chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity
Clinical narrative: 12/22/2020 08:00 AM Nausea, chills, slight headache, sore arm; 12/23/2020 symptoms have slightly relieved
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, fever, chills, nasuea
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: patient complained of burning while vaccine was being injected
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Pain in extremity
Clinical narrative: Notified by girlfriend.  Patient woke up this morning with arm  soreness. States temperature 102.3 this am. Instructed to call primary care.  Instructed patient could have COVID or flu not related to shot.  Waited 30 minutes post vaccination, without complication.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Panic attack
Clinical narrative: panic attack sunday night around 1030-11pm. Had to seek treatment from my family physician to get some antianxiety pills.  As of 12/23/20 I still wake up with severe anxiousness. If COVID weren't around I would have went to the ER. I have never experienced anything like that in all my life.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Nausea, Paraesthesia, Vomiting
Clinical narrative: Vomiting, Cheeks feel tingling, Slight difficulty swallowing.  Rest and will take oral Benadryl when gets home.  Will take Phenergan for nausea when gets home as well.  Starting to feel better after 2 hours.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pruritus
Clinical narrative: recipient became flush and began itching all over
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Neck pain, Pain in extremity, Sleep disorder
Clinical narrative: Recieved the vaccine 12/21 and on the evening of 12/22 my arm became very sore, more than usual for other shots such as the flu shot I received in October this year. It kept me awake it hurts at the injection site down to my middle finger and up my neck. No redness or swelling that I could see. No fever that I can tell.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pruritus, Rash, Urticaria
Clinical narrative: Approx 10 min after receiving vaccine- patient developed rash and hives on neck and chest with complaints of itchiness on R arm at vaccine site.  Also developed redness to right ear.  no respiratory difficulties noted.  Patient transported to ED for further evaluation and treatment
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: After administration of COVID vaccine - pfizer, patient noted that he didn't feel that it went into the deltoid, that the injection site had been too low.  Questioned if he should be administered another dose. No symptoms.  consulted with other clinic staff, ID oversite and will follow-up to determine if patient develops appropriate response to vaccine or if will require additional vaccination
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Anxiety, Dysphagia, Heart rate increased, Injection site pain
Clinical narrative: *Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) S: 35 yo F who received Pfizer vaccine at 16:47 w/acute onset of left sided facial swelling and difficulty swallowing.  Within five minutes of being administered vaccination, pt reported pain at the injection site radiating up to her jaw followed by left sided facial swelling. She started reported palpitations and subsequently reported a ball in her throat  O: Pulse was in the 60's,  BP of 128/72, pulse of 88-97 satting at 99% on RA. General: young female, anxious. HEENT: NC, AT, mild left sided cheek swelling, OP clear, MMM.  Neck: Supple, left sided tender cervical LN.  Lungs: CTAB. CV: tachycardic rate, regular rhythm. Extremities: Hands are clenched and cold.  Neuro: Alert & oriented.   A/P:  Anaphylaxis  -Given left facial swelling, 25 mg Benadryl PO administered. pt tolerated well.  -17:22-Throat swelling reported. EPI #1 administered right thigh.  -17:32-EPI #2 administered. Throat felt better at 17:35.  17:36-FD EMS arrived. BP 194/126.  -17:38-EPI #3 administered right thigh. HR 135, BP 154/105.  -17:43-EPI #4 administered left thigh.  -17:46 pt transported to ER via EMS.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pain, Pain in jaw, Pain of skin, Palpitations
Clinical narrative: *Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) S: 35 yo F who received Pfizer vaccine at 16:47 w/acute onset of left sided facial swelling and difficulty swallowing.  Within five minutes of being administered vaccination, pt reported pain at the injection site radiating up to her jaw followed by left sided facial swelling. She started reported palpitations and subsequently reported a ball in her throat  O: Pulse was in the 60's,  BP of 128/72, pulse of 88-97 satting at 99% on RA. General: young female, anxious. HEENT: NC, AT, mild left sided cheek swelling, OP clear, MMM.  Neck: Supple, left sided tender cervical LN.  Lungs: CTAB. CV: tachycardic rate, regular rhythm. Extremities: Hands are clenched and cold.  Neuro: Alert & oriented.   A/P:  Anaphylaxis  -Given left facial swelling, 25 mg Benadryl PO administered. pt tolerated well.  -17:22-Throat swelling reported. EPI #1 administered right thigh.  -17:32-EPI #2 administered. Throat felt better at 17:35.  17:36-FD EMS arrived. BP 194/126.  -17:38-EPI #3 administered right thigh. HR 135, BP 154/105.  -17:43-EPI #4 administered left thigh.  -17:46 pt transported to ER via EMS.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Pharyngeal swelling, Swelling face
Clinical narrative: *Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) S: 35 yo F who received Pfizer vaccine at 16:47 w/acute onset of left sided facial swelling and difficulty swallowing.  Within five minutes of being administered vaccination, pt reported pain at the injection site radiating up to her jaw followed by left sided facial swelling. She started reported palpitations and subsequently reported a ball in her throat  O: Pulse was in the 60's,  BP of 128/72, pulse of 88-97 satting at 99% on RA. General: young female, anxious. HEENT: NC, AT, mild left sided cheek swelling, OP clear, MMM.  Neck: Supple, left sided tender cervical LN.  Lungs: CTAB. CV: tachycardic rate, regular rhythm. Extremities: Hands are clenched and cold.  Neuro: Alert & oriented.   A/P:  Anaphylaxis  -Given left facial swelling, 25 mg Benadryl PO administered. pt tolerated well.  -17:22-Throat swelling reported. EPI #1 administered right thigh.  -17:32-EPI #2 administered. Throat felt better at 17:35.  17:36-FD EMS arrived. BP 194/126.  -17:38-EPI #3 administered right thigh. HR 135, BP 154/105.  -17:43-EPI #4 administered left thigh.  -17:46 pt transported to ER via EMS.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Feeling hot, Paraesthesia
Clinical narrative: Warm feeling to face and ears. Tingling or burning feeling to face.  Started 25 minutes after injection.  still with mild tingling. No breathing issues.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Paraesthesia
Clinical narrative: Warm feeling to face and ears. Tingling or burning feeling to face.  Started 25 minutes after injection.  still with mild tingling. No breathing issues.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin irritation
Clinical narrative: Severe itching, irritation, took oral Benadryl, proceeded to nearest Emergency Room
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Nausea, Rhinorrhoea
Clinical narrative: Headache, nausea, chills, runny nose, cough
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: Hives size of quarters on buttocks and upper legs
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Rash
Clinical narrative: Woke with fat lips and a body rash on torso and arms
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Erythema, Feeling hot, Pruritus
Clinical narrative: employee initially complained of itching on arms, noted slight redness bilaterally upper arms. itching progressed to neck slight redness noted around neck area. complained of feeling "hot",Denied difficulty swallowing. Placed in room and Rapid Response called. Given Epi injection in right upper thigh, INT inserted. and Bendryl 50mg IV, solumedrol 125 mg IV, and Pepid 20 mg IV given IVP. placed on EKG and B\P monitor. RR nurse and Covid Nurse at Bedside. employee transported to ER for continued observation. Client remains alert, talking via transfer to ER. continues to complain of some "itching"
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Mild rash on bilateral upper extremities, non-pruritic rash. No associated symptoms or shortness of breath.
Age: 7.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Expired product administered
Clinical narrative: No adverse reactions were reported by the patient. The Tdap dose given was found to be expired after the patient received it. Expired 12/4/20. Attempts to contact patient were ineffective, mom did not answer calls and voicemail could not be left on phone due to voicemail box not being set up.
Age: 60.0
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: no additional side effects/ adverse events; pneumovax 23 was admnistered on 23-NOV-2020 after the excursion occured; This spontaneous report was received from a registered nurse and refers to a 60-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On 23-NOV-2020, the patient was vaccinated with an improperly stored 1 time dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot # T022294 has been verified as a valid lot #, expiration date 26-MAR-2022 for prophylaxis (exact dose, strength, route of administration and anatomical location were not provided). The temperature excursion as follows: 13.5 Celsius degrees for 3 hours. There were no previous excursions reported. The digital data logger was involved. No additional adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T022294; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: M
Vaccine: VARZOS
Symptoms: Central nervous system lesion, Hypoaesthesia, Magnetic resonance imaging spinal abnormal, Muscular weakness, Myelitis transverse
Clinical narrative: Transverse myelitis/ Acute transverse myelitis/ inflammatory transverse myelitis/ monophasic transverse myelitis; weakness and numbness in his legs; weakness and numbness in his legs; spinal cord lesion; arm pain; This case was reported by a lawyer and described the occurrence of myelitis transverse in a patient who received Herpes zoster (Shingrix) for an unknown indication.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced myelitis transverse (serious criteria GSK medically significant). On an unknown date, the outcome of the myelitis transverse was unknown.   It was unknown if the reporter considered the myelitis transverse to be related to Shingrix.  The initial information received on 10Dec2020 via medical record (The case medically confirmed). On 15 October 2020, the patient had Acute transverse myelitis. The patient had most consistent with inflammatory transverse myelitis. The patient had booster shot of Shingrix vaccine 1 month before onset of symptoms, the Shingrix vaccine caused arm pain for 4 days after the injection. The MRI showed improvement of the original spinal cord lesion. The patient had MRI T-/L-spine which shows T11-L1 FLAIR hyperintensity with enhancement, concerning for transverse myelitis. The patient had RI t-/I-spine DWI/ADC sequences were negative for spinal cord infarction. The patient had The patient diagnosed with most consistent with avaccine-associated monophasic transverse myelitis. The Shingrix vaccine link was suggested by the timing (within 30 days) and the unusual painful reaction in the arm that lasted several days. on March 020, the patient had weakness and numbness in his legs and transverse myelitis which caused hospitalization.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Transverse myelitis/ Acute transverse myelitis/ inflammatory transverse myelitis/ monophasic transverse myelitis; weakness and numbness in his legs; weakness and numbness in his legs; spinal cord lesion; arm pain; This case was reported by a lawyer and described the occurrence of myelitis transverse in a patient who received Herpes zoster (Shingrix) for an unknown indication.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced myelitis transverse (serious criteria GSK medically significant). On an unknown date, the outcome of the myelitis transverse was unknown.   It was unknown if the reporter considered the myelitis transverse to be related to Shingrix.  The initial information received on 10Dec2020 via medical record (The case medically confirmed). On 15 October 2020, the patient had Acute transverse myelitis. The patient had most consistent with inflammatory transverse myelitis. The patient had booster shot of Shingrix vaccine 1 month before onset of symptoms, the Shingrix vaccine caused arm pain for 4 days after the injection. The MRI showed improvement of the original spinal cord lesion. The patient had MRI T-/L-spine which shows T11-L1 FLAIR hyperintensity with enhancement, concerning for transverse myelitis. The patient had RI t-/I-spine DWI/ADC sequences were negative for spinal cord infarction. The patient had The patient diagnosed with most consistent with avaccine-associated monophasic transverse myelitis. The Shingrix vaccine link was suggested by the timing (within 30 days) and the unusual painful reaction in the arm that lasted several days. on March 020, the patient had weakness and numbness in his legs and transverse myelitis which caused hospitalization.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Macule, Pruritus
Clinical narrative: reaction / Slightly itchy; red, macular; red, macular; This case was reported by a physician via call center representative and described the occurrence of pruritus in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced pruritus, erythema and macule. On an unknown date, the outcome of the pruritus, erythema and macule were unknown.   It was unknown if the reporter considered the pruritus, erythema and macule to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The 5 days after 1st dose of Shingrix, patient  started with mild to moderate reaction, red, macular and slightly itchy but the temperature was normal. Consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: she developed hives /  dermatologist who diagnosed her with hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, between 2 and 3 months after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were reported as follows: The patient developed hives 2 weeks ago (from the date of reporting) on her feet, hands, back and stomach.  The hives on the back and stomach began a day or two after the hives started on the feet and hands. The hives were not as bad but were still ongoing. The patient went to a dermatologist who diagnosed her with hives. Did not consent to follow-up.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Last shot patient got made ill; Initial information was received on 09-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer or non-health care professional (Patient).  This case involves patient [age and gender unspecified] who experienced ill (illness), while patient received INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, last shot made patient ill.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 17-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer or non-health care professional.  This case involves male patient who experienced flu (influenza), while he received INFLUENZA VACCINE [Flu shot] . Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, patient got flu every time he took flu shot.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: patient was administered Tenivac instead of TDAP with Pertussis; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Regulatory Authority (Reference number-00372219) and transmitted to Sanofi on 25-Nov-2020.  This case involves a 27-years-old female patient who received a 0.5 ml dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (TENIVAC) (lot number U6669AA, expiration date 15-May-2022, prefilled syringe, standard dose) once via an intramuscular route in left deltoid for prophylactic vaccination, on 23 -Nov-2020 instead of DIPHTHERIA TETANUS ACELLULAR PERTUSSIS (DTAP) not produced by Sanofi Pasteur (reported as another manufacturer's TDAP with Pertussis) (wrong product administered).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was administered concomitantly.  This was an actual medication error case due to wrong vaccine administered (latency same day).  At the time of reporting, no adverse event was reported.  Reporter stated that this was first time this product was used in patient. Reporter asked if the patient could get the rest of the ingredient vaccines in the TDAP with Pertussis so the patient could receive the intended full vaccine.  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: 34.0
Sex: F
Vaccine: TYP
Symptoms: Arthralgia, Hypersensitivity
Clinical narrative: severe joint pain; extremely severe allergic reaction to Typhim Vi; Initial information regarding this unsolicited valid non-serious case received from a patient and transmitted to Sanofi on 25-Nov-2020.  This case involved a 34 year old female patient who experienced severe joint pain (arthralgia) and extremely severe allergic reaction to Typhim Vi (Allergy to vaccine), while she received vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  Relevant medical history, medical treatment, vaccination details and family history were not provided.  At the time of the event, the patient possibly had an ongoing egg allergy.  No concomitant medication was taken by the patient.   On an unknown date in 2019, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot number and expiry date not reported) via intramuscular route in the left arm prophylactic vaccination.  On an unknown date in 2019, the patient had extremely severe allergic reaction to Typhim Vi (Allergy to vaccine), unknown latency following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.   On 26-Dec-2019, the patient developed a non-serious severe joint pain (arthralgia), unknown latency following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.   It was reported that she had not received a flu shot for many years because she felt sick for about a week afterwards.   Relevant laboratory test was not reported.  No corrective treatment was received.  On an unknown date, the event outcome was recovered for arthralgia and unknown for allergy to vaccine.  There would be no information available on batch number for this case.  Additional information regarding this unsolicited valid non-serious case received from a patient and transmitted to Sanofi on 25-Nov-2020.  New event allergy to vaccine was added. Corresponding fields and narrative updated accordingly.
Sex: U
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: patient given an expired dose of Tenivac, no AE; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient (unknown demographics) who was vaccinated with an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  Patient did not received other vaccines.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U610AA and expiry date: 23-Oct-2020) via an intramuscular route in the left arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  Reporter relationship: HCP (health care professional)  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered the Flublok vaccine who is outside of the advised age on the PI with no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number-00382427) and transmitted to Sanofi on 04-Dec -2020 via call-center.  This case involves a 6-years-old patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV on an unknown date (lot number and expiry date were unknown) on an unknown date via unknown route at unknown site who was outside of the advised age on the PI (Product administered to patient of inappropriate age) for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   It was an actual medication error case due to vaccine administered to patient of inappropriate age (latency: unknown).  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: 5.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: 5 year old female patient administered expired dose of IPOL, no AE; Initial information received on 08-Dec-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a five year old female patient who was inadvertently vaccinated with an expired dose of IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 08-Dec-2020, the patient received a 0.5 ml second dose of suspect IPV (VERO) (lot P41F54 and expiry date: 07-Dec-2020) via an intramuscular route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  Reporter relationship: HCP (health care professional), Product used: not applicable  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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Full blood count normal, Malaise, Metabolic function test
Clinical narrative: Patient with hx of SVT stood up after receiving COVID-19 vaccine and did not feel well - sat back down.  put pulse ox on and HR was 180.  Pt vagaled twice, HR sitting in the 90s - brought to ED for evaluation.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever body aches chills fatigue starting 16 hrs after vaccine.   Symptoms continued for 4 days after vaccine before reducing in severity.   All symptoms still present today, 5th day after vaccine  .   Max temp recorded 100.7
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Myalgia
Clinical narrative: Intense muscle pain, shivering, pain at injection site
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: After receiving the vaccine, the patient developed a hard quarter sized bump above the injection site. Ice applied to site. No bruising, bleeding, pain, or redness noticed.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Patient received vaccine during the day and overnight pateint developed chills, rigors, headache and body aches. Tylenol has helped a little but did not completely resolve symptoms
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Pharyngeal swelling
Clinical narrative: About 30-40 minutes after patient received COVID-19 vaccine, she felt that she was having difficulty swallowing.  Denied respiratory distress.  Some swelling felt in middle of throat.  No fever, chills, pain, shortness of breath or wheezing.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Swelling face
Clinical narrative: facial swelling, numbness in face, red patches on neck and face.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Ocular discomfort, Pain
Clinical narrative: Headache with Pressure on eyes, body aches
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Woke up with severe bodyaches worse on injection site with fever of 100.6 degrees farenheit.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Next day after vaccination redness and swelling to injection site. Later that day and still today redness, swelling and now itching.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Chest discomfort, Condition aggravated, Erythema, Eye swelling
Clinical narrative: On the date of the vaccine that night my blood pressure went up to 143/130 which is higher than it has ever been. My blood pressure the bottom number would not go under 100. The entire night my head felt like I was in a tunnel and my heart and chest felt tight. I was unable to work the following day due to not getting any sleep out of fear of something tragic happening to me. In addition last night or early this morning at 3 AM I woke up and my body was itching all over. The palms of my hands were itching my gums were itching I had red marks on my body and had Not done anything out of the ordinary or eight anything out of the ordinary. I took two Benadryl?s and was able to fall back to sleep for a little while and now the itching has stopped but my eyes are swollen.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Gingival pruritus, Head discomfort, Hypertension, Impaired work ability
Clinical narrative: On the date of the vaccine that night my blood pressure went up to 143/130 which is higher than it has ever been. My blood pressure the bottom number would not go under 100. The entire night my head felt like I was in a tunnel and my heart and chest felt tight. I was unable to work the following day due to not getting any sleep out of fear of something tragic happening to me. In addition last night or early this morning at 3 AM I woke up and my body was itching all over. The palms of my hands were itching my gums were itching I had red marks on my body and had Not done anything out of the ordinary or eight anything out of the ordinary. I took two Benadryl?s and was able to fall back to sleep for a little while and now the itching has stopped but my eyes are swollen.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Sleep disorder
Clinical narrative: On the date of the vaccine that night my blood pressure went up to 143/130 which is higher than it has ever been. My blood pressure the bottom number would not go under 100. The entire night my head felt like I was in a tunnel and my heart and chest felt tight. I was unable to work the following day due to not getting any sleep out of fear of something tragic happening to me. In addition last night or early this morning at 3 AM I woke up and my body was itching all over. The palms of my hands were itching my gums were itching I had red marks on my body and had Not done anything out of the ordinary or eight anything out of the ordinary. I took two Benadryl?s and was able to fall back to sleep for a little while and now the itching has stopped but my eyes are swollen.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: dizziness, chest tightness, light headedness, SOB
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Lightheaded, dizziness, flushed face, sweating
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Myalgia
Clinical narrative: Patient experienced severe symptoms such as severe headache, severe myalgias, brain fog, and dizziness. Upon waking up currently he is currently fine, but symptoms yesterday were very severe
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Rash, Rash macular
Clinical narrative: Past 24hours after being vaccinated, I got home from work and realized I had a rash over my stomach and both arm. Felt achy and had a sore throat. The rash was tiny red spots all over.  I still have rash on me today, and same symptoms. It has not gotten any worse.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 12/22/2020 07:00PM Rash on back
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Limb discomfort, Limb injury, Magnetic resonance imaging, Pain
Clinical narrative: Received the flu vaccine on August 30, 2020 from the pharmacist on duty. Initially did not have any reaction, but after about two hours of being home, did have pain in the right arm and into the shoulder. Pain continued to worsen, and started to have a clicking in the arm/ shoulder region. When I was unable to take the pain any longer did seek out an orthopedic to evaluate. Have seen the ortho three times now and it is listed as a vaccine related shoulder injury. Have had an injection to assist with pain and physical therapy. MRI tomorrow, and then discussion with the ortho as to where we go from here. Pain is at its worst at night and when I raise my arm above shoulder level.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, X-ray limb
Clinical narrative: Received the flu vaccine on August 30, 2020 from the pharmacist on duty. Initially did not have any reaction, but after about two hours of being home, did have pain in the right arm and into the shoulder. Pain continued to worsen, and started to have a clicking in the arm/ shoulder region. When I was unable to take the pain any longer did seek out an orthopedic to evaluate. Have seen the ortho three times now and it is listed as a vaccine related shoulder injury. Have had an injection to assist with pain and physical therapy. MRI tomorrow, and then discussion with the ortho as to where we go from here. Pain is at its worst at night and when I raise my arm above shoulder level.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Nausea, Rash
Clinical narrative: RASH ON FACE, NECK, CHEST AND ARMS.  MILD NAUSEAS AND ELEVATED BLOOD PRESSURE. TREATED WITH BENADRYL 50MG IV. RASH LASTED 15 MINUTES AFTER IV TREATEMENT.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Chromaturia, Eye swelling, Fatigue, Headache
Clinical narrative: 12/23@9:35am EST- Caller stated on12/22/20  at midnight he felt fever 103.0, chills, muscle soreness and aching, nausea and extreme fatigue. Caller called Primary and  was told to take Tylenol 1gr.  Benadryl and naproxen for headache and body aches. Rash covered  arms , neck and thighs and patika on elbow and armpit. This morning rash is still prominent, eyes are swollen and urine is bright red.  Caller is  awaiting primary to call back.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia, Rash
Clinical narrative: 12/23@9:35am EST- Caller stated on12/22/20  at midnight he felt fever 103.0, chills, muscle soreness and aching, nausea and extreme fatigue. Caller called Primary and  was told to take Tylenol 1gr.  Benadryl and naproxen for headache and body aches. Rash covered  arms , neck and thighs and patika on elbow and armpit. This morning rash is still prominent, eyes are swollen and urine is bright red.  Caller is  awaiting primary to call back.
Age: 54.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Malaise, Peripheral swelling, Rash
Clinical narrative: PATIENT REPORTED SWELLING OF THE ARM THE SIZE OF BASEBALL, REDNESS, RASH, AND GENERAL MALAISE
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching started on left arm  and then around the temples of the head and on right shoulder.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Pain
Clinical narrative: Sore arm, fever (Max 100.5), body aches, chills, headache, fatigue, general malaise
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm, fever (Max 100.5), body aches, chills, headache, fatigue, general malaise
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Tryptase
Clinical narrative: Patient descrived a metallic taste in her mouth 10 minutes after getting the COVID19 Vaccine. Soon after, she described the posterior left side of her tongue was feeling numb. No itching of throat, no swelling of lip or tongue. No respiratory or GI symtpoms. No urticaria or pruritis.  She was treated with loratadine 10 mg and famotidine 20 mg orally.  She was observed for 2 hours with no progression or additional symptoms. She was discharged to home.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pain, Pain in extremity
Clinical narrative: Pfizer-BioNTech COVID - 19 Vaccine EUA  Had injection at about 1230 on 12/22/20, woke up at 6am on 12/23/20 with chills, fever of 100.1, headache, dizziness, body aches, sore arm. I had COVID 3 months ago and some of these side effects are worse now then when I had COVID.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pfizer-BioNTech COVID - 19 Vaccine EUA  Had injection at about 1230 on 12/22/20, woke up at 6am on 12/23/20 with chills, fever of 100.1, headache, dizziness, body aches, sore arm. I had COVID 3 months ago and some of these side effects are worse now then when I had COVID.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: 12-22-2020 1am- arm soreness at sight 12-22-2020 7 am -arm, armpit, and chest muscle soreness 12-22-2020 1 pm chills, muscle pinches , shooting muscle pain (legs, body upper body) 12-22-2020 4 pm additional pain in right toes along with same symptoms above, facial muscle pain, irritable, tiredness 12-22-2020 10 pm headache
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Myalgia, Pain, Pain in extremity
Clinical narrative: 12-22-2020 1am- arm soreness at sight 12-22-2020 7 am -arm, armpit, and chest muscle soreness 12-22-2020 1 pm chills, muscle pinches , shooting muscle pain (legs, body upper body) 12-22-2020 4 pm additional pain in right toes along with same symptoms above, facial muscle pain, irritable, tiredness 12-22-2020 10 pm headache
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Eye pain
Clinical narrative: Patient feels metalic taste on the right side of her tongue, along with pain behind the right eye.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Nausea, Vomiting
Clinical narrative: approximately  12 hours after receiving the Covid 19 vaccine on 12/18 that I had nausea and vomiting. The vomiting lasted about 2 hours from approx 5:30 AM to 7:30 AM on 12/19. Also, I was extremely fatigued for the rest of 12/19. I slept the entire day only being awake for approx 4 hours. The next day I was slightly nauseated but able to go about my day as normal.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles, left T4 dermatome. Treated with valacyclovir. Adequate response to treatment.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: urticarial rash to bilateral upper extremities
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered after expiration date.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular pain, Testicular swelling
Clinical narrative: swollen and painful testicle
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash, Injection site vesicles, Pain in extremity
Clinical narrative: Itching, blister like rash around the injection site. Pain in arm for extended period.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Facial spasm
Clinical narrative: 12/21/2020 2:20PM Facial spasms, left side of face-- eye, nose,  lip (prominent) - occurring for minutes at time, symptoms have not resolved
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: tiredness, muscle ache for approximately 12 to 14 hours
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Dyspnoea, Electrocardiogram, Immediate post-injection reaction
Clinical narrative: Patient was given covid vaccine, and within 3 minutes, began to develop tachycardia. Patient was placed in chair to be assessed, vital signs done. HR was 160 to begin, dropping to 140, and 117 when being transported to ED for evaluation. Patient stated that she felt like her chest was on fire, and heart was going to beat out of chest. Rapid Response Team called, and team responded, bringing patient to ED for closer evaluation.  From the ER MD: 39 year old female patient who was a rapid response after receiving her Covid vaccination.  She began to have palpitations and was tachycardic.  She appeared to be very tremulous and anxious.  She has no known history of allergic reactions.  She denies recent illnesses including fevers and chills.  Patient felt short of breath.  She had an O2 sat of 100% on room air.  Lorazepam 1mg po x1 dose ordered and was administered.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tachycardia, Tremor
Clinical narrative: Patient was given covid vaccine, and within 3 minutes, began to develop tachycardia. Patient was placed in chair to be assessed, vital signs done. HR was 160 to begin, dropping to 140, and 117 when being transported to ED for evaluation. Patient stated that she felt like her chest was on fire, and heart was going to beat out of chest. Rapid Response Team called, and team responded, bringing patient to ED for closer evaluation.  From the ER MD: 39 year old female patient who was a rapid response after receiving her Covid vaccination.  She began to have palpitations and was tachycardic.  She appeared to be very tremulous and anxious.  She has no known history of allergic reactions.  She denies recent illnesses including fevers and chills.  Patient felt short of breath.  She had an O2 sat of 100% on room air.  Lorazepam 1mg po x1 dose ordered and was administered.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Tongue pruritus
Clinical narrative: Patient felt like back of tongue swelling and itchy ~ 15 min after administration  Patient received 12.5 mg Benadryl, 125 mg soul-Medrol in ED Sent home with an epi pen and steroids x 4 days
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry throat, Immediate post-injection reaction, Injection site pruritus, Paraesthesia oral, Swollen tongue
Clinical narrative: Patient felt like back of tongue swelling and itchy ~ 15 min after administration  Patient received 12.5 mg Benadryl, 125 mg soul-Medrol in ED Sent home with an epi pen and steroids x 4 days
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Nausea, Pain in extremity
Clinical narrative: Reported fever of 100.8, nausea, headache, chills, arm pain- which is common reported side effects of vaccine. Patient reported walking up in the middle of the nights gasping for air- short of breath. Only lasted 3 times during the night, no interventions were done. Went away on it's own.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Reported fever of 100.8, nausea, headache, chills, arm pain- which is common reported side effects of vaccine. Patient reported walking up in the middle of the nights gasping for air- short of breath. Only lasted 3 times during the night, no interventions were done. Went away on it's own.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Lip swelling, Pharyngeal paraesthesia, Swollen tongue
Clinical narrative: tingling in throat, swelling of tongue Became very anxious upper lip swelling
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Myalgia, Nausea
Clinical narrative: Seen in urgent care approx. 30 minutes after vaccination for diffuse muscle aches, nausea and dizziness, her BP was elevated. Treatment dugs:
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Diarrhoea, Nausea
Clinical narrative: The day after vaccination  development of abdominal cramping, urgency, repeated episodes of diarrhea. Some nausea, no vomiting.  Abdominal cramping still episodic 3 days later.  No fever.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Defaecation urgency, Diarrhoea, Gastrointestinal disorder, Muscle spasms
Clinical narrative: The day after vaccination  development of abdominal cramping, urgency, repeated episodes of diarrhea. Some nausea, no vomiting.  Abdominal cramping still episodic 3 days later.  No fever.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Patient was seen on 12/5/2020 and treated for cellulitis with Clindamycin 300mg - Take 1 capsule every 8 hours for 7 days. (symptoms, signs , time course and outcome unknown)
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Oral discomfort, Paraesthesia oral, Throat tightness
Clinical narrative: Patient began feeling lip numbness shortly after receiving the vaccine.  Patient reported feeling tightness in throat that felt like muscle tightening, not airway compromise.  Refused IM epinephrine.  Patient awake, alert, mild symptoms.  Patient given water and is resting.   0704 HR 70, oxygen saturation per pulse oximetry 95%, BP 130/70.  0712 BP110/80, pulse 80, 0732 BP 116/74 and 25 mg Benadryl given.  At 0830 lip tingling and throat symptoms have resolved. Patient report lips feel cool, but all other symptoms have resolved.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal sounds abnormal, Nausea
Clinical narrative: Woke up the morning after receiving vaccine with some queasiness, and stomach gurgling.  Still having the queasiness and gurgling. No diarrhea or vomiting.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Injection site reaction, Nausea
Clinical narrative: The morning after the vaccine, I experienced fatigue and nausea. Soon after, I had a headache and fever. Throughout the day and into the next day, the injection site was sore with the skin showing red irritated patches around the area. The second day the fever, headache, nausea and fatigue were gone, but the injection site was still sore with irritated skin surrounding.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash macular, Skin irritation
Clinical narrative: The morning after the vaccine, I experienced fatigue and nausea. Soon after, I had a headache and fever. Throughout the day and into the next day, the injection site was sore with the skin showing red irritated patches around the area. The second day the fever, headache, nausea and fatigue were gone, but the injection site was still sore with irritated skin surrounding.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Flushing, Pharyngeal swelling, Swollen tongue, Urticaria
Clinical narrative: Development of flushing, hives, throat and tongue swelling, difficulty breathing, all developed within 30 min of administration, and resolved after admin of epinephrine and IM Benadryl.