chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Headache, Heart rate increased, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient, from Pfizer Sponsored Program. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and ongoing. The patient's concomitant medications were not reported. On an unknown date, the patient experienced pneumonia, rapid heartbeat, short of breath, and headache. The clinical course was as follows: The patient received the vaccine and had a reaction which was clarified as a rapid heartbeat and short of breath. She had COPD and was not sure if the shortness of breath was related to receiving the vaccine or COPD. She also had a headache. She had pneumonia for a while. The clinical outcome of the pneumonia was recovered on an unknown date after about 2 weeks. The clinical outcomes of rapid heartbeat, short of breath, and headache were not recovered. The batch/lot numbers for the vaccine, pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), were not provided and will be requested during follow up.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 69-year-old female patient started to receive PREVNAR 13; (lot number X30160 and expiration date Sep2020), via an unspecified route of administration on an unspecified date at 0.5 ml, single on the deltoid muscle of left arm for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm had red circle and pain for 3 weeks. The patient never had problems with other vaccines in the past. Outcome of the events was recovered on an unspecified date.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 19 October 2015. This case involves a 26-year-old female patient who was vaccinated intramuscularly with a dose of FLUZONE QIV (batch number UI443AA, Expiry date 30 June 2016, dose and dose in series was not reported) in right deltoid on 18 October 2015. Illness at time of vaccination was unknown and Pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. On 18 October 2015, same day following the vaccination, the patient experienced pain in arm and injection site was red, warm and sore. Lab data and corrective treatments were not reported. The patient was not recovered from events. List of documents held by sender: none. Follow-up information received from a pharmacist on 27 January 2016. It was reported that the patient did not receive any vaccination within 4 weeks prior to 18 October 2015. Adverse events following prior vaccination was reported none. On an unspecified date within few days the patient recovered. No additional information was received. Follow-up information was received from a pharmacist on 12-Feb-2019. Patient age was reported as 52 years. Patient was vaccinated with one time dose (also reported as 0.5 mg) of FLUZONE QIV (batch number: UJ040AA and expiry date 12 June 2019) via intravenous route. It was a case of actual medication error due to inappropriate route of vaccination because the vaccine was administered via intravenous route. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow-up information received from a pharmacist on 13-Feb-2019. No new information was received. Documents held by the sender: none.
Sex: F
Vaccine: FLU4, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 01-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 22 months old female patient who received 0.25 ml dose of vaccine FLUZONE QUADRIVALENT (batch number: UT6315PA, expiry date: 30-Jun-2019) 14 hours after a needle was placed. The patient's past vaccination(s) included Flu vaccine (INFLUENZA VACCINE) in SEP-2017 and FLU Vaccine (INFLUENZA VACCINE) in DEC-2017. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant vaccination included a dose of Hepatitis A vaccine in right thigh. It was case of actual medication error due to incorrect product storage. It was reported that Prefilled syringe that tip cap had been removed & needle attached was given the next day after it had been accessed and placed back in the fridge overnight. Nurse reports that FLUZONE QUADRIVALENT 0.25 ml tip cap was removed and needle attached at the end of the day but the patient did not come in as scheduled. When she arrived the next day the same syringe was used for vaccination. No side effects were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chills, Erythema, Flushing, Headache, Pain
Clinical narrative: Initial information received on 01-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves female patient (unknown age) who experienced body aches, cheeks were red and flushed, rash on her face, headache, fever and chills, while she received vaccines MENACTRA and TRUMENBA. The patient's past vaccination(s) included MENACTRA in DEC-2006 without a reaction. The patient's past medical history, medical treatment(s) and family history were not provided. On 16-Aug-2017, the patient received a second 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5567CA via intramuscular route in the left arm. On 16-Aug-2017, the patient received a 0.5 ml dose of suspect TRUMENBA lot S26985 via intramuscular route in the right arm. On an unknown date, the patient developed a non-serious body aches, cheeks were red and flushed, rash on her face, headache, fever and chills few hours following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. (Other relevant tests included no lab data.) Final diagnosis was chills, fever, headache, rash, flushing and pain. It was not reported if the patient received a corrective treatment. The patient recovered from chills, fever, headache, rash, flushing and pain the next day. List of documents held by sender: none.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pyrexia, Rash
Clinical narrative: Initial information received on 01-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves female patient (unknown age) who experienced body aches, cheeks were red and flushed, rash on her face, headache, fever and chills, while she received vaccines MENACTRA and TRUMENBA. The patient's past vaccination(s) included MENACTRA in DEC-2006 without a reaction. The patient's past medical history, medical treatment(s) and family history were not provided. On 16-Aug-2017, the patient received a second 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5567CA via intramuscular route in the left arm. On 16-Aug-2017, the patient received a 0.5 ml dose of suspect TRUMENBA lot S26985 via intramuscular route in the right arm. On an unknown date, the patient developed a non-serious body aches, cheeks were red and flushed, rash on her face, headache, fever and chills few hours following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. (Other relevant tests included no lab data.) Final diagnosis was chills, fever, headache, rash, flushing and pain. It was not reported if the patient received a corrective treatment. The patient recovered from chills, fever, headache, rash, flushing and pain the next day. List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves Adult female patient who was administered with only the diluent of PENTACEL without mixing it with the ACTHIB diluent. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route. It was a case of actual medication error due to Inappropriate reconstitution technique. It was unknown whether adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction
Clinical narrative: Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 68 years old female patient who experienced dried liquid at the injection site, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines was received. On 31-Jan-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5872AA via intramuscular route in the deltoid nos. On an unknown date, the patient developed a non-serious dried liquid at the injection site following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. No lab test reported. Final diagnosis was dried liquid at the injection site. No corrective treatment received. The patient outcome is reported as Unknown for dried liquid at the injection site.
Sex: F
Vaccine: DTAPIPV, PNC13, RVX
Symptoms: Product preparation issue, Product storage error
Clinical narrative: Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a non-health care professional (other). This case involves a 5 months old female patient who received vaccine PENTACEL. The patients past medical history and family history were not provided. Concomitant medications included PREVNAR 13 and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE). On 04-Feb-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5427BA, expiry date 31-Oct-2019 via intramuscular route in the right thigh. The DTap/IPV Lot: C5427BA, Expiration Date: 13Oct2019, ACTHIB Lot: C5575AA, Expiration Date: 13Oct2019. PENTACEL Box Lot: C5575AA, Expiration Date: 13Oct2019. It was an actual medication error due to inappropriate reconstitution technique and incorrect product storage. It was reported that patient was given today the DTaP/IPV and not the ActHIB. The ACTHIB was left out an hour. Cumulative excursions up to 72 hours at 46 degree F through 77 degree F (8.1 degree C through 25 degree C). Half of the Pentacel, the liquid portion, was administered It was unknown whether patient experienced 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old male patient who received a dose of vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included first dose of FLUARIX on 18-DEC-2018 and the baby was unwell. The patient's past medical history, medical treatment(s) and family history were not provided. On 28-Dec-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ088AB via intramuscular route in the left thigh. It was a case of actual medication error due to inappropriate schedule of vaccine administered as the patient received a first dose of FLUARIX 0.5ml on 18-Dec-2018 and FLUZONE QUAD on 28-Dec-2018 (within 4 weeks apart). It was not reported if the patient experienced any event after the administration of FLUZONE QUADRIVALENT. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient who was less than 65 years old (of an unknown age and gender), received vaccine FLUZONE HIGH DOSE (lot number, expiry date, dose, dose in series not reported) via unknown route in unknown administration site) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 70 years old female patient who experienced itching at the site of injection, while she received vaccines B12-VITAMIIN and FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left arm. On an unknown date, the patient received a dose of suspect B12-VITAMIIN not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious itching at the site of injection (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and B12-VITAMIIN. (Other relevant tests included No lab data). Final diagnosis was itching at the site of injection. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of document held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves three patients who were vaccinated with 1.0 ml dose instead of 0.5 ml dose of FLUZONE (lot: UJ005AE, expiry date: 30-Jun-2019) via unknown route in unknown administration site, on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to vaccine overdose. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 67.0
Sex: U
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 67 years old patient who was vaccinated with an expired dose of TENIVAC (lot: U5525AA, expiry date: 07-Jan-2019) in the left arm on 03-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expired vaccine used. It was reported that the patient came for an abrasion on her right arm and received an expired dose of TENIVAC. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Gait inability, Guillain-Barre syndrome, Nerve compression, Paralysis, Sensory loss
Clinical narrative: This is a serious spontaneous case initially received from other health professional on 07-Feb-2019, concerning a 27-year-old, adult female patient. On an unspecified date in Sep-2017, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On an unspecified date in Sep-2017, eight hours after vaccination, the patient lost feeling in one of her legs which doctor had put down to a pinched nerve from her time in the gym. On an unspecified date in Sep-2018, 3 days later, the patient was unable to walk. The patient was left paralysed from the waist down. The patient was taken to the hospital and was finally diagnosed with Guillain-Barre Syndrome (GBS). The outcome of the event was not reported.; Reporter's Comments: A 27-year-old, female patient experienced lost feeling in one of her legs, 8 hours after administration of INN Flu Vaccine which was finally diagnosed as Guillain-Barre Syndrome. The case meets level 4 of Brighton Collaboration criteria of diagnostic certainty. Considering the plausible temporal relationship between vaccination and reported event, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the event of Guillain-Barre Syndrome as possibly related to suspect vaccine. The event of pinched nerve was assessed as not related to suspect vaccine as the clinical course suggests that the reported time in the gym as a more plausible explanation for the event. The company assessed the case as serious (medically significant).
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Hypersomnia
Clinical narrative: Within 3 hours I had chills and fever, fatigue, no appetite, slept for 14 hours one day this lasted 2 days and it was probably a week before I got my energy back and my stopped aching I could not stop shaking with the chills even with many blankets on. My temperature went up to 103 this has been happening since I have had to take the 65 and over vaccine  (about 3 or 4 years) before that no problem with the flue vaccine.
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Within 3 hours I had chills and fever, fatigue, no appetite, slept for 14 hours one day this lasted 2 days and it was probably a week before I got my energy back and my stopped aching I could not stop shaking with the chills even with many blankets on. My temperature went up to 103 this has been happening since I have had to take the 65 and over vaccine  (about 3 or 4 years) before that no problem with the flue vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Pain at injection site, headache, muscle aching, all joints aching, fever, felt like hit by a truck started 11 pm at night. Woke up 5 am 2/19/19  with severe headache, fever, aching  took 2 advil and  had sweats and by 2 pm 2/19/19 finally symptoms had resolved.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Pain at injection site, headache, muscle aching, all joints aching, fever, felt like hit by a truck started 11 pm at night. Woke up 5 am 2/19/19  with severe headache, fever, aching  took 2 advil and  had sweats and by 2 pm 2/19/19 finally symptoms had resolved.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUX, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Pt came for doctor's office visit for routine well care check on 2/8/19. 4 yo vaccines administered per routine. KINRIX, MMRV and flu administered. Pt tolerated well post vaccination. KINRIX administered in Right deltoid, MMRV administered LUOA, Flu vaccine administered Left deltoid. Pt complained of Right arm redness, swelling 2/10/19 and was taken to ED on 2/11/19 by mother. During ED visit pt dx with cellulitis and BACTRIM prescribed. Pt seen for f/u by PCP on 2/15/19 with resolution of cellulitis but still completing 2-3 days more of BACTRIM.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR
Symptoms: Injection site erythema, Urticaria
Clinical narrative: After receiving vaccines, redness noted to right arm and hives noted on the knees. Mom stated that she had this reaction at 12 months of age after receiving MMR, Varicella and Hep. A vaccines. A red streak was noted in leg that she received the MMR vaccine in. After the redness and hives noted with vaccines given  02/18/2019, Benadryl was given. No distress noted.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Irritability
Clinical narrative: PT WAS VERRY FUSSY ALL DAY, PER MOM. LATER THAT DAY PT HAD A BM WITH BLOOD IN STOOL. MOM STATES PT WAS NOT FUSSY AFTER BM.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Induration, Pyrexia, Rash pruritic
Clinical narrative: Itching rash and indurated; 2x3cm on left arm. Also fever.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Pain
Clinical narrative: "About 4 hours after the vaccine I felt fuzzy headed, flu like and body aches."
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Ear pruritus, Lip pruritus, Lip swelling, Urticaria
Clinical narrative: Itchy ears and lips are swelling and itchy. Hives. Was rec for loratidine for 5 days. IF not helping by 3 PM, then would use steroids. Prednisone 40 mg /d for 5 d.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Injection site pain, Mobility decreased, Pain
Clinical narrative: Pain at location of shot - unable to move arm on day of shot. Day 2 fever of 101.3, chills, body aches, and extreme fatigue with pain at shot location. Day 3 still severe pain in arm with limited use, fatigue. Same reaction to first series of shot, but thought it was due to flu shot last time.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pain at location of shot - unable to move arm on day of shot. Day 2 fever of 101.3, chills, body aches, and extreme fatigue with pain at shot location. Day 3 still severe pain in arm with limited use, fatigue. Same reaction to first series of shot, but thought it was due to flu shot last time.
Age: 9.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt presented to office for a nurse visit with a school form vaccine checklist indicating he was due for DTaP, IPV, Hep B, MMR, and Varicella. The other MA and myself did not catch that the pt was too old to receive a DTaP. The CDC indicates that the DTaP can count as a TDaP in this case, and re-vaccination is not necessary.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Skin warm, Tenderness
Clinical narrative: Redness, warmth, and tenderness to the L) posterior arm, as per the patient in message and photograph to clinic. Unknown start time. Recommended cold compress to the area for discomfort and to be evaluated if the area or discomfort increased.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Vaccination site pain, X-ray limb normal
Clinical narrative: Right arm in area of vaccination has hurt since it was done but no visible marks or masses or bruising on arm and arm is fully functional, arm can hurt resting and with movement.
Sex: U
Vaccine: PNC13
Symptoms: Crohn's disease
Clinical narrative: This is a spontaneous report from a contactable consumer (physician assistant) received from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced crohn's disease on an unspecified date. It was reported that patient with Crohn's disease had pneumococcal 13-val conj vac (dipht crm197 protein) shot as a child and at time of report patient was adult and wanted to know the protocol, asking if patient should get shot again since the patient is an adult. The outcome of event crohn's disease was unknown.
Sex: M
Vaccine: PNC13
Symptoms: Ankle fracture, Lower limb fracture
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program Pfizer RXPathways, received from a contactable consumer (patient's friend). An 81-year-old male patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient broke his ankle and his leg on an unspecified date. The patient's friend stated that the patient is in like a board and care because of the events. The outcome of the events was unknown. The information on the lot number and expiration date had been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Injection site pain, Muscle spasms, Pain, Pain in extremity
Clinical narrative: Shoulder pain in right arm start after the shot, pain start in left arm and leg a week later, then followed by entire body pain and severe leg cramps. Patient still has shoulder pain , but no more leg pain. Had blood workups which showed no problems with any disease.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Culture, Parvovirus B19 test negative, Rash, Streptococcus test negative
Clinical narrative: Patient present to clinic 24 hours after receiving vaccinations with rash on left arm, rash also on right side of neck, wrapped around the back of the neck and also the front of the neck.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Dyspnoea, Headache
Clinical narrative: Shivering, extreme muscle ache in entire body; ankles, knees, hips, arms, shoulders, difficulty walking 3-4 hours. Redness in arm where vaccine was given with soreness for 3-4 days. Stomach pain, nausea, headache, shortness of breath and sore throat for approximately 24-36 hours. This was the second vaccine and I had the same symptoms with the first without the shortness of breath, so I knew it would eventually go away. I received the first vaccine on October 19, 2018 at the same Pharmacy.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Musculoskeletal pain, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: Shivering, extreme muscle ache in entire body; ankles, knees, hips, arms, shoulders, difficulty walking 3-4 hours. Redness in arm where vaccine was given with soreness for 3-4 days. Stomach pain, nausea, headache, shortness of breath and sore throat for approximately 24-36 hours. This was the second vaccine and I had the same symptoms with the first without the shortness of breath, so I knew it would eventually go away. I received the first vaccine on October 19, 2018 at the same Pharmacy.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Shivering, extreme muscle ache in entire body; ankles, knees, hips, arms, shoulders, difficulty walking 3-4 hours. Redness in arm where vaccine was given with soreness for 3-4 days. Stomach pain, nausea, headache, shortness of breath and sore throat for approximately 24-36 hours. This was the second vaccine and I had the same symptoms with the first without the shortness of breath, so I knew it would eventually go away. I received the first vaccine on October 19, 2018 at the same Pharmacy.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blood cholesterol increased, Blood triglycerides normal, Chest X-ray normal, Chest discomfort
Clinical narrative: Shivering, extreme muscle ache in entire body; ankles, knees, hips, arms, shoulders, difficulty walking 3-4 hours. Redness in arm where vaccine was given with soreness for 3-4 days. Stomach pain, nausea, headache, shortness of breath and sore throat for approximately 24-36 hours. This was the second vaccine and I had the same symptoms with the first without the shortness of breath, so I knew it would eventually go away. I received the first vaccine on October 19, 2018 at the same Pharmacy.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dyspepsia, Dyspnoea, Electrocardiogram normal, High density lipoprotein normal
Clinical narrative: Shivering, extreme muscle ache in entire body; ankles, knees, hips, arms, shoulders, difficulty walking 3-4 hours. Redness in arm where vaccine was given with soreness for 3-4 days. Stomach pain, nausea, headache, shortness of breath and sore throat for approximately 24-36 hours. This was the second vaccine and I had the same symptoms with the first without the shortness of breath, so I knew it would eventually go away. I received the first vaccine on October 19, 2018 at the same Pharmacy.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Low density lipoprotein normal, Myalgia, Nausea, Rash, Total cholesterol/HDL ratio normal
Clinical narrative: Shivering, extreme muscle ache in entire body; ankles, knees, hips, arms, shoulders, difficulty walking 3-4 hours. Redness in arm where vaccine was given with soreness for 3-4 days. Stomach pain, nausea, headache, shortness of breath and sore throat for approximately 24-36 hours. This was the second vaccine and I had the same symptoms with the first without the shortness of breath, so I knew it would eventually go away. I received the first vaccine on October 19, 2018 at the same Pharmacy.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tremor, Very low density lipoprotein normal
Clinical narrative: Shivering, extreme muscle ache in entire body; ankles, knees, hips, arms, shoulders, difficulty walking 3-4 hours. Redness in arm where vaccine was given with soreness for 3-4 days. Stomach pain, nausea, headache, shortness of breath and sore throat for approximately 24-36 hours. This was the second vaccine and I had the same symptoms with the first without the shortness of breath, so I knew it would eventually go away. I received the first vaccine on October 19, 2018 at the same Pharmacy.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Gastrointestinal disorder, Influenza like illness, Injection site pain, Pain, Pain in extremity
Clinical narrative: Pain at injection site in three hours of shot. Pain moving arm 5 hours after shot. 14 hours after shot assorted body aches and tummy issues. Felt almost like flu symptoms.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received a booster vaccination for his meningococcal too early. Confirmed with CDC that no harm should be to come to patient.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation
Clinical narrative: Patient's left arm is red and inflamed (1 inch diameter, 1 inch below injection site). BAND AID removed today.
Age: 20.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effect. Tdap 0.5 mL was ordered but 0.5 mL of DtaP was administered.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: Large raised welt about 5-6 inches in size, warm to the touch. lasted for 3-5 days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Back pain, Dizziness, Headache, Myalgia
Clinical narrative: Pain down left arm to fingers, upset stomach, headache, muscle pain in back and neck, dizzy spells.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain down left arm to fingers, upset stomach, headache, muscle pain in back and neck, dizzy spells.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, chills, muscle ache, fatigue.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash, Rash pruritic
Clinical narrative: Patient reported a rash that started on the opposite arm from the vaccination (right arm) 2 days after receiving the vaccine. The rash then showed up on the arm where she received the vaccine 3 days after receiving the vaccine. It was slightly itchy, but not warm to the touch, and not painful. It didn't interrupt her sleep. It was in the elbow area of her arm.
Age: 38.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects, just reporting incident.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Joint range of motion decreased, Pain, Product administered at inappropriate site
Clinical narrative: During injection of flu immunization (IM) on 03DEC2018, administrating employee placed the needle too high on the shoulder possibly affecting the joint instead of the muscle. Patient was in pain initially and still sore weeks after the incident. NSAIDS were prescribed for pain, and physical therapy for physical strength/range of motion.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: PT HAD A RASH ON RIGHT ARM WHERE INJECTION SITE WAS, IT WAS WARM TO THE TOUCH.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site discolouration, Injection site erythema
Clinical narrative: NO ADVERSE EVENT FOR 2 DAYS THEN ARM BECAME RED AT INJECTION SITE WITH WHITE SPOT IN CENTER. PATIENT STATES THAT ARM BURNED WHEN LAYING ON IT. STILL RED NOW BUT NOT AS BAD AS PREVIOUSLY.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Infection, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient presented to pharmacy 2/19/19 to get a prescription for an antibiotic filled and stated it was to treat an infection from the vaccine. Patient reported that he had redness, swelling, and pain in his arm and couldn't raise his arm above his shoulder.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Arthritis, Chiropractic, Gait inability, Immobile
Clinical narrative: Arm was sore and went away in a few days. Pain, stiffness and immobility started at the hips 9 days after vaccine, could not walk. Also, had pain at base of skull and neck started at same time (as the hip pain), pain still exists and is minimal depending on treatment. Arthritis on all fingers starting Dec. 31st, which lasted about a week. Left index palm knuckle formed a knot after the end of January in which pain still exists with touch. Patient did not see a physician with symptoms however she did see a chiropractor due to the fact that the symptoms were arthritic, patient tried TYLENOL, ibuprofen, which did not ease the pain, naproxen did help with pain and stiffness. Patient used hot tub morning and night, heated massage unit, emu oil rub, TIGER BALM. Chiropractor did adjustments and electrical stimulation.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Joint stiffness, Neck pain, Nodule, Pain in extremity, Tenderness
Clinical narrative: Arm was sore and went away in a few days. Pain, stiffness and immobility started at the hips 9 days after vaccine, could not walk. Also, had pain at base of skull and neck started at same time (as the hip pain), pain still exists and is minimal depending on treatment. Arthritis on all fingers starting Dec. 31st, which lasted about a week. Left index palm knuckle formed a knot after the end of January in which pain still exists with touch. Patient did not see a physician with symptoms however she did see a chiropractor due to the fact that the symptoms were arthritic, patient tried TYLENOL, ibuprofen, which did not ease the pain, naproxen did help with pain and stiffness. Patient used hot tub morning and night, heated massage unit, emu oil rub, TIGER BALM. Chiropractor did adjustments and electrical stimulation.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chest X-ray normal, Chills, Cough, Culture urine negative
Clinical narrative: Within about 4 hours started feeling fatigue, then chills. By 8 PM significant joint pain, chills, and fever near 101. The following day was continued joint pain, headache which lasted approximately 36 hours, with continued chills and fever. By day 2, joint pain and aches were gone as well as the headache, but afternoon fatigue and evening fever continued, over 100 but less than before. By day 3 there was no morning fever or aches, but afternoon fatigue returned. Fever returned approximately 8 PM and went higher than initially after the shot. It reached as high as 102.4 before falling. At that point, I was worried I had something else such as the flu or pneumonia. I made a doctor appointment for day 4. In the morning, fever was gone. I had what felt more like a bad cold with a cough by then. I was swabbed for flu which was negative. I had a chest x-ray which ruled out pneumonia, as well as blood work and urinalysis, all negative. All the symptoms were apparently from the vaccine. The fever has not returned. I missed 3 days of work from a vaccine taken on a Saturday morning.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Full blood count normal, Headache, Impaired work ability, Influenza A virus test negative
Clinical narrative: Within about 4 hours started feeling fatigue, then chills. By 8 PM significant joint pain, chills, and fever near 101. The following day was continued joint pain, headache which lasted approximately 36 hours, with continued chills and fever. By day 2, joint pain and aches were gone as well as the headache, but afternoon fatigue and evening fever continued, over 100 but less than before. By day 3 there was no morning fever or aches, but afternoon fatigue returned. Fever returned approximately 8 PM and went higher than initially after the shot. It reached as high as 102.4 before falling. At that point, I was worried I had something else such as the flu or pneumonia. I made a doctor appointment for day 4. In the morning, fever was gone. I had what felt more like a bad cold with a cough by then. I was swabbed for flu which was negative. I had a chest x-ray which ruled out pneumonia, as well as blood work and urinalysis, all negative. All the symptoms were apparently from the vaccine. The fever has not returned. I missed 3 days of work from a vaccine taken on a Saturday morning.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza B virus test, Influenza virus test negative, Metabolic function test normal, Nasopharyngitis, Pyrexia
Clinical narrative: Within about 4 hours started feeling fatigue, then chills. By 8 PM significant joint pain, chills, and fever near 101. The following day was continued joint pain, headache which lasted approximately 36 hours, with continued chills and fever. By day 2, joint pain and aches were gone as well as the headache, but afternoon fatigue and evening fever continued, over 100 but less than before. By day 3 there was no morning fever or aches, but afternoon fatigue returned. Fever returned approximately 8 PM and went higher than initially after the shot. It reached as high as 102.4 before falling. At that point, I was worried I had something else such as the flu or pneumonia. I made a doctor appointment for day 4. In the morning, fever was gone. I had what felt more like a bad cold with a cough by then. I was swabbed for flu which was negative. I had a chest x-ray which ruled out pneumonia, as well as blood work and urinalysis, all negative. All the symptoms were apparently from the vaccine. The fever has not returned. I missed 3 days of work from a vaccine taken on a Saturday morning.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Urine analysis normal
Clinical narrative: Within about 4 hours started feeling fatigue, then chills. By 8 PM significant joint pain, chills, and fever near 101. The following day was continued joint pain, headache which lasted approximately 36 hours, with continued chills and fever. By day 2, joint pain and aches were gone as well as the headache, but afternoon fatigue and evening fever continued, over 100 but less than before. By day 3 there was no morning fever or aches, but afternoon fatigue returned. Fever returned approximately 8 PM and went higher than initially after the shot. It reached as high as 102.4 before falling. At that point, I was worried I had something else such as the flu or pneumonia. I made a doctor appointment for day 4. In the morning, fever was gone. I had what felt more like a bad cold with a cough by then. I was swabbed for flu which was negative. I had a chest x-ray which ruled out pneumonia, as well as blood work and urinalysis, all negative. All the symptoms were apparently from the vaccine. The fever has not returned. I missed 3 days of work from a vaccine taken on a Saturday morning.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu-like symptoms: body aches, shivering and shaking (unable to stop the shaking), headache, general malaise, tired, weak x 2 days, then improved symptoms on day 3, then felt better, although still a bit weak and tired from being so ill for 2-3 days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Tremor
Clinical narrative: Flu-like symptoms: body aches, shivering and shaking (unable to stop the shaking), headache, general malaise, tired, weak x 2 days, then improved symptoms on day 3, then felt better, although still a bit weak and tired from being so ill for 2-3 days.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Pain, Pain in extremity
Clinical narrative: I am just reporting that I experienced mild flu like symptoms the day after my 1st dose of the shingles vaccine. I got it at a pharmacy. I had a fairly sore arm with a red spot about 3 inches across at the injection site. I had mild chills and body ache like I was getting the flu. By Tues I am feeling ok, but still have a faded red spot around the site. I am fine and plan to get the second shot in a few months, but I just wanted to report this. I am an otherwise very healthy person and jog about 20 miles a week.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling cold, Headache, Influenza, Pain
Clinical narrative: Flu symptoms - very bad headache, low low energy, aches, felt cold.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Blood glucose normal, Crying, Musculoskeletal stiffness
Clinical narrative: 5 YO female had a physical exam within normal limit, received 4 YO vaccines KINRIX, PROQUAD, Influenza, 3 minutes after vaccines were given the mom called out for help and the patient was on the floor with arm stiffness and then crying. Lock rolled patient to left side, checked pupils they were equal react to light briskly. Patient was moved to an exam table. Patient was breathing spontaneously with no distress. Pulse oximetry showed Pulse 98, BP: 130/91 Glucose via finger stick was 98. Patient was responsive neuro checks at baseline, paramedics were called. Patient was continuously monitored until paramedics arrived. Mother was informed and updated. Parents were advised to have the paramedics take the patient to ED for further evaluation. The father refused and wanted to take the patient home. Father and Mother were both advised on seeking immediate medical care if further signs of seizure or altered neuro status.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Dyspnoea, Gait inability, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Blurred vision; mussel weakness (unable to walk); problems breathing, swallowing, talking.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Speech disorder, Vision blurred
Clinical narrative: Blurred vision; mussel weakness (unable to walk); problems breathing, swallowing, talking.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Dry mouth, Fatigue, Headache, Pain
Clinical narrative: I went to pharmacy to get my yearly flu shot for work. As I left the store I felt head-achy and slightly light headed. On my drive home the head ache got worse and body aches developed. By the time I got home (about 20 min.after the vaccine) I felt feverish and fatigued. I did not take my temperature because i could not find the thermometer. As I looked for the thermometer I noticed I had hives on my arms and chest. later that afternoon I noticed my eyes were puffy and a numb/dry mouth sensation so I took Benadryl. The next day the Hives and puffiness were gone. I took my vaccine confirmation to work. The Nurse practitioner on site suggested that I file a Vaers report.