chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuralgia, Rash
Clinical narrative: Had severe joint pain and fatigue from 04/26/21-05/02/21, then woke up in the middle of the night with a burning sensation to left side of abdomen and flank. Severe numbness and burning from (05/02-05/07), diagnosed with Neuralgia 05/07 /21, then developed rash the night of 05/07/21. Went to urgent care the morning of 05/08 and diagnosed with Shingles. Prescribed Neurontin and Lyrica for Shingles. I do not have any auto-immmune disorders diagnosed currently but have been tested in the past, not immunocompromised, not under stress, and I have not been exposed to anyone with Shingles or chickenpox.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Night sweats, Pain in extremity, Pyrexia
Clinical narrative: Pain in the arm,  fever (102.5 highest and 99.5 lowest), headache, chills, night sweats, for two nights (Saturday and Sunday ). I took Tylenol and ibuprofen .
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Headache, Pain
Clinical narrative: Body aches, temperature elevation, fatigue, headache.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound scan
Clinical narrative: DVT left calf
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Migraine, Rhinorrhoea
Clinical narrative: Pain in the arm of injection(at site and when moving arm), migraine/headache, forehead feels hot, exhaustion, runny nose.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Pain in the arm of injection(at site and when moving arm), migraine/headache, forehead feels hot, exhaustion, runny nose.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: Rash on left arm started the day after the injection.  Gradually became worse .  By 1 week, large  red spots, extremely itchy,  hot to touch.  Small spots appeared on left side of abdomen and lower right arm.  Started calamine lotion and Benadryl cream.  Rash continues on but  has not spread any more.  At 2.5 weeks  rash still noticeable but less itchy.  Pain at times to left arm, left side of back and left abdomen.  Symptoms seem to be getting better at almost 3 weeks.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Headache that won't go away. (Even with rest, food, water, Tylenol, ibuprofen, aspirin, and/or a mixture of those.) I also have painful, swollen lymph nodes along my left collar bone and on the left side of my neck. I've used gentle heat, it only helps a little. Ibuprofen helps with the pain from the nodes in my collar bone but not my neck.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Tonsillar disorder
Clinical narrative: Tonsil stones. Self extraction.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Feeling abnormal, Feeling hot, Flushing
Clinical narrative: I received my second Moderna dose at about 16:25 in the afternoon. Within a minute or two, I then felt a strange flushing sensation in my left shoulder, neck and left side of the head (the same side where the shot was injected) . This made me very uneasy but I went outside to wait while my husband got his shot. Within five minutes, I felt my heart begin to race and pound extremely hard, like a hammer against my chest. My whole body began to feel hot and I felt weak and shaky. I put my fist on my breastbone and tried to breathe slowly. I wasn't sure if this was anaphylaxis because I've never experienced that before, but this did not feel normal. I texted to my sisters what I was feeling in case something bad happened. I almost got up to tell the pharmacist that I needed help but felt too shaky and didn't want to make a scene. When my husband came out to join me, I told him I wasn't feeling right and my heart was pounding. But I was breathing okay. My tongue started to feel "fuzzy" and thick, so I kept breathing slowly and talking as a way to check if I was going to be okay or get worse. After about ten minutes this strange reaction started to pass. By 16:50, I texted my sisters that I was feeling well enough to get up and complete my shopping. The strangest part was that my heart was beating extremely fast and very hard, like a fist beating against my chest. And that my whole body felt weak and shaky while that was happening.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Palpitations, Tongue disorder
Clinical narrative: I received my second Moderna dose at about 16:25 in the afternoon. Within a minute or two, I then felt a strange flushing sensation in my left shoulder, neck and left side of the head (the same side where the shot was injected) . This made me very uneasy but I went outside to wait while my husband got his shot. Within five minutes, I felt my heart begin to race and pound extremely hard, like a hammer against my chest. My whole body began to feel hot and I felt weak and shaky. I put my fist on my breastbone and tried to breathe slowly. I wasn't sure if this was anaphylaxis because I've never experienced that before, but this did not feel normal. I texted to my sisters what I was feeling in case something bad happened. I almost got up to tell the pharmacist that I needed help but felt too shaky and didn't want to make a scene. When my husband came out to join me, I told him I wasn't feeling right and my heart was pounding. But I was breathing okay. My tongue started to feel "fuzzy" and thick, so I kept breathing slowly and talking as a way to check if I was going to be okay or get worse. After about ten minutes this strange reaction started to pass. By 16:50, I texted my sisters that I was feeling well enough to get up and complete my shopping. The strangest part was that my heart was beating extremely fast and very hard, like a fist beating against my chest. And that my whole body felt weak and shaky while that was happening.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles. Onset 3/23/21 at 4 pm. Treatment with Acyclovir started 3/29/21
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess, Chills, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Fever, chills x 1 day left upper arm: erythema, warmth, tenderness, swelling, early abscess formation . left upper arm pain x 5 days
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills x 1 day left upper arm: erythema, warmth, tenderness, swelling, early abscess formation . left upper arm pain x 5 days
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Pain, Rash erythematous, Swelling, Tenderness
Clinical narrative: Red rash on arm, a few inches away from actual injection site. Swelling, tender, pain.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pruritus, Swelling
Clinical narrative: Injection site is very itchy, like a mosquito bite. Arm is still swollen and red, 3 days after injection.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Dairy intolerance, Diarrhoea, Nausea, Parosmia
Clinical narrative: loss of smell / rancid  Slightly  nauseated  Sharp  taste  Loose stool/ cramping Dairy products  > loose bowels
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: loss of smell / rancid  Slightly  nauseated  Sharp  taste  Loose stool/ cramping Dairy products  > loose bowels
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip swelling
Clinical narrative: On 5/9 at approx 8 or 9pm patient started experiencing a severe headache. Given her history of allergies and angioedema, I had her take 25 mg of oral Benadryl in addition to 500mg of Tylenol. This morning (5/10) when she woke up her upper lip was severely swollen. This sometimes happens with her angioedema, but it is always unilateral, stopping abruptly at midline. This time the swelling was bilateral, involving the entire upper lip, and was more severe than she has ever experienced. She took 240mg Allegra and 40mg Prednisone per MD instructions. Swelling started improving in the afternoon. Patient has known triggers for angioedema, but had none recently, nor had she experienced any angioedema in the last few months.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm for two days. That's ALL, nothing more. THANK YOU for the opportunity to get this vaccine!
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular, Pregnancy test urine negative
Clinical narrative: My menstrual cycle after the first dose came four days late and was much different than normal. After the second dose,  I had Spotting or light menstrual cycle come two weeks earlier than expected. I normally have very consistent cycles and no spotting. I am unsure if the 9 days of spotting I have experienced after my second dose is my menstrual cycle coming two weeks early or breakthrough spotting.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: After the shot the ATM starred to hurt by the elbow and feels no strength in arm. Getting worst
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Tremor
Clinical narrative: After patient received the vaccine of Janssen I saw a hand shake.  When I was going over side effect patient's hand was shaking more.  I asked the patient if hand shaking was normal she stated no and she passed out.  I was able to her upper body from falling.  I asked her husband to hold her and I got an epinephrine 0.3mg Lot # 026a20aa exp 02/22.  I injected epi into her left thigh.  patient woke up after 20 second but she didn't have any memories what happened
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Influenza like illness, Musculoskeletal stiffness, Neck pain
Clinical narrative: SORE AND ACHING JOINTS WITH FLU LIKE SYMPTOMS APPROX 1 1/2 DAYS AFTER SHOT. ON SECOND DAY AFTER SHOT STIFF NECK WITH PAIN ON BOTH SIDES. FLU SYMPTOMS LAST FOR 2 WEEKS AND NECK PROBLEM CONTINUES UNTIL 3 DAYS BEFORE NEXT SHOT BEING 4/25. NECK PAIN BECOMING UNBEARABLE . NOTHING I TAKE WILL HELP. FELT GOOD FOR 3 DAYS.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperreflexia, Hypoaesthesia, Laboratory test, Limb immobilisation, Transient ischaemic attack
Clinical narrative: Lost use of my right arm so I went to the hospital they checked for a clot I teated slightly positive with the blood test then the did an ultrasound and couldn?t find one. The only explication for my Paralysis is a mini stroke.a  Also besides the  numbness and loss of use  I have hyperreflexia.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Headache, Pain
Clinical narrative: Fever103, body aches,  chills,  head ache, chest heaviness/difficulty breathing,  x48 hours Left arm pain-- ongoing
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever103, body aches,  chills,  head ache, chest heaviness/difficulty breathing,  x48 hours Left arm pain-- ongoing
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Urinary tract infection
Clinical narrative: UTI symptoms and frequent urgency starting day after shot
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dosage administered
Clinical narrative: The needle was not all the way tight on syringe and some vaccine dripped out during administration. Most of the dose is believed to be administered.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Tinnitus
Clinical narrative: Tinnitus left ear Hearing loss left ear  Previously never had tinnitus or hearing problems. After about 1 week of 2nd Moderna dose I developed Tinnitus and loss of hearing
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Headache, Heavy menstrual bleeding, Menstruation irregular, Pain
Clinical narrative: Period started day of the shot (Sat), heavier and more cramping than usual, 1 week earlier than expected which is unusual (was not stressed leading up to appt) Fever starting Saturday night, as high as 103, dropped down to 100 at the end of the second day, still ongoing Headache Sunday and Monday Soreness on Saturday, mostly went away on Sunday, but I spent a lot of time swinging my arm around
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Period started day of the shot (Sat), heavier and more cramping than usual, 1 week earlier than expected which is unusual (was not stressed leading up to appt) Fever starting Saturday night, as high as 103, dropped down to 100 at the end of the second day, still ongoing Headache Sunday and Monday Soreness on Saturday, mostly went away on Sunday, but I spent a lot of time swinging my arm around
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Initially I didn't have many adverse outcomes of the shot, but after three weeks I have had a serious outbreak of shingles on my body at 31 years of age.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Chills, Dizziness, Electrocardiogram
Clinical narrative: Chest pains, irregular heartbeat, chills, cold hands, nauseous, light headed/fainting, sweats
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Hyperhidrosis, Peripheral coldness
Clinical narrative: Chest pains, irregular heartbeat, chills, cold hands, nauseous, light headed/fainting, sweats
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Patient states getting JandJ vaccine yesterday, was seen in the ED for same s/s except stating lost of taste and smell starting today. Denies contact with Covid-19
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash on chest/arms/back w/HA x 3 days with itchiness; denies any SOB/N/V/Photophobia/vision changes; reports taking Tylenol 1000mg at 0530 with some relief; J&J rec'd 5May21
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Asthenia, Body temperature increased, Dizziness, Fatigue, Headache
Clinical narrative: Severe muscle soreness, weakness, exhaustion, erratic temp. 96.0 - 99.4, headache, dizzy.
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Myalgia
Clinical narrative: Severe muscle soreness, weakness, exhaustion, erratic temp. 96.0 - 99.4, headache, dizzy.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Arm red and warm to touch around injection site
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Pt present with c/c of headache, chills, and muscle aches x 5 days after getting the covid vaccine. The pt has been taking Tylenol and ibuprofen but state states it has not helped with the symptoms. Pt last took ibuprofen at approx 0900.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue, Pain in extremity
Clinical narrative: An employee of the pharmacist (later told to me by the pharmacist to be an intern) injected me, my wife, and my father-in-law each with an expired Moderna vaccine dose, rather than the Johnson & Johnson dose we had ordered (note: the Johnson & Johnson dose and its lot number were written on our vaccination cards). Our vaccines were administered one after another by the same intern between 11:15am and 11:45am. We were unaware of the error until the pharmacist, called me after I had returned home and eaten lunch (around 12:40pm). The pharmacist explained that his intern had administered the Moderna doses from a stock that was supposed to be disposed of on 4/26/21, suggesting that the doses were expired. Unbelievably, those expired Moderna doses were apparently drawn from their vials into syringes on 4/26/21 and left, at room temperature, in a non-segregated area of the pharmacy, near the Johnson & Johnson doses. My wife, father-in-law, and I were completely distraught and unsure of what would happen. Each of us called our primary care physicians, but the advice was unclear given the uncertainty. Our online searches of Moderna and related vaccine studies also revealed no information on what we could expect to occur from receiving expired doses. In my case, my arm was sore on 4/29 and 4/30, and on 4/30 I was extremely fatigued. My wife and father-in-law experienced similar symptoms, although my wife's were more severe.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Nausea, Pain
Clinical narrative: About 7 hours or so after I was vaccinated I began to feel a pulsing type of headache, but i was tired so I fell asleep. About 3 hours later (around 6am) I woke up with the worst headache I've ever felt. On a  pain scale of 0 to 10 it was a solid 10. It was a splitting headache, a pulsing and crippling pain, it was also sensitive to light. Every time I moved or changed the direction in which I was looking the pain would surge through my head and paralyzed me. I took 1000 MG of acetaminophen and then half an hour later I took 800 MG of ibuprofen. The headache calmed down a for a while, but 8 hours later I was already feeling just as bad as when I felt the headache the worst, so I took another dose of acetaminophen and ibuprofen. The entire day went on like that, along with body aches, some nausea and fatigue. Throughout the next four days,  all of those symptoms gradually diminished. On the third day after vaccination, the injection site felt very sore; my whole arm would hurt every time I moved it.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: About 7 hours or so after I was vaccinated I began to feel a pulsing type of headache, but i was tired so I fell asleep. About 3 hours later (around 6am) I woke up with the worst headache I've ever felt. On a  pain scale of 0 to 10 it was a solid 10. It was a splitting headache, a pulsing and crippling pain, it was also sensitive to light. Every time I moved or changed the direction in which I was looking the pain would surge through my head and paralyzed me. I took 1000 MG of acetaminophen and then half an hour later I took 800 MG of ibuprofen. The headache calmed down a for a while, but 8 hours later I was already feeling just as bad as when I felt the headache the worst, so I took another dose of acetaminophen and ibuprofen. The entire day went on like that, along with body aches, some nausea and fatigue. Throughout the next four days,  all of those symptoms gradually diminished. On the third day after vaccination, the injection site felt very sore; my whole arm would hurt every time I moved it.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Nausea
Clinical narrative: Arm was burning immediately after injection  several hours later pain in lft arm pain left upper chest around to lft back shoulder blade, very nauseated interrupted sleep very fatigued . No treatment waiting on Dr to call me.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Dizziness, Fatigue, Headache
Clinical narrative: Hot/Cold flashes, fever, stomach pain when urinating, nausea, swelling at the injection site, bruising at the injection site, body aches, head/neck aches, muscle pain in upper chest, headache, migraine, extreme fatigue, excessive sweating, swollen lymph nodes, dizziness
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hyperhidrosis, Injection site bruising, Injection site swelling, Lymphadenopathy
Clinical narrative: Hot/Cold flashes, fever, stomach pain when urinating, nausea, swelling at the injection site, bruising at the injection site, body aches, head/neck aches, muscle pain in upper chest, headache, migraine, extreme fatigue, excessive sweating, swollen lymph nodes, dizziness
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Nasopharyngitis, Nausea, Pain
Clinical narrative: Hot/Cold flashes, fever, stomach pain when urinating, nausea, swelling at the injection site, bruising at the injection site, body aches, head/neck aches, muscle pain in upper chest, headache, migraine, extreme fatigue, excessive sweating, swollen lymph nodes, dizziness
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Hot/Cold flashes, fever, stomach pain when urinating, nausea, swelling at the injection site, bruising at the injection site, body aches, head/neck aches, muscle pain in upper chest, headache, migraine, extreme fatigue, excessive sweating, swollen lymph nodes, dizziness
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscle spasms, Peripheral swelling, Pyrexia
Clinical narrative: Severe chills, and high fever at least over a 103.0, but I'm not sure how high it went because I was to sick to check. This was followed by intense muscle cramping in my chest due to the high fever.  I had migraines several times a week that have last lasted until the 2nd dose (today 5/10/2021).  Left arm also swelled to almost double the normal size for about 3 days.  Post shot fatigue lasted about a week.  I checked with an allergist and they said this was a strong immune response because I had had Covid previously, and not an allergic reaction. They also said that my second dose reaction should be less strong.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Gingival blister, Herpes zoster, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: On 24th onset of severe pain on trigeminal nerve and fever of up to 101. Continued through 25th, went to Urgent care on 26th. Started on prednisone. Assumed just a trigeminal flare up. Then blisters erupted on gum and roof of mouth on 27th making it clear it was shingles. Started on antiviral (valtrex) that day. I had chicken pox as an adult in my mid 20s and have had two bouts of shingles before this. This was the worst by far. I had the first dose of Shingrex about 2 years before vaccination. Was also given antibiotic on 26th, which I did not take as the doctor said not to as long as it appeared viral. Which it turned out to definitely be. My GP on my visit today said to use the form here to report this.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Trigeminal neuralgia
Clinical narrative: On 24th onset of severe pain on trigeminal nerve and fever of up to 101. Continued through 25th, went to Urgent care on 26th. Started on prednisone. Assumed just a trigeminal flare up. Then blisters erupted on gum and roof of mouth on 27th making it clear it was shingles. Started on antiviral (valtrex) that day. I had chicken pox as an adult in my mid 20s and have had two bouts of shingles before this. This was the worst by far. I had the first dose of Shingrex about 2 years before vaccination. Was also given antibiotic on 26th, which I did not take as the doctor said not to as long as it appeared viral. Which it turned out to definitely be. My GP on my visit today said to use the form here to report this.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact
Clinical narrative: Had a very small amount of poison oak on left wrist at time of shot. Few days after shot the poison oak morphed into a very disturbing looking dark crater with white haze over it and had become most likely cellulitis that required antibiotics
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash, SARS-CoV-2 test negative
Clinical narrative: severe headache within 24 hours (resolved within 1 day), rash between breasts and onto upper abdomen - applying prescription ointment, remains ongoing
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: High pitched ringing in my ears began on the dates listed on this form. It has not yet subsided.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Pallor, Syncope
Clinical narrative: Patient received vaccine and was waiting in front of pharmacy for his allotted time. I noticed his head was down and he was kind of sunk in his chair. Went out to assist him, but he had fainted. I grabbed his shoulder and shook him for about 30 seconds and he came to. He was a little disoriented and pale and pulse was fast. he refused us calling for an  ambulance. I directed him to sit on the floor. We sat and talked for about 30 minutes until he felt well enough to drive home
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Diarrhoea, Dizziness, Fatigue
Clinical narrative: 1st dose; arm soreness, body ache and tiredness for 3 days. 2nd dose; arm soreness, body ache and tiredness first two days. Third day, left arm fully sore up to the armpit. Arm swollen area where shot was done. Full body ache, weak, dizziness. Diarrhea from 4am to 7pm. Cloudy mind, heart palpitations.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site swelling, Pain, Pain in extremity, Palpitations
Clinical narrative: 1st dose; arm soreness, body ache and tiredness for 3 days. 2nd dose; arm soreness, body ache and tiredness first two days. Third day, left arm fully sore up to the armpit. Arm swollen area where shot was done. Full body ache, weak, dizziness. Diarrhea from 4am to 7pm. Cloudy mind, heart palpitations.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Pruritus, Rash
Clinical narrative: Got lightheaded intialky. Through out the day I slept b hurt then I woke up short of breath and itchy with a slight rash on my chest. I had but if itchiness in my arms but no sign of rash and she watched me an additional 15 minutes to the original 10. Pharmacist gave me shot in left arm.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Specialist consultation, Visual impairment, Vitreous floaters
Clinical narrative: 04/21/2021,  a few hours after the 2nd vaccine shot, I developed a fever and saw black spots. It went away after 24 hours. Then on 05/01/2021, in the evening, the spots returned this time with wiggly lines and floaters. it is mostly in the right eye... and it remains presently.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Adnexa uteri pain, Menstruation delayed, Premenstrual pain
Clinical narrative: I missed my period but have felt all of the pre-period symptoms which include tenderness of breast, cramps, bloating, etc.  My ovaries also feel swollen or tender but no period.   It is now more than 10 days late.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypotension, Syncope
Clinical narrative: Reflex syncope (vasovagal reflex); Decreased blood pressure 60/40; This is a spontaneous report from a contactable consumer (parent). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA 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's medical history and concomitant medications were not reported. The patient experienced decreased blood pressure 60/40 and reflex syncope (vasovagal reflex) on unspecified date. The clinical outcome of decreased blood pressure 60/40 and reflex syncope (vasovagal reflex) was unknown. Information about lot/batch number has been requested.
Age: 0.33
Sex: U
Vaccine: HIBV, PNC13
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No additional adverse event reported; PEDVAX HIB was possible given in the thigh/more medially than as recommended in the prescribing information; Caller unsure of which product was given more laterally and which one was given more medially; This spontaneous report was received from a physician concerning a 4-months-old patient of unknown gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 29-MAR-2021, the patient was vaccinated with the second dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliters intramuscular route, lot number T026067 expiration date 01-APR-2023 for prophylaxis. On the same date the patient was vaccinated pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) 0.5 milliliters intramuscular route, lot number DX8301 and expiration date 31-JAN-2023 also for prophylaxis.   The dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB was possibly given in the thigh, more medially than recommended by the prescribing information. The dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) was also given on the same thigh. It was not clear which product was administered more medially or laterally. No additional adverse event was reported.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported, and no further information provided. No PQC identified; the patient had been inadvertently administered PROQUAD and V ARlV AX at the same appointment.; the patient had been inadvertently administered PROQUAD and V ARlV AX at the same appointment.; This spontaneous report has been received from a health care professional, referring about a 1-year-old male patient. Information about the patient's pertinent medical history, concurrent conditions and previous drug reactions and allergies was not provided. The patient's pertinent concomitant medications included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine inactivated (unspecified) (+) tetanus toxoid (DTap), hepatitis A virus vaccine inactivated (HAVRIX), Hib conj vaccine (tet toxoid) (ACTHIB), and pneumococcal 13v conj vaccine (CRM197)( PREVNAR 13/PCV13). The patient had 3 siblings (2 brothers and 1 sister).   On 15-APR-2021, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type: rHA), at a dose of 0.5 milliliter (mL), administered subcutaneously, in the right thigh; lot number T013542, with and expiration date on 17-OCT-2021 for prophylaxis. On the same date, the patient was also vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX), at a dose of 0.5 mL, administered subcutaneous in the left thigh, lot number T006345 and expiration date 20-FEB-2022 (conflicting information since it was also reported as "15-AUG-2019") for prophylaxis. The nurse practitioner reported that the patient was administered both vaccines inadvertently by the health professional since it was in training probation period. (inappropriate schedule of product administration) (incorrect dose administered). She inquired what to tell the parents to watch in regard to safety. No additional adverse event reported.  The vaccines were not available for returned for evaluation since they were used as a single used syringe. No temperature excursion occurred as a result of a reading from a Digital Data logger.
Age: 1.5
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product temperature excursion issue
Clinical narrative: No additional AE; temperature excursion on VARlVAX and was administered; This spontaneous report was received from an office manager referring to a 18-month-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 03-MAY-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dosage form, lot number T021825, expiration date 25-JUN-2022 (route of administration not provided) for prophylaxis. No adverse event was reported.  The vaccines experienced a temperature excursion between -50 degrees Celsius (°C) and -15°C with a maximun temperature of 5.3°C for 45 minutes. The call was due to digital data logger. There were no previous temperature excursions.  This is one of 2 reports notified by the same reporter; Sender's Comments:  US-009507513-2105USA000689:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; an expired dose of PROQUAD was administered to a patient; This spontaneous report was received from a medical assistant regarding a 5 year old patient. No information regarding concurrent conditions, drug allergies or reactions, medical history or concomitant medications was provided.  On 04-MAY-2021 the patient was administered an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) rHA 0.5 ml  for prophylaxis (lot S035108  with expiration date reported and verified as valid on 03-MAY-2021) (expired product administered). No temperature excursions or additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; PROQUAD was administered on 05MAY2021 that expired on 02MAY2021; This spontaneous report as received from a pharmacist and medical assistant concerning  a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.   The pharmacist and Medical assistant reported that on 05-MAY-2021, the patient was vaccinated with an expired  dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S035111, expiration date reported as 02-MAY-2021 but upon internal validation established as 03-MAY-2021), dose:0.5 milliliter for prophylaxis (dose number was not reported).    Concomitant therapies included sterile diluent (STERILE DILUENT).     The Medical assistant reported that the patient denied further adverse event or temperature excursion with the vaccine. No product quality complaint. No additional adverse event details. No additional adverse events reported
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; M-M-R-II expired was administered on may 6th 2021; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.       On 06-MAY-2021, the patient was vaccinated with expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHa), at a dose of 0.5 milliliter for prophylaxis (strength, route of administration and anatomical location were not reported, lot # S013536  had been verified to be a valid number; expiration date 02-MAY-2021). It was reported the use of sterile diluent (STERILE DILUENT VACCINES). No additional adverse event reported.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Caller states customer reported a 15 year old female patient developed hives after 3rd dose of GARDASIL 9; This spontaneous report was received from a consumer, referring to a 15-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies were not reported.  On an unknown date, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, frequency, anatomical site of injection, route of administration, lot number and expiration date were not reported) as prevention of human papillomavirus infection (HPV) (prophylaxis).  On an unknown date, the patient developed hives (urticaria) after the administration of the dose.  The outcome of urticaria and the causal relationship between the event and the suspect therapy were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: HEART RATE HIGH; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient was on beta blockers and high blood pressure medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date, the patient experienced heart rate high. Patient was hospitalized (date unspecified) for 3 days with a code blue called. Patient wore a fitbit and had a record of heart rate for a year.152 sitting was too high. On an unspecified date in 2021, Laboratory data included: Heart rate (NR: not provided) 152. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reaction was not reported. This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0: 20210504075-COVID-19 VACCINE  AD26.COV2.S-Heart Rate High. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a company representative concerned a 42 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry were unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, between three to ten days later after vaccination the patient died due to blood clots. It was unknown, whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0;20210510772-covid-19 vaccine ad26.cov2.s-Thrombosis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOT
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: ITCHING ON WRISTS, FOREARMS AND ANKLES; RASH ALL OVER BODY; This spontaneous report received from a patient concerned a 23 year old female. The patient's weight was 152 pounds, and height was 61 inches. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAY-2021, the subject experienced itching on wrists, forearms and ankles. On 04-MAY-2021, the subject experienced rash all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash all over body, and itching on wrists, forearms and ankles. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Decreased appetite, Feeling abnormal, Weight decreased
Clinical narrative: NO APPETITE; LOOSING WEIGHT; ABDOMINAL PAIN THAT FEELS LIKE STARVING; FEELING MISERABLE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced no appetite. On 2021, the subject experienced loosing weight. On 2021, the subject experienced abdominal pain that feels like starving. On 2021, the subject experienced feeling miserable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the no appetite, loosing weight, abdominal pain that feels like starving and feeling miserable was not reported. This report was non-serious. This case, from the same reporter is linked to 20210511723.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included dizziness, numbness, and vitamin d deficiency, and concurrent conditions included hypertension, and chronic pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: LIKE A FLU; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced like a flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of like a flu was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: UNEXPECTED BENEFIT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included tiredness, and sleeping a lot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced unexpected benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected benefit was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: VERY TIRED; This spontaneous report received from a patient concerned a 95 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included skin cancer, neuropathy, and no-healing wound in leg. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included gabapentin for skin cancer. On 07-MAY-2021, the subject experienced very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: ANXIETY; This spontaneous report received from consumer concerned 64 patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anxiety was not reported. This report was non-serious.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Disturbance in attention, Dizziness, Dry mouth
Clinical narrative: FEELS DRAINED; FEELS SLEEPY; HARDER TO BREATHE; LOSING TRACK OF THOUGHT/COGNATIVE THOUGHT IS OFF; TEETH ACHE; LOSS OF APPETITE; LIGHTHEADED; MASSIVE RINGING THE EARS; DRY MOUTH; LEFT HAND FEELS TINGLY; LEFT HAND FEELS NUMB; CHILLS; FEELS EXHAUSTED; LEFT ARM IS SORE AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 52 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced feels sleepy. On 08-MAY-2021, the subject experienced harder to breathe. On 08-MAY-2021, the subject experienced losing track of thought/cognative thought is off. On 08-MAY-2021, the subject experienced teeth ache. On 08-MAY-2021, the subject experienced loss of appetite. On 08-MAY-2021, the subject experienced lightheaded. On 08-MAY-2021, the subject experienced massive ringing the ears. On 08-MAY-2021, the subject experienced dry mouth. On 08-MAY-2021, the subject experienced left hand feels tingly. On 08-MAY-2021, the subject experienced left hand feels numb. On 08-MAY-2021, the subject experienced chills. On 08-MAY-2021, the subject experienced feels exhausted. On 08-MAY-2021, the subject experienced left arm is sore at the injection site. On 08-MAY-2021 20:00, the subject experienced feels drained. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from teeth ache, and massive ringing the ears, and had not recovered from feels drained, chills, feels sleepy, harder to breathe, losing track of thought/cognative thought is off, loss of appetite, lightheaded, dry mouth, left hand feels tingly, left arm is sore at the injection site, feels exhausted, and left hand feels numb. This report was non-serious.