24 hours from when the shivering started and some of the pain was starting to subside. This was the worst of her shot experience. The patient stated that the GlaxoSmithKline should know while they kept track of side effects. If patients did not report, then how would GlaxoSmithKline know.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of myalgia in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and SHINGRIX, the patient experienced myalgia, fatigue and shivering. On an unknown date, the outcome of the myalgia, fatigue and shivering were recovered/resolved. The reporter considered the myalgia, fatigue and shivering to be related to SHINGRIX and SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced myalgia, fatigue, shivering after receiving SHINGRIX. The events lasted for 2 to 3 days. The reporter did think events related to the vaccine. The reporter agreed to to follow up from GlaxoSmithKline.