chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX
Symptoms: Death
Clinical narrative: Flu shot killed the patient; Initial information was received on 22-Nov-2020 regarding an unsolicited valid serious case received from a consumer.  This case involves a male patient (unknown age) who died (death), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient died (death) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Case Detail: Product name was not provided. Since this was a public post on the Sanofi flu shot campaign it was assumed that the consumer was referring to the Sanofi flu vaccine  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  It was unknown if an autopsy was done and the cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: This was a poorly documented case involves a male patient (unknown age) who died (death) after receiving INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. Additional information regarding patient's relevant medical history, health condition at time of vaccination and laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: death NOS
Sex: U
Vaccine: FLUX
Symptoms: Death
Clinical narrative: patient die from flu vaccine; Initial information was received on 20-Nov-2020 regarding an unsolicited valid serious case from the consumer or non-health care professional (patient's friend) via social media.   This case involves an unknown demographic patient who died (death), after vaccination with INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient died (death), (unknown latency) following the administration of INFLUENZA VACCINE. Also, this (death) event was assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, it was unknown if an autopsy was done and the cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns a patient of unknown age who died (death) after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Also, the patient's medical condition at the time of vaccination, concomitant therapy, allergic history, previous vaccination and tolerance, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed; Reported Cause(s) of Death: patient die from flu vaccine
Age: 52.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: gave an expired dose of Tenivac vaccine to a patient/ no AE; Initial information was received on 06-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional via Medical Information (Reference number- 00349245) and transmitted to Sanofi on 06-Nov-2020.  This case involves a 52-old male patient who was vaccinated with 0.5 ml dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6101AA expiry date 23-Oct-2020) via unknown route in the left deltoid on an unknown date for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  No other vaccinations or medications were given at that visit  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  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: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Headache, Myalgia, Sleep disorder
Clinical narrative: Pain at injection site started within hours Late evening it progressed to muscle aches in shoulders, neck, and upper back Awoke multiple times between 2:00a and 5:00a with increasing muscles aches and headache Read about side affects around 6:00a and took an ibuprofen 800 At this time (~7:45a) muscle aches and headache seem to be lessening
Age: 69.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Condition aggravated, Cough, Dehydration, Fatigue
Clinical narrative: Cough, extreme fatigue, weakness, dehydration, bad long term pain in arm,  aggravation of Migraine and tendinitis. In bed all week. Still ill on 11/25/2020
Age: 69.0
Sex: F
Vaccine: FLUC4
Symptoms: Migraine, Mobility decreased, Pain in extremity, Tendonitis, Urine analysis
Clinical narrative: Cough, extreme fatigue, weakness, dehydration, bad long term pain in arm,  aggravation of Migraine and tendinitis. In bed all week. Still ill on 11/25/2020
Age: 69.0
Sex: F
Vaccine: FLUC4
Symptoms: X-ray
Clinical narrative: Cough, extreme fatigue, weakness, dehydration, bad long term pain in arm,  aggravation of Migraine and tendinitis. In bed all week. Still ill on 11/25/2020
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling, Myalgia, Rash
Clinical narrative: Muscular pains  Rash covering injection site, left arm, body trunk, front and back, from collar bone down, right arm , slight rash inner thighs slight swelling at injection site
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Dyspnoea, Pruritus, Urticaria, Wheezing
Clinical narrative: Child left office and then was brought back with trouble breathing and itchiness over entire body.  Wheezing and urticaria were present.  Given nebulizer treatment and oxygen @2L/min.  Squad called and transported to Emergency Room
Sex: F
Vaccine: HPV9
Symptoms: Drug ineffective, Therapeutic procedure, Vulvar dysplasia
Clinical narrative: A 30-year-old female was vaccinated with GARDASIL 9 and she had a lack of effect from the product. / She had undergone "4-5 procedures for VIN".; A 30-year-old female was vaccinated with GARDASIL 9 and she had a lack of effect from the product. / She had undergone "4-5 procedures for VIN".; This spontaneous report was received from a pharmacist  and refers to her coworker who is a currently 30-year-old female patient. Her concurrent conditions, medical history and concomitant therapies were not provided.   On an unknown date (in appropriate age when the patient was an adolescent), she was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), intramuscularly (strength, dose, frequency, lot number and expiration date were not reported) as prophylaxis.  The patient reported that she had a lack of effect from the vaccine since on an unspecified date, she experienced vulval intraepithelial neoplasia (VIN) and she sought medical attention. She had undergone 4-5 procedures for the VIN. It was unknow if any lab diagnostics or studies were performed. The outcome of the lack of effect from the vaccine and vulval intraepithelial neoplasia was reported as not recovered.  The causality between the events and HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, vulval intraepithelial neoplasia was considered to be a medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: Plasma cell myeloma
Clinical narrative: Diagnosed with myeloma; This case was reported by a nurse via call center representative and described the occurrence of myeloma in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myeloma (serious criteria GSK medically significant). On an unknown date, the outcome of the myeloma was unknown.   It was unknown if the reporter considered the myeloma to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The nurse practitioner reported that a patient that received 1st dose of Shingrix and after that, was diagnosed with myeloma. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hypoaesthesia, Neuropathy peripheral, Vertigo
Clinical narrative: 4 days after / vaccine / peripheral neuropathy; Numbness of her left foot that is on and off; Having the sensation that she might fall; Vertigo; This case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 4 days after receiving Shingrix, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), numbness in feet, feeling abnormal and vertigo. On 18th November 2020, the outcome of the vertigo was recovered/resolved. On an unknown date, the outcome of the peripheral neuropathy, numbness in feet and feeling abnormal were not recovered/not resolved.   It was unknown if the reporter considered the peripheral neuropathy, numbness in feet, feeling abnormal and vertigo to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. Caller reported that she got her 1st dose of Shingrix about 3 weeks ago.  The patient reported that 4 days after receiving the vaccine, she began to experience peripheral neuropathy, numbness of her left foot that was on and off, and feeling a sensation like she may fall. About 2 weeks after the vaccine the patient did experience one episode of vertigo that was now gone.  Outcome date for events peripheral neuropathy, having the sensation that she might fall, vertigo was reported as 18th November 2020. She was still experiencing the other symptoms. The reporter did not consent to follow-up.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient have never had the flu Untill patient got a flu shot; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves a unknown demographics patient who have never had the flu untill patient got a flu shot (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient have never had the flu untill patient got a flu shot (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: patient was sicker than a dog; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves patient who experienced was sicker than a dog (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious patient was sicker than a dog (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a social media consumer.  This case involves patient (unknown demographics) who experienced sick (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not reported.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Inappropriate release of product for distribution, No adverse event, Product distribution issue, Product storage error
Clinical narrative: The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via The Agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310760, 2020SA310759, 2020SA310762, 2020SA310761, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via an unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised which was administered to a patient, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via The Agency via call center (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310760, 2020SA310759, 2020SA310763, 2020SA310761, 2020SA310769, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310762 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] Injection (lot number: UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via an unknown route and administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage (latency: same day).  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hours guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: the shipment was received outside the 72 hour guideline for standard shipping, it was received in 76 hours and was potentially compromised with no adverse event; the shipment was received outside the 72 hour guideline for standard shipping, it was received in 76 hours and was potentially compromised with no adverse event; Initial information regarding this unsolicited valid non-serious case via The Agency (reference number: 00303291) was received from other health care professional and transmitted to Sanofi 06-Oct-2020.  This case was linked to 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310354, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310464, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310559, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310708, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769, 2020SA310770 and 2020SA277871 (same reporter).  This case involved a patient with unknown demographics who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] prefilled syringe (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline, it was received in 76 hours and was potentially compromised (product storage error and product distribution issue). No thermometer was in packaging and product was cold when they received it.  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised which was given to a patient, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via The Agency (Reference number- 00303291) via call center and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310760, 2020SA310759, 2020SA310763, 2020SA310761, 2020SA310764, 2020SA310765, 2020SA310762, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] Injection (lot number: UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage (latency: same day).  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Inappropriate release of product for distribution, No adverse event, Product distribution issue, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised which was given to a patient, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via agency via call center (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310760, 2020SA310759, 2020SA310763, 2020SA310761, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310762 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] Injection (lot number: UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via an unknown route and administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage (latency: same day).  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: 44.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Patient came in for a second Hep B dose, and was mistakenly administered a Hep A dose. Mistake was relayed to patient and correct vaccine was given.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: intense pain in area of injection and spreading up shoulder and down arm,  with nausea but without vomiting.  intense pain lasted for 4 hours and now 48 hours later is still dull.  taking ibuprofen to relieve, which is slightly effective .  reduced range of motion
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: On October 3, the patient went to the pharmacy and got her flu shot.  A few weeks later, she realized she had limited movement in her arm because of pain.  She spoke with a friend who is a Physician?s Assistant and she said it sounded like Sirva.  The Patient visited her PCP, who prescribed prednisone, and also recommended the patient see an Orthopedic if the medication didn?t help.  The Patient saw an Orthopedic in November who  recommended physical therapy which was started last week. The patient mentioned on November 19th that her arm does seem to be getting a little better.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills, extreme body aches, fatigue and headaches
Age: 74.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: two days after vax: Arm was sore and a little aching, woke up with severe pain in left shoulder and neck. Pain slowly spread across shoulder down left arm. Could not move my head, unable to get up. Immediately called physician and was prescribed tylenol and warm compressants. No relief, after a few days on tylenol, started to feel a little relief. About a week later, symptoms disappeared.
Age: 44.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: swelling and pain at the site of injection. soreness and can't move the shoulder.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient states that since the moment she got her vaccine, her arm hurt. She said today that she did not have any redness, swelling, or heat in the area where the vaccine was given. She says that her arm has been throbbing and has been applying a heating pad. I told her not to apply heat and that she should apply ice and take tylenol if needed. I called the protocol doc and he said since there was no redness or swelling that she needs to follow up with her primary care doctor. She met with Dr, her primary doc and he prescribed diclofenac and tizanidine. She she just had heart surgery, her cardiologist recommended that she not take either med. I called patient back to let her know that she should follow-up with her doctor if she is still having pain.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Heart rate irregular, Palpitations
Clinical narrative: Palpitations and irregular heart rhythm
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Heart rate increased
Clinical narrative: Caller stated once injection was given she was fine  and then six hours later during the night left arm was hurting extremely, dizzy, weak , shivering, fast heart beat and sweating. Patient did call doctors office and inform nurse of symptoms but did not make appointment. Patient  stated she flushed her system with water and felt better this morning except for the the weakness and fatigue.
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Pain in extremity
Clinical narrative: Caller stated once injection was given she was fine  and then six hours later during the night left arm was hurting extremely, dizzy, weak , shivering, fast heart beat and sweating. Patient did call doctors office and inform nurse of symptoms but did not make appointment. Patient  stated she flushed her system with water and felt better this morning except for the the weakness and fatigue.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Headache 12 hours after injection, fever and body aches 12 hours after injection, pain at injection site
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired dose of VAQTA; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.    On 10-NOV-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S030588 with expiration date of 20-OCT-2020 (strength,  dose, route, frequency, and anatomical location were not provided) for prophylaxis (expired product administered). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S030588; expirationdate: 20-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional adverse effect reported; expired VARIVAX was inadvertently administered to a patient on 11/16/2020; expired VARIVAX was inadvertently administered to a patient on 11/16/2020; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 16-NOV-2020 the patient was inadvertently vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dosage form, lot number, expiration date 14-OCT-2020 R029518 (route of administration was not provided) for prophylaxis. No additional adverse effect were reported.        .
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) by a physician for long-term prevention of shingles and zoster related conditions (prophylaxis). Subsequently, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the vaccine live (ZOSTAVAX) vaccine, the patient had and will continue 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 cost included 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 suffered such losses, and damages in the future. The outcome of the event shingles was not provided. Therefore, the causality for the event was related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) by a pharmacist for long-term prevention of shingles and zoster related conditions (prophylaxis). Subsequently, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the vaccine live (ZOSTAVAX) vaccine, the patient had and will continue 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 cost included 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 suffered such losses, and damages in the future. The outcome of the event shingles was not provided. Therefore, the causality for the event was related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively, in 2014, the patient's healthcare providers included but not limited to a pharmacist, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequent to the vaccination, the patient was treated 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 suffered 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 shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: HPV9
Symptoms: Underdose
Clinical narrative: some of the fluid had leaked out onto her daughter's arm; some of the fluid had leaked out onto her daughter's arm; some of the fluid had leaked out onto her daughter's arm; no additionall adverse event; This spontaneous report was received from a consumer and refers to a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, concomitant therapies and drug reactions and allergies were not reported.  On an unknown day, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, administered to arm (lot # and expiration date were not provided) for prophylaxis. During the vaccination some of the fluid has leaked out onto the patient's arm, therefore the patient experienced product leakage, exposure via skin contact and underdose. The reporter was concerned if the patient did not receive the full dose, however the nurse administering the vaccine mentioned that the patient received the full amount required. The reporter inquired about the full dose needed for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No additional adverse event details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: red / injection site; swollen / injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown 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 age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient asked to use ice on a red and swollen Shingrix injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Welts on my other arm; This case was reported by a consumer via interactive digital media and described the occurrence of welts in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced welts. On an unknown date, the outcome of the welts was unknown.   It was unknown if the reporter considered the welts to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had welts on other arm.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: bad case of hive; allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2020, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced allergic reaction and hives. On an unknown date, the outcome of the allergic reaction and hives were unknown.   It was unknown if the reporter considered the allergic reaction and hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving dose of Shingrix, the patient experienced allergic reaction and bad case of hive for 4 weeks. The patient was asking how long does or when will it go away. The reporter did not consent to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Allergy test, Anaphylactic reaction, Immediate post-injection reaction
Clinical narrative: Had anaphylaxis immediately after flu vaccine in 2019; This case was reported by a physician via sales rep and described the occurrence of anaphylaxis in a female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of no adverse event (never had an issue).   On an unknown date, the patient received Fluarix Tetra. On an unknown date, immediately after receiving Fluarix Tetra, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was recovered/resolved.   It was unknown if the reporter considered the anaphylaxis to be related to Fluarix Tetra.  Additional details were reported as follows: The age at vaccination was not reported. In 2019, the patient received Fluarix vaccine 2019 and had an anaphylaxis immediately. In 2020, the patient received FluLaval Quadrivalent 2020. The patient saw allergist who performed allergy testing on 2020 Flu. The reported asked that someone from vaccine division could tell what might be causing the Anaphylaxis. It was unknown if reporter consent to follow-up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Rash papular, Tenderness
Clinical narrative: Shingles around the eye; Experienced an outbreak of Shingles; Tender; Bumps; This case was reported by a pharmacist via call center representative and described the occurrence of ophthalmic herpes zoster in a 71-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number TS3A9, expiry date 4th June 2022) for prophylaxis.   On 31st August 2020, the patient received the 1st dose of Shingles vaccine. In September 2020, between 3 and 4 weeks after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, tenderness and raised rash. On an unknown date, the outcome of the ophthalmic herpes zoster was unknown and the outcome of the shingles, tenderness and raised rash were not recovered/not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, shingles, tenderness and raised rash to be related to Shingles vaccine.  Additional details were provided as follows: The patient had experienced an outbreak of Shingles three weeks and a half after receiving the first dose of Shingrix. The patient still was under care having symptoms (tender and bumps) at the time of reporting. Pharmacy technician later reported that the patient had reported an outbreak of shingles around her eye following dose one of Shingrix. Health care professional did not provide outcome of shingles outbreak. The reporter consented to follow-up. This case had been linked to US2020229504 which is deleted from the database.
Sex: U
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: severe dizziness; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involved adult patient who experienced severe dizziness (Dizziness), while patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number- U6737AA) via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency after vaccination the patient experienced severe dizziness (Dizziness).  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown.