chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase normal, Blood magnesium normal, Full blood count normal, Glomerular filtration rate, Metabolic function test normal
Clinical narrative: Approximately 2 weeks after the first dose, I began having muscle spasms in my right forearm...I had just started playing softball again after an extended hiatus so I didn't think anything about.  I went to a chiropractor for Active Release therapy to get the spasming to stop.  A week later I got my second dose (5/5/21) and I went back for a second game and knelt on my right knee and started getting spasms in my right quad muscle.  I switched to my left and it immediately started getting the same spasm in my left quad muscle.   The spasm began in my hip muscle and continued down the front of my leg to the knee. The spasms continued to get worse over the next hour to the point I couldn't walk without significant pain.  Over the next week, I began getting spasms in both legs at the same time - calves, quads, feet.  I would also get spasms in my neck, my upper back and shoulders.   They would hit at all times during the day and there was no warning signs.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Serum ferritin normal, Vitamin D
Clinical narrative: Approximately 2 weeks after the first dose, I began having muscle spasms in my right forearm...I had just started playing softball again after an extended hiatus so I didn't think anything about.  I went to a chiropractor for Active Release therapy to get the spasming to stop.  A week later I got my second dose (5/5/21) and I went back for a second game and knelt on my right knee and started getting spasms in my right quad muscle.  I switched to my left and it immediately started getting the same spasm in my left quad muscle.   The spasm began in my hip muscle and continued down the front of my leg to the knee. The spasms continued to get worse over the next hour to the point I couldn't walk without significant pain.  Over the next week, I began getting spasms in both legs at the same time - calves, quads, feet.  I would also get spasms in my neck, my upper back and shoulders.   They would hit at all times during the day and there was no warning signs.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of vaccine outside expiration window (thawed, refrigerated vaccine beyond 30 days-vaccine error). Error discovered 07/06.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient indicated that one week after receiving her Shingrix vaccine she experienced a red rash on the arm she was given the injection. She says she rubbed alcohol on it and applied neosporin and it went away. She did not contact the pharmacy or her physician.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a dose of vaccine outside expiration window (thawed, refrigerated vaccine beyond 30 days-vaccine error). Error discovered 07/06.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Patient was given her second dose of Moderna, at 5:51pm. During post-observation timeframe at 6:10pm, patient complained of lightheadedness and nausea and husband notified pharmacist. I came out with another technician and we placed the patient on her back on the floor and elevated her legs onto a chair. We also provided a cool compress and water to sip. I asked my technician to stay with the patient and notify me if anything changed while I called a code white in the store. Management did show up and helped monitor the patient. The patient was not left alone and was asked how she was feeling frequently by all present staff members. At 6:25pm, the patient felt well enough to attempt to get back into the chair to sit. She never lost consciousness. She continued to sit in the chair outside the pharmacy until 6:40pm when her and her husband left the pharmacy area. She stated she was feeling much better.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive
Clinical narrative: Congestive heart failure. Pumps at 15% when normal is 60
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Nausea, Unresponsive to stimuli
Clinical narrative: On 7/06/21 patient received his first dose Janssen vaccine (LOT#: 207A21A EXP: 8/07/21) at 1332. Patient alerted EMT's at 1345. Patient stated that he felt nauseous, hot and sweaty. Patient was not responsive to verbal or physical stimuli for approximately 5 seconds at 1349. Patient gained consciousness quickly at 1350. EMT took patients vital signs at 1350. BP: 118/72, pulse: 46, O2: 99%. At 1352 patient stated that he was feeling better. Patient was moved to anti-gravity chair at 1352 by EMT's. EMT retook patients vital signs and reassessed patient at 1353. BP: 110/60, HR: 51, O2: 99%. Patient stated that he had eaten breakfast in the morning. Patient stated that he has no allergies. PHN offered patient EMS. Patient denied EMS at 1353. EMT reassessed and retook patient vitals signs at 1357. BP:116/60, HR: 61, O2: 98%. Patient stated that he no longer felt lightheaded, dizzy or nauseous. EMT reassessed and retook patient vital signs at 1402. BP: 110/66, HR: 51, O2: 99%. Patient stated that he was feeling better. EMT reassessed and retook patient vital signs at 1410. BP:116/58, HR: 48, O2: 97%. EMT reassessed and retook patient vital signs at 1416. Patient stated he was feeling better and denied EMS for a second time. BP: 116/60, HR: 54, O2: 96%. Patient was educated by EMT of worsening signs and symptoms that would warrant a trip the emergency room/urgent care. Patient verbalized understanding of education. Patient left vaccination site with a steady gait at 1421.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a dose of vaccine outside expiration window (thawed, refrigerated vaccine beyond 30 days-vaccine error). Error discovered 07/06.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Palpitations, Syncope
Clinical narrative: about a week after my shot, I started having heart palpitations and fainting spells. It feels like my heart is substantially weaker and its not improving.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram normal, Nausea
Clinical narrative: patient complained of shortness of breath ,nausea and pain in chest .  benadrly  was given and ems called
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of vaccine outside expiration window (thawed, refrigerated vaccine beyond 30 days-vaccine error). Error discovered 07/06.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of vaccine outside expiration window (thawed, refrigerated vaccine beyond 30 days-vaccine error). Error discovered 07/06.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of vaccine outside expiration window (thawed, refrigerated vaccine beyond 30 days-vaccine error). Error discovered 07/06.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of vaccine outside expiration window (thawed, refrigerated vaccine beyond 30 days-vaccine error). Error discovered 07/06.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a dose of vaccine outside expiration window (thawed, refrigerated vaccine beyond 30 days-vaccine error). Error discovered 07/06.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Dysphagia, Fatigue, Headache
Clinical narrative: Light headache immediately after and the day following the vaccination. Fatigue set in around 36 hours. I was very tired for the next 24 hours. Also experienced abdominal cramps and loose stools. Around 72-hour mark, throat swelling, difficulty swallowing, extreme fatigue, headache and overall sickness. Went to ER. Doctor said that my lymph nodes were a little swollen but did not suspect anaphylaxis. I was given Maalox, Mylanta, lidocaine viscous and ibuprofen. Now at hour 96 with continued fatigue and headache. I have been sleeping almost 100% of the time.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Illness, Immediate post-injection reaction, Lymphadenopathy, Pharyngeal swelling
Clinical narrative: Light headache immediately after and the day following the vaccination. Fatigue set in around 36 hours. I was very tired for the next 24 hours. Also experienced abdominal cramps and loose stools. Around 72-hour mark, throat swelling, difficulty swallowing, extreme fatigue, headache and overall sickness. Went to ER. Doctor said that my lymph nodes were a little swollen but did not suspect anaphylaxis. I was given Maalox, Mylanta, lidocaine viscous and ibuprofen. Now at hour 96 with continued fatigue and headache. I have been sleeping almost 100% of the time.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Light headache immediately after and the day following the vaccination. Fatigue set in around 36 hours. I was very tired for the next 24 hours. Also experienced abdominal cramps and loose stools. Around 72-hour mark, throat swelling, difficulty swallowing, extreme fatigue, headache and overall sickness. Went to ER. Doctor said that my lymph nodes were a little swollen but did not suspect anaphylaxis. I was given Maalox, Mylanta, lidocaine viscous and ibuprofen. Now at hour 96 with continued fatigue and headache. I have been sleeping almost 100% of the time.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node on my left side neck
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation delayed
Clinical narrative: After first dose my period came early (as in that night). After my second dose the next month, I have not had my period since. I have tested multiple times, I am not pregnant. I am not on birth control as I am trying to get pregnant. So this is very distressing to my husband and myself. I have made an appointment with my OB/GYN but he is booked solid and the appointment is not for a few weeks.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia
Clinical narrative: Chronic left shoulder joint pain and weakness starting a few days after first injection and persisting today (3.5 months later). Thinking it is SIRVA.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Refusal of treatment by patient
Clinical narrative: Client received her second dose of Moderna lot #: 017C21A exp. 5.23.21. The client removed her mask while sitting in the observation area following vaccination. EMTs responded. The client reported she ?is having a little breathing issue?. EMT took client's vitals: blood pressure 162/95, oxygen saturation 97%, heart rate 76, and respiration 18. Client disclosed she has high blood pressure and did not take her blood pressure medication today. Co-lead RN assisted EMTs with assessing client. Client states she is using a new mask, which has made it harder for her to breathe. She also stated that she has Ataxia and cannot breathe well when she has a mask on. She denied her shortness of breath is caused by getting her vaccination. Client denied any issues with her first dose of Moderna.  Co-lead RN educated client via interpreter to seek immediate medical emergency care if she is experiencing any adverse reactions after she leaves vaccination site. EMT offered to take client out to the courtyard where she can wait without wearing a mask. She declined and insisted she was fine to go. She insisted her time was up and then left with her husband in a steady gait and in no distress at 2:20 pm.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Concussion, Dizziness, Electrocardiogram
Clinical narrative: Woke up, felt strange, went to get a drink of water, lost consciousness and hit head on tile kitchen floor. Still dealing with vertigo and persistent dizziness due to sustained concussion.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Feeling abnormal, Head injury, Loss of consciousness, Vertigo
Clinical narrative: Woke up, felt strange, went to get a drink of water, lost consciousness and hit head on tile kitchen floor. Still dealing with vertigo and persistent dizziness due to sustained concussion.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Dyspnoea exertional
Clinical narrative: Patient reported to the administering pharmacist today that he has been experiencing dyspnea and shortness of breath, which began approximately two days prior to date and time that the event was reported (i.e. beginning on or around July 4th, 2021).  Patient states that he has been experiencing dyspnea and shortness of breath both upon exertion (and, even upon minimal exertion ? for example, when walking from car in parking lot into the pharmacy today) and also while at rest.  Patient states that he has no known history of dyspnea or shortness of breath similar to the symptoms he is currently experiencing. After contacting the patient?s primary care physician?s office and discussing the signs and symptoms the patient was experiencing with the medical office personnel, the patient was advised by the pharmacist to seek immediate medical attention and report to the nearest hospital emergency department. The patient stated that he would seek immediate medical attention at the local hospital emergency department, as his primary care physician did not have any appointment availability to be able to see him in office today.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: patient came in on 06/12/2021 and got a moderna covid vaccine. This pharmacy system does not allow us to add moderna to our vaccine schedule so patient was added as a pfizer in the system. patient came in 07/06/2021 for a second and forgot his covid 19 vaccination record and our vaccine schedule showed he was a pfizer patient so we gave him pfizer as a second dose. when patient came back and brought his card we noticed he had moderna and should have gotten moderna second dose on 07/10/2021 instead of the pfizer he got today.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dry mouth, Pain in extremity, Thirst
Clinical narrative: - Constant thirst **I hadn't read about this anywhere as a side effect so felt like I should report it. I am certain its related to vaccine because I don't ever experience this and there isn't anything else unusual about my last few days that would have made my mouth dry and feeling thirsty all day  - Arm pain increasing throughout the day - very sore, moves into shoulder blade
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alcohol intolerance, Feeling abnormal, Intellectual disability, Mental fatigue, Pyrexia
Clinical narrative: Severe brain fog/mental fatigue for an extended period of time following Pfizer Covid shot (severe several weeks, extended several months). Inability to process complex though or focus, brain moving slowly, mental fatigue. Couldn?t effectively do my job. Also noted alcohol had a negative effect, with hangovers increased 4x. After 13 days, I notice that coffee is causing the issue to amplify. I quit my daily coffee and immediately noticed an improvement. After 3 days of caffeine withdrawals, I finally felt better. So essentially, the combination of the vaccine symptoms and caffeine caused extended brain fog.   Feeling better, I got the second shot. Had a typical real bad reaction with fever etc., but no extended brain fog like previous, only a little loopiness immediately after. However, 1-2 weeks later after I think all is well, I get some brain fog/mental fatigue returning with the use of alcohol and caffeine, reactions that would not be typical with mild usage. I quit coffee/caffeine again to stop the symptoms. After 2 weeks, alcohol did not have a negative effect, but caffeine continued to, so I stayed off. At this point, I started a Vitamin D supplement since my doctor noted I was low.   2 months after the initial shot, I try coffee again, and it slows my brain down quite a bit. So it?s quite an extended issue at this time. At 3 months, I saw a neurologist, who recommended trying different and smaller amounts of caffeine. Trying tea, the issues remained. But trying Coke, it felt like normal caffeine, but had me wired. After this, I was able to slowly increase from extremely small coffee/caffeine amounts without feeling brain fog, and this is where I?m at today.   My Doctor and I have a more detailed summary of issues if that would be useful.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Reaction to food additive
Clinical narrative: Severe brain fog/mental fatigue for an extended period of time following Pfizer Covid shot (severe several weeks, extended several months). Inability to process complex though or focus, brain moving slowly, mental fatigue. Couldn?t effectively do my job. Also noted alcohol had a negative effect, with hangovers increased 4x. After 13 days, I notice that coffee is causing the issue to amplify. I quit my daily coffee and immediately noticed an improvement. After 3 days of caffeine withdrawals, I finally felt better. So essentially, the combination of the vaccine symptoms and caffeine caused extended brain fog.   Feeling better, I got the second shot. Had a typical real bad reaction with fever etc., but no extended brain fog like previous, only a little loopiness immediately after. However, 1-2 weeks later after I think all is well, I get some brain fog/mental fatigue returning with the use of alcohol and caffeine, reactions that would not be typical with mild usage. I quit coffee/caffeine again to stop the symptoms. After 2 weeks, alcohol did not have a negative effect, but caffeine continued to, so I stayed off. At this point, I started a Vitamin D supplement since my doctor noted I was low.   2 months after the initial shot, I try coffee again, and it slows my brain down quite a bit. So it?s quite an extended issue at this time. At 3 months, I saw a neurologist, who recommended trying different and smaller amounts of caffeine. Trying tea, the issues remained. But trying Coke, it felt like normal caffeine, but had me wired. After this, I was able to slowly increase from extremely small coffee/caffeine amounts without feeling brain fog, and this is where I?m at today.   My Doctor and I have a more detailed summary of issues if that would be useful.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness
Clinical narrative: pt passed out. fell to ground. 911 was called. after testing the pt the EMTs gave pt the all clear
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: fatigue and nausea
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pallor, Pulse abnormal, Syncope, Unresponsive to stimuli
Clinical narrative: Covid-19 Ad26 Vaccine administered to Left deltoid muscle per standard IM injection protocol.  Within a few moments after administration patient stated "Oh. I'm going to faint."  Pt. was assisted to supine position and observed to be unresponsive to name calling, appeared pale and slightly diaphoretic with a weak thready pulse. Clinic staff was notified of vasovagal syncope, patient self-revived within 30 seconds. Afterwards cool compress was applied to forehead and pt. provided with water for hydration and was also offered crackers and juice, which she declined. Pulse re-checked approx 2 minutes after pt. revived found to be approx 65bpm and strong, 2+  color returned to pt. face and she stated she felt much better. pt. was observed by clinic staff for full 15 minutes following vaccine administration and vasovagal episode without further issue. Pt. left exam room and clinic under own power in stable condition.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain, Headache, Sleep disorder
Clinical narrative: Middle left ear blockage since July 2, 7pm Severe pain in left ear since July 2 Severe headache  Pain was severe enough to disrupt sleep.  There is some relief for a few hours whenever she takes advil.  I went to a CVS Pharmacist on July 4th and she recommended melatonin to help her sleep  As of the time of this report, the ear blockage comes and goes, the ear pain and accompanying headache was still severe. She has taken Advil to ease the pain so she can sleep
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear swelling, Eustachian tube disorder, Impaired work ability, Inner ear inflammation
Clinical narrative: My first Pfizer Vaccine was on April 19, 2021 and my second vaccination was taken on May 10, 2021.  Four days after the second vaccination, I started having ear problems, dizziness and vertigo whilst working in front of my computer in the office and outside of work related duties.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: My first Pfizer Vaccine was on April 19, 2021 and my second vaccination was taken on May 10, 2021.  Four days after the second vaccination, I started having ear problems, dizziness and vertigo whilst working in front of my computer in the office and outside of work related duties.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, X-ray normal
Clinical narrative: 1st Moderma Covid-19 vaccine caused Lack of movement in Arm and shoulder and has been getting worse.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: Frber, chills, fatigue, minor joint pain, flu like symptoms
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Paracentesis, Pericardial drainage, Pericardial effusion
Clinical narrative: Large volume pericardial effusion.  1.2 Liters removed via paracentesis.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inflammation, Joint range of motion decreased, Neck pain, Pain in extremity
Clinical narrative: Incredible pain in arm that is still present 7 weeks later. Mobility is increasing, but still do not have full range of motion. In treatment and extreme inflammation has been noted. In first weeks, pain extended up neck and left side of head. Slight tingling on left side of tongue that has resolved. Inflammation currently in shoulder muscles, scapula, neck, and upper arm.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Incredible pain in arm that is still present 7 weeks later. Mobility is increasing, but still do not have full range of motion. In treatment and extreme inflammation has been noted. In first weeks, pain extended up neck and left side of head. Slight tingling on left side of tongue that has resolved. Inflammation currently in shoulder muscles, scapula, neck, and upper arm.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Burns second degree
Clinical narrative: Small burning blisters on neck, behind ears. Under chin/jaw. Up cheeks. Around hair line, brows/eyes.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Pallor
Clinical narrative: Patient fell on floor about 2 minutes after vaccination. No injury. No loss of consciousness. EMS called but pt did not go to emergency room. Pt felt better and declined emergency room visit. EMS responder said pt looked pale. Mother  was present and said pt did not drink water before the vaccination. No injection site swelling No fever. No other signs or symptoms, including no signs of anaphylaxis (difficulty breathing, swallowing, pevioval edema).    Pt. appear to have recovered.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Shot given 06/14/2021, pt Fainted 6/16/21 Mom reported on 7/5/21. Unsure op correllation. So filed vaers in case. pt was fine after episode
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: discovered the vaccine administered was from the day before, not the current day vial
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: discovered the vaccine administered was from the day before, not the currentvial
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: discovered the vaccine administered was from the day before, not the current day
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: discovered the vaccine  administed was from the day  before,  not the current   day vial
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: discovered the vaccine administered was from the day before, not the current day vial
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: discovered the vaccine administered was from the day before, not current day
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Blood test, Cellulitis, Limb mass, Magnetic resonance imaging
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (cellulitis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced MASS (lumps on her face (one on the forehead and another one on the nose which extends down to her lower cheek)/lumps on her left lower arm (on the elbow and wrist)) and RASH ERYTHEMATOUS (lumpy red rash on her left armpit). In May 2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (cellulitis), MASS (lumps on her face (one on the forehead and another one on the nose which extends down to her lower cheek)/lumps on her left lower arm (on the elbow and wrist)) and RASH ERYTHEMATOUS (lumpy red rash on her left armpit) had not resolved. Concomitant medications were not provided. Patient consulted a dermatologist who initially thought it was cellulitis for which a blood test and puncture biopsy was done and also given a unspecified medicine but it did not resolve. She was then referred to neurologist and MRI was done and awaiting results. The lumps were still present at the time of the call. Company comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: follow up received on 02-Jul-21 with no new information. Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Rash erythematous
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (cellulitis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced MASS (lumps on her face (one on the forehead and another one on the nose which extends down to her lower cheek)/lumps on her left lower arm (on the elbow and wrist)) and RASH ERYTHEMATOUS (lumpy red rash on her left armpit). In May 2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (cellulitis), MASS (lumps on her face (one on the forehead and another one on the nose which extends down to her lower cheek)/lumps on her left lower arm (on the elbow and wrist)) and RASH ERYTHEMATOUS (lumpy red rash on her left armpit) had not resolved. Concomitant medications were not provided. Patient consulted a dermatologist who initially thought it was cellulitis for which a blood test and puncture biopsy was done and also given a unspecified medicine but it did not resolve. She was then referred to neurologist and MRI was done and awaiting results. The lumps were still present at the time of the call. Company comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: follow up received on 02-Jul-21 with no new information. Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Incorrect diluent volume (i.e., the vial contents were diluted with a diluent volume more than 1.8 ml, but a 0.3 ml dose was still administered.)
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Full body hives and swelling of the face.  Hives began exactly two weeks from the first shot.  I had to delay the second shot by one week.  All healthcare providers and department of health doctor thought it was not related to the vaccine.  I got the second shot and two weeks to the day the Hives erupted even worse than the first time and they have not gone away.  I am being treated by a pimary care provider and an immunologist.  I now get a Xolair shot once a month and take 4 Zyrtec in the morning and 4 again at night which gives some relief but I still wake up to hives on my legs, arms and buttoks.  See previous report
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Rash, Swelling face, Urticaria
Clinical narrative: Full body hives and swelling of the face.  Hives began exactly two weeks from the first shot.  I had to delay the second shot by one week.  All healthcare providers and department of health doctor thought it was not related to the vaccine.  I got the second shot and two weeks to the day the Hives erupted even worse than the first time and they have not gone away.  I am being treated by a pimary care provider and an immunologist.  I now get a Xolair shot once a month and take 4 Zyrtec in the morning and 4 again at night which gives some relief but I still wake up to hives on my legs, arms and buttoks.  See previous report
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Decreased appetite, Fatigue
Clinical narrative: Chills; General gastric discomfort;  Extreme fatigue;  Nausea;  Feeling unwell;  Loss of appetite;  Tiredness;  Dizziness;  Weakness.   Treatment for above:  administering small amounts of liquids and soft nutritious food when he was willing.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Asthenia, Chills, Decreased appetite, Dizziness
Clinical narrative: Chills; General gastric discomfort;  Extreme fatigue;  Nausea;  Feeling unwell;  Loss of appetite;  Tiredness;  Dizziness;  Weakness.   Treatment for above:  administering small amounts of liquids and soft nutritious food when he was willing.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Fluid intake reduced, Hypophagia, Malaise, Nausea
Clinical narrative: Chills; General gastric discomfort;  Extreme fatigue;  Nausea;  Feeling unwell;  Loss of appetite;  Tiredness;  Dizziness;  Weakness.   Treatment for above:  administering small amounts of liquids and soft nutritious food when he was willing.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dyspnoea, Electrocardiogram, Heart rate increased, Nausea
Clinical narrative: Difficulty breathing; Spike in heart rate(182 BPM); Elevated blood pressure(approximately 210/110); Severe tingling in hands and feet; Closing throat; Hives; Rash; Red blotches on skin; Itching; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 19Mar2021 13:45 (Batch/Lot Number: ER2613) at the age of 51 years old, as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included discoid lupus, hypothyroidism, asthma, allergy to sulfa, iodine, latex, shellfish, tree nuts, fruits with pits, pollen, dust mites. The patient was not pregnant at the time of vaccination. The patient received other unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021, 14:00 patient experienced difficulty breathing, spike in heart rate (182 BPM), elevated blood pressure (approximately 210/110), severe tingling in hands and feet, closing throat, hives, rash and red blotches on skin, itching. The events resulted in Emergency room/department or urgent care. Treatment received for the events was Benadryl. The patient was monitored for the events. The events were reported as non-serious by the reporter. The patient was recovering from all the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Paraesthesia, Pruritus, Taste disorder, Throat tightness
Clinical narrative: Difficulty breathing; Spike in heart rate(182 BPM); Elevated blood pressure(approximately 210/110); Severe tingling in hands and feet; Closing throat; Hives; Rash; Red blotches on skin; Itching; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 19Mar2021 13:45 (Batch/Lot Number: ER2613) at the age of 51 years old, as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included discoid lupus, hypothyroidism, asthma, allergy to sulfa, iodine, latex, shellfish, tree nuts, fruits with pits, pollen, dust mites. The patient was not pregnant at the time of vaccination. The patient received other unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021, 14:00 patient experienced difficulty breathing, spike in heart rate (182 BPM), elevated blood pressure (approximately 210/110), severe tingling in hands and feet, closing throat, hives, rash and red blotches on skin, itching. The events resulted in Emergency room/department or urgent care. Treatment received for the events was Benadryl. The patient was monitored for the events. The events were reported as non-serious by the reporter. The patient was recovering from all the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Difficulty breathing; Spike in heart rate(182 BPM); Elevated blood pressure(approximately 210/110); Severe tingling in hands and feet; Closing throat; Hives; Rash; Red blotches on skin; Itching; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 19Mar2021 13:45 (Batch/Lot Number: ER2613) at the age of 51 years old, as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included discoid lupus, hypothyroidism, asthma, allergy to sulfa, iodine, latex, shellfish, tree nuts, fruits with pits, pollen, dust mites. The patient was not pregnant at the time of vaccination. The patient received other unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021, 14:00 patient experienced difficulty breathing, spike in heart rate (182 BPM), elevated blood pressure (approximately 210/110), severe tingling in hands and feet, closing throat, hives, rash and red blotches on skin, itching. The events resulted in Emergency room/department or urgent care. Treatment received for the events was Benadryl. The patient was monitored for the events. The events were reported as non-serious by the reporter. The patient was recovering from all the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Difficulty breathing; Spike in heart rate(182 BPM); Elevated blood pressure(approximately 210/110); Severe tingling in hands and feet; Closing throat; Hives; Rash; Red blotches on skin; Itching; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 19Mar2021 13:45 (Batch/Lot Number: ER2613) at the age of 51 years old, as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included discoid lupus, hypothyroidism, asthma, allergy to sulfa, iodine, latex, shellfish, tree nuts, fruits with pits, pollen, dust mites. The patient was not pregnant at the time of vaccination. The patient received other unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021, 14:00 patient experienced difficulty breathing, spike in heart rate (182 BPM), elevated blood pressure (approximately 210/110), severe tingling in hands and feet, closing throat, hives, rash and red blotches on skin, itching. The events resulted in Emergency room/department or urgent care. Treatment received for the events was Benadryl. The patient was monitored for the events. The events were reported as non-serious by the reporter. The patient was recovering from all the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pruritus, Rash, Rash macular, Throat tightness
Clinical narrative: Difficulty breathing; Spike in heart rate(182 BPM); Elevated blood pressure(approximately 210/110); Severe tingling in hands and feet; Closing throat; Hives; Rash; Red blotches on skin; Itching; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 19Mar2021 13:45 (Batch/Lot Number: ER2613) at the age of 51 years old, as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included discoid lupus, hypothyroidism, asthma, allergy to sulfa, iodine, latex, shellfish, tree nuts, fruits with pits, pollen, dust mites. The patient was not pregnant at the time of vaccination. The patient received other unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021, 14:00 patient experienced difficulty breathing, spike in heart rate (182 BPM), elevated blood pressure (approximately 210/110), severe tingling in hands and feet, closing throat, hives, rash and red blotches on skin, itching. The events resulted in Emergency room/department or urgent care. Treatment received for the events was Benadryl. The patient was monitored for the events. The events were reported as non-serious by the reporter. The patient was recovering from all the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Platelet count, Platelet count decreased
Clinical narrative: patient's second dose was compromised; platelets count crashed; platelets count crashed; This is a spontaneous report from a contactable Nurse (who is also the patient, reported for herself). This case refers to the second dose of vaccination. A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201, expiry date was not provided), via unspecified route of administration, on 16Feb2021 (at the age of 72-year-old), as a dose 2, single for COVID-19 immunization. The patient's medical history included ongoing ITP (Idiopathic thrombocytopenic purpura). Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261, expiry date was not provided), via unspecified route of administration, on 25Jan2021, as a single dose for COVID-19 immunization and on first dose patient's platelet count go down. Patient reported that, after second dose, her platelets count crashed on an unspecified date in 2021 and the patient's second dose was compromised on 16Feb2021. Patient reported that she had ITP, idiopathic thrombocytopenic purpura, and it kind of reacts to viruses and made her platelets go down. Patient thought the second dose was compromised and wants to know if there's any way to know if she has any immunity. Patient was told that the first dose of the Covid-19 vaccine would have been fine, but that the second dose was compromised. Patient received treatment of prednisone (40 mg for 3 days, tapered after that) for the event platelets count crashed. Outcome of the events was unknown.   Additional information has been requested. Further information is expected.; Sender's Comments: Based on the information in the case report, A possible causal relationship between events platelet count decreased and suspect drug BNT162B2 cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Platelet count decreased, Poor quality product administered
Clinical narrative: patient's second dose was compromised; platelets count crashed; platelets count crashed; This is a spontaneous report from a contactable Nurse (who is also the patient, reported for herself). This case refers to the second dose of vaccination. A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201, expiry date was not provided), via unspecified route of administration, on 16Feb2021 (at the age of 72-year-old), as a dose 2, single for COVID-19 immunization. The patient's medical history included ongoing ITP (Idiopathic thrombocytopenic purpura). Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261, expiry date was not provided), via unspecified route of administration, on 25Jan2021, as a single dose for COVID-19 immunization and on first dose patient's platelet count go down. Patient reported that, after second dose, her platelets count crashed on an unspecified date in 2021 and the patient's second dose was compromised on 16Feb2021. Patient reported that she had ITP, idiopathic thrombocytopenic purpura, and it kind of reacts to viruses and made her platelets go down. Patient thought the second dose was compromised and wants to know if there's any way to know if she has any immunity. Patient was told that the first dose of the Covid-19 vaccine would have been fine, but that the second dose was compromised. Patient received treatment of prednisone (40 mg for 3 days, tapered after that) for the event platelets count crashed. Outcome of the events was unknown.   Additional information has been requested. Further information is expected.; Sender's Comments: Based on the information in the case report, A possible causal relationship between events platelet count decreased and suspect drug BNT162B2 cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Muscular weakness
Clinical narrative: skin turned bright red everywhere; rash went away after 30 minutes.; dizzy; This is a spontaneous report from a contactable consumer (reporting on herself) of 34-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) (at the age of 34-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included bleeding disorder FACTOR V Leiden and cartilage grew backward. The patient's concomitant medications were not reported. It was reported that patient received the Pfizer first shot on 07Apr2021, 15 minutes after getting the vaccine her skin turned bright red everywhere, she was rushed to the hospital, the rash went away after 30 minutes.  Caller states, they only gave her something for nausea, because she felt dizzy. She turned into something out of the walk of lands, turned red and blotchy, if you pressed on her skin the imprint would stay about a minute. They didn't give her anything for a rash. Caller states, it was not a rash, felt like my blood was trying to escape her skin. Caller states, when she scheduled for the second dose, they told her no. She would like to know how she can get the second shot. Her doctor said maybe she just shouldn't get it. Response received regarding the second dose confirmation was if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. Outcome of the event dizzy was unknown. Outcome of the other events was recovered on unspecified date in 2021.