chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: two months old patient received a dose of pneumovax23; no adverse effect; This spontaneous report was received from a registered nurse referring to a 2-month-old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy details were not reported.     On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route of administration, lot# and expiry date were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported. No product quality(PQC) complaint was filed.; Sender's Comments:  US-009507513-1909USA002944:
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was administered Gardasil 9 after administered first dose of HPV series (unknown if it was Gardasil Quadrivalent or Gardasil 9); 25 year old patient was administered Gardasil 9 on unspecifieddate after was administered first dose of HPV series as 11 year old; No adverse effects reported; This spontaneous report was received from a physician, referring to a 25 year old patient of unknown gender. The patient's pertinent medical history, concomitant therapies, drug allergies or reactions, and concurrent conditions were not reported.      On an unknown date, reported as "the patient was 11 years-old", the patient was vaccinated with the first dose of Human Papilloma Virus (HPV) series; however it was unknown if the vaccine administered was quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, frequency, route of administration, anatomical site of vaccination, lot # and expiration date were not provided).  Afterwards, on an unknown date, when the patient was 25 years-old, a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was administered (strength, frequency, route of administration, anatomical site of vaccination, lot # and expiration date were not provided) (interchange of vaccine products and inappropriate schedule of product administration). No adverse effects were reported.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Amenorrhoea, Inappropriate schedule of product administration, Pregnancy test
Clinical narrative: first dose of GARDASIL 9 was on 12-DEC-2016 and the second was on 07-AUG-2019; "absence of menstruation" for the past 4 months; This spontaneous report was received from a the mother of the patient who reported to the physician regarding a 16-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 16-DEC-2016, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage schedule, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.         On an unknown date in May 2019 (reported as: "for the past 4 months"), the patient has experienced absence of menstruation (amenorrhoea). On 07-AUG-2019, the patient was administered a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). The patient was sent to take a pregnancy test but results were still not available. The patient has still not have her period and the physician considered that either the amenorrhoea was caused by the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or that the patient was pregnant.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Dyspnoea, Food allergy
Clinical narrative: patient had custard icecream and afterwards had an extreme reaction/ patient had strawberry yogurt and had another reaction/ teacher gave the patient a donut hole and patient had allergic reaction; Chest was sunken in and he could hardly breath; Chest was sunken in and he could hardly breath; This spontaneous report was received from the patient's mother referred to a 2 year old (currently 15 year old) male patient. The patient did not have any medical history, and concomitant medications. The patient had numerous food allergies including pears, peaches, legumes, soy, mustard, hot dogs, pepperoni, peanuts, eggs, chicken, pumpkin, squash, and strawberries. On an unknown date, approximately in 2006 (reported as about 13 years ago), when the patient was 2-year-old, he was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) dose 1, for prophylaxis (normal shots from pediatrician) injected in the arm (dose, route, lot # and expiry date were not reported). On an unknown date, approximately in 2006 (reported as about 13 years ago), one week after receiving the vaccine, patient had custard ice cream and afterwards had an extreme reaction. It was reported that, the patient's chest was sunken in and he could hardly breath (chest discomfort, dyspnoea). The next week the patient had strawberry yogurt and had another reaction. The reporter took the patient to pediatrician on an unknown date after the first reaction and the patient had skin and blood tests for allergies. The reporter stated that, the patient was allergy tested every 6 months and on an unspecified date switched allergy testing every year. At the time of reporting, the patient was being tested yearly. The patient had gradually outgrown all the allergies but eggs, tree nuts, peanuts and chicken (reporter was not sure about chicken). On an unknown date, a teacher in school gave the patient a doughnut hole and patient had an allergic reaction (food allergy). At the time of reporting, the patient was extremely allergic to eggs. The patient was treated with diphenhydramine (BENADRYL) for the reactions. The outcome of the events was not resolved. The reporter did not provide any causality assessment. Product quality complaint was not involved.
Sex: U
Vaccine: MMRV
Symptoms: Injection site extravasation, No adverse event, Underdose
Clinical narrative: NO adverse effect reported; patient was administered a dose of PROQUAD that was less than the full recommended; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 03-SEP-2019, the patient was vaccinated with  a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, frequency, route and vaccination site were not reported) lot # S006828, expiration date 02-SEP-2020, for prophylaxis that was less than the full recommended dose. Medical assistant reports that after administration a "few drops" of the vaccine "dripped from the insertion site". No adverse effect reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; one patient received an improperly stored PROQUAD; This spontaneous report was received from a registered nurse referring to a 4 year old patient of unknown gender. The patient's pertinent medical history, concomitant medications, drug reactions and allergies were not reported.    On 21-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R023499 with an expiration date on 13-FEB-2020 and lot# R026722 with expiration date on 17-MAR-2020 (dose, route and site of administration were not reported) indicated for prophylaxis, which were reconstituted with properly stored sterile diluent(MERCK STERILE DILUENT) (lot# and expiration date was not reported).  The nurse did not have the specific lot and expiration date of administered vaccine to the patient, but it was one of the listed above.  No adverse effect reported.       The administered doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) experienced two temperature excursions, one on 12-AUG-2019 and the other one was on 13-AUG-2019 for a time frame of  -14°C Celsius degrees to -10 °C (-11.91 °C) for 8 hours, as recorded by a data logger.   There were no previous excursions reported.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: "redness near the injection site has spread in diameter to to 16 cm in length and 10 cm in width which was initially bard and has now softened".; the patient starting "feeling fatigue and experiencing pain at the injection site".; the patient starting "feeling fatigue and experiencing pain at the injection site".; "fever, extreme fatigue, and redness near the injection site has spread in diameter to to 16 cm in length and 10 cm in width which was initially bard and has now softened".; "redness near the injection site was initially hard and has now softened".; "fever, extreme fatigue, and redness near the injection site has spread in diameter to to 16 cm in length and 10 cm in width which was initially bard and has now softened".; This spontaneous report as received from a consumer refers to a 34 year old female patient..   The patient's pertinent medical history included Crohn's disease. The patient did not have any drug reaction or allergy. Concomitant therapies included adalimumab (HUMIRA) and azathioprine (IMURAN (AZATHIOPRINE).  On 03-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), route of administration reported as injection, for prophylaxis (dose, lot# and expiration date were not provided).   Later that same day, the patient starting feeling fatigue and experiencing pain at the injection site. The patient also reported that every day since being vaccinated her adverse symptoms range from fever, extreme fatigue, and redness near the injection site (injection site erythema) had spread in diameter to to 16 cm in length and 10 cm in width which was initially hard (vaccination site induration) and had now softened. She contacted her physician by telephone. The patient was given treatment with diphenhydramine (BENADRYL) on an unknown date. No further symptoms were provided. At the time of reporting, the patient had not recovered from the events of fever, vaccination site pain, fatigue, injection site erythema. The outcome of vaccination site induration was recovering. The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Severe reaction; This case was reported by a consumer and described the occurrence of adverse event in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. On Monday, the patient received her my first shingrix shot and experienced severe reaction. Because of this the patient assumeed that she should not get the second shot. The patient question was would the first shot provided any protection if she are unable to take the second shot.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Neuropathy peripheral, Paraesthesia
Clinical narrative: classic neurophathy; warm on the bottom of feet; face tingling; This case was reported by a consumer via call center representative and described the occurrence of neuropathy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th February 2019, refer case US2019AMR161883 ). Concurrent medical conditions included bone spur.   In May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant), localized feeling of warmth and tingling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the neuropathy and tingling were unknown and the outcome of the localized feeling of warmth was not recovered/not resolved.   It was unknown if the reporter considered the neuropathy, localized feeling of warmth and tingling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received dose 2 of Shingrix and that months later he started to feel warm on the bottoms of his feet and it feels like, classic neuropathy to him. He states he sought medical care and his physician told him it was bone spurs and not related to Shingrix, but patient felt it was incorrect.  The patient stated that 3 weeks ago he experienced like his face was started tingling as well. The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: patient received expired Menactra/ No AE; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA244699 same reporter.  This case involves a 17 years old female patient who received 0.5 mL dose of expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U5835AA, expired date: 17-FEB-2019 (Frequency- once) via intramuscular route in the left deltoid on 02-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  It was unknown whether the patient had any 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.  Documents held by sender: none.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired Menactra, no AE; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA244698 (same reporter).  This case involves a 15 years old male patient who received an expired 0.5 ml dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U5835AA, Exp. Date 27-Feb-2019) via intramuscular route in the right arm, on 25-Mar-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  It was reported that there were three different patients total who received expired doses of vaccines. Two patients received expired Menactra and one patient received expired ActHIB.  At the time of reporting no adverse reactions were 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.   Documents held by the sender: none.
Sex: M
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: are there any adverse reactions expected due to third dose being given too early, No AE; Initial information received on 30-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age (reported as 6) patient who received 0.5 ml third dose of vaccine IPV (VERO) [IPOL] (lot: N1J45, expiry date: 05-Oct-2019) too early on 22-Aug-2019, via intramuscular route in the left thigh.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  no concurrent vaccines given  It was an actual medication error due to inappropriate schedule of vaccine administration.  At the time of reporting the 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.  List of documents held by sender: none.
Age: 3.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered .5ml of Flublock Quad to a 3 year old,/ NO AE; Initial information received on 29-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse  This case involves a 3 years old female patient who was vaccinated with 0.5 ml dose of Flublock quad vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant therapy was given.   On 28-Aug-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1905, exp date: May 21, 2020, via unknown route in the right thigh.  It was a case of actual medication error due to Inappropriate age at vaccine administration.  At the time of the 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.  List of documents held by the sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: same leg of the injection site of the thigh to swell to double its size that night; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 7 years old male patient who experienced same leg of the injection site of the thigh to swell to double its size that night (swelling), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past vaccination(s) included Fluzone Quadrivalent with no reaction.  The patient's past medical history, medical treatment(s) and family history were not provided.    On 10-Nov-2018, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6262LA via intramuscular route in the thigh nos.  On 10-Nov-2018, the patient developed a non-serious same leg of the injection site of the thigh to swell to double its size that night (swelling) on same day at night following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was same leg of the injection site of the thigh to swell to double its size that night.  the consumer was taken to the emergency room on the same day of the injection; that the exact treatments were not known by the caller but possible Benadryl, that the consumer was advised not to get the Fluzone Quadrivalent again.  The father of the consumer, a physician as well, is contemplating the nasal mist influenza immunization.  The patient outcome is reported as Unknown for same leg of the injection site of the thigh to swell to double its size that night.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Gingival pain, Pain in jaw, Temporomandibular joint syndrome
Clinical narrative: Developed jaw pain on left side, similar to TMJ only much worse than usual.  Sore gums on left lower jaw.  Pre-existing but aggravated after the shot.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal discomfort, Dizziness, Syncope, Tremor
Clinical narrative: After vaccination patient felt dizzy and shaky. Stomach upset. Syncope with no injuries. Afterwards slightly shaky but resolved after sitting for 10 minutes and drinking water. No seizure symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event gave combo vaccination out of series
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Cyanosis, Full blood count, Influenza virus test negative, Metabolic function test, Respiratory syncytial virus test negative
Clinical narrative: Almost 3 days after vaccination patient presents signs of seizure with temperature of 37.6 Celsius, mother indicates child was with father when he called ambulance and that the child was cyanotic, drowsy and unresponsive.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Seizure, Somnolence, Unresponsive to stimuli
Clinical narrative: Almost 3 days after vaccination patient presents signs of seizure with temperature of 37.6 Celsius, mother indicates child was with father when he called ambulance and that the child was cyanotic, drowsy and unresponsive.
Age: 1.42
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rhinorrhoea, Urticaria
Clinical narrative: 3 DAYS AFTER VACCINES ADMINISTERED, DEVELOPED HIVES  ON ABDOMEN  AND  HANDS.  PERIODIC IN NATURE.  TAKEN TO EMERGENCY ROOM ON 09/03/19 AND WAS PRESCRIBED PREDNISOLONE  AND BENADRYL.      NO LABS OR OTHER TESTING WERE DONE.   NO RESPIRATORY PROBLEMS.   NO LIP OR TONGUE SWELLING.       FOLLOWED UP IN CLINIC ON 09/05/19.  HIVES IMPROVED, NOT COMPLETELY RESOLVED.    SL. RUNNY NOSE.   EATING AND DRINKING WELL.   ALERT.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Fall, Fatigue, Joint injury, Pyrexia
Clinical narrative: patient received fluad in pharmacy on 09/02/19 was feeling fine when she left the store. the next day she went to her cardiologist and told him she received her flu shot. the md then administered a pneumonia shot to her. patient developed tiredness and fever after the pneumonia shot the next day. a few days later patient called to say she had weakness and fell when she tried to get out of bed and hurt her ankle. she visited  md to examine her ankle.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Soreness or achhiness; This case was reported by a consumer via call center representative and described the occurrence of pain in a 73-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced soreness or achhiness. This case has been linked with US2019148654, reported by the same reporter.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Skin haemorrhage
Clinical narrative: Shingles; Holes with blood spurting out; Pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (outbreak in December 2005), blister, nerve damage and pain in arm. Concomitant products included Herpes zoster (Shingrix).   On 10th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 17th July 2019, 7 days after receiving Shingrix, the patient experienced shingles, skin bleeding and pain. On an unknown date, the outcome of the shingles, skin bleeding and pain were unknown.   It was unknown if the reporter considered the shingles, skin bleeding and pain to be related to Shingrix.  Additional information received were as follows: The patient had shingles in December 2005 which occurred on the right upper arm (including under the arm), right shoulder, and back of right should (around scapula). The patient received Shingrix on left arm. The patient experienced shingles again on the right upper arm (and under the right upper arm), right shoulder, and right scapula area of the back. The patient reportsed that this outbreak was milder, and he had less pain than when he had the first outbreak. He also reported that with the first outbreak he had blisters. This time the patient had holes with blood spurting out. The patient reported that he had nerve damage and pain in his right arm since having the shingles in December 2005. The reporter gave permission for his physician to be contacted.
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Severe pain; The initial case was missing the following minimum criteria: unspecified patient and event. Upon receipt of follow-up information on (03Sep2019), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: X70865) intramuscularly (IM) on 09May2019 at a single dose for routine shot (immunization). The patient's medical history was not reported. There was no concomitant medication. The patient experienced severe pain on an unspecified date. The outcome of event was unknown.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient received an expired dose of Menactra on 30Aug2019, No AE; 21-year-old male received a delayed dose of Menactra  intramuscularly on 30Aug2019 as dose number 2 out of 2. the patient received dose number 1 as a child, No AE; Initial information received on 30-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse in the United States.  This case involves a 21 years old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) in right deltoid via intramuscular route for immunisation, on 30-Aug-2019.  On 30-Aug-2019, the patient received a delayed (second dose) and expired dose 0.5 ml dose once of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot: U5984AB, expiry date: 14-Aug-2019) via intramuscular route in the left deltoid.  It was also reported that the patient received dose number 1 as a child.  It was an actual medication error due to inappropriate schedule of vaccine administration and expired vaccine used.  At the time of reporting 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.  List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: FEVER OF 103.5 AND LEFT LEG SORENESS.  Motrin given for the fever and pain with the fever coming down.  Left leg remained sore.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt reported redness, swelling and pain at site of injection
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Patient is 32.6 weeks pregnant, she received adacel on 09/06/2019 and previous dose  of Adacel was on 08/19/2019. Estimated due date 10/30/19.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling of most of the left arm- She just started prednisone- pt put on Prednisone 9/9/19
Age: 69.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Chills, Cold sweat, Erythema, Head injury, Peripheral swelling
Clinical narrative: The night of 9/2, patient fainted and hit her head. Her husband helped her up and she did not go to hospital or call her Dr.  She was clammy and had chills.  Also she had a swollen, red and warm LEFT arm only (pneumovax arm).  The only professional visit was to stop in here (pharmacy) and tell me about it.
Age: 69.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Skin warm, Syncope
Clinical narrative: The night of 9/2, patient fainted and hit her head. Her husband helped her up and she did not go to hospital or call her Dr.  She was clammy and had chills.  Also she had a swollen, red and warm LEFT arm only (pneumovax arm).  The only professional visit was to stop in here (pharmacy) and tell me about it.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Enlarged uvula, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Left arm EXTREMELY sore, almost totally unusable for 24-36 hours, Uvula swollen to approx twice normal size-3 days to fully return to normal
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling hot, Syncope
Clinical narrative: Fainted with in 10 seconds, was out about 10 seconds.  Felt warm for about 15 minutes, laid down for roughly 20-25 minutes.  felt fine afterwards and was able to leave on his own.  Patient stated that he has a history of fainting during shots or lab tests but did not faint during his flu shot last year
Age: 12.0
Sex: F
Vaccine: MMRV, MNQ, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: PATIENT WAS IN FOR IMMUNIZATIONS AND IS NEEDING TO USE A CATCH UP SCHEDULE.  THE DOCTOR ORDER "IPOL" AS SHE NEEDED A POLIO AND IS ABOVE THE AGE OF 6 WHEN THE COMBINATION  Dtap IMMUNIZATIONS RECOMMEND NOT USING. THE IPOL WAS GIVEN AND WHEN WENT TO ENTER INTO REPORTING SYSTEM THE EXPIRATION DATE CAME UP EXPIRED. THE PATIENT SHOWED NO SYMPTOMS.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Given dose of Trumenba on 9/3/2019, client had already received dose of Bexsero on 07/15/2019. inadvertently gave wrong Men B product which are not interchangeable
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: patient did at home pregnancy test, on 8/24/2019, that was positive; no adverse effects; This spontaneous prospective pregnancy report was received from a nurse practitioner and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-AUG-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included sterile diluent. The patient did an at home pregnancy test on 24-AUG-2019, that was positive. The patient became pregnant with last menstrual period LMP of 10-AUG-2019, approximate date of conception was 24-AUG-2019 and estimated date of delivery (EDD) was 16-MAY-2020 (all dates calculated based on LMP). Initial exposure to varicella virus vaccine live (oka/merck) (VARIVAX) was at 1 week. The pregnancy outcome was pending. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: a bit of soreness; This case was reported by a consumer and described the occurrence of pain 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, less than 3 months after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix 2 months before the time of reporting and experienced only a bit of soreness. For tolerances of 2nd dose refer case US2019AMR160237, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash erythematous, Rash vesicular
Clinical narrative: On one side of her chest and neck there is a very red rash with blisters; Blisters; Very painful; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vesicular rash, blister and pain. On an unknown date, the outcome of the vesicular rash, blister and pain were unknown.   It was unknown if the reporter considered the vesicular rash, blister and pain to be related to Shingrix.  Additional details were reported as follows: The reporter reported adverse events experienced by their mother in law. The age at vaccination was not reported but it could be 83 years or 84 years. The patient was vaccinated about a year before the reporting date. The reporter believed that, the patient had shingles and described symptoms of it. On one side of the patient's chest and neck there was a very red rash with blisters. It started small and spread over a couple of days. It was very painful and looked just like images of shingles that the reporter seen during research. The reporter also asked, could a person who was vaccinated with Shingrix develop shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: On one side of her chest and neck there is a very red rash with blisters; Blisters; Very painful; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vesicular rash, blister and pain. On an unknown date, the outcome of the vesicular rash, blister and pain were unknown.   It was unknown if the reporter considered the vesicular rash, blister and pain to be related to Shingrix.  Additional details were reported as follows: The reporter reported adverse events experienced by their mother in law. The age at vaccination was not reported but it could be 83 years or 84 years. The patient was vaccinated about a year before the reporting date. The reporter believed that, the patient had shingles and described symptoms of it. On one side of the patient's chest and neck there was a very red rash with blisters. It started small and spread over a couple of days. It was very painful and looked just like images of shingles that the reporter seen during research. The reporter also asked, could a person who was vaccinated with Shingrix develop shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pyrexia
Clinical narrative: Fever; Blisters; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced fever and blister. On an unknown date, the outcome of the fever and blister were unknown.   It was unknown if the reporter considered the fever and blister to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingles vaccine and developed a fever and blister. The reporter was unable to provide any additional details. This case linked with US2019160421, reported by same reporter.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Ipol was inadvertently administered, the vaccine was 4 days beyond expiration when it was given/ no AE; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old patient who received vaccine IPV (VERO) [IPOL] and reported that expired Ipol was inadvertently administered to a patient in the right thigh, the vaccine was 4 days beyond expiration when it was given (product storage error).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL).  On 06-Aug-2019, the patient received 4th dose of suspect IPV (VERO) lot N1G511M via unknown route in the right thigh.  It was a case of actual medication error due to expired vaccine used.  At the time of the report, adverse event was not 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.  List of documents held by sender- none.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: ActHIB portion only of a Pentacel vaccine was given, diluted with 04 % sodium chloride. The DTaP/ IPV portion was not given, no AE; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 15 months old male patient who received a fourth 0.5 ml dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ097AA and Exp. Date 19-Sep-2020 via intramuscular route in the left vastus lateralis, on 03-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was reported that the ActHIB portion only of a Pentacel vaccine was given, diluted with 0.4 % sodium chloride. The DTaP/ IPV portion was not given.  At the time of reporting no adverse reactions were 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.  List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of Menactra from her provider on 03-Sep-2019, no AE; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves female patient (age reported as possibly 20-30) who received an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired in June or July 2019) lot number not reported via unknown route in unknown administration site, on 03-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  It was a case of actual medication error due to expired vaccine used.  It was reported that a female of unknown age (possibly 20-30) said she received an expired dose of Menactra from her provider on 03-Sep-2019. Consumer reported the Menactra expired in June or July 2019.  At the time of reporting no adverse reactions were 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.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flublock was given inadvertently to a 10 year old child, no AE; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 10 years old male patient who was vaccinated with a 0.5 mL dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1901, expiry date: 17-May-2020 via unknown route in unknown administration site on 21-Aug-2019.  It is an actual medication error case due to Inappropriate age at vaccine administration.  It was not known whether the patient had any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Allergy with Tetanus toxoid; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves unknown demographic patient who experienced allergy with tetanus toxoid, while received vaccine TETANUS TOXOID.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious allergy with tetanus toxoid (allergy to vaccine) (Unknown latency) following the administration of TETANUS TOXOID.  (Other relevant tests included no lab data).  Final diagnosis was allergy with tetanus toxoid.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for allergy with tetanus toxoid.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Body temperature increased, Streptococcus test, Urticaria
Clinical narrative: Patient woke - up at 7:00 am on 9/10/19 with hives. Also has a temp of 100.9. Patient got tylenol and Benadryl in office.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Immediately after vaccine administration patient had a syncopal episode. Patient was placed in supine position for 15 min until he felt better. He drank gatorade and left office in good condition after 30 mins.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test, Unevaluable event
Clinical narrative: None stated.
Age: 78.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Dyspnoea, Erythema
Clinical narrative: Patient stood up and walked around corner and started complaining about trouble breathing, had patient sit down and continued to complain of trouble breathing, face started getting red.  Called 911 gave patient epipen and started feeling better. EMS came and took patient to hospital.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Flushing, Headache, Nausea, Vomiting
Clinical narrative: Documentation of appropriately spaced primary childhood series followed by negative titer upon hire.  Challenge dose of Heplisav-B.  No immediate reaction.  Reported that approximately 30-45 minutes later she felt flushed, developed headache, nausea and vomiting.  No rash or any respiratory symptoms.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia, Chills, Headache, Pain
Clinical narrative: Sore arm started about 2 hours after injected. In next 2 hours body/ joint aches began.  Two hours later headache and tummy pain began- took NSAID and went to bed. Woke up in morning with 101.1 f fever- chills, tremor, tummy ache, and extreme headache.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: Sore arm started about 2 hours after injected. In next 2 hours body/ joint aches began.  Two hours later headache and tummy pain began- took NSAID and went to bed. Woke up in morning with 101.1 f fever- chills, tremor, tummy ache, and extreme headache.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Extra dose administered
Clinical narrative: pt also recieved a flu shot from the doctor but failed to communicate that when asked if she wants her flu shot with prevnar 13 at the pharmacy