chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Ear pain, Erythema
Clinical narrative: pain in her lower right arm; pain in her neck; started having pain in her head; started having pain in her ears; her ears were bright red; had extreme pain in her stomach; Nausea; Vomiting; Diarrhea; tiredness; had weak spells; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 3rd February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, neck pain, fatigue and weakness. On 4th February 2020, the patient experienced headache, ear pain and erythema ear. On 6th February 2020, the patient experienced stomach pain, nausea, vomiting and diarrhea. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pain in arm, neck pain, ear pain, erythema ear, stomach pain, nausea, vomiting and fatigue were resolved with sequelae and the outcome of the headache, diarrhea and weakness were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema ear, vomiting, diarrhea and weakness to be related to Shingrix. The reporter considered the neck pain, headache, ear pain, stomach pain, nausea and fatigue to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experianced pain in her lower right arm and neck. She stated that, she had no pain around injection site.  She said that the next day, she started having pain in her head and ears, her ears were bright red, the pain in her neck also continued.  She said the following Thursday, on 06th February 2020, 3 days after receiving Shingrix, she had extreme pain in her stomach, with nausea and diarrhea, Benadryl helped ease these symptoms.  The patient said, she also had weak spells and tiredness for a week after receiving the vaccine. She said that, all other symptoms also resolved in 7 days.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Neck pain, Pain in extremity
Clinical narrative: pain in her lower right arm; pain in her neck; started having pain in her head; started having pain in her ears; her ears were bright red; had extreme pain in her stomach; Nausea; Vomiting; Diarrhea; tiredness; had weak spells; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 3rd February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, neck pain, fatigue and weakness. On 4th February 2020, the patient experienced headache, ear pain and erythema ear. On 6th February 2020, the patient experienced stomach pain, nausea, vomiting and diarrhea. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pain in arm, neck pain, ear pain, erythema ear, stomach pain, nausea, vomiting and fatigue were resolved with sequelae and the outcome of the headache, diarrhea and weakness were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema ear, vomiting, diarrhea and weakness to be related to Shingrix. The reporter considered the neck pain, headache, ear pain, stomach pain, nausea and fatigue to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experianced pain in her lower right arm and neck. She stated that, she had no pain around injection site.  She said that the next day, she started having pain in her head and ears, her ears were bright red, the pain in her neck also continued.  She said the following Thursday, on 06th February 2020, 3 days after receiving Shingrix, she had extreme pain in her stomach, with nausea and diarrhea, Benadryl helped ease these symptoms.  The patient said, she also had weak spells and tiredness for a week after receiving the vaccine. She said that, all other symptoms also resolved in 7 days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Herpes zoster, Injection site erythema
Clinical narrative: red circle  at injection site; red circle which is painful/sore; red circle which is painful and swollen; light headache on and off; chills/shivering; small amount of muscle pain; a little tired; maybe she had a small fever; rash on upper body /shingles; Rash; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose about 2.5 months prior to the second dose refer case US2020AMR032007).   On 18th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site pain, injection site swelling, headache, chills, myalgia, fatigue, fever, shingles and rash. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling, shingles and rash were recovering/resolving and the outcome of the headache, chills, myalgia, fatigue and fever were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling, headache, chills, myalgia, fatigue and fever to be related to Shingrix. The reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and had side effects at the injection site (local side effects),red circle which was painful/sore and swollen which was not resolved.  The patient had expected systemic side effects chills, light headache on and off, small amount of muscle pain, a little tired, shivering, and she was not sure if she had a fever because she did not had a thermometer but she says maybe she had a small fever. These systemic side effects had resolved. The patient experienced a rash which she thinks may be shingles. She says the rash was basically on her entire upper body. It was on both sides of her face an on her forehead, it was on both arms as well as her chest, back, and stomach. (No rash on her legs or lower body). It had not resolved.  The reporter feeled that this rash was due to the Shingrix.  The follow up consent was granted.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pyrexia, Rash
Clinical narrative: red circle  at injection site; red circle which is painful/sore; red circle which is painful and swollen; light headache on and off; chills/shivering; small amount of muscle pain; a little tired; maybe she had a small fever; rash on upper body /shingles; Rash; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose about 2.5 months prior to the second dose refer case US2020AMR032007).   On 18th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site pain, injection site swelling, headache, chills, myalgia, fatigue, fever, shingles and rash. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling, shingles and rash were recovering/resolving and the outcome of the headache, chills, myalgia, fatigue and fever were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling, headache, chills, myalgia, fatigue and fever to be related to Shingrix. The reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and had side effects at the injection site (local side effects),red circle which was painful/sore and swollen which was not resolved.  The patient had expected systemic side effects chills, light headache on and off, small amount of muscle pain, a little tired, shivering, and she was not sure if she had a fever because she did not had a thermometer but she says maybe she had a small fever. These systemic side effects had resolved. The patient experienced a rash which she thinks may be shingles. She says the rash was basically on her entire upper body. It was on both sides of her face an on her forehead, it was on both arms as well as her chest, back, and stomach. (No rash on her legs or lower body). It had not resolved.  The reporter feeled that this rash was due to the Shingrix.  The follow up consent was granted.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 9DE73, expiry date 6th December 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient received Shingrix and developed Shingles. Reporter cnsented to follow up.
Age: 73.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Tinnitus
Clinical narrative: Patient received Pneumovax 23 and Shingrix on 2-26-20 at approximately 2:47 pm.  Patient's wife called around 6:00pm to let us know that he had been having tinnitus for about an hour.  I called patient back around 6:30 after speaking with Merck and patient's wife stated that it had gotten better but not resolved completely.  I advised patient to seek medical attention if symptoms got worse or if he felt he needed to see a provider.  I called the patient in the morning and he stated that they symptoms had completely resolved and he did not have to seek medical attention overnight.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest X-ray, Computerised tomogram head, Dizziness, Impaired driving ability, Loss of personal independence in daily activities
Clinical narrative: She got dizzy leaving church on holiday night, including nausea and vomiting.  Woke up slightly better holiday morning until about mid morning, then dizziness came back along with nausea and vomiting continuing all day.  On 12/26 at 11:45 am, went to Urgent Care, the attending physician,  FNP, immediately referred her to Hospital ER, (Reason: Emergency medicine, Neuro, evaluation due to Nystagmus, ABNL Exam,).  The ER physician, Dr., ran CT Scan checking for stroke or seizure and then transferred by ambulance to larger ER for MRI and further neurological evaluation. MRI Brain without contrast was performed along with additional CT Scan without IV contrast and chest X-Rays, was treated with physical therapy for Vertigo, kept overnight and was prescribed Meclizine 25 mg and released the following day diagnosed with Benign Positional Vertigo.  After no change in dizziness and continued nausea approx. 2 weeks later, scheduled appointment for January 16, with ENT Specialist.  Dr. he performed further testing on January 22, and diagnosed with Vestibular Neuritis with 70% permanent damage.  Currently still having same problems with dizziness and nausea, unable to perform simple daily activities, drive vehicles, etc.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Magnetic resonance imaging brain, Nausea, Neuritis, Vertigo, Vertigo positional
Clinical narrative: She got dizzy leaving church on holiday night, including nausea and vomiting.  Woke up slightly better holiday morning until about mid morning, then dizziness came back along with nausea and vomiting continuing all day.  On 12/26 at 11:45 am, went to Urgent Care, the attending physician,  FNP, immediately referred her to Hospital ER, (Reason: Emergency medicine, Neuro, evaluation due to Nystagmus, ABNL Exam,).  The ER physician, Dr., ran CT Scan checking for stroke or seizure and then transferred by ambulance to larger ER for MRI and further neurological evaluation. MRI Brain without contrast was performed along with additional CT Scan without IV contrast and chest X-Rays, was treated with physical therapy for Vertigo, kept overnight and was prescribed Meclizine 25 mg and released the following day diagnosed with Benign Positional Vertigo.  After no change in dizziness and continued nausea approx. 2 weeks later, scheduled appointment for January 16, with ENT Specialist.  Dr. he performed further testing on January 22, and diagnosed with Vestibular Neuritis with 70% permanent damage.  Currently still having same problems with dizziness and nausea, unable to perform simple daily activities, drive vehicles, etc.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: She got dizzy leaving church on holiday night, including nausea and vomiting.  Woke up slightly better holiday morning until about mid morning, then dizziness came back along with nausea and vomiting continuing all day.  On 12/26 at 11:45 am, went to Urgent Care, the attending physician,  FNP, immediately referred her to Hospital ER, (Reason: Emergency medicine, Neuro, evaluation due to Nystagmus, ABNL Exam,).  The ER physician, Dr., ran CT Scan checking for stroke or seizure and then transferred by ambulance to larger ER for MRI and further neurological evaluation. MRI Brain without contrast was performed along with additional CT Scan without IV contrast and chest X-Rays, was treated with physical therapy for Vertigo, kept overnight and was prescribed Meclizine 25 mg and released the following day diagnosed with Benign Positional Vertigo.  After no change in dizziness and continued nausea approx. 2 weeks later, scheduled appointment for January 16, with ENT Specialist.  Dr. he performed further testing on January 22, and diagnosed with Vestibular Neuritis with 70% permanent damage.  Currently still having same problems with dizziness and nausea, unable to perform simple daily activities, drive vehicles, etc.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Eye discharge, Eye pruritus, Lip swelling, Paraesthesia oral, Swollen tongue
Clinical narrative: Developed lower lip swelling and tingling, later noted both lips and tongue felt swollen.  Mild itching of both eyes with drainage.  Symptoms improved after taking Zyrtec 10 mg.   Reports had also eate Indian food prior to receiving the vaccine, had never eaten Indian food in the past.  (Ist Influenza vaccine, Ist time eating Indian food).
Age: 18.0
Sex: F
Vaccine: TYP
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic, Scab
Clinical narrative: Patient took the Vivotif on 1/22/20, 1/24/20/, 1/26/20, and 1/28/20. On approximately 2/18/20, she began to develop a rash on her arms.  The rash/ hives continue to develop on her arms, hands, neck, back and as of today 2/27/20 continue to appear.  She has had one on her ankle, but mostly arms and back trunk.  They are raised, red, and extremely itchy.  They seem to have a whitish center that "crusts" or "scabs" as it heals.  But so far, new spots appear, but none have gone away completely.  She has no fever or trouble breathing.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: sore muscles headache redness and swelling at injection site
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: Severe myalgias
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Pain, Swelling
Clinical narrative: parent reports pain swelling and loss of range of motion
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Neck pain
Clinical narrative: Symptoms started 24 hours after TDAP vaccine. Reported to clinic this AM at 48 hours post injection. Circular red raised circle measuring 60 cm. No redness, streaking extending below injection site. Reports this AM neck soreness on the side of the vaccine site.  Took meloxicam yesterday and today.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Pain, Pain in extremity
Clinical narrative: Starting the day after I received these vaccines, I began to suffer from extreme body aches, fatigue, chills, ringing in my ears and general misery. The arm with the injection sites continues to be painful three days later, but the worst of the other symptoms seems to have subsided. I cannot say which vaccine caused these adverse effects, or whether it might have been the combination of the two. I missed two half-days of work and am now reluctant to have the Shingrix booster when the recommended time for that comes.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Tinnitus
Clinical narrative: Starting the day after I received these vaccines, I began to suffer from extreme body aches, fatigue, chills, ringing in my ears and general misery. The arm with the injection sites continues to be painful three days later, but the worst of the other symptoms seems to have subsided. I cannot say which vaccine caused these adverse effects, or whether it might have been the combination of the two. I missed two half-days of work and am now reluctant to have the Shingrix booster when the recommended time for that comes.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hypoaesthesia, Injection site induration, Injection site mass
Clinical narrative: 02/08 Arm sore from injection and stiffening up - Kept moving it and took Ibuprofen- a week 02/08 Afternoon - Fatigue and body aches - Fatigue lasted a couple days - slept 02/09 Headache, fever, and body aches - Ibuprofen and bathes 02/10 Rash at injection site size of quarter and hard, arm sore and warm - Ibuprofen 02/11 Rash, pain, and itchy has grown in size 4"x3"  02/12 Rash, pain, and itchy still present - Contacted Teladoc to discuss reactions; advised to circle rash to see if rash spreads and follow up if rash spreads and to contact (company that administered vaccine) 02/13 Rash, pain, and itchy not spreading - took some Benadryl - did not do follow up since it had not spread. Rash, pain, and itchiness have subsided to a degree. Site still has a lump where rash was and is itchy at times still.  I have also experienced numbness in the arm which comes and goes.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: 02/08 Arm sore from injection and stiffening up - Kept moving it and took Ibuprofen- a week 02/08 Afternoon - Fatigue and body aches - Fatigue lasted a couple days - slept 02/09 Headache, fever, and body aches - Ibuprofen and bathes 02/10 Rash at injection site size of quarter and hard, arm sore and warm - Ibuprofen 02/11 Rash, pain, and itchy has grown in size 4"x3"  02/12 Rash, pain, and itchy still present - Contacted Teladoc to discuss reactions; advised to circle rash to see if rash spreads and follow up if rash spreads and to contact (company that administered vaccine) 02/13 Rash, pain, and itchy not spreading - took some Benadryl - did not do follow up since it had not spread. Rash, pain, and itchiness have subsided to a degree. Site still has a lump where rash was and is itchy at times still.  I have also experienced numbness in the arm which comes and goes.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: 02/08 Arm sore from injection and stiffening up - Kept moving it and took Ibuprofen- a week 02/08 Afternoon - Fatigue and body aches - Fatigue lasted a couple days - slept 02/09 Headache, fever, and body aches - Ibuprofen and bathes 02/10 Rash at injection site size of quarter and hard, arm sore and warm - Ibuprofen 02/11 Rash, pain, and itchy has grown in size 4"x3"  02/12 Rash, pain, and itchy still present - Contacted Teladoc to discuss reactions; advised to circle rash to see if rash spreads and follow up if rash spreads and to contact (company that administered vaccine) 02/13 Rash, pain, and itchy not spreading - took some Benadryl - did not do follow up since it had not spread. Rash, pain, and itchiness have subsided to a degree. Site still has a lump where rash was and is itchy at times still.  I have also experienced numbness in the arm which comes and goes.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No additional adverse effects were reported; adult patient received a pediatric dose of VAQTA; This spontaneous report was received from a physician an adult patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions or concomitant medications.  On 17-DEC-2019 the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated(VAQTA) for prophylaxis (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided). No additional adverse effects were reported in the patient.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Low grade fever and myalgia
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Asthenia, Epistaxis, Injection site pain, Joint injection
Clinical narrative: Shortly after I got the vaccine - I started to develop some minor reactions. (1) began to have the inside of my mouth get puffy - not like I couldn't breath. That cleared up in about 3 days. (2) Then the inside of my nasal cavity - lost all its moisture and every time I would sneeze or blow my nose - blood + scabs would come up. I was told to use Vaseline to coat the inside until it became moist again - and it cleared up. - of course my arm was very sore (right) I was aware that was coming. It worked its way up to my right shoulder + very painful. I made an appointment with the Sports Medicine Clinic. They xrayed my right shoulder and found arthritis, and all kinds of small damage (old). I was given an injection where the arthritis was (it was done in the imaging clinic) Do to where the pain, inflamation etc was - the wanted me to see 2 surgeons that do shoulder replacements. Very good surgons. (2-18-2020) I have no broken bones in that shoulder - so I was not keen on surgery at this time because I felt it would calm down with time + PT. Now (2-24-2020) it is a bit better + some of the reactions are gone - I do not feel the vaccine did the damage in my shoulder - but I do feel it inflamed the shoulder (any may be responsible for the left shoulder + the aching of my bones + muscles). I am weaker than I have ever been and I am running a low grade fever for at least 2 months. Please feel to call me if you have any questions.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging, Mucosal dryness, Nasal crusting, Oedema mucosal, Pain in extremity
Clinical narrative: Shortly after I got the vaccine - I started to develop some minor reactions. (1) began to have the inside of my mouth get puffy - not like I couldn't breath. That cleared up in about 3 days. (2) Then the inside of my nasal cavity - lost all its moisture and every time I would sneeze or blow my nose - blood + scabs would come up. I was told to use Vaseline to coat the inside until it became moist again - and it cleared up. - of course my arm was very sore (right) I was aware that was coming. It worked its way up to my right shoulder + very painful. I made an appointment with the Sports Medicine Clinic. They xrayed my right shoulder and found arthritis, and all kinds of small damage (old). I was given an injection where the arthritis was (it was done in the imaging clinic) Do to where the pain, inflamation etc was - the wanted me to see 2 surgeons that do shoulder replacements. Very good surgons. (2-18-2020) I have no broken bones in that shoulder - so I was not keen on surgery at this time because I felt it would calm down with time + PT. Now (2-24-2020) it is a bit better + some of the reactions are gone - I do not feel the vaccine did the damage in my shoulder - but I do feel it inflamed the shoulder (any may be responsible for the left shoulder + the aching of my bones + muscles). I am weaker than I have ever been and I am running a low grade fever for at least 2 months. Please feel to call me if you have any questions.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, X-ray limb abnormal
Clinical narrative: Shortly after I got the vaccine - I started to develop some minor reactions. (1) began to have the inside of my mouth get puffy - not like I couldn't breath. That cleared up in about 3 days. (2) Then the inside of my nasal cavity - lost all its moisture and every time I would sneeze or blow my nose - blood + scabs would come up. I was told to use Vaseline to coat the inside until it became moist again - and it cleared up. - of course my arm was very sore (right) I was aware that was coming. It worked its way up to my right shoulder + very painful. I made an appointment with the Sports Medicine Clinic. They xrayed my right shoulder and found arthritis, and all kinds of small damage (old). I was given an injection where the arthritis was (it was done in the imaging clinic) Do to where the pain, inflamation etc was - the wanted me to see 2 surgeons that do shoulder replacements. Very good surgons. (2-18-2020) I have no broken bones in that shoulder - so I was not keen on surgery at this time because I felt it would calm down with time + PT. Now (2-24-2020) it is a bit better + some of the reactions are gone - I do not feel the vaccine did the damage in my shoulder - but I do feel it inflamed the shoulder (any may be responsible for the left shoulder + the aching of my bones + muscles). I am weaker than I have ever been and I am running a low grade fever for at least 2 months. Please feel to call me if you have any questions.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blister, Body temperature increased, Cellulitis, Erythema, Hypersensitivity
Clinical narrative: A 11 year old boy received Tdap, MCV4 and HPV on Wednesday 2/12/20. Tdap and MCV4 were in the left deltoid. HPV in the right deltoid. Mom called Thursday 2/13/20 afternoon to report his arm was red and swollen and hard, 3 fingers wide, the length of her fingers. He also did not feel well. I told her warm compresses and NSAIDs. Take to care if not better. In a follow-up call to mother Tuesday 2-18-20 she reported that later on Thursday 2/13/20, the arm, shoulder to elbow, and starting up his neck, and around under his arm and into the arm pit was red, and hard. He did not feel well, and temp 99 to 101. 2/14/20 he was seen in clinic, via telemed, and was told to go to an ER. They went to Hospital ER. Diagnosis reportedly was allergic reaction and cellulitis. The skin had blistered. He was given Keflex and Bactrim. Tuesday 2/18/20, mom reports the arm was back to normal, except scabs where the blisters were, the skin is soft, and just looks like he had been sunburnt. He is a sensitive kid and reacts to many things.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Induration, Malaise, Peripheral swelling, Scab
Clinical narrative: A 11 year old boy received Tdap, MCV4 and HPV on Wednesday 2/12/20. Tdap and MCV4 were in the left deltoid. HPV in the right deltoid. Mom called Thursday 2/13/20 afternoon to report his arm was red and swollen and hard, 3 fingers wide, the length of her fingers. He also did not feel well. I told her warm compresses and NSAIDs. Take to care if not better. In a follow-up call to mother Tuesday 2-18-20 she reported that later on Thursday 2/13/20, the arm, shoulder to elbow, and starting up his neck, and around under his arm and into the arm pit was red, and hard. He did not feel well, and temp 99 to 101. 2/14/20 he was seen in clinic, via telemed, and was told to go to an ER. They went to Hospital ER. Diagnosis reportedly was allergic reaction and cellulitis. The skin had blistered. He was given Keflex and Bactrim. Tuesday 2/18/20, mom reports the arm was back to normal, except scabs where the blisters were, the skin is soft, and just looks like he had been sunburnt. He is a sensitive kid and reacts to many things.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak 5 days following first Shingrix
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Depressed mood, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: After about three hours I began to feel a little down ... like I was going to have the flu. At the six hour point I began to feel like I had a fever, slight shivering. By the 12 hour point I was shivering quite a bit. At the 15 hour point I was shivering uncontrollably, as if I had a serious fever.  It lasted until about the  21 hour point ... then I began to recover. AT the 24 hour point I was 90 percent recoveredd, and 100% at the 28 hour point. Also had a pretty sore arm at the shot site.
Age: 26.0
Sex: F
Vaccine: HEP, HEPA, HPV9, TD
Symptoms: Feeling abnormal, Feeling hot, Loss of consciousness, Muscle rigidity, Paraesthesia
Clinical narrative: After receiving the HPV, Hep B, Hep A, and Td vaccines patient passed out, whole body went ridged, came to within a few minutes, dry heaved, and complained of feeling hot, and having tingling in hands with a feeling of being off.  Patient given ice packs, water, and time to recover in treatment room, patient left on our accord and stated she felt better after 30 mins of being watched by healthcare team
Age: 26.0
Sex: F
Vaccine: HEP, HEPA, HPV9, TD
Symptoms: Retching
Clinical narrative: After receiving the HPV, Hep B, Hep A, and Td vaccines patient passed out, whole body went ridged, came to within a few minutes, dry heaved, and complained of feeling hot, and having tingling in hands with a feeling of being off.  Patient given ice packs, water, and time to recover in treatment room, patient left on our accord and stated she felt better after 30 mins of being watched by healthcare team
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Rash, Rash pruritic
Clinical narrative: Rash on right and left tricep, right and left abdomen, right and left thighs. Week two less severe rash on right and left hands. Week two spread to left breast, and some intermittent spots elsewhere.  Week two, rash became itchy.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Patient started experiencing pain in the vaccinated arm as well as redness below the injection site on the left upper arm.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Influenza, Polymerase chain reaction positive, Rash vesicular, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Diseemianted varicella, confirmed vaccine strain. Developed rash while admitted at Medical Center, around ~1/28.  Transferred to Hospital on 2/5/20.  Rash felt to look vesicular on evaluation at Hospital.  VZV PCR from lesion positive for varicella. Varicella PCR from blood positive, and VZV positive from BAL.  Testing now completed by CDC; varicella from BAL confirmed as vaccine strain.
Age: 25.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Vision blurred
Clinical narrative: Patient stated that they felt dizzy and had blurred vision. Manager on duty was notified and emergency personel was called to seen. Patient was asked to sit down and was monitored. Emergency personel arrived and proceeded to assist patient with questioning. Patient stated that they felt better. Pharmacist asked patient to stay longer to be monitored. Patient complied. Left 20 minutes later. Stated that they were feeling much better. Patient asked to contact pharmacist if they had any other issues or questions.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Brain neoplasm, Brain oedema, Condition aggravated, Meningioma
Clinical narrative: Edema in Meningioma  increased  BRAIN TUMOR EDEMA
Age: 55.0
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 55 years old was administered Gardasil 4; no adverse effects reported; This spontaneous report as received from a nurse and refers to a 55 year old patient of unknown gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.     On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (route of administration, dose, frequency, lot number and expiration date were not reported). However, no adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse effect reported; on 20-FEB-2020 patient received a dose of improperly stored VAQTA; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.       On 20-FEB-2020, the patient was vaccinated with a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) (dosage regimen, route of administration and anatomical location were not reported; lot number S025993 has been verified to be valid, expiration date reported and validated as 17-OCT-2020)  as prophylaxis (product storage error). No further adverse effect reported.  The temperature excursion was reported as: below 36 degrees Fahrenheit for 27 minutes. No previous temperature excursions reported.  A data logger was used. ; Sender's Comments:  US-009507513-2002USA010005: US-009507513-2002USA010017: US-009507513-2002USA010018: US-009507513-2002USA010021: US-009507513-2002USA010023: US-009507513-2002USA010046: US-009507513-2002USA010054: US-009507513-2002USA010078: US-009507513-2002USA010083: US-009507513-2002USA010140: US-009507513-2002USA010152: US-009507513-2002USA010216:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse effect reported; on 19-FEB-2020 patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.       On 19-FEB-2020, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (strength and dosage regimen were not reported; lot number S014947 has been verified to be valid, expiration date reported and validated as 10-DEC-2020) as prophylaxis (product storage error). No further adverse effect reported.  The temperature excursion was reported as: below 36 degrees Fahrenheit (34 degrees Fahrenheit) for 27 minutes. No previous temperature excursions reported.  A data logger was used.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA009991: US-009507513-2002USA010017: US-009507513-2002USA010018: US-009507513-2002USA010021: US-009507513-2002USA010023: US-009507513-2002USA010046: US-009507513-2002USA010054: US-009507513-2002USA010078: US-009507513-2002USA010083: US-009507513-2002USA010140: US-009507513-2002USA010152: US-009507513-2002USA010216:
Age: 29.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an injection with Menactra which expired on 09-Oct-2019, no AE; Initial information received on 20-Feb-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 29 years old female patient who was vaccinated with an 0.5 mL expired first injection of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Expired product administered) (lot U6016AA, expiry date: 09-Oct-2019) via an unknown route in the left deltoid for prophylactic vaccination in 20-Feb-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Patient did not take any concomitant medication.  It is a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: 18 month old female patient received an expired dose of Daptacel, no AE; Initial information was received on 20-Feb-2020 regarding an unsolicited valid non-serious case from a consumer.  This case involves an 18-month-old female patient who received 0.5 mL dose expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5367AA and expiry date: 30-Jan-2020) via an intramuscular route in the left thigh for prophylactic vaccination, on 19-Feb-2020 (Expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); HIB VACCINE (HIB); INFLUENZA VACCINE (INFLUENZA); MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO); and PNEUMOCOCCAL VACCINE CONJ (PCV13).  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: the consumer received two Flu vaccines in the same flu season, No AE; Initial information received on 20-Feb-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 65 years old female patient for whom it was reported that the the consumer received two flu vaccines in the same flu season (extra dose administered) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient had received a regular flu vaccine in Oct-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.   On 19-Feb-2020, the patient received a dose of 0.5 ml of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ307AA, exp date: 29-Jun-2020 via unknown route in unknown administration site (right side). It was a case of actual medication error due to extra dose administered.   The patient wanted the flu shot and a different shot. The patient wanted the shingles and pneumonia shot. Caller stated that the patient turned 65 in December and got the regular flu shot back in October. Caller stated that the patient received Fluzone High Dose today.  No adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Rash
Clinical narrative: rash on torso, resolved after 10 days,  very sore arm 4-5 days, felt "unwell" for 3 days.  did not seek medical treatment/report until today when asking about getting 2nd dose  of shingrix.  dose deferred until consults with pcp
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Inflammation, Nodule, Skin mass, Tenderness
Clinical narrative: Within a week after my flu shot, I started to notice a bump on my arm that wasn't going away.  It was a small nodule under the skin that was sore to touch.  Over time it has continued to get larger and it is now red and tender all of the time several months after the shot.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Eczema, Erythema, Feeling hot, Pruritus, Skin exfoliation
Clinical narrative: Symptoms presented within 12 hours of injection.  Ezcema-like symptoms, including itching, redness, flaking and cracked skin, and warm sensation on hands (including wrists and knuckles). Anterior thighs also itching.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Skin fissures
Clinical narrative: Symptoms presented within 12 hours of injection.  Ezcema-like symptoms, including itching, redness, flaking and cracked skin, and warm sensation on hands (including wrists and knuckles). Anterior thighs also itching.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Could not sleep on left arm because of pain Hard Round rising red welp form at injection site
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Injection site mass, Injection site necrosis, Ultrasound scan abnormal
Clinical narrative: Subcutaneous fat necrosis on the anterior right thigh.  Parents noted a mass in the thigh approx the size of a walnut approx 3 days after the vaccination.  She was acting well and there were no overlying skin changes.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Approx 5 cm in diameter erythema and approx. 7 cm swelling anterior left thigh. Treated with Cephalexin 125MG/5ML, 6 Milliliter every 12 hours x 10 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Approx. 21 hours after injection, I began feeling cold.  Chills persisted for 5-6 hours, culminating in a fever of 100.5.  Muscle aches concurrent with chills and fever.  When fever subsided (1-2 hours duration), I was better, including good appetite.  This is in addition to very sore upper arm at injection site.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Administered Influenza vaccine on 02/27/2020 and patient had already received flu vaccine for this flu season in October 2019
Age: 16.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MENB, MNQ
Symptoms: Confusional state, Dizziness, Hyperhidrosis, Hypopnoea, Speech disorder
Clinical narrative: Patient received five vaccines at 5:25 pm; after waiting five minutes, patient mother and sister began to make way to waiting room to finish out recommended fifteen minute wait. Right outside of exam room, patient became dizzy and was assisted to the ground by the mother. Blood pressure was taken (81/40) and SPO2 was 92%. Pulse was stable at 61 bpm. Patient appeared confused and was mumbling for short period of time but never lost consciousness; he was sweating and breaths became more shallow at 22-24 bpm. 0.5 ml of epinephrine 1:1 was given and EMS called. Blood pressure was taken about five minutes after epinephrine was given; blood pressure was stable and patient states he felt better. Approximately five minutes later, EMS arrive and patient was assisted to a chair. Vital signs stable and patient remained in chair for about ten minutes. Patient is axox4 and vital signs still stable. Mother signed refusal to transport and EMS left. Patient remained in chair for fifteen minutes after EMS left. Mother and patient decided he was okay to rise out of chair after blood pressure was taken again and read 122/71. Patient states he felt normal and was ready to leave. Advised mother to take patient to hospital if any other issues occurred after leaving clinic, mother verbalized understanding.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient received  PPV23 on 1/29/2019 and received same vaccine 10 months later. He should have gotten his second dose 1/29/2020 and it should have been Pneumo13.  There were no Adverse Reactions or patient complaints.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache, chills, body aches
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous, Rash vesicular
Clinical narrative: My 12 month old baby developed a chickenpox like rash all over her body. It is pink in color and bumpy.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: After an hour to the next day, patient reported excruciating pain and limited mobility to the injected arm. Recommended otc analgesic treatment and patient's arm is feeling better  acouple days after using analgesic treatment.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient received vaccination AM of 2/27...called our pharmacy PM of 2/27 stating she was having extreme pain in the arm and could not move it.  She went on to say movement from the elbow to the hand was fine but was having a hard time lifting her arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac monitoring, Myalgia, Neck pain, Neuralgia, Pain
Clinical narrative: Radiating left arm, neck nerve/muscle pain, patient not sure if related to vaccination or to exercise, pinched nerve, etc.  Patient presented to urgent care due to discomfort, being unable to sleep lying down until last night (2/26/20).  Getting better but still some discomfort.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Radiating left arm, neck nerve/muscle pain, patient not sure if related to vaccination or to exercise, pinched nerve, etc.  Patient presented to urgent care due to discomfort, being unable to sleep lying down until last night (2/26/20).  Getting better but still some discomfort.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Zoster (Shingrix) is given SQ which is incorrect route. Vaccine should have been given IM. Patient is contacted and informed of incorrect route and instructed to inform us if she has any adverse reactions such as high fever or localized swelling.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Musculoskeletal pain, Myalgia, Pain, Pain in extremity
Clinical narrative: PATIENT CAME IN STORE ON 2/27/20 COMPLAINING OF SHOULDER PAIN AND RADIATING PAIN DOWN INSIDE OF ARM.  SHE STATES SHE HAD PAIN IN MUSCLE FOR 2 WEEKS IMMEDIATELY AFTER SHOT THEN PAIN BEGAN COMING FROM OTHER PARTS OF HER ARM AND SHOULDER.  THE MUSCLE DOES NOT HURT.  PATIENT HAS NOT SOUGHT TREATMENT OR CARE TO DATE.  SHE WAS ADVISED TO FOLLOW UP WITH HER PCP FOR FURTHER EVALUATION.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Skin reaction
Clinical narrative: The patient had a decently large rectangular red, swollen area on her arm. She said that it was itchy too.