chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pulse absent, Pulseless electrical activity, Respiratory failure, Resuscitation, Troponin increased
Clinical narrative: Possible PEA arrest unclear etiology ~1 hour after receiving first dose COVID-19 moderna vaccine, s/p ROSC in field after 3 minutes CPR, no meds given. Intubated in field, extubated after 2 days.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: After vaccine pt felt dizzy. Drank water and sat an additional 15 minutes and felt better
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Injection site pain, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Fainting / Unresponsive-Medium
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fatigue, back and muscle pain, low grade fever, chills, teeth chatter
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Stridor
Clinical narrative: Vaccine was injected approximately 7:20 am. Patient was in observation area for 15 minutes and left the facility. 7:50 am patient was in the employee parking lot and complained of shortness of breath. Parking security radioed back to the facility. The doctor and onsite EMS staff ran to assist, and found patient short of breath with stridor, o2 sat in 70's with heart rate 140. Epi pen was administered. Patient was transported to Medical Center. EMS who transported him reported improved breathing and O2sat in 90's, heart rate 120's. The Occupational Health RN will follow-up with the patient.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash around injection site, with extreme itching and slight bumps like tiny insect bites. Rash was 3 to 4 inches in diameter. Researched it immediately and found info saying this delayed reaction had already been seen in a small percentage of patients. Source suggested ice and topical antihistamine, so I applied a bit of Benadryl liquid (for bug bites) to decrease the intense itching.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: ? 1155 Pfizer covid 19 vaccine administered.   ? 1210 Patient complained of bump, left deltoid.  Ice pack applied to left arm. ? 1235 Nurse reiterated common side effects with vaccine, patient verbalized understanding and advised to contact pcp and/or urgent care if worsens. Left with no other complaints.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Mobility decreased, Pain
Clinical narrative: A week of extreme weakness, dizziness, aches and pains, headaches. Just couldn?t get out of bed. After a week I have weakness and dizziness.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Swelling face
Clinical narrative: beginning 2 days after shot, woke up w/ puffy eyes, became to become more swollen including bridge of nose, cheeks.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Night sweats, Pain
Clinical narrative: Began having upper chest pain when taking deep breaths and when lying down. Chills Night sweats Fatigue Body Aches and pains
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: At 1:39 PM, patient reported "dizziness" to Lead RN. Lead RN sat patient down and had EMT assess patient. Patient reported allergies to bee pollen, no current medications, and last oral intake at 10:30 AM. Blood pressure 118/68 and pulse 63 beats per minute with unlabored breathing. Patient given water. Patient monitored for 15 minutes. Patient symptoms resolved after 5 minutes. Patient left facility at approximately 1:55 PM with steady gait and unlabored breathing.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 'Covid Arm'   Red, Swollen, itchy.  Patch about 4"x6" near injection site.  I would not call it a rash, but a skin/muscle reaction.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Dyspnoea, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperventilation
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Myalgia, Pyrexia
Clinical narrative: Chills, fever (102.9), diarrhea  fatigue, muscle pain in back, knee, and arm,
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events reported, was instructed to complete VAERS form due to age 16 at time of vaccination.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Moderna COVID?19 Vaccine EUA
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Metamorphopsia, Pharyngeal swelling
Clinical narrative: Client has a previous history of severe allergic reactions and carries an epi pen. At 1148 am, she reported her vision was changing and her voice was changing. She could feel her throat closing. 0.3ml of epinephrine given in the left deltoid at 1150 am. Within 2 minutes, her voice returned and she felt relief of the throat closing symptoms. Vital signs improved over 30 minutes. Took 50 mg of benadryl orally. She left the vaccine clinic with her epi pen in her purse with instructions to call her provider. We had a retired physician and two registered nurses at the clinic during this time.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Chills, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: Symptoms included: Body aches Fatigue  Chills Fever Headache Nausea  Some diarrhea (mostly clear liquid) Runny nose clear Some congestion  Difficulty breathing - arrhythmia from 11pm to 4am night after vaccine administered
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Symptoms included: Body aches Fatigue  Chills Fever Headache Nausea  Some diarrhea (mostly clear liquid) Runny nose clear Some congestion  Difficulty breathing - arrhythmia from 11pm to 4am night after vaccine administered
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Symptoms included: Body aches Fatigue  Chills Fever Headache Nausea  Some diarrhea (mostly clear liquid) Runny nose clear Some congestion  Difficulty breathing - arrhythmia from 11pm to 4am night after vaccine administered
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site induration, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: A huge rash under the injection site began to develop 7 days after the 1st dose.  It began as 2 bumps around the injection site that were hard, warm, and a little pink. Then a rash became hotter to the touch as the days progressed. It was raised, hot to the touch and sensitive. It was painful and uncomfortable to have; it caused me to not be able to sleep at night. I emailed my PCP, and she recommended: "we are recommending taking Benadryl, it can be oral or the cream and just take Tylenol if needed. Sometimes using a warm compress on the site helps as well." I took Tylenol in the morning and Benadryl at night to help with the rash. I would also use anti-itch ointment to help with the discomfort. The rash lasted for another 5 days before the symptoms started to subside. I felt fatigue and week for roughly two weeks after the 1st dose.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: A huge rash under the injection site began to develop 7 days after the 1st dose.  It began as 2 bumps around the injection site that were hard, warm, and a little pink. Then a rash became hotter to the touch as the days progressed. It was raised, hot to the touch and sensitive. It was painful and uncomfortable to have; it caused me to not be able to sleep at night. I emailed my PCP, and she recommended: "we are recommending taking Benadryl, it can be oral or the cream and just take Tylenol if needed. Sometimes using a warm compress on the site helps as well." I took Tylenol in the morning and Benadryl at night to help with the rash. I would also use anti-itch ointment to help with the discomfort. The rash lasted for another 5 days before the symptoms started to subside. I felt fatigue and week for roughly two weeks after the 1st dose.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Dizziness, Fatigue, Hypokinesia
Clinical narrative: Got dizzy and I needed to take deep breaths About 3 hours later it was hard to move like exhaustion then all my bones and my old injuries really hurt for about 2 hours
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Rash
Clinical narrative: Pt had a sore arm immediately after vaccination and days to follow which improved. 8 days later rash and swollen arm appeared. 10 days after rash traveled to other areas of body legs and arms with itching. Pt noted improvement today 3/8/21.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Fear of injection, Loss of consciousness, Staring, Unresponsive to stimuli
Clinical narrative: Patient seemed to pass out. Reported fear of needles. Happened about 13 minutes after vaccine was administered. She wasn't responsive to voice for short time period with a blank stare. Once she snapped out of it, she jerked and then we tried to make her more comfortable. EMS was contacted to verify patient was okay. Patient did not want to go to hospital or ER.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Chills, general body aches,  99.8 temperature, headache, nausea (no vomiting). sore vaccination site, moderate fatigue  (basic flu-like symptoms for 24 hours) I did not seek medical help.  I also had the "Covid Arm" rash 13 days after my first vaccination.  I had a "video visit" with my health care provider regarding that reaction who then reported it to this site at that time.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Nausea, Pain
Clinical narrative: Chills, general body aches,  99.8 temperature, headache, nausea (no vomiting). sore vaccination site, moderate fatigue  (basic flu-like symptoms for 24 hours) I did not seek medical help.  I also had the "Covid Arm" rash 13 days after my first vaccination.  I had a "video visit" with my health care provider regarding that reaction who then reported it to this site at that time.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immune thrombocytopenia, Petechiae, Platelet count decreased, Purpura
Clinical narrative: Acute ITP (idiopathic thrombocytopenic purpura). Presented to clinic with diffuse purpura and petechiae. Platelets critical at 33,000.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Platelet count decreased, Pyrexia, Rash macular, Vomiting
Clinical narrative: Acute ITP (idiopathic thrombocytopenic purpura). Presented to clinic with diffuse purpura and petechiae. Platelets critical at 33,000.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Immune thrombocytopenia, Platelet count decreased
Clinical narrative: Acute ITP (idiopathic thrombocytopenic purpura). Presented to clinic with diffuse purpura and petechiae. Platelets critical at 33,000.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Rash
Clinical narrative: severe whole body vascular appearing rash ( or thrombocytopenia.. platelets pending) started ~7-10days after 1st dose and worsening over subsequent 3 weeks. work up / labs in process
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Hypersomnia
Clinical narrative: Low grade fever, chills, flu-type aching, loss of appetite, extreme fatigue, pain at injection site, joint and muscle pain. The worst of it was the Wednesday after late Monday afternoon vaccination; ie on day two post-vax. Felt like a case of bad flu. Lasted about 2 to 3 days, with tapering severity. A week later, energy level is still down; sleeping more than usual.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Low grade fever, chills, flu-type aching, loss of appetite, extreme fatigue, pain at injection site, joint and muscle pain. The worst of it was the Wednesday after late Monday afternoon vaccination; ie on day two post-vax. Felt like a case of bad flu. Lasted about 2 to 3 days, with tapering severity. A week later, energy level is still down; sleeping more than usual.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: Diarrhea. Patient stated he had stomach issues/diarrhea since 1st dose. Cancelled 2nd dose.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Nausea, Pyrexia
Clinical narrative: Vile scary nauseating metallic taste in my mouth, still  Here a week later!  Fever and chills were no match for this awful taste   I felt like I was poisoned!
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Joint range of motion decreased
Clinical narrative: Right when she got the vaccine she felt acute pretty severe discomfort. She did not really look but noted later where they put the Band-Aid that the vaccine was given way too high. Since that time she is had moderate to severe discomfort in the acromial area and subacromial area as well as radiation of pain to the clavicle and really limited range of motion with her arm. Patient  went to urgent care on 1/30/21 with possible bursitis-like reaction to vaccine that was injected close   to the acromium subacromial area. Treated with anti-inflamatory therapy (Toradol)
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no additioanl AE reported; a five year old patient received a dose of RECOMBIVAX HB on 05-OCT-2020 and 23-OCT-2020; This spontaneous report was received from a physician and refers to a 5-year-old female patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.  On 05-OCT-2020 and 23-OCT-2020, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB)(dose, strength, route of administration, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). There was no additional adverse events reported.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: SMILE (stratified mucin producing intraepithelial lesions).; diagnosed with Human Papillomavirus; pap smear abnormal; This spontaneous report was received from a doctor of pharmacy, via a company representative, and refers to a 27-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 06-NOV-2006, the patient was vaccinated with first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) 0.5 milliliter, intramuscular injection (anatomical location, lot # and expiration date were not provided). On 09-JAN-2007, she was vaccinated with second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) 0.5 milliliter, intramuscular injection (anatomical location, lot # and expiration date were not provided). On 30-APR-2007, the patient was administered third dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) 0.5 milliliter, intramuscular injection (anatomical location, lot # and expiration date were not provided). All vaccines were administered for human papillomavirus (HPV) prevention. On 28-SEP-2020, the patient had a pap test performed. On 07-OCT-2020, she was notified that her pap was abnormal. On 23-NOV-2020, the patient had further testing and was told she had HPV and stratified mucin producing intraepithelial lesions (SMILE). The HPV result was as follows: HPV high risk type 16 was negative, HPV high risk type 18 was negative, "other high risk types that were positive: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 66." On 18-FEB-2021, the patient had the loop electrosurgical excision procedure (LEEP) performed as a treatment for the events. It was reported that, the patient sought medical attention. The outcome of the events was reported as recovering.   The causal relationship between Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) and the events was not provided.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration, No adverse event
Clinical narrative: a now 13 year old initiated GARDASIL 9 series at other institution or facility at the age of 12; a now 13 year old initiated GARDASIL 9 series at other institution or facility at the age of 12; no adverse event; This spontaneous report was received from an office manager and refers to a currently 13-year-old patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date (reported as at the age of 12 years old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.   The reporter was inquiring on behalf of a physician, how to proceed when the patient initiated hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series at other institution or facility. The patient's mother called because a pharmacy would not give her the second dose in the series (inappropriate schedule of product administration and circumstance or information capable of leading to medication error). Caller declined follow-up with physician as the patient's mother reported they were going elsewhere. No additional adverse events was reported. No further information was provided.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: feeling like going to pass out, Consumer/Patient had a reaction to GARDASIL 9/felt dizzy while at school for the whole week following GARDASIL 9 administration; confirmed GARDASIL 9 injection being really painful; Poor quality vaccine administered; Suspected product quality issue; This spontaneous report as received from a consumer referring to 10-year-old female patient. The patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.    On 22-FEB-2021, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot # 1691180 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 15-NOV-2022; strength, dose, route were not reported) for prophylaxis by a health professional at physician's office.   The patient confirmed HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection was being really painful (vaccination site pain). The patient waited in physician's office for 5 minutes before leaving, the patient had a reaction to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), she felt like going to pass out. The patient also felt dizzy while at school for the whole week following HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administration. The reporter stated this was the first purchase of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) per prescription from the physician's required. One quantity was involved in the product's packaging and the product was not available for return back to manufacturer. The reporter asserted how affected HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) must be a bad batch and requested report once results were available regarding bad batch (poor quality vaccine administered and suspected product quality issue). The reporter also mentioned how attorneys required manufacturer to notify of the affected HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) batch status and had sent to Legal. The outcome was reported as not recovered. The causality between vaccination site pain and the suspect was not provided.  This is one of two cases received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1691180; expirationdate: 15-NOV-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA001066:
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Third dose 28 days after the second one; A spontaneous report was received from a pharmacist concerning a female patient (age approximately 60+ years old) who received a third dose of Moderna's COVID-19 vaccine(mRNA-1273). (Case crosslinked to MOD21-037355, MOD21-037500, MOD21-037502, MOD21-037503). No Adverse events were reported.  The patient's medical history was not provided. No relevant concomitant medications were provided.   On 22 Feb 2021, the patient received their third dose of mRNA-1273 (Lot/batch: unknown) through unknown route of administration for prophylaxis of COVID-19 infection.  The third dose was given 28 days after the second one, which had also been given 28 days after the first dose (extra dose administered).  No treatment information was provided .  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event third dose was given 28 days after the second one was considered recovered on 22 Feb 2021.; Reporter's Comments: This case refers to  a patient, (age approximately 60+ years old) who had an "extra dose administered" of Moderna's COVID-19 vaccine(mRNA-1273)(Lot/batch: unknown) with no associated  AEs. Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dizziness, Fatigue, Heart rate, Heart rate abnormal
Clinical narrative: Afib issues; Heart rate would increase and decrease; Feeling really tired; woke up really dizzy; A spontaneous report was received from a Consumer concerning herself, a 68- year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, afib issues, heart rate would increase and decrease, feeling really tired, and severe dizziness like vertigo,   The patient's medical history, as provided by the reporter included, Afib and underwent surgery on 13 Jan 2021 for Afib issues. Concomitant products were not reported.  On 19 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 19 Feb 2021, it was reported that the patient experienced the events, Afib issues, heart rate would increase and decrease, went to bed feeling really tired and woke up with severe dizziness like vertigo, heart was down in the 40s and then spike up to the 80s. The patient was concerned that vaccine may have triggered Afib.   On 19 Feb 2021, the lab test performed included heart rate 40s, heart rate 80s.  No treatment information was provided.     Action taken with mRNA-1273 in response to the event(s) was unknown.  The outcome of events, Afib issues, heart rate would increase and decrease, feeling really tired and severe dizziness was unknown.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the start date of the events and excluding all other etiologies, a causal relationship with the events cannot be excluded.  However, causality for Afib issues is confounded by the patient concurrent history of Afib. Fatigue is consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Allergic bronchitis
Clinical narrative: allergies turned to bronchitis with mucus; A spontaneous report (United States) was received from a consumer on 25-FEB-2021 concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a medically significant event of allergic bronchitis (reported as allergies turned to bronchitis with mucous).  The patient's medical history included asthma and allergy. Relevant concomitant medications were not provided.  On an unspecified date, the patient received Moderna COVID-19 Vaccine for COVID-19 vaccination. Tomorrow it´s being 5 weeks since her first shot. Some later, the patient developed allergies turned to bronchitis with mucus which started 3 or 4 weeks ago. She is going to receive her second shot the following week and will like not to miss it.   Treatment of the event included antibiotics and steroids.  Action taken with mRNA-1273 in response to the events was not reported.   The events, allergies turned to bronchitis was considered not recovered/not resolved at the time of reporting.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lung neoplasm malignant
Clinical narrative: Lung cancer; A spontaneous report was received from a consumer concerning her mother, a female patient, who was diagnosed with lung cancer/lung neoplasm malignant.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.  On unknown date , the patient received their first of their two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, post-vaccination, the patient was diagnosed with lung cancer. Treatment  information was not provided.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event, lung cancer, was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Syncope
Clinical narrative: Fainting; Aches; Extreme Nausea; Chills; A spontaneous report was received from a consumer, concerning a 75-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme nausea, chills, aches and fainting.  The patient's medical history, as provided by the reporter, included COVID-19 infection on last March. Concomitant medications reported included atorvastatin and levothyroxine sodium.  On 20Feb2021, approximately 4 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch nmber:015M20A) for prophylaxis of COVID-19 infection.  On 20Feb2021, the patient experienced extreme nausea, chills, aches and fainting.  Treatment for events included ondansetron and paracetamol.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events, extreme nausea, chills, aches were considered recovering/resolving.  The outcome of the event, fainting, was considered recovered/resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dysstasia, Paralysis
Clinical narrative: Paralyzed from the waist down for a few minutes and fell down; Feels disoriented; Sometimes can't even stand up; A spontaneous report () was received from a physician concerning a 77-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was paralyzed from the waist down and fell down/paralysis, feels disoriented/disorientation and sometimes can't even stand up/dysstasia.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included poly vitamins.  On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 015M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 10 Feb 2021, approximately a few hours post vaccination, the patient experienced paralysis from the waist down for approximately 15 minutes which made her fall down. This event occurred two times. The patient stated she felt disoriented and could not stand up.   Treatment information was not provided.  The outcome of the events, was paralyzed from the waist down and fell down/paralysis, feels disoriented/disorientation and sometimes can't even stand up/dysstasia, were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: Lost all my vision; A spontaneous report was received from a consumer who was an 83-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lost all my vision (blindness).   The patient's medical history, as provided by the reporter, included an eye transplant 9 or 10 years ago. Concomitant medication included acetylsalicylic acid, metformin, tamsulosin, ropinirole, Ramipril, and gabapentin.  On 09 Feb 2021 at 10:00 AM, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Lot number: 031M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 09 FEB 2021, at exactly 10:00 PM,  the patient "lost all my vision."  He stated he had an adverse reaction to his first injection and said "my first shot messed up my vision."  By 5 am, his vision was perfect.  No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was unknown.  The event of lost all my vision was considered resolved on 10 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: Myelitis transverse; A spontaneous report  report was received from a physician concerning a male patient of an unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and who developed transverse myelitis.   The patient's medical history was not provided nor was concomitant medication use.   On an unknown date, approximately nine days prior to the onset of the event, the patient received his first of two scheduled doses of mRNA-1273 (LOT unknown) intramuscularly for prophylaxis of Covid-19 infection.   It was reported that the patient, a physician, after an extensive neurological workup, was diagnosed with transverse myelitis.  His symptoms began, according to report, approximately nine days following vaccine administration. Treatment for the reported event was not provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, transverse myelitis,  was considered unknown.  .; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Loss of consciousness, Vomiting
Clinical narrative: Passing out and falling; vomiting; Feeling strange; A spontaneous report ( was received from a consumer concerning a 84-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events loss of consciousness, vomiting, feeling  abnormal.    The patient's medical history included thyroid disorder and hypertension. Concomitant medications used by the patient were thyroid medication and blood pressure medication.  On 12 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced passing out and falling, vomiting and feeling strange. She was taken to the emergency room and was administered IV and had some tests done. The patient was not admitted. The event passing out and falling (loss of consciousness) was considered as medically significant . No Laboratory details were provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 13 Feb 2021, the outcome of the events, loss of consciousness, vomiting, feeling abnormal were considered as recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Rash
Clinical narrative: Difficulty in breathing; Rash all over her body; Anaphylactic reaction; A spontaneous report  was received from a pharmacist for a 47-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction, rash all over her body and difficulty in breathing.  The patient's medical history was not provided. No concomitant product use was reported.  On 15 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 24 Feb 2021, 10 days after vaccination the patient experienced an anaphylactic reaction. The patient had severe itching on her palm and knee which later turn into rash. The patient also had swelling of her lips and face. The patient went to the emergency room where she got prednisone 50mg for 3 days.  On 26 Feb 2021, the patient got rash all over her body and difficulty in breathing. The patient went again to the emergency room.   Treatment information included prednisone 50mg for 3 days.  Action taken with mRNA-1273 was unknown.  The outcome of the event, anaphylactic reaction was not recovered/ not resolved and the outcome for events rash all over her body and difficulty in breathing was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: Hospitalised; A spontaneous report  was received from a consumer, concerning a male patient of unspecified age, of unknown age, who received Moderna's COVID-19 vaccine and was hospitalized.   The patient's medical history included allergic to iodine. Concomitant product use was not provided by the reporter.    On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknow) via unknown route for prophylaxis of COVID-19 infection.    On an unspecified date, after vaccination, the patient was hospitalized. Treatment information was not provided.    Action taken with mRNA-1273 in response to event were not provided.  The outcome of the event hospitalized was unknown at the time of this report..; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Blood glucose increased, Haemoglobin, Haemoglobin decreased
Clinical narrative: possible infection around hvalve; hemoglobin dropping rapidly; All over body aches; extreme all over weakness; Blood sugar over 400; This is a spontaneous report from a contactable consumer.  A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9261), via an unspecified route of administration on 02Feb2021 at 16:30 (at the age of 78-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included esophagectomy on an unspecified date. The patient previously took morphine (UNKNOWN MANUFACTURER) and adhesive tape (UNKNOWN MANUFACTURER and experienced allergy. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1284) on 05Jan2021 at 16:30. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN),  atorvastatin (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B-12 MANUFACTURER UNKNOWN), clopidogrel (MANUFACTURER UNKNOWN), cyclobenzaprine (MANUFACTURER UNKNOWN), empagliflozin (JARDIANCE), magnesium oxide (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), methocarbamol (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN), "orevastatin" (MANUFACTURER UNKNOWN), terazosin (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), co-q10 (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) multivitamin (MANUFACTURER UNKNOWN), turmeric curcumin (MANUFACTURER UNKNOWN), vitamin d-3, b-12-E (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), dicyclomine (MANUFACTURER UNKNOWN) all from unknown indications from unknown dates and unknown if ongoing. On 16Feb2021 at 09:00, the patient experienced all over body aches, extreme all over weakness, blood sugar over 400 and hemoglobin dropping rapidly. The patient was taken to the Emergency Room and was hospitalized. The patient received treatment for the events which included an infusion of iron for dropping hemoglobin and infusion antibiotic for possible infection around "hvalve."  Lab data included a nasal swab SARS-COV 2  test on 16Feb2021 which was negative. The clinical outcomes of the events hemoglobin dropping rapidly, generalized aching, extreme weakness, blood sugar increased and possible infection were unknown. It was also reported that since the vaccination, the patient had been tested for COVID-19 (on 16Feb2021) and it was negative.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Infection, Pain, SARS-CoV-2 test
Clinical narrative: possible infection around hvalve; hemoglobin dropping rapidly; All over body aches; extreme all over weakness; Blood sugar over 400; This is a spontaneous report from a contactable consumer.  A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9261), via an unspecified route of administration on 02Feb2021 at 16:30 (at the age of 78-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included esophagectomy on an unspecified date. The patient previously took morphine (UNKNOWN MANUFACTURER) and adhesive tape (UNKNOWN MANUFACTURER and experienced allergy. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1284) on 05Jan2021 at 16:30. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN),  atorvastatin (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B-12 MANUFACTURER UNKNOWN), clopidogrel (MANUFACTURER UNKNOWN), cyclobenzaprine (MANUFACTURER UNKNOWN), empagliflozin (JARDIANCE), magnesium oxide (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), methocarbamol (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN), "orevastatin" (MANUFACTURER UNKNOWN), terazosin (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), co-q10 (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) multivitamin (MANUFACTURER UNKNOWN), turmeric curcumin (MANUFACTURER UNKNOWN), vitamin d-3, b-12-E (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), dicyclomine (MANUFACTURER UNKNOWN) all from unknown indications from unknown dates and unknown if ongoing. On 16Feb2021 at 09:00, the patient experienced all over body aches, extreme all over weakness, blood sugar over 400 and hemoglobin dropping rapidly. The patient was taken to the Emergency Room and was hospitalized. The patient received treatment for the events which included an infusion of iron for dropping hemoglobin and infusion antibiotic for possible infection around "hvalve."  Lab data included a nasal swab SARS-COV 2  test on 16Feb2021 which was negative. The clinical outcomes of the events hemoglobin dropping rapidly, generalized aching, extreme weakness, blood sugar increased and possible infection were unknown. It was also reported that since the vaccination, the patient had been tested for COVID-19 (on 16Feb2021) and it was negative.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Dysgeusia, Fatigue, Feeling abnormal
Clinical narrative: groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have vertigo spell or throw up; balance unsteady; feeling numbness in left arm; Exhausted/tired; feeling faint; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (No Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9267), left arm on 18Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included overweight, pre-diabetic. The patient did not diagnose with COVID-19. No allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included multivitamin. Shot on Thursday. No problem on Friday. Headache Saturday morning 20Feb2021 06:30 AM. After dinner on 20Feb2021, she had a metallic taste in her mouth started sweating and feeling faint then started shivering and feeling like she was going to either have a vertigo spell or throw up. Ballance unsteady. Drank water got into bed and then she started feeling numbness in her left arm. Exhausted and tired. Sunday tired and groggy. Monday still tired and groggy. Events were non serious. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Hypoaesthesia, Somnolence, Syncope
Clinical narrative: groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have vertigo spell or throw up; balance unsteady; feeling numbness in left arm; Exhausted/tired; feeling faint; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (No Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9267), left arm on 18Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included overweight, pre-diabetic. The patient did not diagnose with COVID-19. No allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included multivitamin. Shot on Thursday. No problem on Friday. Headache Saturday morning 20Feb2021 06:30 AM. After dinner on 20Feb2021, she had a metallic taste in her mouth started sweating and feeling faint then started shivering and feeling like she was going to either have a vertigo spell or throw up. Ballance unsteady. Drank water got into bed and then she started feeling numbness in her left arm. Exhausted and tired. Sunday tired and groggy. Monday still tired and groggy. Events were non serious. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oxygen saturation decreased
Clinical narrative: severe reaction/ she said she was very very sick; oxygen level was down for 3-4 hours; everything hurt and was aching; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization, and remdesivir (REMDESIVIR), via an unspecified route of administration from an unspecified date to an unspecified date at an unknown dose ("4 doses") for COVID-19. Medical history included COVID-19 from Jan2021 to Jan2021. The patient's concomitant medications were not reported. Patient had COVID-19 on January. While she has the COVID-19 infection, she took 4 doses of remdesivir. When she got out of the hospital, after 4 weeks, she had the first dose of the Pfizer COVID-19 vaccine. She thinks that she had taken the vaccine too close to her medication (remdesivir) and because of that, she developed a "severe reaction" with the first dose of the vaccine. She said she was "very very sick: her oxygen level was down for 3-4 hours, everything hurt and was aching". She said it's like having COVID-19 all over again. Her symptoms lasted for a day but 3-4 days later she still didn't feel good. She wanted to know if she should take the second dose after her reaction with the first dose. She said she wanted to speak with a doctor about her concern. The patient underwent lab tests and procedures which included oxygen saturation: down on her oxygen level was down for 3-4 hours. The action taken in response to the event for remdesivir was post-therapy. The outcome of the events was unknown. The event severe reaction/ she said she was very very sick was assessed as serious.  Information on the lot/batch number has been requested.