chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/; HCP reported AE for inadvertently administering an expired dose of GARDASIL 9. No TEs reported. No symptoms reported. Obtained consent to contact HCP. MIR Filed (Case #02498538). No additional AE/PQC.; This spontaneous report was received from a medical assistant and referred to an 11-year-old patient of unknown age. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.   On 26-OCT-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml/dose, lot #U034201, expiration date: 21-OCT-2023, administered for prophylaxis (strength, anatomical site of administration and route of administration were not provided) (expired vaccine used). No additional adverse event.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: No additional AE/PQC reported; inadvertently administered a dose of VARIVAX; This spontaneous report was received from a medical assistant and referred to a 20-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-FEB-2023 (at the 12-month-old appointment), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, (two dose series), administered for prophylaxis (lot #, expiry date, anatomical location and route of administration were not provided). On 31-AUG-2023 (at the 18-month-old appointment), the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter (two dose series), administered for prophylaxis (lot #, expiry date, anatomical location and route of administration were not provided) (wrong product administered). The reporter had not received any information of the patient experiencing any symptoms or medical concerns.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported. No additional AE.; HCP calling to report patient received supported TE VARIVAX vaccine.; This spontaneous report was received from a nurse and referred to a 12-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, single dose, (lot number X017489 has been verified to be a valid lot number, expiration date reported and validated as 25-JUN-2025 [expiration date also reported as 14-JAN-2025, discrepant information) administered for prophylaxis (strength, vaccination scheme, anatomical location and route of administration were not provided) after a temperature excursion of 29.8 Fahrenheit (F) degrees during a time frame of 2 hours and 18 minutes (product storage error). No adverse effects were reported.
Age: 64.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Extra dose administered
Clinical narrative: none
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Eczema, Insomnia, Pruritus, Urticaria
Clinical narrative: Had what was diagnosed as non specific urticaria.  Later biopsied and determined to be spongiatic excema.  Suffered sleepless nights and unbearable itching.  Still have occasional flares.  Have been treated with dupixent and now rinvoq
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Tinnitus
Clinical narrative: Noticed ringing in my ears (Tinnitus) 2-3 days after second injection. Did not and has not gone away as of todays date., 11/15/2023.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest pain, Palpitations
Clinical narrative: Heart palpitations, sudden heart fluttering and chest pain beginning about 12hrs after vaccination and lasting 3 days.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Confusional state, Hypotension, Intensive care, Laboratory test
Clinical narrative: The patient developed fever and confusion with thrombocytopenia.  She was admitted to ICU with hypotension on non-invasive ventilatory support.  Work up in progress.   Husband reported similar reaction with prior COVID shots and was worried about getting this one.  This reaction has been the worst.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical ventilation, Pyrexia, Thrombocytopenia
Clinical narrative: The patient developed fever and confusion with thrombocytopenia.  She was admitted to ICU with hypotension on non-invasive ventilatory support.  Work up in progress.   Husband reported similar reaction with prior COVID shots and was worried about getting this one.  This reaction has been the worst.
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Surgery
Clinical narrative: The site was hot to touch; a red circle around injection site; lump in center; This serious case was reported by a consumer and described the occurrence of injection site erythema in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 27-SEP-2023, the patient received Arexvy (unknown arm). On 28-SEP-2023, 1 days after receiving Arexvy, the patient experienced injection site erythema (Verbatim: a red circle around injection site) (serious criteria clinically significant/intervention required) and injection site lump (Verbatim: lump in center) (serious criteria clinically significant/intervention required). On an unknown date, the patient experienced injection site warmth (Verbatim: The site was hot to touch) (serious criteria clinically significant/intervention required). The patient was treated with cefalexin (Keflex) and doxycycline. The outcome of the injection site erythema, injection site lump and injection site warmth were not reported.   It was unknown if the reporter considered the injection site erythema, injection site lump and injection site warmth to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site lump and injection site warmth to be related to Arexvy.   Additional Information: GSK Receipt date: 09-NOV-2023 A reporter reported that his sister (patient) received the RSV vaccine. The day after receiving the vaccine her arm had a red circle around injection site with a small lump in center. The site was hot to touch and informed pharmacy of condition, they told her to see her physician.  Made appointment with family doctor and visited family doctor on 6th October 2023, was prescribed Keflex.  Returned to Family physician on 20th October 2023, conditioned worsened.  He prescribed Doxycycline and sent her to wound Specialist and saw wound specialist on 25th October 2023.  The patient had surgery on vaccine site on 3rd November 2023. The reporter provided the patient's email address for any email exchanges. The reporter consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: aches and pain for a day or two; little fever (99°F); This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (aches and pain for a day or two) and PYREXIA (little fever (99°F)) in an 83-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     Patient has lots of allergies (not specified), she has a loop recorder. Patient taken medication for blood pressure.  The patient's past medical history included Pericarditis (since 12 years ago) in 2011, GERD and Renal aneurysm. Previously administered products included for Blood pressure: Losartan (80 mg once a day) and Amlodipine (225 mg once a day); for GERD: Prevacid (30 mg once a day); for Hypercholesterolemia: Livalo (2.5 mg once a day); for Product used for unknown indication: HCTZ (25 mg once a day), Vitamin D (500 mcg,), Vitamin B12 (500), Multivitamin, Pregabalin (100 mg twice a day) and Aspirin (81 mg once a day); for an unreported indication: NASALCROM (nose drops twice a day.). Past adverse reactions to the above products included No adverse event with Amlodipine, Aspirin, HCTZ, Livalo, Losartan, Multivitamin, Pregabalin, Prevacid, Vitamin B12 and Vitamin D. Concurrent medical conditions included Angiomyolipoma and Hypercholesterolemia.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches and pain for a day or two) and PYREXIA (little fever (99°F)). At the time of the report, PAIN (aches and pain for a day or two) and PYREXIA (little fever (99°F)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 °F.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported,  she already received all her Moderna COVID-19 Vaccines (She did not remember dates) without any major issues, just maybe a little fever (99°F), aches and pain for a day or two. She currently wanted to get Spikevax, but she wanted to know: what was the recommendation if she has pericarditis.  No treatment information was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm continues to hurt; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm continues to hurt) in a 67-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm continues to hurt). At the time of the report, PAIN IN EXTREMITY (arm continues to hurt) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient's arm continues to hurt more than a month ago. It was unknown if the patient experienced any additional symptoms/events.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain
Clinical narrative: pain in her chest and left back shoulder; pain in her chest and left back shoulder; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (pain in her chest and left back shoulder) and ARTHRALGIA (pain in her chest and left back shoulder) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 11-Nov-2023, the patient experienced CHEST PAIN (pain in her chest and left back shoulder) and ARTHRALGIA (pain in her chest and left back shoulder). At the time of the report, CHEST PAIN (pain in her chest and left back shoulder) and ARTHRALGIA (pain in her chest and left back shoulder) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Pharmacist states that one of their patient received an expired dose of MENACTRA the other day with no reported adverse event; Initial information received on 02-Nov-2023 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves an unknown age and unknown gender patient where pharmacist states that one of their patient received an expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] the other day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine Solution for injection (lot U7492AA and expiration date- 26-Oct-2023) via unknown route in unknown administration site (strength: not provided) for Immunisation (expired product administered) (latency- same day)  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Poor quality product administered
Clinical narrative: nurse administered the DTAP-IPV component to the patient without reconstituting the HIB component with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 18 months old female patient who experienced nurse administered the diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] component to the patient without reconstituting the hib component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection lot UJ849AA via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (poor quality product administered) (latency- same day).  Reportedly, only the DTAP-IPV component was given and not the HIB component. As per caller one of their nurses was rushing and did not realize there is a 2nd vial. The nurse administered the DTAP-IPV component to the patient without reconstituting the HIB component  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Smell chemical smells often. People around me don't smell it.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 2 years and a half old, received Kinrix; 2 years and a half old, received Kinrix; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 30-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3UMFG, expiry date 13-FEB-2026) for prophylaxis.   On 03-NOV-2023, the patient received Kinrix. On 03-NOV-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 years and a half old, received Kinrix) and inappropriate schedule of vaccine administered (Verbatim: 2 years and a half old, received Kinrix). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-NOV-2023 The physician reported that the 2 years and half old patient received Kinrix. This was the 3rd Dtap dose in the series. The vaccine administration facility was the same as primary reporter. The patient received a dose of Kinrix at an age of 2 years and a half old and it was the 3rd Dtap dose in the series, which led to inappropriate age at vaccine administration and Inappropriate schedule of vaccine administered. The reporter did not consent to follow up.
Sex: M
Vaccine: COVID19-2
Symptoms: Salivary hypersecretion
Clinical narrative: Increased saliva production that occurred shortly after receiving Moderna vaccine; This spontaneous case was reported by a physician and describes the occurrence of SALIVARY HYPERSECRETION (Increased saliva production that occurred shortly after receiving Moderna vaccine) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Obstructive sleep apnea.  Concurrent medical conditions included Obstructive sleep apnoea syndrome.    On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. In October 2022, the patient experienced SALIVARY HYPERSECRETION (Increased saliva production that occurred shortly after receiving Moderna vaccine). At the time of the report, SALIVARY HYPERSECRETION (Increased saliva production that occurred shortly after receiving Moderna vaccine) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient had increased saliva production that occurred shortly after receiving Moderna vaccine (as I understand things, Bivalent). This was occurred about 3 weeks after vaccine receipt and continues now. The patient underwent biopsy of salivary glands. The result was not reported. The patient did not experience any additional symptoms/events.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Myalgia
Clinical narrative: Extreme fatigue and muscle pain
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Discomfort, Headache, Mobility decreased
Clinical narrative: Headache stomach ache  congestion myalgias arthrslgias most of the side effects luster degree of discomfort was worse than covid disease symptoms which means could barely get out off bed whoop score was less than 1%
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Respiratory tract congestion
Clinical narrative: Headache stomach ache  congestion myalgias arthrslgias most of the side effects luster degree of discomfort was worse than covid disease symptoms which means could barely get out off bed whoop score was less than 1%
Age: 36.0
Sex: M
Vaccine: FLU4, HEP, TDAP
Symptoms: Breast swelling, Full blood count, Laboratory test
Clinical narrative: swollen breast
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pain
Clinical narrative: Nausea, Shivers, fatigue, body aches
Age: 1.92
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: child may have received the entire single dose vial of child Moderna vaccine.
Age: 70.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Blood glucose increased, Chills, Dyspnoea, Exercise tolerance decreased, Muscle twitching
Clinical narrative: Patient is here today with possible allergic reaction.  States that he received the Covid and RSV (GSK) vaccine Oct 30th.  Since then he has had some "shivers", and "frozen muscles".  Had woken up with the shivers after the vaccines.  When he woke up to go to bathroom, he had episodes of "shaking" and just frozen in place, like seizure without the body twitching.  Had sx for few days. Went on a walk with neighbor on Thursday 11/2 - was fine.   Monday 11/6 went walking and legs got weak about a block in and had to go home. Didn't check sugar when got home. Before went on walk sugar was 130 and ate a yogurt and kind bar.  With one of his episodes, (keeps saying seizure), his BS was over 250 which is out of his normal range. States Monday episode was after took another dose of Mounjaro. Today tried walking again and only able to go about a block before sx started.   He also started new dose of the Mounjaro (12.5mg) 2 wk's before this. Has been on mounjaro for over 6 months before this.   Has been having more sob "for a while." Last few weeks. No chest pain. Hard to catch breath - showering, didn't notice any more then expected with walking. States mostly just when showering but "maybe some with walking but not more then I would expect."
Age: 70.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Muscular weakness, Musculoskeletal stiffness, Seizure like phenomena, Tremor
Clinical narrative: Patient is here today with possible allergic reaction.  States that he received the Covid and RSV (GSK) vaccine Oct 30th.  Since then he has had some "shivers", and "frozen muscles".  Had woken up with the shivers after the vaccines.  When he woke up to go to bathroom, he had episodes of "shaking" and just frozen in place, like seizure without the body twitching.  Had sx for few days. Went on a walk with neighbor on Thursday 11/2 - was fine.   Monday 11/6 went walking and legs got weak about a block in and had to go home. Didn't check sugar when got home. Before went on walk sugar was 130 and ate a yogurt and kind bar.  With one of his episodes, (keeps saying seizure), his BS was over 250 which is out of his normal range. States Monday episode was after took another dose of Mounjaro. Today tried walking again and only able to go about a block before sx started.   He also started new dose of the Mounjaro (12.5mg) 2 wk's before this. Has been on mounjaro for over 6 months before this.   Has been having more sob "for a while." Last few weeks. No chest pain. Hard to catch breath - showering, didn't notice any more then expected with walking. States mostly just when showering but "maybe some with walking but not more then I would expect."
Age: 34.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Asthenia, Dizziness, Gait inability
Clinical narrative: Dizziness and weakness after 10-15 minutes of vaccination. Unable to carry on walking. Self-treated by sitting down for an hour, then ate a light meal with sugary juice. Symptoms improved after 3-4 hours.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia
Clinical narrative: Left shoulder pain the day following injection that has persisted for 2 months.  Also had flu shot administered in same arm at the same time as Arexy, however has had flu shot many times in the past.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, COVID-19, Diabetes mellitus inadequate control, Fall, Gastrointestinal haemorrhage
Clinical narrative: Hospitalization for GI bleed, syncope, acute on chronic renal failure, COVID-19 infection, elevated troponin level, uncontrolled diabetes, nausea and vomiting, fall, skin tear on dates 11/4/2023- 11/11/2023. Treated with  vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Skin laceration, Syncope, Troponin increased, Vomiting
Clinical narrative: Hospitalization for GI bleed, syncope, acute on chronic renal failure, COVID-19 infection, elevated troponin level, uncontrolled diabetes, nausea and vomiting, fall, skin tear on dates 11/4/2023- 11/11/2023. Treated with  vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Lacrimation increased, Malaise
Clinical narrative: I received the flu and COVID-19 vaccine on the same day. I do not know which one is to blame for my delayed and strong reaction. I want to report my symptoms since receiving the vaccines because 1) the timing of symptoms is not as expected (delayed by several days) and 2) symptoms are bad. I received the vaccine on Friday around lunchtime. I did not feel that bad over the weekend at all, just a terrible runny nose. I didn't even have much pain in my arm. But by Tuesday morning, I was feeling sick. My throat hurt and I was coughing a lot, sometimes productively with a bit of phlegm. And my nose is running constantly and eyes are tearing. I have a mild headache. Very fatigued. It is Thursday and I still feel miserable. No one else in my household is sick. My husband and I have 3 children. My husband got the vaccines the Tuesday before I did and he had a similar reaction - very congested and runny nose for several days. His symptoms, while the same as mine, did not seem to be as delayed as mine but lasted longer than the guidance states.   The information regarding the vaccines should be updated to state that symptoms can persist 3 - 7 days after getting the vaccine, rather than will be resolved by day 3, if others are reporting this as well.   While I am generally a proponent of vaccines, and have recovered well from flu vaccines in the past, my reaction this time will certainly make me think twice before getting a COVID-19 vaccine again. And/or may choose not to get both on the same day.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Productive cough, Rhinorrhoea
Clinical narrative: I received the flu and COVID-19 vaccine on the same day. I do not know which one is to blame for my delayed and strong reaction. I want to report my symptoms since receiving the vaccines because 1) the timing of symptoms is not as expected (delayed by several days) and 2) symptoms are bad. I received the vaccine on Friday around lunchtime. I did not feel that bad over the weekend at all, just a terrible runny nose. I didn't even have much pain in my arm. But by Tuesday morning, I was feeling sick. My throat hurt and I was coughing a lot, sometimes productively with a bit of phlegm. And my nose is running constantly and eyes are tearing. I have a mild headache. Very fatigued. It is Thursday and I still feel miserable. No one else in my household is sick. My husband and I have 3 children. My husband got the vaccines the Tuesday before I did and he had a similar reaction - very congested and runny nose for several days. His symptoms, while the same as mine, did not seem to be as delayed as mine but lasted longer than the guidance states.   The information regarding the vaccines should be updated to state that symptoms can persist 3 - 7 days after getting the vaccine, rather than will be resolved by day 3, if others are reporting this as well.   While I am generally a proponent of vaccines, and have recovered well from flu vaccines in the past, my reaction this time will certainly make me think twice before getting a COVID-19 vaccine again. And/or may choose not to get both on the same day.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Atrial fibrillation, Back pain, COVID-19, Coronary arterial stent insertion
Clinical narrative: Hospitalization for hypoxic respiratory failure/COVID-19, CAD S/p 3V CABG, recent DES x1, atrial fibrillation on Eliquis, acute renal failure, hyperkalemia,  altered mental status, GERD, chronic lumbar back pain on dates 11/3/2023- 11/6/2023. Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery bypass, Coronary artery disease, Gastrooesophageal reflux disease, Hyperkalaemia, Mental status changes
Clinical narrative: Hospitalization for hypoxic respiratory failure/COVID-19, CAD S/p 3V CABG, recent DES x1, atrial fibrillation on Eliquis, acute renal failure, hyperkalemia,  altered mental status, GERD, chronic lumbar back pain on dates 11/3/2023- 11/6/2023. Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory failure
Clinical narrative: Hospitalization for hypoxic respiratory failure/COVID-19, CAD S/p 3V CABG, recent DES x1, atrial fibrillation on Eliquis, acute renal failure, hyperkalemia,  altered mental status, GERD, chronic lumbar back pain on dates 11/3/2023- 11/6/2023. Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Accelerated hypertension, COVID-19, Gait disturbance, Hyperglycaemia, Hypomagnesaemia
Clinical narrative: Hospitalization for Trans-ischemic attack (TIA), sinusitis, COVID-19 infection, accelerated hypertension, hyperglycemia, hypomagnesemia, hyponatremia, gait instability, on dates 11/2/2023- 11/4/2023. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Hyponatraemia, Sinusitis, Transient ischaemic attack
Clinical narrative: Hospitalization for Trans-ischemic attack (TIA), sinusitis, COVID-19 infection, accelerated hypertension, hyperglycemia, hypomagnesemia, hyponatremia, gait instability, on dates 11/2/2023- 11/4/2023. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 97.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, CSF protein increased, Guillain-Barre syndrome, Imaging procedure, Immunoglobulin therapy
Clinical narrative: 11/11 Acute onset progressive ascending weakness; neuro eval/imaging for cva/TIA unremarkable. 11/13 LP with elevated Protein. 11/14 started on IgG for findings consistent with Guillan Barre Syndrome
Age: 97.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: 11/11 Acute onset progressive ascending weakness; neuro eval/imaging for cva/TIA unremarkable. 11/13 LP with elevated Protein. 11/14 started on IgG for findings consistent with Guillan Barre Syndrome
Age: 97.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, CSF protein increased, Guillain-Barre syndrome, Imaging procedure, Immunoglobulin therapy
Clinical narrative: Reported to us that he was hospitalized with Gillain-Baree
Age: 97.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Reported to us that he was hospitalized with Gillain-Baree
Age: 75.0
Sex: M
Vaccine: FLUA4, PNC20
Symptoms: Chest pain, Dizziness, Limb discomfort
Clinical narrative: dizziness, chest pain, lightness in his legs
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, Underdose
Clinical narrative: OB Hx: G2P0100 EDD 06/04/23. Previous hx of preeclampsia w/ severe features  Pt was due for updated covid vaccine. No previous hx of concerns w/ vaccines or allergies. Pt was supposed to get the Moderna 12+ vaccine 0.5mL. However, the pediatric dose 5-11yr was given. The dosing for 5-11 yr is 0.25mL. Pt received 0.5mL of pediatric dose.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: She got her vaccine, initially she could feel the medicine in.  As the day went on it started to give the pain, easy at first.  Then as they got further into the day it became more painful, and it seemed to settle right in the muscle.  It was just a painful feeling of the muscle.  Every time she used it to stretch and use it and as time has gone on it has gotten harder to extend the muscle and not able to reach for something or turning a light on the pain seems to "talk back to her".  It has been babying it due to the pain.  She has taken Tylenol for her symptoms, 1 500 mg and has been taking it every other day and she usually takes it first thing in the morning.  She has not notified her doctor, but her pulmonologist informed her that it should have gone away within 2 weeks.  He told her anything after that to at least call somebody.
Age: 74.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received 2nd dose of vaccine.  patient came to pharmacy requesting RSV vaccine. Once the patient left pharmacy pharmacist saw history that first one was received 8/19/23, roughly 3 months prior. this is a one dose series. no side effects reported at this time.
Age: 92.0
Sex: F
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature excursion for high dose flu vaccines. The manufacturers recommendation was to not use them after it had been administered to patient.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Contusion
Clinical narrative: Brusing in both arms not at the site of injection
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature excursion for high dose flu vaccines. The manufacturers recommendation was to not use them after it had been administered to patient.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Nausea, Pain
Clinical narrative: Soreness in arm (hurts to mild touch), body aches, fatigue, nausea, lack of concentration - overall just feel disfunctional. (reporting same day of feeling this way. I think I will be ok but thought to report when I was looking up side effects on CDC website)
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Tenderness
Clinical narrative: Soreness in arm (hurts to mild touch), body aches, fatigue, nausea, lack of concentration - overall just feel disfunctional. (reporting same day of feeling this way. I think I will be ok but thought to report when I was looking up side effects on CDC website)
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature excursion for high dose flu vaccines. The manufacturers recommendation was to not use them after it had been administered to patient.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature excursion for high dose flu vaccines. The manufacturers recommendation was to not use them after it had been administered to patient.
Age: 86.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature excursion for high dose flu vaccines. The manufacturers recommendation was to not use them after it had been administered to patient.
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Pfizer 12+ instead of the appropriate age
Age: 9.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Vaccine Meningococcal MCV4 Menquadfi was administered to patient before mentioned. For no  known reason, the vaccine was showing in health maintenance when administered it showed as an error in ALERT. Provider on site was notified as well as the patient. Patient was in observation for over 40 minutes and no reactions were presented.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature excursion for high dose flu vaccines. The manufacturers recommendation was to not use them after it had been administered to patient.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient died from COVID on 11-13-2023
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: It was an administration error. The Pfizer vaccine is supposed to be diluted before giving the vaccine for 6 month to 4 years of age. And this was not diluted before being administered to the patient.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Ear discomfort, Ear swelling, Feeling abnormal, Injection site pain
Clinical narrative: 9/21 - 10am Vaccinated w/ Covid & flu, 8pm started feeling typical body aches, ickiness 9/22 - felt typical flu icky most the day, started getting better at night 9/23 - Back to normal from flu effects. Able to exercise. 9/24 - woke up itchy, afternoon hives began showing up 9/25 - intense full body hives with burning, itching, including scalp. Ears especially burned, itched and swelled. Took Benadryl 12pm - Full body hives getting worse, plus eyes, ears, ankles, fingers, and feet swelling. Feet so swollen, very painful to walk. Lifting big toe sent pain up my shin. Extremely achy neck pain in muscles, hard to turn head left and right.  6pm - Swelling starts to go down, hives still prevalent. 9/26 - Hives slowly fading, still itchy, but not burning.  9/27 - Mostly back to normal, hives mostly gone. Ache in shot arm at injection site when using muscle. Able to exercise. 10/7 - Shot arm muscle still slightly sore at shot location when using the muscle. Taking a long time to heal. 11/15 - Shot arm FINALLY back to normal
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Neck pain, Pain, Peripheral swelling, Pruritus
Clinical narrative: 9/21 - 10am Vaccinated w/ Covid & flu, 8pm started feeling typical body aches, ickiness 9/22 - felt typical flu icky most the day, started getting better at night 9/23 - Back to normal from flu effects. Able to exercise. 9/24 - woke up itchy, afternoon hives began showing up 9/25 - intense full body hives with burning, itching, including scalp. Ears especially burned, itched and swelled. Took Benadryl 12pm - Full body hives getting worse, plus eyes, ears, ankles, fingers, and feet swelling. Feet so swollen, very painful to walk. Lifting big toe sent pain up my shin. Extremely achy neck pain in muscles, hard to turn head left and right.  6pm - Swelling starts to go down, hives still prevalent. 9/26 - Hives slowly fading, still itchy, but not burning.  9/27 - Mostly back to normal, hives mostly gone. Ache in shot arm at injection site when using muscle. Able to exercise. 10/7 - Shot arm muscle still slightly sore at shot location when using the muscle. Taking a long time to heal. 11/15 - Shot arm FINALLY back to normal
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 9/21 - 10am Vaccinated w/ Covid & flu, 8pm started feeling typical body aches, ickiness 9/22 - felt typical flu icky most the day, started getting better at night 9/23 - Back to normal from flu effects. Able to exercise. 9/24 - woke up itchy, afternoon hives began showing up 9/25 - intense full body hives with burning, itching, including scalp. Ears especially burned, itched and swelled. Took Benadryl 12pm - Full body hives getting worse, plus eyes, ears, ankles, fingers, and feet swelling. Feet so swollen, very painful to walk. Lifting big toe sent pain up my shin. Extremely achy neck pain in muscles, hard to turn head left and right.  6pm - Swelling starts to go down, hives still prevalent. 9/26 - Hives slowly fading, still itchy, but not burning.  9/27 - Mostly back to normal, hives mostly gone. Ache in shot arm at injection site when using muscle. Able to exercise. 10/7 - Shot arm muscle still slightly sore at shot location when using the muscle. Taking a long time to heal. 11/15 - Shot arm FINALLY back to normal
Age: 68.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature excursion for high dose flu vaccines. The manufacturers recommendation was to not use them after it had been administered to patient.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Bursitis, Dizziness, Injected limb mobility decreased, Magnetic resonance imaging abnormal, Muscle oedema
Clinical narrative: Dizziness and pain in right arm that began at time of immunization.  Decreased range of motion in in right shoulder.  Patient still experiencing pain and limited range of motion in right shoulder.  MRI completed on 11/13/23 which showed Full-thickness slitlike nonretracted tear of the posterior supraspinatus/anterior infraspinatus junction with background tendinopathy of the supraspinatus and infraspinatus. Severe subacromial/subdeltoid bursitis. Mild supraspinatus and superior infraspinatus muscle edema.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Pain in extremity, Rotator cuff syndrome, Tendon disorder
Clinical narrative: Dizziness and pain in right arm that began at time of immunization.  Decreased range of motion in in right shoulder.  Patient still experiencing pain and limited range of motion in right shoulder.  MRI completed on 11/13/23 which showed Full-thickness slitlike nonretracted tear of the posterior supraspinatus/anterior infraspinatus junction with background tendinopathy of the supraspinatus and infraspinatus. Severe subacromial/subdeltoid bursitis. Mild supraspinatus and superior infraspinatus muscle edema.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Atrial fibrillation, COVID-19, Death, Endotracheal intubation
Clinical narrative: He tested positive for covid 11-05.   Was admitted with fatigue and malaise and per medical records developed pneumonia,  acute kidney injury with persistent hyperkalemia, , paroxysmal afib,  and resp failure  requiring  intubation and hypotension requiring  vasopressor support.  several specialists were involved in his care.     Placed on comfort measures  and the patient passed away on  11-12-23
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperkalaemia, Hypotension, Malaise, Pneumonia
Clinical narrative: He tested positive for covid 11-05.   Was admitted with fatigue and malaise and per medical records developed pneumonia,  acute kidney injury with persistent hyperkalemia, , paroxysmal afib,  and resp failure  requiring  intubation and hypotension requiring  vasopressor support.  several specialists were involved in his care.     Placed on comfort measures  and the patient passed away on  11-12-23
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: He tested positive for covid 11-05.   Was admitted with fatigue and malaise and per medical records developed pneumonia,  acute kidney injury with persistent hyperkalemia, , paroxysmal afib,  and resp failure  requiring  intubation and hypotension requiring  vasopressor support.  several specialists were involved in his care.     Placed on comfort measures  and the patient passed away on  11-12-23
Age: 84.0
Sex: F
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature excursion for high dose flu vaccines. The manufacturers recommendation was to not use them after it had been administered to patient.
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature excursion for high dose flu vaccines. The manufacturers recommendation was to not use them after it had been administered to patient.
Age: 93.0
Sex: F
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature excursion for high dose flu vaccines. The manufacturers recommendation was to not use them after it had been administered to patient.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Injection site bruising, Product administered at inappropriate site
Clinical narrative: Patient came to pharmacy today 11/16/2023 complaining of shoulder pain and bruise. Patient stated that the pain started after she received covid vaccine on 11/14/2023. I took a look at site of injection and notice big bruise on patient 'shoulder. Vaccine was injected too high and almost touched the shoulder bone.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: no reaction at this point
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Aphasia, Asthenia, Chest X-ray, Condition aggravated, Echocardiogram
Clinical narrative: She got her vaccine, nothing other than the usual arm pain.  The following day she had a slight peripheral vision problem on her left side, and that went away, occular migraines which she gets rarely but does get them.  Around 9:00 PM she got another occular migraine on the right side, and about the same time she lost the ability to speak, could not get words out, some words she could and diagnosed with expressive aphasia.  Thinking she was having a stroke, and she was with a friend and close to a hospital so they went to the hospital.  She was admitted until Monday night had EKG, echo, chest x-rays and a chemical work.  Diagnosis was probable TIA.    She was discharged on Monday, and was put on a baby aspirin, an and also Atorvastatin.  She now has a cardiologist and a neurologist for which she has no appointment for yet.  The cardiologist is ruling out A-fib with a heart monitor which she has not had applied yet.  She got home and took the week off and said that her brain and her body had been assulted, and took it easy and had no energy, all things that she expeced after that kind of a trauma.  She was very tired, just not feeling like herself.  She is better now, and awaiting her appointments, and is psychologically affected by this.  She is a very physical person, does very strenuous exercises and it's common for most people her age to play pickle ball and is actually nervous about all of that.    On 9/16/23 she had her flu shot, and had her latest COVID shot as well prior to the flu shot.  She did not have any reactions with those vaccines.    She saw her cardiologist yesterday and he said that he would not recommend any other vaccines.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Electrocardiogram, Fatigue, Feeling abnormal, Injury, Laboratory test
Clinical narrative: She got her vaccine, nothing other than the usual arm pain.  The following day she had a slight peripheral vision problem on her left side, and that went away, occular migraines which she gets rarely but does get them.  Around 9:00 PM she got another occular migraine on the right side, and about the same time she lost the ability to speak, could not get words out, some words she could and diagnosed with expressive aphasia.  Thinking she was having a stroke, and she was with a friend and close to a hospital so they went to the hospital.  She was admitted until Monday night had EKG, echo, chest x-rays and a chemical work.  Diagnosis was probable TIA.    She was discharged on Monday, and was put on a baby aspirin, an and also Atorvastatin.  She now has a cardiologist and a neurologist for which she has no appointment for yet.  The cardiologist is ruling out A-fib with a heart monitor which she has not had applied yet.  She got home and took the week off and said that her brain and her body had been assulted, and took it easy and had no energy, all things that she expeced after that kind of a trauma.  She was very tired, just not feeling like herself.  She is better now, and awaiting her appointments, and is psychologically affected by this.  She is a very physical person, does very strenuous exercises and it's common for most people her age to play pickle ball and is actually nervous about all of that.    On 9/16/23 she had her flu shot, and had her latest COVID shot as well prior to the flu shot.  She did not have any reactions with those vaccines.    She saw her cardiologist yesterday and he said that he would not recommend any other vaccines.