chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Product administered at inappropriate site
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 19-year-old female patient. The patient had no pertinent medical history, concomitant medications, drug reactions and allergies. On 21-AUG-2018, the patient was vaccinated with PNEUMOVAX 23, intramuscularly in an unspecified hip, lot# R007722, expiration date 10-MAR-2020 (also reported as lot# N024717, expiration date: 30-APR-2019 but it was confirmed that lot# R007722 was administered to the patient) for prophylaxis. On an unknown date in August 2018, the patient developed swelling and erythema with a yellow cnter the size of "50 cent piece" at the injection site. The patient sought medical attention via an emergency room visit and was given an unspecified treatment for the events. No lab diagnostic testes were performed. The outcome of the events was reported as not recovered. The relatedness between the events and vaccination with PNEUMOVAX 23 was not reported.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Injection site nodule
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a 64-year-old female patient who received SHINGRIX (batch number L9CS4, expiry date 22nd February 2021) for prophylaxis. On 28th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced local swelling and injection site tenderness. On an unknown date, the outcome of the local swelling was unchanged and the outcome of the injection site tenderness was unknown. It was unknown if the reporter considered the local swelling and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that the patient experienced a lump on aspect of arm in bicep area after receiving second dose of SHINGRIX. The healthcare professional also reported that the patient experienced tenderness at the injection however was more concerned at the lump which developed. No further information was reported regarding the event.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Mass, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a 64-year-old female patient who received SHINGRIX (batch number L9CS4, expiry date 22nd February 2021) for prophylaxis. On 28th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced local swelling and injection site tenderness. On an unknown date, the outcome of the local swelling was unchanged and the outcome of the injection site tenderness was unknown. It was unknown if the reporter considered the local swelling and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that the patient experienced a lump on aspect of arm in bicep area after receiving second dose of SHINGRIX. The healthcare professional also reported that the patient experienced tenderness at the injection however was more concerned at the lump which developed. No further information was reported regarding the event.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Mobility decreased, Musculoskeletal pain, Pain, Peripheral swelling
Clinical narrative: Entire shoulder, upper arm grossly swollen, very hard, painful to touch and unable to move arm,  shoulder without excrutiating pain.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Entire shoulder, upper arm grossly swollen, very hard, painful to touch and unable to move arm,  shoulder without excrutiating pain.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Extreme aching, headache, chills, really sore arm.
Age: 34.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site pain, Muscular weakness, Pain, Weight bearing difficulty
Clinical narrative: Ongoing weakness of left arm, and pain in left arm where TDAP injection happened. Pain shooting from site of injection to elbow. Reports that it started after injection. She is unable to lift newborn infant. Reported this pain at her postpartum checkup. Referred to physical therapy.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Feeling cold
Clinical narrative: Cold to the point of shivering uncontrollably, headache, aching joints, fatigue; after that, fever, weakness, general malaise.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: Cold to the point of shivering uncontrollably, headache, aching joints, fatigue; after that, fever, weakness, general malaise.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Eye movement disorder, Ophthalmological examination normal, Vision blurred
Clinical narrative: About a week after pt received the immunization, she began to complain of her eyes "shaking back and forth" and immediately having blurred vision. She reported the shaking to be a few seconds and the blurred vision to last a min or so, sometimes longer. She reported it happening at least twice per hour, sometimes more. No other symptoms reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored M-M-R II rHA (recombinant Human albumin) (lot # N023024, Expiry date : 23-AUG-2019) 1 DF for prophylaxis (product storage error). It was reported that the vaccine experienced a temperature excursion of 47 degrees Fahrenheit (F) up to 77 degrees F for 1 hour 20 minutes, multiple excursion was involved. There was previous temperature excursion of 47 degrees Fahrenheit (F) up to 77 degrees F and 51.9 degrees F for 4 hours 24 minutes. The call was due to data logger. No adverse effects were reported. No product quality complaint was involved.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician assistant referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. The patient was allergic to ceftriaxone (ROCEPHIN). Concomitant therapies included albuterol sulfate(PROAIR). On 31-AUG-2018 the patient was vaccinated with GARDASIL 9 injection for routine vaccination (dosing details, route and lot/batch# not reported). On 02-SEP-2018 (also reported as two days after the vaccination), the patient had a confirmed pregnancy test. The patient became pregnant with Last Menstrual Period of 27-JUL-2018 and Estimated Date of Delivery of 03-MAY-2019. Initial exposure to GARDASIL 9 was at 5 weeks. The pregnancy outcome was outcome pending.
Age: 0.17
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from the nurse regarding a 2 year old patient of unknown gender. Information on patient's pertinent medical conditions, concomitant medication and drug reactions or allergies was not reported. On 27-AUG-2018, the patient was vaccinated with GARDASIL 9 (dosing details were not reported) lot # N035955, expiry date: 09-OCT-2020 for prophylaxis instead of PEDVAXHIB. No adverse effect reported. No product quality complaint involved.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported similar event for 3 patients. This is the first of 3 reports. A patient of unspecified age and gender received TRUMENBA via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced passing out. At the time of the report, the outcome of the event was unknown. The information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018357772 similar report from same reporter; US-PFIZER INC-2018357773 similar report from same reporter.
Sex: U
Vaccine: MENB
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported similar event for 3 patients. This is the second of 3 reports. A patient of unspecified age and gender received TRUMENBA via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced passing out. At the time of the report, the outcome of the event was unknown. The information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018353910 similar report from same reporter; US-PFIZER INC-2018357773 similar report from same reporter.
Sex: U
Vaccine: MENB
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported similar events for 3 patients. This is 3rd of 3 reports. A patient of unknown age and gender received TRUMENBA at single dose on unknown date for immunization. Relevant medical history and concomitant medications were unknown. On unknown date the patient passing out. The outcome of the event was unknown. Information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018357772 same reporter, same event and drug, different patient; US-PFIZER INC-2018353910 same reporter, same event and drug, different patient
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Back pain, Chills, Diarrhoea, Dyspnoea
Clinical narrative: Pain at injection, formed a knot and moves up to shoulder. Shoulder pain for 2 days. At 4am on sept 6. Violent vomiting, diarrhea, chills, back pain, sweats, shortness of breath, intense stomach cramps.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Injection site nodule, Injection site pain, Musculoskeletal pain, Vomiting
Clinical narrative: Pain at injection, formed a knot and moves up to shoulder. Shoulder pain for 2 days. At 4am on sept 6. Violent vomiting, diarrhea, chills, back pain, sweats, shortness of breath, intense stomach cramps.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site nodule, Local reaction, Rash papular
Clinical narrative: Patient given HPV vaccine on Friday 08/31/2018. Initially developed a localized reaction (nodule) in the injection site. Later he developed papular rashes on the right  upper eye lid, trunk, neck and chest, thighs and legs. No shortness of breathing. The rash was developed after one day after the shot was given.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient called and reported she had a fever and redness, pain, and swelling at the injection site that started the day after the injection and continued for 3-4 days. Sore knot then developed. Instructed to come in for evaluation if symptoms persisted or she had any concerns about the site.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Blood glucose, Blood magnesium, Drug level, Full blood count
Clinical narrative: Complained of Red rash, sore at injection site. Started 1 day after injection. Feels weak.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Metabolic function test, Rash erythematous
Clinical narrative: Complained of Red rash, sore at injection site. Started 1 day after injection. Feels weak.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Seizure, Syncope
Clinical narrative: 11:12AM Patient was receiving third shot when had a syncopal episode. I asked dad to help me to raise his legs while I held him. When dad got closer to him and was talking to him he was convulsing for less than 30 seconds. He recovered rapidly. Patient did not have anything to eat prior to receiving the vaccine. Provider was made aware of the incident.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Flu vaccine was administered in the morning on an empty stomach and patient passed out, called EMT services and primary MD was informed about the incident.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Decreased appetite, Diarrhoea, Diet refusal, Somnolence
Clinical narrative: Markedly decreased appetite, refusal to drink, loose stools, increased sleepiness.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Feeling abnormal, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Complained of chills, fever and feeling "really bad". Red, painful at injection site.
Age: 12.0
Sex: M
Vaccine: HPV9, MENB, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine was administered.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Dehydration, Fatigue, Injected limb mobility decreased, Injection site erythema, Pain
Clinical narrative: Woke up in the early hours of the next morning with my right arm throbbing. During the next 3 days physically I was so tired and dragging myself around. My right arm started with a slight rash and at the height, probably Saturday Sept 1, had extreme difficulty in raising my right arm and had a hot red spot covering about 4" around the injection spot. I slept for most of the time until Monday September 3rd. And until Wednesday I was mostly tired but forcing myself to stay away.   Today is Thursday September 6th my arm is still tender but at least I am awake. FYI I was also dehydrated for most of the time.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity, Rash, Tenderness
Clinical narrative: Woke up in the early hours of the next morning with my right arm throbbing. During the next 3 days physically I was so tired and dragging myself around. My right arm started with a slight rash and at the height, probably Saturday Sept 1, had extreme difficulty in raising my right arm and had a hot red spot covering about 4" around the injection spot. I slept for most of the time until Monday September 3rd. And until Wednesday I was mostly tired but forcing myself to stay away.   Today is Thursday September 6th my arm is still tender but at least I am awake. FYI I was also dehydrated for most of the time.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Feeling abnormal, Feeling cold, Lethargy, Pain in extremity
Clinical narrative: I work out at a gym 3 times a week so am in good health. Last night I was very cold while sleeping. I like my house cool and the A/C runs 24 hrs per day. I'm never cold. I was cold last night and had to dig out a comforter to put over the sheet that I normally use. Never really got warm. This morning I have no energy and am lethargic. Arm is a bit sore but that is nothing. Just feel "hazy". No energy. Probably not that unusual reaction. When I had the first shot a few months ago I never experienced any adverse effects. Probably just my body doing its thing with the vaccine but thought I better report it anyhow. I am not in dire straits. Probably will take a couple of days to get back to normal.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 08-AUG-2018, the patient was inadvertently vaccinated intramuscularly with M-M-R II (recombinant human albumin) lot # N023150 with expiration date on 24-AUG-2019 (dose was not reported) for prophylaxis. The patient said that after administration (on the same day), the injection site stung. The patient did not seek medical attention and no treatment was given. She did not require hospitalization. The stinging went away and the patient recovered (on 08-AUG-2018). The causality assessment between the event and M-M-R II was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an office administrator (also reported as: medical assistant) refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 20-APR-2015 the patient was vaccinated with first dose of vaccination series with GARDASIL HPV-4 (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. On 13-AUG-2018, the patient was vaccinated with second dose of vaccination series with GARDASIL 9 0.5 ml/once (lot # R001263, expiry date: 10-NOV-2020) intramuscularly for prophylaxis. No adverse effects were reported. No product quality complaint was involved. Lot number [R001263] has been verified to be a valid lot number for GARDASIL 9.
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Headache
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VAQTA injection, 25/0.5 (units not provided) for prophylaxis (frequency, route of administration, lot #, expiration date were not reported). On an unknown date, the patient after administration of the vaccine began to experience headaches and stomachaches. The outcome of the events and causality relatedness was not reported.
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Musculoskeletal stiffness, Neck pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient's friend). A 10-decades-old female patient (reported as in her 90's) received PREVNAR 13, via an unspecified route of administration on 30Aug2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had some problems with her arm movement, as well as pain, and stiffness in her neck on an unspecified date in 2018. The patient wanted to know if limitation of arm movement was a common side effect with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). Outcome of the events was unknown. No follow up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Day after administration, right upper anterolateral arm with 80 mm x 110 mm area of erythema, equiv increase in warmth. Non-tender. No palpable mass.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Myalgia, Nausea
Clinical narrative: 11 hours after injection starting having headache, muscle aches, nausea, fatigue. Lasted about 2-3 days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient said she had warmth, redness, swelling, severe itching for a week at injection site (resolved on it's own). MD does not want patient to receive 2nd dose.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The morning after the vaccine was administered, pt woke up at 0600 and noticed red, warm circle around injection site. Pt states the area is tender. Does not impair movement or function of arm. At 1115am I assessed the site and it measured 6cm x 6cm, was reddened and warm to touch. No palpable areas of swelling. Pt states pain is mild. Encouraged cold compresses if needed and to seek further medical care if reaction worsens or does not improve in the next 2-3 days.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever to 102 rectally. Fever responded to TYLENOL. No other symptoms reported.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site cellulitis, Injection site warmth
Clinical narrative: The left arm was with a large area of cellulitis that is hot to touch with no pustules. There is a puncture site from vaccine to the superior, proximal boarder of cellulitis to the deltoid region.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pain
Clinical narrative: Patient describes reaction as a rash at the injection site and she experienced "pain all over" her body.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Inflammation, Nausea, Peripheral swelling, Skin warm
Clinical narrative: Mild nausea on 9/5/18. Left arm swelling, redness, warmth on 9/5/18 and 9/6/18. Recommended ice and Ibuprofen for inflammation.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Swelling
Clinical narrative: Pt describes 3 inch circumference of swelling. Site feels like it may be an allergic reaction.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Excessive eye blinking, Hypotension, Loss of consciousness, Malaise
Clinical narrative: After giving the last injection which was HPV patient stated she didn't feel well and then her eyes fluttered then she passed out. Patients mom was standing next to her and caught her we laid her down and she woke up instantly. I gave patient some water when she felt better she sat back up I took her BP which was very low I let PA know what was going on and she advised I let the patient sit an extra 15 minutes on top of the 15 she was already doing and check BP again. I continued to check on patient and she felt fine although BP was still low patient was feeling fine and was released to go home told to rest and drink a lot of fluids.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Febrile seizure, lasted 2-3 minutes. Seen at ER. Tmax 105.3.
Age: 71.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Cough, Exercise tolerance decreased, Fatigue, Headache
Clinical narrative: Received PNEUMOVAX 23 in right arm and SHINGRIX (second dose) in left arm on same day. Within 12 hours, began having flu-like symptoms (myalgias, lethargy, headache, low grade fever) and extremely sore injection site area. I'd had similar but milder symptoms after the first SHINGRIX injection. At about 14 hours, I developed shaking chills over about a 2 hour period, interfering with sleep. At around 24 hours I noted some cough, nasal congestion, and exercise intolerance. Headache continued up to about 36 hours. Fatigue lasted until nearly 48 hours, then most symptoms had cleared.
Age: 71.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Influenza like illness, Injection site pain, Lethargy, Myalgia, Nasal congestion
Clinical narrative: Received PNEUMOVAX 23 in right arm and SHINGRIX (second dose) in left arm on same day. Within 12 hours, began having flu-like symptoms (myalgias, lethargy, headache, low grade fever) and extremely sore injection site area. I'd had similar but milder symptoms after the first SHINGRIX injection. At about 14 hours, I developed shaking chills over about a 2 hour period, interfering with sleep. At around 24 hours I noted some cough, nasal congestion, and exercise intolerance. Headache continued up to about 36 hours. Fatigue lasted until nearly 48 hours, then most symptoms had cleared.
Age: 71.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pyrexia, Sleep disorder, Tremor
Clinical narrative: Received PNEUMOVAX 23 in right arm and SHINGRIX (second dose) in left arm on same day. Within 12 hours, began having flu-like symptoms (myalgias, lethargy, headache, low grade fever) and extremely sore injection site area. I'd had similar but milder symptoms after the first SHINGRIX injection. At about 14 hours, I developed shaking chills over about a 2 hour period, interfering with sleep. At around 24 hours I noted some cough, nasal congestion, and exercise intolerance. Headache continued up to about 36 hours. Fatigue lasted until nearly 48 hours, then most symptoms had cleared.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Feeling hot, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer. A 68-year-old female patient of an unspecified ethnicity received PREVNAR 13, (Lot # T52790, Exp date Jan2020) via an unspecified route of administration at 0.5 ml, single on 23Aug2018 for immunisation, administered at pharmacy. Medical history included high blood pressure and hypothyroidism, both diagnosed many years before and ongoing. There were no concomitant medications. On 29Aug2018 the patient experienced like cellulitis and is hot, the area was red and swollen up. The outcome of the events was not recovered. There were relevant tests. She will see the doctor about 31Aug2018. She was putting ice on the area in the morning, lunch, and in the evening. She said that she was also taking Naprosen 500mg 3 times a day and an antibiotic CLEOCIN 300mg. Information about lot number already provided.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a patient's mother who referred to her daughter the female patient of an unknown age. the patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. In July 2018, the patient was vaccinated with the second dose of M-M-R II injection (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On unknown dates in 2018, the patient had unspecified tests performed that showed titers were still negative. No other symptoms or specifics were provided. There was no treatment given for the event. At the time of this report, the outcome of the event was reported as not recovered. The causality assessment between the event and  M-M-R II was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date (reported as "several years ago"), the patient was vaccinated with GARDASIL 9 (route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) for prophylaxis, and was currently in the office now for her second dose. No adverse effects were reported in the patient. This is a non-valid case due to no patient identifiers.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Drug effect incomplete
Clinical narrative: This spontaneous report as received from a female patient of unknown age consumer regarding herself. The patient's concurrent conditions, medical history, concomitant medications and drug reaction/ allergies were not reported. On an unknown date, the patient was vaccinated with as stated "an unknown "chicken-pox" vaccine"(manufacturer unknown) for prophylaxis (strength, frequency, route of administration and lot number of all suspected vaccines were not reported).   On an unknown date, the patient's body basically did not have an effective immune response to the vaccination because she said she only became "65 percent immune" to the varicella virus". The outcome of drug effect incomplete and the causality assessment with the unspecified chicken pox vaccine were unknown.
Age: 0.25
Sex: M
Vaccine: IPV, PNC13, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Ileocolic Intussusception Symptoms: Vomitting and blood in stool Time course: 12 hours. Was sent to Hospital - intussusception confirmed by abdominal ultasound. Air contrast enema reduced intussusception.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site bruising, Injection site swelling
Clinical narrative: Swelling, bruising, at site of injection, given sub Q Rather than IM.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Eyelid oedema, Lacrimation increased, Pruritus, Rash, Rhinorrhoea
Clinical narrative: Approximately 20-30 minutes post vaccine, he developed itching, a rash on his arms and legs. His sclera became inflamed, eyelids swollen. Nose runny and eyes were watery. No difficulty breathing, or swallowing and no vomiting. His symptoms resolved fairly quickly with oral BENADRYL. We do not have his previous records, but mom reports he has had one every year due to a history of asthma.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Scleral disorder
Clinical narrative: Approximately 20-30 minutes post vaccine, he developed itching, a rash on his arms and legs. His sclera became inflamed, eyelids swollen. Nose runny and eyes were watery. No difficulty breathing, or swallowing and no vomiting. His symptoms resolved fairly quickly with oral BENADRYL. We do not have his previous records, but mom reports he has had one every year due to a history of asthma.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Induration, Pain, Swelling
Clinical narrative: Patient received PNEUMOVAX 23 on 09/04/18 and started having pain in the night. The next day he noticed the pain was so bad that he couldn't lay on it. It started to feel hard and it was burning. It was red and swollen. Today 09/06/18 he came to the pharmacy to report the incident. He said the redness and swelling has spread even further. He says he doesn't feel burning today.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pain, Pyrexia
Clinical narrative: Extreme chills/fever, body aches, headache, stomach upset.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: The next morning after the vaccination pt had a sore arm and felt achy with chills but remained at work. No problems until 4 days later. Pt hands felt sl. swollen and like they were on fire. After that she noticed 2 blister-like welts about the size of a silver dollar on the top of her legs. They faded away after a short time. For the next 3 days (about once a day) pt. would feel like her hands were on fire and then she would notice a group of "welts" ranging in size from 6 mm to 1-2 mm that would appear on her arms, legs, buttocks either on top or on inner aspect of the limb. They would fade away after short time. She did not see a physician but took oral BENADRYL and spray BENADRYL for the welts. It seemed to help. They didn't hurt or itch but seemed to appear after a hot shower and once after working outside in 90 degree weather. After Sept 3, 2018 the pt. had no further problems.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: The next morning after the vaccination pt had a sore arm and felt achy with chills but remained at work. No problems until 4 days later. Pt hands felt sl. swollen and like they were on fire. After that she noticed 2 blister-like welts about the size of a silver dollar on the top of her legs. They faded away after a short time. For the next 3 days (about once a day) pt. would feel like her hands were on fire and then she would notice a group of "welts" ranging in size from 6 mm to 1-2 mm that would appear on her arms, legs, buttocks either on top or on inner aspect of the limb. They would fade away after short time. She did not see a physician but took oral BENADRYL and spray BENADRYL for the welts. It seemed to help. They didn't hurt or itch but seemed to appear after a hot shower and once after working outside in 90 degree weather. After Sept 3, 2018 the pt. had no further problems.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Patient complained of fever 1one day past immunization along with general malaise, dizziness, and weakness. Two days past immunization, patient noticed redness, swelling, and whelps at injection site. States she self treated with BENADRYL and pain relievers.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Pyrexia
Clinical narrative: Patient complained of fever 1one day past immunization along with general malaise, dizziness, and weakness. Two days past immunization, patient noticed redness, swelling, and whelps at injection site. States she self treated with BENADRYL and pain relievers.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Inflammation, Peripheral swelling, Rash
Clinical narrative: Rash lower down on arm from injection site (inflammation, redness, swelling).
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Rash erythematous
Clinical narrative: The evening of 9/04/2018 Pt started with a moderate red rash on abdomen, groin, left and right arms.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Flu vaccine was administered in the morning on an empty stomach and patient passed out/informed primary MD.
Age: 27.0
Sex: F
Vaccine: TYP
Symptoms: Erythema, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Pyrexia
Clinical narrative: Reaction with fever, neck and shoulder pain and stiffness, redness and swelling to face and upper body. No meningismus. No weakness or neurological deficits. Got better with Benadryl 50mg IM. Will be continued on Claritin 10mg 1 tablet daily x 7 days.
Age: 27.0
Sex: F
Vaccine: TYP
Symptoms: Swelling face
Clinical narrative: Reaction with fever, neck and shoulder pain and stiffness, redness and swelling to face and upper body. No meningismus. No weakness or neurological deficits. Got better with Benadryl 50mg IM. Will be continued on Claritin 10mg 1 tablet daily x 7 days.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Decreased appetite, Exposure during pregnancy, Fatigue
Clinical narrative: I was receiving Tdap on my 3rd trimester of pregnancy (EDD: 10/31/2018). Within 30 minutes I developed severe fatigue, followed by fever (101), tachycardia (HR 140-150's), myalgia, arthralgias, nausea, vomiting, pain on site of injection, bruising on site of injection, severe headache, body aches, lethargy, lack of appetite, and chills. I had to be hospitalized for 2 days.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site bruising, Injection site pain, Lethargy, Liver function test increased
Clinical narrative: I was receiving Tdap on my 3rd trimester of pregnancy (EDD: 10/31/2018). Within 30 minutes I developed severe fatigue, followed by fever (101), tachycardia (HR 140-150's), myalgia, arthralgias, nausea, vomiting, pain on site of injection, bruising on site of injection, severe headache, body aches, lethargy, lack of appetite, and chills. I had to be hospitalized for 2 days.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nausea, Pain, Pyrexia, Tachycardia
Clinical narrative: I was receiving Tdap on my 3rd trimester of pregnancy (EDD: 10/31/2018). Within 30 minutes I developed severe fatigue, followed by fever (101), tachycardia (HR 140-150's), myalgia, arthralgias, nausea, vomiting, pain on site of injection, bruising on site of injection, severe headache, body aches, lethargy, lack of appetite, and chills. I had to be hospitalized for 2 days.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: I was receiving Tdap on my 3rd trimester of pregnancy (EDD: 10/31/2018). Within 30 minutes I developed severe fatigue, followed by fever (101), tachycardia (HR 140-150's), myalgia, arthralgias, nausea, vomiting, pain on site of injection, bruising on site of injection, severe headache, body aches, lethargy, lack of appetite, and chills. I had to be hospitalized for 2 days.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Discomfort, Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Red and raised area. Warm and tender to touch. Complained of discomfort to area. Advised patient to follow up at ED for further evaluation.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Headache, Hypersomnia, Injection site induration
Clinical narrative: Painful headache on right side of head that radiated to neck, lasting 3 days. Extreme malaise for 2 days - patient reported sleeping most of the day for the 2 days following the vaccine (would not have been able to work; had trouble doing regular house hold chores - cooking dinner, etc.). Imbalance/dizziness for 2 days (patient reports of feeling her equilibrium was "off"). Painful hard spot at location of vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Malaise, Neck pain
Clinical narrative: Painful headache on right side of head that radiated to neck, lasting 3 days. Extreme malaise for 2 days - patient reported sleeping most of the day for the 2 days following the vaccine (would not have been able to work; had trouble doing regular house hold chores - cooking dinner, etc.). Imbalance/dizziness for 2 days (patient reports of feeling her equilibrium was "off"). Painful hard spot at location of vaccine.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Allergy test positive, Asthenia, Dizziness, Dysphagia, Dyspnoea
Clinical narrative: Pt received vaccine on 8/23/18- pt noticed 1 hive on 8/24/18-noticed increased hives on 8/27/18-pt felt weak and dizzy-had trouble swallowing-went to ER and was given epinephrine and prednisone-sent home with prednisone, BENADRYL and ZANTAC. Pt continued to have hives-seen in our office 8/29/18-went back into the ER 8/29/18 evening because of increased hives and trouble breathing-In ER was given BENADRYL and observed. Pt was sent home and continued with BENADRYL and tapering the prednisone. We drew labs for allergies when in our office 8/29-results positive for food allergies and referred to allergist.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Pt received vaccine on 8/23/18- pt noticed 1 hive on 8/24/18-noticed increased hives on 8/27/18-pt felt weak and dizzy-had trouble swallowing-went to ER and was given epinephrine and prednisone-sent home with prednisone, BENADRYL and ZANTAC. Pt continued to have hives-seen in our office 8/29/18-went back into the ER 8/29/18 evening because of increased hives and trouble breathing-In ER was given BENADRYL and observed. Pt was sent home and continued with BENADRYL and tapering the prednisone. We drew labs for allergies when in our office 8/29-results positive for food allergies and referred to allergist.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Pruritus
Clinical narrative: Systemic itching and redness and headache. The vaccine I received is listed as "Inactivated Influenza Vaccine", so I am not sure how it fits with categories given under Vaccine.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Initial information received on 17-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional, Nurse. This case involves a 5 years old male patient who came to receive to DTAP but mistakenly given PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No Concomitant medication received. On 07-Jul-2017, patient received 0.5 ml single dose of PENTACEL (lot: C5456AA) via intramuscular route in left leg. It was also a case of actual medication error due to wrong vaccine administered as patient received PENTACEL instead of DTAP and extra dose administered as received extra dose of ACT-HIB. It was not reported if adverse event occurred 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.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concurrent, historical conditions and concomitant medications were not provided. On 29-AUG-2018, the patient was vaccinated with properly stored but expired M-M-R II (lot number: M029918 with an expiration date 13-JUN-2018) for prophylaxis. No adverse effects were reported.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Erythema, Gait disturbance, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 59-year-old male patient who received BOOSTRIX (batch number 9GM3R, expiry date 20th January 2020) for prophylaxis. On 21st May 2018, the patient received the 1st dose of BOOSTRIX. In May 2018, 2 days after receiving BOOSTRIX, the patient experienced knee pain, walking difficulty, swelling of knees, swelling of legs and redness of legs. On 22nd May 2018, the patient experienced injection site swelling and injection site erythema. The patient was treated with prednisone. On an unknown date, the outcome of the injection site swelling and swelling of knees were recovering/resolving and the outcome of the knee pain, walking difficulty and injection site erythema were not recovered/not resolved and the outcome of the swelling of legs and redness of legs were unknown. It was unknown if the reporter considered the injection site swelling, knee pain, walking difficulty, injection site erythema, swelling of knees, swelling of legs and redness of legs to be related to BOOSTRIX. Additional details were reported as follows: The caller was wife of the patient. The patient received BOOSTRIX on right arm. The day after the patient experienced arm swelling and redness at the site. The day after that the patient had swelling and redness of his right thigh and his knee was painful and swollen. The patient had difficulty walking as well. The patient was seen at urgent care and received prednisone to help reduce the swelling. The patient had since then experienced pain and swelling in his other knee, ankles and wrists. She stated the swelling had reduced but the pain remained. He had been prescribed pain medication from his physician. The wife reported she believed the issues were worse because they were moving around. She added the initial joint pain in his right knee was not as bad, but he was still limping when he walked. She stated at the reporting time it was the other knee and the pain in the wrists comes and goes.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 59-year-old male patient who received BOOSTRIX (batch number 9GM3R, expiry date 20th January 2020) for prophylaxis. On 21st May 2018, the patient received the 1st dose of BOOSTRIX. In May 2018, 2 days after receiving BOOSTRIX, the patient experienced knee pain, walking difficulty, swelling of knees, swelling of legs and redness of legs. On 22nd May 2018, the patient experienced injection site swelling and injection site erythema. The patient was treated with prednisone. On an unknown date, the outcome of the injection site swelling and swelling of knees were recovering/resolving and the outcome of the knee pain, walking difficulty and injection site erythema were not recovered/not resolved and the outcome of the swelling of legs and redness of legs were unknown. It was unknown if the reporter considered the injection site swelling, knee pain, walking difficulty, injection site erythema, swelling of knees, swelling of legs and redness of legs to be related to BOOSTRIX. Additional details were reported as follows: The caller was wife of the patient. The patient received BOOSTRIX on right arm. The day after the patient experienced arm swelling and redness at the site. The day after that the patient had swelling and redness of his right thigh and his knee was painful and swollen. The patient had difficulty walking as well. The patient was seen at urgent care and received prednisone to help reduce the swelling. The patient had since then experienced pain and swelling in his other knee, ankles and wrists. She stated the swelling had reduced but the pain remained. He had been prescribed pain medication from his physician. The wife reported she believed the issues were worse because they were moving around. She added the initial joint pain in his right knee was not as bad, but he was still limping when he walked. She stated at the reporting time it was the other knee and the pain in the wrists comes and goes.
Age: 5.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Circumstance or information capable of leading to medication error, Drug administered to patient of inappropriate age, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 5-year-old female patient who received MENVEO for prophylaxis. Co-suspect products included BEXSERO for prophylaxis. Concomitant products included HAVRIX. On 23rd August 2018, the patient received MENVEO and BEXSERO. In August 2018, 12 hrs after receiving MENVEO and not applicable after receiving BEXSERO, the patient experienced injection site erythema and injection site swelling. On 23rd August 2018, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to MENVEO. Additional details were reported as follows: The patient received BEXSERO and MENVEO in the mid right lateral thigh and HAVRIX in her left thigh. The patient received BEXSERO at 5 years of age, which led to inappropriate age at vaccination. The patient's mother called the office concerned that, on 24th August 2018, the patient experienced 2 inch localized reaction of redness and swelling. The health care professional (HCP) mentioned that, the patient was on a catch-up schedule as she was adopted. The HCP was concerned because she didn't know whether it would be a typical local reaction or whether it could be a bruise forming or a hematoma since the patient wasn't cooperating and was kicking her legs while she was being administered the vaccines.  The HCP didn't have the lot or expiration date at the reporting time.