chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: At 9:30 pm, I started feeling achy-like chills. At about 12 am, I checked my temperature and had a low-grade fever of 100.6. I took Tylenol. It was difficult to sleep. Next day on 4/18/2021, I was still achy but no fever. Very sleepy. The next morning, Monday 4/19/2021, I felt much better (besides pain where I received the vaccine).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient received his first dose tonight. Shortly after he came to the counter complaining of being light headed. He was instructed to sit down and take some deep breaths. Within seconds he tipped his head back and had passed out. EMTs came on site shortly after he came to. He was checked out and given the all-clear.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Ear pain, Hypersensitivity, Oropharyngeal pain, Pain in jaw
Clinical narrative: Patient waited the required 15 minutes after I administered his second dose of the Moderna vaccine. When he handed the timer back to me, he said he was starting to feel a strange pain on the right side his jaw, ear and throat suddenly. I told him to have a seat so that I can monitor him further. A few minutes later he said his vision started to become blurry and his mouth became very dry. We brought him a bottle of water. He said he didn't feel any better and was feeling worse. I suggested to the caregiver that was with him to take him to the emergency room since he was able to talk, walk and breath on his own still. I told his caregiver to call me back at the pharmacy to update me on his status. The caregiver did call me back and it was confirmed that he was having an allergic reaction and he had to be given high dose Benadryl.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Patient waited the required 15 minutes after I administered his second dose of the Moderna vaccine. When he handed the timer back to me, he said he was starting to feel a strange pain on the right side his jaw, ear and throat suddenly. I told him to have a seat so that I can monitor him further. A few minutes later he said his vision started to become blurry and his mouth became very dry. We brought him a bottle of water. He said he didn't feel any better and was feeling worse. I suggested to the caregiver that was with him to take him to the emergency room since he was able to talk, walk and breath on his own still. I told his caregiver to call me back at the pharmacy to update me on his status. The caregiver did call me back and it was confirmed that he was having an allergic reaction and he had to be given high dose Benadryl.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccine positive rechallenge
Clinical narrative: Customer got itchy once she received the vaccine.  This happened with the first vaccine as well.  No trouble breathing, just itching. Gave her 50 mg Benadryl and she waited 30 minutes until she felt comfortable to leave.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Hypoaesthesia
Clinical narrative: About 90 seconds after my technician gave the COVID19 second dose the patient felt dizzy and sat down in the lobby immediately. He began to drip sweat and his hands looked clammy. Patient said his hands were numb. He seemed to be breathing fine and when I asked if he felt tightness in his airway or chest he said no. I observed the patient and called down the street to urgent care to see if they could see him. I did no suspect an allergy so I did not use the epi pen, but I thought it could be an adverse reaction. The patient returned after urgent care and said since it was less then a minutes when it happened the provider thought it was actually a panic attack and not an adverse reaction, but I thought it deserved a report just in case.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling hot, Hyperhidrosis, Joint swelling
Clinical narrative: her middle finger on the brass knuckle which felt swollen and painful; her middle finger on the brass knuckle which felt swollen and painful; the very tip of her middle finger there is red bump with a sharp pain; the very tip of her middle finger there is red bump with a sharp pain; nausea; sweaty; hot; body aches but without chills; tired; a little marble, a pea size place on her collarbone on the left side/the bump on her collarbone/you even touched it hurt; more sleepy than usual; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 10:00 (Batch/Lot Number: EW0169) at the age of 31-years-old as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 27Mar2021 10:00 AM at Left Arm for covid-19 immunization, the patient also received flu shot on 10Mar2021. The patient had experienced side effect specifically on her middle finger on the brass knuckle which felt swollen and painful on 18Apr2021. She wanted to know if she can have an X-ray done and if it will interact with the vaccine. Now she was having problems with one of her fingers. Reported after the second dose she felt fine. Then the next morning on 17Apr2021 on the left side, her left arm and shoulder, she went to rub it and felt a little marble, a pea size place on her collarbone on the left side. Yesterday on 18Apr2021, the very tip of her middle finger there is red bump with a sharp pain. Add it is the middle finger, the last knuckle closest to the nail. There was a sharp pain, and couldn't move it, and it felt like there was a needle inside trying to come out. Adds it only hurts when she tries to move it. Added she has also felt nausea; sweaty and hot; body aches but without chills, body tired ache on 17Apr2021; more sleepy than usual on 16Apr2021. With regard to the bump on her collarbone, she stated the bump was still there but the pain was down. Before if you even touched it hurt. Adds her knuckle was still red and more swollen and if you touch it it really hurts. The nausea came in waves since she woke up the next day after the second dose. The body aches also come and go, but now they are not as bad. Adds she usually does not sleep as much but she can tell it is more now. She is planning to go the clinic to have her finger looked at. The outcome of the events 'more sleepy than usual', 'body aches but without chills' was recovering, the outcome of the event tired was unknown, and the outcome of the other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nodule, Pain, Pain in extremity, Rash papular
Clinical narrative: her middle finger on the brass knuckle which felt swollen and painful; her middle finger on the brass knuckle which felt swollen and painful; the very tip of her middle finger there is red bump with a sharp pain; the very tip of her middle finger there is red bump with a sharp pain; nausea; sweaty; hot; body aches but without chills; tired; a little marble, a pea size place on her collarbone on the left side/the bump on her collarbone/you even touched it hurt; more sleepy than usual; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 10:00 (Batch/Lot Number: EW0169) at the age of 31-years-old as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 27Mar2021 10:00 AM at Left Arm for covid-19 immunization, the patient also received flu shot on 10Mar2021. The patient had experienced side effect specifically on her middle finger on the brass knuckle which felt swollen and painful on 18Apr2021. She wanted to know if she can have an X-ray done and if it will interact with the vaccine. Now she was having problems with one of her fingers. Reported after the second dose she felt fine. Then the next morning on 17Apr2021 on the left side, her left arm and shoulder, she went to rub it and felt a little marble, a pea size place on her collarbone on the left side. Yesterday on 18Apr2021, the very tip of her middle finger there is red bump with a sharp pain. Add it is the middle finger, the last knuckle closest to the nail. There was a sharp pain, and couldn't move it, and it felt like there was a needle inside trying to come out. Adds it only hurts when she tries to move it. Added she has also felt nausea; sweaty and hot; body aches but without chills, body tired ache on 17Apr2021; more sleepy than usual on 16Apr2021. With regard to the bump on her collarbone, she stated the bump was still there but the pain was down. Before if you even touched it hurt. Adds her knuckle was still red and more swollen and if you touch it it really hurts. The nausea came in waves since she woke up the next day after the second dose. The body aches also come and go, but now they are not as bad. Adds she usually does not sleep as much but she can tell it is more now. She is planning to go the clinic to have her finger looked at. The outcome of the events 'more sleepy than usual', 'body aches but without chills' was recovering, the outcome of the event tired was unknown, and the outcome of the other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: her middle finger on the brass knuckle which felt swollen and painful; her middle finger on the brass knuckle which felt swollen and painful; the very tip of her middle finger there is red bump with a sharp pain; the very tip of her middle finger there is red bump with a sharp pain; nausea; sweaty; hot; body aches but without chills; tired; a little marble, a pea size place on her collarbone on the left side/the bump on her collarbone/you even touched it hurt; more sleepy than usual; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 10:00 (Batch/Lot Number: EW0169) at the age of 31-years-old as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 27Mar2021 10:00 AM at Left Arm for covid-19 immunization, the patient also received flu shot on 10Mar2021. The patient had experienced side effect specifically on her middle finger on the brass knuckle which felt swollen and painful on 18Apr2021. She wanted to know if she can have an X-ray done and if it will interact with the vaccine. Now she was having problems with one of her fingers. Reported after the second dose she felt fine. Then the next morning on 17Apr2021 on the left side, her left arm and shoulder, she went to rub it and felt a little marble, a pea size place on her collarbone on the left side. Yesterday on 18Apr2021, the very tip of her middle finger there is red bump with a sharp pain. Add it is the middle finger, the last knuckle closest to the nail. There was a sharp pain, and couldn't move it, and it felt like there was a needle inside trying to come out. Adds it only hurts when she tries to move it. Added she has also felt nausea; sweaty and hot; body aches but without chills, body tired ache on 17Apr2021; more sleepy than usual on 16Apr2021. With regard to the bump on her collarbone, she stated the bump was still there but the pain was down. Before if you even touched it hurt. Adds her knuckle was still red and more swollen and if you touch it it really hurts. The nausea came in waves since she woke up the next day after the second dose. The body aches also come and go, but now they are not as bad. Adds she usually does not sleep as much but she can tell it is more now. She is planning to go the clinic to have her finger looked at. The outcome of the events 'more sleepy than usual', 'body aches but without chills' was recovering, the outcome of the event tired was unknown, and the outcome of the other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Migraine, Muscle twitching, Spinal pain, Tinnitus
Clinical narrative: Two weeks after receiving my second Moderna vaccination shot I started to have pain in my cervical spine with loud pulsating tinnitus in my left ear, the next day a began to have migraine headaches and eye pain. I have now been suffering from the neck pain, tinnitus, migraines and eye pain for 5 weeks. I also have been having some sort of twitch or spasam in my head. Please help me if you can.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I  have had ringing in my ears. I have never, never had this before.  It's miserable.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Daydreaming, Dry eye, Eye swelling, Fatigue
Clinical narrative: Fever (as high as 103.5) for 48 hours, severe leg pain in both legs (especially in both knees) , chills, swollen and dry eyes, restless legs, arm pain (same arm as shot), big red rash on same arm as shot (still there  4 days later) , mouth blisters, fever blisters on lips, fatigue,  lethargic (still occurring), day dreaming (still occurring),  severe headaches, blurry vision, change in taste (still occurring)
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lethargy, Lip blister, Oral herpes, Oral mucosal blistering
Clinical narrative: Fever (as high as 103.5) for 48 hours, severe leg pain in both legs (especially in both knees) , chills, swollen and dry eyes, restless legs, arm pain (same arm as shot), big red rash on same arm as shot (still there  4 days later) , mouth blisters, fever blisters on lips, fatigue,  lethargic (still occurring), day dreaming (still occurring),  severe headaches, blurry vision, change in taste (still occurring)
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash erythematous, Restless legs syndrome, Taste disorder
Clinical narrative: Fever (as high as 103.5) for 48 hours, severe leg pain in both legs (especially in both knees) , chills, swollen and dry eyes, restless legs, arm pain (same arm as shot), big red rash on same arm as shot (still there  4 days later) , mouth blisters, fever blisters on lips, fatigue,  lethargic (still occurring), day dreaming (still occurring),  severe headaches, blurry vision, change in taste (still occurring)
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Fever (as high as 103.5) for 48 hours, severe leg pain in both legs (especially in both knees) , chills, swollen and dry eyes, restless legs, arm pain (same arm as shot), big red rash on same arm as shot (still there  4 days later) , mouth blisters, fever blisters on lips, fatigue,  lethargic (still occurring), day dreaming (still occurring),  severe headaches, blurry vision, change in taste (still occurring)
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I noticed my ears ringing much louder than they usually do.  Asked my general doctor and pharmacist if they had heard of any correlation to which they replied they had not.  Made appointment with my ENT and he also had not heard of any tinnitus related effects.  Had hearing aid evaluation for device with masking  but have not made any purchase as of this time.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Pain in extremity, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: After the vaccination in the morning, Sa-04-17-2021, have been in Urgent Care in the afternoon for an ongoing kidney stones issue that had occurred earlier this week. Felt tightness and pain in both lower legs which continued the next day, and it became worse.  Mentioned this issue to the primary physician the following Monday 04-19-2021, but predominance had been given to the Kidney stones issue. On 04-26-2021 mentioned again the pain predominantly in the left calf to the primary physician.  The same day, blood clots were found in both lower legs by Urgent Care. Had received information for Deep Vein Thrombosis by physician who prescribed Lovenox (enoxaparin) injections and advised to report the findings to V-safe. Continued narrative: Being informed by Urgent Care on 04-30-2021 that blood clots were not only in both lower legs, but also in both upper legs, now, after complaining about more pain. Ultrasound checks.  Being advised to move and rest moderately.  Received again information about Deep Vein Thrombosis.  Advised to consider to skip the second Pfizer vaccination. Being on sick leave since 04-13-2021.  Had switched from Lovenox to Pradaxa per prescription starting from Sa-05-01-2021. Urgent Care, 05-03-2021 conducted another ultrasound check.  Another blood clot had developed.  Again advised to consider to skip the second Pfizer vaccination, on SA-05-08-2021, to avoid more complications and risks.  Under continued observation. Being alerted that this condition can lead to permanent damage and can turn life-threatening. Continued sick leave, considering medical leave.  Concerned about the decision to take the second Pfizer vaccination, on Sa-05-08-2021.
Sex: M
Vaccine: COVID19
Symptoms: Infectious mononucleosis
Clinical narrative: mononucleosis; This is a spontaneous report from a contactable consumer (mother). A 19-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated that her son was diagnosed with mononucleosis. The caller asked if her son could get the second dose of the vaccine. The reporter was calling to reschedule her son's second dose for the Pfizer Covid-19 vaccine because he missed the appointment for it. The caller was not sure when the first dose of the vaccine was given to him as the vaccination card was with her son. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pallor, Presyncope
Clinical narrative: Pt experienced full vaso vagal reaction post COVID vaccine.  Cold packs were administered to back of neck and forehead.  Pt sweating resolved and color came back.  Aided pt to stand until feeling came back in legs/feet.  Called Dad into room.  He stated he was a nurse and understood the situation.    Everyone was calm.  Had pt stay for additional time and offered snack once feeling better. Pt was not thirsty so allowed sip on water and gave reese cup.  Dad walked around store for a bit before getting into the car.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Oligomenorrhoea
Clinical narrative: Heavier than normal longer menstrual period with severe pain cramps. The night of first dose pain stiffness trouble walking next a fever 2 Days Later rash on my arm lasted 1 month. The site of the vaccine was swollen the size of baseball for 2 weeks. severe cramping like a menstrual period. After second dose period started early on the day of the vaccine 3/28/2021 with severe and heavy long menstrual period. Next month of April menstrual period late 4 days longer and heavier several pain. On 05/05/2021 ovulating with severe cramps pain.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, SARS-CoV-2 antibody test negative
Clinical narrative: I had the normal reaction the first 3 days - the 3rd day being the worst. Fatigue, chills and body aches. Ibuprofen mediated the effects. Since then I've had body aches and mild fatigue in the latter part of every day. I've taken 200 to 1000 milligrams of Ibuprofen every day to alleviate the effects so that I can work normally. The 2nd dose on 03/25 didn't change things much. I had the PNEUMOVAX shot on 4/21. The reaction to that was more severe than the 1st covid shot, same sort of symptoms. After that subsided the body aches and mild fatigue continued.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: redness in ipsilateral arm, reddish non well circumscribed patch with warmth and slight induration. most affected area is distal and medial to the deltoid where the presumed injection occurred.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Seizure like phenomena
Clinical narrative: Pt was approached by RN and asked if she felt fine. Pt stated she felt lightheaded, refused vital signs, water, and snack. Vaccination was given at 1606, patient noted to have seizure like activity at 1613, STAT RN called by nurse and 911 called immediately , patient's airway was protected, patient's placed on 6L of oxygen via nasal cannula, vital signs were taken. IV was attempted by nurse, unable to succeed due to poor vasculature. Paramedics arrived at 1626, daughter was present at clinic, daughter was informed and husband was called and updated with patient's current medical status. Husband stated patient has a history of seizures. Pt was still seizing en route to hospital with paramedics.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough started ~8 hours after shot and continued since then.. Doctor today advised me to increase water intake and use an Albuterol inhaler
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Sensitivity to weather change
Clinical narrative: She specified she gets achy back; gets achy back specially during rainy temperatures; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer (patient) reported that a 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Apr2021 (Batch/Lot number was not reported) as SINDLE DOSE for covid-19 immunisation. Medical history included accident years ago. Concomitant medications included tramadol taken for back issues resulting from an accident years ago, start and stop date were not reported; acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE) taken for headache, migraine, she has been having for her whole life, start and stop date were not reported. The patient specified she got achy back specially during rainy temperatures in Apr2021 with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Tinnitus was at a manageable level, like crickits in background, After the shot, a high pitch ringing started and it has not stopped. I will not take the 2nd shot due to not knowing  how worse the tinnitus might elevate. I have had tinnitus for approx 2.5 years ( with some hearing loss ), but I have been able to train my brain to handle this. The tinnitus is 24x7, non stop, only relief is when you actually get to sleep. It's been a bigger issue to deal with since I took the Moderna shot. Had I known it would have affected tinnitus, I would not have taken the 1st shot. My daughter advised me to google moderna/tinnitus. I did and read all the reports on that. I wish I had read that first. I looked at the list of side effects, tinnitus was not on the list, so it never occurred to me it would be an issue. It is a big issue when you deal with it everyday of your life.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Food intolerance
Clinical narrative: Much increased sensitivity to spicy and high temperature food. Have never experienced this before.  Even just onions or black pepper now hard to tolerate.  Not a debilitating problem, interesting as one who has always enjoyed hot/spicy food.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Uterine spasm
Clinical narrative: Unusually Severe uterine/menstrual cramping, heavier flow than normal. This has continued through the next menstrual cycle as well.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoacusis, Neuropathy peripheral, Swelling, Tinnitus
Clinical narrative: Within 5-15 minutes, neuropathy in both hands progressed significantly from just the fingertips to encompassing the full fingers and palms, with feeling of edema, but no clear edema.  Neuropathy in the feet, pre-vaccine included only the toes and balls of the soles, bilaterally; shortly post-vaccine the entire soles were involved.     The evening of the vaccine, it was noted that tinnitus was worse than prior to the vaccine,  (not sure when started, as noise levels were high enough to make that unclear.  That evening, when listening for tree frogs, it was noted that they could no longer be heard, although husband had no problems hearing them.   Neuropathy has improved, but is not back to pre-vaccine baseline.  Increased tinnitus and loss of ability to hear tree frogs continues.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: reddness and itching at injection site
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Petechiae, Tinnitus
Clinical narrative: tinnitus in left ear since second shot, still present. no treatment. severe petechia on face began one week after second shot, resolved on it's own. no treatment.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Seizure
Clinical narrative: Seizure, Not breathing.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Breast swelling, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: weird rash welts on my body; My body is itchy; her legs, shoulders, back, forearm, neck and everywhere; Swell up on my breasts; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0161; Expiration Date: 31Jul2021) via intramuscular on 16Apr2021 at single dose for COVID-19 immunization at Pharmacy. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL) at 400 mg, once a day (as needed tablet) for headache and muscle pain. Patient Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7534; Expiration Date: 31Jul2021) first dose on 26Mar2021 for COVID-19 immunization. The patient reported that she received the Pfizer COVID vaccine recently and after the three weeks on Friday, 16Apr2021, she received second shot and she had very weird rash welts on her body like swelling on skin not at the injection site but on her legs, breasts, shoulders, back, right on her chest, forearm, neck and everywhere. My body was itchy. The patient reported that it did not seem normal, and they come and go. It was persistent throughout the day. It was not in the same spot during the day. It would get really hot like a normal itch. She reported that her body was itchy and when she scratch it little bit, it swell up. The patient reported that she took Diphenhydramine 25 mg, capsule, one per day. So, she took 2 pills for 2 days, one pill for one day and another for second day. The consumer stated that she had blood drawn probably on 31st January2021, no diabetes, cholesterol and everything was fine. It was a normal check for physical. She had to find the paperwork. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: Intense HSV1 outbreak beginning two days after second dose of Moderna vaccine. Symptoms lasted for about a week. Acyclovir 800mg twice a day for 5 days was taken for symptoms.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test, Echocardiogram, Electrocardiogram, Injection site pain
Clinical narrative: Soreness to the injection site for 2-3 days.  Sudden onset of palpitations 5 days after the vaccine, which lasted 3 days.  Diagnosed as Atrial Fibrillation of unknown origin.  No previous history or known risk factors.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Soreness to the injection site for 2-3 days.  Sudden onset of palpitations 5 days after the vaccine, which lasted 3 days.  Diagnosed as Atrial Fibrillation of unknown origin.  No previous history or known risk factors.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram ambulatory normal, Heart rate decreased
Clinical narrative: Dizziness a few days after receiving. Also after 2nd vaccine and went to the ER because my dad got scared. The doctor recommended a pacemaker! His pulse was very low. At doctor follow up he was given a heart rate monitor to wear for 2 days
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired dose.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Initial insomnia, Sleep disorder, Tinnitus
Clinical narrative: Tinnitus,  mostly in left ear. Can be severe. Disrupting sleep and ability to fall asleep. Started April 1.  Is there 24 hours a day.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Injection site pain
Clinical narrative: It's not really an adverse reaction I'm just worried my first shot was done down further on my arm the second one is way up top and .worried its.not gonna work to.protect me if it was done in the wrong spot and I've only had minor side effects like where the shot was given is only sore if it is touched or.pressed on I just.want to.make sure I'm going to get the full efficacy of the medicine and when he pulled the shot.out some of the medicine came out to
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia oral, Nausea, Vomiting
Clinical narrative: CLIENT COMPLAINED OF DIZZINESS, NAUSEA, MILD NUMBNESS TO TONGUE AFTER VACCINATION,  CLIENT HAD VOMITING EPISODE X1, REPORTS ANXIETY PRIOR TO VACCINATION, VITALS SIGNS STABLE, RESP EVEN AND UNLABORED , CLIENT SYMPTOMS RESOLVED AFTER 15 MIN OBSERVATION; RETURN TO BASELINE WITH NO FURTHER INCIDENT
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Rash pruritic
Clinical narrative: Slightly swollen, red / inflamed, itchy rash area around vaccine injection site on left arm; about 3 inches in diameter; very sensitive to touch; lasted about 4 days. No treatment (did not disrupt normal functioning). Receded after about 4 days, no more symptoms.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Insomnia, Muscle spasms, Pain in extremity
Clinical narrative: leg started hurting; couldn't go back to sleep; have cramps in her right leg/ cramps in left leg; I began having a stomach on sabbath afternoon around 6 pm; stomach aches/stomach hurt; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 16Apr2021 10:00 am (Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation. Medical history included total thyroidectomy, allergy: Codine, Narco, naproxen. Concomitant medications included levothyroxine (LEVOTHYROXINE); calcium (CALCIUM); colecalciferol (VITAMIN D 3); cyanocobalamin (B 12); black cohosh extract (BLACK COHOSH EXTRACT). The patient began having a stomach on sabbath afternoon around 6 pm on 17Apr2021. On Saturday (17Apr2021), she stated to have stomach aches, making her stomach hurt. Clarifies that she had stomach aches a little, not a lot. Then on Sunday (18Apr2021), the patient began to have cramps in her right leg that finally went away. Monday (19Apr2021), the patient started to have cramps in left leg and have persisted from maybe 2 am in the morning and she is still experiencing leg cramps at this time which is 12:19 pm, she has took some Ibuprofen for the pain. Her left leg started hurting while she was asleep and woke her up this morning so that she couldn't go back to sleep. The patient clarifies that it started cramping while she was in sleep, it woke her up, so she was unable to sleep very well because her leg is cramping. Therapeutic measures were taken as a result of leg started hurting. No treatment received for other events. The outcome of the event have cramps in her right leg/cramps in left leg was not recovered, the outcome of the other events was unknown. The patient is not pregnant at the time of vaccination.  No Follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Entire body aches that has not subsided. Joint pain throughout my body that has continued since the vaccine was administered. These symptoms did not exist prior to the vaccine. I hurt everyday and I am at a loss as to what to do.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Dysstasia, Impaired work ability, Pain
Clinical narrative: Vertigo, feeling very dizzy. I feel like I'm spinning, and having difficulty standing up steady. It started when I woke up from a nap with a low fever around 1:30 this morning. I work 3rd shift. I took the night off work because I was having body aches and stomach cramps. It is now around 9:00 pm, and the dizziness has gradually gotten worse through the day.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: Vertigo, feeling very dizzy. I feel like I'm spinning, and having difficulty standing up steady. It started when I woke up from a nap with a low fever around 1:30 this morning. I work 3rd shift. I took the night off work because I was having body aches and stomach cramps. It is now around 9:00 pm, and the dizziness has gradually gotten worse through the day.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: had no sense of taste; had no sense of smell; This is a spontaneous report from a contactable consumer reporting for herself. A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 16Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated that she had gotten her second dose of the Pfizer covid 19 vaccine 3 days ago, Friday and since then (16Apr2021) she had no sense of taste and smell. Wanted to know if this was normal. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Pyrexia
Clinical narrative: Fever and heartburn. Fever occurred the night that I received the vaccine (12h after). Heartburn lasted entire next day
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Pain
Clinical narrative: Within 12 hours and lasted 12 hours: chills, heavy sweating, fully body shakes  Within 12hrs and lasted 24hrs: dizziness, headache, lightheaded
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Within 12 hours and lasted 12 hours: chills, heavy sweating, fully body shakes  Within 12hrs and lasted 24hrs: dizziness, headache, lightheaded
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lethargy, Muscle spasms
Clinical narrative: leg cramps inner thigh, headache,  lethargic
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: 1)101.9 fever the day after the Vaccine 5-2-2021 @ 6:18pm; treated with Tylenol throughout the night. Fever gone by midday 5?3-2021 2) Constant headache a few hours after the vaccine to present.  3) Fatigue a few hours after the vaccine until May 3, 2021.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash all over her body; itchy from head to toe; This is a spontaneous report from a contactable consumer (patient's mother).   A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 19-year-old via an unspecified route of administration, administered in left arm on 16Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included allergic to trees, alopecia. No family medical history. No history of all previously immunizations. No prior vaccination within 4 weeks. No additional vaccines administered on same date. No relevant tests. Ongoing Concomitant medications included hyoscyamine sulfate (LEVSIN) taken for abdominal discomfort; fluoxetine hydrochloride (PROZAC) taken for anxiety; cetirizine hydrochloride (CETIRIZIN) taken for allergic to trees.  On 17Apr2021 the patient developed a rash all over her body/ rash from top to bottom and was itchy from head to toe. Patient's mother took her to the emergency room and they gave her stuff to take care of it. When in the ER, got two meds for the rash that could be purchased over the counter. They said it was a reaction from the Covid shot, from the body giving something that shouldn't be there. Said if patient had a hard time breathing to come back. She was not admitted. The events outcome was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Nausea, Pain
Clinical narrative: Severe arm pain from shoulder to elbow, patchy redness on arm, high fever, chills, body aches, nausea and fatigue.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Severe arm pain from shoulder to elbow, patchy redness on arm, high fever, chills, body aches, nausea and fatigue.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient fainted 5 minutes after vaccination. Patient said she felt a little dizziness. She rested and we monitored her for 1 hour and patient said she felt better afterward. We instructed her boyfriend to take her home, and not allowing her to drive.
Sex: F
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: sinus headaches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reporting for herself that a 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated: "first dose was on 30Mar2021, scheduled second dose of the vaccine tomorrow 20APR2021. Yesterday (18Apr2021) woke up with sinus headaches, last night was scared to take sinus-headache medication because of getting fully vaccinated - is it okay to take: a store brand by Equate for severe allergy, maximum strength, Acetaminophen and diphenhydramine" When referred to HCP for treatment recommendations caller stated: "got it at a pharmacy (Vaccination), they are not doctors". The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient called the pharmacy about 630pm stating she had severe, sudden nausea, vomiting and diarrhea beginning about 5p.m. after her second dose of Pfizer. No fever, patient reported the symptoms seemed to have slowed.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: After receiving the moderna vaccine #1, the patient was advised to be seated in the waiting area of the pharmacy. She was accompanied by her father. She passed out while sitting on the chair and her father lifted her legs and called out her name so the other pharmacist on duty and myself immediately ran to the area she was seated and attended to the patient. I brought her a bottle of water and removed her mask. She woke up after a minute, took a couple sips of water and passed out again a second time, minutes later. She was communicating with us and even said she had a dream. She was alert and responsive. I called 911 and asked for assistance. After about 10 minutes or so, the fire department came, checked her blood pressure while seated and standing, monitored patient, and then released her to go home with her father. At 3:45 PM, the second pharmacist called the parents to inquire about her well-being, and they assured us that she was doing well. No follow up is needed at this time.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Malaise
Clinical narrative: Shingles and I have never had shingles before   Also, very ill for a month
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Joint swelling, Peripheral swelling, Pyrexia
Clinical narrative: Chills; Fever; Swelling on her arm and down to her elbow; Swelling on her arm and down to her elbow; Dizziness; 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) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced chills, fever, swelling on her arm and down to her elbow, dizziness. Therapeutic measures were taken as a result of fever which included treatment with unspecified medicine. Clinical course: Patient wanted to know if the side effects that she was presenting with the Pfizer COVID-19 vaccine would go away prior to her second dose. She received the first dose of the COVID-19 vaccine on Saturday and had developed the following side effects: chills, fever, swelling on her arm and down to her elbow (currently the swelling was going down), dizziness so bad she could not drive. Patient also wanted to know if it is known what ingredients of the vaccine could cause an allergic reaction. Patient believes that the second dose is "worst" than the first one in terms of the severity of the side effects. She took medicine for the fever. Patient also wanted to know if the second dose would provoke her the same adverse reactions as the first one or more. Response: Per attached CONS, according to the CDC some of these side effects are normal signs that the body is building protection and should go away in a few days. No specific information on the duration of her side effects. Per attached CONS, Dizziness and weakness could be signs of a severe allergic reaction. Per attached CONS, there is information for the purpose of the vaccine on the formulation, no information on what ingredients could cause an allergic reaction. Per PI, 6.1 Clinical Trials Experience, LAB-1457-7.0, Revised: 06Apr2021, the incidence of side effects are higher with the second dose, no information on the severity of the side effects. Patient wanted to know for how long would she have the side effects that she is presenting and why is her second dose of the vaccine "worst" than the first one, when she was provided with the information available she stated that she had already received this information from her doctor and that she did not received any "other answers" by calling to the Medical Information line. Patient was informed that she should consult her case with her physician. Patient wanted to know if the first and second dose of the vaccine contain the same ingredients and have the same dose, and was informed that each dose is a 0.3 mL dose containing the same ingredients. Outcome of the event swelling on her arm and down to her elbow was recovering, of the other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Vaccination site rash, Vaccination site warmth
Clinical narrative: Patient got a rash on her arm at the vaccination site. It started 5/3/2021 and has been the same since it appeared. She has not been treating it but will contact PCP if the rash worsens. She described it as red, itchy, and warm.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired dose
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact
Clinical narrative: poison ivy; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program COVAX US Support.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced poison ivy and was placed on Prednisone.  She called in to ask if she needs to postpone her second dose appointment due on Friday 23Apr2021. The event outcome was unknown.    No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain
Clinical narrative: Client received first dose of COVID vaccine @ 10:00 am.  Complained of dizziness @ 10:05 am.  Placed in zero-gravity chair and given water to drink.  At 10:10am client reports less dizziness, vital signs stable.  At 10:17 am client reports not dizzy anymore but pain in arm where received vaccine.  At 10:30 am client reports no longer dizzy, sore arm where vaccinated, vital signs stable.  Client left observation area @ 10:40am with family, walking with steady gait.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: patient states he felt a little dizzy
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: today he is experiencing body aches.; This is a spontaneous report received from Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of Covid-19 vaccine (unspecified trade name or manufacture) via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The patient was experiencing body aches on 15Apr2021. Consumer called in to get help with his second appointment. His first shot was 11Mar2021. He has been waiting around to receive a call or email for his second shot. Outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone increased, Chest X-ray, Differential white blood cell count, Dizziness, Electrocardiogram
Clinical narrative: I was driving in my car and i felt my chest pounding fast.  I used my pulse ox machine to check my pulse, and it was at 160. I almost passed out driving. I pulled over, called an ambulance. When they got there 5 minutes later my pupse was 145. I was nauseous, light headed, dizzy and it felt like my heart was coming out of my chest. I went to the ER where they performed various tests. See below.  On 5/4.  I had another bad tachy episode while at work, where my pulse got to 160.  I was able to bring it down, but it took my 1 hrs to not feel dizzy and light headed again. I was again nauseous, dizxy, chest pounding, sweating.   I got an appointment with my PCP that day and had further tests.