chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: c/o right deltoid very swollen, red and warm to the touch. dr adv mother to tx with advil and cool compress.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Lare area of Redness, Swelling, Pain at injection site.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: PT REPORTS DELAYED PAIN IN ARM, DIFFICULTY RAISING ARM, NUMBNESS DOWN THE OUTSIDE OF THE ARM AND TERMINATING INTO THE LEFT PINKY/RING FINGER. ADVISED PT USE OTC PAIN RELIEVER OF CHOICE AND THAT I WOULD FOLLOW UP IN 2 DAYS, IN THE MEANTIME CALL DOCTOR IF SYMPTOMS WORSEN
Age: 49.0
Sex: F
Vaccine: FLUR4
Symptoms: Aphasia, Cough, Dyspnoea, Hypoaesthesia, Speech disorder
Clinical narrative: Pretreated with 75 mg diphenhydramine PO and 200 mg cimetidine PO 30 minutes prior to injection due to previous reactions to vaccinations in previous years. 20-30 seconds after receiving Flublok, the patient began having difficulty speaking and forming words, as well as a numbing sensation in her feet, but was able to feel when touched. The patient began coughing and having difficulty breathing shortly after, and was administered 0.3 mg epinephrine IM during transfer to the ED.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Pain in extremity, Paraesthesia, Skin discolouration
Clinical narrative: Patient has pain in left forearm and sore and prickly feeling that began 1 day after receiving vaccine. Reports "Hot feeling" as well as "discoloration" (discoloration not seen by provider). Reports ongoing tingling as of present day.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Flushing, Headache, Laboratory test, Muscular weakness
Clinical narrative: Rec'd the vaccine and within minutes developed redness, flushing and hives. Pt was d/c to allergy office and treated 15 minutes later with prednsione,allerga,ranititdine and singulair. Whole body hives. D/c home continued to worsen the next few days bright red race and hives while on prednisone. Seen the allergist 3 times that week for continued reaction, develped terrible headache, progressive muscle weakness and was found unresponsive in her bed. called 911 and was taken to ER. Was treated in ER than seen neurologist the next day and was admitted for further workup. She continued to have progressive muscle weakness,bright red hives and terrible headache. We were admitted for several days. We are still recovering at home. Continues to have left leg weakness, facial tightness and leg pain. Doing physical therapy 3 times per week and will have EMG done 11/18/19 . neurologist is unsure if mild GBS or immune mediated vaccine reaction
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Pain in extremity, Skin tightness, Unresponsive to stimuli, Urticaria
Clinical narrative: Rec'd the vaccine and within minutes developed redness, flushing and hives. Pt was d/c to allergy office and treated 15 minutes later with prednsione,allerga,ranititdine and singulair. Whole body hives. D/c home continued to worsen the next few days bright red race and hives while on prednisone. Seen the allergist 3 times that week for continued reaction, develped terrible headache, progressive muscle weakness and was found unresponsive in her bed. called 911 and was taken to ER. Was treated in ER than seen neurologist the next day and was admitted for further workup. She continued to have progressive muscle weakness,bright red hives and terrible headache. We were admitted for several days. We are still recovering at home. Continues to have left leg weakness, facial tightness and leg pain. Doing physical therapy 3 times per week and will have EMG done 11/18/19 . neurologist is unsure if mild GBS or immune mediated vaccine reaction
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site reaction, Muscular weakness
Clinical narrative: Pt describes normal site reaction soreness, but when she called she mentioned that her fingers had some numbness and overall her arm felt weak.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Swelling
Clinical narrative: Patient had raised bump with no redness immediately after vaccine administration. Patient exhibited no other symptoms.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient described a severe rash that developed after receiving the vaccine and lasted for an extensive period of time ("About a month")
Age: 5.0
Sex: F
Vaccine: MMR, MMRV, UNK, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects have been reported; she had received the M-M-R II on 20-SEP-2019/ administered PROQUAD on 23-SEP-2019; she had received the M-M-R II on 20-SEP-2019/ administered PROQUAD on 23-SEP-2019; Information has been received from a nurse referring to a 5 years old female patient. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided.  The nurse reported that she received correspondence on 24-SEP-2019 that on 20-SEP-2019, the patient was administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot S005248, expiration date 20-FEB-2021; strength, dose and route were not reported) for prophylaxis at an unspecified clinic. There was no information available on the sterile diluent (Merck manufactured) (strength, dose, route, lot#, expiration date were not reported) for prophylaxis used to reconstitute the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) or if both products were properly stored. On 23-SEP-2019, the female patient was seen for a well visit and was administered properly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot S005880, expiration date 25-AUG-2020; strength, dose and route were not reported) for prophylaxis as the parent did not let the nurse know that the patient had received the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) on 20-SEP-2019 (Overdose; Inappropriate schedule of product administration). The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was reconstituted with properly stored sterile diluent (Merck manufactured) (lot S025290, expiration date 20-MAR-2022; strength, dose and route were not reported) for prophylaxis. No adverse effects had been reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effects reported; A 15 yeard old patient was adminitered a dose of PROQUAD; This spontaneous report was received from a licensed practical nurse, referring to a 15-year-old patient of an unknown gender. The patient's pertinent concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported.  On 24-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) 0.5 milliliter (ml) (strength, vaccine schedule, and indication of use were not reported; lot number S008574 and expiration date 16-SEP-2020) (product administered to patient of inappropriate age). There was no adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient received improperly stored vaccine; This spontaneous report was received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions, allergies or concomitant medication.     On an unknown date, the patient was vaccinated with an improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) one dose (lot # S003865 and expiration date 08-AUG-2020) (strength, dosage schedule and route of administration were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 32.5 Fahrenheit for 8 hours. The vaccine did not have a previous temperature excursion and the call was because of data logger.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No adverse effects were reported; patient was meant to have received MMR, not PROQUAD; This spontaneous report was received from a nurse regarding a 17-month-old patient of unknown gender. There was no information reported about the patient's concomitant medications, pertinent medical history and drug reactions or allergies.   On 16-OCT-2019, the patient was administered varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) at the same office visit (strength, dose, route of administration, lot numbers and expiration dates were not provided). The patient was meant to have Measles, Mumps, and Rubella (M-M-R) administered instead of inadvertently being administered Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (wrong product administered). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient was treated for shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2011, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the patient's vaccination with zoster vaccine live(ZOSTAVAX), the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, the patient had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: The patient was treat for shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 07-NOV-2007, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the patient's vaccination with zoster vaccine live(ZOSTAVAX), the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, the patient had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications. On an unspecified date in 2012, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention of shingles and zoster-related injuries. On an unspecified date, the patient was treated by a physician for shingles. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, Plaintiff had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown.   The event shingles was considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored doses of proquad; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.   On 16-OCT-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S007069 has been verified to be a valid lot number with expiration date:06-SEP-2020, subcutaneous for prophylaxis. Other suspect therapies included sterile diluent and it was unknown if the sterile diluent was stored properly (product storage error). The vaccine was exposed to a temperature -11.5 Celsius for 76 hours. There was no previous temperature excursion. It was reported that the call was because of a digital data logger. The patient experienced no adverse event. No product quality complaints were involved.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Pain in extremity
Clinical narrative: Inappropriate route of vaccination; Painful arm lasting more then a week; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2019, the patient received Shingrix (subcutaneous). On 5th October 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In October 2019, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The Pharmacist called and reported that she administered the Shingrix on right arm. She recalls that she gave it intramuscular but the patient claimed that they received the vaccine subcutaneously.She stated that she did not know if she did inadvertently give it subcutaneously, which led to intramuscular formulation administered by other route. The patient had painful arm lasting more than a week. The pharmacist would be following up with the patients. She also stated that GlaxoSmithKline can contact her if there are any additional questions. This case linked with US2019AMR190695, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Pain in extremity
Clinical narrative: Inappropriate route of vaccination; Painful arm lasting more then a week; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2019, the patient received Shingrix (subcutaneous). On 5th October 2019, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In October 2019, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The Pharmacist called and reported that she administered the Shingrix on right arm. She recalls that she gave it intramuscular but the patient claimed that they received the vaccine subcutaneously. She stated that she did not know if she did inadvertently give it subcutaneously, which led to intramuscular formulation administered by other route. The patient had painful arm lasting more than a week. The pharmacist would be following up with the patients. She also stated that GlaxoSmithKline can contact her if there are any additional questions. This case linked with US2019AMR190688, reported by same reporter.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Severe Arm Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid. The patient experienced severe arm pain. The pharmacist asked if there was any information on immunity with 1st dose of Shingrix vaccine. The reporter did not consent to follow-up.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Left deltoid muscle got hard; Warm at injection site; Pain at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site induration in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number 5KF37, expiry date 14th April 2020) for prophylaxis.   On 7th August 2019, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site induration, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site induration, injection site warmth and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site induration, injection site warmth and injection site pain to be related to Shingrix.  Additional details were provided as follows: The registered pharmacist reported that patient received the first dose of Shingrix on left deltoid. The patient left deltoid muscle got hard, large pach, warm, painful at injection site. It lasted several weeks until it subsided. The healthcare professional (HCP) would like to know if patient should receive 2nd dose after these reactions. The reporter was consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness at the injection site / Redness traveling down left arm and about 7 inches long.  It was below the bicep area but above the elbow; Swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix. On 15th October 2019, couple of hours after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on the left arm.  A few hours later, the patient had redness and swelling at the injection site. The next day, the patient saw redness travelling down her left arm and about 7 inches long. It was below the bicep area but above the elbow. The reporter was did not consent to follow-up.
Sex: F
Vaccine: PNC13
Symptoms: Headache, Immediate post-injection reaction, Musculoskeletal pain, Pain in extremity, Sleep disorder
Clinical narrative: pains in her right arm that starts at shoulder and goes to the elbow/ pains were radiating from her shoulder to the back of her head; pain had been waking her up; Developed shoulder and arm pain immediately after the shot; Developed shoulder and arm pain immediately after the shot; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) via unspecified route of administration in Oct2018 at a single dose for immunization. Medical history included that the patient was diabetic since 2009 (diagnosed 10 years ago). There were no concomitant medications. The patient reported that last year in October she got a pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccination at the prompting of her primary care physician. She developed shoulder and arm pain immediately after the shot and it has continued ever since. Patient stated she was still getting pains in her right arm that starts from the shoulder and goes to the elbow. Lately on unknown date, the pains were radiating from her shoulder to the back of her head. The pain had been waking her up. Patient stated that immediately after the vaccination it improved slightly and then it has gotten worse over time. The vaccine was administered to her by a pharmacist. Her primary care insisted that she get the vaccine. Patient did not know the dose she was given, but stated that she received the standard dosage. She wanted to know how long is this pain supposed to last. The patient was suggested that the patient consult her healthcare provider, as it has been a year that she received the vaccine and was still experiencing the pain. The outcome of the event 'pain had been waking her up' was unknown; while the outcome of the other events was not recovered.  Information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Induration, Injected limb mobility decreased, Peripheral swelling, Swelling
Clinical narrative: Had swelling in her neck to her back and into her arm (injection arm)./her whole arm was swollen; As per caller her whole arm was swollen and "rock hard" and could not move her arm; Had swelling in her neck to her back and into her arm (injection arm).; This is a spontaneous report from a contactable consumer reporting for herself.  A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on 16Oct2019 at single dose in arm for immunisation . The patient medical history and concomitant medications were not reported. On an unspecified date in Oct2019, the patient had swelling in her neck to her back and into her arm (injection arm). Patient reported her whole arm was swollen and "rock hard" and could not move her arm. She remained in bed all day "lying on a heating pad". She called the doctor who told her to take ibuprofen. The final outcome of the events was unknown. Information on the batch number has been requested.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Influenza, Peripheral swelling, Pneumonia
Clinical narrative: had pneumonia twice in the past few years; had pneumonia twice in the past few years; One of my arms swelled up so big; I was in the bed for a week for what I thought was the flu; This is a spontaneous report from a contactable consumer who reported for herself, an 85-year-old female patient who received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown) and influenza vaccine (FLU), both via an unspecified route of administration in the arm, on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient got the flu shot and the pneumonia shot the same day, one in each arm - several years ago. One of her arms swelled up so big and she was in the bed for a week for what she thought was the flu. She had pneumonia twice in the past few years. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: she had a sore arm and it was achy for 1/2 a day; This is a spontaneous report from a contactable consumer.  A 66-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) , via an unspecified route of administration in 2016  at single dose for immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced a sore arm and it was achy for half a day on an unspecified date with outcome of unknown.  The reported event was non serious.  The information on the batch number has been requested.  Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.
Age: 1.67
Sex: F
Vaccine: MMR
Symptoms: Aphasia, Decreased eye contact, Head banging, Noninfective encephalitis, Staring
Clinical narrative: stopped talking, head banging, stopped making eye contact, brain iflamation, blank stares,
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test abnormal, Cardiac function test normal, Computerised tomogram head normal, Concussion, Dehydration
Clinical narrative: Fever beginning the morning of 10/19/19 that went up to 103.6. Two syncopal episodes, one with injury. Nausea and headache. General feeling of body aches similar to the flu.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Head injury, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: Fever beginning the morning of 10/19/19 that went up to 103.6. Two syncopal episodes, one with injury. Nausea and headache. General feeling of body aches similar to the flu.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Syncope
Clinical narrative: Fever beginning the morning of 10/19/19 that went up to 103.6. Two syncopal episodes, one with injury. Nausea and headache. General feeling of body aches similar to the flu.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Bone pain, Chills, Dizziness, Dysuria
Clinical narrative: Starting 1 h after the flu shot: achiness in the arm where was put the injection, gradually increasing, but well  tolerable.  Starting 5-6 h after the flu shot for the last 9 years: body aches, muscle aches, especially in jar, gums; bone pain; fever; chills, sweatiness, muscle spasms, racing heart rate, increased respirations and using a mouth to breath; dizziness, weakness,  difficulty urination with painful urination, nausea, multiply vomiting with inability to hold urine while vomiting, muscle cramps, muscle twitching, pumping headache, excessive sweating and weakness, dizziness with ambulation.  Lasts for about 3-4h.   I am not sure about the type of the flu vaccine (see item 17)
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Gingival pain, Headache, Hyperhidrosis, Injection site pain, Mouth breathing
Clinical narrative: Starting 1 h after the flu shot: achiness in the arm where was put the injection, gradually increasing, but well  tolerable.  Starting 5-6 h after the flu shot for the last 9 years: body aches, muscle aches, especially in jar, gums; bone pain; fever; chills, sweatiness, muscle spasms, racing heart rate, increased respirations and using a mouth to breath; dizziness, weakness,  difficulty urination with painful urination, nausea, multiply vomiting with inability to hold urine while vomiting, muscle cramps, muscle twitching, pumping headache, excessive sweating and weakness, dizziness with ambulation.  Lasts for about 3-4h.   I am not sure about the type of the flu vaccine (see item 17)
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Muscle spasms, Muscle twitching, Myalgia, Nausea, Pain
Clinical narrative: Starting 1 h after the flu shot: achiness in the arm where was put the injection, gradually increasing, but well  tolerable.  Starting 5-6 h after the flu shot for the last 9 years: body aches, muscle aches, especially in jar, gums; bone pain; fever; chills, sweatiness, muscle spasms, racing heart rate, increased respirations and using a mouth to breath; dizziness, weakness,  difficulty urination with painful urination, nausea, multiply vomiting with inability to hold urine while vomiting, muscle cramps, muscle twitching, pumping headache, excessive sweating and weakness, dizziness with ambulation.  Lasts for about 3-4h.   I am not sure about the type of the flu vaccine (see item 17)
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Pain in jaw, Palpitations, Pyrexia, Respiratory rate increased, Vomiting
Clinical narrative: Starting 1 h after the flu shot: achiness in the arm where was put the injection, gradually increasing, but well  tolerable.  Starting 5-6 h after the flu shot for the last 9 years: body aches, muscle aches, especially in jar, gums; bone pain; fever; chills, sweatiness, muscle spasms, racing heart rate, increased respirations and using a mouth to breath; dizziness, weakness,  difficulty urination with painful urination, nausea, multiply vomiting with inability to hold urine while vomiting, muscle cramps, muscle twitching, pumping headache, excessive sweating and weakness, dizziness with ambulation.  Lasts for about 3-4h.   I am not sure about the type of the flu vaccine (see item 17)
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Oral pruritus, Pruritus
Clinical narrative: ITCHING MOUTH, FACE,NECK, LASTED 3-4 DAYS TOOK BENEDRYL
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Paraesthesia
Clinical narrative: Numbness in the immediate and surrounding areas where shot administered and numbness and tingling down left arm to left hand and left scapular areas down to left side of rib cage.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Anaphylactic reaction, Pruritus, Urticaria
Clinical narrative: Patient left clinic with mom and when arrived at a fast food restaurant and he was itching all over and had developed hives. He then presented to the ED, where he received epinephrine and dex for anaphylaxis, and now is being watched for 4-6 hours.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dry skin, Fatigue, Feeling hot, Local reaction, Muscular weakness
Clinical narrative: general fatigue and achiness within 12 hours, weakness in arm, localized reaction showed heat, swelling, dry skin and itching
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: general fatigue and achiness within 12 hours, weakness in arm, localized reaction showed heat, swelling, dry skin and itching
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Depressed level of consciousness, Laboratory test, Loss of consciousness, Pallor
Clinical narrative: Within 10 minutes, a floor assistant came to get the pharmacist stating patient had "passed out."  Pharmacist immediately went to patient and she was sitting in a chair in the aisle, upright, breathing, semi-conscious, pallor face.  After about 1-2 minutes, patient started to have a seizure that lasted about 5 seconds.  Pt was breathing throughout.  Post-seizure patient was confused for about 5 minutes.  After 5 minutes, she recognized her daughter and son-in-law who were caring for her and the pharmacist that administered the vaccine.  We attempted to check her BP but her sweatshirt was too thick and we could not get a reading. Pt felt warm and we placed a cool cloth on her forehead.  After about 10 minutes, she was feeling much better, her normal color had returned.  She was wheeled in a chair to her car where her daughter and son-in-law brought her home.   *While speaking with daughter while monitoring patient, she stated her mom had one seizure about 3-4 months ago which resulted in a hospitalization for 1 week with multiple tests being run and no identifiable cause found.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Seizure, Skin warm
Clinical narrative: Within 10 minutes, a floor assistant came to get the pharmacist stating patient had "passed out."  Pharmacist immediately went to patient and she was sitting in a chair in the aisle, upright, breathing, semi-conscious, pallor face.  After about 1-2 minutes, patient started to have a seizure that lasted about 5 seconds.  Pt was breathing throughout.  Post-seizure patient was confused for about 5 minutes.  After 5 minutes, she recognized her daughter and son-in-law who were caring for her and the pharmacist that administered the vaccine.  We attempted to check her BP but her sweatshirt was too thick and we could not get a reading. Pt felt warm and we placed a cool cloth on her forehead.  After about 10 minutes, she was feeling much better, her normal color had returned.  She was wheeled in a chair to her car where her daughter and son-in-law brought her home.   *While speaking with daughter while monitoring patient, she stated her mom had one seizure about 3-4 months ago which resulted in a hospitalization for 1 week with multiple tests being run and no identifiable cause found.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Crying, Gait inability, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient received the flu vaccination and the next day couldn't walk, and complained about his leg hurting.  It has been a week and he still keeps his leg stiff straight, barely will bend at the knee. No abnormal redness at injection site. Child cries when his thigh is lightly touched, or when he is picked up from the pain. He says, "owe! it hurts!" It's been concluded that child is likely suffering from Rhabdomyolysis, with the hopes that he should regain full mobility and function in the next week.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Rhabdomyolysis, X-ray normal
Clinical narrative: Patient received the flu vaccination and the next day couldn't walk, and complained about his leg hurting.  It has been a week and he still keeps his leg stiff straight, barely will bend at the knee. No abnormal redness at injection site. Child cries when his thigh is lightly touched, or when he is picked up from the pain. He says, "owe! it hurts!" It's been concluded that child is likely suffering from Rhabdomyolysis, with the hopes that he should regain full mobility and function in the next week.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Vomiting
Clinical narrative: Patient called today and said she was vomiting and couldn't get out of bed on Monday and today she is able to eat but the left arm where the shot was given is highly sensitive below the injection site on both areas. Patient received both the Pneumonia 23 and Flu shot in the same arm. I asked her if she would keep calling each day so we can just make sure she is getting better.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site of injection swelled up and red.  Pharmacist recommended ice and tylenol for pain since patient can not take ibuprofen or other nsaids due to kidney insufficiency.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Walking aid user
Clinical narrative: Some redness at injection site. Extreme dizziness about 12 hours after injection that lasted several hours.  Couldn't walk without help and had to crawl to the bathroom in the middle of the night.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Began having a headache on 10/17/19. Was given Tylenol but continued to get worse. Was taken to emergency room on 10/20/19 with pain in top of head down to forehead and was given Tylenol 3 for pain and referred to PCP. Saw PCP on 10/22/19 they said to continue to rotate the Tylenol with ibuprofen it it worsens call back. Still having pain in the top of his head and down into his forehead. Nothing seems to take the pain away.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal disorder, Transient ischaemic attack
Clinical narrative: The morning of the event, patient gave a fasted blood sample at his doctors clinic @ 8:30am (he not 100% certain but believes the sample was drawn from his right arm).  Came home and ate apple sauce, coffee, and breakfast apple butter bread.   Then went to his shop where he was working on his garage door at roughly 9:35am.  He had both arms raised above his head holding the door and his right arm fell to his side.  He was taken by ambulance to Hospital and treated for what was believed to be a TIA.  Patient had no history of stroke or other neurological events.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: PAIN, REDNESS AT SITE OF INJECTION, HEADACHE, MUSCLE ACHES, FEVER, FATIGUE
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: PAIN, REDNESS AT SITE OF INJECTION, HEADACHE, MUSCLE ACHES, FEVER, FATIGUE
Age: 61.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Musculoskeletal stiffness, Pyrexia, Rash macular
Clinical narrative: Red splotches upper arm stiffness fever
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Anxiety, Condition aggravated, Dyspnoea, Respiratory rate increased
Clinical narrative: Patient was given a flu shot at a School Located Vaccine Clinic.  Pt left the waiting area after 15 minutes.  Was returned within 3 minutes by teacher and was reporting difficulty breathing.  Pt was coached to slow respirations and to calm down.  Pt was placed supine with feet elevated.  Pt continued to breath rapidly.  Pt complaining of difficulty breathing.  911 was called; Patient was given Bendadryl 25mg po x 1; Pt was once again place supine because" she could breath better in this position".  First responders arrived, teacher returned with medical history of anxiety and reported other instances of anxiety attacks in school.  Patients mom notified, patient spoke with sister by phone, EMS arrived and she was transported to Hospital and treated for anxiety.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Eye swelling, Lip swelling
Clinical narrative: Both eyes and lips were swollen. He had a round of Benedryl and steroids.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient stated her arm became swollen and red. She received the vaccine on 10-12-19 and was seen by a physician on 10-22-19 who prescribed Naproxen and informed patient to return if  no improvement.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Daughter says Patient's right arm had a large red area of upper arm/bicep and that the arm was sore.  She said no swelling or evidence of a lump or knot and no systemic reaction or any other symptoms.  Patient was advised to use a cold pack for pain and contact his regular doctor.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Dizziness, Fall, Nausea, Pallor
Clinical narrative: Upon rising from the chair, the client fell backwards and complained of being dizzy and nauseous.  Client went very pale and allowed to lay on a cot for about 20 mins, given water to drink.  Vitals were all WNL  Temp. = 97.5, pulse = 65, bp = 105/62.  Client was fully recovered after 20 mins and left clinic area.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Feeling hot
Clinical narrative: Two hours after administration of the shot, patient called the pharmacy and explained that she was feeling hot/burning sensation running along her neck on the side the shot was administered.  Patient did not report any other side effect (swelling, pain, fever, etc), but asked that this side effect be reported as she was speaking to a gentlemen who had experienced the same from getting a high dose shot from another facility.
Age: 68.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: redness, swelling, and pruritus at injection site, both vaccines were given in same arm
Age: 0.17
Sex: F
Vaccine: DT, RV5
Symptoms: Asthenia, Depressed level of consciousness, Dyspnoea, Grunting, Hyperhidrosis
Clinical narrative: On the day of the visit before the vaccination was given the doctor declared the 2 month year patient above the average in age milestones. She exhibited alertness, strength, and high consciousness. Within 12 hours after the vaccine, the 2 month-year-old patient was breathing harder than usual, making wheezing sounds, sweating, and grunting(sings of uncomfortableness).  24 hours after the vaccine the patient exhibited low consciousness, weakness, lethargicness, and an inability to hold her head up.
Age: 0.17
Sex: F
Vaccine: DT, RV5
Symptoms: Lethargy, Posture abnormal, Wheezing
Clinical narrative: On the day of the visit before the vaccination was given the doctor declared the 2 month year patient above the average in age milestones. She exhibited alertness, strength, and high consciousness. Within 12 hours after the vaccine, the 2 month-year-old patient was breathing harder than usual, making wheezing sounds, sweating, and grunting(sings of uncomfortableness).  24 hours after the vaccine the patient exhibited low consciousness, weakness, lethargicness, and an inability to hold her head up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Myalgia, Nausea, Pyrexia
Clinical narrative: Chills, fever, muscle aches, dizziness, nausea. I thought I was going to die.
Age: 64.0
Sex: M
Vaccine: FLUA3
Symptoms: Asthenia, Epistaxis, Headache, Pyrexia
Clinical narrative: Fever and weakness morning after vaccination (fever 99 to 100.4) persisted all day. Headache in evening. Profuse unusual bleeding from nostril before bed.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Cough, Injection site swelling, Pain, Pyrexia
Clinical narrative: Developed fever within one hour after vaccination that persisted for greater than 72 hours.  Body aches present at the time and for several days after.  Left deltoid area of arm remained swollen for greater than 72 hours (injection site).   Nearly one week since vaccine administration and still have intermittent fever and body aches with chest tightness and cough.  Self treatment with occasional ibuprofen to help sleep.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Cough, Influenza, Nausea, Pain
Clinical narrative: Unusually strong flu symptoms: fever, chills, body aches, nausea, and cough lasting approximately 12 hours.  I normally have mild flu symptoms after vaccination, but this was the most severe reaction I have had.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Unusually strong flu symptoms: fever, chills, body aches, nausea, and cough lasting approximately 12 hours.  I normally have mild flu symptoms after vaccination, but this was the most severe reaction I have had.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Periorbital swelling, Swelling face
Clinical narrative: Patient told the school nurse the following day that she had swelling in the face, puffy eyes, a heavy chest, and trouble breathing.  She took Benadryl and used her inhaler 3 times which seemed to relieve some of the symptoms.
Sex: F
Vaccine: HPV9
Symptoms: Vaccination site nodule, Vaccination site pain
Clinical narrative: small knot at the vaccination site; but was still sore; This spontaneous report was received from a  female pharmacist of unknown age via a company representative refers to herself. There was no information about the patient's concurrent conditions, medical history, drug reactions, allergies or concomitant medication.       On 07-OCT-2019, the patient was vaccinated with the first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R029117 and expiration date 10-JUL-2021) intramuscular to prevent human papilloma virus (strength were not reported).   On that day, after vaccination, the patient developed a small knot at the vaccination site (vaccination site nodule) and soreness (vaccination site pain). On 09-OCT-2019 (2 days after vaccination), the knot resolved but the site was still sore. The patient did not seek medical attention.   The causal relationship between the events and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Age: 11.0
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, Immunisation, No adverse event
Clinical narrative: an expired Adacel vaccine was administered on 22-Jul-2019, no AE; Based on information received on 16-OCT-2019, the report previously considered as non-valid became valid: patient information reported  Initial information received on 24-Jul-2019 regarding an unsolicited non-valid non-serious case received from a pharmacist.  This case involves a 11 years old patient (143.2 cm and 45.351 kg) who received 0.5 mL expired dose (booster dose) of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine on 22-Jul-2019 lot number U5729AA, expiry date 21-Jul-2019 via intramuscular route in left deltoid.  It was an actual medication error due to expired vaccine used. The vaccine dose was repeated on 31-Jul-2019.  No adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Follow-up information received on 26-Aug-2019 regarding an unsolicited non-valid non-serious case received from a licensed practical nurse.  Vaccine details and event description updated.  Follow-up information received on 16-OCT-2019 regarding an unsolicited valid non-serious case received from a licensed practical nurse.  The report previously considered as non-valid became valid.   Patient details, date of vaccination, lot number and expiry date updated in field and narrative.