chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: she broke into a rash but not in the site of injection; This spontaneous case was reported by a patient and describes the occurrence of RASH (she broke into a rash but not in the site of injection) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (she broke into a rash but not in the site of injection). At the time of the report, RASH (she broke into a rash but not in the site of injection) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported as unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient reported that after moderna vaccine, broke into a rash but not in the site of injection but below on the arm. Patient wanted to know is it a normal side effect from the vaccine to have a rash in a site different than site of injection. No treatment medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (she tested positive for COVID-19) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 13-Jul-2023, the patient experienced COVID-19 (she tested positive for COVID-19). At the time of the report, COVID-19 (she tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2023, SARS-CoV-2 test: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient's all previous doses were Moderna vaccines. Patient queried how long she need to wait for received the Moderna vaccines. Treatment information was not provided.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Gait inability, Pain
Clinical narrative: she can't walk; Intense pain all over the body; This spontaneous case was reported by a patient and describes the occurrence of GAIT INABILITY (she can't walk) and MYALGIA (Intense pain all over the body) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3834B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 01-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced MYALGIA (Intense pain all over the body). On an unknown date, the patient experienced GAIT INABILITY (she can't walk). At the time of the report, GAIT INABILITY (she can't walk) and MYALGIA (Intense pain all over the body) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not provided.
Sex: F
Vaccine: UNK
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive to COVID-19 on 8OCT2023; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (tested positive to COVID-19 on 8OCT2023) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 08-Oct-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (tested positive to COVID-19 on 8OCT2023). At the time of the report, COVID-19 (tested positive to COVID-19 on 8OCT2023) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported as unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient husband was stated that was staying in a health care center for rehab, but COVID-19 was spreading quickly through the facility and decided to take out but tested positive to covid-19. It could be a false positive since patient was not having any symptoms and a nurse said that it can be possible. Patient's husband wanted to know can vaccine itself to cause a false positive. No treatment medications were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had Covid) in an elderly male patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     Patient has medical history of having a pacemaker.     On 11-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had Covid). At the time of the report, COVID-19 (had Covid) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient reported he was seniors and had their previous vaccines all Moderna and had Covid 2 times within the last three years. He reported he just got back from a cruise and have Covid now. His question was for the new Covid vaccine coming out, how long do they have to wait to get the vaccine since they have covid now and going on another cruise in December.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745076 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745076:Wife case
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in an elderly female patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Coronary artery disease.    On 11-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter reported him and his wife were both seniors and had their previous vaccines all Moderna and had Covid 2 times within the last three years. He reported they just got back from a cruise and have Covid now. His question was for the new Covid vaccine coming out, how long do they have to wait to get the vaccine since they have covid now and going on another cruise in December. .  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745075 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745075:husband case
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 08-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes) was resolving.            Concomitant medication not reported.   Treatment medication not reported.  The patient experienced swollen lymph nodes. It was unknown if the patient experienced any additional symptoms/events. The patient had no medical history, concomitant disease, or risk factor. There were no lab data/results available.
Sex: M
Vaccine: UNK
Symptoms: Pain
Clinical narrative: get some pain after the vaccine/here is normally a slight soreness.; This spontaneous case was reported by a patient and describes the occurrence of PAIN (get some pain after the vaccine/here is normally a slight soreness.) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 10-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PAIN (get some pain after the vaccine/here is normally a slight soreness.). At the time of the report, PAIN (get some pain after the vaccine/here is normally a slight soreness.) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient had a booster shot a few minutes ago. Every now and then patient get some pain after the vaccine. Patient queried that if patient could take treatment medication Tylenol or Advil. Treatment information was not provided.   Reporter did not allow further contact
Age: 74.0
Sex: U
Vaccine: UNK
Symptoms: Blood cholesterol decreased, High density lipoprotein decreased, Hypocholesterolaemia
Clinical narrative: HDL - good cholesterol really dipped to 39 when they are usually in the 70 or 80s; covid infection; This spontaneous case was reported by a patient and describes the occurrence of HYPO HDL CHOLESTEROLAEMIA (HDL - good cholesterol really dipped to 39 when they are usually in the 70 or 80s) and COVID-19 (covid infection) in a 74-year-old patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch nos. ASKU, ASKU, ASKU and ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form, dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPO HDL CHOLESTEROLAEMIA (HDL - good cholesterol really dipped to 39 when they are usually in the 70 or 80s) and COVID-19 (covid infection). At the time of the report, HYPO HDL CHOLESTEROLAEMIA (HDL - good cholesterol really dipped to 39 when they are usually in the 70 or 80s) outcome was unknown and COVID-19 (covid infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: lipid panel showed HDL - good cholesterol really dipped to 39 (usually usually in the 70 or 80s). Cholesterol reading come out really low in the 120's.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient was fully vaccinated with Moderna. fully vaccinated with the Moderna, the initial series and two boosters.  Patient had a covid infection in the summer the first week of August. In about a week they were over it. Bad cold symptoms. Soon after that they did do some bloodwork. About 3 weeks after they had covid, and on their lipid panel they HDL-good cholesterol really dipped to 39 when they are usually in the 70 or 80s. It made their cholesterol reading come out really low in the 120's. Treatment medication was not reported.   Reporter did not allow further contact
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia, Rash, Skin warm, Thrombosis
Clinical narrative: diarrhea; hot rash; fever; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea), PYREXIA (fever) and RASH (hot rash) in an 82-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 80777010296) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer on 19-Jan-2021 and Pfizer on 09-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Drug allergy (amlodipine besylate), Allergy to antibiotic (amoxicillin), Drug allergy (atorvastatin), Drug allergy (codeine), Drug allergy (dextromethorphan hydrobromide), Allergy to NSAIDs (ibuprofen), Allergy to antibiotic (Levofloxacin,), Drug allergy (levaxin), Drug allergy (lisinopril), Drug allergy (metoprolol), Allergy to antibiotic (noroxin), Drug allergy (tirosint), Drug allergy (prevastatin) and Egg allergy.    On 06-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 07-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced PYREXIA (fever). On an unknown date, the patient experienced DIARRHOEA (diarrhea) and RASH (hot rash). At the time of the report, DIARRHOEA (diarrhea) and PYREXIA (fever) had resolved and RASH (hot rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Oct-2023, Body temperature: temperature of 100 degree fahrenheit. On 08-Oct-2023, Body temperature: temperature of 100 degree fahrenheit.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient past Moderna-covid 19 vaccine included third dose on 29-Dec-2021 with batch number 059H21A and fourth dose on 27-Oct-2022 with batch number 059F22A. She received the vaccine on Friday and then on Saturday and Sunday she had a fever. Patient queried that if she could take treatment medication Benadryl in every 6 hours. Patient was doing better than yesterday. Then she also experienced a hot rash and diarrhea. Everything is gone except the rash. It has been started that patient had a bad reaction - blood clots with the Pfizer vaccine.   This case was linked to MOD-2023-745139 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: little grade fever; fatigue; nausea; For previous shots he experienced symptoms (not specified what kind of symptoms) during 1 day; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (For previous shots he experienced symptoms (not specified what kind of symptoms) during 1 day), PYREXIA (little grade fever), FATIGUE (fatigue) and NAUSEA (nausea) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Spinal cord injury since 1988 and Spasms. Concomitant products included BACLOFEN and DIAZEPAM for Spasms.   On 05-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2023, the patient experienced PYREXIA (little grade fever), FATIGUE (fatigue) and NAUSEA (nausea). On an unknown date, the patient experienced IMMUNISATION REACTION (For previous shots he experienced symptoms (not specified what kind of symptoms) during 1 day). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (For previous shots he experienced symptoms (not specified what kind of symptoms) during 1 day) had resolved and PYREXIA (little grade fever), FATIGUE (fatigue) and NAUSEA (nausea) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient stated he already received 5 Moderna COVID-19 Vaccines so far, he did not remember dates for previous vaccines but last dose of Spikevax received on 05-Oct-2023. For previous shots he experienced symptoms (not specified what kind of symptoms) for 1 day, but with last dose it's been already 5 days since he got it and he still has a little grade fever, fatigue, nausea all around there. Patient was taking Ibuprofen and Tylenol to treat symptoms.
Age: 30.0
Sex: M
Vaccine: COVID19, FLUC4, TDAP
Symptoms: Syncope
Clinical narrative: Pt had syncope, put cold rags on neck and gave him some water.  About 15 minutes he was fine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain
Clinical narrative: 24 hours: chills, body aches 36 hours: diarrhea
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect dose was give. Unable to contact parent afterwards.  Adverse event unknow
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 88.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: The patient received the vaccine on Friday 10/06/2023 and said on Saturday her left arm became sore and swollen. Then on Sunday, she said she couldn't move her arm and on Monday it was still very sore and she still hardly could move it. She said it hurts from her neck down to her fingers. She went to the doctors and they gave her Nsaids and muscle relaxers to treat the issue. She said the shot was given very low and even the doctor said they could tell it was give only like 1.5 inches above her elbow. She said her right arm was just red, but also given very low as well.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: headache, tired, hand aching, stiff body
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 1.25
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms, no reaction has occurred.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Injection site discolouration, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: patient received a flu shot on 10-02-23. mom says the area is red. last night his arm felt hot and there was a lump at the injection.   Mother states left arm was swollen from shoulder to the elbow with area distal to injection site that was a Firm purple lump that was warm.   Gave 12.5 ml of ibuprofen. Patient states he felt like he had asthma after taking the ibuprofen.  "felt burning in my lungs" with breathing in and out.   Denies tongue or lip swelling. No vomitting.  Denies diarrrhea.   This morning the swelling and the lump much improved.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: patient received a flu shot on 10-02-23. mom says the area is red. last night his arm felt hot and there was a lump at the injection.   Mother states left arm was swollen from shoulder to the elbow with area distal to injection site that was a Firm purple lump that was warm.   Gave 12.5 ml of ibuprofen. Patient states he felt like he had asthma after taking the ibuprofen.  "felt burning in my lungs" with breathing in and out.   Denies tongue or lip swelling. No vomitting.  Denies diarrrhea.   This morning the swelling and the lump much improved.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STOREGE UNIT
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: only received adjuvant
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product administration error
Clinical narrative: PATIENT WAS GIVEN 0.5ML OF NOVAVAX 23/24 BEYOND THE USE DATE. VACCINE WAS FIRST PUNCTURED AROUND 430PM 10/12/23 AND WAS LEFT OUTSIDE OF THE FRIDGE AFTER 7PM 10/12/23 (CLOSING TIME). THERE WAS ONE DOSE REMAINING FROM THIS EXPIRED VIAL AND  UNFORTUNATELY THE PATIENT WAS ACCIDENTALLY GIVEN THE LAST DOSE FROM THIS VIAL (PHARMACIST ERROR). NOVAVAX WAS IMMEDIATELY CONTACTED FOR STABILITY INFORMATION FOR BEYOND USE DATE OVER 12 HOURS AND PATIENT WAS INFORMED OF THE ERROR. PATIENT DID NOT REPORT ANY DISCOMFORT OR ADVERSE REACTIONS. NOVAVAX REACHED BACK AND UNFORTUNATELY DOES NOT HAVE STABILITY INFORMATION BEYOND 12 HOURS OF FIRST PUNCTURE. THEY FOLLOW THE CDC RECOMMENDATION (APPENDIX B) WHICH IS: IF THE MANUFACTURER DOES NOT HAVE DATA TO SUPPORT THE STABILITY OF THE VACCINE, REPEAT THE DOSE IMMEDIATELY (NO MINIMAL INTERVAL). INFORMED PATIENT AND HE WOULD LIKE TO GET RE-VACCINATED IMMEDIATELY (SAME DAY).
Age: 31.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Rash
Clinical narrative: Rash on patient's inner thighs
Age: 94.0
Sex: F
Vaccine: COVID19, FLU4, FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt mistakenly administered two doses of Fluzone HD at same visit in addition to COVID booster (SPIKEVAX).  No adverse effect reported as of 10/13/2023 7:10pm
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Patient had rash and swelling of the upper left arm (injection site).
Age: 24.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: pt stated feeling lightheaded then collapsed to the floor. Ems was immediately called and pt was layed on his side until consciousness was regained. he refused an ambulance and visit to hospital.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Head injury, Loss of consciousness, Syncope
Clinical narrative: PT PASSED OUT WITHIN SECONDS OF STANDING UP AFTER RECEIVING VACCINATION. SHE HIT HEAD ON A CARDBOARD BOX. ALMOST IMMEDIATELY AFTER VASOVAGAL SYNCOPAL EVENT, PT AWOKEN AND WAS FRIGHTENED. MONITORED PT FOR 20 MIN AFTER EVENT AND SHE WAS FINE.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: 9/20/2023 I came in to get the annual flu vaccination and my right upper arm has been in pain and its hard to hyperextend and stretch my arm. During the administration, It was painful (Intermittently) but as usual I thought it is only just for a little bit and it wont last. but up until now my arm has been really in pain, decreased range of motion, general right shoulder weakness as well as stiffness. I tried taking pain reliever and move my arm more as i thought it is going to be effective and it will relieve the pain but it is still there, specially when waking up in the morning.
Age: 26.0
Sex: F
Vaccine: FLUC4, HEP, VARCEL
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: approx 3 cm round erythematous rash around right posterior arm at site of the varicella vaccine reported by the patient . patient noticed it 4-5 hours after vaccine was administered. pt states it was itchy rash and over the next 24-34 hours the rash got larger. at todays visit rash was 6cm in diameter. pt had not taken any medications for the rash/allergic response.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted and believes he had a brief seizure.  He was unconscious for about 20 seconds.  He woke with no apparent lingering issues.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient signed up for the RSV Vaccine and received Spikevax instead.
Age: 91.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Lipoma, Loss of personal independence in daily activities
Clinical narrative: Patient got the Fluzone HD vaccine on 9-22 in her right arm. She started having pain  on 10-1 in her right shoulder.  she could not use her arm to do any work and was in constant pain.  She visited the doctor on 10/4 and Dr diagnosed as LIPOMA. She was given Meloxicam 1st.  She was still in pain, so, a few days later, got Celebrex, then Tramadol was given for pain. She is also doing physical therapy. She is little better
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient signed up for RSV Vaccine and received the Spikevax instead.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Pruritus, Swelling
Clinical narrative: Large area of redness, swelling, itching, blistering
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Patient had sore shoulder and arm . She went to urgent care and her primary care doctor. Her Primary care doctor said it would take a few months to get better. She is still having trouble raising it.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood test, Muscle spasms
Clinical narrative: Severe nerve reaction cause all back muscles to spasm causing massive pain. I was in the ER 3 different times to deal with the amount of pain caused. This was the newest Covid booster shot I just received.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Eyelid function disorder, Presyncope
Clinical narrative: Dizziness, Fluttering eyes 911 called and arrived 10.30am Temp 97,pulse 60 and BP 138/82 Patient has history of TIA as confirmed by grand daughter
Age: 61.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This vaccine was given by error to a 61 year old female while it is approved 65+ patient with no adverse reaction.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Welts, redness, itching on the skin. Arms, legs, abdomen. beginning 5 days after vaccine , continuing on days 6,7. Self treatment with diphenhydramine and cortisone cream.  No new soaps, lotions, laundry detergents were used. No new medications or foods were ingested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, redness, and swelling of upper arm well beyond the injection site, which is the deltoid muscle.  The reaction was noted approximately 32 hours after administration of the vaccine, but it is unknown when it first appeared, due to the affected patient wearing sleeves that covered the area.  No adverse reactions have occured with any previously administered vaccines.  No treatment at this time, but the reaction was reported to the healthcare provider that administered the vaccine.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Drug hypersensitivity, Headache, Pain
Clinical narrative: Headache, weakness, fever of 100.8, nausea,  lack of appetite, body aches
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Headache, weakness, fever of 100.8, nausea,  lack of appetite, body aches
Age: 92.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Pt granddaughter called and indicated that her grandmother had pain and redness radiating down her arm from the site of injection on the right arm.  They had to take her to ER and was given a cold compress.
Age: 76.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Chills, Dyspnoea, Fatigue, Feeling cold, Tremor
Clinical narrative: About 2 weeks after receiving the vaccines, the patient had severe chills, extreme tiredness, felt as if she was freezing and was trembling.  She also had shortness of breath.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous
Clinical narrative: Resident noted to have a pink rash - Dime sized areas on bilateral upper extremities, rash improving
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse drug reaction, Pruritus, Urticaria
Clinical narrative: This patient has been receiving i.v. Immune globulin infusions monthly since 05/09/2019 without any adverse effects until 01/05/2023, when she developed an acute urticaria reaction while receiving her infusion of immune globulin. She's had this reaction with all subsequent infusions. Of interest is that the hives always begin at the left deltoid, the location of all four of her COVID-19 immunizations, and then travel down that arm. They occur about 30 minutes after the start of the infusion, always on the left deltoid and arm, regardless of which arm is infused.The next day, and subsequent days the pruritic hives are also noted at the scalp hairline and in the axillae and inframammary areas. They respond to oral corticosteroids, but not to oral antihistamines. They have occurred with both Gammagard and with Privigen brands of immune globulin.
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Miscarriage at 13 weeks gestation due to fetal cystic hygroma; Miscarriage at 13 weeks gestation due to fetal cystic hygroma; This case is considered invalid due to incorrect ID.  This is a spontaneous report from a non-contactable consumer who reported for herself and her baby via a Pfizer sales representative. This case was also reported by a contactable Pharmacist. This is the baby case. A 32-year-old female (mother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), intramuscular on left upper arm, on 18Dec2020 10:00 (given pre/peri conception), as a single dose for COVID-19 immunization. The mother received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246), intramuscular on left upper arm, on 08Jan2021 10:00 (given around 4 weeks gestation), as a single dose for COVID-19 immunization. The mother was vaccinated at a hospital. The mother's medical history was not reported. Concomitant medication was not provided. On 03Mar2021, the mother experienced a miscarriage at 13 weeks gestation due to fetal cystic hygroma. An autopsy was not done.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (16Mar2021): New information reported from a contactable Pharmacist included: new reporter, patient's mother's age, vaccination date and time, routes of administration, lot numbers, and clinical information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (10Oct2023): This is a follow-up report to notify that this case 2021288616 was submitted to the trading partners with the 2020516672 of case 202300324023. Case 202300324023 is going to be resubmitted to confirm information and case 2021288616 is considered invalid and corresponding information is re-entered under this new manufacturer report number 202300324023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020516672 Mother case;; Reported Cause(s) of Death: Miscarriage at 13 weeks gestation due to fetal cystic hygroma; Miscarriage at 13 weeks gestation due to fetal cystic hygroma
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Gastrointestinal disorder, Muscle twitching, Pain, Paraesthesia
Clinical narrative: a stomach issue; tingling in her calves, mainly her left calf; twitches in her calves, mainly her left calf; pain in her mid spine/lumbar region; pain in her mid spine/lumbar region that radiates to the right; This non-serious case was reported by a consumer via call center representative and described the occurrence of stomach discomfort in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number K2B5N, expiry date 28-MAY-2024) for prophylaxis.   The patient's past medical history included shingles (had shingles in her mid 30's). Previously administered products included Shingrix (1st dose received in April 2023, refer case US2023137032). Concurrent medical conditions included osteoporosis. Concomitant products included PITAVASTATIN CALCIUM (LIVALO) and RISEDRONIC ACID (RISEDRONATE).   On 29-JUL-2023, the patient received the 2nd dose of Shingrix (intramuscular, right arm). On 15-AUG-2023, 17 days after receiving Shingrix, the patient experienced stomach discomfort (Verbatim: a stomach issue), tingling (Verbatim: tingling in her calves, mainly her left calf), twitching of limbs (Verbatim: twitches in her calves, mainly her left calf), pain in lumbar spine (Verbatim: pain in her mid spine/lumbar region) and radiating pain (Verbatim: pain in her mid spine/lumbar region that radiates to the right).  The outcome of the stomach discomfort was unknown and the outcome of the tingling, twitching of limbs, pain in lumbar spine and radiating pain were not resolved.   It was unknown if the reporter considered the stomach discomfort, tingling, twitching of limbs, pain in lumbar spine and radiating pain to be related to Shingrix.     It was unknown if the company considered the stomach discomfort, tingling, twitching of limbs, pain in lumbar spine and radiating pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023137032   Additional Information: GSK receipt date: 05-OCT-2023 The patient also reported that she received her 2nd dose of Shingrix and 2 to 3 weeks later, she experienced pain in her mid-spine or lumbar region that radiated to the right. The patient also reported twitches and tingling in her calves, mainly her left calf, that did not hurt. The patient reported she had a CAT Scan for a stomach issue.  The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023137032:same patient, 1st dose
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Spinal pain
Clinical narrative: a stomach issue; tingling in her calves, mainly her left calf; twitches in her calves, mainly her left calf; pain in her mid spine/lumbar region; pain in her mid spine/lumbar region that radiates to the right; This non-serious case was reported by a consumer via call center representative and described the occurrence of stomach discomfort in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number K2B5N, expiry date 28-MAY-2024) for prophylaxis.   The patient's past medical history included shingles (had shingles in her mid 30's). Previously administered products included Shingrix (1st dose received in April 2023, refer case US2023137032). Concurrent medical conditions included osteoporosis. Concomitant products included PITAVASTATIN CALCIUM (LIVALO) and RISEDRONIC ACID (RISEDRONATE).   On 29-JUL-2023, the patient received the 2nd dose of Shingrix (intramuscular, right arm). On 15-AUG-2023, 17 days after receiving Shingrix, the patient experienced stomach discomfort (Verbatim: a stomach issue), tingling (Verbatim: tingling in her calves, mainly her left calf), twitching of limbs (Verbatim: twitches in her calves, mainly her left calf), pain in lumbar spine (Verbatim: pain in her mid spine/lumbar region) and radiating pain (Verbatim: pain in her mid spine/lumbar region that radiates to the right).  The outcome of the stomach discomfort was unknown and the outcome of the tingling, twitching of limbs, pain in lumbar spine and radiating pain were not resolved.   It was unknown if the reporter considered the stomach discomfort, tingling, twitching of limbs, pain in lumbar spine and radiating pain to be related to Shingrix.     It was unknown if the company considered the stomach discomfort, tingling, twitching of limbs, pain in lumbar spine and radiating pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023137032   Additional Information: GSK receipt date: 05-OCT-2023 The patient also reported that she received her 2nd dose of Shingrix and 2 to 3 weeks later, she experienced pain in her mid-spine or lumbar region that radiated to the right. The patient also reported twitches and tingling in her calves, mainly her left calf, that did not hurt. The patient reported she had a CAT Scan for a stomach issue.  The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023137032:same patient, 1st dose
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Chest pain, Insomnia, Pain in extremity, Sleep disorder
Clinical narrative: pain at injection site; pain in the armpit; radiated down the arm outwards and went to the rib cage; radiated down the arm outwards and went to the rib cage; radiated down the arm outwards and went to the rib cage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Sep2023, outcome "not recovered", described as "pain at injection site"; AXILLARY PAIN (non-serious) with onset Sep2023, outcome "not recovered", described as "pain in the armpit"; PAIN (non-serious), PAIN IN EXTREMITY (non-serious), MUSCULOSKELETAL CHEST PAIN (non-serious) all with onset Sep2023, outcome "not recovered" and all described as "radiated down the arm outwards and went to the rib cage".  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Axillary pain, Musculoskeletal chest pain, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: pain at injection site; pain in the armpit; radiated down the arm outwards and went to the rib cage; radiated down the arm outwards and went to the rib cage; radiated down the arm outwards and went to the rib cage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Sep2023, outcome "not recovered", described as "pain at injection site"; AXILLARY PAIN (non-serious) with onset Sep2023, outcome "not recovered", described as "pain in the armpit"; PAIN (non-serious), PAIN IN EXTREMITY (non-serious), MUSCULOSKELETAL CHEST PAIN (non-serious) all with onset Sep2023, outcome "not recovered" and all described as "radiated down the arm outwards and went to the rib cage".  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial spasm, Gastrointestinal pain, Muscle tightness, Neck pain, Pyrexia
Clinical narrative: Seizures; Vomiting; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (disability, medically significant) with onset 2021, outcome "not recovered", described as "Seizures"; VOMITING (non-serious) with onset 2021, outcome "unknown". The event "seizures" required physician office visit. Therapeutic measures were taken as a result of seizure. Additional information: The patient reported that he was experiencing seizures and it seems like he was vomiting while he's call was on hold with the agent. The patient stated that he's nearly dying as a result of Pfizer utilizing him/her and his/her body for medical research for the company (in regards to the vaccination). It was between 2021 and 2022, over several months. The patient was trying to get his/her seizure medication Gabapentin (clarified as Pfizer medication as the patient knows) and he's almost "dying" without it. His/her primary care physician was aware that she was prescribing Gabapentin for the treatment of seizure disorder. The patient stated that he/she was dying due to the company and he/she was actively having seizures while he/she was on the phone with the agent. He/she also mentioned that he/she was disabled.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tetanus
Clinical narrative: Seizures; Vomiting; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (disability, medically significant) with onset 2021, outcome "not recovered", described as "Seizures"; VOMITING (non-serious) with onset 2021, outcome "unknown". The event "seizures" required physician office visit. Therapeutic measures were taken as a result of seizure. Additional information: The patient reported that he was experiencing seizures and it seems like he was vomiting while he's call was on hold with the agent. The patient stated that he's nearly dying as a result of Pfizer utilizing him/her and his/her body for medical research for the company (in regards to the vaccination). It was between 2021 and 2022, over several months. The patient was trying to get his/her seizure medication Gabapentin (clarified as Pfizer medication as the patient knows) and he's almost "dying" without it. His/her primary care physician was aware that she was prescribing Gabapentin for the treatment of seizure disorder. The patient stated that he/she was dying due to the company and he/she was actively having seizures while he/she was on the phone with the agent. He/she also mentioned that he/she was disabled.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Seizure, Vomiting
Clinical narrative: Seizures; Vomiting; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (disability, medically significant) with onset 2021, outcome "not recovered", described as "Seizures"; VOMITING (non-serious) with onset 2021, outcome "unknown". The event "seizures" required physician office visit. Therapeutic measures were taken as a result of seizure. Additional information: The patient reported that he was experiencing seizures and it seems like he was vomiting while he's call was on hold with the agent. The patient stated that he's nearly dying as a result of Pfizer utilizing him/her and his/her body for medical research for the company (in regards to the vaccination). It was between 2021 and 2022, over several months. The patient was trying to get his/her seizure medication Gabapentin (clarified as Pfizer medication as the patient knows) and he's almost "dying" without it. His/her primary care physician was aware that she was prescribing Gabapentin for the treatment of seizure disorder. The patient stated that he/she was dying due to the company and he/she was actively having seizures while he/she was on the phone with the agent. He/she also mentioned that he/she was disabled.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Blood pressure measurement, Facial spasm, Hypertension, Neck pain
Clinical narrative: Seizures; Vomiting; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (disability, medically significant) with onset 2021, outcome "not recovered", described as "Seizures"; VOMITING (non-serious) with onset 2021, outcome "unknown". The event "seizures" required physician office visit. Therapeutic measures were taken as a result of seizure. Additional information: The patient reported that he was experiencing seizures and it seems like he was vomiting while he's call was on hold with the agent. The patient stated that he's nearly dying as a result of Pfizer utilizing him/her and his/her body for medical research for the company (in regards to the vaccination). It was between 2021 and 2022, over several months. The patient was trying to get his/her seizure medication Gabapentin (clarified as Pfizer medication as the patient knows) and he's almost "dying" without it. His/her primary care physician was aware that she was prescribing Gabapentin for the treatment of seizure disorder. The patient stated that he/she was dying due to the company and he/she was actively having seizures while he/she was on the phone with the agent. He/she also mentioned that he/she was disabled.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.