chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; Illness; Arm hurt; Ache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old patient who received Herpes zoster (Shingrix) 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 fever, feeling unwell, pain in arm and pain. On an unknown date, the outcome of the fever, feeling unwell, pain in arm and pain were recovered/resolved.   It was unknown if the reporter considered the fever, feeling unwell, pain in arm and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in unknown arm. After the first shot of Shingrix the patient had a slight fever, arm hurt, illness and ached for a couple of days.  The patient reported that fever was very minor. The patient had 2nd shingles shot on the day of reporting. The patient asked whether to take Aspirin right after the 2nd shot to keep from having the same issues after 2nd shot. The reporter recommend that to speak with healthcare provider regarding the same issue.
Sex: M
Vaccine: VARZOS
Symptoms: Bed rest, Chills, Feeling hot, Pyrexia
Clinical narrative: chills/ shivers; subjective fever; This case was reported by a nurse via sales rep and described the occurrence of chills in a elderly male patient who received Herpes zoster (Shingrix) 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 chills and feeling hot. On an unknown date, the outcome of the chills and feeling hot were unknown.   It was unknown if the reporter considered the chills and feeling hot to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced chills, shivers, subjective fever and required bed rest for approximately 1 week. The reporter agreed to follow up.
Sex: U
Vaccine: PNC13, PNC13, PNC13, PNC13
Symptoms: Antibody test negative
Clinical narrative: Titers had fallen below protective levels in 7 serotypes; This is a spontaneous report from a contactable physician. This report was received from a Pfizer sales representative via Medical Information Team. A 5-year-old patient of an unspecified gender received the first, second, third and fourth doses of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), all via unspecified routes of administration on unspecified dates of therapy at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The physician stated that the 5-year-old patient had to receive a follow-up dose of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) because after seeing allergy and immunology specialist, was informed by immunologist that titers had fallen below protective levels in 7 serotypes. The outcome of the event was unknown. The information on the batch number has been requested.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Burning sensation, Erythema, Induration, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable Nurse (licensed practical nurse). This Nurse reported for a 80-year-old female patient that: An 81-year-old female patient of an unspecified age received PREVNAR 13 (Batch/lot # X70865, exp date 01Dec2020) intramuscular at 0.5ml to left deltoid once on 07May2019 15:30 for immunization, prescribed by the Family Practice HCP.  Medical history was unknown. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was unknown. Additional vaccines administered on same date of the Pfizer suspect were none. Prior Vaccinations (within 4 weeks) were none. On 08May2019 the patient experienced swollen at the site, hot to touch, blisters on upper forearm, itching, burning, induration possible phlebitis from shoulder to elbow. All events were considered serious as medically significant: the events require a visit to Physician Office (not to Emergency Room). The doctor ordered to use Benadryl cream and Tylenol and to follow up in 24-48 hours and to inform the doctor if she experiences worsening or difficulty. The blisters have dried up now. It was still lightly swollen. It was itching, burning and red but improved. The outcome of swollen at the site was not recovered, of all other events was recovering. Therapeutic measures were taken as a result of swollen at the site, hot to touch, itching, burning. The reporter considered there was a reasonable possibility that the events were related to the study medication. A Product Complaint was filed for Benadryl since it was still itching and Tylenol for it was still swollen at the site and hot to touch.; Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of events vaccination site pain, swelling and warmth cannot be fully excluded. Blisters on upper forearm, itching, induration possible phlebitis from shoulder to elbow more likely represent intercurrent medical conditions unrelated to PREVNAR 13. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Skin warm
Clinical narrative: This is a spontaneous report from a contactable Nurse (licensed practical nurse). This Nurse reported for a 80-year-old female patient that: An 81-year-old female patient of an unspecified age received PREVNAR 13 (Batch/lot # X70865, exp date 01Dec2020) intramuscular at 0.5ml to left deltoid once on 07May2019 15:30 for immunization, prescribed by the Family Practice HCP.  Medical history was unknown. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was unknown. Additional vaccines administered on same date of the Pfizer suspect were none. Prior Vaccinations (within 4 weeks) were none. On 08May2019 the patient experienced swollen at the site, hot to touch, blisters on upper forearm, itching, burning, induration possible phlebitis from shoulder to elbow. All events were considered serious as medically significant: the events require a visit to Physician Office (not to Emergency Room). The doctor ordered to use Benadryl cream and Tylenol and to follow up in 24-48 hours and to inform the doctor if she experiences worsening or difficulty. The blisters have dried up now. It was still lightly swollen. It was itching, burning and red but improved. The outcome of swollen at the site was not recovered, of all other events was recovering. Therapeutic measures were taken as a result of swollen at the site, hot to touch, itching, burning. The reporter considered there was a reasonable possibility that the events were related to the study medication. A Product Complaint was filed for Benadryl since it was still itching and Tylenol for it was still swollen at the site and hot to touch.; Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of events vaccination site pain, swelling and warmth cannot be fully excluded. Blisters on upper forearm, itching, induration possible phlebitis from shoulder to elbow more likely represent intercurrent medical conditions unrelated to PREVNAR 13. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: itchy warm arm; itchy warm arm; her arm was red sore and slightly swollen; her arm was red sore and slightly swollen; her arm was red sore and slightly swollen; This is a spontaneous report from contactable nurse via a Pfizer sales representative. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on 13May2019 at a single dose in the right deltoid for immunization. The patient's medical history and concomitant medications were not reported. The patient previously took Pneumovax 23 on 10Nov2010 for immunization and experienced redness and swelling. It was reported that the patient was given pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the right deltoid on 13May2019 and complained of an itchy warm arm, her arm was red sore and slightly swollen on an unspecified date. She returned to the doctor today on 15May2019. Some of the symptoms are still there but dissipating. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site mass
Clinical narrative: Swell, developed hard lump at injection site; Redness, hot, like allergic reaction; Redness, hot, like allergic reaction; Redness, hot, like allergic reaction; Uncomfortable when clothes would touch injection site; Slight bruise; This is a spontaneous report from a contactable Physician via Pfizer sales representative.   A 62-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot # X93809) via an unspecified route of administration at single dose on 02May2019 for immunisation.   Medical history included diabetes, hypertension, high cholesterol. The patient's concomitant medications were not reported.  The patient experienced swell, developed hard lump at injection site on an unspecified date with outcome of unknown, redness, hot, like allergic reaction on an unspecified date with outcome of unknown,  uncomfortable when clothes would touch injection site on an unspecified date with outcome of unknown, slight bruise on an unspecified date with outcome of recovering.    On 02May2019 at night started to swell, she developed hard lump at injection site, redness, hot, like allergic reaction. The lump was about the size of silver dollar for about 3 days, then it started to decrease in size. Tender to the touch. Uncomfortable when clothes would touch injection site. On 14May2019, still slight bruise, almost gone, with smaller than a dime-size lump. The outcome of still slight bruise was recovering, of all events was unknown.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swell, developed hard lump at injection site; Redness, hot, like allergic reaction; Redness, hot, like allergic reaction; Redness, hot, like allergic reaction; Uncomfortable when clothes would touch injection site; Slight bruise; This is a spontaneous report from a contactable Physician via Pfizer sales representative.   A 62-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot # X93809) via an unspecified route of administration at single dose on 02May2019 for immunisation.   Medical history included diabetes, hypertension, high cholesterol. The patient's concomitant medications were not reported.  The patient experienced swell, developed hard lump at injection site on an unspecified date with outcome of unknown, redness, hot, like allergic reaction on an unspecified date with outcome of unknown,  uncomfortable when clothes would touch injection site on an unspecified date with outcome of unknown, slight bruise on an unspecified date with outcome of recovering.    On 02May2019 at night started to swell, she developed hard lump at injection site, redness, hot, like allergic reaction. The lump was about the size of silver dollar for about 3 days, then it started to decrease in size. Tender to the touch. Uncomfortable when clothes would touch injection site. On 14May2019, still slight bruise, almost gone, with smaller than a dime-size lump. The outcome of still slight bruise was recovering, of all events was unknown.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Burning sensation, Concussion, Diarrhoea, Erythema
Clinical narrative: Pain, redness, swelling, burning, throbing pinching mucle pain, tired, weak Headache, diarrhea, throwing up, fainted lost 8 lbs, still cannot eat slight concussion when I fainted Black eye from fainting. This cost me $163.09 to be so very sick.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye contusion, Fatigue, Feeding disorder, Headache, Malaise
Clinical narrative: Pain, redness, swelling, burning, throbing pinching mucle pain, tired, weak Headache, diarrhea, throwing up, fainted lost 8 lbs, still cannot eat slight concussion when I fainted Black eye from fainting. This cost me $163.09 to be so very sick.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Swelling, Syncope, Vomiting
Clinical narrative: Pain, redness, swelling, burning, throbing pinching mucle pain, tired, weak Headache, diarrhea, throwing up, fainted lost 8 lbs, still cannot eat slight concussion when I fainted Black eye from fainting. This cost me $163.09 to be so very sick.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Weight decreased
Clinical narrative: Pain, redness, swelling, burning, throbing pinching mucle pain, tired, weak Headache, diarrhea, throwing up, fainted lost 8 lbs, still cannot eat slight concussion when I fainted Black eye from fainting. This cost me $163.09 to be so very sick.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site mass, Skin warm
Clinical narrative: Two days after injection patient began getting a red area at injection site.  It had a pea sized lump at that time.  The bump under the skin has gotten larger.  Now 25mmx25mm with redness of 20mm over lump.  Skin is warm to touch.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Vaccine stung when it went in. Left arm was very sore, had shivers and not sure if had fever.  The 2nd day, arm was better, no shivers but felt very weak. Today patient feels fine.   Received first dose on 12/28/18 with no problems.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Pain in extremity
Clinical narrative: By the next day arm was hurting.  Patient had no shivers but felt like had the flu--very weak.     12/28/18 Nothing happened.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT WALKED IN STATING ARM WAS SWOLLEN,WARM, AND PAINFUL AT INJECTION SITE. PT DID NOT TAKE ANY PAIN MEDS PRIOR TO WALKING IN REQUESTING TO BE SEE BY PROVIDER. PROVIDER PRESCRIBED HC CREAM, TYLENOL AND KEFLEX.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Decreased appetite, Gait disturbance, Headache, Injection site movement impairment
Clinical narrative: Screaming in pain, fever of 104.7 under the arm, whole body twitching, headache, pain at injection site, dragging leg when attempting to walk, loss of appetite,  constant crying,  waking up crying saying his leg hurts, refusing to walk.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site pain, Muscle twitching, Pain, Pyrexia
Clinical narrative: Screaming in pain, fever of 104.7 under the arm, whole body twitching, headache, pain at injection site, dragging leg when attempting to walk, loss of appetite,  constant crying,  waking up crying saying his leg hurts, refusing to walk.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Injection site rash, Rash erythematous, Urticaria
Clinical narrative: my son got bumps all over his legs right after the injection, within about 20 minutes. they looked like giant swollen bug bites. they then turned bright red and were a little less swollen but still all over his legs. it looks like hives or some sort of allergic reaction. he does not have any food allergies adn eats all sorts of foods, eggs, peanuts, everything .. no problems
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Developed swelling of upper lip within 6 hours of vaccine administration.  Took diphenhydramine 50 mg and went to ED.  Swelling had reduced before could be seen by MD.  Recurred next day and again responded to diphenhydramine.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain, Cough, Decreased appetite, Diarrhoea, Erythema
Clinical narrative: patient reported to Hospital ER 5/19/19 with 101.4 fever diarrhea, cough,  runny nose and not feeding, hx of MMR vacation on  5/16/19 was dx with fever and nasal congestion no labs or tests performed  patient reports to PCP office 5/21/19 for ER f/up stating pt running fever x 5 days highest 103, presents extremely fussy, red faced and diarrhea was dx with fever and abdominal pain
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Full blood count, Irritability, Nasal congestion, Platelet count decreased, Pyrexia
Clinical narrative: patient reported to Hospital ER 5/19/19 with 101.4 fever diarrhea, cough,  runny nose and not feeding, hx of MMR vacation on  5/16/19 was dx with fever and nasal congestion no labs or tests performed  patient reports to PCP office 5/21/19 for ER f/up stating pt running fever x 5 days highest 103, presents extremely fussy, red faced and diarrhea was dx with fever and abdominal pain
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rhinorrhoea
Clinical narrative: patient reported to Hospital ER 5/19/19 with 101.4 fever diarrhea, cough,  runny nose and not feeding, hx of MMR vacation on  5/16/19 was dx with fever and nasal congestion no labs or tests performed  patient reports to PCP office 5/21/19 for ER f/up stating pt running fever x 5 days highest 103, presents extremely fussy, red faced and diarrhea was dx with fever and abdominal pain
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: PATIENT GOT MMR VACCINE ON 05-09-19 AND SHE HAD A FEVER AND BROKE OUT IN A HEAD TO TOE RASH ON 5-20-19.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Tenderness
Clinical narrative: patient describes "after almost one week after vaccine I experienced tenderness in my arm, difficulty lifting, and can rotate shoulder, but cannot reach backward to lift pants."
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: The patient called the pharmacy 5/18/19 reporting a silver dollar sized area over the injection site that was very red, burning and itching.  She tried icing the area and hydrocortisone cream.  On 5-21-19 she came into the pharmacy as the site of irritation had increased in size to about 3x3 inches.  The area was red, had slight raised bumps/rash and warmth.  She was instructed to try benedryl to reduce itching and redness at the site.  There was no nodule/knot/swelling or red streaking at the injection site.  She had no impairment of use of the limb.  She had tried to contact her primary provider regarding the incident, but has been unsuccessful.  She will continue to try to contact him if the antihistamines do not work.  I have planned to follow up with the patient in the next two days to see the results of what we discussed.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: The patient called the pharmacy 5/18/19 reporting a silver dollar sized area over the injection site that was very red, burning and itching.  She tried icing the area and hydrocortisone cream.  On 5-21-19 she came into the pharmacy as the site of irritation had increased in size to about 3x3 inches.  The area was red, had slight raised bumps/rash and warmth.  She was instructed to try benedryl to reduce itching and redness at the site.  There was no nodule/knot/swelling or red streaking at the injection site.  She had no impairment of use of the limb.  She had tried to contact her primary provider regarding the incident, but has been unsuccessful.  She will continue to try to contact him if the antihistamines do not work.  I have planned to follow up with the patient in the next two days to see the results of what we discussed.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Afternoon/evening of the vaccines pt developed urticaria. Mostly concentrated on right buttocks and thigh. Spread to arm and few on trunk and face. Resolved without treatment
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site inflammation, Nausea
Clinical narrative: PT SAID SHE FELT DIZZY AFTER RECEIVING IMZ, THEN SYMPTOMS CONTINUED TO GET WORSE THAT EVENING. SHE HAD SEVERE FATIGUE, NAUSEA AND DIZZINESS.  HAD SOME REDNESS/INFLAMMATION AROUND INJECTION SITE. THESE SYMPTOMS STARTED TO GET A LITTLE BETTER BY THE THIRD DAY, BUT SHE WAS STILL HAVING SOME SYMPTOMS BY SEVENTH DAY (TODAY).
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Fatigue, Feeling abnormal, Immediate post-injection reaction, Myalgia
Clinical narrative: PT SAID SHE FELT DIZZY AFTER RECEIVING IMZ, THEN SYMPTOMS CONTINUED TO GET WORSE THAT EVENING. SHE HAD SEVERE FATIGUE, NAUSEA AND DIZZINESS.  HAD SOME REDNESS/INFLAMMATION AROUND INJECTION SITE. THESE SYMPTOMS STARTED TO GET A LITTLE BETTER BY THE THIRD DAY, BUT SHE WAS STILL HAVING SOME SYMPTOMS BY SEVENTH DAY (TODAY).
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea
Clinical narrative: PT SAID SHE FELT DIZZY AFTER RECEIVING IMZ, THEN SYMPTOMS CONTINUED TO GET WORSE THAT EVENING. SHE HAD SEVERE FATIGUE, NAUSEA AND DIZZINESS.  HAD SOME REDNESS/INFLAMMATION AROUND INJECTION SITE. THESE SYMPTOMS STARTED TO GET A LITTLE BETTER BY THE THIRD DAY, BUT SHE WAS STILL HAVING SOME SYMPTOMS BY SEVENTH DAY (TODAY).
Age: 79.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site pain
Clinical narrative: Long lasting dull left shoulder pain. Received (2) shots. 1- Flu/ 1- Shingles #2. Both shots given in the same left arm, one after the other. I was seated. The RX pharmacist was standing. No warning about side affects getting those (2) shots together. Paperwork did not list duel side affects.  Shingrix 50mcg susr NDC#58160-0819-12 Glaxo Smith Kline Fluad PF 0.5 SUSY 2018-19 NDC#70461-0018-03  Seqirus
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Loss of consciousness, Pallor, Vomiting
Clinical narrative: About 15 min after the vaccines, client passed out as reported by his friend. He was sitting on the floor when I came to him, very pale. Stated his stomach hurt, then had small emesis. Cold pack applied to forehead, moved him to supine position with knees elevated. Stayed with client for about an hour until school resumed. He as feeling better by then, drinking apple juice
Sex: F
Vaccine: UNK
Symptoms: Injection site discomfort, Injection site pain, Injection site swelling
Clinical narrative: injection site pain; injection site swelling; injections site discomfort; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 89-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   In September 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced injection site pain, injection site swelling and injection site discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site discomfort were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling and injection site discomfort to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received her influenza vaccine in September of 2018. The patient reported that after receiving the influenza vaccine, she experienced pain, swelling and discomfort at the injection site. The symptoms began the following day after the vaccination and lasted a couple of days and then resolved. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Lip swelling, Pyrexia, Rash
Clinical narrative: Swelling of lips, rash, fever
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Skin discolouration
Clinical narrative: After receiving vaccines, both legs became itchy, red and swollen. Feet turned purple color. Physician was immediately called to the exam room for assessment and treatment.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Back pain, Chills
Clinical narrative: The effects were numerous, it first felt like flu symptoms, Ache all over, muscle soreness, joint pain, swelling and pain in the injection area.  Extreme weakness with difficulty raising my arms and legs.  Some breathing difficulty when taking deep breaths.  Stomach and back ache, and a severe headache. At first I thought it was the worse case of the flu that I have ever had but although I had chills, I didn't experience any fever or vomiting.  The symptoms lasted for about 48 hours and after that, all the symptoms went away.  I consulted the info that I received with the shingles shot and realized that the symptoms were probably due to the vaccination.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Headache, Influenza, Injection site pain, Mobility decreased
Clinical narrative: The effects were numerous, it first felt like flu symptoms, Ache all over, muscle soreness, joint pain, swelling and pain in the injection area.  Extreme weakness with difficulty raising my arms and legs.  Some breathing difficulty when taking deep breaths.  Stomach and back ache, and a severe headache. At first I thought it was the worse case of the flu that I have ever had but although I had chills, I didn't experience any fever or vomiting.  The symptoms lasted for about 48 hours and after that, all the symptoms went away.  I consulted the info that I received with the shingles shot and realized that the symptoms were probably due to the vaccination.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Swelling
Clinical narrative: The effects were numerous, it first felt like flu symptoms, Ache all over, muscle soreness, joint pain, swelling and pain in the injection area.  Extreme weakness with difficulty raising my arms and legs.  Some breathing difficulty when taking deep breaths.  Stomach and back ache, and a severe headache. At first I thought it was the worse case of the flu that I have ever had but although I had chills, I didn't experience any fever or vomiting.  The symptoms lasted for about 48 hours and after that, all the symptoms went away.  I consulted the info that I received with the shingles shot and realized that the symptoms were probably due to the vaccination.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Patient got a rash around injection site.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Gastrointestinal viral infection, Pyrexia, Vomiting
Clinical narrative: She developed fever (tmax of 101.5) and vomiting on the day of vaccines and so far on the day after. Most likely she picked up a viral GI illness however felt it should be reported.
Age: 54.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Blood glucose increased, Blood pressure increased, Erythema, Pyrexia, Swelling
Clinical narrative: Redness, swelling, fever,  increase in blood pressure and blood glucose
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: LARGE REDNESS ON UPPER LEFT ARM( SITE OF SHINGRIX VACCINATION) AND WARM TO TOUCH WITH SOME ITCHINESS
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Very bad headache, Fever, chills, fatigue, weakness
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain of skin
Clinical narrative: slight nausea, tiredness, fuzzy thinking, headache, very strong shivers first night.  This just after the first day, and still  some fuzzy headedness, and tiredness.  No more shivers. And this is an odd thing... related to the headache -- the roots of my hair or the scalp is sensitive.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Thinking abnormal
Clinical narrative: slight nausea, tiredness, fuzzy thinking, headache, very strong shivers first night.  This just after the first day, and still  some fuzzy headedness, and tiredness.  No more shivers. And this is an odd thing... related to the headache -- the roots of my hair or the scalp is sensitive.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Basophil percentage, Eosinophil percentage, Erythema, Lymphocyte percentage, Monocyte percentage increased
Clinical narrative: 3-4 days after injection patient developed itching and swelling of her whole arm, dark pink - there was no lymphadenitis or axillary lymph node swelling. No fever no chills. White count was 6.6 with 14% monocytes, 54% segs, 30% lymphs
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Neutrophil percentage, Peripheral swelling, Pruritus, White blood cell count normal
Clinical narrative: 3-4 days after injection patient developed itching and swelling of her whole arm, dark pink - there was no lymphadenitis or axillary lymph node swelling. No fever no chills. White count was 6.6 with 14% monocytes, 54% segs, 30% lymphs
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hive like reaction that persisted for 1 week in area below deltoin and above elbow
Age: 1.25
Sex: M
Vaccine: MMR, UNK, UNK, VARCEL
Symptoms: Injection site pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: CHILD SEEN 05/03/2019 FEVER X2 DAYS AFTER VACCINE ADMINISTRATION 4/29/1/2019 T-max - 102.3, RIGHT LEG PAIN, RED RASH ON PT'S CHEST AND ABDOMEN AND RASH HAD SPREAD TO FACE, NECK, ARMS AND LEGS
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Lethargy, Loss of personal independence in daily activities, Malaise
Clinical narrative: Patient states having severe pain in her entire arm, not just the injection site.  She also states extreme lethargy and chills and inability to function normally due to feeling so ill.  I explained mild symptoms are normal, however she maintained that this was an extreme reaction.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient states having severe pain in her entire arm, not just the injection site.  She also states extreme lethargy and chills and inability to function normally due to feeling so ill.  I explained mild symptoms are normal, however she maintained that this was an extreme reaction.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: Patient described achy joints and stiffness, especially after going from sitting to standing.  It started about a day after the vaccine and is still happening (4 days after).  He said it is not usual for him but he feels ok otherwise.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swelling, pain, redness, warm to the touch at injection site.  Observation.  Allergy to drug in contact with skin, this maybe more of a local irritative reaction rather than a true allergy, but should not receive another shingrix injection.  No cellulitis.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness, Pain in extremity
Clinical narrative: vaccine administered on monday may 13, patient called 5-20-19, stating that she began experiencing a burny throat, tingling lips and joint pain on wednesday may 15 and beginning friday may 17 and into saturday may 18 she had dull headache, flu like symptoms and very tired and on monday May 20 when she called the pharmacy she stated that she still was experiencing pain in her left arm from the injection
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral, Throat irritation
Clinical narrative: vaccine administered on monday may 13, patient called 5-20-19, stating that she began experiencing a burny throat, tingling lips and joint pain on wednesday may 15 and beginning friday may 17 and into saturday may 18 she had dull headache, flu like symptoms and very tired and on monday May 20 when she called the pharmacy she stated that she still was experiencing pain in her left arm from the injection
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: 2 episodes of seizures, low grade fever
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin ulcer
Clinical narrative: A couple days after receiving the 2nd dose of shingrix the patient reported having sores on her right buttock.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Headache, Musculoskeletal pain
Clinical narrative: Pain from shoulder down arm, joint pain, chills, bad headache, muscle pain, weakness
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Pain from shoulder down arm, joint pain, chills, bad headache, muscle pain, weakness
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Injected limb mobility decreased, Insomnia, Pain, Pain in extremity
Clinical narrative: Patient reported arm pain after four hours of receiving the vaccine. Advised him he could take Tylenol for the pain if needed. Sister called the next day to question my method of giving vaccine. I reassured her the correct needle length was used. Patient experienced:   Severe("unbearable") arm pain- would not move it as a result   Fever (100.6 degrees F)   Dizziness Patient not able to sleep for a few days as the result of the pain. Started taking naproxen instead of Tylenol on Sunday saw doctor on Monday and said continue with naproxen. Called patient Tuesday and patient said he can now move his arm a little (in other words with bearable pain). Still in pain.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reported arm pain after four hours of receiving the vaccine. Advised him he could take Tylenol for the pain if needed. Sister called the next day to question my method of giving vaccine. I reassured her the correct needle length was used. Patient experienced:   Severe("unbearable") arm pain- would not move it as a result   Fever (100.6 degrees F)   Dizziness Patient not able to sleep for a few days as the result of the pain. Started taking naproxen instead of Tylenol on Sunday saw doctor on Monday and said continue with naproxen. Called patient Tuesday and patient said he can now move his arm a little (in other words with bearable pain). Still in pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Injection site pain, Injection site pruritus, Injection site vesicles
Clinical narrative: The day after getting the vaccine, I was aching all over and just felt lousy, and just wanted to lay around.  My left arm, which I had the shot in, was extremely sore and uncomfortable to even sleep on for the first two days after the shot and then still very sore for at least 4 days as far as touching the site and moving the arm around. About one week to two weeks after the shot, I got two small blisters at the injection site.  They didn't bother me but other than itched a little.  The spots took a coupe of weeks to completely go away.  About a week after the two spots at the injection site appeared, I got two more small spots on my right side near my stomach.  They didn't blister as much as the two on the arm, they were just red and they didn't really bother me at all.  They cleared up within a week or so. I didn't do anything about the areas other than just watch them to be sure they didn't get any worse and tried to not scratch the ones on my arm so that they didn't pop.  I was afraid if they popped, they might make more or get infected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Malaise, Pain, Pain in extremity
Clinical narrative: The day after getting the vaccine, I was aching all over and just felt lousy, and just wanted to lay around.  My left arm, which I had the shot in, was extremely sore and uncomfortable to even sleep on for the first two days after the shot and then still very sore for at least 4 days as far as touching the site and moving the arm around. About one week to two weeks after the shot, I got two small blisters at the injection site.  They didn't bother me but other than itched a little.  The spots took a coupe of weeks to completely go away.  About a week after the two spots at the injection site appeared, I got two more small spots on my right side near my stomach.  They didn't blister as much as the two on the arm, they were just red and they didn't really bother me at all.  They cleared up within a week or so. I didn't do anything about the areas other than just watch them to be sure they didn't get any worse and tried to not scratch the ones on my arm so that they didn't pop.  I was afraid if they popped, they might make more or get infected.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: PAIN AT INJECTION SITE AND IN SHOULDER.  PATIENT STATED SHE WAS SEEN IN AN URGENT CARE CENTER ABOUT 12 HOURS AFTER THE INJECTION.  PATIENT DID NOT HAVE ANY RECORDS AND WAS UNSURE OF WHAT TREATMENT WAS ADMINISTERED AT THE URGENT CARE.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Disorientation, Dizziness, Pallor, Syncope, Visual impairment
Clinical narrative: Patient felt dizzy, vision changed, then she fainted. MA alerted me that she fainted. Patient became alert within 5 seconds/as I was walking back into the exam room. She was disoriented, was re-oriented & became pale & then vomited.  She had some water, a cool compress, she rested & her vitals were re-taken. She was stable. I discussed with her parent. She remained resting & then went back to school
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Vomiting
Clinical narrative: Patient felt dizzy, vision changed, then she fainted. MA alerted me that she fainted. Patient became alert within 5 seconds/as I was walking back into the exam room. She was disoriented, was re-oriented & became pale & then vomited.  She had some water, a cool compress, she rested & her vitals were re-taken. She was stable. I discussed with her parent. She remained resting & then went back to school
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Ecchymosis, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Neuropathy peripheral
Clinical narrative: Localized swelling, ecchymosis. Pain medial RUE/Detoid with swelling into (R) axillary and (R) anterior chest. Decreased ROM, neuropathic symptoms numbness extending down (R) arm.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Swelling, Ultrasound scan
Clinical narrative: Localized swelling, ecchymosis. Pain medial RUE/Detoid with swelling into (R) axillary and (R) anterior chest. Decreased ROM, neuropathic symptoms numbness extending down (R) arm.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, UNK
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: INJECTION SITE REACTION TO PREVNAR. PATIENT HAS A DIME SIZE PINKISH RED SPOT WITH A QUARTER SIZE KNOT UNDERNEATH AT INJECTION SITE. REACTION STARTED ON 10/16/07 AND STILL PRESENT ON 10/18/07 IN OFFICE.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5, UNK
Symptoms: Diarrhoea, Stool analysis, Vomiting
Clinical narrative: DIARRHEA UP TO 11 TIMES 3 DAYS AFTER VACCINES YESTERDAY 10/17/07 DIARRHEA X 6 VOMITING    TREATMENT: PEDIALYTE , DOWN JUICES
Age: 0.33
Sex: F
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: wrong drug administered; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act, concerning a 4-month-old female patient. The patient's historical condition was not reported. Current illness included bronchiolitis.  On 29-SEP-2017, the patient was scheduled to receive unspecified Haemophilus influenzae type b (HIB) vaccine (manufacturer unknown), but by mistake was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in the right leg, lot number N018273, expiration date 17-JUN-2019 (exact dose was not provided). It was reported that the patient's mom was notified of error by Dr.  Other medications included ranitidine and budesonide (PULMICORT). There were no lab diagnostic data provided.   The outcome of event was unknown.  Follow up information has been received from a healthcare professional on 25-FEB-2019.  The report refers to the patient.  The patient's concomitant therapy included second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), second dose of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13), second dose of hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (PENTACEL).  Follow up information was received from the health care professional on 16-MAY-2019.  The patient's birth weight was of 9lbs/0.3ozs and she had one brother.  The dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered in the patient's right thigh and it was reported that treatment was not required for the event.
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Injection site pain, Pain
Clinical narrative: pain in her arm where she was administered Gardasil 9; This spontaneous report was received from a physician and refers to a 10 years old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-DEC-2018, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (frequency, lot # and expiration date were not reported) for prevention of HPV.  On 01-DEC-2018, the patient experienced pain in her arm, where she was administered the vaccine. The reporter informed that the patient continued to complain about pain in her arm (date unspecified). The patient was seen by the physician on 29-APR-2019. It was reported that the patient received the treatment for the event.  The outcome of the event was reported as not recovered. The causality assessment was not provided by the reporter.
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Complex regional pain syndrome, Injection site pain
Clinical narrative: pain in her arm where she was administered Gardasil 9; This spontaneous report was received from a physician and refers to a 10 years old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-DEC-2018, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (frequency, lot # and expiration date were not reported) for prevention of HPV.  On 01-DEC-2018, the patient experienced pain in her arm, where she was administered the vaccine. The reporter informed that the patient continued to complain about pain in her arm (date unspecified). The patient was seen by the physician on 29-APR-2019. It was reported that the patient received the treatment for the event.  The outcome of the event was reported as not recovered. The causality assessment was not provided by the reporter.
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Injection site pain
Clinical narrative: pain in her arm where she was administered Gardasil 9; This spontaneous report was received from a physician and refers to a 10 years old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-DEC-2018, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (frequency, lot # and expiration date were not reported) for prevention of HPV.  On 01-DEC-2018, the patient experienced pain in her arm, where she was administered the vaccine. The reporter informed that the patient continued to complain about pain in her arm (date unspecified). The patient was seen by the physician on 29-APR-2019. It was reported that the patient received the treatment for the event.  The outcome of the event was reported as not recovered. The causality assessment was not provided by the reporter.
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Adacel was inadvertently given to patient/ no AE; Initial information received on 13-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is related to case- 2019SA136941 same reporter.  This case involves a 32 years old male patient received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history and family history were not provided. concomitant medication was not received.   On 05-May-2019, the patient received a Booster dose 0.5ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5656AA, expiry date 02-May-2019 via intramuscular route in the right deltoid.  It was an actual medication error due to expired vaccine used.  It was reported that expired dose of Adacel was inadvertently given to patient.  The patient did not experience any adverse reaction after the injection.   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 and Module VI of the 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.  List of documents held by sender- none.
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Adacel was inadvertently given to patient/ no AE; Initial information received on 13-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is related to case- 2019SA136941 same reporter.  This case involves a 32 years old male patient received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history and family history were not provided. concomitant medication was not received.   On 05-May-2019, the patient received a Booster dose 0.5ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5656AA, expiry date 02-May-2019 via intramuscular route in the right deltoid.  It was an actual medication error due to expired vaccine used.  It was reported that expired dose of Adacel was inadvertently given to patient.  The patient did not experience any adverse reaction after the injection.   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 and Module VI of the 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.  List of documents held by sender- none.