chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasal congestion, Pain, Pyrexia
Clinical narrative: Upon drinking alcohol, my nose turns bright red from bridge to tip and swells to twice the normal size. Takes as little as 3 sips of wine to initiate reaction. Persists most of the evening, subsided my morning. Has happened every time I've had any amount of a drink since my 2nd covid vaccine shot (total 3 times). No other observed reactions (aside from the fevers/chills/pain for 48 hours following 2nd injection). Have not experimented with other types of alcohol or types of wine. All 3 occasions were the same wine.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Furuncle, Rash pruritic, Rash pustular
Clinical narrative: boils on the lower left leg and knee, started out as what looked like large bug bites that were very itchy then turned into pus filled boils on the leg.   treated with doxycycline and triamcinolone acetonide, day 9 still have spots but drastically reduced.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Fatigue, Headache, Peripheral swelling
Clinical narrative: chills, headache, fatigue, fever, lt arm swollen, loss of taste
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills, headache, fatigue, fever, lt arm swollen, loss of taste
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: My period came over a week early after my second shot. I then got my period again less than 3 weeks later. My periods are always completely regular.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Paraesthesia
Clinical narrative: Received shot at 7:30am. Around 1pm, started experiencing tingling in hands and feet. Called an on call nurse through my insurance to see if this was anything concerning, and she recommended I go to the ER. My hands/feet tingled for  about 10 hours continuously, with some numbness in my feet as well. The ER did lab work but everything came back normal.  By the next morning, the tingling/numbness was gone.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Wheezing
Clinical narrative: Wheezing and hives about 3 hours after the injection Took Benadryl immediately and subsided my wheezing and hives
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: patient has several raised inflamed spots on her upper left arm surrounding the deltoid area.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: COVID symptoms -Sore throat; low grade Temperature; headache; tired.  I did two virtual visits at the start and then correspondence through my chart.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Feeling jittery, Injection site urticaria, Pruritus
Clinical narrative: Patient received her 1st COVID Pfizer vaccine at 1658 pm.  She developed hives around the vaccine site L deltoid and forearm approximately 5 min post injection. She was given po Benadryl 25 mg po x 1. No report of SOB initially. VS at 1710: 169/104 HR 86 Pulse ox : 96 %. Sipping water without difficulty.  1715: VS: 153/104 HR: 87  Pulse ox 96% room air. States feeling like she is short of breath. Benadryl 25 mg IM x 1 at 1715.  1720: States no improvement, c/o difficulty breathing and feels like her throat is closing up and difficulty swallowing water. Epi Autojet 0.3 mg IM given L thigh x 1. 911 called for transport for eval of acute allergic reaction with no prior history. NO HX of any acute reactions to anything in the past, she does not carry an epi pen. Only HX of environmental allergies to dust and mold. She does not take any regular meds.   She felt jittery after the epi but began to improve greatly.  1730: VS: 178/94 HR: 102 RR: 20, states breathing is greatly improved, itching less and hives much less. EMS here, report to EMS. 1745 Patient released in care of EMS to go to Hospital. Feeling much better. VS: 162/68 HR 93 Pulse ox 97%. Does not feel SOB any more, she is breathing easier, able to drink water. Hives gone.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Patient received her 1st COVID Pfizer vaccine at 1658 pm.  She developed hives around the vaccine site L deltoid and forearm approximately 5 min post injection. She was given po Benadryl 25 mg po x 1. No report of SOB initially. VS at 1710: 169/104 HR 86 Pulse ox : 96 %. Sipping water without difficulty.  1715: VS: 153/104 HR: 87  Pulse ox 96% room air. States feeling like she is short of breath. Benadryl 25 mg IM x 1 at 1715.  1720: States no improvement, c/o difficulty breathing and feels like her throat is closing up and difficulty swallowing water. Epi Autojet 0.3 mg IM given L thigh x 1. 911 called for transport for eval of acute allergic reaction with no prior history. NO HX of any acute reactions to anything in the past, she does not carry an epi pen. Only HX of environmental allergies to dust and mold. She does not take any regular meds.   She felt jittery after the epi but began to improve greatly.  1730: VS: 178/94 HR: 102 RR: 20, states breathing is greatly improved, itching less and hives much less. EMS here, report to EMS. 1745 Patient released in care of EMS to go to Hospital. Feeling much better. VS: 162/68 HR 93 Pulse ox 97%. Does not feel SOB any more, she is breathing easier, able to drink water. Hives gone.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Ultrasound scan
Clinical narrative: Severe swelling and pain at the RT arm with decrease ROM
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Loss of personal independence in daily activities, Paraesthesia
Clinical narrative: 2 days after 2nd vaccination of Moderna patients left arm started to tingle from top of shoulder to finger tips, unable to grip, and injection site is sore.  No discoloration/deformity noted painful to touch. Patient states she saw her private doctor on 5/3/2021 the doctor referred patient to a nerve doctor appointment is 5/19/2021 and is following up with her private doctor on 5/132021. Patient was given V-Safe Health checker information for another way to report.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nasopharyngitis, Pain in extremity, Paraesthesia, Sensory loss, Tenderness
Clinical narrative: 2 days after 2nd vaccination of Moderna patients left arm started to tingle from top of shoulder to finger tips, unable to grip, and injection site is sore.  No discoloration/deformity noted painful to touch. Patient states she saw her private doctor on 5/3/2021 the doctor referred patient to a nerve doctor appointment is 5/19/2021 and is following up with her private doctor on 5/132021. Patient was given V-Safe Health checker information for another way to report.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Pain in extremity, Paraesthesia, Product administered at inappropriate site
Clinical narrative: 2 days after 2nd vaccination of Moderna patients left arm started to tingle from top of shoulder to finger tips, unable to grip, and injection site is sore.  No discoloration/deformity noted painful to touch. Patient states she saw her private doctor on 5/3/2021 the doctor referred patient to a nerve doctor appointment is 5/19/2021 and is following up with her private doctor on 5/132021. Patient was given V-Safe Health checker information for another way to report.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient walked in with his mother to receive a COVID-19 J&J vaccine on 5/1/2021 in the afternoon. The patient filled out the consent form and indicated his date of birth (16 years old). A Janssen vaccine was then administered and the patient was monitored for 15 minutes. The patient denied any signs or symptoms of complications and went home. On Monday morning, a pharmacy intern reviewed the consent forms to bill for the vaccines and noticed that the patient was not within the approved age range to receive the J&J vaccine and notified the pharmacy manager and the immunizing pharmacist. It was determined that there was an administration error, however, it was not associated with any adverse event(s).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blister, Chest pain, Herpes zoster, Malaise
Clinical narrative: I recently received the second Moderna vaccine, April 20. The next day I experienced severe body aches and extreme tenderness to the skin of the arms and upper torso, followed by 1-2 days of malaise. Then, on 29-30 April, I began having extreme pain in the lower back, migrating up the thoracic spine and around the left to the mid-chest area. I took one 500mg Naproxen 3x/day which helped mitigate the pain temporarily. I then discovered a red blister on my side 1 May. Since then my symptoms have been painful back/chest and stabbing pain at the site of the blisters which followed the path of the pain described above. I was diagnosed with Shingles yesterday, 3 May. I have been prescribed 1000mg of Valacyclovir
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Spinal pain, Tenderness
Clinical narrative: I recently received the second Moderna vaccine, April 20. The next day I experienced severe body aches and extreme tenderness to the skin of the arms and upper torso, followed by 1-2 days of malaise. Then, on 29-30 April, I began having extreme pain in the lower back, migrating up the thoracic spine and around the left to the mid-chest area. I took one 500mg Naproxen 3x/day which helped mitigate the pain temporarily. I then discovered a red blister on my side 1 May. Since then my symptoms have been painful back/chest and stabbing pain at the site of the blisters which followed the path of the pain described above. I was diagnosed with Shingles yesterday, 3 May. I have been prescribed 1000mg of Valacyclovir
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Gout, Urticaria
Clinical narrative: hives 7 days after Pfizer #2.  saw dermatology. tx with antihistamines and topical steroid.   (also reported mild gout flares 48 hours after both Pfizer doses- resolved after a few days each time. no need for prn medications. tx with rest at home.)
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: According to the patient she had a minor heart attack She was seen by MD
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Blood test, Myocardial infarction, SARS-CoV-2 test, Troponin increased
Clinical narrative: According to the patient she had a minor heart attack She was seen by MD
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: According to the patient she had a minor heart attack She was seen by MD
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Feeling abnormal, Lymphadenopathy, Pain
Clinical narrative: On April 28, (morning after the second dose) I woke up with fever, chills, & body aches; which I was prepared for. I didn't take any medicine--I just "toughed it out.  On April 29th, the aforementioned symptoms continued, and the lymph nodes in my left armpit were swollen and sore.  By April 29th, the fever & chills subsided. By April 30th the body aches were waning. The swollen and sore lymph nodes continued. By May 1, I started to develop hives on the left side of my face and neck. By May 3, the swollen sore lymph nodes had subsided, but the hives were in my hairline, across my torso, groin and legs. This is absolutely miserable. The hives are itchy, painful, and weeping.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: On April 28, (morning after the second dose) I woke up with fever, chills, & body aches; which I was prepared for. I didn't take any medicine--I just "toughed it out.  On April 29th, the aforementioned symptoms continued, and the lymph nodes in my left armpit were swollen and sore.  By April 29th, the fever & chills subsided. By April 30th the body aches were waning. The swollen and sore lymph nodes continued. By May 1, I started to develop hives on the left side of my face and neck. By May 3, the swollen sore lymph nodes had subsided, but the hives were in my hairline, across my torso, groin and legs. This is absolutely miserable. The hives are itchy, painful, and weeping.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Culture stool, Decreased appetite, Diarrhoea, Echocardiogram
Clinical narrative: Started not able to eat or drink, then started throwing up and not sble to keep anything down.  Then had diarrhea somewhat also had a headache.  Then wasn't voiding at all either one.  Turned into kidney failure.   Shut down her kidneys.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Headache, Renal failure, Scan, Vomiting
Clinical narrative: Started not able to eat or drink, then started throwing up and not sble to keep anything down.  Then had diarrhea somewhat also had a headache.  Then wasn't voiding at all either one.  Turned into kidney failure.   Shut down her kidneys.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: Injected at 3:15 PM patient experienced left arm tingling, burning sensation and numbness after 15 minute observation (3:30PM) Dr. examined patient, no irritation nor swelling was noticed. Monitored patient for additional (30) minutes symptoms were relieved and per Dr. okay to go home. patient notified if symptoms worsen please go to emergency room or contact his Primary Care Provider for additional assistance .
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received Moderna vaccine at Pharmacy on 5-4-21 after filling out paperwork that he had not recieved a previous covid-19 vaccine.  Later discovered that he originally recieved the Pfizer covid-19 vaccine at hospital on 1-23-21.  Infectious disease doctors told him to restart his vaccine series with Moderna, will consult with them to see what steps to take.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Skin discolouration
Clinical narrative: She was patient at the COVID imz event today. She suddenly got very cold after her COVID  imz and her fingers turned blue. This happened while she was waiting the 15 minutes.   She did tell me she has Raynaud?s , however the room was very warm.  There was a nurse on site who evaluated her, checked BP, listened to lungs, HR. The nurse stayed with her and I checked on her periodically.  After about 30 minutes she felt fine and returned to work.  She did tell me she was a little skittish about getting shots  when I gave her the vaccine.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered 0.5 mL of vaccine instead of 0.3 mL
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain, Head discomfort, Paranasal sinus discomfort, Tinnitus
Clinical narrative: Sinus/ear pressure and ear discomfort/pain. 2 short mild instances of tinnitus. Each lasted about 5 seconds then went away. One was in left ear, one in right. Head and ear pressure have gotten much better since first onset, but still comes and goes, not totally resolved.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Dyspnoea, Injection site pain, Palpitations
Clinical narrative: About 5 minutes after the shot I felt pain in the area where they put the shot. About 15 minutes later I started to feel disoriented, lightheaded and felt like I was going to lose consciousness and I felt my heart racing. When they took my blood pressure it was 148/80. Then I started to have difficulty breathing. They took me to the ER in the same facility but the symptoms had resolved I believe because I drank plenty of water while I had the symptoms.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: About 5 minutes after the shot I felt pain in the area where they put the shot. About 15 minutes later I started to feel disoriented, lightheaded and felt like I was going to lose consciousness and I felt my heart racing. When they took my blood pressure it was 148/80. Then I started to have difficulty breathing. They took me to the ER in the same facility but the symptoms had resolved I believe because I drank plenty of water while I had the symptoms.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Flushing, Headache
Clinical narrative: The patient received the Janssen vaccine lot # 1808980 in his left deltoid muscle at 1250pm on the side of the road from our mobile foot team. He was seated on the sidewalk during vaccination and remained seated for his observation period.  At 1301 the patient said he felt "fuzzy," and "light headed" but said "I do not feel like I'm going to pass out." The patient refused to lay down. He was offered a mat or the back of the car to lie down on. He was also given water by RNs and a snack by the police. He drank a few sips of water and refused the snack. His BP was 150/100, HR 76 and regular per palpation, RR 16 and unlabored. No signs of respiratory distress. The patients skin was dry and color was appropriate for ethnicity. At 1306 the patient said " I feel the same, a little light headed." RNs and asked him to describe what he meant by light headed as he still denied feeling like he was going to pass out. He said "I feel dizzy." RNs asked patient if he felt like he was spinning but he said no. BP 158/90, RR 18 and unlabored, HR 74 and regular per palpation. Pt still declined to lay down. At 1311 the patient still felt the same. RNs asked the patient to lie down again. The patient agreed to lay down in the back of the car. The patient stood up and said he felt short of breath upon standing. He has a Hx of COPD and said that he often feels SOB when he first stands. He took his own Ventolin Inhaler before laying down in the back of the car with the air conditioning on. It was 1316 when he laid down and vitals were taken again. BP 130/90, HR 70 and regular per palpation, RR 18 and unlabored. At 1321 the patient said "I feel a little better but still light headed and my head is throbbing but I get headaches every day." Vitals: 138/90, HR 70, Spo298%. At 1326 the patient tried to sit up but became flushed and said he felt "weird." Vitals were 144/90, HR 75, RR 18, Spo2 97%. RNs assisted the patient to lay back down. At 1328  RN asked the police to call 911 while RN placed a call to our lead RN. Vitals were taken again at 1331 BP 150/90, RR 18 and unlabored, HR 81, Spo2 98%. At 1337 the paramedics arrived with the ambulance and resumed care. The patient was transported to Hospital.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth, Rash
Clinical narrative: Hot rash starting below the injection site, which has now spread down my arm and past me elbow to 1/2 way to my wrist.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Headache
Clinical narrative: Around the time stated in form I began feeling slightly flushed in the face, general fatigue, as well as a slight headache.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Patient states feeling dizzy and nauseated. Patient legs elevated and paramedics assess patient. Blood pressure checked by paramedics and was elevated. 2L oxygen was administered by paramedics via nasal cannula for 2 minutes.    After 5 minutes patient states feeling better. denies any any nausea and BP rechecked was within normal limits .
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Persistent tinnitus; high-pitch frequency tone in the ears.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation delayed
Clinical narrative: I am over 30 days late on my period. The only time I?ve been late is when I was pregnancy twice. I was supposed to have my period the week of 4/11 and no period to date.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered 0.5 mL of vaccine instead of 0.3 mL
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Headache, Hypertension, Migraine
Clinical narrative: I started to get Migraines the day of the shot. I was nauseous and I did have seizure which only happens twice a year. My seizures are not always triggered by migraine. I have a history of hives and I get reactions to bites. I decided to get the Johnson & Johnson because it seemed to be a better option. Ten days after the vaccine I had a Migraine that was so bad I had to go to the doctor. When I got there my blood pressure was high. I was given some migraine medicine, but it did not help. The migraine was there for four weeks after the shot. I still got a numbing headache after the shot until five weeks after the shot.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Seizure
Clinical narrative: I started to get Migraines the day of the shot. I was nauseous and I did have seizure which only happens twice a year. My seizures are not always triggered by migraine. I have a history of hives and I get reactions to bites. I decided to get the Johnson & Johnson because it seemed to be a better option. Ten days after the vaccine I had a Migraine that was so bad I had to go to the doctor. When I got there my blood pressure was high. I was given some migraine medicine, but it did not help. The migraine was there for four weeks after the shot. I still got a numbing headache after the shot until five weeks after the shot.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Muscular weakness
Clinical narrative: Within one hour, got very lightheaded, weak in arms and legs, almost felt like stroke coming on.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was signed up to receive Pfizer vaccine when making the appointment online at ; however, our clinic  had not yet started administering Pfizer, only Moderna. Father stated Moderna was ok to give. Administrating provider did not realize the patient was less than 18 years old.  No known adverse symptoms occured.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen arm and redness in the area to this day after the application of vaccination and without pain. The pain was only for the first two days.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Cold sweat, Dizziness, Loss of consciousness, Nausea
Clinical narrative: Patient administered Janssen vaccine on 5/5/21 at 1011AM by pharmacist on duty. Patient did not admit any anxiety surrounding vaccine during counseling prior to receiving the vaccine. After administration patient mentioned she has can get anxious sometimes and has tendency to create symptoms in her head. She asked what to be on the look out for for signs of syncope and described starting to feel nauseous, clamy, and tunnel vision. Within seconds she briefly lost consciousness and started to slump in chair within immunization room. Pharmacist prevented her from falling out of chair while opening door to waiting room and asked for assistance from patients boyfriend. Together we held patient in place on chair and propped feet up on another chair. Immediately patient regained consciousness enough to explain what she was feeling but then quickly lost consciousness again and started snoring as if she immediately fell asleep. Boyfriend said no history of sleep issues/narcolepsy, together we laid patient on floor of immunization room with feet slightly elevated and boyfriend at her head and again she immediately regained consciousness. Patient explained that she was immediately starting to feel better and felt dizzy and described having very odd dream like scenarios. She laid on floor for 10 min, Alert and orientedx4, moved to seated position for another 10 min, accepted offer for apple juice, moved to waiting area to sit for another 10min before OK leaving. MOD/PDM aware....Called patient at 6pm that same evening and patient reported feeling great.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tunnel vision
Clinical narrative: Patient administered Janssen vaccine on 5/5/21 at 1011AM by pharmacist on duty. Patient did not admit any anxiety surrounding vaccine during counseling prior to receiving the vaccine. After administration patient mentioned she has can get anxious sometimes and has tendency to create symptoms in her head. She asked what to be on the look out for for signs of syncope and described starting to feel nauseous, clamy, and tunnel vision. Within seconds she briefly lost consciousness and started to slump in chair within immunization room. Pharmacist prevented her from falling out of chair while opening door to waiting room and asked for assistance from patients boyfriend. Together we held patient in place on chair and propped feet up on another chair. Immediately patient regained consciousness enough to explain what she was feeling but then quickly lost consciousness again and started snoring as if she immediately fell asleep. Boyfriend said no history of sleep issues/narcolepsy, together we laid patient on floor of immunization room with feet slightly elevated and boyfriend at her head and again she immediately regained consciousness. Patient explained that she was immediately starting to feel better and felt dizzy and described having very odd dream like scenarios. She laid on floor for 10 min, Alert and orientedx4, moved to seated position for another 10 min, accepted offer for apple juice, moved to waiting area to sit for another 10min before OK leaving. MOD/PDM aware....Called patient at 6pm that same evening and patient reported feeling great.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Eye swelling, Pruritus, Rash macular, Urticaria
Clinical narrative: 2 days after receiving dose 2 I developed hives on left and right arm, red, itchy, blotches on my legs below the knee and 4 days later my eyes swelled up
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Dizziness, Electrocardiogram normal, Hyperventilation, Supraventricular tachycardia
Clinical narrative: Pt received vaccine and within minutes of receiving the vaccine, pt stated that he had dizziness and felt light headed.  Neuro assessment was performed by reporting nurse and neuro assessment WNL.  Pt started hyper ventilating and pt was advised to slow down his breathing.  Pt continued to complain of feeling dizzy and lightheaded.  Pt had bilateral feet elevated on a chair and bilateral arms raised.  Site was called to the patient and they assessed the patient.  Pt was laid down on the floor and bilateral feet elevated. Pt had a 12 lead ECG performed showed 60 with a run of SVT with rate of 182.  Pt had VS taken initally 80/40, 62, 24. continued treating patient, FSBS was 79.  Pt was advised to go to the ER for further assessment and treatment.   provided O2 2L via , 12 lead ECG monitoring, IV access to right AC, 20g secured with opsite, 0.9% NS bolus of 200ml.  Pt was transported.  Ship staff aware of incident and will f/u with patient status.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Pharyngeal swelling, Swollen tongue, Throat tightness
Clinical narrative: Anaphylaxis- throat and tongue swollen and closed up
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Extremely swollen and sore lymph node in left armpit. Began at 10:30 AM on May 5th - worsening throughout the day.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal hernia, Urticaria
Clinical narrative: Pt sat down to wait and c/o itching and hives. MD immediately assessed pt and requested for 20mg of Cetrizine Hydrochloride PO to be given. Medication given as per MD orders. Pt observed for additional 20min. Pt denied any SOB, CP, or further complications. Pt cleared by MD to go home at 1700. Pt instructed to call 911 should she have a medical emergency on the way home. Pt verbalized agreement and understanding to this.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blindness, Chest pain, Feeling abnormal, Headache
Clinical narrative: On day 1 (April 15) of noticing my body was very off after the vaccine I had Leg pain and severe headaches, I say severe because though I rarely get headaches and stay hydrated I could tell this headache really hurt and lasted the full day and several days after (something I have never had happen to me) Also on April 15, I had leg pain, If I took a step off a few inches curb or stair step I felt sharp pain shoot up my leg. On April 16th I still had the headaches and leg pain , but also while driving I began loosing my vision and started to pass out/faint. I Pulled over and waited at least a half hour. during that time I. noticed I couldn't type or read anything on my phone as I was trying to reach a friend to help me. eventually after time had passed I was able to drive myself to a friends where I thought the best thing would be to sleep it off. the headaches and leg pain lasted a couple more days and I thought it was going to go away, but it is now May 5th and today and last couple days the leg pain feels more like someone has been punching my left leg. five had chest pain and headaches return. I do not have medical insurance and have avoided going to the hospital or primary care because I am afraid. today the pain is so irritating and sore I wish I could escape my body.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Irritability, Loss of consciousness, Pain, Pain in extremity
Clinical narrative: On day 1 (April 15) of noticing my body was very off after the vaccine I had Leg pain and severe headaches, I say severe because though I rarely get headaches and stay hydrated I could tell this headache really hurt and lasted the full day and several days after (something I have never had happen to me) Also on April 15, I had leg pain, If I took a step off a few inches curb or stair step I felt sharp pain shoot up my leg. On April 16th I still had the headaches and leg pain , but also while driving I began loosing my vision and started to pass out/faint. I Pulled over and waited at least a half hour. during that time I. noticed I couldn't type or read anything on my phone as I was trying to reach a friend to help me. eventually after time had passed I was able to drive myself to a friends where I thought the best thing would be to sleep it off. the headaches and leg pain lasted a couple more days and I thought it was going to go away, but it is now May 5th and today and last couple days the leg pain feels more like someone has been punching my left leg. five had chest pain and headaches return. I do not have medical insurance and have avoided going to the hospital or primary care because I am afraid. today the pain is so irritating and sore I wish I could escape my body.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis, X-ray
Clinical narrative: THE PHARMACIST ADMINISTER  THE VACCINE TO THE PATIENT , AFTER 10 MINUTESTHE PATIENT BECOME DIZZINES, SWETY AND WITH SHOTNESS OF BREATH. SEHE RECOVERED IN 5 MINUTES ANT THE PHARMACIST GO TO LUNCH AND TELL ME  (RPH) THET THETE WERE 2 MINUTES LEFT TO COMPLETE THE 15 MINUTES WAIT. SHE BECAME SICK AGAIN WITH THE SAME SYMPTOMS. (IMZ TECH) CALL 911 AND ALERT STORE MANAGER WITH CODE WHITE. I CHECK THE PATIENT, (IMZ TECH GAVE HER AN ALCOHOL PAD TO BREATH AND I ASK IF SHE CAN MOVE  AND SHE SAID SHE DIDNT, I PROCEDEED TO  APPLY A COLD COMPRES S TO HER WRIST. THE AMBULANCE CAME AND TOOK HER TO THE EMERGENCY ROOM (1:10pm) HER BROTHER  CALLED 5:03PM TO INDICATE THAT SHE IS FINE WITHOUT SYMPTOMS.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever up to 102 - 24 hours; chills 12 hours; fatigue 24 hours Stayed in bed first day.  Second day able to shower, eat, etc.  Third day felt normal.  Did not see doctor.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Brain stem thrombosis, Imaging procedure abnormal, Pulmonary imaging procedure abnormal, Pulmonary thrombosis, Unresponsive to stimuli
Clinical narrative: Found unresponsive but still breathing at  assisted living. Sent by ambulance to the hospital
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: Patient came in for 2nd Pfizer covid-19 vaccination and had marked that she had an allergic reaction after getting the 1st Pfizer vaccine.  Patient states that she got very red around her neck and that she was itching while in clinic after receiving the vaccination.  Patient states that the NP that gave her the vaccine told her to go home and take Benadryl.  Patient states that she went home and after she got home her neck started swelling and she took Benadryl and states that it improved.  Patient states that the hives were behind her ears until 1 day ago.   Patient was informed that she could not receive the 2nd covid-19 vaccine due to having an allergic reaction and that if she did receive it, her reaction could be much worse.  Patient informed that she should have received some immunity from having only one vaccine but to continue to wear a mask and social distance.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Pruritus, Rash, Urticaria
Clinical narrative: Patient got 1st dose of COVID-19 vaccine on 4/6/21 and started developing rash/hives at night on her inner thigh with severe itching and puffiness around her eyes. She took two Benadryl capsules and rashes were gone after 6-12 hours. She did not have any shortness of breath or swelling on her face, neck or tongue. Patient called to inform this at pharmacy on 5/5/21 to ask if she should still take her 2nd dose
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia
Clinical narrative: Patient started to felt dizzy and have hard time swallowing her water. Before this event, I counseled her on potential side effects and confirm her health status. When I came to assist her, she was not having any respiratory distress nor having any severe anaphylactic reaction so no Epipen was used. I applied ice pack on her and she started to feel better a few minutes later.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given first vaccine April 16th. Second shot was due May 14th. This was a med error as she was not due for her second shot.  Pt was told of the med error and agency guidelines were followed as I instructed patient not to get a second shot.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Lymphoma
Clinical narrative: My father had a triple bypass in June of 2020 and then in October of 2020 had a stent.  He had his chest wide open in June and then CAT scan in October and clean scan, after stent.  Then he gets the vaccine in March of 2021 and then two days ago was diagnosed with Lymphoma.  I think there is a correlation.  My father also was diagnosed and treated in 2017 for STAGE 1 bladder cancer.  No chemo or radiation, just surgery and clean bill of health.  I think the vaccine may have "woken up" cancer cells?  I don't know.  But it makes no sense to me.  I begged him not to get the vaccine until it was FDA approved.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Heavy menstrual bleeding, Migraine, Pain
Clinical narrative: Mild fever, intense body aches (especially in calves), migraine headaches, dizziness. I was also on the fourth day of my mensuration cycle, which was very heavy. After receiving the vaccine, my flow almost completely stopped.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea, Pyrexia
Clinical narrative: Mild fever, intense body aches (especially in calves), migraine headaches, dizziness. I was also on the fourth day of my mensuration cycle, which was very heavy. After receiving the vaccine, my flow almost completely stopped.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient developed a painful rash to the left buttock a week after vaccine administration. Was diagnosed with herpes zoster
Age: 13.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional adverse events were reported in this case.; patient who received first dose of GARDASIL-9 at age 13 and second dose at age 17, which is outside of the recommended dosing schedule in the prescribing information; This spontaneous report was received from a medical assistant referring to a 17-year-old patient of unknown gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On an unspecified date in approximately 2017, when the patient was 13-year-old, she received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number, and expiration date were not reported). Then, on 21-JAN-2021, when the patient was 17-year-old, she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe lot # S033308 with an expiration date on 08-APR-2022, at a dose of 0.5 milliliter for prophylaxis (route and anatomical location were not provided); which is outside of the recommended dosing schedule in the prescribing information (inappropriate schedule of product administration). 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: S033308; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug allergies or reactions were not reported. On 29-APR-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), prefilled syringe, at the dose of 0.5 milliliter (ml), lot # S037576 with an expiration date reported and validated as 10-APR-2021 (expired product administered) for prophylaxis (strength, schedule, anatomical location and route of administration were not reported). The hepatitis a vaccine, inactivated (VAQTA) had no known temperature excursions. She denied further adverse event. No product quality complaint.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: NUMBNESS OF TONGUE AND LIPS; TINGLING ON TONGUE AND LIPS; DIZZINESS; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205421A expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 13:30 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAY-2021, the subject experienced numbness of tongue and lips. On 04-MAY-2021, the subject experienced tingling on tongue and lips. On 04-MAY-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness of tongue and lips, dizziness, and tingling on tongue and lips. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Eye irritation, Migraine, Myalgia
Clinical narrative: Body Swelling; eyes on fire; eyes completely puffy; extremely Migraine; vision went blurry; Dizzy; could not keep her balance; eyes completely red; body ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING (Body Swelling), EYE IRRITATION (eyes on fire), PERIORBITAL SWELLING (eyes completely puffy), MIGRAINE (extremely Migraine), VISION BLURRED (vision went blurry), DIZZINESS (Dizzy), BALANCE DISORDER (could not keep her balance), OCULAR HYPERAEMIA (eyes completely red) and MYALGIA (body ache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced SWELLING (Body Swelling) (seriousness criterion hospitalization), EYE IRRITATION (eyes on fire) (seriousness criterion hospitalization), PERIORBITAL SWELLING (eyes completely puffy) (seriousness criterion hospitalization), MIGRAINE (extremely Migraine) (seriousness criterion hospitalization), VISION BLURRED (vision went blurry) (seriousness criterion hospitalization), DIZZINESS (Dizzy) (seriousness criterion hospitalization), BALANCE DISORDER (could not keep her balance) (seriousness criterion hospitalization), OCULAR HYPERAEMIA (eyes completely red) (seriousness criterion hospitalization) and MYALGIA (body ache) (seriousness criterion hospitalization). The patient was hospitalized from 26-Apr-2021 to 27-Apr-2021 due to BALANCE DISORDER, DIZZINESS, EYE IRRITATION, MIGRAINE, MYALGIA, OCULAR HYPERAEMIA, PERIORBITAL SWELLING, SWELLING and VISION BLURRED. At the time of the report, SWELLING (Body Swelling), EYE IRRITATION (eyes on fire), PERIORBITAL SWELLING (eyes completely puffy), MIGRAINE (extremely Migraine), VISION BLURRED (vision went blurry), DIZZINESS (Dizzy), BALANCE DISORDER (could not keep her balance), OCULAR HYPERAEMIA (eyes completely red) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment included Adrenaline (Epinephrine).  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.; Sender'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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Periorbital swelling, Swelling, Vision blurred
Clinical narrative: Body Swelling; eyes on fire; eyes completely puffy; extremely Migraine; vision went blurry; Dizzy; could not keep her balance; eyes completely red; body ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING (Body Swelling), EYE IRRITATION (eyes on fire), PERIORBITAL SWELLING (eyes completely puffy), MIGRAINE (extremely Migraine), VISION BLURRED (vision went blurry), DIZZINESS (Dizzy), BALANCE DISORDER (could not keep her balance), OCULAR HYPERAEMIA (eyes completely red) and MYALGIA (body ache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced SWELLING (Body Swelling) (seriousness criterion hospitalization), EYE IRRITATION (eyes on fire) (seriousness criterion hospitalization), PERIORBITAL SWELLING (eyes completely puffy) (seriousness criterion hospitalization), MIGRAINE (extremely Migraine) (seriousness criterion hospitalization), VISION BLURRED (vision went blurry) (seriousness criterion hospitalization), DIZZINESS (Dizzy) (seriousness criterion hospitalization), BALANCE DISORDER (could not keep her balance) (seriousness criterion hospitalization), OCULAR HYPERAEMIA (eyes completely red) (seriousness criterion hospitalization) and MYALGIA (body ache) (seriousness criterion hospitalization). The patient was hospitalized from 26-Apr-2021 to 27-Apr-2021 due to BALANCE DISORDER, DIZZINESS, EYE IRRITATION, MIGRAINE, MYALGIA, OCULAR HYPERAEMIA, PERIORBITAL SWELLING, SWELLING and VISION BLURRED. At the time of the report, SWELLING (Body Swelling), EYE IRRITATION (eyes on fire), PERIORBITAL SWELLING (eyes completely puffy), MIGRAINE (extremely Migraine), VISION BLURRED (vision went blurry), DIZZINESS (Dizzy), BALANCE DISORDER (could not keep her balance), OCULAR HYPERAEMIA (eyes completely red) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment included Adrenaline (Epinephrine).  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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Death, Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: Passed out; Abdominal pain; Trouble breathing; Sweats; Didn't feel well; Fatigue; death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (death) and LOSS OF CONSCIOUSNESS (Passed out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Trouble breathing), HYPERHIDROSIS (Sweats), VACCINATION COMPLICATION (Didn't feel well) and FATIGUE (Fatigue). The patient died on 26-Apr-2021. The reported cause of death was Passed out. It is unknown if an autopsy was performed. At the time of death, LOSS OF CONSCIOUSNESS (Passed out), ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Trouble breathing), HYPERHIDROSIS (Sweats), VACCINATION COMPLICATION (Didn't feel well) and FATIGUE (Fatigue) outcome was unknown.            No treatment information provided by the reporter and no history of concomitant medication was reported  Regarding the events of loss of consciousness, malaise, abdominal pain, dyspnea, hyperhidrosis and fatigue, 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. However regarding the event of death, Very limited information regarding this event has been provided at this time.  Further information has been requested; Sender's Comments: Regarding the events of loss of consciousness, malaise, abdominal pain, dyspnea, hyperhidrosis and fatigue, 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. However regarding the event of death, Very limited information regarding this event has been provided at this time.  Further information has been requested; Reported Cause(s) of Death: passed out