chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Akinesia, Dizziness, Fear, General physical health deterioration, Headache
Clinical narrative: can no longer walk without assistance, can't do anything; no feelings in my arms, hands, feet, and half way down my chest.; no feelings in my arms, hands, feet, and half way down my chest.; trying to get facts on reversing the effects of the ZOSTERVAX; dizziness; tingling in the muscles on my arms and legs; patient was so scared she will be paralyzed by then; my health had deteriated immensely; have gone downhill fast; severe headaches; This spontaneous report has been received from a 61 years old female patient referring to herself. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, route and dose details were unknown) for prophylaxis. The patient was not having any health problem when received the vaccine.        The patient stated that her health has deteriated immensely on an unknown date. On unknown dates (reported as within months), the patient started having dizziness, severe headaches, tingling in the muscles on her arms and legs. Then it was progressed to no feelings in her arms, hands, feet, and half way down her chest (hypoaesthesia). The patient had been referred to a neuromuscular specialist and had an appointment in March 2019. The patient was so scared that she would be paralyzed by then. The patient could no longer walk without assistance and could not do anything (akinesia). The patient's daughter had to come over to help the patient get a bath. The patient had gone downhill fast, and never thought this could happen to herself. The patient kept her grandchildren every day and walked 4 miles daily. The patient was trying to get facts on reversing the effects of the zoster vaccine live (ZOSTAVAX).  The outcome of the events was unknown. The causality assessment between the events and the zoster vaccine live (ZOSTAVAX) was related.  The adverse events "no feelings in her arms, hands, feet, and half way down her chest" were considered to be significant disability due to the patient could no longer walk without assistance and could not do anything. Upon internal review, the akinesia was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities, Paraesthesia, Walking aid user
Clinical narrative: can no longer walk without assistance, can't do anything; no feelings in my arms, hands, feet, and half way down my chest.; no feelings in my arms, hands, feet, and half way down my chest.; trying to get facts on reversing the effects of the ZOSTERVAX; dizziness; tingling in the muscles on my arms and legs; patient was so scared she will be paralyzed by then; my health had deteriated immensely; have gone downhill fast; severe headaches; This spontaneous report has been received from a 61 years old female patient referring to herself. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, route and dose details were unknown) for prophylaxis. The patient was not having any health problem when received the vaccine.        The patient stated that her health has deteriated immensely on an unknown date. On unknown dates (reported as within months), the patient started having dizziness, severe headaches, tingling in the muscles on her arms and legs. Then it was progressed to no feelings in her arms, hands, feet, and half way down her chest (hypoaesthesia). The patient had been referred to a neuromuscular specialist and had an appointment in March 2019. The patient was so scared that she would be paralyzed by then. The patient could no longer walk without assistance and could not do anything (akinesia). The patient's daughter had to come over to help the patient get a bath. The patient had gone downhill fast, and never thought this could happen to herself. The patient kept her grandchildren every day and walked 4 miles daily. The patient was trying to get facts on reversing the effects of the zoster vaccine live (ZOSTAVAX).  The outcome of the events was unknown. The causality assessment between the events and the zoster vaccine live (ZOSTAVAX) was related.  The adverse events "no feelings in her arms, hands, feet, and half way down her chest" were considered to be significant disability due to the patient could no longer walk without assistance and could not do anything. Upon internal review, the akinesia was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: My injection site is red/red spot; This case was reported by a consumer and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received Shingrix. On 26th January 2020, 2 days after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovering/resolving.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The patient experienced injection site was red about the size of a large Booca ball after receiving Shingrix. The red spot on arm which was basketball sized on 26th January 2020, which was fading away looks much better and seems like it will be ok. The patients pharmacist advised put ice on the spot. No other information was provided.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Neuralgia
Clinical narrative: burning in feet while sleeping; nerve pain; This case was reported by a pharmacist via call center representative and described the occurrence of burning foot in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number 5552S, expiry date 26th February 2022) for prophylaxis.   On 22nd January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced burning foot and nerve pain. On an unknown date, the outcome of the burning foot and nerve pain were unknown.   It was unknown if the reporter considered the burning foot and nerve pain to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix vaccine and about 10 days later he reported to the pharmacist that he was experiencing burning in feet while sleeping and nerve pain.  It was unknown if the events were ongoing or resolved. The reporter reported that the patient had it for several nights and only when sleeping. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Injection site erythema
Clinical narrative: headache; redness at the injection site; first dose of the Shingrix vaccine about a year ago; This case was reported by a consumer via call center representative and described the occurrence of headache in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 28th January 2020, the patient received the 2nd dose of Shingrix. On 28th January 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced headache and injection site erythema. On an unknown date, the outcome of the headache, injection site erythema and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the headache and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the first dose of the Shingrix vaccine about a year ago and did not receive the second dose yet. The patient was planning to get the second dose of Shingrix on the reporting date, which led to lengthening of the vaccination schedule.  She states he did experience headache and redness at the injection site with the first dose.  Customer did not want to provide her address.  No additional information provided. The reporter consented to follow up.  This case has been linked with US2020015819, reported by same reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Injection site erythema
Clinical narrative: headache; redness at the injection; First dose of the Shingrix vaccine about a year ago; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In January 2020, the patient received the 2nd dose of Shingrix. In January 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced headache and injection site erythema. On an unknown date, the outcome of the headache, injection site erythema and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the headache and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Wife stating her husband received the first dose of the Shingrix vaccine about a year ago and received the second dose past the six month period, which led to lengthening of the vaccination schedule.  He received the second dose last week. She states he did experience headache and redness at the injection site with the first dose.  Customer did not want to provide her address.  No additional information provided. The reporter consented to follow up.  This case has been linked with US2020015816, reported by same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Outbreak of shingle on lower Left Leg, small
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria, Lip erythema, Lip swelling, Malaise, Pruritus
Clinical narrative: Urticaria. Resolved with Benadryl Received flu shot at 1045 by 430pm patient had a generalized feeling of not feeling well. By 730pm patient started itching and by 830pm he had hives on his face at the injection site and his lips were dark red and swollen. Mother gave benadryl and by 1AM most hives were gone. Patient is still itching today 1/23/20. Patient taking Claritin and benadryl.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Urticaria. Resolved with Benadryl Received flu shot at 1045 by 430pm patient had a generalized feeling of not feeling well. By 730pm patient started itching and by 830pm he had hives on his face at the injection site and his lips were dark red and swollen. Mother gave benadryl and by 1AM most hives were gone. Patient is still itching today 1/23/20. Patient taking Claritin and benadryl.
Age: 1.83
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Urticaria
Clinical narrative: Child developed hive reaction located to the face (cheeks) approximately 45 minutes after vaccine administration
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 1/25/2020 and was administered 1/29/2020.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient's parents reported that later that evening child had a vomiting episode and a low grade fever of 99.0
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Patient reports lingering muscle pain in arm & shoulder since 2nd vaccine. He has tried massage.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site induration, Pain in extremity
Clinical narrative: Patient seen for right arm pain and a small 2-3 mm area of induration on right deltoid 3 days following HPV vaccination. No numbness/weakness. No signs of infection. Full strength.
Age: 1.83
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Induration
Clinical narrative: light pink indurated area 5in x 4in
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: within 12 to 18 hours developed a large swollen tender area distal to injection site -- not seen by provider, but consistent with large local reaction acutely by hx.   4 months later still has a large palpable "mass" not otherwise specified at the site of the large local reaction
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Dizziness, Pain, Pyrexia, Tremor
Clinical narrative: dizzy, body aches, fever, shakes, cold sweats
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Per mother, the child woke up the next morning with excessive pruritis of the injection site. She was scratching at the area incessantly. She also developed a "raised, red, sore" area at the injection site  that remained for around 10 days. Since then, the edema and itching has been coming and going. Appears better one day and then returns.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: pt stated a sore arm after vaccine. She said she has been having trouble for ~5 months raising her arm and with mobility. She states a friend had a vaccine and had bone cancer later and was concerned.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Nausea, Pain, Pyrexia
Clinical narrative: The day after the shot I noticed these side effects: ache in whole body fever nausea stomachache
Age: 17.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Bacterial vaginosis, Papilloma viral infection, Vaginal discharge, Vaginal infection, Vaginal odour
Clinical narrative: believes that she may have cancer; "thick white creamy" vaginal discharge/ started having a fishy smell; serious problems" in her vaginal area; she was advised that she has "HPV on (her) cervix; "thick white creamy" vaginal discharge; bacterial vaginosis; This spontaneous report as received from an approximately 17-year-old female patient. The patient had no pertinent medical history and drug reactions or allergies. Her concomitant therapies included folic acid.  On an unknown date in 2009, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), intramuscularly (dose, lot # and expiration date were not reported) for prophylaxis.   On an unknown date in approximately 2009, (also reported as a week after she got the vaccination), the patient started getting lots of vaginal infections. According to the patient, on unknown dates, multiple doctors did visual examinations and the patient was told that she had bacterial vaginosis. The patient received unspecified medications for the event.  In approximately 2011 (reported as 2 or 3 years after getting quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (douse, route of administration, lot # and expiration date were not reported) to "help protect from anything else happening".  On an unknown date in 2012, the patient started having a "thick white creamy" vaginal discharge and on an unknown date (reported as "over time") it started having a fishy smell. Approximately in 2013 (reported as in 2013 or 2014), the patient was advised that she had human papillomavirus (HPV) on her cervix. The patient had been to four different hospitals to try to get this events treated, however she was released from each hospital without being admitted. On an unknown date, the patient experienced "serious problems" in her vaginal area and she believed she might have a cancer. Patient stated that she was considering legal action because of the events.  The outcome of the events was reported as not recovered.  The relatedness between the events and the suspect vaccines was not reported.  Upon internal review, the event of cancer was considered to be medically significant.
Sex: M
Vaccine: MMRV
Symptoms: Influenza virus test negative, Injection site reaction, Injection site swelling, Papule, Pyrexia
Clinical narrative: fever; 2.5 cm diameter raised ciruclar lesion around the injection site; papules on the back; This spontaneous report was received from a registered nurse, referring to a 12 month old male patient. The patient did not have pertinent medical history, drug reactions or allergies. Concomitant therapies included pneumococcal 13v conj vaccine (crm197)(PREVNAR 13), hepatitis a virus vaccine inactivated(HAVRIX) and sterile diluent.     On 24-JAN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # S013711, expiration date: 01-NOV-2020 (also reported as 02-NOV-2020), subcutaneously, for 1 year wellness visit vaccines (dosage information, route and anatomical site of vaccination were not reported).   On 31-JAN-2020, the patient experienced fever, raised 2.5 cm diameter raised circular lesion around the injection site, and papules on the back. The nurse reported that the patient sought for medical attention and on 01-FEB-2020, he was prescribed Benadryl every 8 hours and cortisone cream for a week.   The outcome of pyrexia, papule and skin lesion was unknown. The causality assessment was not provided.  The reporter considered the events pyrexia, papule and skin lesion to be serious since required intervention to prevent serious criteria.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2002USA001425: US-009507513-2002USA001548: US-009507513-2002USA001507: US-009507513-2002USA001496:
Sex: M
Vaccine: MMRV
Symptoms: Skin lesion
Clinical narrative: fever; 2.5 cm diameter raised ciruclar lesion around the injection site; papules on the back; This spontaneous report was received from a registered nurse, referring to a 12 month old male patient. The patient did not have pertinent medical history, drug reactions or allergies. Concomitant therapies included pneumococcal 13v conj vaccine (crm197)(PREVNAR 13), hepatitis a virus vaccine inactivated(HAVRIX) and sterile diluent.     On 24-JAN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # S013711, expiration date: 01-NOV-2020 (also reported as 02-NOV-2020), subcutaneously, for 1 year wellness visit vaccines (dosage information, route and anatomical site of vaccination were not reported).   On 31-JAN-2020, the patient experienced fever, raised 2.5 cm diameter raised circular lesion around the injection site, and papules on the back. The nurse reported that the patient sought for medical attention and on 01-FEB-2020, he was prescribed Benadryl every 8 hours and cortisone cream for a week.   The outcome of pyrexia, papule and skin lesion was unknown. The causality assessment was not provided.  The reporter considered the events pyrexia, papule and skin lesion to be serious since required intervention to prevent serious criteria.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2002USA001425: US-009507513-2002USA001548: US-009507513-2002USA001507: US-009507513-2002USA001496:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient experienced no symptoms; a patient was administered an expired dose of VAQTA; 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 medications were not reported.  On 31-JAN-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscularly, lot# R031045, expiration date: 18-NOV-2019 (exact dose and site of administration were not reported) for prophylaxis. The patient did not experience any symptoms.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Erythema, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Client contacted office, via telephone, 4 days after receiving vaccines, reporting his right arm is swollen, red, warm to the touch and pain to his elbow.  Client states the redness to his whole upper right arm started the day after receiving the vaccines, moved to his lower right arm by the third day post vaccines, and unable to move his elbow by the fourth day post vaccine. Client states he placed ice on his arm and it was effective on decreasing the pain, swelling and the  redness. Client came to the clinic for the nurse to observe the adverse reaction. Client's right arm noted to warm to the touch, red from mid-forearm to mid-upper arm, and client had good range of motion in his elbow. Client reported that he did not want to go to his PCP since the ice was helping the reaction, however states he would contact his PCP if the reaction did not decrease in the next couple days. Contacted client today, and client reports that the swelling and redness has gone down significantly and he denies having any pain at this time. Client states he does not feel he needs to be seen by his PCP at this time.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Client contacted office, via telephone, 4 days after receiving vaccines, reporting his right arm is swollen, red, warm to the touch and pain to his elbow.  Client states the redness to his whole upper right arm started the day after receiving the vaccines, moved to his lower right arm by the third day post vaccines, and unable to move his elbow by the fourth day post vaccine. Client states he placed ice on his arm and it was effective on decreasing the pain, swelling and the  redness. Client came to the clinic for the nurse to observe the adverse reaction. Client's right arm noted to warm to the touch, red from mid-forearm to mid-upper arm, and client had good range of motion in his elbow. Client reported that he did not want to go to his PCP since the ice was helping the reaction, however states he would contact his PCP if the reaction did not decrease in the next couple days. Contacted client today, and client reports that the swelling and redness has gone down significantly and he denies having any pain at this time. Client states he does not feel he needs to be seen by his PCP at this time.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash
Clinical narrative: RASH AND ITCHYNESS
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Pt woke up feeling "room was spinning" the next morning and vertigo continued intermittently. seen by myself at clinic on 2/5/2020. Rx meclizine PRN. rest and fluids
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Patient reports an onset of shoulder pain 24-48 hours after vaccine administration. Patient reports progressive limitations of her range of motion of her left shoulder and increasing pain.
Age: 1.08
Sex: M
Vaccine: FLU4, HEPA, MMR, MMRV, PNC13
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: PROQUAD instead of Varivax given to pt. along with the MMR and other above listed vaccines.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: 01/30/2020 Patient presents to clinic for evaluation of LUE redness at site of recent immunization. Had shingles vaccine administered on 1/27/2020 and noted some redness at site shortly thereafter. States that day before yesterday was approximately 1 inch diameter but increased in size over the next 24 hours. States that she has been taking ibuprofen and applying warm compresses for treatment of local reaction without resolution of symptoms. Today notes increasing pain and heat at site. Erythematous lesion has increased in size to her entire deltoid region. Denies fevers, nausea, vomiting, or other concerns. Assessment/Plan Cellulitis Rx Keflex 1000 mg BID x 7 days. Perimeter of lesion outlined - advised CO that a small amount of expansion beyond the border is expected over the next 24 hours, but at 24 hours should not see any additional expansion, and should note reduction in size of lesion within 48 hours. If significant expansion, advised to seek medical attention. Notify PCP or return to clinic if no improvement in condition over the next 2 days. CO verbalized understanding and agrees with plan of care. Orders: cephalexin, 1,000 mg = 2 cap(s), Oral, BID, x7 day(s), # 28 cap(s), 0 Refill(s), Start: 01/30/20 17:27:00, Stop: 02/06/20 17:27:00, Prescription Type: Internal Pick Up 2/2/20 Chief Complaint Pt was seen at Clinic for cellulitis to left upper arm. States received a shingle shot last Monday and then a rash developed. Pt was started on Keflex Thursday but the rash has increased. Pt told to come here if didn't get better. VSS, ambulatory History of Present Illness Cellulitis Local reaction to immunization Orders: cephalexin, 1,000 mg =2 cap(s), Oral, TID, for skin infection; add to your current prescription and begin taking three times daily, x 7 day(s), #12 cap(s), 0 Refill(s), Start: 02/02/20 12:35:00, Stop: 02/09/20 12:35:00, Stop: 02/09/20 12:35:00, Prescription Type: internal Pic...lactobacillus rhamnosus GG, See Instructions, Oral, BID, Give contents of 1 capsule sprinkled on soft food three daily while taking antibiotics to prevent diarrhea, x 7 day(s), #30 cap(s), 0 Refill(s), Start: 02/02/20 12:35:00, Stop: 02/09/20 12:35:00, Prescription T... Discharge Patient59 yo female with PMH DM2, DJD, hyperlipidemia presents with worsening cellulitis left arm where she received a Shingles immunization 6 days ago. Per report a 2.5 cm diameter area of redness increased to 10 cm 3 days after the injection. She was placed on Cephalexin 100mg PO BID x 7 day. CO report an increase in the the area of redness yesterday. No fever, chills, nausea, vomiting. Reports generalized HA, relieved with Advair. Usual appetite. 2/5/20 Phone follow-up patient reports that she is "much better" had recovered well.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: 01/30/2020 Patient presents to clinic for evaluation of LUE redness at site of recent immunization. Had shingles vaccine administered on 1/27/2020 and noted some redness at site shortly thereafter. States that day before yesterday was approximately 1 inch diameter but increased in size over the next 24 hours. States that she has been taking ibuprofen and applying warm compresses for treatment of local reaction without resolution of symptoms. Today notes increasing pain and heat at site. Erythematous lesion has increased in size to her entire deltoid region. Denies fevers, nausea, vomiting, or other concerns. Assessment/Plan Cellulitis Rx Keflex 1000 mg BID x 7 days. Perimeter of lesion outlined - advised CO that a small amount of expansion beyond the border is expected over the next 24 hours, but at 24 hours should not see any additional expansion, and should note reduction in size of lesion within 48 hours. If significant expansion, advised to seek medical attention. Notify PCP or return to clinic if no improvement in condition over the next 2 days. CO verbalized understanding and agrees with plan of care. Orders: cephalexin, 1,000 mg = 2 cap(s), Oral, BID, x7 day(s), # 28 cap(s), 0 Refill(s), Start: 01/30/20 17:27:00, Stop: 02/06/20 17:27:00, Prescription Type: Internal Pick Up 2/2/20 Chief Complaint Pt was seen at Clinic for cellulitis to left upper arm. States received a shingle shot last Monday and then a rash developed. Pt was started on Keflex Thursday but the rash has increased. Pt told to come here if didn't get better. VSS, ambulatory History of Present Illness Cellulitis Local reaction to immunization Orders: cephalexin, 1,000 mg =2 cap(s), Oral, TID, for skin infection; add to your current prescription and begin taking three times daily, x 7 day(s), #12 cap(s), 0 Refill(s), Start: 02/02/20 12:35:00, Stop: 02/09/20 12:35:00, Stop: 02/09/20 12:35:00, Prescription Type: internal Pic...lactobacillus rhamnosus GG, See Instructions, Oral, BID, Give contents of 1 capsule sprinkled on soft food three daily while taking antibiotics to prevent diarrhea, x 7 day(s), #30 cap(s), 0 Refill(s), Start: 02/02/20 12:35:00, Stop: 02/09/20 12:35:00, Prescription T... Discharge Patient59 yo female with PMH DM2, DJD, hyperlipidemia presents with worsening cellulitis left arm where she received a Shingles immunization 6 days ago. Per report a 2.5 cm diameter area of redness increased to 10 cm 3 days after the injection. She was placed on Cephalexin 100mg PO BID x 7 day. CO report an increase in the the area of redness yesterday. No fever, chills, nausea, vomiting. Reports generalized HA, relieved with Advair. Usual appetite. 2/5/20 Phone follow-up patient reports that she is "much better" had recovered well.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swollen Red Arm
Sex: F
Vaccine: FLU4
Symptoms: Ear infection, Influenza, Pyrexia
Clinical narrative: ear infection; flu; high fever which reached 104.3 F; Initial information was received on 25-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 3 years old female patient who experienced ear infection(ear infection), flu(influenza) and high fever which reached 104.3 F (pyrexia) while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.   On 19-Dec-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) via unknown an route in her left thigh for prophylactic vaccination.  On 25-JAN-2020, the patient developed non-serious ear infection(ear infection) ,flu (influenza) and high fever which reached 104.3 f (pyrexia)1 month 6 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Relevant laboratory test results included: Body temperature - On an unknown date:  [104.3F]  Final diagnosis were influenza and ear infection.  The patient was treated with OSELTAMIVIR (OSELTAMIVIR) 60 ml BID and CEFDINIR (CEFDINIR) 60 ml 1xday.  At the time of reporting patient was recovering from all the events.  Information on the batch number was requested.
Age: 0.42
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: a patient was given only the liquid component of Pentacel/No AE; Initial information was received on 28-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a five month old patient who received only the liquid component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for prophylactic vaccination.  On 24-Jan-2020, the patient received second 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Box Lot- UJ115ABA Expiration date: 30/11/2020, IPV/DTAP Lot- UJ056AAA Expiration date: 27/10/2020 ACTHIB Lot- UJ115AB Expiration date: 23/11/2020) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique.  No adverse event was reported (well child).  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: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of Pentacel was inadvertently administered/No AE; Initial information was received on 28-Jan-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves patient of an unknown demographics who received expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot C5543AA) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error as an expired dose of Pentacel was inadvertently administered.  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: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: A patient received third dose of Menactra, outside of schedule, no AE; patient mistakenly received Menactra instead of Bexsero/No AE; Initial information received on 28-Jan-2020 and additional information was received on 29-Jan-2020 regarding an unsolicited valid non-serious case received from physician assistant.  This case involves a 17 year old female patient who received third dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] instead of MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV [BEXSERO] (extra dose administered and wrong product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant vaccination included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX).  The patient received first and second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number not reported) via unknown route in unknown administration site on an unknown date and in Aug-2019 respectively for prophylactic vaccination.   On 28-Jan-2020 the patient received a 0.5 ml third dose of the suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number U6585AA, expiry date 11-Apr-2021) via unknown route in the right deltoid for prophylactic vaccination.  It was an actual medication error due to extra dose administered and wrong vaccine administered.  Patient received a third dose of Menactra vaccine outside the schedule. She was supposed to receive Bexsero. The Medical Assistant who was administering the vaccine mistakenly grabbed Menactra instead of Bexsero. Menactra was administered in the right deltoid. It was realized a few moments later that she had already received two doses of Menactra in the past, and that it was given by accident for this third dose. When the mistake was realized, Bexsero was then administered.  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.  Information on the lot number was requested.
Sex: F
Vaccine: TDAP
Symptoms: Pertussis
Clinical narrative: Pertussis; Initial information and additional information received on 28-Jan-2020 regarding an unsolicited valid serious case received from a other health professional.  This case involves 62 year female patient who developed pertussis (pertussis), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past vaccination(s) included a dose of ADACEL on 08-OCT-2007.  The patient's past medical history, medical treatment(s) and family history were not provided.   On 29-Mar-2017, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U5607AA and expiry date: 22-Mar-2019) via unknown route in the right deltoid.  On an unknown date, the patient was diagnosed with pertussis (pertussis), (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.   No lab data was reported.  Final diagnosis was pertussis.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as Unknown for pertussis.; Sender's Comments: This case involves a 62 years old female patient who presented with pertussis after vaccination with ADACEL. Time to onset is was unknown. However, patient's medical condition at the time of vaccination, lab data and received concomitant was reported. Other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot assessed.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a dose of Fluzone quadrivalent was administered to a 5 month old/ no AE; Initial information was received on 28-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a five month old male patient who was received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided.   On 24-Dec-2019, the patient received first 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number U6712AB, expiry date- 30-Jun-2020) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to inappropriate age at vaccine administration  The nurse reported that a 0.5 ml dose of Fluzone quadrivalent was administered to a five months old patient.  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: 1.67
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 20 month old has received 3 Fluzone Quad vaccination, no AE; Initial information received on 28-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 20 month old female patient who received 0.5 ml third dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UT6695MA, Exp. Date 30-Jun-2020) via unknown route in the left thigh on 27-Jan-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to extra dose administered.  It was reported that 20 month old has received three Fluzone Quad vaccinations, this season.  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 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.
Age: 2.0
Sex: U
Vaccine: TD
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2 year old patient received dose of Tenivac vaccine/No AE; 2 year old patient received dose of Tenivac vaccine in the left thigh/No AE; Initial information was received on 28-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 2-year-old patient who received 0.5 mL dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] [lot U6021AA, expiry date: 27-JUL-2020] via an intramuscular route at the left thigh on 24-Jan-2020.  Medical history, medical treatment, vaccination and family history were not provided. At the time of the event, the patient had ongoing Head injury.   It was a case of actual medication error due to inappropriate age at vaccine administration and vaccine administered at inappropriate site.  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 and Module VI of the 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: M
Vaccine: DTAP, DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received QUADRACEL vaccine instead of DAPTACEL vaccine/No AE; 18 month old patient received a dose of Quadracel/No AE; Initial information was received on 28-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to case 2020SA026250. [same reporter]  This case involves an 18-month-old male patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered  and product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  On 08-Jan-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5656AA, expiry date: 13-Aug-2021] via an intramuscular route at the outer thigh for prophylactic vaccination.  It was a case of actual medication error due to Wrong product administered and Inappropriate age at vaccine administration.  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: 1.5
Sex: F
Vaccine: DTAP, DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient received Quadracel given in error instead of Daptacel, no AE; 18 month old patient received Quadracel, no AE; Initial information was received on 28-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to case 2020SA025963. [same reporter]  This case involves an 18-month-old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered  and product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  On 09-Jan-2020, the patient received a 0.5 mL fourth dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5656AA, expiry date: 13-Aug-2021 via an intramuscular route at the left outer thigh for prophylactic vaccination.  It was a case of actual medication error due to Wrong product administered and Inappropriate age at vaccine administration.  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 and Module VI of the 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: M
Vaccine: RAB, UNK
Symptoms: Antibody test negative
Clinical narrative: after 4th dose antibody level was 0.1/ no AE; Initial information received on 29-Jan-2020 regarding an unsolicited valid non-serious case received from the  consumer/non-healthcare professional.  This case involves a 80 year old male patient who received 4 doses of RABIES (HDC) VACCINE [IMOVAX RABIES] and received IMMUNOGLOBULINS and after 4th dose antibody level was 0.1 (antibody test negative).  Other Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient was bitten by a bat on 30-Dec-2019. The patient had been suffering from hypogammaglobulinemia.  On 01-Jan-2020, the patient started taking IMMUNOGLOBULINS dosage unknown via an route unknown (with an unknown batch number) for animal bite.  On 01-Jan-2020, the patient received a first dose of suspect RABIES (HDC) VACCINE (lot number not reported) via an unknown route at an unknown administration site and than received the next injections for day 3,7,14 respectively lot number not reported) via an unknown route at an unknown administration site for post-exposure immunization.  It was reported that after 4th dose (unknown latency) titer was done and the titer was 0.1 (antibody test negative).  Case details: Caller states he was unaware he was bitten by a bat on 30-Dec-2019 and saw his local doctor on 31-Dec-2019 but the bite was not noticed until 01-Jan-2020 when he saw the clear bite mark so he went to the emergency room and started his injections and they gave him Immunoglobulin on that visit.   The patient received last dose on 28-Jan-2020.  Lab data included titer was 0.1.  It was not reported if the patient received any corrective treatment.  The event outcome was not applicable.