chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: fever sore arm chills muscle ache
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Haemorrhage, Immediate post-injection reaction, Nodule, Peripheral swelling
Clinical narrative: A knot in the arm swelled up immediately after injection. It bled moderately but the swelling would not go down. It was a soft knot about the size of a cherry.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Dose 2 was inadvertently administered 31 days after Dose 1, instead of the recommended 2 month interval.  No adverse reactions reported.  GSK did not have information on consequences of administering early.
Age: 77.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Ped dose given to adult
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pyrexia
Clinical narrative: Pt was contacted on Tuesday afternoon regarding routine labs and reported that he received the Adacel vaccine on Friday 2/28/20. On Saturday 2/29/20 patient reported that he noted a fever of 101 with associated chills. Patient denied any redness, swelling or pain in the injection site beyond what he endorses as normal post injection soreness. Pt denied  any symptoms of illness, including upper respiratory symptoms, rash, or other symptoms of general illness. Pt denied that anyone else in his household is ill. Pt reported that his symptoms have resolved, denied any further fevers or chills, and denied the need for follow up at this time. Pt was informed that a report would be made regarding the vaccine reaction and was agreeable.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, MMR
Symptoms: Expired product administered
Clinical narrative: MMR vaccine was given and it was found to be an expired vaccine after it was already administered to patient.  MMR lot # R002049, exp 2020Jan22. Parent was notified of the mistake and informed that vaccine is invalid and to return in 4 weeks to have it readministered.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: MMR vaccine was given and it was found to be an expired vaccine after it was already administered to patient.  MMR lot # R002049, exp 2020Jan22. Parent was notified of the mistake and informed that vaccine is invalid and to return in 4 weeks to have it readministered.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Cold sweat, Fall, Feeling abnormal, Head injury, Loss of consciousness
Clinical narrative: Shortly after being administered the vaccine (within 5 minutes), patient had passed out in the lobby and fell and hit his head.  He was taking back to the exam room and assessed by the provider.  Patient was pale, clammy, and appeared dazed.  He was able to answer simple questions when asked.  Once symptoms improved and were resolved, patient was able to walk out of the office without assistance.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Pallor
Clinical narrative: Shortly after being administered the vaccine (within 5 minutes), patient had passed out in the lobby and fell and hit his head.  He was taking back to the exam room and assessed by the provider.  Patient was pale, clammy, and appeared dazed.  He was able to answer simple questions when asked.  Once symptoms improved and were resolved, patient was able to walk out of the office without assistance.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Patient experienced pain scaling to a 10 plus, arm swelled to almost twice its size and became stiff, injection site soreness, itching, cellulitis and extreme redness; arm swelled to almost twice its size and became stiff; itching; injection site soreness; This spontaneous report has been received from a 71-year-old female consumer, referring to herself.  The patient's concurrent conditions included an allergy to sulfonamide (reported as "sulfa drugs"). Her concomitant medications were reported as "traditional medication that had been taken for years". The patient did not have any medical history.   On 11-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) one dosage form via intramuscular, for prophylaxis (reported as due for second pneumococcal disease) (concentration, frequency of vaccination scheme, and anatomical location of vaccination were not reported; lot number and expiry date were unknown to the reporter).   Following the vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), the patient experienced pain scaling to a 10 plus, arm swelled to almost twice its size and became stiff, injection site soreness, itching, cellulitis and extreme redness (cellulitis, musculoskeletal stiffness, pruritus, injection site pain).   The patient sought medical attention and saw a physician. A site exam was performed on an unknown day in February 2020, and the patient's events were treated with acetaminophen (TYLENOL), diphenhydramine (BENADRYL), cephalexin and methylprednisolone 4 milligrams (mg).   On 14-FEB-2020, the patient recovered from the events.    The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) vaccination and the patient's events was not reported.    Upon internal review, cellulitis was determined to be a medically significant event
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Patient experienced pain scaling to a 10 plus, arm swelled to almost twice its size and became stiff, injection site soreness, itching, cellulitis and extreme redness; arm swelled to almost twice its size and became stiff; itching; injection site soreness; This spontaneous report has been received from a 71-year-old female consumer, referring to herself.  The patient's concurrent conditions included an allergy to sulfonamide (reported as "sulfa drugs"). Her concomitant medications were reported as "traditional medication that had been taken for years". The patient did not have any medical history.   On 11-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) one dosage form via intramuscular, for prophylaxis (reported as due for second pneumococcal disease) (concentration, frequency of vaccination scheme, and anatomical location of vaccination were not reported; lot number and expiry date were unknown to the reporter).   Following the vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), the patient experienced pain scaling to a 10 plus, arm swelled to almost twice its size and became stiff, injection site soreness, itching, cellulitis and extreme redness (cellulitis, musculoskeletal stiffness, pruritus, injection site pain).   The patient sought medical attention and saw a physician. A site exam was performed on an unknown day in February 2020, and the patient's events were treated with acetaminophen (TYLENOL), diphenhydramine (BENADRYL), cephalexin and methylprednisolone 4 milligrams (mg).   On 14-FEB-2020, the patient recovered from the events.    The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) vaccination and the patient's events was not reported.    Upon internal review, cellulitis was determined to be a medically significant event
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; patient received improperly stored vaccine; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, and previous drug allergies or reactions were not reported.      On 20-FEB-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) injection (strength, dosage regimen, route of administration, and anatomical location were not reported; and lot number S000132 has been verified to be valid, expiration date reported and validated as 02-JAN-2021) as prophylaxis (product storage error). The sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was properly stored. No additional adverse event.  The temperature excursion was reported as: temperature total time in the range 6 degrees Fahrenheit to 14 degrees Fahrenheit (-14 degrees Celsius to -10 degrees Celsius) 6.7 degrees Fahrenheit. The time frame was 5 minutes. No previous temperature excursions reported. A data logger was used.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA010011:
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swelling at the injection site; redness at the injection site; This spontaneous report was received from a nurse concerning a currently 30-year-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions and allergies.  On 24-FEB-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), 1 dose, administrated subcutaneously, lot number R017643, expiration date 20-JUN-2020 for prevention of varicella. The vaccine was reconstituted with diluent MRK (lot number and expiration date were not reported).   On an unknown date in February 2020, the patient experienced swelling and redness at the injection site where she received varicella virus vaccine live (oka/merck) (VARIVAX) (injection site swelling and injection site erythema). Furthermore, the patient called the physician's office; however the patient did not receive treatment for the events and no laboratory diagnostics or studies were performed.  The outcome of injection site swelling and injection site erythema was reported as recovering. The causal relationship between the aforementioned events and therapy with varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.
Sex: U
Vaccine: MENB
Symptoms: Meningococcal infection
Clinical narrative: Meningococcal disease in an Individual who had received 3 doses of Trumenba, Disease occurred 2 yrs after vaccination; Meningococcal disease; This is a spontaneous report from a contactable healthcare professional via Pfizer sales representative. A patient of unspecified age and gender received the first, second and third dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that Meningococcal disease in an Individual who had received 3 doses of Trumenba, Disease occurred 2 yrs after vaccination. Outcome of the event was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with TRUMENBA in this patient cannot be completely excluded. Further information like confirmative serotype results and vaccination schedule are needed for full medical assessment.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Back pain, Blood test, Chest pain, Muscle twitching, Myalgia
Clinical narrative: Excruciating pain in my muscles; Excruciating pain on the front of my chest; Excruciating pain down my back near my scapula; Excruciating pain down my back near my scapula; Muscle twitching it's like someone has stabbed put a knife in my muscle and twisting; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on 19Feb2020 at single dose for immunisation. Medical history was none. Concomitant medication included bimatoprost (LUMIGAN). On an unspecified date, the patient experienced excruciating pain in his muscles, excruciating pain on the front of his chest, excruciating pain down his back near his scapula and muscle twitching that it was like someone had stabbed put a knife in his muscle and twisting. On an unspecified date, the patient underwent lab tests and procedures which included blood test and physical examination with unknown results. Therapeutic measure was taken as a result of excruciating pain in his muscles which included ibuprofen 800 mg every day. Clinical outcome of events was unknown.
Sex: U
Vaccine: MENB
Symptoms: Back pain, Diarrhoea, Nausea, Pyrexia
Clinical narrative: fever; back pain; nausea; diarrhea; This is spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 5 patients. This is the 2nd of 5 reports. A patient of unspecified age and gender received the 1st dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient experienced fever, back pain, nausea and diarrhea all on an unspecified date with outcome of unknown. The events were considered serious as caused patient's hospitalization, because the reaction was so severe.  The information on the lot/batch number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.,Linked Report(s) : US-PFIZER INC-2020096703 Same reporter/ drug/ event, different patient
Sex: U
Vaccine: MENB
Symptoms: Back pain, Diarrhoea, Nausea, Pyrexia
Clinical narrative: fever; back pain; nausea; diarrhea; This is spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 5 patients. This is the 3rd of 5 reports. A patient of unspecified age and gender received the 1st dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient experienced fever, back pain, nausea and diarrhea all on an unspecified date with outcome of unknown. The events were considered serious as caused patient's hospitalization, because the reaction was so severe.  The information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020096703 Same reporter/ drug/ event, different patient
Sex: U
Vaccine: MENB
Symptoms: Back pain, Diarrhoea, Nausea, Pyrexia
Clinical narrative: fever; back pain; nausea; diarrhea; This is spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 5 patients. This is the 4th of 5 reports. A patient of unspecified age and gender received the 1st dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient experienced fever, back pain, nausea and diarrhea all on an unspecified date with outcome of unknown.  The information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020096703 Same reporter/ drug/ event, different patient
Sex: U
Vaccine: MENB, MENB
Symptoms: Back pain, Diarrhoea, Nausea, Pyrexia
Clinical narrative: fever; back pain; nausea; diarrhea; This is spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 5 patients. This is the 5th of 5 reports. A patient of unspecified age and gender received the 1st dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient experienced fever, back pain, nausea and diarrhea all on an unspecified date with outcome of unknown. The information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020096703 same reporter/ drug/ event for different patients.
Sex: U
Vaccine: HIBV, IPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: adult patient received childhood polio vaccination and childhood haemophilus type b vaccination, no AE; Initial information received on 27-Feb-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves an adult patient who received a childhood dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE and a childhood dose of suspect POLIOMYELITIS VACCINE (INACTIVATED) produced by unknown manufacturer (lot number not reported) via unknown route at an unknown administration site for prophylactic vaccination (PT: Product administered to patient of inappropriate age).  Past vaccination and family history were not provided.  At the time of the event, the patient had ongoing cancer  Concomitant therapy included chemotherapy(for cancer)  It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  Information on the batch number was requested.  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: 1.58
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Daptacel was given to a patient/No AE; Initial information was  received on 27-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 19 months old female patient who was administered an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment, vaccination and family history were not provided.   On 27-Feb-2020, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number C5366 AA, expiry date: 07-Feb-2020) via an intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  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: 1.25
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok injected to a 15 month old male patient / no AE; Initial information received on 28-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Office Staff).  This case involves a 15 months old male patient who received 0.5 ml once dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Expiry date unknown) via intramuscular route in the left thigh for Prophylactic vaccination on an unknown date. (PT: Product administered to patient of inappropriate age)  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration.   At a 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.  Information on the batch number was requested.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: two years old patien was receiving routine vaccines and inadvertently received Quadracel/ No AE; Initial information was received on 28-Feb-2020 regarding an unsolicited valid non-serious case received from an  other health care professional.  This case involves a 24 months 27 days old male patient who inadvertently received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5532AA) via intramuscular route in the right thigh for prophylactic vaccination while receiving routine vaccines (product administered to patient of inappropriate age).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT HIB) and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  It was also a case of actual medication error due to inappropriate age at vaccine administration.  At the time of reporting no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of Adacel / no AE; Initial information received on 28-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves male patient of unknown age who was vaccinated with an expired vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and Expiry date unknown) via unknown route in unknown administration site on an unknown date for Prophylactic vaccination (Expired product administered ).  Medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used (Expired product administered).  At a time of reporting no adverse event reported.  Information on the batch number was requested.  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: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pentacel with a Pediarix was administered on the same date so patient had a double dose of the DTaP and polio/no AE; Initial information received on 28-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a patient( unknown demographics) who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with a DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID on the same date so he had received double dose of the dtap and polio(batch number, expiry date, route and administration site not reported) on an unknown date for prophylactic vaccination (extra dose administered).   Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to extra dose administered.   At the time of reporting, no adverse event 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.
Sex: U
Vaccine: FLUR4
Symptoms: Rash
Clinical narrative: rash on the lower inner arm; Initial information received on 28-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA055799 (same reporter).  This case involves a patient of unknown demography who experienced rash on the lower inner arm (rash), while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious rash on the lower inner arm (rash) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Laboratory data was not reported.  Final diagnosis was rash.  It was not reported if the patient received a corrective treatment.  The patient had recovered from the event on an unknown date.  Information on the batch number was requested.
Age: 64.0
Sex: M
Vaccine: RAB
Symptoms: Computerised tomogram, Dysphagia, Oropharyngeal discomfort, Peritonsillar abscess, Pharyngeal swelling
Clinical narrative: One tonsil is enlarged with surrounding abscess or cyst; possibly tonsilitis; swollen throat; throat discomfort; problems swallowing; enlarged tonsils; Initial information received on 28-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a adult male patient (unknown age) who experienced one tonsil is enlarged with surrounding abscess or cyst and possibly tonsilitis, while he received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  Medical history included kitten bite [Animal bite].  Medical treatment, vaccination and family history were not provided.   In October 2019, the patient received a dose of suspect RABIES (HDC) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for post exposure immunization.  On an unknown date, the patient developed non-serious one tonsil is enlarged with surrounding abscess or cyst (tonsillar cyst) and possibly tonsilitis (tonsillitis) with the symptoms of swollen throat (pharyngeal swelling), throat discomfort (oropharyngeal discomfort), problems swallowing (dysphagia) and enlarged tonsils (tonsillar hypertrophy) (unknown latency) following the administration of RABIES (HDC) VACCINE.  Relevant laboratory test results included: Computerised tomogram - On an unknown date: to rule out tonsil cysts vs. tonsillitis.  Final diagnosis was tonsilitis and tonsillar cyst.  The patient is being treated by ENT [Ear, Nose, Throat].  The outcome was unknown for all the events.  Information on batch number was requested.
Age: 64.0
Sex: M
Vaccine: RAB
Symptoms: Tonsillar cyst, Tonsillar hypertrophy, Tonsillitis
Clinical narrative: One tonsil is enlarged with surrounding abscess or cyst; possibly tonsilitis; swollen throat; throat discomfort; problems swallowing; enlarged tonsils; Initial information received on 28-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a adult male patient (unknown age) who experienced one tonsil is enlarged with surrounding abscess or cyst and possibly tonsilitis, while he received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  Medical history included kitten bite [Animal bite].  Medical treatment, vaccination and family history were not provided.   In October 2019, the patient received a dose of suspect RABIES (HDC) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for post exposure immunization.  On an unknown date, the patient developed non-serious one tonsil is enlarged with surrounding abscess or cyst (tonsillar cyst) and possibly tonsilitis (tonsillitis) with the symptoms of swollen throat (pharyngeal swelling), throat discomfort (oropharyngeal discomfort), problems swallowing (dysphagia) and enlarged tonsils (tonsillar hypertrophy) (unknown latency) following the administration of RABIES (HDC) VACCINE.  Relevant laboratory test results included: Computerised tomogram - On an unknown date: to rule out tonsil cysts vs. tonsillitis.  Final diagnosis was tonsilitis and tonsillar cyst.  The patient is being treated by ENT [Ear, Nose, Throat].  The outcome was unknown for all the events.  Information on batch number was requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash
Clinical narrative: Patient experienced redness around injection site and rash on trunk of the body
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Myalgia, Pain, Pyrexia
Clinical narrative: fever 103 F, pain, redness to site of injection, muscle pain, shivering. All these symptoms occurred for 2 days
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Influenza, Influenza B virus test positive, Injection site erythema, Injection site infection, Injection site warmth
Clinical narrative: Several hours after vaccines were administered, patient developed an erythmatous area to left lateral thigh. Patient was brought into ED the evening of 03/03/2020. The erythmatous area measured approximately 4cmx3cm at that time. Area was also warm to touch. Patien had also developed a fever of approximately 101. Provider, deemed the erythmatous area to be a skin infection and started patient on antibiotics. Patient followed up in the clinic the morning of 03/04/2020. Erythmatous area was decreased in size, however the patient's fever continued to increase. Patient was febrile at 102.2 during clinic visit. Patient was accompanied by siblings, one of which exhibited influenza symptoms. An influenza swab was performed on the patient at the clinic visit and patient was diagnosed with influenza B.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Several hours after vaccines were administered, patient developed an erythmatous area to left lateral thigh. Patient was brought into ED the evening of 03/03/2020. The erythmatous area measured approximately 4cmx3cm at that time. Area was also warm to touch. Patien had also developed a fever of approximately 101. Provider, deemed the erythmatous area to be a skin infection and started patient on antibiotics. Patient followed up in the clinic the morning of 03/04/2020. Erythmatous area was decreased in size, however the patient's fever continued to increase. Patient was febrile at 102.2 during clinic visit. Patient was accompanied by siblings, one of which exhibited influenza symptoms. An influenza swab was performed on the patient at the clinic visit and patient was diagnosed with influenza B.
Age: 2.0
Sex: F
Vaccine: FLU4, HEP, IPV
Symptoms: Abnormal behaviour, Analgesic drug level, Balance disorder, Blood ethanol, Blood sodium normal
Clinical narrative: Mom called our office on 1/13/2020 describing patient with buckled legs, equilibrium off, dilated pupils, not blinking alot and just "acting odd". Mom was instructed to go ahead and bring patient to our office. At our office, patient was evaluated and diagnosed with Acute Cerebellar Ataxia and sent to Hospital Emergency Dept.
Age: 2.0
Sex: F
Vaccine: FLU4, HEP, IPV
Symptoms: Cerebellar ataxia, Culture urine, Differential white blood cell count, Drug screen negative, Full blood count normal
Clinical narrative: Mom called our office on 1/13/2020 describing patient with buckled legs, equilibrium off, dilated pupils, not blinking alot and just "acting odd". Mom was instructed to go ahead and bring patient to our office. At our office, patient was evaluated and diagnosed with Acute Cerebellar Ataxia and sent to Hospital Emergency Dept.
Age: 2.0
Sex: F
Vaccine: FLU4, HEP, IPV
Symptoms: Liver function test normal, Mean cell volume normal, Mean platelet volume normal, Metabolic function test normal, Monocyte count increased
Clinical narrative: Mom called our office on 1/13/2020 describing patient with buckled legs, equilibrium off, dilated pupils, not blinking alot and just "acting odd". Mom was instructed to go ahead and bring patient to our office. At our office, patient was evaluated and diagnosed with Acute Cerebellar Ataxia and sent to Hospital Emergency Dept.
Age: 2.0
Sex: F
Vaccine: FLU4, HEP, IPV
Symptoms: Mydriasis, Neutrophil count increased, Protein total normal, Red blood cells urine positive, Specific gravity urine increased
Clinical narrative: Mom called our office on 1/13/2020 describing patient with buckled legs, equilibrium off, dilated pupils, not blinking alot and just "acting odd". Mom was instructed to go ahead and bring patient to our office. At our office, patient was evaluated and diagnosed with Acute Cerebellar Ataxia and sent to Hospital Emergency Dept.
Age: 2.0
Sex: F
Vaccine: FLU4, HEP, IPV
Symptoms: Urine ketone body present, White blood cell count increased, White blood cells urine
Clinical narrative: Mom called our office on 1/13/2020 describing patient with buckled legs, equilibrium off, dilated pupils, not blinking alot and just "acting odd". Mom was instructed to go ahead and bring patient to our office. At our office, patient was evaluated and diagnosed with Acute Cerebellar Ataxia and sent to Hospital Emergency Dept.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site pain
Clinical narrative: I was restless in the evening of Feb. 29th, 2020, and felt very tired during day of March 1st.  I had a headache, severe left, upper-arm pain, feverish and had shivers.  I had no appetite throughout the day, and battled with  a 'racing' heart. By the morning of March 2nd, I had developed a rash on my right, lower leg and experienced itching over most of my body. The left arm pain has reduced in severity on this date (3/4/20) but is still achy.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Pruritus, Pyrexia, Rash, Restlessness
Clinical narrative: I was restless in the evening of Feb. 29th, 2020, and felt very tired during day of March 1st.  I had a headache, severe left, upper-arm pain, feverish and had shivers.  I had no appetite throughout the day, and battled with  a 'racing' heart. By the morning of March 2nd, I had developed a rash on my right, lower leg and experienced itching over most of my body. The left arm pain has reduced in severity on this date (3/4/20) but is still achy.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: Patient approached pharmacist to discuss adverse reaction she had several days after receiving TDaP. On 2/23 patient noticed swelling on her left deltoid. Patient showed arm to pharmacist who noticed pronounced swelling of the upper arm extending from shoulder to right above the elbow. Pharmacist referred patient to PCP. PCP later diagnosed cellulitis and patient was placed on oral antibiotic therapy.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: redness, pain and moderate edema of approximately 8 cm in diameter at injection sites.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Progressive pain afterward.  Ongoing shoulder pain afterward
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Headache, Hyperhidrosis, Tremor
Clinical narrative: Chills, shaking, sweating, severe headache
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine was administered on 3/2/2020, pt messaged on 3/4/2020 stating major swelling, pain, itching and some burning at the site of the injection site.  Pain/swelling wrapped around inner bicep. Injection site warm to touch.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Exposure during pregnancy, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site warmth, swelling, redness, and pain for at least 2 days after vaccination. Apparent full resolution. Patient was 29.4 weeks pregnant at time of vaccination. Patient also had some systemic symptoms, including fever (100.4 F), tachycardia (120 bpm), and fatigue. These may have been early symptoms of an upper respiratory infection that was diagnosed a few days later rather than related to the vaccine reaction.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pyrexia, Tachycardia, Upper respiratory tract infection
Clinical narrative: Injection site warmth, swelling, redness, and pain for at least 2 days after vaccination. Apparent full resolution. Patient was 29.4 weeks pregnant at time of vaccination. Patient also had some systemic symptoms, including fever (100.4 F), tachycardia (120 bpm), and fatigue. These may have been early symptoms of an upper respiratory infection that was diagnosed a few days later rather than related to the vaccine reaction.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Pain, Pain in extremity, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Client given High dose intended for 65 years and over.  Client 36 years old.  Client denies any adverse effect.  Stated she had a slight fever and some pain when raising arm above head for 1 to 2 days.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous, Rash papular
Clinical narrative: Patient reported a red raised rash around the injection site that was warm to the tough and about as big as a softball. only lasted a few days less, than a week.  Patient did not specify what he did/ took for rash.
Age: 11.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event, Wrong patient received product
Clinical narrative: Client was given a PCV13 vaccine which was intended for the sibling.  No adverse effects were noted.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Erythema, pain, warm to touch Started on doxycycline bid until 3-4-2020
Age: 27.0
Sex: M
Vaccine: HEPA
Symptoms: Anxiety, Dyspnoea, Fear of injection, Pallor, Syncope
Clinical narrative: Patient was fainted for 2 seconds, pale and labored breathing. 911 was called and paramedics came, patient gradually become normal after 5 seconds, color come back and breathing normally.  All vitals are normal per paramedics and patient refused to go to ER. Patient admitted that he has fear of needle and did not had anything to eat or drink in the morning. Paramedics think that patient is having an anxiety attack due to needle.
Age: 50.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Chills, Erythema, Induration, Pain, Papule
Clinical narrative: Fever, swelling in L arm and rash to abdomen.  Chills first night.  Took TSA, the bump on L arm is flattening out.  Was painful before - more sensitive than pain.  Today exam shows: L arm 2x3 cm induration, warm; scattered erythema papules abd, chest.
Age: 50.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Peripheral swelling, Pyrexia, Rash, Sensitive skin, Skin warm
Clinical narrative: Fever, swelling in L arm and rash to abdomen.  Chills first night.  Took TSA, the bump on L arm is flattening out.  Was painful before - more sensitive than pain.  Today exam shows: L arm 2x3 cm induration, warm; scattered erythema papules abd, chest.
Age: 50.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Discomfort, Injection site rash, Pyrexia, Rash, Rash vesicular
Clinical narrative: Fever, swelling in L arm and rash to abdomen.  Chills first night.  Took TSA, the bump on L arm is flattening out.  Was painful before - more sensitive than pain.  Today exam shows: L arm 2x3 cm induration, warm; scattered erythema papules abd, chest.
Age: 50.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Vaccination site induration, Vaccination site warmth
Clinical narrative: Fever, swelling in L arm and rash to abdomen.  Chills first night.  Took TSA, the bump on L arm is flattening out.  Was painful before - more sensitive than pain.  Today exam shows: L arm 2x3 cm induration, warm; scattered erythema papules abd, chest.
Age: 1.17
Sex: F
Vaccine: MMR
Symptoms: Erythema, Immediate post-injection reaction, Underdose, Urticaria
Clinical narrative: 0.1 ML OF VACCINE ADMINISTERED BEFORE WHEAL APPEARED ON SKIN. VACCINE ADMINSRATION STOPPED. WHEAL MEASURED AT 1 CM WITH 7.5 CM BORDER AT 15 MIN POST VACCINATION. CERTRIZINE 2.5 ML ADMINSTERED. WHEAL DECREASED TO 0.5 CM AND 1.5 CM ERYTHEMA BORDER AT 45 MIN POST VACCINE ADMINISTRATION. PATIENT LEFT AT 1 HOUR POST VACCINE ADMINISTRATION WITH WHEAL AND BORDER DECREASED SIGNIFICANTLY.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt was getting an Adacel vaccination and fainted.  Collapsed backward in chair without injury.  after about 10-15 seconds returned to conciousness.  Provided bottled water, ice pack and towel, and instructed pt to let me know if he needed anything more.  Pt had warned beforehand that he has gotten lightheaded with vaccinations, and even said he would faint before he did.  After about 15 minutes he got up and left, responding when asked that he was now doing fine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Headache, fever, chills, aches throughout body, fatigue
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Joint dislocation
Clinical narrative: The patient came in today and claimed that he has chronic left shoulder pain and the pain started since he got the pneumovax vaccine in April. He said he came in the store and we recommended ibuprofen for him. He said he would need surgery for his left shoulder and in the process of getting one. He does not want any other vaccines now or in the future. Patient does not want anything from the store and patient does not want us to put a report in but we told him we have to because he came and told us the situation.    Spoke to staff at the office and to let MD know about the situation. Staff said he has left AC separation injury since June 2019 and there is no notes from the doctor that this is caused by getting the vaccine. Staff will letMD know.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Severe injection site swelling and pain, mild fever, body aches and extreme fatigue
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Injection site rash, Sneezing
Clinical narrative: Patient said that she had sneezing and coughing for about 24 hours after the vaccination. She said that she has developed a rash around the site of the injection and that it is spreading.
Age: 65.0
Sex: M
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Bronchoalveolar lavage, Chest X-ray normal, Computerised tomogram thorax abnormal, Lung disorder, Malaise
Clinical narrative: Was healthy prior to vaccine.  This was the 2nd dose, the first shot had no side effects.  After the 2nd shot, patient started to feel ill on the day after.  Due to  him fighting sinus infections he went to Dr.  and he was prescribed antibiotics.  His main symptoms in his lungs seemed to be getting worse.  Back to the  dr.  Chest x-ray showed no infection.  A week later after finishing antibiotics still not  feeling well, got a CT of his lungs.  Double pneumonia.   5 weeks  later after intense antibiotics, steroids, and breathing treatments, and a lung washing , patient is just now feeling somewhat normal.   After looking on the internet and speaking with others that have had a similar reaction to the 2nd shingle shot, I feel it that these  types of side effects are very serious and patients, and medical Personel  need to made aware of the possibility?s
Age: 65.0
Sex: M
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Pneumonia, Scan with contrast, Sinusitis
Clinical narrative: Was healthy prior to vaccine.  This was the 2nd dose, the first shot had no side effects.  After the 2nd shot, patient started to feel ill on the day after.  Due to  him fighting sinus infections he went to Dr.  and he was prescribed antibiotics.  His main symptoms in his lungs seemed to be getting worse.  Back to the  dr.  Chest x-ray showed no infection.  A week later after finishing antibiotics still not  feeling well, got a CT of his lungs.  Double pneumonia.   5 weeks  later after intense antibiotics, steroids, and breathing treatments, and a lung washing , patient is just now feeling somewhat normal.   After looking on the internet and speaking with others that have had a similar reaction to the 2nd shingle shot, I feel it that these  types of side effects are very serious and patients, and medical Personel  need to made aware of the possibility?s
Age: 65.0
Sex: M
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Bronchial secretion retention, Computerised tomogram thorax abnormal, Pneumonia, Scan with contrast abnormal, Sinusitis
Clinical narrative: Was healthy prior to vaccine.  This was the 2nd dose, the first shot had no side effects.  After the 2nd shot, patient started to feel ill on the day after.  Due to  him fighting sinus infections he went to Dr.  and he was prescribed antibiotics.  His main symptoms in his lungs seemed to be getting worse.  Back to the  dr.  Chest x-ray showed no infection.  A week later after finishing antibiotics still not  feeling well, got a CT of his lungs.  Double pneumonia.   5 weeks  later after intense antibiotics, steroids, and breathing treatments, and a lung washing , patient is just now feeling somewhat normal.   After looking on the internet and speaking with others that have had a similar reaction to the 2nd shingle shot, I feel it that these  types of side effects are very serious and patients, and medical Personel  need to made aware of the possibility?s
Age: 25.0
Sex: M
Vaccine: FLU4, HEPA, HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: MA  reported that AccuVax dispensed  Influenza dispensed instead of Engerix-B. She reported that she gave influenza vaccine in error. The patient was contacted. Pt was assessed by NP with no adverse reactions reported after assessment. Patient vitals was obtained and charted and within normal limits per NP and MA.  Patient reported he no adverse reactions. DON notified. Accuvax  report submitted with  no findings at this time.  Incident reported  and corrective actions in process for employee and training.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: redness and swelling