chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.92
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PPV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 01-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 21 months old male patient who was inadvertently vaccinated with an expired dose of PENTACEL (DTaP portion lot number: C5262AA, expiry date: 18-Dec-2018, ACT-HIB portion lot number: C5456AA, expiry date: 18-Dec-2018, via intramuscular route in unknown administration site on 18-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PVC 13) for Immunisation. It is an actual medication error case due to expired vaccine used. It was unknown whether the patient had any adverse event or not. 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: 70.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Headache
Clinical narrative: SMALL HEADACHE, SLIGHTLY DIZZY.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Cardiac function test normal, Chest pain, Chills, Electrocardiogram normal, Hyperventilation
Clinical narrative: Chest pain acutely with chills - started on the evening of 02/27/2019 and went into the morning of 02/28/2019 - vitals signs were obtained and were in within normal limits.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Laboratory test normal, X-ray normal
Clinical narrative: Chest pain acutely with chills - started on the evening of 02/27/2019 and went into the morning of 02/28/2019 - vitals signs were obtained and were in within normal limits.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Large red/hard/warm area at site of flu vaccine injection - redness nearly to elbow.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness and swelling around site--started same day, lasted 4 days ever/headache/nausea/fatigue--started next day, only lasted one day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Pain, redness and swelling around site--started same day, lasted 4 days ever/headache/nausea/fatigue--started next day, only lasted one day.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Facial paralysis
Clinical narrative: Bells palsey.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: On March 1st at 10.30 AM Patient called to say he was experiencing dizziness and wondered if it was from the vaccine. Patient was told to come to Walk in for check. Patient came to the walk in clinic that afternoon. Provider reviewed side effects with patient where 1% may feel dizziness. Patient acknowledged and understood that should he have worsening or additional symptoms to seek care at the ER.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Just like having the flu, persistent.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, VARCEL
Symptoms: Arthropod bite, Erythema, Haemorrhage, Secretion discharge, Swelling
Clinical narrative: Began 2/28/19-Redness approx. size of quarter. Not hot, some swelling, no fever. Parameters marked. Tender to touch, ice helps. Called urgent care 3/1/19. Recommended ER but ER said to watch not come. Gave BENADRYL, Tyl/Ibu. Came to head and patient scratched off - bled, drainage. Poss. insect bite. No increase swelling, redness.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, VARCEL
Symptoms: Tenderness
Clinical narrative: Began 2/28/19-Redness approx. size of quarter. Not hot, some swelling, no fever. Parameters marked. Tender to touch, ice helps. Called urgent care 3/1/19. Recommended ER but ER said to watch not come. Gave BENADRYL, Tyl/Ibu. Came to head and patient scratched off - bled, drainage. Poss. insect bite. No increase swelling, redness.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Myalgia in the arm that vaccine was administered which was more than usual vaccination. No treatment needed. Resolved in a week.
Age: 1.25
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pruritus, Rash generalised, Rash macular
Clinical narrative: Patient developed pink, macular rash from head to toe with mild pruritis. BENADRYL given for pruritis and rash starting to slowly resolve after 2 days.
Age: 0.5
Sex: F
Vaccine: DTAP, RV5
Symptoms: Crying, Diarrhoea, Frequent bowel movements, Injection site erythema, Pyrexia
Clinical narrative: About 30 minutes after vaccination baby was inconsolable crying, leg was really red and she threw up. This continued for a few days and then severe diarrhea and fever started about 36 hours after vaccination. Child was going about 16 times a day. Taken to medical center they could not figure out what was wrong said maybe pneumonia. They said they were not equipped to treat baby in such medical condition so they transferred is to another hospital where they ruled out pneumonia and all other possible causes. They gave her an IV. And said people have reactions to vaccinations but it is highly unlikely.
Age: 0.5
Sex: F
Vaccine: DTAP, RV5
Symptoms: Vomiting
Clinical narrative: About 30 minutes after vaccination baby was inconsolable crying, leg was really red and she threw up. This continued for a few days and then severe diarrhea and fever started about 36 hours after vaccination. Child was going about 16 times a day. Taken to medical center they could not figure out what was wrong said maybe pneumonia. They said they were not equipped to treat baby in such medical condition so they transferred is to another hospital where they ruled out pneumonia and all other possible causes. They gave her an IV. And said people have reactions to vaccinations but it is highly unlikely.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Burning sensation, Immediate post-injection reaction, Injected limb mobility decreased, Injection site discolouration
Clinical narrative: Immediate burning. For weeks following vaccination arm hard to lift and had no strength. Also have permanent knot and discoloration at injection site. Pain in my arm is still there. Received vaccine following birth of my child.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site nodule, Pain in extremity
Clinical narrative: Immediate burning. For weeks following vaccination arm hard to lift and had no strength. Also have permanent knot and discoloration at injection site. Pain in my arm is still there. Received vaccine following birth of my child.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in left arm with various movements.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: On 1/11/2019 Patient reports that shortly after receiving the injection of GARDASIL on 1/10/2019 that her left upper arm became red and hot to the touch. Patient also states that the site was raised. Patient received vaccine in the deltoid muscle on Thursday 1/10/2019. On 1/14/2019 Patient states that it has been painful, warm to touch at the site of vaccination. Patient says the pain is decreasing but there is a bump that looks like a mosquito bite. I asked the patient to come in today so that we can assess the site. Patient refused. Patient said she will call us tomorrow with a follow up. On 1/15/2019 Patient states that the area is improving. Patient made an appointment for 1/17/2019 so that APN, CNP can assess the site. On 1/17/2019 The Left Deltoid Muscle is still healing from receiving the GARDASIL vaccine.  No induration, no rash, no warm to touch at the site. Take Tylenol 500mg po , or Ibuprofen 600mg TID for discomfort. Avoid manipulating the site. May use a cold compress to the site. On 2/15/2019 The patient is calling today to report that she has a thickened area the size of a nickle on her left deltoid. She states there is no rash no itching. She is able to sleep on her side. I advised that she should avoid sleeping on her arm. Patient states that she is going to be seen by her new PCP.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The male patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2015, the patient, approximately 70 years old at time of vaccination, was administered the ZOSTAVAX by a physician at a physician's office (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician at the physician's office for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to self, loss of consortium, loss of services and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Sex: M
Vaccine: PNC13
Symptoms: C-reactive protein increased
Clinical narrative: This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received PREVNAR 13 (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history included Crohn's disease from an unknown date and reported that patient has been in remission. The patient's concomitant medications were not reported. On an unspecified date, the patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and his C reactive protein was elevated. The outcome of the event was unknown. The following information on the batch number has been requested.
Age: 2.0
Sex: M
Vaccine: FLUX, MMRV
Symptoms: Anaphylactic reaction, Autopsy, Cardio-respiratory arrest, Death, Tryptase increased
Clinical narrative: This is a literature case, initially received on 19-Feb-2019, concerning a 2-year-old, male child. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. The patient's medical history included premature birth at 33 weeks of gestation, hypoplastic left heart syndrome with subsequent cavopulmonary shunt procedure. The current conditions of the patient included periodic cyanosis. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, the patient was also administered a combined non-company suspect vaccine, Measles vaccine;Mumps vaccine;Rubella vaccine;Varicella zoster vaccine (anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, 20 minutes after the vaccination, the patient experienced a cardiopulmonary arrest and the patient died. Autopsy was performed, and the cause of death was reported as anaphylactic reaction (related). On post-mortem laboratory tests revealed an increased serum tryptase level. The outcome of the event cardiopulmonary arrest was not reported. The reporter assessed this case as serious (death).; Reporter's Comments: A 2-year-old, male patient with medical history/concurrent condition (premature birth at 33 weeks of gestation, hypoplastic left heart syndrome with subsequent cavopulmonary shunt procedure and periodic cyanosis) experienced fatal cardiopulmonary arrest, 20 minutes after administration of INN Flu Vaccine. The autopsy reported the cause of death as anaphylactic reaction. The case meets level 2 of Brighton Collaboration criteria of diagnostic certainty for anaphylactic reaction. Considering the plausible temporal relationship between vaccination and reported fatal events (anaphylactic reaction and cardiopulmonary arrest) and lack of alternative more plausible causes, the company conservatively assessed the events as possibly related to suspect vaccine. However, co-administered combined measles, mumps, rubella and varicella vaccine was considered as non company suspect in this case. The company assessed the event 'anaphylactic reaction' as serious (medically significant).; Reported Cause(s) of Death: Anaphylactic reaction.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Autopsy, Death, Respiratory failure, Tryptase increased
Clinical narrative: This is a literature case, initially received on 19-Feb-2019, concerning a 42-year-old, adult, female patient. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. The patient's historical conditions included hepatitis C infection. The patient's current conditions included: asthma, hereditary onychoosteodysplasia and was allergic to penicillin, quinolones and naproxen. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal              (anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, the patient was administered non-company suspect drug ceftriaxone (route of administration: intramuscular, anatomical location, dose, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, 2 minutes after vaccination, the patient experienced respiratory failure and died. The autopsy was performed and the laboratory tests revealed an increased serum tryptase level. The documented cause of death was reported as anaphylactic reaction (causality: related). The reporter assessed the case as serious (death).; Reporter's Comments: A 42-year-old, female patient with medical history/concurrent condition (asthma, hereditary onychoosteodysplasia and was allergic to penicillin, quinolones and naproxen) experienced fatal respiratory failure, 2 minutes after administration of INN Flu Vaccine. The reported cause of death was anaphylactic reaction. The case meets level 2 of Brighton Collaboration criteria of diagnostic certainty for anaphylactic reaction. Considering the plausible temporal relationship between vaccination and reported fatal events (anaphylactic reaction and respiratory failure) and lack of alternative more plausible causes, the company conservatively assessed the events as possibly related to suspect vaccine. However, multiple drug allergies especially and co-administered ceftriaxone (non company suspect) confound this case. The company assessed the events respiratory failure and anaphylactic reaction as serious (medically significant).; Reported Cause(s) of Death: Anaphylactic reaction.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Autopsy, Death, Respiratory tract oedema, Tryptase increased
Clinical narrative: This is a literature case, initially received on 19-Feb-2019, concerning a 43-year-old, adult female patient. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. The patient's historical condition included depression and current condition included: hypertension. Patient did not have hypersensitivities. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. The following morning, after vaccination, patient was found dead. On autopsy, the body was noted to have patches of urticaria and airway swelling. The laboratory tests revealed an increased serum tryptase level. The documented cause of death was anaphylactic reaction (causality: related). The reporter assessed the case as serious (death). The author concluded that anaphylaxis of severe or life-threatening severity was very uncommon but could occur even among the persons without hypersensitivity. Most persons recovered fully with treatment, but serious complications, including possibility of death is a rare event. This case is cross-linked to the original case: 201902085 due to the same reporter.; Reporter's Comments: A 43-year-old, female patient with medical history (depression and hypertension) was found dead, 1 day after administration of INN Flu Vaccine. The autopsy reported patches of urticaria, airway swelling and the cause of death as anaphylactic reaction. The case meets level 1 of Brighton Collaboration criteria of diagnostic certainty for anaphylactic reaction. Considering the plausible temporal relationship between vaccination and reported fatal event (anaphylactic reaction) and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the event anaphylactic reaction as serious (medically significant).; Reported Cause(s) of Death: Anaphylactic reaction.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: This is a literature case, initially received on 19-Feb-2019, concerning a 43-year-old, adult female patient. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. The patient's historical condition included depression and current condition included: hypertension. Patient did not have hypersensitivities. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. The following morning, after vaccination, patient was found dead. On autopsy, the body was noted to have patches of urticaria and airway swelling. The laboratory tests revealed an increased serum tryptase level. The documented cause of death was anaphylactic reaction (causality: related). The reporter assessed the case as serious (death). The author concluded that anaphylaxis of severe or life-threatening severity was very uncommon but could occur even among the persons without hypersensitivity. Most persons recovered fully with treatment, but serious complications, including possibility of death is a rare event. This case is cross-linked to the original case: 201902085 due to the same reporter.; Reporter's Comments: A 43-year-old, female patient with medical history (depression and hypertension) was found dead, 1 day after administration of INN Flu Vaccine. The autopsy reported patches of urticaria, airway swelling and the cause of death as anaphylactic reaction. The case meets level 1 of Brighton Collaboration criteria of diagnostic certainty for anaphylactic reaction. Considering the plausible temporal relationship between vaccination and reported fatal event (anaphylactic reaction) and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the event anaphylactic reaction as serious (medically significant).; Reported Cause(s) of Death: Anaphylactic reaction.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Asthma, Autopsy, Cardio-respiratory arrest, Death, Wheezing
Clinical narrative: This is a literature case, initially received on 19-Feb-2019, concerning a 46-year-old, adult, male patient. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. The patient's historical conditions included gout, chronic headaches and current conditions included hypertension, asthma and unspecified allergies (since unspecified dates). On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On an unspecified day, after the vaccination, the patient developed wheezing with subsequent cardiopulmonary arrest. Autopsy was performed, and the cause of death was acute reported as asthmatic bronchitis. The reporter assessed the case as serious (death). This case was linked to 201902085 due to same reporter.; Reporter's Comments: A 46-year-old, male patient with current conditions (hypertension and asthma and unspecified allergies) developed wheezing with subsequent fatal cardiopulmonary arrest, on an unspecified day after administration of INN Flu Vaccine. The autopsy reported the cause of death as asthmatic bronchitis. The case lacks information important for the causality assessment, such as onset latency between the vaccination and reported events, concurrent medical condition and investigations to provide alternate aetiologies, and vaccination details, the company assessed the causality as unassessable. The case will be reassessed upon receipt of follow-up information.; Reported Cause(s) of Death: Acute asthmatic bronchitis.
Age: 65.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Autopsy, Cardio-respiratory arrest, Death, Respiratory tract oedema
Clinical narrative: This is a serious literature case, initially received on 19-Feb-2019, concerning a 65-year-old, elderly male patient. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. All serious reports and all nonserious reports with available medical records to determine if they met the Brighton Collaboration case definition for anaphylaxis or received a physician's diagnosis were reviewed. The patient had no historical condition. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, 15 minutes after vaccination, the patient experienced airway swelling and cardiopulmonary arrest. Autopsy was performed, and the cause of death was reported as anaphylactic shock. The reporter assessed this case as serious (death).; Reporter's Comments: A 65-year-old, male patient developed airway swelling and subsequent fatal cardiopulmonary arrest, 15 minutes after administration of INN Flu Vaccine. The autopsy reported the cause of death as anaphylactic shock. Considering the plausible temporal relationship between vaccination and reported fatal events and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the event 'anaphylactic shock' as serious (medically significant).; Reported Cause(s) of Death: Anaphylactic shock.
Age: 65.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction, Cardio-respiratory arrest, Death, Respiratory tract oedema
Clinical narrative: This is a serious literature case, initially received on 19-Feb-2019, concerning a 65-year-old, elderly male patient. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. All serious reports and all nonserious reports with available medical records to determine if they met the Brighton Collaboration case definition for anaphylaxis or received a physician's diagnosis were reviewed. The patient had no historical condition. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, 15 minutes after vaccination, the patient experienced airway swelling and cardiopulmonary arrest. Autopsy was performed, and the cause of death was reported as anaphylactic shock. The reporter assessed this case as serious (death).; Reporter's Comments: A 65-year-old, male patient developed airway swelling and subsequent fatal cardiopulmonary arrest, 15 minutes after administration of INN Flu Vaccine. The autopsy reported the cause of death as anaphylactic shock. Considering the plausible temporal relationship between vaccination and reported fatal events and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the event 'anaphylactic shock' as serious (medically significant).; Reported Cause(s) of Death: Anaphylactic shock.
Sex: M
Vaccine: FLUA3
Symptoms: Autopsy, Death, Sjogren's syndrome
Clinical narrative: This is a literature case, initially received on 19-Feb-2019, concerning a 75-year-old, elderly male patient. This is a review of safety profile of aIIV3 vaccine by analysing the reports of aIIV3 submitted from 01-Jul-2016 through 30-Jun-2018 to the vaccine adverse event reporting system (VAERS). On an unspecified date, the patient was administered FLUAD (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported] for an unknown indication. On an unspecified date, after vaccination, the patient died due to Sjogren's syndrome. Autopsy was performed and the cause of death was reported as Sjogren's syndrome. The reporter assessed this case as serious (death).; Reporter's Comments: A 75-year-old, male patient developed fatal Sjogren's syndrome, on an unspecified day after administration of FLUAD (TIV) Vaccine. The case lacks information important for the causality assessment, such as onset latency between the vaccination and reported event, vaccination details, concurrent medical conditions and investigations to provide alternate aetiologies, the causal role of suspect vaccine was assessed as unassessable. The case will be reassessed upon receipt of follow-up information.; Reported Cause(s) of Death: Sjogren's syndrome.
Age: 20.0
Sex: F
Vaccine: FLUA3
Symptoms: Chills, Myalgia, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: This is a literature case, initially received on 19-Feb-2018, concerning a 20-year-old, adult, female patient. This is a review of safety profile of aIIV3 vaccine by analysing the reports of aIIV3 submitted from 01-Jul-2016 through 30-Jun-2018 to the vaccine adverse event reporting system (VAERS).   On an unspecified date, the patient under 65 years was administered FLUAD (TIV) (Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose, route of administration, anatomical location, batch number and expiry date: not reported) for an unknown indication (explicitly coded as inappropriate age at vaccine administration). On an unspecified date after vaccination, the patient developed fever chills and myalgia. At the time of the report, the outcome of the events was not reported. The reporter assessed the case as serious (medically significant).; Reporter's Comments: A 20-year-old, female patient developed fever, chills, and myalgia, on an unspecified day after administration of FLUAD (TIV) Vaccine. The case lacks information important for the causality assessment, such as onset latency between the vaccination and reported events, vaccination details, concurrent medical conditions and investigations to provide alternate aetiologies, the causal role of the suspect vaccine was assessed as unassessable. The case will be reassessed upon receipt of follow-up information. The event of inappropriate age at vaccine administration appears to be an informed medical decision making by the physician and/or accidental in nature and is not related to any property of the vaccine, per se.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Crying, Gene mutation identification test positive, Immediate post-injection reaction, Irritability, Listless
Clinical narrative: Immediately after showed signs of listlessness throughout the rest of the day into the night. The following 3 days had uncontrollable crying and fussiness. Also came down with rash on face.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: Immediately after showed signs of listlessness throughout the rest of the day into the night. The following 3 days had uncontrollable crying and fussiness. Also came down with rash on face.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Gait disturbance, Headache, Myalgia, Nausea
Clinical narrative: Patient experienced fever, headache, nausea, and muscle pain that started the day of the vaccine on 2-13-19. She was in bed for 7 days and feeling very unstable while walking and tremors. Patient reported these side effects and also reported that she was trying to "keep moving" and tried her best to continue her workout routine, moving her arm around to help with pain. Patient we to the doctor after blisters started to appear over her body and had thought a spider/bug was in the bed that had bitten her.   Patient saw her MD 12 days after the injection and the md stated, per the patient, "that this was a toxic reaction".
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Toxicity to various agents, Tremor
Clinical narrative: Patient experienced fever, headache, nausea, and muscle pain that started the day of the vaccine on 2-13-19. She was in bed for 7 days and feeling very unstable while walking and tremors. Patient reported these side effects and also reported that she was trying to "keep moving" and tried her best to continue her workout routine, moving her arm around to help with pain. Patient we to the doctor after blisters started to appear over her body and had thought a spider/bug was in the bed that had bitten her.   Patient saw her MD 12 days after the injection and the md stated, per the patient, "that this was a toxic reaction".
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Throat tightness, Tremor
Clinical narrative: Patient stated beginning 1-2 hours after receiving vaccination they experienced nausea, tightness in throat, moderate/severe uncontrollable body shaking. Patient rested for several hours; said 24 hours later they felt much better. Patient notified and discussed with primary care physician.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discomfort, Injection site swelling, Nausea, Throat tightness, Tremor
Clinical narrative: Patient stated beginning 1-2 hours after receiving vaccination they experienced nausea, tightness in throat, moderate/severe uncontrollable body shaking. Patient rested for several hours; said 24 hours later they felt much better. Patient notified and discussed with primary care physician.
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Crying, Immediate post-injection reaction, Irritability, Listless, Rash
Clinical narrative: Same as last time, immediate listlessness, glazed over look for the rest of the night. Extreme crankiness and constant crying for days following. Bad rash on face.
Age: 83.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Pruritus, Skin reaction, Swelling
Clinical narrative: PT HAD A DELAYED REACTION TO THE PREVNAR SHOT. PT GOT REDNESS, ITCHING, AND SWELLING 2 DAYS AFTER RECEIVING THE SHOT.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Injection site erythema, Injection site rash, Neck pain
Clinical narrative: Severe headache, neck pain, and back ache. Injection site redness and rash down arm.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Severe headache, neck pain, and back ache. Injection site redness and rash down arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Loss of consciousness, Pyrexia
Clinical narrative: Patient returned to pharmacy 3/4/2019, reported passing out about 4 hours following administration of SHINGRIX. Patient was alone at the time, but reported "coming out of it" quickly. Patient returned home and went to bed. She reported chills and fever that continued for 2 days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: I had full-blown flu like symptoms: headache, nausea, muscle body aches, fatigue. Hit me super hard for one day and then -- boom  -- gone.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever of 100.8 degrees for more than 12 hours, less than 24 hours. Body ache (6 out of 10 scale) for more than 12 hours, less than 24 hours. Treated initially with ADVIL (1 dose)/no beneficial effect. Treated with aspirin (1 dose/325 mg) - relief sufficient to be comfortable/sleep.
Age: 11.0
Sex: M
Vaccine: RAB
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The child came home from school with a large golf ball sized red, warm and raised spot where the vaccine was given. Child also had a headache after the last shot that started that evening and went until the next day.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain, Peripheral swelling, Skin discolouration, Skin warm
Clinical narrative: Mom called on 3/5/19 stating the following: After the first Men B. vaccine, patient's upper arm swelled and was black, blue and red. She had red patches of hives all the way down her arm. Not itchy. Hot to the touch. This occurred about 2-3 days after the vaccine was given. It lasted for 2-3 weeks. She went to the nurse at college but nothing was done. She was achy all over.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Mom called on 3/5/19 stating the following: After the first Men B. vaccine, patient's upper arm swelled and was black, blue and red. She had red patches of hives all the way down her arm. Not itchy. Hot to the touch. This occurred about 2-3 days after the vaccine was given. It lasted for 2-3 weeks. She went to the nurse at college but nothing was done. She was achy all over.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Injected limb mobility decreased, Laboratory test, Musculoskeletal pain
Clinical narrative: Severe L arm pain and unable to move it for 2 days and then feels has had Bilateral shoulder, knee, ankle and low back pain since getting the vaccine 1/28/19.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Severe L arm pain and unable to move it for 2 days and then feels has had Bilateral shoulder, knee, ankle and low back pain since getting the vaccine 1/28/19.
Age: 22.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site rash, Rash
Clinical narrative: RASH RIGHT HAND, ARM, SHOULDER THAT HAS STARTED COMING UP ON LEFT ARM NOW.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Delayed (8 days after injection) onset of local injection site redness, swelling, pain and warm to touch. MOP declines any fever following the vaccination. MOP observed the reaction get approx. 3 inches in diameter. Redness, swelling, pain and warm to touch symptoms lasted approximately 5-6 days. Bruising onset following the redness for approximately 14 days, 1 inch red mark still remains at injection site, no other symptoms currently.
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Erythema, Nodule, Skin warm
Clinical narrative: Mother of patient says redness, knot warmth to the left arm started the day after the vaccine was given. It lasted "awhile".  She says it went away then came back - decided to come see the dr.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 7-year-old patient of unspecified gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 29-JAN-2019 the patient was vaccinated with VARIVAX first dose (dosage schedule, route, anatomical location, lot number and expiration date were not reported), indicated for prophylaxis. Then on 25-FEB-2019 the patient was vaccinated with the second dose of VARIVAX (drug dose administration interval too short).
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Morning following injection, MOP noticed redness, swelling, warm to touch, tenderness, lump at left thigh injection site. Symptoms lasted approximately 2 more days. Primary Care Provider saw patient 3 days following and noted much less symptoms at time of encounter. No treatments were done at that time.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Polymerase chain reaction positive, Rash, Rash pruritic, Varicella virus test positive
Clinical narrative: Patient develop painful and itchy rash on left arm (same arm as the vaccine) that tested positive for varicella zoster. Interestingly, patient had shingles on left arm in the 1980s.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Persistent rash left face, ear, neck that started one day after shot in left shoulder, and is lasting over 3 weeks now with new areas showing up. Itchy, red, raised spots. No other likely explanation.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin, Inappropriate schedule of product administration, Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Persistent rash left face, ear, neck that started one day after shot in left shoulder, and is lasting over 3 weeks now with new areas showing up. Itchy, red, raised spots. No other likely explanation.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash macular, Rash vesicular, Skin burning sensation, Skin erosion
Clinical narrative: Persistent rash left face, ear, neck that started one day after shot in left shoulder, and is lasting over 3 weeks now with new areas showing up. Itchy, red, raised spots. No other likely explanation.
Age: 49.0
Sex: F
Vaccine: TYP
Symptoms: Chills, Hypersensitivity, Hypoaesthesia oral, Immediate post-injection reaction, Malaise
Clinical narrative: Client reported immediate reaction to vaccine: chills, malaise, tongue & throat went numb but denied swelling. Client took 2 benadryl about an hour apart and symptoms resolved somewhat. Client then contacted office where she received vaccine and was informed to immediately discontinue vaccine and to follow up with PCP. From conversation between client & writer today, she was was placed on prednisone by PCP but "still doesn't feel better". Client advised to continue to follow up with PCP and if cause of allergic reaction is determined to contact writer back.
Age: 49.0
Sex: F
Vaccine: TYP
Symptoms: Pharyngeal hypoaesthesia
Clinical narrative: Client reported immediate reaction to vaccine: chills, malaise, tongue & throat went numb but denied swelling. Client took 2 benadryl about an hour apart and symptoms resolved somewhat. Client then contacted office where she received vaccine and was informed to immediately discontinue vaccine and to follow up with PCP. From conversation between client & writer today, she was was placed on prednisone by PCP but "still doesn't feel better". Client advised to continue to follow up with PCP and if cause of allergic reaction is determined to contact writer back.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Neck pain, Pruritus
Clinical narrative: Extreme itchy hands and feet. Living on BENADRYL. Sorry neck. Non stop headache.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Headache, Pyrexia, Tremor, Vomiting
Clinical narrative: Received shot at 8:30 AM. Side effects started around noon with chills, shakes, headache, and fever. Vomiting that night around 11:00 PM.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Red rash with white center. Patient states the rash has changed shape and size several times. She says it is bigger today and has some heat. Patient states she does not have a fever. She has been taking benadryl, ibuprofen, and using compresses after our recommendation on Sunday but rash is not getting better. This is day 6  so we told her to add hydro-cortisone cream tonight and if no better by tomorrow to seek treatment.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: Cold like symptoms and fever 101, we discuss using TYLENOL for fever and contacting her PCP.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Chills, Crying, Diarrhoea, Eczema, High-pitched crying
Clinical narrative: Child went to sleep shortly after vaccinations. After waking up about 3 hours later, child was crying with a very high pitch and was inconsolable. Child was offered to breastfeed, bottle feeding, rocked, held in arms and nothing would calm him down. He was shivering and screaming. An hour later, child accepted to be breastfeed and did so in a very lethargic way. He continued to breastfeed weekly through the night, but mostly sleeping. He ran a mild fever and not offered Tylenol as per instructions of the pediatrician. Child continued to be lethargic for a day and a half. Child had mild diarrhea for two days after vaccination. 3 days after vaccination, the child had an allergic reaction (rash) on the bottom but also had swollen penis and redness in the area. By the first days of august (first picture with proof is dated August 5th), the child started to show signs of eczema (seborrheic dermatitis). Shortly after, eczema expanded to all of his body including legs, arms, chest.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Hypersensitivity, Lethargy, Penile erythema, Penile swelling, Pyrexia
Clinical narrative: Child went to sleep shortly after vaccinations. After waking up about 3 hours later, child was crying with a very high pitch and was inconsolable. Child was offered to breastfeed, bottle feeding, rocked, held in arms and nothing would calm him down. He was shivering and screaming. An hour later, child accepted to be breastfeed and did so in a very lethargic way. He continued to breastfeed weekly through the night, but mostly sleeping. He ran a mild fever and not offered Tylenol as per instructions of the pediatrician. Child continued to be lethargic for a day and a half. Child had mild diarrhea for two days after vaccination. 3 days after vaccination, the child had an allergic reaction (rash) on the bottom but also had swollen penis and redness in the area. By the first days of august (first picture with proof is dated August 5th), the child started to show signs of eczema (seborrheic dermatitis). Shortly after, eczema expanded to all of his body including legs, arms, chest.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Screaming
Clinical narrative: Child went to sleep shortly after vaccinations. After waking up about 3 hours later, child was crying with a very high pitch and was inconsolable. Child was offered to breastfeed, bottle feeding, rocked, held in arms and nothing would calm him down. He was shivering and screaming. An hour later, child accepted to be breastfeed and did so in a very lethargic way. He continued to breastfeed weekly through the night, but mostly sleeping. He ran a mild fever and not offered Tylenol as per instructions of the pediatrician. Child continued to be lethargic for a day and a half. Child had mild diarrhea for two days after vaccination. 3 days after vaccination, the child had an allergic reaction (rash) on the bottom but also had swollen penis and redness in the area. By the first days of august (first picture with proof is dated August 5th), the child started to show signs of eczema (seborrheic dermatitis). Shortly after, eczema expanded to all of his body including legs, arms, chest.
Age: 73.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT CALLED THE PHARMACY ON 03.05.19 STATING THAT HER RIGHT ARM IS SWOLLEN AND PAINFUL DUE TO GETTING PREVNAR 13 VACCINATION ON 02.28.19. PATIENT ALSO STATED THAT SHE FORGOT TO LET US KNOW THAT SHE HAD RECEIVED A PNEUMOCOCCAL VACCINATION 2 YEARS AGO, AND HAD A BAD REACTION TO IT. SHE IS NOT SURE OF WHICH PNEUMOCOCCAL VACCINATION SHE HAD RECEIVED. SHE HAS BEEN INSTRUCTED TO TAKE OTC PAIN MEDICATION FOR THE PAIN AND SWELLING.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Encephalitis, Immediate post-injection reaction, Loss of consciousness, Posture abnormal, Screaming
Clinical narrative: Four month old become unresponsive immediately following vaccines, arms flexed straight out from her body like Frankenstein. Remained unconscious and unresponsive for eight hours when she had previously never slept for more than one to two, followed by severe high pitched screaming. Doctor mentioned the word encephalitis when we explained the episode.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Four month old become unresponsive immediately following vaccines, arms flexed straight out from her body like Frankenstein. Remained unconscious and unresponsive for eight hours when she had previously never slept for more than one to two, followed by severe high pitched screaming. Doctor mentioned the word encephalitis when we explained the episode.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Amniotic cavity infection, Caesarean section, Eczema, Exposure during pregnancy
Clinical narrative: Birth weight: 7 lb 9 oz No issues during pregnancy. Baby was delivered via csection. Birth complications: Chorioamnionitis Vaccine adverse reaction was eczema that started within a week of vaccination. Eczema is on hands of mother and thought to be gone after delivery of baby, but it has instead become permanent. Eczema is triggered by stress and contact with soaps and antibacterial lotions.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient came in to store on 3/5/19 letting us know her arm had swollen up, was red, hot and had gone to the ER for treatment. She said it started about 2 days after receiving the first dose of SHINGRIX.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Mouth swelling, Pruritus generalised
Clinical narrative: Pt reported to me on 3/5/19 that several hours after her vaccination that she had swelling in her mouth and lips. In addition, she had itching on her body. She reported she took Benadryl and her symptoms resolved in about 24 hours.