chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blepharitis, Colitis, Dry eye, Immune thrombocytopenic purpura, Laboratory test
Clinical narrative: Strong immune response resulting in triggering ITP, platelet count fell from stable to 22.  Also, elevated liver functions.  Addtionally, 10 days following Dose 1 and Dose 2 an inflammatory flare in the colon.  Inflammatory response may also have resulted in inflammation of eyelids and chronic dry eye disease ie. Blepharitis.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Liver disorder, Liver function test increased, Platelet count decreased
Clinical narrative: Strong immune response resulting in triggering ITP, platelet count fell from stable to 22.  Also, elevated liver functions.  Addtionally, 10 days following Dose 1 and Dose 2 an inflammatory flare in the colon.  Inflammatory response may also have resulted in inflammation of eyelids and chronic dry eye disease ie. Blepharitis.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Heart rate increased, Muscular weakness, Pyrexia
Clinical narrative: Pt said 4 hours after her shot her legs felt weak + she felt tired, she said her heart started beating real fast-up to 100 beats per minute. Stayed increased until 8:00 AM on 6-22-19 when pt. took a Xanax + it slowed down. Heart rate went back up 6-23-19 late afternoon + stayed up until 8:00 AM 6-24-19. Also on 6-23-19 had chills + fever.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Eyelid rash, Malaise, Rash, Swelling
Clinical narrative: Pt did not feel well 6/20/19. On 6/21/19 had swelling & Rash on (R) side only of Face, Eye, neck & chest
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Pt did not feel well 6/20/19. On 6/21/19 had swelling & Rash on (R) side only of Face, Eye, neck & chest
Sex: U
Vaccine: HEPA
Symptoms: Liquid product physical issue, Product complaint
Clinical narrative: cloudy precipitant in Vaqta vaccine syringe reported to merck 6-17-19 and awaiting results
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: I had my second dose of shingrix on 6/12/19. About 12 hours later I developed burning muscle and joint pain as well as shivering - shaking and nausea. The injection site is red and very painful. I have a terrible headache and it literally hurts to walk. My heart races sporadically. I didn't have any reaction to the first shot. Even my fingers are throbbing. I hope this is a "normal" reaction. I'm just concerned about how long this will last.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Palpitations
Clinical narrative: I had my second dose of shingrix on 6/12/19. About 12 hours later I developed burning muscle and joint pain as well as shivering - shaking and nausea. The injection site is red and very painful. I have a terrible headache and it literally hurts to walk. My heart races sporadically. I didn't have any reaction to the first shot. Even my fingers are throbbing. I hope this is a "normal" reaction. I'm just concerned about how long this will last.
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: I had my second dose of shingrix on 6/12/19. About 12 hours later I developed burning muscle and joint pain as well as shivering - shaking and nausea. The injection site is red and very painful. I have a terrible headache and it literally hurts to walk. My heart races sporadically. I didn't have any reaction to the first shot. Even my fingers are throbbing. I hope this is a "normal" reaction. I'm just concerned about how long this will last.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Bronchitis, Chest X-ray normal, Cough, Dyspnoea, Fatigue
Clinical narrative: I received the Pneumovax 23 shot at 8:30 am. By afternoon I was so ill I knew I would not be able to work the following day. I had fever, body aches, cough, difficulty breathing, headache, nasal congestion, runny nose, sneezing and unusual tiredness. On Friday, 6/7/19, I went to urgent care and was diagnosed with pneumonia. I was prescribed benzonatate, doxycycline, and cough syrup. I missed five days of work. On Monday, 6/10/19, I was seen by Dr. of Primary Care. They took a chest x-ray and the results were clear of pneumonia. The doctor indicated that I may have bronchitis, not pneumonia. Regardless of the label, I was exceptionally ill.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Loss of personal independence in daily activities, Malaise, Nasal congestion, Pain
Clinical narrative: I received the Pneumovax 23 shot at 8:30 am. By afternoon I was so ill I knew I would not be able to work the following day. I had fever, body aches, cough, difficulty breathing, headache, nasal congestion, runny nose, sneezing and unusual tiredness. On Friday, 6/7/19, I went to urgent care and was diagnosed with pneumonia. I was prescribed benzonatate, doxycycline, and cough syrup. I missed five days of work. On Monday, 6/10/19, I was seen by Dr. of Primary Care. They took a chest x-ray and the results were clear of pneumonia. The doctor indicated that I may have bronchitis, not pneumonia. Regardless of the label, I was exceptionally ill.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Pneumonia, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: I received the Pneumovax 23 shot at 8:30 am. By afternoon I was so ill I knew I would not be able to work the following day. I had fever, body aches, cough, difficulty breathing, headache, nasal congestion, runny nose, sneezing and unusual tiredness. On Friday, 6/7/19, I went to urgent care and was diagnosed with pneumonia. I was prescribed benzonatate, doxycycline, and cough syrup. I missed five days of work. On Monday, 6/10/19, I was seen by Dr. of Primary Care. They took a chest x-ray and the results were clear of pneumonia. The doctor indicated that I may have bronchitis, not pneumonia. Regardless of the label, I was exceptionally ill.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site erythema, Nausea
Clinical narrative: The patient reported having had a reaction to the Shingrix vaccine. On 6/10/2019 she received her first dose of Shingrix and later that day experienced fever, chills, headache, nausea, injection-site redness, and joint pain. She was subsequently given steroid injection which has helped according to the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: The patient reported having had a reaction to the Shingrix vaccine. On 6/10/2019 she received her first dose of Shingrix and later that day experienced fever, chills, headache, nausea, injection-site redness, and joint pain. She was subsequently given steroid injection which has helped according to the patient.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Eye movement disorder, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: She had Rapid eye movement and loss of consciousness immediately on removal of the needle with tremors and snoring. She regained consciousness after approximately 1 minute, Responded coherently, then had vasovagal syncopal episode with rolling back of eyes, sweating and LOC. She was placed on her back and she regained consciousness. Dizziness lasted approximately 10 minutes following episode.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Snoring, Syncope, Tremor
Clinical narrative: She had Rapid eye movement and loss of consciousness immediately on removal of the needle with tremors and snoring. She regained consciousness after approximately 1 minute, Responded coherently, then had vasovagal syncopal episode with rolling back of eyes, sweating and LOC. She was placed on her back and she regained consciousness. Dizziness lasted approximately 10 minutes following episode.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: redness/warmth/swelling on left arm from shoulder to elbow symptoms were at their worst one day after administration resolved 36 hours after administration
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: gardisal was administered at 220pm. Patient felt lightheaded. Pt was layed flat BP 74/38 Pulse 52. Blood prersure + pulse were monitored intermittently - 80/60, 89/51 HR 61, 93/58 HR 88 89/51, 100/62. Patient sat up and no longer felt lightheaded BP 100/62. Patient was given, orange juice, sucker, peanut butter, water. Patient left office. Dr. evaluated patient
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Injection site erythema, Injection site joint pain, Injection site pruritus
Clinical narrative: Received zoster vaccine on 2/6/19 and on 2/12/19 reports that she developed swelling and redness with itchiness, joint pain and N/V to the injection site and extremity in general. She did see a PCP and reported the reaction to them and was advised to no receive the second injection. To my knowledge she did not receive any treatments for the reaction.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Peripheral swelling, Pruritus, Vomiting
Clinical narrative: Received zoster vaccine on 2/6/19 and on 2/12/19 reports that she developed swelling and redness with itchiness, joint pain and N/V to the injection site and extremity in general. She did see a PCP and reported the reaction to them and was advised to no receive the second injection. To my knowledge she did not receive any treatments for the reaction.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Patient developed welt right to the right of the injection site
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, redness sat injection site, radiating to neck & (R) armpit and then to (R) elbow and forearm. Area warm to touch.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Neck pain, Oedema peripheral, Pain in extremity, Peripheral swelling
Clinical narrative: Pain, swelling, redness sat injection site, radiating to neck & (R) armpit and then to (R) elbow and forearm. Area warm to touch.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Pain, swelling, redness sat injection site, radiating to neck & (R) armpit and then to (R) elbow and forearm. Area warm to touch.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Hyperhidrosis, Nausea
Clinical narrative: Received vaccine about 7pm. Upon awakening 6/18/19 pt experienced Nausea, sweats, chills, diarrhea, knee pain, all-over aches.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Received vaccine about 7pm. Upon awakening 6/18/19 pt experienced Nausea, sweats, chills, diarrhea, knee pain, all-over aches.
Age: 23.0
Sex: U
Vaccine: TD
Symptoms: Rash
Clinical narrative: Chest rash move up
Age: 19.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Moaning, Tremor
Clinical narrative: After receiving both vaccines, patient immediately stated he felt dizzy and began to lose consciouness. Pt started midly shaking and moaning. Technician called 911. My intern and I monitored the patient as he regained consciousness. Once he regained consciousness, we gave him water and glucose gel (patient stated he had not ate that morning) and had him lay on floor with with feet elevated. I checked blood pressure which was around 90/50mmHg but was unable to get an entire accurate reading bc of position patient was laying in. Patient laid on ground with cold pack on his forehead until 911 arrived and took over. Patient was taken out in stretcher but eventually refused to go to hospital as 15 minutes later patient patient came back into pharmacy to retrieve paperwork. Patient left feeling fine and stated he didn't like needles.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site erythema; Injection site pain; Injection site swelling; Injection site warmth; This report was identified from a line listing obtained on request by the Company from FDA under the Act (HA# 741374). This spontaneous report was received from a regulatory authority and refers to a 13-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 11-DEC-2017, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular in the left arm, lot no. N017094 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 31-AUG-2018 and the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) ) intramuscular in the right arm, lot no. N017686 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 02-FEB-2020 for prophylaxis.      On 13-DEC-2017(also reported as 2 days following the vaccination), the patient experienced right upper arm swelling, redness, warmth and pain peaking. The patient received treatment for the events ice, NSAID and was monitored.      The outcome of injection site erythema, injection site warmth, injection site swelling and injection site pain was reported as resolved on an unknown date also reported as within 3-5 days. No causal relationship was provided.  Follow up information has been identified from a line listing obtained on request by the Company from FDA under the Act (HA # 741374) on 23-MAY-2019. The primary reporter was a physician. The patient was a male. His concurrent condition included allergic rhinitis. He had no other illnesses at the time of vaccination and up to one month prior, not known drug allergies and no medication, dietary supplements or herbal remedies were taken at the time of vaccination. The patient has no adverse events following any previous vaccine. He was vaccinated with both vaccines on 11-DEC-2017 at 15:00.  Follow up information has been received from the physician on 17-JUN-2019.  The patient's information was updated. On 12-DEC-2017 (also reported as 2 days following second Human Papilloma Virus (HPV) which referring to 13-DEC-2017), the patient experienced right upper arm swelling, redness, warmth, pain peaking. The outcome of the events was reported as recovered on an unknown date in December 2017 (also reported as within 3-5 days).
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient states she initially developed soreness and redness at the injection site that continued to worsen and harden over the next 7-10 days.  Patient states injection site are had a hard lump about 1 inch in diameter larger than the palm of her hand which was very painful.  A flat rash also developed over the same site and expanded down her arm as well.  She felt exhausted, had significant pain, and flu like symptoms which did not resolve for 7-10 days.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Local reaction, Skin reaction, Vital signs measurement
Clinical narrative: Patient states she initially developed soreness and redness at the injection site that continued to worsen and harden over the next 7-10 days.  Patient states injection site are had a hard lump about 1 inch in diameter larger than the palm of her hand which was very painful.  A flat rash also developed over the same site and expanded down her arm as well.  She felt exhausted, had significant pain, and flu like symptoms which did not resolve for 7-10 days.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Patient states she initially developed soreness and redness at the injection site that continued to worsen and harden over the next 7-10 days.  Patient states injection site are had a hard lump about 1 inch in diameter larger than the palm of her hand which was very painful.  A flat rash also developed over the same site and expanded down her arm as well.  She felt exhausted, had significant pain, and flu like symptoms which did not resolve for 7-10 days.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Rash
Clinical narrative: Patient states she initially developed soreness and redness at the injection site that continued to worsen and harden over the next 7-10 days.  Patient states injection site are had a hard lump about 1 inch in diameter larger than the palm of her hand which was very painful.  A flat rash also developed over the same site and expanded down her arm as well.  She felt exhausted, had significant pain, and flu like symptoms which did not resolve for 7-10 days.
Age: 8.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Seizure
Clinical narrative: Seizure with full body convulsions and loss of consciousness; 911 called and responded; patient appeared post-ictal for a period of about two hours followed by being responsive, complaining of pain; appeared to have another seizure around 11:30am; post-ictal once again (reactive, not responsive), followed by being responsive. Taken to pediatrician's office in afternoon.
Age: 8.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Loss of consciousness, Pain, Postictal state, Seizure
Clinical narrative: Seizure with full body convulsions and loss of consciousness; 911 called and responded; patient appeared post-ictal for a period of about two hours followed by being responsive, complaining of pain; appeared to have another seizure around 11:30am; post-ictal once again (reactive, not responsive), followed by being responsive. Taken to pediatrician's office in afternoon.
Age: 67.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Rash vesicular
Clinical narrative: Pt described a rash resembling chickenpox that started on 6/21/19. The rash started on the trunk on the aforementioned date, and proceeded to spread around the body. The pt described the rash as more alarming than severe, and described an itching on the affected areas with a 2/10 pain severity. The pt notified me of the reaction on 6/24/19, and had reported that the rash had been near-fully resolved by that point.
Age: 67.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: Pt described a rash resembling chickenpox that started on 6/21/19. The rash started on the trunk on the aforementioned date, and proceeded to spread around the body. The pt described the rash as more alarming than severe, and described an itching on the affected areas with a 2/10 pain severity. The pt notified me of the reaction on 6/24/19, and had reported that the rash had been near-fully resolved by that point.
Age: 82.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Injection site pain
Clinical narrative: Chills; Soreness; This case was reported by a consumer via call center representative and described the occurrence of chills in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced chills and pain. On an unknown date, the outcome of the chills and pain were unknown.   It was unknown if the reporter considered the chills and pain to be related to Shingrix.  Additional details were provided as follows: The patient expereinced chills and soreness after receiving a dose of Shingrix.
Age: 82.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pain
Clinical narrative: Chills; Soreness; This case was reported by a consumer via call center representative and described the occurrence of chills in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced chills and pain. On an unknown date, the outcome of the chills and pain were unknown.   It was unknown if the reporter considered the chills and pain to be related to Shingrix.  Additional details were provided as follows: The patient expereinced chills and soreness after receiving a dose of Shingrix.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Lethargy, Pyrexia, Vomiting projectile
Clinical narrative: Projectile vomiting, lethargic, 103 fever, body bright red
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Immune thrombocytopenic purpura, Increased tendency to bruise, Platelet count decreased
Clinical narrative: Patient was diagnosed with ITP approximately 6 weeks after his MMR vaccine with a platelet count of around 11,000. He had experienced increased bruising in the weeks leading up to his diagnosis that we initially dismissed as him being a toddler
Age: 45.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Ongoing acute pain in left shoulder which limits range of motion
Age: 45.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Middle insomnia, Pain in extremity
Clinical narrative: Ongoing acute pain in left shoulder which limits range of motion
Age: 45.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Impairing left arm pain with limited ROM. Has used advil and ice packs consistently the past three weeks without relief. No redness, swelling, fever, chills, drainage. Occurred immediately after vaccine and has been persistent since.  Waking patient up in the middle of the night.
Age: 45.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Middle insomnia, Pain in extremity
Clinical narrative: Impairing left arm pain with limited ROM. Has used advil and ice packs consistently the past three weeks without relief. No redness, swelling, fever, chills, drainage. Occurred immediately after vaccine and has been persistent since.  Waking patient up in the middle of the night.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 56-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2015 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for Herpes Zoster resulting from the use of zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of Herpes Zoster was unknown. The reporter considered Herpes Zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: M
Vaccine: DTAP, IPV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: IPol and Infarnix were administered to a patient, mixed in the same syringe; Initial information received on 17-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age male patient who received vaccines INFANRIX and IPV (VERO) [IPOL].  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 IPV (VERO) lot number not reported via unknown route. On an unknown date, the patient received a  dose of suspect INFANRIX not produced by Sanofi Pasteur lot number not reported via unknown route.  It was of actual medication error case due to  Product compounding error.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: a patient received Menactra subcutaneously rather than IM; Initial information received on 20-Jun-2019 regarding an unsolicited valid non-serious case received from a physician by phone.  This case involves adult patient of unknown demographics who was vaccinated with a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Batch number, expiry date, dose, dose in series and site of administration not reported) via subcutaneous route on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a  case of actual medication error due to inappropriate route of vaccination because patient received vaccine subcutaneously rather than intramuscular 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Information on the batch number was requested.  Documents held by the sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Caller stated that an expired dose of Adacel was given; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff) by phone.  This case involves adult patient of unknown demographics who was vaccinated with an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to expired vaccine used.  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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Information on the batch number was requested.  Documents held by the sender: none.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Full blood count normal, Headache, Metabolic function test normal, Mononucleosis heterophile test negative
Clinical narrative: Headache neck pain fever (100.1+) orthostatic red/painful arm
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Headache neck pain fever (100.1+) orthostatic red/painful arm
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Irritability, Rash, Rash papular, Skin lesion
Clinical narrative: Child presented to office in the morning of 6/26 following a fussy night and emergence of red papules on face.  He started with 5 lesions and by the time he got to the office had 17 lesions on face and shoulders. He was afebrile on exam today and was otherwise well.  Today is day#21 following first varicella vaccine.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Migraine, Pain
Clinical narrative: I had a Tdap vaccine as a booster shot and I that night I had a headache start then body aches and my glass under my arms hurt all that week. The headache turned into a full blown migraine the next morning and hasn?t stopped since. I?ve called my pcp multiple times about it I?ve been to urgent care once and ER twice and no one has been able to stop it. I?ve NEVER had a migraine and it?s been almost 4 weeks now and it?s not stopping. I know it was from the Tdap vaccine. I?ve never had these symptoms before and there?s nothing else it could be.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Patient states that >24 hours after receiving vaccine she developed a red, itchy rash at the site of injection.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Headache, Nausea
Clinical narrative: Fever, stomach ache, chills, nausea, headache, aches, weakness
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, stomach ache, chills, nausea, headache, aches, weakness
Age: 45.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Fatigue, Feeling abnormal, Pyrexia, Trance
Clinical narrative: Pt reported 4 days of "high fever" starting the day of administration and also "several" episodes of a "trance like state". Lasting 1 minute with a strange feeling afterward and feeling very tired. Pt states that this has not reccurred for approximately 1 week as of 6-26-19.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Chest X-ray normal, Chest pain, Dyspnoea, Electrocardiogram normal
Clinical narrative: Extreme muscle aches/soreness in the entire body began within a couple of hours of the vaccination.  3 days out from the vaccine patient developed intermittent chest pain that continued to worsen.  4 days out had significant chest pain, difficulty breathing and appeared very pale.  911 was called and was taken to the hospital to be evaluated for a heart attack.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pallor
Clinical narrative: Extreme muscle aches/soreness in the entire body began within a couple of hours of the vaccination.  3 days out from the vaccine patient developed intermittent chest pain that continued to worsen.  4 days out had significant chest pain, difficulty breathing and appeared very pale.  911 was called and was taken to the hospital to be evaluated for a heart attack.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP, HIBV, HIBV, PNC13, PNC13, RV5, RV5
Symptoms: Aldosterone urine, Blood corticotrophin, Culture stool, Culture urine, Dehydration
Clinical narrative: This patient received her initial vaccines as scheduled at 2 mo of age. She did have fever and congestion within the first 48 hours after receiving the vaccines. Approximately 4 days after receiving the vaccines, she developed frequent watery stools and vomiting. The patient was taken to the Emergency Center by her parents and subsequently admitted to the pediatrics floor. Diagnosis severe dehydration;gastroenteritis due to Rotavirus vaccine. Labs indicated hyponatremia, hyperkalemia associated with severe metabolic acidosis.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP, HIBV, HIBV, PNC13, PNC13, RV5, RV5
Symptoms: Diarrhoea, Escherichia test, Full blood count, Gastroenteritis rotavirus, Hyperkalaemia
Clinical narrative: This patient received her initial vaccines as scheduled at 2 mo of age. She did have fever and congestion within the first 48 hours after receiving the vaccines. Approximately 4 days after receiving the vaccines, she developed frequent watery stools and vomiting. The patient was taken to the Emergency Center by her parents and subsequently admitted to the pediatrics floor. Diagnosis severe dehydration;gastroenteritis due to Rotavirus vaccine. Labs indicated hyponatremia, hyperkalemia associated with severe metabolic acidosis.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP, HIBV, HIBV, PNC13, PNC13, RV5, RV5
Symptoms: Hyponatraemia, Laboratory test abnormal, Metabolic acidosis, Metabolic function test, Pyrexia
Clinical narrative: This patient received her initial vaccines as scheduled at 2 mo of age. She did have fever and congestion within the first 48 hours after receiving the vaccines. Approximately 4 days after receiving the vaccines, she developed frequent watery stools and vomiting. The patient was taken to the Emergency Center by her parents and subsequently admitted to the pediatrics floor. Diagnosis severe dehydration;gastroenteritis due to Rotavirus vaccine. Labs indicated hyponatremia, hyperkalemia associated with severe metabolic acidosis.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP, HIBV, HIBV, PNC13, PNC13, RV5, RV5
Symptoms: Renin, Respiratory tract congestion, Rotavirus test, Stool analysis, Vomiting
Clinical narrative: This patient received her initial vaccines as scheduled at 2 mo of age. She did have fever and congestion within the first 48 hours after receiving the vaccines. Approximately 4 days after receiving the vaccines, she developed frequent watery stools and vomiting. The patient was taken to the Emergency Center by her parents and subsequently admitted to the pediatrics floor. Diagnosis severe dehydration;gastroenteritis due to Rotavirus vaccine. Labs indicated hyponatremia, hyperkalemia associated with severe metabolic acidosis.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Breast pain, Culture urine negative, Herpes zoster
Clinical narrative: Patient diagnosed with shingles after receiving Shingrix.  Had pain with dermatomal distribution unilateral from back to breast.  Treated with Acyclovir and Prednisone.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Cyanosis, Electrocardiogram normal, Nervousness, Pallor
Clinical narrative: Mom called around noon time  on 6/25/19 stating that patient's  bilateral hands were turning white, all fingers are turning blue with chills and feeling shaky.  Advised mom to take him to nearest ED.  Patient went to ED  and  was discharged home the same day. No treatment was needed  at  ED due to normal  ECG, vitas and measurements,
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt said his arm and shoulder were sore the day after the immunization and he felt very weak, he reported he also felt this way after his flu shot last year
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Skin warm
Clinical narrative: Area of vaccine site was red and was about 2" in diameter. Hard to tell if the area was hot since whole arm was warm. The site did not seem warmer than the rest of the arm.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose of Heplisav-B given; Initial Report Received on 14-Jun-2019  A medical assistant reported that patient SC, a 44-year-old female patient (race not provided), received an expired dose of Heplisav-B (hepatitis B vaccine) for hepatitis B immunization.   Relevant medical history included obesity, chronic bilateral low back pain with sciatica, and vitamin D deficiency. The patient has allergies to cyclobenzaprine.   Concomitant medications were not reported. The reporter stated that the patient takes some medications for numbness and tingling, but did not disclose medication description.   On 14-Jun-2019, the patient received an expired dose of Heplisav-B (lot #1034864, expiration date: 13-Jun-2019, NDC # unknown). The injection was administered by the medical assistant at a clinic. It was reported that the patient was unaware of the expired dose given.   At the time of the report, there were no adverse events reported.   The reporter did not provide a seriousness assessment for this event.   Company comment: The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Varicella post vaccine
Clinical narrative: Pox break out starting from right arm and now over whole body
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site warmth, Product administered at inappropriate site
Clinical narrative: 6/26/19 10:45 AM Patient was given a Men B vaccine yesterday and went to urgent care this morning at Urgent care. While there the mother of the patient states she was told that the vaccine was given in the wrong place and that it's possible that it went in the bursa, causing the shoulder and arm pain that the patient is complaining of and if it is not better in a couple of days she should come back to urgent care for an MRI. She was then sent here to the Health Department to inform us and mom said she was told by the doctor that this is not the first time they have seen someone with the same complaint following a vaccine from our facility. RN also came in to speak with the mom and teen and from her observation of the injection site, it appears to be in the left deltoid as evidence by visible needle stick site; no redness noted, but area felt warm to touch. VIS sheet was reviewed and it was pointed out that muscle/joint pain was noted as possible side effect of the vaccine for up to 7 days. Patient states pain is currently 7/10 and last took 400mg ibuprofen last night. She was instructed to take ibuprofen every 4-6 hours and to keep moving her arm and a nurse will contact her daily over the next couple of days to check on status of pain. VAERS report will also be done to document this event.
Age: 18.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Dizziness, Fall, Head injury, Incoherent, Loss of consciousness
Clinical narrative: Pt was given Vaccines at 10:45AM on 6/24/19. She was carrying on a conversation per normal before, during and after the vaccines were given. Pt was still sitting on the exam table, before leaving the room @ 10:50 AM, asked pt if she felt ok at this point she looked pale, and she verbalized that she felt lightheaded and advised her to lay on the table, as this nurse told the pt to lay back pt started falling forward and fainted. She fell off the exam table onto her head, help was called for, multiple ppl came to the room to assist, 911 was called. after fall pt was incoherent for about 15-30 seconds and appeared to be shaking, pt verbalized that she did black out at somepoint. Ambulance came within 10 minutes to the scene and took pt to the ER. ER report states that she had a syncope episode, no seizure activity noted per ER dr.
Age: 18.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Pallor, Syncope, Tremor
Clinical narrative: Pt was given Vaccines at 10:45AM on 6/24/19. She was carrying on a conversation per normal before, during and after the vaccines were given. Pt was still sitting on the exam table, before leaving the room @ 10:50 AM, asked pt if she felt ok at this point she looked pale, and she verbalized that she felt lightheaded and advised her to lay on the table, as this nurse told the pt to lay back pt started falling forward and fainted. She fell off the exam table onto her head, help was called for, multiple ppl came to the room to assist, 911 was called. after fall pt was incoherent for about 15-30 seconds and appeared to be shaking, pt verbalized that she did black out at somepoint. Ambulance came within 10 minutes to the scene and took pt to the ER. ER report states that she had a syncope episode, no seizure activity noted per ER dr.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Loss of consciousness, Nausea, Pain in extremity, Vomiting
Clinical narrative: Seen at around 11:30 for WCC received  2 vaccines - meningococcal B and Menveo . Patient stated and waited 15minutes after vaccines administered. Patient left office and denied any signs or symptoms of reaction. Mom states on way home he complained his left arm felt sore. This was the arm he received the MenB in.  He did feel nauseated at the time. Mom states he took at nap when getting home. Later in the afternoon around  4:10 he begin to vomit and he passed out. His older sibling call 911 and EMT came and checked him out. Pt vomited again while EMT was present but vitals were WNL and patient  was fine. Patient complained of headache the remainder of the day.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Hypokalaemia, Ventricular extrasystoles
Clinical narrative: Patient reported to ED complaining of chest pressure. Has a previous hx. of abnormal EKG's and chest pain.  Patient also had PVCs and Hypokalemia at the ED visit.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Discomfort, Feeling abnormal, Headache, Hyperaesthesia
Clinical narrative: Got much sicker second time around with the flu.  Other than arm pain at vaccine site along with later skin sensitivity all over my body (as before),  I was sick to my stomach with bad headache and overall body pain and weakness.  Couldn't sleep the whole night due to discomfort and pain and nausea.  [Once i learned that there can be bad reactions to this vaccine, I figured I would just need to wait it out.]  I still don't quite feel right, like feel weak with occasional slight nausea, but don't know if that's from any lingering effect of the vaccine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Insomnia, Nausea, Pain, Vaccination site pain
Clinical narrative: Got much sicker second time around with the flu.  Other than arm pain at vaccine site along with later skin sensitivity all over my body (as before),  I was sick to my stomach with bad headache and overall body pain and weakness.  Couldn't sleep the whole night due to discomfort and pain and nausea.  [Once i learned that there can be bad reactions to this vaccine, I figured I would just need to wait it out.]  I still don't quite feel right, like feel weak with occasional slight nausea, but don't know if that's from any lingering effect of the vaccine.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: Shingles diagnosed at local Urgent Care on 6/25/2019.  Rash and blisters on upper left chest just next to injection site.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Shingles diagnosed at local Urgent Care on 6/25/2019.  Rash and blisters on upper left chest just next to injection site.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Anxiety, Asthenia, Herpes zoster, Hypersensitivity, Injection site pain
Clinical narrative: Shingles diagnosed at local Urgent Care on 6/25/2019.  Rash and blisters on upper left chest just next to injection site.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Shingles diagnosed at local Urgent Care on 6/25/2019.  Rash and blisters on upper left chest just next to injection site.
Age: 21.0
Sex: F
Vaccine: HPV9, TD
Symptoms: Fatigue, Oropharyngeal pain, Pyrexia, Streptococcus test negative
Clinical narrative: Fever (<100 F), sore throat, fatigue 1 d after vaccination. Exact sx per pt last year after 1+PV9 #1.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain, Crying, Dyspnoea, Hypersensitivity, Urticaria
Clinical narrative: 6/25/19 - 2:30pm: patient received vaccinations in office. 6/25/19 - 3:30pm: Mom called stating patient crying and saying that his belly hurt.  was instructed to monitor for rash/hives, any wheezing or difficulty breathing. 6/25/19 - 4:13pm: Mom called back stating that patient now with hives in his groin and c/o difficulty breathing, they were already in the car heading to our office or ER.  Per Dr. family was advised to go straight to nearest ER, they were 5-10mins from Hospital. 6/25/19 - 4:56pm: Triage nurse called mom to f/u.  Pt was in ED, IV was placed and getting ready to receive Benadryl.  Breathing issue had calmed down at this point.  Mom not sure of exact ER plan at this time. 6/26/19 - 9:23am: Triage nurse called mom to f/u.  Per mom patient was doing better this morning.  Was told that he had some type of allergic reaction to one of the immunizations but unable to pinpoint which one.  In ED was given IV Benadryl, Prevacid and a steroid.  Prescribed Prednisone for 5 days.  Per Dr. was instructed to take either Zyrtec or Benadryl today.  Take the steroids for 3 days, and do the full 5 day course of the steroid if any symptoms recur.  Instructed to f/u with allergist, allergy number given.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Full body rash that itches. We were told by the doctor?s office to stay home until rash goes away.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 82-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 08-DEC-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) by a heath provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of herpes zoster was not reported. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; improperly stored VARIVAX; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 14-JUN-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number R035226 with expiration date in 04-DEC-2020 (strength, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot number, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; improperly stored VARIVAX; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 17-JUN-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number R035226 with expiration date in 04-DEC-2020 (strength, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot number, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: