chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance, Swelling, Swelling face
Clinical narrative: Moderna COVID- 19 Vaccine EUA Patient received vaccine on 3/17/21 around 415 pm.  Stayed for 15 min observation.  In the evening went home and noticed swelling on the left side of her face along with a sensation change.  Patient reached out via email. Encouraged pt to try icing facial area and take some ibuprofen.  On 3/18/21 a follow up was provided, patient stated that the swelling went away, but the sensation on the left side of her face was still different.  No other symptoms present.  On 3/23/21 additional email communication with the patient was provided. Pt stated all facial reactions resolved, but she now noticed a lump in the groin area which she is seeing a PCP on 3/24/21.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site mass, Injection site warmth, Pain, Pain in extremity
Clinical narrative: After Dose 1 the night exp chills, body aches went to bed early. The next day I woke up arm was sore. Then 6 days around 11pm  I was laying on my left side arm was hurting the injection site appeared as if I got stung by abee and warm to touch. I seen in the paper to contact Ohio State about reactions was not given much information to seek medical attention. I took Benadryl for teh symptoms.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Skin reaction
Clinical narrative: covid arm: redness and itching starting 9 days after vaccination. lasted about 7 days
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Incomplete course of vaccination, Oxygen saturation decreased
Clinical narrative: About 10:30pm on 2-27-2021 patient became short of breath and ended up with O2 Saturation of low 70%. This was explained to our staff when she returned for her second dose. it was discussed and decided not to receive second dose. 3 day in the hostipal.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood test normal, Body temperature increased, Fall, Head injury
Clinical narrative: At about 10:00 p.m. on March 10 patient lost her balance and fell, bumping her head in the process. Residential care staff called emergency services. EMTs detected somewhat elevated heart rate (140+ BPM) and temperature (approximately 102 degrees) and recommended she go to the ER. She was attended to and tests were administered to detect any underlying infections. Tests were all negative. Patient was kept overnight for observation. By Thursday, March 11, her heart rate and temperature were normal and she was discharged just after mid-day. She has had no lingering effects post-hospitalization.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Urine analysis normal
Clinical narrative: At about 10:00 p.m. on March 10 patient lost her balance and fell, bumping her head in the process. Residential care staff called emergency services. EMTs detected somewhat elevated heart rate (140+ BPM) and temperature (approximately 102 degrees) and recommended she go to the ER. She was attended to and tests were administered to detect any underlying infections. Tests were all negative. Patient was kept overnight for observation. By Thursday, March 11, her heart rate and temperature were normal and she was discharged just after mid-day. She has had no lingering effects post-hospitalization.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Ache, headache, fever 101.4, chills.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Paraesthesia, Throat tightness, Vital signs measurement
Clinical narrative: Patient received the Covid-19 vaccine. She reports symptoms of Anaphylaxis Patient was dizzy, light-headed, and BUE tingling @1111.  At this time denies shortness of breath and difficulty breathing.  Patient was given juice, water, and granola bar.  No difficulty swallowing noted.  1116: Patient noted that she was feeling worse with throat tightness without difficulty breathing.  Vital signs stable with 100% O2 saturation.  1118: Rapid response called.  Patient reports throat feels tighter and difficulty swallowing noted.  Lungs clear, HR regular both radial and apical.  I have observed for 40 minutes. Treatment/intervention:  Patient observed.  Taking given water, juice, and granola bar.  Vital signs taken every 5 minutes per protocol.  1120: rapid response team arrived.    1111 98.9 82 128/73 16-18/100%  1116 93 148/86 16-18/100%  1120 95 164/95 16-18/100% Patient took 2 puffs of her personal albuterol inhaler  1127 Care transferred to rapid response team.  Patient transported to ER via cart.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease, Blood thyroid stimulating hormone, Dyspnoea, Tachycardia, Thyroxine free
Clinical narrative: Graves disease; shortness of breath; tachycardia; A spontaneous report was received from a health professional concerning a 49-years-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and had graves disease (basedow's disease), shortness of breath (dyspnoea), tachycardia  No medical history was provided. No concomitant medications were provided.  On 12 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: not provided), intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient developed tachycardia and shortness of breath. On 13 Feb 2021, she had medical evaluation done that showed she did not have a pulmonary embolus. On 23 Feb 2021, lab data showed undetectable thyroid stimulating hormone (TSH). On 01 Mar 2021, she had full set of thyroid function tests that still showed an undetectable TSH and elevated free T4 and a total T3. She was confirmed to have Graves' disease (medically significant) based off elevated thyroid stimulating immunoglobulins.  The patient had been started on treatment.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The outcome of the events of graves disease (basedow's disease), shortness of breath (dyspnea), tachycardia was unknown.  The reporter assessed the events to be possibly related to the study drug.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tri-iodothyronine
Clinical narrative: Graves disease; shortness of breath; tachycardia; A spontaneous report was received from a health professional concerning a 49-years-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and had graves disease (basedow's disease), shortness of breath (dyspnoea), tachycardia  No medical history was provided. No concomitant medications were provided.  On 12 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: not provided), intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient developed tachycardia and shortness of breath. On 13 Feb 2021, she had medical evaluation done that showed she did not have a pulmonary embolus. On 23 Feb 2021, lab data showed undetectable thyroid stimulating hormone (TSH). On 01 Mar 2021, she had full set of thyroid function tests that still showed an undetectable TSH and elevated free T4 and a total T3. She was confirmed to have Graves' disease (medically significant) based off elevated thyroid stimulating immunoglobulins.  The patient had been started on treatment.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The outcome of the events of graves disease (basedow's disease), shortness of breath (dyspnea), tachycardia was unknown.  The reporter assessed the events to be possibly related to the study drug.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: red, swollen, and itchy injection site. "COVID Arm"
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Sore throat runny nose and low grade fever 3/10 and 3/11 COVID POSITIVE 3/14/2021 -rapid COVID Positive  3/15/2021 -PCR COVID Positive 3/22/2021- PCR
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Peripheral swelling
Clinical narrative: After 1 st dose very little side effect. After 2nd dose March 3, the side of injection was very red about 3" in diameter, a little pain as expected. This symptoms diapered in a week. March 19, started to feel some soreness  on injection side again. March 23 found a big swelling from injection side down to the elbow. March 24 left a message to the doctor office.. tarted to use cold  pack.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling cold, Flushing, Heart rate increased, Nausea
Clinical narrative: 1st dose, 12:10 pm pt c/o feeling flushed, rapid pulse, cold legs and body, funny taste in mouth, light headed, and nauseous. BP 140/80 HT 84  O2Sat 99% , Repeat VS 140/80 HR 72 O2sat 98%. Pt reports history of allergy to Augmentin, with hives. Denies anaphylaxis.  12:15 PM pt reported feeling a little better. Pt declined EMS evaluated that was offered. Pt signed Chesprocott refusal form and was given ED precautions. Pt was advised to contact her PCP this afternoon. Pt?s husband who was present the entire time will drive the pt home.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Taste disorder, Vital signs measurement
Clinical narrative: 1st dose, 12:10 pm pt c/o feeling flushed, rapid pulse, cold legs and body, funny taste in mouth, light headed, and nauseous. BP 140/80 HT 84  O2Sat 99% , Repeat VS 140/80 HR 72 O2sat 98%. Pt reports history of allergy to Augmentin, with hives. Denies anaphylaxis.  12:15 PM pt reported feeling a little better. Pt declined EMS evaluated that was offered. Pt signed Chesprocott refusal form and was given ED precautions. Pt was advised to contact her PCP this afternoon. Pt?s husband who was present the entire time will drive the pt home.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain at injection site.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: developed a facial droop, bell's palsy; A spontaneous report (United States) was received from a nurse concerning a 47-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a facial droop and was diagnosed with Bell's palsy/facial paralysis with seriousness criteria as hospitalization.   The patient's medical history was not provided by the reporter. Concomitant medications reported included humera, high blood pressure medication and arthritis medication.  On 13 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 016M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 13 Feb 2021, after two hours, the patient experienced, a facial droop and was concerned for stroke therefore was hospitalized and recognized this as Bell's palsy.   Lab details were not provided by the reporter.  Treatment for the events included vitamin B12 and was on steroids for 5 days, both for Bell's palsy.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, facial droop and bell's palsy were recovering.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Malaise, Speech disorder
Clinical narrative: Felt unwell; Coudn't walk; Couldn't talk; A spontaneous report (United States) was received from a consumer concerning a 87 year old male patient, who experienced feeling unwell (malaise), couldn't walk (gait disturbance), and couldn't talk (speech disorder).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received the first dose of  mRNA-1273 (lot number 029L201A) on 14 Jan 2021.   On 11 Feb 2021, the  patient received their second of two planned doses of mRNA-1273 (Lot number 030M20A) intramuscularly in the right arm for COVID-19 infection prophylaxis.  On 14 Feb 2021, the patient felt unwell for a few days, and couldn't walk or talk.  On 16 Feb 2021, the patient was admitted to the ICU for 7 days. Then, moved to rehabilitation and remains there. Wife stated that she wants Moderna to reach out to them with regards to compensation or whatever can be done. She is OK for safety follow-up.   The patient received both scheduled doses of mRNA-1273 prior to the events. Therefore, action taken with the drug in response to the events is not applicable.   The outcome for the events of feeling unwell (malaise), couldn't walk (gait disturbance), and couldn't talk (speech disorder) was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Further information has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Discomfort, Fatigue, Vaccination site pain
Clinical narrative: Sore arm; Heart fluttering; Discomfort; More extreme exhaustion; A spontaneous report was received from a consumer, concerning a 39-year old, male patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced extreme exhaustion, sore arm, discomfort, and heart fluttering.  The patient's medical history was not provided. Concomitant was not provided.  On 12 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number 015M20A) intramuscularly on left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient began to experience extreme exhaustion, sore arm, discomfort and heart fluttering.   There was no change planned to the dosing schedule of mRNA-1273 in response to the events. The patient received their second dose on 12 Mar 2021.   The outcome of the events, extreme exhaustion, sore arm, discomfort,  and heart fluttering, were unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: The moderna vaccine knocked her daughter's heart out of rhythm; A spontaneous report was received from a mother who reported on behalf of her daughter, unknown (age and race) female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event the moderna vaccine knocked her daughter's heart out of rhythm.  The consumer's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the event the consumer received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the consumer experienced the event the moderna vaccine knocked her daughter's heart out of rhythm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event was unknown.  The assessment was not provided for the event.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Critical details such as the exact term for sign, symptom or diagnosis, the patient's medical history, list of concomitant medications, diagnostic findings if any, mRNA-1273 administration date and onset date of the event is lacking. Further information have been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Feeling abnormal, Malaise, Vomiting
Clinical narrative: Dehydrated; Vomiting; Severe diarrhea; Didn't get out of bed; Wasn't feeling good; A spontaneous report was received from consumer, concerning himself, a 78-year-old, male patient, who received Modena's COVID-19 vaccine (mRNA-1273) and experienced a diarrhea, dehydration, vomiting, malaise, feeling abnormal.  The patient's medical history included diabetic (insulin dependent) and rheumatoid arthritis. The concomitant medications included as otilimab and insulin.  On 17 Mar 2021, he got the first of two planned doses of mRNA-1273 (lot 038A21A) in his left arm, intramuscularly for prophylaxis of COVID-19 infection.  On 18 Mar 2021, the patient experienced diarrhea, vomiting, malaise, feeling abnormal. On 19 Mar 2021, patient had dehydration.  The patient was hospitalized for vomiting, diarrhea and dehydration.  Treatment included treated for dehydration, monitoring his heart, and giving his insulin,  Action taken with mRNA-1273 in response to events were not provided.  The outcome of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Further information has been requested.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Dementia, Fatigue
Clinical narrative: Dementia; Uncontrolled blood sugar; Fatigue; A spontaneous report  was received from a consumer concerning her mother an 86-years-old female patient, who received Moderna's COVID-19 vaccine and experienced dementia, fatigue and uncontrolled blood sugar/ blood glucose abnormal.   The patient's medical history included Diabetes which was untreated. No relevant concomitant medications were reported  On 04 March 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 015M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 04 March 2021, the patient experienced a medically significant event dementia, fatigue and uncontrolled blood sugar.  No treatment medication was reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, dementia, fatigue and uncontrolled blood sugar was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: had small bruising on his arm; This is a spontaneous report from a non-contactable consumer for his father-in-law. This elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  1, single dose via an unspecified route of administration on an unknown date for COVID-19 vaccination. There was no relevant medical history. Concomitant medications were not reported. It was unknown if the patient received  any other vaccine within 4 weeks prior to the vaccine. On an unknown date, the patient experienced small bruising on his arm. It was unknown if treatment was received for small bruising on his arm. The clinical outcome of small bruising on his arm was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information received on 19-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves patient (unknown demographics) who experienced sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  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 sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that they had High Dose for senior flue shot last August when the flue shot first available. Thankfully, due to masks and shut down, they were not exposed to what ever other versions of the flue for got to put in the shot for 2020/2021. Most years is so incompetent, negligent, stupid that they fail to put the right virus in the flue virus in the shot and son and they get what ever virus they didn't put in the shot for that year and we are sick for a week or more  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the lot number for this case.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: they gave a Pentacel without the Diluent ,No AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Global Medical Information(Reference number- 00487716) and transmitted to Sanofi on 22-FEB-2021.  This case involves a 2 year old female patient who received DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) without the Diluent, (batch number U6890AA,expiry date 22-mar-2022 ) via Intramuscular route in unknown administration site for prophylactic vaccination on 19-Feb-2021(Product preparation issue).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to active ingredient not added to diluent(latency same day).  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: F
Vaccine: FLU4
Symptoms: Blister, Herpes zoster, Pain, Pruritus, Skin burning sensation
Clinical narrative: hives were all over her body; itching; became like blisters on her chest, lower back, thighs and torso, upper legs and arms, groin and throat; Shingles; felt like it was burning; stinging; Initial information received on 02-Mar-2021 regarding an unsolicited valid non-serious case received from a consumer..  This case involves a 71 year old female patient who experienced shingles (herpes zoster), felt like it was burning (burning sensation), stinging (pain), hives were all over her body (urticaria), itching (pruritus) and became like blisters on her chest, lower back, thighs and torso, upper legs and arms, groin and throat (blister), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   In 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  In 2019, the patient developed a non-serious shingles (herpes zoster), felt like it was burning (burning sensation) and stinging (pain), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  In 2020, the patient developed a non-serious hives were all over her body (urticaria), itching (pruritus) and became like blisters on her chest, lower back, thighs and torso, upper legs and arms, groin and throat it was everywhere (blister) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reaction were mild.  It was also reported that while there were marks and now it is clear. No breathing difficulty noticed. It was basically a bad skin reaction. It was inside her groin and she was afraid it may go inside. She is currently seeing an Allergist too to assess what triggered the adverse event.  Details of laboratory data not reported.    Corrective treatment: Doctor prescribed her a topical steroid ointment and oral steroid tablets. Only thing that calmed her down was ice packs.  On an unknown date, the patient recovered from the all events (also reported that it lasted for 3 weeks and disappeared gradually).  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: hives were all over her body; itching; became like blisters on her chest, lower back, thighs and torso, upper legs and arms, groin and throat; Shingles; felt like it was burning; stinging; Initial information received on 02-Mar-2021 regarding an unsolicited valid non-serious case received from a consumer..  This case involves a 71 year old female patient who experienced shingles (herpes zoster), felt like it was burning (burning sensation), stinging (pain), hives were all over her body (urticaria), itching (pruritus) and became like blisters on her chest, lower back, thighs and torso, upper legs and arms, groin and throat (blister), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   In 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  In 2019, the patient developed a non-serious shingles (herpes zoster), felt like it was burning (burning sensation) and stinging (pain), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  In 2020, the patient developed a non-serious hives were all over her body (urticaria), itching (pruritus) and became like blisters on her chest, lower back, thighs and torso, upper legs and arms, groin and throat it was everywhere (blister) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reaction were mild.  It was also reported that while there were marks and now it is clear. No breathing difficulty noticed. It was basically a bad skin reaction. It was inside her groin and she was afraid it may go inside. She is currently seeing an Allergist too to assess what triggered the adverse event.  Details of laboratory data not reported.    Corrective treatment: Doctor prescribed her a topical steroid ointment and oral steroid tablets. Only thing that calmed her down was ice packs.  On an unknown date, the patient recovered from the all events (also reported that it lasted for 3 weeks and disappeared gradually).  There will be no information available on the batch number for this case.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: The patient received only the liquid portion of the PENTACEL with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Agency (Reference number- 00504437) and transmitted to Sanofi on 04-Mar-2021.  This case involves a four months old female patient who received only the liquid portion first 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Solution for injection, lot of powder portion UJ336AA, lot number of liquid portion U6842BA and expiration date: 05-Jul-2021) via intramuscular route in the right quad for prophylactic vaccination on 04-Mar-2021 (product preparation issue). This occurred because the powder was not mixed with the liquid as administrator did not see the powder portion in the box.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  It was actual medication error due to inappropriate reconstitution technique (on same day).  The reporter asked what should he/she do now?  At the time of report, the patients experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUX, UNK
Symptoms: Asthma, Hypersensitivity, Malaise
Clinical narrative: very sick with asthma and bronchitis/asthma; little allergy; Initial information received on 11-Mar-2021 regarding an unsolicited valid non-serious case received from a patient.  This case involves an unknown age female patient who was very sick with asthma and bronchitis/asthma and little allergy, while she was treated with dupilumab (Dupixent), delivered via dupilumab pre-filled pen and influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided. At the time of the event, the patient had ongoing allergies to egg whites and 10-15 other things.   Since an unknown date, the patient started taking dupilumab (strength: 300 mg; formulation, dosage, route, frequency, batch number, expiry: unknown) used for her long-time skin condition of 35 years, delivered via dupilumab prefilled pen. In the context of COVID19 crisis, the batch number and expiration date were not requested. On an unknown date, patient received a influenza vaccine (flu shot) (did not remember the specific name of the flu shot that she received) (strength, formulation, dosage, route, frequency, batch number, expiry: unknown) used for an unknown indication. On an unknown date, after unknown latency, flu shot made her very sick with asthma and bronchitis (asthma). She was told by her doctors that she should not receive flu shots in the future due to that experience. Since an unknown date, after unknown latency, patient happened to have asthma and had noticed that dupilumab had also helped her asthma. She said dupilumab really worked for her and had made her more comfortable. On an unknown date, after unknown latency, patient still had a little allergy (hypersensitivity), but she could deal with that. Patient uses the dupilumab pen and wanted to know if she could get the COVID (coronavirus disease) vaccine because she was scared as she could not get the flu vaccine due to her allergies to egg whites and 10-15 other things.   First time product used: No   Action taken: unknown for asthma and hypersensitivity with dupilumab; not applicable for asthma and hypersensitivity with influenza vaccine.  It was not reported if the patient received a corrective treatment.  Outcome: unknown for asthma but not recovered for little allergy.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, Medication error
Clinical narrative: patient received an IPOL dose that expired two days ago (13-Mar-2021)/no AE; Initial information was received on 15-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of unknown demographics who was vaccinated with expired dose of IPV (VERO) [IPOL] (batch number R1B251M and expiry date 15-Mar-2021) via an unknown route at an unknown administration site on 15-Mar-2021 for prophylactic vaccination (expired product administered).  Caller wanted to know if the patient should be re-vaccinated.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   It was a case of a actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Result of assessment was not reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain
Clinical narrative: Severe fatigue, headache,  body aches. Fatigue and muscle aches lasted 36 hours. Headache is lingering at the 36 hour mark.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vital signs measurement
Clinical narrative: At 9;05 am Patient reported  nausea in recovery sitting in chair R22, B/P132/88, P86.   At 9;36 am B/P 136/88, R20, P88,. patent declined any medical care/transport released at 9;35 to go home.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Started around 9am yesterday with a sore arm and some fatigue, quickly developed a fever (100.6), headache, chills, body aches, and nausea. symptoms were improved by tylenol but came back each time it wore off. Fever broke around midnight. Today I still have severe body aches and a headache, as well as fatigue
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Started around 9am yesterday with a sore arm and some fatigue, quickly developed a fever (100.6), headache, chills, body aches, and nausea. symptoms were improved by tylenol but came back each time it wore off. Fever broke around midnight. Today I still have severe body aches and a headache, as well as fatigue
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypoaesthesia oral
Clinical narrative: Dizziness 10 mins numbness to mouth, 4 mins
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Night sweats
Clinical narrative: Unusual Thirst Tiredness Chills Low fever 100.3 Achy all over  Sweated all night  Swollen armpit lymph node Headache
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Thirst
Clinical narrative: Unusual Thirst Tiredness Chills Low fever 100.3 Achy all over  Sweated all night  Swollen armpit lymph node Headache
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Mydriasis, Pallor
Clinical narrative: Patient was on his way out of the door and stated that he was feeling dizzy.  Patient sat down in the chair and became pale, sweaty, and he loss consciousness for a brief moment.  Patient's pupils were dilated and moving rapidly from side to side.  Patient quickly regained consciousness.  Patient stated that this happens every time that he receives a vaccination or has blood drawn.  Denies any history of seizures.  It appeared that patient had a focal seizure.  Patient's vitals were monitored until WNL and was able to fully regain consciousness.  Patient didn't want to go to the ED for treatment.  Patient advised not to drive and advised to follow up with PCP ASAP.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Rapid eye movements sleep abnormal, Vital signs measurement
Clinical narrative: Patient was on his way out of the door and stated that he was feeling dizzy.  Patient sat down in the chair and became pale, sweaty, and he loss consciousness for a brief moment.  Patient's pupils were dilated and moving rapidly from side to side.  Patient quickly regained consciousness.  Patient stated that this happens every time that he receives a vaccination or has blood drawn.  Denies any history of seizures.  It appeared that patient had a focal seizure.  Patient's vitals were monitored until WNL and was able to fully regain consciousness.  Patient didn't want to go to the ED for treatment.  Patient advised not to drive and advised to follow up with PCP ASAP.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: Patient presented at vaccination table after having documents and appointment reviewed by non-clinical staff, and identity was confirmed by nurse vaccinator using two unique identifiers (including DOB). Nurse vaccinator reviewed patient's responses to screening form completed in PrepMod and screened patient to confirm she was feeling well, had no history of anaphylaxis, does not carry an epi-pen for allergies, and had not received COVID vaccine previously. RN vaccinator educated patient on possible side effects of Moderna product. Patient indicated she wished to be immunized, received Moderna vaccine, and proceeded to observation area where she waited for fifteen minutes before departing from clinic without reporting any adverse event. Patient was later found to be five months under the minimum age of 18 years for receiving Moderna COVID-19 vaccine, thereby rendering the medication as administered outside the age limit of the applicable order.   Immediate Action/Intervention: Patient was under observation for CDC-mandated 15-minute period following vaccine administration. Upon review of records and discovery that dose was administered to patient who was five months too young to be eligible. Director of Nursing was informed of error and tasked with completing required documentation and performed root cause analysis.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Migraine, Pyrexia, Vaccine positive rechallenge
Clinical narrative: First shot left me with a fever of 102 for two days, plus being chilled and migraine. Second shot left me with a fever of 100.5, chilled, and migraine.
Age: 95.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Laboratory test, SARS-CoV-2 test positive
Clinical narrative: Resident tested positive to COVID 19 by PCR test on 3/18/21.  Lab run twice to ensure positivity.  Resident asymptomatic
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Chills, Cough, Fatigue
Clinical narrative: joint and muscle ache and fatigue, fever, chills, sweating, headache, shaking, cycling between feeling cold and shaking to hot and sweating.    I was positive for COVID-19 in April of 2020, the reaction to the first shot of the vaccine was worse than the virus itself (with the exception of chest congestion and cough).  it is nearly 48 hours from receiving the vaccine and I feel slight improvement, but still have body and muscle aches, slight fever, chills.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Hyperhidrosis, Myalgia, Pulmonary congestion
Clinical narrative: joint and muscle ache and fatigue, fever, chills, sweating, headache, shaking, cycling between feeling cold and shaking to hot and sweating.    I was positive for COVID-19 in April of 2020, the reaction to the first shot of the vaccine was worse than the virus itself (with the exception of chest congestion and cough).  it is nearly 48 hours from receiving the vaccine and I feel slight improvement, but still have body and muscle aches, slight fever, chills.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: joint and muscle ache and fatigue, fever, chills, sweating, headache, shaking, cycling between feeling cold and shaking to hot and sweating.    I was positive for COVID-19 in April of 2020, the reaction to the first shot of the vaccine was worse than the virus itself (with the exception of chest congestion and cough).  it is nearly 48 hours from receiving the vaccine and I feel slight improvement, but still have body and muscle aches, slight fever, chills.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram normal, Headache, Hypertension
Clinical narrative: Tightness in chest, difficulty breathing, hypertensive, headache, 4 lead showed normal sinus rhythm, repeat blood pressure showed 180/100, Patient transported to hospital ER.   178/106, 68, 16, 100 % RA, BS 214
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Chills, fever, body aches, headache, nausea
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tremor, Visual impairment
Clinical narrative: Patient experienced lightheadedness, spots in vision, and shakiness approximately 30 mins after receiving the vaccine. Was monitored for 25 mins with no resolution in symptoms and was sent to the emergency room for additional evaluation.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness of right arm still present more than one month after administration
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: For past 24hours- Low grade fever has remained between 100.1 and 99.3.  Muscle Aches Headache
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: After a week of the 1st dose of the Moderna Covid 19 vaccine I developed red, itchy arm along with a welt at the vaccine site.  The welt was about 3 inches in diameter and the redness grew  from the site all the way to my shoulder.  I applied Benedryl cream for several days.   After about 4 days it is finally better.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Palatal swelling, Peripheral swelling, Swelling
Clinical narrative: PATIENT SAID HE HAD SWELLING IN FEET, KNEES, HANDS, NECK, PALATE (UPPER PART OF MOUTH)
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody negative, Arthritis, C-reactive protein increased, Immobile, Loss of personal independence in daily activities
Clinical narrative: PATIENT SAID HE HAD SWELLING IN FEET, KNEES, HANDS, NECK, PALATE (UPPER PART OF MOUTH)
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Monocyte count, Musculoskeletal stiffness, Pain, Red blood cell sedimentation rate increased, Rheumatoid factor positive
Clinical narrative: PATIENT SAID HE HAD SWELLING IN FEET, KNEES, HANDS, NECK, PALATE (UPPER PART OF MOUTH)
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling, White blood cell count normal
Clinical narrative: PATIENT SAID HE HAD SWELLING IN FEET, KNEES, HANDS, NECK, PALATE (UPPER PART OF MOUTH)
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: I have intermittent loud pitch ringing in earing and get the clogged feeling
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Between 8-10 days after the injection the patient reported a rash starting around the injection site. The injection site itself became hard, warm to the touch, and itchy. The rash currently covers her right deltoid muscle and extend down the upper third of her tricep. She reports the rash is looking better each day.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Nausea, Pain
Clinical narrative: Woke up this morning with body aches and chills.  Didn't sleep good last night because of arm and shoulder pain.  Nausious and diarrhea.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Woke up this morning with body aches and chills.  Didn't sleep good last night because of arm and shoulder pain.  Nausious and diarrhea.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Herpes zoster, Pain, Paraesthesia
Clinical narrative: After seeing the PA  at the doctors office, I was diagnosed with Shingles  on my left lower back which he prescribed 800 Acyclovir and for one week and 300 mg gabapentin one a day for 30 days. my symptoms were very painful, tingling, rash, headache and chills. As of today, my rash is starting to fade away but still have pain from shingles
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: After seeing the PA  at the doctors office, I was diagnosed with Shingles  on my left lower back which he prescribed 800 Acyclovir and for one week and 300 mg gabapentin one a day for 30 days. my symptoms were very painful, tingling, rash, headache and chills. As of today, my rash is starting to fade away but still have pain from shingles
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test, Chest X-ray, Delirium, Headache
Clinical narrative: Severe headache, blood pressure approx. 200/150, fast heart rate - 118, temperature of 103.4, delirium
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia, Vital signs measurement
Clinical narrative: Severe headache, blood pressure approx. 200/150, fast heart rate - 118, temperature of 103.4, delirium
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: Face swelling mainly around the eyelid/eyes that started 9 days after the vaccine was given to me. I emailed my GP with pictures and took antihistamine and went through it.  It lasted ~ 5 days.  Important to note that I have had 2 episodes of face swelling in July and August 2020 of unknown cause. Swelling is gone and
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Eye swelling, Pruritus, Swelling face, Swelling of eyelid
Clinical narrative: Face swelling mainly around the eyelid/eyes that started 9 days after the vaccine was given to me. I emailed my GP with pictures and took antihistamine and went through it.  It lasted ~ 5 days.  Important to note that I have had 2 episodes of face swelling in July and August 2020 of unknown cause. Swelling is gone and
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Lymphadenopathy, Rash erythematous
Clinical narrative: I had a large, red, rectangular rash @ injection site. Was swollen + sore. Significant and uncomfortable swelling in lymph node @ left underarm. Still swollen as almost 2 weeks since receiving vaccine. Rash is gone.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Eight days after the initial vaccine injection, a painful nodule appeared.  I consumed a large amount of (simple and complex sugar) calories (around 4,000) the night before 3/13/21.  On the day of 3/13/21 I woke up with swelling and noticed a painful lump, the size of a small grape above the left medial clavicle, within the supraclavicular cervical triangle.  Saw my doctor on 3/18/21 and she mentioned that the inflamed lymph node is probably due to the vaccine.  The lump is still with me, the size is the same, however the area in and around the lump  is not as tender and painful today 3/24/21.  This coming Friday 3/26/21 is my  appointment for the second dose of the Pfizer BioNTECH vaccine shot.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mass, Pain, Swelling
Clinical narrative: Eight days after the initial vaccine injection, a painful nodule appeared.  I consumed a large amount of (simple and complex sugar) calories (around 4,000) the night before 3/13/21.  On the day of 3/13/21 I woke up with swelling and noticed a painful lump, the size of a small grape above the left medial clavicle, within the supraclavicular cervical triangle.  Saw my doctor on 3/18/21 and she mentioned that the inflamed lymph node is probably due to the vaccine.  The lump is still with me, the size is the same, however the area in and around the lump  is not as tender and painful today 3/24/21.  This coming Friday 3/26/21 is my  appointment for the second dose of the Pfizer BioNTECH vaccine shot.