chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain
Clinical narrative: Patient said he  started having chills and all-over body aches on the evening of the day he got the vaccines. He said the injection site of the Pneumovax23 was swollen and red. He put a thermometer on the site at the reading was 102 degrees. He stated he took his temperature orally and it was 101.6. He took Tylenol and his body temperature returned to normal but the injection site remained inflammed and hot to the touch. On 9/17/20 he was not feeling any better and sought care at Urgent Care. He was given Diphenhydramine 50mg, 2 adult Tylenol tablets and a prescription for Clindamycin 300mg. I spoke with him today (9/18/20) and he said his arm was still red but "not as puffy and swollen." He said he was instructed to continue to take Benadryl and to seek medical attention at the emergency room if the redness expanded outside the line drawn on his arm. He said the redness was outside the line but he is feeling much better and the swelling was subsiding.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: My arm was still sore the next day from the shot. Over the next few weeks it continued to be sore in the muscle/ upper area. I really don't run to the doctor over every ache and pain, after all I'm 71-72 and it's to be expected.  My wife also received the shot at the same time I did. I had a pre-op appointmenet with my doctor in April so I mentioned it to him that my arm was still sore after approx. two months after I got the flu shot. He ordered an xray and mri. Based on the results he referred my to the Institue. They recommended physicla therapy which I'm doing.  My arm still hurts  y arm still hurst rer rm still hurstti  r
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: PT CAME TODAY AND REPORTED  THAT SHE HAS STARTED EXPERIENCING PAIN ON HER HAND WHERE SHE RECEIVED VACCINE ON 09/13 . SHE STATED SHE DID NOT HAVE ANY PAIN WHEN SHE RECEIVED VACCINE ON 8/6.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around treatment area. redness spreading lower to elbow
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure decreased, Dyspnoea, Hyperhidrosis, Nausea, Tremor
Clinical narrative: It is reported that appx 10 minutes after receiving vaccine, client complained of shortness of breath, was diaphoretic, and complained of nausea before vomiting. BP was reported to be apprx 172/95 with pulse in 90's. Patient continued to be short of breath. Nurse administered 0.5 mg of epinephrine and called 911. It is reported that near immediately, the client began to breathe easier, color returned and while a bit shaky called her family. Client was at medical facility so oxygen at 2 liter/min was applied. Supervisor had a portable pulse oxyimeter and reported that O2 sats were 98/99 during the entire event. It is reported that BP dropped down a bit but exact number were not provided. EMS arrived and took client to the hospital. It is reported that she was in no apparent distress when leaving the clinic.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: It is reported that appx 10 minutes after receiving vaccine, client complained of shortness of breath, was diaphoretic, and complained of nausea before vomiting. BP was reported to be apprx 172/95 with pulse in 90's. Patient continued to be short of breath. Nurse administered 0.5 mg of epinephrine and called 911. It is reported that near immediately, the client began to breathe easier, color returned and while a bit shaky called her family. Client was at medical facility so oxygen at 2 liter/min was applied. Supervisor had a portable pulse oxyimeter and reported that O2 sats were 98/99 during the entire event. It is reported that BP dropped down a bit but exact number were not provided. EMS arrived and took client to the hospital. It is reported that she was in no apparent distress when leaving the clinic.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Hyperhidrosis, Loss of consciousness, Pyrexia
Clinical narrative: Patient received vaccine around 2pm and by about 8pm was experiencing fever, chills, and sweating. Tthoughout the night she had bad sweats and high fever. Following morning patient states she passed out.
Age: 0.42
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: adult dose of hepatitis  b vaccine energix B given to pediatric patient no known adverse reaction at this time.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe arm pain with limited mobility
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Abdominal discomfort, Chills, Dizziness, Fatigue, Injection site pain
Clinical narrative: Injection site very painful along with pain going up into my neck.  Over the course of two days I experienced dizziness, chills, upset stomach, congestion and fatigue.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Neck pain, Respiratory tract congestion
Clinical narrative: Injection site very painful along with pain going up into my neck.  Over the course of two days I experienced dizziness, chills, upset stomach, congestion and fatigue.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: patient presented with large red irritation around injection site
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Pain
Clinical narrative: has pain, tingling, numbness in arm during and immediately after injection pain radiating down arm and continued after dosing with ibuprofen 400mg and massaging  3 hours later patient states pain in shoulder recommended seeing physician if pain continued after medication and ice she stated if not better tomorrow she will see physician
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: has pain, tingling, numbness in arm during and immediately after injection pain radiating down arm and continued after dosing with ibuprofen 400mg and massaging  3 hours later patient states pain in shoulder recommended seeing physician if pain continued after medication and ice she stated if not better tomorrow she will see physician
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Patient said it turned red and was warm to the touch almost immediately. She thought it may go away but it got worse. She went to the ER department that evening and they gave her antibiotics. She said it was cellulitis.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Hypoaesthesia, Movement disorder, Paraesthesia, Rotator cuff syndrome
Clinical narrative: Waiting on MD, signs of shoulder impingement, loss of movement, severe bruising, numbness, tingling
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: including any and all of it sequelae/as well as other severe and permanent health consequences.; Guillain Barre Syndrome (GBS); This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently unknown gender elderly patient of 70 year-old. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 10-FEB-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number, and route not specified) for prophylaxis. As a result on or about 01-SEP-2015, the patient suffered Guillain Barre Syndrome (GBS). As a result of his receipted of zoster vaccine live (ZOSTAVAX), the patient had suffer severe personal injuries, pain suffering, and emotional distress, as well as to incur substantial economic damages. As a direct and proximate results of  defective design of zoster vaccine live (ZOSTAVAX), the patient suffered severe and permanent physical injuries, including but no limited to GBS, as well as other severe and permanent health consequences. The patient will continue to suffer economic loss, and had otherwise been physically, emotionally and economically injured. Also, injuries and damages were permanent and will continued in the future.The outcome of the event Guillain Barre Syndrome (GBS), and Ill-defined disorder was reported as not recovered.   Upon internal review, the event Guillain Barre Syndrome (GBS) was considered to be medically significant.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: including any and all of it sequelae/as well as other severe and permanent health consequences; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently unknown gender elderly patient of 69year-old. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around unknown date in  2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number, and route not specified) for long-term prevention of shingles and zoster-related conditions (prophylaxis). Shortly after vaccination, on or about June 2012, the patient suffered shingles. Subsequently, the patient was treated for the injury: shingles. As a direct and proximate result of his receipted of zoster vaccine live (ZOSTAVAX), the patient had suffer severe and permanent injuries, including but not limited to shingles, as well as other severe and permanent heath consequences. Also, had endured substantial pain and suffering, had incurred significant expenses for medical care and treatment, and will continue to incur such expenses in the future. Had suffered and will continue to suffer economic loss, and had otherwise been physically, emotionally, and economically injured. The patient injuries and damages were permanent and will continue in the future.The outcome of the event shingles and Ill-defined disorder was reported as not recovered.
Age: 4.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered
Clinical narrative: PROQUAD and MMRII were administered on the same day; This spontaneous report as received from a other health professional refers to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in 2017 (reported as at 1-year-old), the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (exact dose, route of administration, anatomical location, lot #, albumin status and expiration date were not reported). On 14-SEP-2020, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), dose 0.5 milliliters, lot # S030211, expiry date 25-MAR-2021, albumin status rHA (route of administration and anatomical location were not reported) and the second dose of measles, mumps and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), dose 0.5 milliliters, lot # S020962, expiry date 07-JUL-2021, albumin status rHA (route of administration and anatomical location were not reported) both for prophylaxis. The reporter inquired if a patient should expect any untoward reactions if the vaccines were administered on the same day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Induration, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: hard; painful; hard, painful bicep "charlie horse"; itching at the injection site; chills; warm skin rash; warm skin rash below the injection site; This case was reported by a consumer via call center representative and described the occurrence of chills in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 4RF5J, expiry date 25th April 2022) for prophylaxis.   On 8th September 2020, the patient received the 1st dose of Shingrix (intraparietal) .5 ml. On 8th September 2020, less than a day after receiving Shingrix, the patient experienced chills. On 11th September 2020, the patient experienced induration, pain localized, charley horse and injection site itching. In September 2020, the patient experienced skin warm and skin rash. The patient was treated with paracetamol (Tylenol) and camphor + diphenhydramine hydrochloride + zinc oxide (Benadryl Lotion). On 10th September 2020, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the skin warm, skin rash, induration, pain localized, charley horse and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the chills, skin warm, skin rash, induration, pain localized, charley horse and injection site itching to be related to Shingrix.  Additional details were reported as follows: On 8th Sep 2020 the patient had chills until 10th Sep 2020. 48 hours after receiving the injection, the patientg developed a warm skin rash below the injection site, this rash was still ongoing at the time of reporting.  On 11th Sep 2020, the patient developed a hard, painful bicep "charlie horse" and itching at the injection site, these symptoms were ogoing at the time of reporitng.  The patient treated these with heat, tylenol and benadryl lotion. The reported batch number 4RFSJ for Shingrix did not exist and was updated to 4RF5J as per the sales database. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Muscle spasms, Pain, Rash, Skin warm
Clinical narrative: hard; painful; hard, painful bicep "charlie horse"; itching at the injection site; chills; warm skin rash; warm skin rash below the injection site; This case was reported by a consumer via call center representative and described the occurrence of chills in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 4RF5J, expiry date 25th April 2022) for prophylaxis.   On 8th September 2020, the patient received the 1st dose of Shingrix (intraparietal) .5 ml. On 8th September 2020, less than a day after receiving Shingrix, the patient experienced chills. On 11th September 2020, the patient experienced induration, pain localized, charley horse and injection site itching. In September 2020, the patient experienced skin warm and skin rash. The patient was treated with paracetamol (Tylenol) and camphor + diphenhydramine hydrochloride + zinc oxide (Benadryl Lotion). On 10th September 2020, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the skin warm, skin rash, induration, pain localized, charley horse and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the chills, skin warm, skin rash, induration, pain localized, charley horse and injection site itching to be related to Shingrix.  Additional details were reported as follows: On 8th Sep 2020 the patient had chills until 10th Sep 2020. 48 hours after receiving the injection, the patientg developed a warm skin rash below the injection site, this rash was still ongoing at the time of reporting.  On 11th Sep 2020, the patient developed a hard, painful bicep "charlie horse" and itching at the injection site, these symptoms were ogoing at the time of reporitng.  The patient treated these with heat, tylenol and benadryl lotion. The reported batch number 4RFSJ for Shingrix did not exist and was updated to 4RF5J as per the sales database. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Patient reported that she received the 1st dose of Shingrix 2 years ago and experienced flu like symptoms shortly after receiving the injection and the symptoms lasted for a week so she decided not to get the 2nd dose of Shingrix. The reporter consented to follow-up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2020, the patient received the 1st dose of Shingrix. On 10th September 2020, 24 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: Reporter was physician assistant. On 10 September 2020, the patient experienced an episode of shingles after been administrated with Shingrix. The reporter consented to follow-up.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone High-Dose Quadrivalent given to 60 years old female patient/ NO AE; Fluzone High-Dose Quadrivalent given to 60 years old female patient/ NO AE; Initial information received on 19-Aug-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 60-years-old female patient who received a 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] Injection (batch number: UJ454AA, expiry date: 30-Jun-2021) via an unknown route it the left deltoid on 19-Aug-2020 for prophylactic vaccination. Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration and it was a case of overdose (latency: same day).  At the time of reporting, the patient had no side effects.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 3-years-old patient who was vaccinated with FLUZONE HIGH-DOSE QUADRIVALENT by mistake, No AE; 3-years-old patient who was vaccinated with FLUZONE HIGH-DOSE QUADRIVALENT by mistake, No AE; Initial information received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA242184, 2020SA242186 and 2020SA242187 (same reporter).  This case involves a 3-years-old patient (gender unknown) who was vaccinated with a dose (unclear whether 0.5 mL or 0.7 mL was administered) of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] by mistake (Lot number: UJ450AB and expiration date:30-Jun-2021) via unknown route in an unknown administration site as prophylactic vaccination on an unknown date (product administered to patient of inappropriate age and overdose).  Medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration and overdose.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Dizziness, Hypotension, Tremor
Clinical narrative: The patient experienced low blood pressure (hypotension), diarrhea, dizziness and tremors.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash papular
Clinical narrative: Papular rash on right face
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, VARCEL
Symptoms: No adverse event, Wrong patient received product
Clinical narrative: Patient received these 3 vaccines in error. Patient has not had any reported adverse events.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain, Pain, Tenderness
Clinical narrative: Pt states pain began on date of event; pain at site of injection that has caused tenderness in her right upper arm into her armpit. States there is slight shoulder joint pain rated on a scale of 4/10. Date of injection 9/14, report submitted on 9/18.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Lymph node pain, Lymphadenopathy, Mobility decreased
Clinical narrative: Pt with report of swollen lymph node around left clavicle within 24 hours of vaccines.  Painful, unable to move arm, visible lump
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Tenderness, Urinary retention, Urine analysis
Clinical narrative: Two weeks after injection skin on torso became very sensitive to touch, became weak Symptoms began to move from torso to the head  At this time became unable to urinate, after two days of being unable to urinate went to emergency room to have catheter installed
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Patient developed hives within a few hours of receiving the vaccine and they have continued  almost daily since then.
Age: 72.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Chills, Insomnia, Limb immobilisation, Pain, Peripheral swelling
Clinical narrative: Immobilized left arm (2.5 days), swollen and hot red arm, sleeplessness (36 hours), hives outbreak, chills and achy.
Age: 72.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Skin reaction, Skin warm, Urticaria
Clinical narrative: Immobilized left arm (2.5 days), swollen and hot red arm, sleeplessness (36 hours), hives outbreak, chills and achy.
Age: 5.0
Sex: F
Vaccine: FLUA4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received the vaccine on 9/17/20 at 16:15. No adverse effects noted.  However, next day noted that the vaccine given was from a lot of expired flu vaccines (last years flu vaccines).
Age: 75.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Skin irritation, Swelling
Clinical narrative: Patient called to informed she was diagnosed with cellulitis (given antibiotics cipro) after receiving a HD flu vaccine and pneumovax vaccine together in the same arm. She stated she had irritation and swelling prior to being diagnosed. Her diagnosing provider stated she should have only gotten 1 vaccine at a time and that the pharmacist was wrong in giving both. Patient had received HD flu vaccine from same location for past 3 years w/o any issues or concerns. Upon further questioning, patient stated the vaccines were given about 1 inch apart, and was informed it was common practice to give more than 1 vaccine in one sitting but some give them in opposite arms. Also, patient was told proper protocol and procedure was taken but would be followed up to ensure no steps were missed.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Injection site streaking, Lymph node pain, Lymphadenopathy
Clinical narrative: very bad reaction for about four days after the pneumonia vaccine. Severe swelling and redness with a fever and chills. The night that I received the vaccine the arm swelled up and they were swelling all in my armpit and several of my lymph nodes were swollen and pain was so bad I could barely move my arm and that's when I had a fever and chills. The next day, Saturday I was very swollen and red and it hot to the touch with red streaks going from the injection site up underneath my armpit to where the lymph nodes were swollen and painful. I used ice and ibuprofen and cortisone cream to ease the symptoms. Today is day six it is 1 AM and it is painful and itchy and still slightly swollen however the heat is gone. I have never had any type of injection react this way.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Oedema peripheral, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: very bad reaction for about four days after the pneumonia vaccine. Severe swelling and redness with a fever and chills. The night that I received the vaccine the arm swelled up and they were swelling all in my armpit and several of my lymph nodes were swollen and pain was so bad I could barely move my arm and that's when I had a fever and chills. The next day, Saturday I was very swollen and red and it hot to the touch with red streaks going from the injection site up underneath my armpit to where the lymph nodes were swollen and painful. I used ice and ibuprofen and cortisone cream to ease the symptoms. Today is day six it is 1 AM and it is painful and itchy and still slightly swollen however the heat is gone. I have never had any type of injection react this way.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm, Swelling
Clinical narrative: very bad reaction for about four days after the pneumonia vaccine. Severe swelling and redness with a fever and chills. The night that I received the vaccine the arm swelled up and they were swelling all in my armpit and several of my lymph nodes were swollen and pain was so bad I could barely move my arm and that's when I had a fever and chills. The next day, Saturday I was very swollen and red and it hot to the touch with red streaks going from the injection site up underneath my armpit to where the lymph nodes were swollen and painful. I used ice and ibuprofen and cortisone cream to ease the symptoms. Today is day six it is 1 AM and it is painful and itchy and still slightly swollen however the heat is gone. I have never had any type of injection react this way.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Headache, Pain in extremity
Clinical narrative: Severe chills, headaches, arm pain
Age: 8.0
Sex: M
Vaccine: HEPAB
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Incorrect Immunization dosage was given to patient out of age range. No medical/clinical reaction was experienced.
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Catatonia, Fall, Muscle twitching
Clinical narrative: PT RECEIVED VACCINE,  AFTER WHICH PT FELL TO FLOOR, BECAME CATATONIC, TWITCH... PT REMAINED ON FLOOR FOR APPROXIATLEY 20 MINUTES,  WAS OFFERED MEDICAL ATTENTION, BUT REFUSED...PT EVENTIALLY STOOD UP, AND LET WITH CARETAKER. (PARENT)
Age: 66.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site haematoma, Injection site haemorrhage, Injection site swelling
Clinical narrative: site bleed and has swelling. Appeared to be an acute hematoma.  Patient was instructed to monitor and ice at home.  Upon follow up on 9/18/2020, patient reported no pain or soreness or any issues.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: hives on wrist and back of hand
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic, Skin disorder
Clinical narrative: patient developed raised itchy red rash on neck right below hairline.  Patient had not seen a physician yet for symptoms when reported.  She had seen the dermatologist earlier in the week for other skin related issue.
Age: 0.42
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered
Clinical narrative: The medical Assistant administered a Pentacel and then another IPV instead of PCV. Pt was double dosed with IPV that day.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dyspnoea
Clinical narrative: Mom called the clinic stating that he is being taken to ED w/ difficulty breathing.  No cough.  No rash.  No fever.  No other sx.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Lip swelling, Urticaria
Clinical narrative: Severe diffuse hives with minimal lip swelling developed 8 days after vaccination. Improvement with benadryl however required ongoing dosing every 6 hours with recurrence and relief of symptoms. Started on zyrtec and prednisolone. Ongoing symptoms at time of report
Age: 1.33
Sex: M
Vaccine: HEPAB
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Incorrect dosage given to patient out of age range with no adverse reaction.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test normal, Electrocardiogram normal, Full blood count normal, Loss of consciousness, Pregnancy test urine negative
Clinical narrative: Pt received Gardasil and Menactra vaccine while seated on exam table. Was told to stay for 15 minutes. She got up to talk to the chair from the exam table, made it to the chair but passed out, was unconscious for 30 seconds-1 minute. This is a hospital based clinic so hospital rapid response called and evaluate pt, recommended transfer to ER.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall
Clinical narrative: Patient received a flu shot, approximately 10 minutes later she felt light headed and fell.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: When taking immunizations out of refrigerator nurse  took out the wrong medication Bexsero.  Patient should have been given Menactra.
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events reported upon wellness check, FluBlok was administered to someone under 18
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: pt broke out in large welts/hive on left arm and they spread over to his right arm
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Blood albumin decreased, Blood calcium decreased, Blood potassium decreased, Chills
Clinical narrative: INJECTION SITE PAIN WITH SORE ARM BODY ACHES MUSCLE PAIN AND ACHES IN LEGS AND CALFS  TIRENESS, WEAKNESS HEADACHES DIZZINESS CHILLS
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: INJECTION SITE PAIN WITH SORE ARM BODY ACHES MUSCLE PAIN AND ACHES IN LEGS AND CALFS  TIRENESS, WEAKNESS HEADACHES DIZZINESS CHILLS
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: INJECTION SITE PAIN WITH SORE ARM BODY ACHES MUSCLE PAIN AND ACHES IN LEGS AND CALFS  TIRENESS, WEAKNESS HEADACHES DIZZINESS CHILLS
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Impaired work ability, Injection site pain, Nausea
Clinical narrative: Approximately 8 hours after the vaccination, I started having pain at the injection site.  Over the next 12 hours, I experienced fever, chills, nausea, headache and body aches.  No vomiting.  Symptoms began to ease approximately 24 hours after the injection.  Injection site pain lasted around 5 days, others approximately 48 hours post injection.  Missed 4 hours of work due to reaction.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Approximately 8 hours after the vaccination, I started having pain at the injection site.  Over the next 12 hours, I experienced fever, chills, nausea, headache and body aches.  No vomiting.  Symptoms began to ease approximately 24 hours after the injection.  Injection site pain lasted around 5 days, others approximately 48 hours post injection.  Missed 4 hours of work due to reaction.
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Hypoaesthesia, Nausea, Vomiting
Clinical narrative: Starting at least 12 hours after vaccination, patient began to experience nausea, vomiting, anxiety, and numbness in the hands.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Came in today 09/18/20 and said his arm is still tingly and sore. Shot given 09/02
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Redness and warmth
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Approximately 6 hours after the vaccination, I started having pain at the injection site.  Based on my reaction to Dose 1 (6/17/20), I began taking 200 mg ibuprofen immediately after the injection.  At bedtime, I increased to 400 mg ibuprofen every 4 hours throughout the night and into the following date.  During the night and the following day, I had no chills, but did have a fever of 100.4 F, along with medium body aches, plus a painful headache. 400 mg of ibuprofen every 4 hours eased the body aches somewhat, but did not eliminate the headache.  Body aches and headache continue for 48 hours, gradually easing.
Age: 86.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient experienced redness and swelling from deltoid down to the elbow.  No treatment
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Peripheral swelling
Clinical narrative: prevnar 13 was adminsitered IM into patient left arm. left arm had mild-moderate swelling within seconds of administration. benadryl was given to help with swelling
Age: 69.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Injection site pain
Clinical narrative: The patient is having muscle pain 19 days post injection. He pointed to the area with pain and it is in the deltoid as it should be. He was not wanting to call his family doctor today , I suggested ice and massaging the area as he said the massaging had helped.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Musculoskeletal disorder, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient states that within 24 hours after receiving vaccination, she began to experience arm pain that resulted in limited mobility and that progressed to very little use of the left arm, and pain that radiated up the left side of the neck.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Local reaction, Pain, Pyrexia
Clinical narrative: Redness, tenderness warm to touch local reaction the next day.  Fever  (100.3) , HA, body aches the next evening
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Tenderness
Clinical narrative: Redness, tenderness warm to touch local reaction the next day.  Fever  (100.3) , HA, body aches the next evening
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness and swelling from deltoid down to elbow, progressed to more painful event on the evening of 09/16/20. Took 200mg Ibuprofen, the pain has now gone down and feeling better progressively thus far.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Analgesic drug level therapeutic, Blood magnesium normal, Blood thyroid stimulating hormone normal, Consciousness fluctuating, Drug screen negative
Clinical narrative: Grandma states that pt was jerking and going in and out of consciousness. Grandma took pt the EC at at 2025.  Diagnosis was determined to be a Pseudo seizure.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Dyskinesia, Full blood count normal, Metabolic function test normal, Psychogenic seizure, Thyroxine normal
Clinical narrative: Grandma states that pt was jerking and going in and out of consciousness. Grandma took pt the EC at at 2025.  Diagnosis was determined to be a Pseudo seizure.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Urine analysis normal
Clinical narrative: Grandma states that pt was jerking and going in and out of consciousness. Grandma took pt the EC at at 2025.  Diagnosis was determined to be a Pseudo seizure.
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Dyspnoea, Vaccination complication
Clinical narrative: Patient's mom called and said pt was having trouble breathing.  Advised by pharmacist on duty to go to the ER. Mom took pt to ER. ER stated pt was having an adverse reaction to the flu shot they received earlier in the day. ED physician gave pt steriods.  Pharmacist on duty followed up with family before close and pt was back home and doing well.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chills, Dizziness, Headache, Hypoaesthesia
Clinical narrative: 20 minutes after injection chills 40 minutes after injection numbness in tips of fingers (both hands) 90 minutes after injection dizziness/weakness Up thru 12 hours of injection, racing heart (per my watch which notified me of heart rate in excess of 120bpm while laying in bed) 24 hours after injection, no racing heart and no dizziness but continued weakness/headache 48 hours after injection no headache/weakness
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Palpitations
Clinical narrative: 20 minutes after injection chills 40 minutes after injection numbness in tips of fingers (both hands) 90 minutes after injection dizziness/weakness Up thru 12 hours of injection, racing heart (per my watch which notified me of heart rate in excess of 120bpm while laying in bed) 24 hours after injection, no racing heart and no dizziness but continued weakness/headache 48 hours after injection no headache/weakness
Age: 1.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: My Child was given the wrong vaccine. There has been no reaction yet
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Chills
Clinical narrative: Patient is a prostate cancer patient and receives chemotherapy and goes to the Clinic.  They do not have vaccines so they sent him to pharmacy.  He said that his doctor told him to get the flu shot. I gave the shot at approximately 10:05am.  At approximately 4:30, the patient's wife called to let me know her husband had chills.  I said possibly due to the chemo or flu shot.  I decided to call her back to see if he had a fever or given Tylenol.  She said no to both.  She then told me after they got home, he worked outside.  It is only around 60 degrees around 2:00pm.  She then said that could be why he has the chills.  She said she would give it a couple hours and if still has chills she would call the squad.  She appreciated me following up and my concern and said she would follow up with me.  I will also follow up with patient or his wife.    adverse event was chills at around 2:30pm  on 09/18 - received call from wife to report adverse effect of chills - will do follow up
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Bacterial test negative, Dyskinesia, Electroencephalogram abnormal, Encephalopathy, Gaze palsy
Clinical narrative: DTap, Hep B, Hib, PCV13, Polio and Rotavirus  Soon after administration, patient became fussy, had decreased intake and became febrile. He then had 5 seizure like episodes of arm and leg jerking and eye rolling in the back of his head. He was admitted to the hospital with negative MRI, LP without bacterial meningitis (pending viral studies) and EEG that showed diffuse encephalopathy. Patient is now on Keppra 70mg BID for increased seizure potential. Per neurology, this has been seen with the pertussis portion of the DTap vaccine before and potentially could have been a reaction to it.
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Hypophagia, Irritability, Lumbar puncture, Magnetic resonance imaging normal, Pyrexia
Clinical narrative: DTap, Hep B, Hib, PCV13, Polio and Rotavirus  Soon after administration, patient became fussy, had decreased intake and became febrile. He then had 5 seizure like episodes of arm and leg jerking and eye rolling in the back of his head. He was admitted to the hospital with negative MRI, LP without bacterial meningitis (pending viral studies) and EEG that showed diffuse encephalopathy. Patient is now on Keppra 70mg BID for increased seizure potential. Per neurology, this has been seen with the pertussis portion of the DTap vaccine before and potentially could have been a reaction to it.
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Seizure like phenomena, Viral test
Clinical narrative: DTap, Hep B, Hib, PCV13, Polio and Rotavirus  Soon after administration, patient became fussy, had decreased intake and became febrile. He then had 5 seizure like episodes of arm and leg jerking and eye rolling in the back of his head. He was admitted to the hospital with negative MRI, LP without bacterial meningitis (pending viral studies) and EEG that showed diffuse encephalopathy. Patient is now on Keppra 70mg BID for increased seizure potential. Per neurology, this has been seen with the pertussis portion of the DTap vaccine before and potentially could have been a reaction to it.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash erythematous
Clinical narrative: red bumps appeared on all over abdomen about 0.5 hours after administration of fluarix vaccine, no fever, red bumps are painful to touch
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: Patient received vaccine around 10:40am. Husband called pharmacy at 3:10pm to report that wife has been nauseous and throwing up.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site reaction, Myalgia
Clinical narrative: Arm remains sore and tender in the muscle of the injection site and in the upper arm.. arm was sore after the shot and remained sore following
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain, Sleep disorder
Clinical narrative: Arm remains sore and tender in the muscle of the injection site and in the upper arm.. arm was sore after the shot and remained sore following
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Patient has soreness in left arm and had trouble sleeping overnight.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hyperaesthesia, Influenza like illness, Malaise, Myalgia
Clinical narrative: tiredness, flu-like symptoms, achey, generally feeling like I was getting sick.     lasted 36 hours.      then 4 days later - right leg muscles on either side of my shin were painful to touch for at least 36 hours.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: tiredness, flu-like symptoms, achey, generally feeling like I was getting sick.     lasted 36 hours.      then 4 days later - right leg muscles on either side of my shin were painful to touch for at least 36 hours.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site swelling, Malaise
Clinical narrative: Daughter called and reported that her mother felt sick after the immunizations. She described fever, body aches, headaches, and a reddish, swollen, and firm arm where the Boostrix was administered. Hard to tell what is caused by the immunizations and what could be from outside diseases. Advised that she see a healthcare provider to get checked out.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Daughter called and reported that her mother felt sick after the immunizations. She described fever, body aches, headaches, and a reddish, swollen, and firm arm where the Boostrix was administered. Hard to tell what is caused by the immunizations and what could be from outside diseases. Advised that she see a healthcare provider to get checked out.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient received vaccine on 9/16/20. Patient then presented to pharmacy on 9/18/2020 with itchy, red rash at injection site and on the trunk area- under breast, across abdomen, and from middle back down to gluteal area.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Back pain, Dermatitis allergic, Headache, Injection site pain, Malaise
Clinical narrative: Within 12 hours aching soreness in right arm extending to shoulder and back. Headache and general malaise. Within 48 hours I developed an allergic rash with blotchy red patches, over the truck of my body, sides of neck, and upper thighs.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity, Rash, Rash macular
Clinical narrative: Within 12 hours aching soreness in right arm extending to shoulder and back. Headache and general malaise. Within 48 hours I developed an allergic rash with blotchy red patches, over the truck of my body, sides of neck, and upper thighs.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient came to pharmacy with complaints of extreme arm pain. She states that the vaccine was given high in her shoulder. She states that the pain started upon administration and gradually got worse. Applying pressure to the sight of administration gives her some relief. She has tried to aleviate the pain with APAP and IBU with no relief. She states that heat, not ice, makes it feel better.
Age: 11.0
Sex: F
Vaccine: FLUA4
Symptoms: Discomfort, Headache, Injection site mass, Rash
Clinical narrative: Per mom, pt has a lump about 2 inches in diameter at injection site and there is a rash on her left arm spanning from left elbow up to her face, nose, chin & neck area, and she has a headache.  Mom has been applying topical cortisone, given her loratine orally, apply ice packs and given oral ibuprofen.  Mom says it is not getting worse, but still very uncomfortable at this point.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Large red rash 4.25 inches diameter at sight of injection with swelling 45 hours after injection.
Age: 69.0
Sex: F
Vaccine: FLUR4
Symptoms: Balance disorder, Chills, Coordination abnormal, Disorientation, Dizziness
Clinical narrative: Loss of balance and coordination, disorientation, severe nausea/vomiting, muscle weakness, fatigue, chills, dizziness
Age: 69.0
Sex: F
Vaccine: FLUR4
Symptoms: Fatigue, Muscular weakness, Nausea, Vomiting
Clinical narrative: Loss of balance and coordination, disorientation, severe nausea/vomiting, muscle weakness, fatigue, chills, dizziness
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot
Clinical narrative: localized redness and warmth
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: patient reported shingles like symptoms after 2nd shingles shot
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: After adminstering the vaccine in the patients left arm the vaccine attached with the BD safetyglide needle was removed. At this time there was an increase amount of blood that ejected from the injection site. The patient experience immediate swelling at the site of injection. She was then monitored for ten minutes to observe the site of injection along with any dizziness or light headedness. The patient explained that she felt great outside of a little tinderness at the injection site. Over the course of the ten minutes the swelling did come down. The patient did also explain before adminsitering the vaccine that she just finished working out.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Eye swelling, Irritability, Pyrexia
Clinical narrative: High fever for 4, fussy for 4 days, swollen eyes on day 3,
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: THE PATIEN IS COMPAINING OF REDNESS AND BULGING IN HER ARM. SHE IS STATING IT IS VERY SWOLLEN AND SLIGHTLY PAINFULL.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Injection site swelling, Pain, Pyrexia
Clinical narrative: chills fever body aches injection site swelling