chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Myalgia, Pain in extremity, Red blood cell sedimentation rate normal, Renal function test normal, Walking aid user
Clinical narrative: Seen in office 9/2/20 - complaints of bilateral leg pain - "Patient is a 10-year-old girl here with father for evaluation of leg pain that has been going on for last couple of days . On Monday child went to park and did way more walking than she is used to. She started complaining of leg pain Monday night.  She had trouble bearing weight and walking on Tuesday morning.  She called the office and was advised to take ibuprofen for pain and if it does not get better they should call for further evaluation.  She comes today on crutches.  She was not able to bear weight.  She complains of bilateral leg pain from thighs to her ankles.  She has been drinking okay and her urine color is normal without any red tinges.  She is eating and drinking well.  Does not complain of belly pain or nausea or vomiting.  She is otherwise a healthy girl." - sent to ER for further work-up - diagnosed with Myalgia 1. Myalgia - "No specific identifiable etiology for bilateral leg pain on visit to the emergency department today.  All labs and x-rays normal.  Continue with increased oral hydration with clear, non-sugary fluids throughout the day.  Children's Motrin every 6-8 hours as needed for discomfort.  Rest while remaining active.  Follow-up with your PCP this week for continued symptoms.  Return the emergency department immediately for any worsening symptoms or additional concerns." -  Follow-up on 9/4/20 - "Patient is a 10-year-old girl with bilateral lower leg myalgia.  She has been evaluated extensively including creatinine kinase, CBC, S CRP, ESR, renal function test and x-ray of the hips.  All the labs have been normal.  Her pain is not getting any significant better.  But the pain is also not getting any worse.  I added prednisone 50 mg twice a day for 5 days in addition to ibuprofen.  I have advised her to take with food to prevent gastric irritation.  I also advised her to drink plenty of fluid.  Per parents concerns, we have reported vaccine adverse reaction form and send it to CDC.  She had gotten her HPV 11 days before." - Seen at orthopedics on 9/8/20 - "Knee pain, bilateral - I ordered and reviewed bilateral knee x-rays as well as reviewed the prior x-rays and labs, all which appeared normal.  I discussed with the mother she is likely having reactive arthritis that should improve in the coming weeks.  I recommended continuing NSAIDs, modifying activities to tolerance, resting, warm soaks, icing as needed, and have written a note keep around gym class for the next 3 weeks.  I will have her follow-up at that point to her monitor her progress.  I discussed the possibility of rheumatoid or other autoimmune disorder, but the general recommendation is against ordering labs for such issues at this point in the presentation of pediatric patients give most will improve without it and the labs will be negative."
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Weight bearing difficulty, X-ray normal, X-ray of pelvis and hip normal
Clinical narrative: Seen in office 9/2/20 - complaints of bilateral leg pain - "Patient is a 10-year-old girl here with father for evaluation of leg pain that has been going on for last couple of days . On Monday child went to park and did way more walking than she is used to. She started complaining of leg pain Monday night.  She had trouble bearing weight and walking on Tuesday morning.  She called the office and was advised to take ibuprofen for pain and if it does not get better they should call for further evaluation.  She comes today on crutches.  She was not able to bear weight.  She complains of bilateral leg pain from thighs to her ankles.  She has been drinking okay and her urine color is normal without any red tinges.  She is eating and drinking well.  Does not complain of belly pain or nausea or vomiting.  She is otherwise a healthy girl." - sent to ER for further work-up - diagnosed with Myalgia 1. Myalgia - "No specific identifiable etiology for bilateral leg pain on visit to the emergency department today.  All labs and x-rays normal.  Continue with increased oral hydration with clear, non-sugary fluids throughout the day.  Children's Motrin every 6-8 hours as needed for discomfort.  Rest while remaining active.  Follow-up with your PCP this week for continued symptoms.  Return the emergency department immediately for any worsening symptoms or additional concerns." -  Follow-up on 9/4/20 - "Patient is a 10-year-old girl with bilateral lower leg myalgia.  She has been evaluated extensively including creatinine kinase, CBC, S CRP, ESR, renal function test and x-ray of the hips.  All the labs have been normal.  Her pain is not getting any significant better.  But the pain is also not getting any worse.  I added prednisone 50 mg twice a day for 5 days in addition to ibuprofen.  I have advised her to take with food to prevent gastric irritation.  I also advised her to drink plenty of fluid.  Per parents concerns, we have reported vaccine adverse reaction form and send it to CDC.  She had gotten her HPV 11 days before." - Seen at orthopedics on 9/8/20 - "Knee pain, bilateral - I ordered and reviewed bilateral knee x-rays as well as reviewed the prior x-rays and labs, all which appeared normal.  I discussed with the mother she is likely having reactive arthritis that should improve in the coming weeks.  I recommended continuing NSAIDs, modifying activities to tolerance, resting, warm soaks, icing as needed, and have written a note keep around gym class for the next 3 weeks.  I will have her follow-up at that point to her monitor her progress.  I discussed the possibility of rheumatoid or other autoimmune disorder, but the general recommendation is against ordering labs for such issues at this point in the presentation of pediatric patients give most will improve without it and the labs will be negative."
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dyspnoea, Gait disturbance, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Immediate sweating and slight  SOB then localized site pain then within 24 hours severe muscle pain and weakness needing assistance with walking for 2 days after .  Symptoms got better on 9/8/2020
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Myalgia
Clinical narrative: Immediate sweating and slight  SOB then localized site pain then within 24 hours severe muscle pain and weakness needing assistance with walking for 2 days after .  Symptoms got better on 9/8/2020
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discharge, Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: Received vaccine on 08/27/2020 and kept bandaid on for 4-5 days afterwards as patient would not allow parent to take off bandaid due to it being painful. Once bandaid was removed on or about 09/01/2020, parent noticed red raised bump about 10mm x 10mm in size. Following morning when parent went to check on arm, patient's shirt was stuck to area and when removed, area opened and began bleeding. Parent is going to keep area clean, apply antibiotic ointment and keep bandaged.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported; a patient was inadvertently administered a second dose of Pneumovax 23 on 9/1/2020 after having received an initial dose 11/6/2018; This spontaneous report as received from a pharmacy technician refers to a 65 year old patient of an unknown gender. No information regarding concurrent conditions, pertinent medical history, drug allergies and concomitant therapies was provided.   On 01-SEP-2020, after having received an initial dose on 06-NOV-2018, the patient was inadvertently vaccinated with  a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 05 milliliter (route of administration, lot # and expiration date were not provided) for prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Pemphigoid
Clinical narrative: bullous pemphigoid post Shingrix vaccination; This case was reported by a other health professional and described the occurrence of bullous pemphigoid in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the bullous pemphigoid was unknown.   It was unknown if the reporter considered the bullous pemphigoid to be related to Shingrix.  Additional details were reported as follows: The age at vaccination were not reported but adult has been selected as age group according to the vaccine. The reporter stated about hearing of an anecdotal report of bullous pemphigoid post shingrix vaccination. No additional details were provided. This case is linked with case US2020AMR178549, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR178549:same reporter
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased
Clinical narrative: Patient reported a temp of 102 degrees the night of getting the shot.  He reported that he felt fine the next day and no fever.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Chest pain, Pericardial effusion, Pericardial excision
Clinical narrative: April 3, 2015 she was admitted into the hospital with chest pain. She was diagnosed with a Pericardial Effusion. She had to have a Pericardial Window to remove fluid from her heart.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Induration, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Rash on extremities (red, raised, itchy) as well as small hard pustule-like hard bumps on left fingers and palm
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Rash pustular
Clinical narrative: Rash on extremities (red, raised, itchy) as well as small hard pustule-like hard bumps on left fingers and palm
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, RV1
Symptoms: Cough, Dyspnoea, SARS-CoV-2 test negative
Clinical narrative: A couple days to about a week after receiving these vaccines, my son developed a cough and trouble breathing. I notified his doctor and we came in for a check-up. She said there wasn?t anything to be concerned about and to monitor the cough to make sure it didn?t last longer than a month and to come back if he had any fevers or other symptoms associated with it.   My son never developed any other symptoms besides this persistent cough. He coughs especially in the morning when he wakes up and it has been 3 months since the cough developed following the vaccinations. The cough is the same, with labored breathing, and no other symptoms.   We relocated to another area and my son was checked by another doctor, with whom I brought up my concern for this cough. She told me she would check his lungs but instead gave him a coronavirus test and sent us home. He does not, nor did he ever have coronavirus and his cough/labored breathing is still persistent.
Sex: U
Vaccine: TDAP
Symptoms: Asthenia, Balance disorder, Condition aggravated, Immune system disorder, Impaired work ability
Clinical narrative: RA like flare ups; immune system ruined; weakness; not able to work; changed nuero including balance; changed nuero including balance; This case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis flare up in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant), immune system disorder, weakness, activities of daily living impaired, balance disorder and neurological impairment. On an unknown date, the outcome of the rheumatoid arthritis flare up, immune system disorder, weakness, activities of daily living impaired, balance disorder and neurological impairment were unknown.   It was unknown if the reporter considered the rheumatoid arthritis flare up, immune system disorder, weakness, activities of daily living impaired, balance disorder and neurological impairment to be related to Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had Tdap in 2012, patient's immune system was ruined, RA like flare ups, weakness, changed nuero including balance, the patient was not able to work.
Sex: U
Vaccine: TDAP
Symptoms: Loss of personal independence in daily activities, Nervous system disorder, Rheumatoid arthritis
Clinical narrative: RA like flare ups; immune system ruined; weakness; not able to work; changed nuero including balance; changed nuero including balance; This case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis flare up in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant), immune system disorder, weakness, activities of daily living impaired, balance disorder and neurological impairment. On an unknown date, the outcome of the rheumatoid arthritis flare up, immune system disorder, weakness, activities of daily living impaired, balance disorder and neurological impairment were unknown.   It was unknown if the reporter considered the rheumatoid arthritis flare up, immune system disorder, weakness, activities of daily living impaired, balance disorder and neurological impairment to be related to Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had Tdap in 2012, patient's immune system was ruined, RA like flare ups, weakness, changed nuero including balance, the patient was not able to work.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Death, Influenza, Pneumonia, Vaccination failure
Clinical narrative: had flu shot and pneumonia shot...she died of the flu that turned into pneumonia; had flu shot and pneumonia shot...she died of the flu that turned into pneumonia; had flu shot and pneumonia shot...she died of the flu that turned into pneumonia; This case was reported by a consumer via interactive digital media and described the occurrence of  suspected vaccination failure in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA SHOT) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and PNEUMONIA SHOT. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria death and GSK medically significant), pneumonia (serious criteria death and GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure, pneumonia and influenza were fatal. The reported cause of death was vaccination failure, pneumonia and influenza.   It was unknown if the reporter considered the vaccination failure, pneumonia and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by patient's son or daughter. The age at vaccination was not reported. It was reported that the flu shots were risky and not very effective. The patient had flu shot and pneumonia shot. The patient was died of the flu that turned into pneumonia. It was reported that there was wrong strain that year. The case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation was not known; Reported Cause(s) of Death: Vaccination failure; Pneumonia; Influenza
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Feeling abnormal, Headache, Injection site pain
Clinical narrative: developing a headache; having general malaise; stomach discomfort; feeling sleeping / taking two naps; discomfort sleeping on left side due to sore arm; the injection was painful; noticing arm was sore and took Advil / arm is still sore; soreness in arm began to creep up neck; soreness in arm / extend down to wrist; still feels off; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced neck pain, wrist pain and feeling bad. On 29th August 2020, the patient experienced injection site pain and pain in arm. On 30th August 2020, the patient experienced headache, general malaise, stomach discomfort, sleepiness and difficulty sleeping. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain, sleepiness, difficulty sleeping, neck pain, wrist pain and feeling bad were unknown and the outcome of the pain in arm and general malaise were not recovered/not resolved and the outcome of the headache and stomach discomfort were recovering/resolving.   It was unknown if the reporter considered the injection site pain, pain in arm, headache, general malaise, stomach discomfort, sleepiness, difficulty sleeping, neck pain, wrist pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm and the injection was painful.  The reported stated that cutting grass and noticing arm was sore and took Advil.  The patient developed a headache, having general malaise, stomach discomfort, feeling sleeping and taking two naps, and discomfort sleeping on left side due to sore arm. The soreness in arm began to creep up neck and extend down to wrist and wondered the soreness was not as localized.  The arm was still sore, but overall feeling a little bit better so far and not headache currently but she still feels off.  The patient had not eaten breakfast yet, so stomach discomfort not present yet. The reporter did not consent to HCP follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Malaise, Neck pain, Pain in extremity, Somnolence
Clinical narrative: developing a headache; having general malaise; stomach discomfort; feeling sleeping / taking two naps; discomfort sleeping on left side due to sore arm; the injection was painful; noticing arm was sore and took Advil / arm is still sore; soreness in arm began to creep up neck; soreness in arm / extend down to wrist; still feels off; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced neck pain, wrist pain and feeling bad. On 29th August 2020, the patient experienced injection site pain and pain in arm. On 30th August 2020, the patient experienced headache, general malaise, stomach discomfort, sleepiness and difficulty sleeping. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain, sleepiness, difficulty sleeping, neck pain, wrist pain and feeling bad were unknown and the outcome of the pain in arm and general malaise were not recovered/not resolved and the outcome of the headache and stomach discomfort were recovering/resolving.   It was unknown if the reporter considered the injection site pain, pain in arm, headache, general malaise, stomach discomfort, sleepiness, difficulty sleeping, neck pain, wrist pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm and the injection was painful.  The reported stated that cutting grass and noticing arm was sore and took Advil.  The patient developed a headache, having general malaise, stomach discomfort, feeling sleeping and taking two naps, and discomfort sleeping on left side due to sore arm. The soreness in arm began to creep up neck and extend down to wrist and wondered the soreness was not as localized.  The arm was still sore, but overall feeling a little bit better so far and not headache currently but she still feels off.  The patient had not eaten breakfast yet, so stomach discomfort not present yet. The reporter did not consent to HCP follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cellulitis orbital, Facial pain, Rash
Clinical narrative: had pain on top of the right eye brow; cellulitis  of the right eye socket; cluster of blisters/cluster of blister and rash near the right hip towards the back; rash near the right hip towards the back /  rash on top of the right eye brow; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 23LD9, expiry date 2nd April 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 5 months ago from reporting date).   On 4th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, 1 week after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), blister and rash. In August 2020, the patient experienced pain. The patient was treated with clindamycin, methylprednisolone, levothyroxine sodium (Synthroid), metformin and vitamins nos (Multivitamins). On an unknown date, the outcome of the cellulitis, blister and rash were recovered/resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the cellulitis, blister, rash and pain to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose in left arm. The patient got the 2nd dose of the Shingrix vaccine and 1 week later she had a cluster of blisters and rash on top of the right eye brow with cellulitis  of the right eye socket. She was seen by a dermatologist 3 days later who started her on 10 days of clindamycin and 4 days of methylprednisolone.  This events were resolved in 2 weeks. Later 5 months after the 2nd dose of the Shingrix vaccine, patient observed cluster of blister and rash near the right hip towards the back which she treated with a band aid. She did not visit a doctor and this resolved in 2 weeks.  The patient stated that she received the 1st dose of the Shingrix vaccine about 5 months ago but she did not remember the date. She reported that about 1 week ago she again had pain on top of the right eye brow but was not diagnosed with shingles. The patient did not have previous episode of shingles. She stated she only takes synthroid and metformin with some multivitamins The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient says left arm still hurts and especially if lifting.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain
Clinical narrative: I woke up at midnight shivering.  I also have a lot of soreness at the injection site.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient reported that her lest arm was swollen. she went to the doctor and was prescribed Motrin 600mg and Benadryl 25mg
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Contusion
Clinical narrative: week long briusing
Age: 9.0
Sex: M
Vaccine: TD
Symptoms: Cellulitis, Swelling
Clinical narrative: Developed Cellulitius. Severe swelling that traveled. By March 6th - patient needed to go back to the Dr. for antibiotics to offset the Cellulitis that was traveling.  Required 7-10 days antibiotics and multiple visits to Dr.    Assumed at the time it was possible " bad shot - however, we gave him ANOTHER dose of Tdap on 8/4/2020 and had the exact same reaction.  Clearly - this child develops Cellulitis immediately with these immunizations.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Decreased appetite, Dyspnoea, Hyperhidrosis
Clinical narrative: Onset of symptoms/signs: Approx 12-14 hours.  Signs & Symptoms: Shortness of breath, joint and muscle pain, loss of appetite, mild nausea, loss of stamina, lethargy, diaphoresis.  All lasting approximately 24 hours from onset.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Myalgia, Nausea
Clinical narrative: Onset of symptoms/signs: Approx 12-14 hours.  Signs & Symptoms: Shortness of breath, joint and muscle pain, loss of appetite, mild nausea, loss of stamina, lethargy, diaphoresis.  All lasting approximately 24 hours from onset.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: little hard bump at site of injection, no treatment recommended but counseled the patient to watch for any color change or warmth and give us a call.
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage, Injection site swelling
Clinical narrative: Immediately after vaccination, there was a small amount of bleeding followed by swelling and bruising at injection site
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Nausea, Unresponsive to stimuli
Clinical narrative: Patient was administered a flu shot by wellness nurse at 1134 on 9/8/2020.  At 1143, patient complained of nausea, became sweaty, and unresponsive.  EMS was called and then cancelled at 1144 when patient came back to.  Patient's vital signs were obtained.  Patient was oriented and tolerated fluids.  Patient moved from siting position to ambulating with no problems by 12:05.   Patient returned call to health department on 9/9/2020 at 12:00 noon.  Patient denies any problems or concerns related to flu vaccination
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm, Vaccination complication
Clinical narrative: Patient was given vaccines by a medical assistant in the clinic on 8/28/2020. It is charted that all vaccines were given in left deltoid.  It was not documented about which vaccine was given first or what part of left deltoid they were given in.  Patient came into clinic on 9/1/2020 with reports of redness, swelling, warmth and itching to left arm.  The provider who examined the patient believed that she had a reaction to one of the vaccines.
Age: 11.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Cellulitis, Swelling
Clinical narrative: Developed Cellulitius. Severe swelling that traveled through shoulder and chest area. By August 5 - patient needed to go back to the Dr. for antibiotics to offset the Cellulitis that was traveling (for the second time to this shot - first reaction was to TD next Reaction was to Tdap).   Required another round of 7-10 days antibiotics and multiple visits to Dr.  Skin was peeling off by August 10th from the extreme swelling.  Benadryl was given for several days in conjunction. Prednisone was also prescribed.   Clearly - this child develops Cellulitis immediately with these immunizations.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site pain, Nausea, Pyrexia
Clinical narrative: site sore, feverish, chills that evening. next morning nauseated, fainted, sweating profusely, but then felt a little better later in the day, then did have temp that night of 100.1
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: site sore, feverish, chills that evening. next morning nauseated, fainted, sweating profusely, but then felt a little better later in the day, then did have temp that night of 100.1
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site swelling, Pregnancy test positive
Clinical narrative: her blood test showing her "levels were low"; she is pregnant; injection site was red and swollen; injection site was red and swollen; This spontaneous prospective pregnancy report was received from a 22-year-old female patient, who was referring to herself. She had none concomitant medications, pertinent medical history or drug reactions/allergies reported.  On an unknown date, when she was a child, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck)(VARIVAX), 1 injection (strength, route of administration, lot number and expiry date were not provided) for prophylaxis. On an unknown date, unspecified blood test was performed, which showed that "her levels were low" (not further clarified). Due to the event, she was recommended to retake the vaccine to "boost her levels". On 09-AUG-2020, the patient performed the pregnancy test, which was negative. On 11-AUG-2020, the patient was vaccinated with another dose (however, she also stated it was her first dose - discrepant information) of varicella virus vaccine live (oka/merck)(VARIVAX), 1 injection in the upper arm (strength, route of administration, lot number and expiry date were not reported) to boost levels.  On approximately 12-AUG-2020 (reported as the day after the vaccination), the injection site became red and swollen. On 26-AUG-2020, the patient performed another pregnancy test, which was positive. On 27-AUG-2020, the patient had a doctor's appointment and it was confirmed that she was pregnant. The patient's last menstrual period (LMP) was reported as 22-JUL-2020, estimated date of conception was calculated as 05-AUG-2020 and estimated date of delivery (EDD) was calculated as 28-APR-2021. The pregnancy outcome was pending. The fetal outcome was unknown. The outcome of the events of levels were low, injection site redness and injection site swelling was not reported (however the patient stated that injection site swelling and redness lasted for 4 days).  The relatedness between the events and the suspect vaccine was not reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a 12 month old was given PROQUAD and VARIVAX togerther; This spontaneous report was received from a nurse practitioner and refers to a 12-month-old patient of an unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 27-AUG-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, route of administration, lot # and expiration date were not reported) together with varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, lot # and expiration date were not reported), both for prophylaxis.  The outcome of inappropriate schedule of product administration was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: zoster related rash; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 15-OCT-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation), the pt was treated by a healthcare provider at a hospital for zoster related rash (herpes zoster). On an unknown date, the pt was admitted to the hospital due to the event. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of this report, the outcome of herpes zoster was unknown. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif on the wrong schedule/took it on Wednesday, Thursday, Saturday and Monday; Spontaneous report received on 20JUL2020.  A nurse reported that a male consumer "took Vivotif on the wrong schedule/took it on Wednesday, Thursday, Saturday and Monday" (PT: Inappropriate schedule of product administration). He was receiving Vivotif for immunisation. On 13JUL2020, the consumer received Vivotif with Yellow fever vaccine. He started taking Vivotif doses on 15JUL2020 and did not take all the doses according to the schedule. He took doses on 15JUL2020, 16JUL2020, 18JUL2020 and 20JUL2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer Vivotif doses on the wrong schedule as he took it on Wednesday, Thursday, Saturday and Monday (inappropriate schedule of product administration) instead of taking Vivotif on every other day. The causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif due to the nature of the event.; Sender's Comments: A consumer Vivotif doses on the wrong schedule as he took it on Wednesday, Thursday, Saturday and Monday (inappropriate schedule of product administration) instead of taking Vivotif on every other day. The causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif due to the nature of the event.
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a Pfizer-sponsored program About Pneumonia Unbranded . A non-contactable consumer (patient) reported for a patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot/batch number and Expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date.The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Laboratory test, Weight increased
Clinical narrative: I gained a little weight; Have the same injection one after the other; I have vaccine twice; I am going through lot of problems, a lot of stress right now; completely forgot; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 02Sep2020 at single dose for immunisation. Medical history included high cholesterol from an unknown date, "for the heart" from an unknown date, high blood pressure from an unknown date. Concomitant medication included amlodipine for high blood pressure, metoprolol for the heart, atorvastatin. Patient received Pneumococcal conjugate vaccine 13-valent for immunisation last year on 22Nov2019 when she was 72 years old. The patient reported she run in to a problem, she realized that she had vaccine twice. The Prevnar 13 for against pneumococcal. She had last year but she completely forgot that she was given it last year and she got one on Wednesday, 02Sep. She walked into Rite aid to buy few things and she was thinking that it might be good to have but she completely forgot that she had one last year. she administered it last year and she administered it this year. She had it twice instead of getting 23, she got 13 for the second time. The patient stated it was last year. This year she was 73, last year she was 72. Patient gained a little weight. She was 170 pounds. The Pulmonologist advised patient and last year she was given it in doctor office. So she has nothing to do with patient walking to Rite aid this year and completely forgot. She was going through lot of problems, a lot of stress right now for the last year due to big trouble and patient completely forgot. It scares her to tell the truth. It scares her that she forgot something like that. Last year it was Pneumococcal conjugate vaccine 13-valent and it was given to patient on 22Nov2019. One time shot. The patient stated, probably a month she had lab test, something. The patient asked If she would have an adverse reaction, if she would grow hairs on her eyes. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: my arm sure is sore; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable consumer (patient) reported that a patient of unknown age and gender received pneumococcal 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN) (PREVNAR 13) on 04Sep2020 at single dose via unknown route of administration for pneumonia shot. Medical history and concomitant medications were not reported. Patient stated his/her arm sure was sore. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected. Information about lot number/ batch number could not be obtained.
Sex: F
Vaccine: PNC13, UNK
Symptoms: Dermatitis contact, Drug hypersensitivity
Clinical narrative: Allergies: Codeine, Adhesive Bandage, Pneumococcal Vaccines; This is a spontaneous report from a Pfizer-sponsored program from two contactable physicians. A 72-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (trade name unknown), via an unspecified route of administration on an unknown date at single dose for immunization;  codeine (trade name unknown), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose and frequency for an unspecified indication.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced allergies: codeine, adhesive bandage, pneumococcal vaccines on an unspecified date. The action taken in response to the event for codeine was unknown. The outcome of the event was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injected limb mobility decreased, Injection site pain, Pain in extremity, Periarthritis
Clinical narrative: Patient is pregnant, 31week 3 days gestation when immunized. Patient received Tdap at a prenatal visit on 8/19. On 8/21 she went to Urgent Care complaining of left arm pain and inability to lift her arm. She was instructed to take Tylenol and apply ice. On 8/24 she called complaining of worsening arm pain, reports she has been to the ER with no relief. 8/26 she sees Orthopedic provider with shoulder pain and inability to lift her arm without assistance. Pain is rated 7/10. No redness or swelling at the original injection site and no fever. Diagnosis Adhesive Capsulitis Left Shoulder. Physical Therapy prescribed. 9/4 returns to Ortho pain improving 3/10.
Age: 68.0
Sex: M
Vaccine: FLUA3
Symptoms: Chills, Disorientation, Dysarthria, Feeding disorder, Loss of personal independence in daily activities
Clinical narrative: Severe pain unable to use left arm, extreme nausea, unable to eat or drink, fever and chills,  Disoriented with slurred speech and  Total incapacitation for over 24 hrs.
Age: 68.0
Sex: M
Vaccine: FLUA3
Symptoms: Musculoskeletal disorder, Nausea, Pain, Pyrexia
Clinical narrative: Severe pain unable to use left arm, extreme nausea, unable to eat or drink, fever and chills,  Disoriented with slurred speech and  Total incapacitation for over 24 hrs.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Joint swelling, Lip swelling, Peripheral swelling
Clinical narrative: Swollen right upper lip, left arm elbow down to finger tips. right index finger and  palm of hand.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Grip strength decreased, Loss of personal independence in daily activities, Muscular weakness, Pain in extremity
Clinical narrative: Pt had the first dose of Shingrix on 2/13/20 at age 77 years and 0 days. Within one hour she was feeling painful and weak at the left arm.  This progressed over hours and days to where she had difficulty with her full strength in the arm, including but not limited to, grip.  For example, she could not lift anything as heavy as a dish.  This lasted for at least two months.  On 9/9/20, visiting with patient today and even now there are reports that she is still in some phase of recovery.  The strength is nearly back to normal.  Still cannot lay on that arm at night.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Chest pain, Chills, Headache, Injection site pain
Clinical narrative: Significant pain at injection site, within hours of injection.  Appr. 3 1/2 days later, intense pain involving entire shoulder girdle,  lower neck, and upper thorax, bilaterally, anterior and posterior, most pronounced in substernal area in vicinity of manubrium.  The pain awakened me from sleep, and was excruciating (I have a high pain threshold), preventing sleep the rest of the night and following day.  It was pleuritic in nature, clearly worsened by deep inspiration, and was unremitting.  Headache, slight fever, and chills developed subsequently, prior to abrupt resolution of symptoms 25 hours after onset, leaving only slight residual dull pain, which gradually disappeared over the ensuing two days.    I have never before experienced any reaction whatever to the flu vaccine.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Neck pain, Pain, Painful respiration, Pleuritic pain, Pyrexia
Clinical narrative: Significant pain at injection site, within hours of injection.  Appr. 3 1/2 days later, intense pain involving entire shoulder girdle,  lower neck, and upper thorax, bilaterally, anterior and posterior, most pronounced in substernal area in vicinity of manubrium.  The pain awakened me from sleep, and was excruciating (I have a high pain threshold), preventing sleep the rest of the night and following day.  It was pleuritic in nature, clearly worsened by deep inspiration, and was unremitting.  Headache, slight fever, and chills developed subsequently, prior to abrupt resolution of symptoms 25 hours after onset, leaving only slight residual dull pain, which gradually disappeared over the ensuing two days.    I have never before experienced any reaction whatever to the flu vaccine.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: Significant pain at injection site, within hours of injection.  Appr. 3 1/2 days later, intense pain involving entire shoulder girdle,  lower neck, and upper thorax, bilaterally, anterior and posterior, most pronounced in substernal area in vicinity of manubrium.  The pain awakened me from sleep, and was excruciating (I have a high pain threshold), preventing sleep the rest of the night and following day.  It was pleuritic in nature, clearly worsened by deep inspiration, and was unremitting.  Headache, slight fever, and chills developed subsequently, prior to abrupt resolution of symptoms 25 hours after onset, leaving only slight residual dull pain, which gradually disappeared over the ensuing two days.    I have never before experienced any reaction whatever to the flu vaccine.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Fear of injection, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient had Swelling, redness, and heat radiating from the site of injection after receiving the vaccine. She tensed up when receiving the vaccine due to fear of injections. She stated that later she felt like she had a low-grade fever (did not take a temperature to verify). Patient says she took two Tylenol 500 mg and then all side effects resolved the same evening.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Tension
Clinical narrative: Patient had Swelling, redness, and heat radiating from the site of injection after receiving the vaccine. She tensed up when receiving the vaccine due to fear of injections. She stated that later she felt like she had a low-grade fever (did not take a temperature to verify). Patient says she took two Tylenol 500 mg and then all side effects resolved the same evening.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Vaccine was declined by mother. Misunderstanding lead vaccine to be given. No adverse effects were noted.
Sex: F
Vaccine: MMR
Symptoms: Product use in unapproved indication
Clinical narrative: Because of what pediatrician believes about a potential connection between MMR and COVID, he, his wife, and his personal physician all recently vaccinated themselves with MMR II for protection against COVID-19.; This spontaneous report was received from a retired pediatrician, referring to a his wife, female patient of unspecified age. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.   Because of what the reporting pediatrician believed was a potential connection between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and coronavirus (COVID-19), he, his physician (captured in cases 2008USA008655 and 2008USA008539 respectively) and his wife all vaccinated themselves with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for protection against COVID-19 on an unspecified date in 2020 (reported as "recently")  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA008539: US-009507513-2008USA008655:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 27-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml, lot # T002848, expiration date: 23-JAN-2022 (route of administration was not reported) for prophylaxis. Vaccine was reconstituted with sterile diluent (STERILE DILUENT).  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 50 minutes in the temperature between 6 degrees Fahrenheit (F) and 14 degrees Fahrenheit (10.56 F) with a previous temperature excursion between 6 F and 14 F (8.47 F) for 30 minutes. Digital Data Logger was involved.  The outcome of medication error was unknown.