chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Musculoskeletal stiffness, Throat irritation, Tremor
Clinical narrative: "Throat is on fire", hot/stiff neck, shortness of breath, very shaky (unable to ambulate).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Injection site swelling, Lethargy, Malaise
Clinical narrative: Started about 5 a.m. this morning.  My left upper arm is very swollen at the injection site.  No redness.  Very sore.  I am tired and achy.  I had a stuffy nose at around 5 a.m. today that appears to be getting better.  I feel lethargic and unwell.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain
Clinical narrative: Started about 5 a.m. this morning.  My left upper arm is very swollen at the injection site.  No redness.  Very sore.  I am tired and achy.  I had a stuffy nose at around 5 a.m. today that appears to be getting better.  I feel lethargic and unwell.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pain
Clinical narrative: Patient is reporting mild body aches and headaches, she also reports fatigue along with nausea and loose bowels.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Palpitations
Clinical narrative: Patient received her first dose of Moderna Covid vaccine on December 30, 2020, at 9:00 am. At 11;15 she started to experience palpitation and dizziness.  911 called and she has elevated blood pressure, she was sent to Medical Center.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate increased, Pain in extremity
Clinical narrative: Employee phoned and reported what he believes is a symptom from the COVID-19 Vaccine. He reported almost like a fluttery, burst of energy feeling. He said his pulse was a little elevated  for him in the 80s, but regular. He stated he felt this way for about 1 hour, and then went away. It felt like he had just chugged 3 red bull drinks. He also said his arm he received the vaccination in was very sore the next day...more so than when getting the flu vaccination. This employee is an ED physician.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Headache, Injection site induration, Injection site pruritus
Clinical narrative: Itching at the vaccine site started about an hour or so after injection. Soreness in the muscle started about 6 hours after injection. Itching continued. Upon waking up the following morning, no more itching, but a raised hard lump at the injection site present. It?s about the size of a quarter, hot to the touch, and extremely sore. As the morning progressed, I felt tightness and burning in my chest upon inspiration that has progressively gotten worse throughout the day. Around 12:30 I have developed a headache and I feel very fatigued.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Itching at the vaccine site started about an hour or so after injection. Soreness in the muscle started about 6 hours after injection. Itching continued. Upon waking up the following morning, no more itching, but a raised hard lump at the injection site present. It?s about the size of a quarter, hot to the touch, and extremely sore. As the morning progressed, I felt tightness and burning in my chest upon inspiration that has progressively gotten worse throughout the day. Around 12:30 I have developed a headache and I feel very fatigued.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Neck pain, Pain
Clinical narrative: At 0100 on 12/29 woke up with severe arm and neck pain.  Treated at that time with Ibuprofen and heating pad.  By 0900 developed a fever, body aches, headache, chills, and skin burning.  Fever persisted until 0100 on 12/30.  Mild residual body aches 12/30 and fatigue.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Skin burning sensation
Clinical narrative: At 0100 on 12/29 woke up with severe arm and neck pain.  Treated at that time with Ibuprofen and heating pad.  By 0900 developed a fever, body aches, headache, chills, and skin burning.  Fever persisted until 0100 on 12/30.  Mild residual body aches 12/30 and fatigue.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Intensive care, Localised oedema, Pharyngeal swelling, Pruritus
Clinical narrative: Patient administered Pfizer-BioNtech vaccine, dose #1 in series at 810AM, without notable concerns for 10 minutes. At 10 minutes post vaccination, patient developed itching and some blotching, throat becoming scratchy. No known allergies to components listed in vaccine, though does have a listed allergy to contrast dye, does not carry an epi-pen.   Patient was walked to urgent/emergency care in the clinic, where she was seen immediately. Patient was given diphenhydramine 25 mg IV, pantoprazole 40 mg IV, with mild uticaria continuing. Patient notes she feels her 'back is on fire'. Patient was then given methylprednisolone 125 mg  IV.  At this time, no SOB is noted, uticaria is still present. 0930 patient reports swelling in throat and respiratory difficulties at this time with visible edema in the neck. 0.3 mg Epinephrine given at 0935, epinephrine drip and racemic epinephrine neb given. 1006 Patient on epinephrine drip 2.5 mics/hour.  Patient transferred to Medical Center ICU, where she remains at the time of this report.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Skin burning sensation, Throat irritation, Urticaria
Clinical narrative: Patient administered Pfizer-BioNtech vaccine, dose #1 in series at 810AM, without notable concerns for 10 minutes. At 10 minutes post vaccination, patient developed itching and some blotching, throat becoming scratchy. No known allergies to components listed in vaccine, though does have a listed allergy to contrast dye, does not carry an epi-pen.   Patient was walked to urgent/emergency care in the clinic, where she was seen immediately. Patient was given diphenhydramine 25 mg IV, pantoprazole 40 mg IV, with mild uticaria continuing. Patient notes she feels her 'back is on fire'. Patient was then given methylprednisolone 125 mg  IV.  At this time, no SOB is noted, uticaria is still present. 0930 patient reports swelling in throat and respiratory difficulties at this time with visible edema in the neck. 0.3 mg Epinephrine given at 0935, epinephrine drip and racemic epinephrine neb given. 1006 Patient on epinephrine drip 2.5 mics/hour.  Patient transferred to Medical Center ICU, where she remains at the time of this report.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: Started the symptoms the next day 12/24: worn down, cough, weak, chill, difficulty breathing.  On Sunday got worse 12/27:  Staff used inhaler.  Went to work and was sent home by his boss. slightly better today, still using inhaler.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling jittery, Heart rate increased, Hot flush
Clinical narrative: Complaints of feeling flush, increased heart rate and jitter at around 8:52 following a COVID-19 injection at 8:45.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Hives and itching to right arm and redness to left arm shortly after vaccine. Patient taken to emergency department for evaluation.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Injection site discomfort, Injection site mass
Clinical narrative: Vaccine is Pfizer-BioNTech COVID-19 Vaccine EAU  Approximately 2 hours after injection small lump and discomfort. By the next morning, warmth, further discomfort, further swelling. Today is day 6 after the injection and I still have a lump with slight tenderness. Itch to the area started on day 3, intermittent and "manageable". Largest spread of redness and firmness was from day 2-4 that was approximately 3.5 inches from top to bottom and 3 inches wide. Today, on day 6, it is down to a little less than 1 inch from top to bottom and a little under 1.5 inches from side to side. It is tender if pushed on, but no longer tender to touch.  Intermittent rigors (severe shaking with chills) occurred on both evenings of nights day of injection and day 2.  Minor low back pain with only posterior upper bilateral leg discomfort occurred on day 2. Minor frontal headache occurred twice and resolved with Tylenol both times, on eve of days 2 and 3. PCP made aware of side effects.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Vaccine is Pfizer-BioNTech COVID-19 Vaccine EAU  Approximately 2 hours after injection small lump and discomfort. By the next morning, warmth, further discomfort, further swelling. Today is day 6 after the injection and I still have a lump with slight tenderness. Itch to the area started on day 3, intermittent and "manageable". Largest spread of redness and firmness was from day 2-4 that was approximately 3.5 inches from top to bottom and 3 inches wide. Today, on day 6, it is down to a little less than 1 inch from top to bottom and a little under 1.5 inches from side to side. It is tender if pushed on, but no longer tender to touch.  Intermittent rigors (severe shaking with chills) occurred on both evenings of nights day of injection and day 2.  Minor low back pain with only posterior upper bilateral leg discomfort occurred on day 2. Minor frontal headache occurred twice and resolved with Tylenol both times, on eve of days 2 and 3. PCP made aware of side effects.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Rash
Clinical narrative: Rash, fever, chills and body aches.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold
Clinical narrative: Patient reported he felt cold all day the subsequent day (12/22/20) to vaccine administration.  Then around 4 pm on 12/22/20 he began experiencing rigors and extreme chills.  The patient did not take his temperature.  He went to bed and felt back to normal the following morning (12/23/20).  This patient is also an infectious disease physician and he had COVID in April 2020.  He has had no further issues.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Skin warm
Clinical narrative: I got my vaccine on Monday 12/21/20, On Tuesday I notice a quarter size red mark it the injection site. On Wednesday I notice the red mark a little bigger. On Thursday I notice the red mark move up to my shoulder and  half way down the arm  to the elbow. The arm is warm to the touch.  Took benadryl and resolved thereafter
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pruritus
Clinical narrative: Itchy over entire body, chills
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Severe muscle pain at injection site, radiating down arm (severity of 7 on 0-10 pain scale) which interfered with activities and sleep. Treated with ibuprofen, ice, heat, and a topical analgesic. This brought pain down to a 2 on 0-10 scale. Severe pain subsided approximately 27 hours later, though very mild pain remains.  Severe fatigue present approximately 48 hours after receiving the vaccine.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Retching
Clinical narrative: Fever, chills, gagging, headache, aching body.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Pain in extremity, SARS-CoV-2 test
Clinical narrative: 12/24/2020 ARM PAIN 12/25/2020 FATIGUE, COUGH, ARM PAIN, HA; PERSISTED .  SECOND PREGNANCY; 18 WEEKS PREGNANT; DOB 06/2/2021
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Headache, light headedness, cold chills, sweats, weakness, nausea
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Headache, light headedness, cold chills, sweats, weakness, nausea
Sex: U
Vaccine: VARZOS
Symptoms: Axillary pain, Oedema peripheral, Swelling, Tenderness
Clinical narrative: my armpit is swollen; my armpit is / tender; This case was reported by a consumer and described the occurrence of local swelling in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 4th December 2020, the patient received Shingles vaccine. In December 2020, less than a week after receiving Shingles vaccine, the patient experienced local swelling and axillary pain. On an unknown date, the outcome of the local swelling and axillary pain were unknown.   It was unknown if the reporter considered the local swelling and axillary pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. It was reported that patient received the Shingles vaccine and after that experienced swollen armpit with tenderness.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Upper respiratory tract infection
Clinical narrative: upper respiratory  infection; was so sick; This case was reported by a consumer via interactive digital media and described the occurrence of upper respiratory tract infection in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent unspecified season. On an unknown date, several days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced upper respiratory tract infection and sickness. The patient was treated with antibiotics nos. On an unknown date, the outcome of the upper respiratory tract infection was unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the upper respiratory tract infection and sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Flu shot once in life.  The patnt had always been healthy.  A few days later the patient got the worst upper respirator infection in life.  The patient was so sick for 12 long weeks.  The patient made 4 trips to the doctor and they had to keep switching the antibiotics and finally patient was on complete bed rest because it would not go away The patient thought wasn't going to make it.  The patient would never take another vaccine.  The patient had not been sick sense that was almost 10 years ago. It was reported They were poison.
Sex: U
Vaccine: FLUX
Symptoms: Gait disturbance, Near death experience
Clinical narrative: almost killed me / every side effect; almost killed me / could not even walk; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced near death experience (serious criteria GSK medically significant and life threatening) and walking difficulty (serious criteria life threatening). On an unknown date, the outcome of the near death experience and walking difficulty were unknown.   It was unknown if the reporter considered the near death experience and walking difficulty to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: 1st and last flu shot, that the patient took almost killed the patient, every side effect the patient got and could not even walk.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Noninfective gingivitis
Clinical narrative: inflamed gums from eye tooth to eye tooth; This case was reported by a consumer via call center representative and described the occurrence of gingival inflammation in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2020, the patient received Shingrix. On an unknown date, between 1 and 3 weeks after receiving Shingrix, the patient experienced gingival inflammation. On an unknown date, the outcome of the gingival inflammation was not recovered/not resolved.   It was unknown if the reporter considered the gingival inflammation to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient.  The age at vaccination was not reported. She reported that she got the Shingrix shot and about a week or two later, she got all inflamed gums from eye tooth to eye tooth. She visited her doctor regarding this and neither she nor her doctor knows if the Shingrix was responsible for causing the gum inflammation. She told that her doctor took bloodwork to help determine the cause.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles in her waist / still have it / second dose / administrated on November 19 2020; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number E9Y5M, expiry date 19th June 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 19th November 2020, the patient received the 2nd dose of Shingrix. On 20th November 2020, 1 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The pharmacist reported that patient had shingles in her waist after the administration of the second dose of Shingrix. The patient still had shingles on day of reporting. The reporter consented to follow up
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash in belly button area; This case was reported by a consumer via call center representative and described the occurrence of rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included mastectomy.   On 30th October 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: A rash presented on the belly button area of the stomach 2-3 days following administration of the 2nd vaccine.  It started small and became larger.   It started at 3 millimeters by 1 centimeter and was much larger measuring about 1 inch by 3 by 4 inch. Did not consent to follow-up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Head discomfort, Headache, Pyrexia
Clinical narrative: head felt heavy; chills; Headache; Fever; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. There were no relevant medical history and concomitant medications.  On 21Dec2020, the patient had the Covid-19 vaccine yesterday and experienced reactions. She works at the hospital and was administered the vaccine. They have to wait and be monitored for 15 minutes following the vaccine. Ten minutes after she had the vaccine her head felt heavy. She said she would be ok. Her blood pressure and oxygen sats were checked. Then she had a fever of 100.4. She also had chills and a headache that came back later in the day and she took acetaminophen. She had chills and a fever of 101.4 again at the time of report (22Dec2020). She had not taken any acetaminophen at the time of report. She does not have any shortness of breath. The patient recovered from the event head felt heavy and headache, while not recovered for chills and fever.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Swelling face
Clinical narrative: patient got up and woke up on the floor; She never passed out. She got out of her chair, turned off the light and woke; Turned off the light and woke w a bruise to my right cheek; swelling to the right side of my head; This is a spontaneous report from a contactable emergency room nurse (patient).  A elderly female patient (also reported as age: 61; unit: unknown) received the first single dose of BNT162B2 (Lot number: El0249, exp date not reported), intramuscular (vaccine location: Left arm) on 21Dec2020 at 06:15 AM for immunization. Medical history included hypertension (HTN). The patient had no known allergies. Concomitant medication included meloxicam (MOBIC), levothyroxine sodium (SYNTHROID), lisinopril, and metoprolol tartrate (LOPRESSOR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020 at 08:45 AM the patient got up and woke up on the floor. She never passed out. She got out of her chair, turned off the light and woke with a bruise on her right cheek and swelling to the right side of her head. She was a bit freaked out just worked "another 12" with no side effects. No treatment was received for the adverse events. The events were considered as non-serious by the reporter. The patient did not receive prior Covid vaccination and was not tested for Covid post vaccination. The patient recovered from the events on an unspecified date in Dec2020.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Paraesthesia
Clinical narrative: stiff neck/other side of her neck was stiff; face started tingling; This is a spontaneous report from a contactable Nurse (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5130, expiry date unknown) via unspecified route of administration at left deltoid on 22Dec2020 at single use for COVID-19 immunization. Medical history included true nut allergies (has an epi pen at home), migraines (used Imitrex injections), menopause. The patient got the COVID-19 vaccination this morning 22Dec2020. They said to wait 10 minutes then she could leave. She felt fine. As she was leaving on 22Dec2020, employee services was far away from where she parked, she was almost to the parking lot and started feeling like she had a stiff neck. She thought she slept wrong, she did not think it was related. Then the other side of her neck was stiff. So she was waiting in her car and did not drive away in case she needed to go back inside. Then her face started tingling. It came on gradual and lasted 4-5 minutes and then it went away. She was fine now. She was at home. She feels fine, she was not short of breath. She did have an epi pen at home due to true nut allergies, but she has no concern over potential respiratory problems or anything like that. In the past she had migraines, and she would use Imitrex injections. Right before it would make her migraine go away, she would feel a muscle spasm in her neck and it would release and her headache would go away. She would compare her symptoms to that. She has not had an Imitrex injection in years. Her headaches went away after menopause and she has not needed them. Her primary care did not administer the vaccination. She received it at the hospital where she worked. She was wondering, should she get the second dose of vaccination. Again, she was not at all concerned, she had felt this similar feeling before, but the face tingling was new. She thought this should be reported as this was a brand new vaccine. The outcome of the events stiff neck/other side of her neck was stiff, face started tingling was recovered on 22Dec2020. The reporter considered the events non-serious and face started tingling related.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Sensation of foreign body, Throat irritation
Clinical narrative: Throat felt like a knot on it side and hot; Throat felt like a knot on it side and hot; This is a spontaneous report from a contactable other healthcare professional.  A 43-year-old female patient received the first dose of bnt162b2 (COVID-19 vaccine) lot no: EJ1685, intramuscular on 22Dec2020 11:45 at a single dose for COVID-19 immunization in the hospital. The patient's medical history was not reported. Concomitant medications included birth control, thyroid meds, stomach meds. No other vaccines were administered in four weeks. On 22Dec2020 12:00, the patient experienced throat felt like a knot on it side and hot. The patient recovered from the events. on 22Dec2020 12:00. The events were reported as non-serious. The patient did not receive treatment for the events.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: body aches; headache; This is a spontaneous report from a contactable unspecified health professional.  A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EH9899, via an unspecified route of administration in the right arm, from 18Dec2020 15:15 at a single dose for covid-19 immunization. Patient is not pregnant. Medical history included sulfa drugs allergy from an unknown date. The patient's concomitant medications were not reported. On 19Dec2020, the patient began having body aches and headache 24 hours after injection that lasted 12 hours. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected. The information on the batch/lot number was obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeding disorder, Fluid intake reduced, Lymphadenopathy
Clinical narrative: vomiting; right gland felt sore and swollen; right gland felt sore and swollen; diarrhea; nausea; unable to eat or drink; already exhausted and went to sleep; This is a spontaneous report from two contactable healthcare professionals (one of which is the patient herself). A 40-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscular at left shoulder muscle (Deltoid Left) on 19Dec2020 14:30 at a single dose for COVID-19 immunisation. There were no medical history and no concomitant medications. The patient has no prior vaccinations (within 4 weeks prior to the first administration of Covid-19 vaccine). The patient reported that within 10 mins of vaccination, her right gland felt sore and swollen, lasted 24 hours and went away. She was already exhausted, and she fell asleep when she went home in Dec2020. She couldn't hold down any food or water for about 24 hours, and this started about 10 minutes after getting the vaccine on 19Dec2020. She has had violent vomiting within 10 minutes of receiving the vaccine on 19Dec2020, and she also had diarrhea really bad on 19Dec2020. She was unable to eat or drink from diarrhea and from nausea also. She was only able to eat on Monday (21Dec2020); she ate 2 granola bars and was able to hold down water. Today on 22Dec2020, she went to the bathroom and it was just water. She has talked to HCP. She would get the second vaccine on the 9th and wanted to know what she should expect. She is asking if she will have these symptoms again or will they worsen, because she has 2 kids to take care of. The adverse events did not require visit to Emergency Room. She reported to have a negative COVID-19 virus test (COVID-19 MC 2000 slide and rapid COVID-19 swab) on unspecified date. The outcome of the events "unable to eat or drink" and diarrhea was not recovered; for the events vomiting and nausea was recovering; while for the other events was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test negative, Vomiting
Clinical narrative: vomiting; right gland felt sore and swollen; right gland felt sore and swollen; diarrhea; nausea; unable to eat or drink; already exhausted and went to sleep; This is a spontaneous report from two contactable healthcare professionals (one of which is the patient herself). A 40-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscular at left shoulder muscle (Deltoid Left) on 19Dec2020 14:30 at a single dose for COVID-19 immunisation. There were no medical history and no concomitant medications. The patient has no prior vaccinations (within 4 weeks prior to the first administration of Covid-19 vaccine). The patient reported that within 10 mins of vaccination, her right gland felt sore and swollen, lasted 24 hours and went away. She was already exhausted, and she fell asleep when she went home in Dec2020. She couldn't hold down any food or water for about 24 hours, and this started about 10 minutes after getting the vaccine on 19Dec2020. She has had violent vomiting within 10 minutes of receiving the vaccine on 19Dec2020, and she also had diarrhea really bad on 19Dec2020. She was unable to eat or drink from diarrhea and from nausea also. She was only able to eat on Monday (21Dec2020); she ate 2 granola bars and was able to hold down water. Today on 22Dec2020, she went to the bathroom and it was just water. She has talked to HCP. She would get the second vaccine on the 9th and wanted to know what she should expect. She is asking if she will have these symptoms again or will they worsen, because she has 2 kids to take care of. The adverse events did not require visit to Emergency Room. She reported to have a negative COVID-19 virus test (COVID-19 MC 2000 slide and rapid COVID-19 swab) on unspecified date. The outcome of the events "unable to eat or drink" and diarrhea was not recovered; for the events vomiting and nausea was recovering; while for the other events was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat; cough; fever; Muscle soreness in right arm; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscular in right arm on 20Dec2020 16:00 at a single dose for COVID-19 immunization. The vaccine was administered in the hospital. The patient has no medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced sore throat, cough, fever, and muscle soreness in right arm on 21Dec2020 08:00 AM. The events were reported as non-serious. The patient did not have COVID prior vaccination and did not have COVID test post vaccination. No treatment was received for the events. The outcome of the events at the time of last observation was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Muscular weakness
Clinical narrative: Left arm nagging ache from elbow to wrist; weakness to each thigh; This is a spontaneous report from a non-contactable other health care professional. An adult patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E51685), intramuscular in left arm, on 18Dec2020 14:30, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took nitrofurantoin (MACROBID) and experienced allergies. The patient experienced left arm nagging ache from elbow to wrist and weakness to each thigh on 19Dec2020 at 18:00. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-10 since vaccination. The reporter assessed the events as non-serious. The outcome of the events was recovered with sequel (reported as recovered with lasting effects).  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: having soreness in her arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable other healthcare professional (patient) reported a 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKF730 and expiration date unknown) via an unspecified route of administration at the arm on 22Dec2020 at a single dose for COVID-19 immunization. The patient has no medical history. There were no concomitant medications. The patient experienced soreness in the arm that the vaccine was given on an unspecified date in Dec2020. The outcome of the event was unknown. The patient was curious if she can take ibuprofen instead of Tylenol. The reporter stated that she does not think that the event soreness in the arm that the vaccine was given was because of the vaccine; not because of the vaccine necessarily and clarified that probably because of the needle being injected in.
Sex: F
Vaccine: COVID19
Symptoms: Contraindication to vaccination
Clinical narrative: cramping / related to her menstrual cycle; This is a spontaneous report from a contactable consumer (patient's mother). A 25-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration in arm on 22Dec2020 (time between 10 and 11), single dose for COVID-19 immunization. There were no medical history and concomitant medications. The mother has a question or concern she was not sure. Her daughter was a nurse and got the vaccine this morning. An hour later she took naproxen sodium (ALEVE). Her daughter was now concerned and anxious, that she has messed up the efficacy of the vaccine. She took the naproxen sodium because she was having cramping pain unrelated to the vaccine. The patient does not know when the cramping started, she states that it was related to her menstrual cycle. She came home from work, she had the vaccine at her work which was the hospital, she was a night nurse, she was having twinging, so she took the naproxen sodium so she could sleep. She took 2 tablets an hour after receiving the vaccine. She has not been positive for COVID. Clarifying she has not tested positive in a COVID test. She was not tested for antibodies. Therapeutic measures were taken as a result of cramping. The outcome of the event was unknown.  Information for Lot/Batch number has been requested.; Sender's Comments: The event cramps menstrual is considered an intercurrent medical condition and is assessed as unrelated to BNT162B2.
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Injected limb mobility decreased, Magnetic resonance imaging abnormal, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Small rotator cuff tear; Extreme pain in her right arm all over; Difficulty lifting and putting behind her back/ could not move right arm; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown) via an unspecified route of administration at the right arm on an unspecified date in 2013 (reported as 7 years ago) in the afternoon at a single dose for prevention because of age in  the doctor's office. Medical history included hypothyroidism from an unknown date. It was reported that hypothyroidism was the only endocrine disorder and it was diagnosed way before receiving pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). Concomitant medication included influenza vaccine administered on the left arm vaccinated on an unspecified date in 2013 (reported as 7 years ago; on the same day with pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein)) for immunization. There were no prior vaccinations (within 4 weeks). On an unspecified date in 2013, extreme pain in her right arm all over, difficulty lifting and putting behind her back. It was reported that 24 hours after vaccination, patient could not move her right arm. It was not just where the injection site was. The patient had excruciating pain and could not lift up anything or put her arm behind her back or anything. This went on for over 4 months. The patient then went from doctor to doctor not thinking it could be from the shot. She finally got to orthopedic sports doctor who does injections. The patient underwent MRI and found a small rotator cuff tear although it was not near the injection site. The patient further clarified that it was not the same location as the pain. The physician ended up giving her a cortisone shot in her shoulder and as soon as he gave it, the pain went away. The patient recovered from the events on an unspecified date. The patient has another concern with the COVID vaccine. She would like to know if Pfizer can tell her if there are any bits of the same ingredients in the injection for COVID that were in the Prevnar 13.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure systolic, Chills, Hyperhidrosis, Hypersensitivity
Clinical narrative: vasodilation; dropped BP/blood pressure drops; diaphoretic; tingling in arms/legs/Tingling all over; chills/Chilled; Hypotensive; This is a spontaneous report from a contactable nurse(patient). A female patient of an unspecified age received BNT162B2 (lot number: EH9899, expiration date: Mar2021), via an unspecified route of administration, on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history included shellfish and the seafood allergy. Concomitant medications were not reported. The patient had the vaccine now about an hour and half or may be two hours ago and within 20 minutes on 22Dec2020. The patient apparently became diaphoretic and hypotensive and 80 Systolic and the patient was tingling all over and chilled. They tried to call the paramedics and tried to bring the patient to ER. The patient stated she had similar reaction to some degree having taken some shellfish and the seafood allergy. Her blood pressure dropped, she supposed it's histamine release kind of drop her pressure. The patient was wondering, was this something that because it was in her system, was she going to continually keep having this episodic or is that just the one time.  The patient reported that she had a reaction similar to her seafood allergy reaction: histamine release, vasodilation, dropped BP, 20 mins after vaccine, became diaphoretic, systolic BP in 80s, had tingling in arms/legs and chills. The patient stated that she sat in the ER for about an hour and was fine after that. The outcome of the events was recovered on 22Dec2020.
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Paraesthesia, Vasodilation procedure
Clinical narrative: vasodilation; dropped BP/blood pressure drops; diaphoretic; tingling in arms/legs/Tingling all over; chills/Chilled; Hypotensive; This is a spontaneous report from a contactable nurse(patient). A female patient of an unspecified age received BNT162B2 (lot number: EH9899, expiration date: Mar2021), via an unspecified route of administration, on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history included shellfish and the seafood allergy. Concomitant medications were not reported. The patient had the vaccine now about an hour and half or may be two hours ago and within 20 minutes on 22Dec2020. The patient apparently became diaphoretic and hypotensive and 80 Systolic and the patient was tingling all over and chilled. They tried to call the paramedics and tried to bring the patient to ER. The patient stated she had similar reaction to some degree having taken some shellfish and the seafood allergy. Her blood pressure dropped, she supposed it's histamine release kind of drop her pressure. The patient was wondering, was this something that because it was in her system, was she going to continually keep having this episodic or is that just the one time.  The patient reported that she had a reaction similar to her seafood allergy reaction: histamine release, vasodilation, dropped BP, 20 mins after vaccine, became diaphoretic, systolic BP in 80s, had tingling in arms/legs and chills. The patient stated that she sat in the ER for about an hour and was fine after that. The outcome of the events was recovered on 22Dec2020.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: he feels flu like after receiving the covid 19 vaccine; I feel sick; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Dec2020, the patient stated he feels flu like after receiving the vaccine. The patient also stated that he feel sick. The outcome of the event was unknown. The patient wanted to know how a person can differentiate between the side effects and the flu.   No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dizziness, Dyspnoea, Headache
Clinical narrative: cold sweat; chills; Headache; Dizziness; Muscle pain; Mild shortness of breath; This is a spontaneous report from a non-contactable other healthcare professional. A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the left arm on 21Dec2020 10:00 AM at single dose for COVID-19 immunization. Medical history included sulfa allergies, depression and von willebrand's bleeding disorder. The patient had Covid prior to vaccination. The patient was not Covid tested post vaccination. Concomitant medications included fluoxetine, bupropion, montelukast, cetirizine and esomeprazole; all from unspecified date for unspecified indication. The patient had no other vaccine in four weeks. On 21Dec2020 10:00 AM, the patient experienced cold sweat, chills, headache, dizziness, muscle pain, mild shortness of breath. The outcome of the events cold sweat, chills, headache, dizziness, muscle pain, mild shortness of breath was recovering. The reporter considered the events non-serious.  No follow-up attempts are possible. Information about lot/Batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: cold sweat; chills; Headache; Dizziness; Muscle pain; Mild shortness of breath; This is a spontaneous report from a non-contactable other healthcare professional. A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the left arm on 21Dec2020 10:00 AM at single dose for COVID-19 immunization. Medical history included sulfa allergies, depression and von willebrand's bleeding disorder. The patient had Covid prior to vaccination. The patient was not Covid tested post vaccination. Concomitant medications included fluoxetine, bupropion, montelukast, cetirizine and esomeprazole; all from unspecified date for unspecified indication. The patient had no other vaccine in four weeks. On 21Dec2020 10:00 AM, the patient experienced cold sweat, chills, headache, dizziness, muscle pain, mild shortness of breath. The outcome of the events cold sweat, chills, headache, dizziness, muscle pain, mild shortness of breath was recovering. The reporter considered the events non-serious.  No follow-up attempts are possible. Information about lot/Batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature increased, Dizziness, Eye pruritus, Headache
Clinical narrative: Mild headache; dizziness; Temp-100.9; sore throats; Abdominal discomfort; eye itching; Pain and mild itching on injection site; Pain and mild itching on injection site; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of bnt162b2 (COVID-19 vaccine, brand PfizerBiontech) lot number EK5730, intramuscular in left arm on 21Dec2020 09:15 at a single dose for COVID-19 immunization in workplace clinic. The patient had no relevant medical history. The patient was not pregnant at the time of report. The patient's concomitant medications were not reported. No other vaccines were administered in four weeks. The patient previously took acetylsalicylic acid (ASPIRIN) and ibuprofen and experienced allergies. On 22Dec2020 at 11:00, the patient experienced mild headache, dizziness, temp100.9, sore throats, abdominal discomfort, eye itching, pain and mild itching on injection site. The patient took paracetamol (TYLENOL) and ceritizine (ZYRTEC) as treatment. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The events were reported as non-serious. The patient had not recovered from the events at the time of report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Oropharyngeal pain
Clinical narrative: Mild headache; dizziness; Temp-100.9; sore throats; Abdominal discomfort; eye itching; Pain and mild itching on injection site; Pain and mild itching on injection site; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of bnt162b2 (COVID-19 vaccine, brand PfizerBiontech) lot number EK5730, intramuscular in left arm on 21Dec2020 09:15 at a single dose for COVID-19 immunization in workplace clinic. The patient had no relevant medical history. The patient was not pregnant at the time of report. The patient's concomitant medications were not reported. No other vaccines were administered in four weeks. The patient previously took acetylsalicylic acid (ASPIRIN) and ibuprofen and experienced allergies. On 22Dec2020 at 11:00, the patient experienced mild headache, dizziness, temp100.9, sore throats, abdominal discomfort, eye itching, pain and mild itching on injection site. The patient took paracetamol (TYLENOL) and ceritizine (ZYRTEC) as treatment. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The events were reported as non-serious. The patient had not recovered from the events at the time of report.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Tenderness
Clinical narrative: unable to raise arm all the way; tenderness under arm pit; This is a spontaneous report from a contactable consumer (patient [first responder/fire fighter]). A 44-year-old male patient started received single dose of BNT162B2 (batch/lot number and exp date not reported), via an unspecified route of administration on19Dec2020 09:00 to 19Dec2020 09:00 for immunization. Medical history included allergy. He tested positive for antibodies in the middle to end of Nov2020 prior to Thanksgiving. His daughter has IGT and his mother had Lupus. He was tested so he could be around them. At some point he had the virus and didn't know. The patient had no other history. Concomitant medication included fluticasone propionate and montelukast (generic of SINGULAIR); both given from 2010 and ongoing for allergy. The patient received the Covid-19 vaccine on a Saturday around 9 am. On 20Dec2020 (Sunday) he started having tenderness under his arm pit. He had an appointment to see his doctor the day of reporting at 4pm. He was also unable to raise his arm all the way up on 21Dec2020. No investigation assessment was performed. The outcome of tenderness under armpit was not recovered: he still had tenderness (ongoing) at the time of reporting; and recovering for unable to raise his arm all the way up wherein at the time of reporting he could raise it some.    Information about lot/batch number has been requested.