chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A four month old patient was administered Quadracel instead of Pentacel, no AE; A four month old patient was administered Quadracel instead of Pentacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information inbound (reference number- 00506213) and transmitted to Sanofi on 05-Mar-2021.  This case involves a 4 month old male patient who was administered 0.5 ml second dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (batch number C5656AA and expiry date: 31-Aug-2021; Strength: regular) via unknown route in unknown administration site for prophylactic vaccination on 05-Mar-2021, instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered and product administered to patient of inappropriate age)  The patient's medical history, medical treatment(s), vaccination(s), and family history were not provided.  The patient's concomitant medications included HEPATITIS B VACCINE, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.   It was a case of an actual medication error due to inappropriate age at vaccine administration and Wrong vaccine administered (latency same day).  The medical assistant reported that earlier today, a 4-month-old child was prescribed Pentacel vaccine, but was inadvertently administered Quadracel. They would administer Act-HIB at 6 months of age. Therefore, the reporter was requesting a guidance.  At the time of this report, it was unknown if the patient experienced any adverse events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/3/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: her arm from shoulder to the elbow is so sore that she can't use it or lay on it/ pain immediately after receiving vaccine and if she forgets and use her left arm accidently she experiences that pain; Initial information received on 05-Mar-2021 regarding an unsolicited valid non-serious case from a consumer via Agency (under reference 00506632).  This case involves a 61 years old female patient whose arm from shoulder to the elbow was so sore, that she cannot use it or lay on it and it cause pain immediately if she forgets and use her left arm accidently, she experiences that pain (pain in extremity), after receiving DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   The patient's states that she cut herself pretty bad while cutting fabric and she went to the urgent care.  On 16-Feb-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6852AA and Expiration date:07-Oct-2022) via unknown route in the left arm for prophylactic vaccination.  On 16-Feb-2021, the patient developed a non-serious sore arm from shoulder to the elbow that she can't use it or lay on it (pain in extremity). Also reported that she experienced the pain immediately after receiving the vaccine and if she forgets and use her left arm accidently she experiences that pain. Patient also wanted to know if that was normal and she thinks they may have hit a bone when administering the shot.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Pregnancy
Clinical narrative: pregnant woman received Adacel twice; once at 31 weeks gestation, once at 35 weeks of gestation with no adverse event; Initial information received on 08-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves adult female patient (age unknown) who was pregnant received  doses of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] twice; once at 31 weeks gestation and once at 35 weeks of gestation (exposure during pregnancy).  Data regarding this pregnancy were received prospectively. The date of last menstrual period was not reported. The estimated due date was not reported. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. The patient had unknown number of previous pregnancy/ies.  On unknown dates, the patient received two doses of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) at 31 weeks of gestation and 35 weeks of gestation via unknown route at unknown administration site for prophylactic vaccination.  It was case of vaccine exposure during pregnancy.  At time of reporting, the outcome of the pregnancy was unknown.   Information on the lot number was requested.
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Hypersensitivity, Nausea, Rash, Urticaria
Clinical narrative: diarrhea; allergic reaction; hives; nausea; rash; vomiting; Initial information regarding an unsolicited valid non-serious case was received from a consumer/ non-healthcare professional via Medical Information (Reference number- 00512839) and transmitted on 10-Mar-2021.   This case involves a 71-year old female patient who experienced diarrhea (diarrhoea), allergic reaction (hypersensitivity), hives (urticaria), nausea, rash and vomiting, after she received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  Medical history included drug allergy (she had an allergy to Thermasol).  Past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and PARACETAMOL (TYLENOL).  On an unknown date, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [lot number: UH442AB and expiration date: unknown] at an unknown dose via unknown route in an unknown site of administration for prophylactic vaccination.  On an unknown date, patient experienced diarrhea (diarrhoea), allergic reaction (hypersensitivity), hives (urticaria), nausea, rash and vomiting, (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events was unknown, at the time of reporting.
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: diarrhea; allergic reaction; hives; nausea; rash; vomiting; Initial information regarding an unsolicited valid non-serious case was received from a consumer/ non-healthcare professional via Medical Information (Reference number- 00512839) and transmitted on 10-Mar-2021.   This case involves a 71-year old female patient who experienced diarrhea (diarrhoea), allergic reaction (hypersensitivity), hives (urticaria), nausea, rash and vomiting, after she received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  Medical history included drug allergy (she had an allergy to Thermasol).  Past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and PARACETAMOL (TYLENOL).  On an unknown date, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [lot number: UH442AB and expiration date: unknown] at an unknown dose via unknown route in an unknown site of administration for prophylactic vaccination.  On an unknown date, patient experienced diarrhea (diarrhoea), allergic reaction (hypersensitivity), hives (urticaria), nausea, rash and vomiting, (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events was unknown, at the time of reporting.
Sex: M
Vaccine: FLUR4
Symptoms: Mobility decreased, Pain in extremity, Rash
Clinical narrative: couldn't raise his arm; stung then that feeling moved from his upper arm down to his elbow; got a bad rash on it looked puffy and had a pain sensation; Initial information regarding an unsolicited valid non-serious case was received from a Non-Healthcare Professional (consumer) via Medical Information (Reference number- 00515208) and transmitted on 11-Mar-2021.  This case involves a male patient of unknown age who couldn't raise his arm (mobility decreased), stung then that feeling moved from his upper arm down to his elbow (pain in extremity), got a bad rash on it looked puffy and had a pain sensation (rash), while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (batch number and expiration date were not reported via unknown route in unknown administration site via prophylactic vaccination.  On an unknown date, the patient couldn't raise his arm (mobility decreased, non-serious), stung then that feeling moved from his upper arm down to his elbow (pain in extremity, non-serious) and got a bad rash on it looked puffy and had a pain sensation (rash) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Also reported that Caller wanted to know if he should be careful of getting the Covid-19 (coronavirus disease)  shot? Caller stated that last month a physician told him that the flu vaccines aren't made the same so probably won't have the same effect. Caller wanted to know how flu vaccines are made differently? Also he wanted to know if patient's can get a flu shot if they have a history of mono or chronic fatigue syndrome.   No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for all the reported events.  There will be no information on the batch number for this case.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Headache
Clinical narrative: Extremely tired and did not get out of bed until 3:30 pm the day following the shot. Had a constant headache. The second night after the shot I developed a 104 temp. I had a headache the entire next day.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Swelling face
Clinical narrative: Swollen cheek, headaches, Ear Pain
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Lethargy, Pain, Peripheral swelling
Clinical narrative: fever as high as 102.3 ( normal is 97.4), very red, swollen, arm with swelling, body aches, "cover headache", vomiting, lethargic,  Took Tylenol, applied ice initially to site, then alternate ice and heat, showers, bed rest, fluids took a full 48 to see I was feeling better....still today not 100%
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: fever as high as 102.3 ( normal is 97.4), very red, swollen, arm with swelling, body aches, "cover headache", vomiting, lethargic,  Took Tylenol, applied ice initially to site, then alternate ice and heat, showers, bed rest, fluids took a full 48 to see I was feeling better....still today not 100%
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Vomiting
Clinical narrative: Pfizer-BioNtech COVID-19 Vaccine EUA Diarrhea Vomiting Headache Stomach cramps
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Janssen COVID-19 Vaccine EUA; Fever ( 99.4 ),  fatigue, general muscle pain, some nausea, lack of appetite , light headache,
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test, Chest X-ray, Dizziness, Ear disorder
Clinical narrative: Within 7 minutes I had a reaction of dizziness, nausea, increased blood pressure, increased heart rate, retching and extreme fatigue. I was taken to the Emergency Room via. Ambulance. In the ambulance I was given an IV and IVY Zolfran - which seemed to make the symptoms worse, at the Emergency room they gave me  Phenergan.  I had a chest x-ray that didn't show anything unusual.   I was then give Meclazine for the naseau and headache and a full bag of IV fluids.  It was enough to get me standing on my own so I could go home after spending several hours in the emergency room. 3/5/21 - 3//21 - still had symptoms - every time I moved I got nauseous and dizzy.   Followed up with my PCP's office on 3/9/21 as I was still very dizzy, nauseas, and had brain fog- I have been on Zolfran and Motion sickness medicine - since the 9th. At that time blood tests were done.  I  had another appointment with my PCP on 3/16/21- as I am still having nausea and while there - got very nauseas while tracking . This is 11 days after the 1st vaccine.   I was referred to Otolarynology on 3/17/21.  The PA I saw there determined it wasn't an ear issue and has referred me to Dr. for an ENG test which is scheduled for 3/31/21 with a follow up with Dr. on 4/13/21.   I have also been in touch with my allergist - who told me to postpone my allergies shot that were scheduled on 3/19/21.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Heart rate increased, Nausea
Clinical narrative: Within 7 minutes I had a reaction of dizziness, nausea, increased blood pressure, increased heart rate, retching and extreme fatigue. I was taken to the Emergency Room via. Ambulance. In the ambulance I was given an IV and IVY Zolfran - which seemed to make the symptoms worse, at the Emergency room they gave me  Phenergan.  I had a chest x-ray that didn't show anything unusual.   I was then give Meclazine for the naseau and headache and a full bag of IV fluids.  It was enough to get me standing on my own so I could go home after spending several hours in the emergency room. 3/5/21 - 3//21 - still had symptoms - every time I moved I got nauseous and dizzy.   Followed up with my PCP's office on 3/9/21 as I was still very dizzy, nauseas, and had brain fog- I have been on Zolfran and Motion sickness medicine - since the 9th. At that time blood tests were done.  I  had another appointment with my PCP on 3/16/21- as I am still having nausea and while there - got very nauseas while tracking . This is 11 days after the 1st vaccine.   I was referred to Otolarynology on 3/17/21.  The PA I saw there determined it wasn't an ear issue and has referred me to Dr. for an ENG test which is scheduled for 3/31/21 with a follow up with Dr. on 4/13/21.   I have also been in touch with my allergist - who told me to postpone my allergies shot that were scheduled on 3/19/21.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: Within 7 minutes I had a reaction of dizziness, nausea, increased blood pressure, increased heart rate, retching and extreme fatigue. I was taken to the Emergency Room via. Ambulance. In the ambulance I was given an IV and IVY Zolfran - which seemed to make the symptoms worse, at the Emergency room they gave me  Phenergan.  I had a chest x-ray that didn't show anything unusual.   I was then give Meclazine for the naseau and headache and a full bag of IV fluids.  It was enough to get me standing on my own so I could go home after spending several hours in the emergency room. 3/5/21 - 3//21 - still had symptoms - every time I moved I got nauseous and dizzy.   Followed up with my PCP's office on 3/9/21 as I was still very dizzy, nauseas, and had brain fog- I have been on Zolfran and Motion sickness medicine - since the 9th. At that time blood tests were done.  I  had another appointment with my PCP on 3/16/21- as I am still having nausea and while there - got very nauseas while tracking . This is 11 days after the 1st vaccine.   I was referred to Otolarynology on 3/17/21.  The PA I saw there determined it wasn't an ear issue and has referred me to Dr. for an ENG test which is scheduled for 3/31/21 with a follow up with Dr. on 4/13/21.   I have also been in touch with my allergist - who told me to postpone my allergies shot that were scheduled on 3/19/21.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: vaccine given to person under 18. no adverse as far as i am aware, just reporting the error
Age: 69.0
Sex: M
Vaccine: COVID19, UNK, COVID19, COVID19
Symptoms: Asthenia, Respiratory failure
Clinical narrative: generalized weakness respiratory failure
Age: 69.0
Sex: M
Vaccine: COVID19, UNK, COVID19, COVID19
Symptoms: Asthenia, Hypotension, Respiratory failure
Clinical narrative: generalized weakness respiratory failure
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Insomnia, Pain in extremity, Swelling, Tenderness
Clinical narrative: During the first and second day, my upper left arm was slightly tender from the shot. When that pain subsided during the second day after the shot, I started to get some swelling and pain in my left armpit. Discomfort was such that it interfered with my ability to sleep through that night. The following day (Day 3 after injection) the discomfort mostly subsided but still has not completely gone away. Currently on Day 6 after injection. No treatments or medications have been applied to alleviate the issue.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: Stroke
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bleeding time prolonged, Disseminated intravascular coagulation, Mouth haemorrhage, Oral disorder, Platelet count decreased
Clinical narrative: Roughly a week following vaccination he cut his hand and was unable to stop the bleeding. 2 days later he developed mucosal lesions inside his mouth which began to bleed without resolution. He also cut himself shaving with prolonged bleeding. Following this event his rehabilitation center performed a CBC and he was found to be profoundly thrombocytopenic with platelets of 7. He presented to hospital where he was transfused with platelets which did not resolve his thrombocytopenia. He was transfused 2 more units with immediate CBC followup which did not improve his platelets; this was very suggestive of a consumptive process. Hematology was consulted and per their recommendations steroids were started. After initiation of systemic IV medrol platelet count began to rise. Per our hematology team, most likely culprit is the COVID vaccine. Patient had no medication changes, had been stable in his chronic conditions, and had never had any autoimmune or thrombocytopenic event before this time.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet transfusion, Skin laceration, Thrombocytopenia
Clinical narrative: Roughly a week following vaccination he cut his hand and was unable to stop the bleeding. 2 days later he developed mucosal lesions inside his mouth which began to bleed without resolution. He also cut himself shaving with prolonged bleeding. Following this event his rehabilitation center performed a CBC and he was found to be profoundly thrombocytopenic with platelets of 7. He presented to hospital where he was transfused with platelets which did not resolve his thrombocytopenia. He was transfused 2 more units with immediate CBC followup which did not improve his platelets; this was very suggestive of a consumptive process. Hematology was consulted and per their recommendations steroids were started. After initiation of systemic IV medrol platelet count began to rise. Per our hematology team, most likely culprit is the COVID vaccine. Patient had no medication changes, had been stable in his chronic conditions, and had never had any autoimmune or thrombocytopenic event before this time.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage, Immunoglobulin therapy, Platelet count decreased, Thrombocytopenia, Transfusion
Clinical narrative: Roughly a week following vaccination he cut his hand and was unable to stop the bleeding. 2 days later he developed mucosal lesions inside his mouth which began to bleed without resolution. He also cut himself shaving with prolonged bleeding. Following this event his rehabilitation center performed a CBC and he was found to be profoundly thrombocytopenic with platelets of 7. He presented to hospital where he was transfused with platelets which did not resolve his thrombocytopenia. He was transfused 2 more units with immediate CBC followup which did not improve his platelets; this was very suggestive of a consumptive process. Hematology was consulted and per their recommendations steroids were started. After initiation of systemic IV medrol platelet count began to rise. Per our hematology team, most likely culprit is the COVID vaccine. Patient had no medication changes, had been stable in his chronic conditions, and had never had any autoimmune or thrombocytopenic event before this time.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 3/20 rash on abdomen/chest (vaccine was on 3/18)
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: A rash on the back of my neck below my hairline. I have a picture of the rash if needed.  Left arm sore.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Loss of consciousness
Clinical narrative: Patient passed out about 5 minutes after injection. Patient has history of passing out from vaccines, was  counseled to sit and wait 30 minutes after vaccine was given. She passed out in chair in the waiting area about 5 minutes after injection. Nurse practitioner next door was notified and she contacted 911.  Patient then came to but was slightly disoriented, EMS walked patient out to car.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Fatigue to the point where I could not get get out of bed.   Right hip joint painful and stiff continuously since day 2
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Pain
Clinical narrative: Headache, 102 fever, chills and body aches.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Communication disorder, Gait inability
Clinical narrative: I had the Pfizer vaccine on Friday, March 21st. An hour after getting the vaccine I could not walk. I could move my feet and legs but couldn?t walk until the next day.  In addition I could understand what people were asking me but couldn?t find the words to answer their questions properly.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: On 03/05/2021 approximately 5 hours after vaccination: headache, aches, chills, possible low-grade fever. Symptoms lasted until mid-day 03/06/2021. Acetaminophen was taken after first symptoms appeared and approximately every 6-8 hours until symptoms passed.  Arm soreness lasted several days after vaccination.  On 03/20/2021: felt 2 large swollen (probably) lymph nodes above collarbone on left side. Lymph nodes are visibly raised under the skin. The one closer to the left arm is larger than the one next to it which is closer to the neck. They are barely sore, if at all. Lymph nodes are still swollen at the time of this writing.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: On 03/05/2021 approximately 5 hours after vaccination: headache, aches, chills, possible low-grade fever. Symptoms lasted until mid-day 03/06/2021. Acetaminophen was taken after first symptoms appeared and approximately every 6-8 hours until symptoms passed.  Arm soreness lasted several days after vaccination.  On 03/20/2021: felt 2 large swollen (probably) lymph nodes above collarbone on left side. Lymph nodes are visibly raised under the skin. The one closer to the left arm is larger than the one next to it which is closer to the neck. They are barely sore, if at all. Lymph nodes are still swollen at the time of this writing.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Myalgia
Clinical narrative: Arm sore Fever Chills Nausea  Muscle and joint pain, hip pain  Tiredness  Dizzy
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Arm sore Fever Chills Nausea  Muscle and joint pain, hip pain  Tiredness  Dizzy
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Headache
Clinical narrative: Lightheaded, dizzy, weak, headache -10:00am Left work by noon. Feeling same
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Lightheaded, dizzy, weak, headache -10:00am Left work by noon. Feeling same
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Lightheaded, dizzy, weak, headache -10:00am Left work by noon. Feeling same
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Pain of skin, Skin warm
Clinical narrative: Within 8 hours, felt very fatigued and had chills. Within 24 hours, lymph node under my left arm swelled to the size of a kiwi. Swelling gradually reduced over 2 days to the size of a large grape. Very hot and painful. I have never had such an extreme reaction to a vaccine.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Headache, Pyrexia
Clinical narrative: On 6 Mar, I had a headache, diarrhea, fever for 3 days  and left hip joint pain is still on going.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Impaired work ability, Malaise, Tremor
Clinical narrative: 03/19/2021 -   4 PM I STARTED TO NOT FEEL WELL. LEFT WORK - WENT HOME , STARTED TO SHAKE REALLY HARD WITH COLD CHILLS. LAID DOWN WITH TWO BLANKETS AND WAITED FOR THE SHAKING TO STOP...THEN FELL ASLEEP.  I  AM GUESSING SHAKING WENT ON FOR A GOOD 1/2 HR TO HOUR.  i WAS VERY WEAK TO GET UP TO GO THE BATHROOM. MY HUSBAND HELPED ME.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: 48 hours after vaccination numbness in the facial area... including lips, left ear, forehead and cheek.  Not severe and no visual effects to date.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Injection site pain, Pain
Clinical narrative: Second Vaccine given on 03/20/21.  The day after (03/21) I experienced extreme all-over body aches, especially lower back and glutes.  Also experienced major fatigue.  Left arm extremely sore at injection site.  Treatment was basically rest and later in the day two prescription Tylenol.  On 03/22, in the morning I still felt all-over body ache, especially lower back.  By 11 am, I started to feel much better.  So I would say that the adverse effects lasted only a day and a half.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Vital signs measurement
Clinical narrative: At approx 13:35, patient, 38 year old, female, with C/o pressure in the chest which began while the Jansssen Vaccine was being administrated by LPN. This nurse was informed of this event a few minutes later and went over to assess patient. on a scale of 1-10, patient described the chest pressure as 2 or 3. She denied any other symptoms. No s/s of resp. distress notes. BP taken noted at 106/72, Pulse 71 pulse Ox on room air 99%.  Within a few minutes more of observing patient, she reported complete resolution of her chest pressure. She remained in observation area for a total of 30 minutes. BP notes at 96/67, PR 70. This nurse suggested for patient to eat some chips and hydrate to increase her BP but patient 97/67 BP was a normal for her since she was vegan. She probably couldn't have the chips. Also informed patient if symptoms  reoccur she should see medical attention. patient verbalized understanding.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: pruritic rash, recommended to use anti itch cortisone cream. Patient agrees to use cream sometime later today.  Also suggested to see primary provider if symptoms worsen.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Limb immobilisation, Mobility decreased, Pain in extremity
Clinical narrative: Right deltoid arm pain that spread down into forearm causing limitation in movement with pronation/supination
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Impaired work ability
Clinical narrative: Pregnant (24 weeks, 6 days at time of vaccination; EDD is 6/23/2021).  I reported on the v-safe's daily check-in that one day I was totally exhausted and had to take a nap. I slept for about 2 hours. The exhaustion was akin to the first semester of pregnancy exhaustion when you can barely stay awake. I was fine after. The exhaustion was significant enough that I could not focus on work, so I decided to nap. On the v-safe reporting, I indicated that this "interferred with my daily work" or whatever that category of assessing the impact is. The agency staff who reached out to me after for details asked that I fill out this form and submit it. I do not remember the exact date of the exhaustion but, if possible to match my v-safe checklist with this report, it is available there. I believe it was 3/16.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling cold, Nausea
Clinical narrative: pt stated that she was at work and she started getting dizzy and collapsed.  She was sent home and has been weak, had chills and nauseated.  On 3/21/2021 she was feeling some better  Today 3/22/2021 she woke up with fatigue and nausea.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: pt stated that she was at work and she started getting dizzy and collapsed.  She was sent home and has been weak, had chills and nauseated.  On 3/21/2021 she was feeling some better  Today 3/22/2021 she woke up with fatigue and nausea.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Anaemia, Cholecystitis infective, Dysphagia, Intensive care unit acquired weakness
Clinical narrative: Prior to the vaccine on 2/13/21, He was a healthy 65 year old active college professor.   32 hours after the vaccination on 2/14/21, He had acute pancreatitis, which led to  septic shock and respiratory failure, and he was placed on a ventilator at  Hospital.   On 2/24/21, he was transferred to Hospital and continued to have additional diagnoses, including polyneuropathy critical illness, acute gangrenous cholecystitis, abdominal pain, anemia, impaired mobility, oropharyngeal dysphagia, pulmonary embolism, and assistance with ADL.  On 3/19/21, he was transferred from Hospital to Acute Rehab Unit for acute physical, occupational, and speech therapy.   He remains there today.   We do not know if this sequence of events is related to the vaccine, but because it occurred one day after the vaccine, we thought it should be reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Lipase increased, Liver function test increased, Loss of personal independence in daily activities, Mechanical ventilation, Mobility decreased
Clinical narrative: Prior to the vaccine on 2/13/21, He was a healthy 65 year old active college professor.   32 hours after the vaccination on 2/14/21, He had acute pancreatitis, which led to  septic shock and respiratory failure, and he was placed on a ventilator at  Hospital.   On 2/24/21, he was transferred to Hospital and continued to have additional diagnoses, including polyneuropathy critical illness, acute gangrenous cholecystitis, abdominal pain, anemia, impaired mobility, oropharyngeal dysphagia, pulmonary embolism, and assistance with ADL.  On 3/19/21, he was transferred from Hospital to Acute Rehab Unit for acute physical, occupational, and speech therapy.   He remains there today.   We do not know if this sequence of events is related to the vaccine, but because it occurred one day after the vaccine, we thought it should be reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pancreatitis acute, Pulmonary embolism, Respiratory failure, Septic shock
Clinical narrative: Prior to the vaccine on 2/13/21, He was a healthy 65 year old active college professor.   32 hours after the vaccination on 2/14/21, He had acute pancreatitis, which led to  septic shock and respiratory failure, and he was placed on a ventilator at  Hospital.   On 2/24/21, he was transferred to Hospital and continued to have additional diagnoses, including polyneuropathy critical illness, acute gangrenous cholecystitis, abdominal pain, anemia, impaired mobility, oropharyngeal dysphagia, pulmonary embolism, and assistance with ADL.  On 3/19/21, he was transferred from Hospital to Acute Rehab Unit for acute physical, occupational, and speech therapy.   He remains there today.   We do not know if this sequence of events is related to the vaccine, but because it occurred one day after the vaccine, we thought it should be reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Electrocardiogram, Presyncope, Syncope
Clinical narrative: Vasovagal syncope
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: She completed 2nd COVID vaccine and reported left arm swelling and redness, occurred one day after administration and  lasted one week.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia, Somnolence
Clinical narrative: Sunday after Saturday night vaccination I woke up with Headache, fever was 101.8, chills ,muscle aches, very tired- spent day on couch sleeping-next day Monday I still have slight fever 98.9 but am feeling better.  NOTE : Sunday at around 5;00 I had to take Excedrin tension headache 1 tab  This got rid of my headache !
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, muscle aches, chills, weekness, exhaustion.  Started about 6 hours after shot, lasted for 224 hours.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Illness, Pyrexia
Clinical narrative: Evan began to feel ill, loss of appetite, feverish, tired.  Napped several hours, took a dose of acetaminophen around 4 pm.  Symptoms subsided after about 6 hours with no recurrence.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain
Clinical narrative: Within 10 hours of getting the Janssen covid vaccine, I had suddent and severe joint pain in multiple joints, severe body chills, fatigue. I was shivering and felt unable to get warm despite truck temperature at 90 degrees along with a blanket and seat warmers on. Took 1000mg of Tylenol and symptoms mostly resolved with some minor joint pain and fatigue but had to continue the tylenol every 8-10 hours for the next 2 days or the symptoms returned in the severe state. Site of injection has also been swore with touch still at day 9. No redness or swelling at injection site. Also had 2xepisodes of random severe fatigue which is not normal and it lasted about 1-2 hours.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Shortly after receiving vaccine, the patient began to experience lightheadedness.  Vital signs taken and within normal limits except for slight increased blood pressure.  Cleared medically.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Pain
Clinical narrative: Within 12 hours, I developed a rash on my leg and neck.  Arm pain was so severe that I was barely able to move it.  Had body aches. Now it is 2 days later.  I have an itchy  rash at the injection site and on my chest.  The injection site area is swollen and painful.   The body aches resolved within 24 hours.  The rash did not.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Within 12 hours, I developed a rash on my leg and neck.  Arm pain was so severe that I was barely able to move it.  Had body aches. Now it is 2 days later.  I have an itchy  rash at the injection site and on my chest.  The injection site area is swollen and painful.   The body aches resolved within 24 hours.  The rash did not.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Angioedema, Aphasia, Dysphagia, Dyspnoea
Clinical narrative: The patient had an anaphylactic reaction. The patient experienced angioedema and could not speak. The patient  presented with difficulty swallowing, shortness of breath, wheezing, and was unable to talk. As a result to the reaction the patient had to be intubated. However, the patient has a  history of excessive anaphylaxis  with multiple intubations.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Endotracheal intubation, Wheezing
Clinical narrative: The patient had an anaphylactic reaction. The patient experienced angioedema and could not speak. The patient  presented with difficulty swallowing, shortness of breath, wheezing, and was unable to talk. As a result to the reaction the patient had to be intubated. However, the patient has a  history of excessive anaphylaxis  with multiple intubations.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Haematocrit normal, Haematuria, Platelet count decreased, Ultrasound scan normal
Clinical narrative: gross hematura for 6 days starting on 2/26- painless told platelets 57K, no others s/s of bleeding or bruising self limited after 6 days to GU, renal sono nomal, scheduled for cystoscopy in May repeat cbc hct 40, plts 160K dx covid in January 2021 vaccine dose #1 on 1/5/21
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pyrexia, Urine analysis
Clinical narrative: Started getting a fever around 7pm the same day as receiving the vaccine. Went to ER around 4am. Dangerously high fever of 104°. Received Torodol and IV fluids.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium decreased, Hypertension
Clinical narrative: High BP variation and sodium level dropped
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Patient had weakness unable to diagnosis specific cause. On site EMS was called vitals BP 80/80 HR 74 BG  87  99% O2 Patient refused evaluation or care and released against medical advise.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling face
Clinical narrative: Sixteen hours after the vaccine, I experienced an itchy feeling on my body.  My forehead was swollen. It lasted for 12 hours.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Nausea, Tremor
Clinical narrative: shakiness, nausea, chest tightness
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: The syringe that was used had a needle that had a auto retractor. The needle was retracted into the syringe before dose could be fully administered thus squirting some dose on patient's shoulder.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Iritis, Vision blurred
Clinical narrative: Iritis    blurred vision pain left eye
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: I started having dizziness 15 minutes after the shot was given on Friday (3/19/21) and I still have dizziness today (3/22/21).  I haven't been given anything to help with the side effects.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dizziness, Nausea, Vomiting
Clinical narrative: BECAME NAUSEATED AND VOMITED  IMMEDIATELY AFTER VACCINE DOSE. BECAME DIZZY WHILE WAITING IN OBSERVATION STATION. BLOOD PRESSURE WAS LOWER THAN USUAL. TREATED WITH ORAL REHYDRATION IN THE FORM OF WATER
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Full body hives. Got worse after 2nd dose on 3/18/2021
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swelling, Throat tightness
Clinical narrative: I had the typical side effects but I also had swelling in my neck and throat and I could feel my throat tightening up. the right side swelling went down overnight and then another day went by before the left side swelling went down.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Injection site soreness, redness and elevated temperature for 2 to 4 days. Also 1 day of mild fatigue and minor joint soreness.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on face beginning approximately 6 hours post vaccine and dissipating approximately 36 hours post vaccine.  Hives on face again beginning  18 days post vaccine.  Patient has never had hives before.  Wondering if it is related to vaccine and whether to proceed with second vaccine.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain for 12 hours after shot
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Feeling jittery, Skin burning sensation
Clinical narrative: Swollen eyes burning skin jittery feeling
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle twitching
Clinical narrative: Numbness in left leg around knee; twitching/pulsing in left jaw
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: I felt tired that night. Right arm at injection site was red, swollen, hot. It stayed that way for 2 weeks, though the swelling went down day by day. Then on 3/20/21 I noticed a red ring and a bigger area of redness than had been before. It looks like the typical "covid arm" pictures online from the Moderna vaccine. It does not hurt. It itches slightly and has not changed in redness since I noticed it.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Vaccination complication
Clinical narrative: Patient notified pharmacy today (03/22/2021) that Janssen Covid-19 Vaccine that she received on 03/03/2021 caused Pneumonia. Patient says that on 03/11/2021 went to hospital for treatment and MD told her that Pneumonia was caused by Janssen Vaccine she had received. Patient says was treated at hospital with 2 kind of IV antibiotics.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Respiratory tract congestion, Wheezing
Clinical narrative: Date and time adverse event started: 2 weeks ago, caller unsure of exact time (3/18/2021) dizziness, wheezing, congestion, states lungs feels like "it is filled with fluid". Has taken neb tx to alleviate symptoms but has no relief. Recommended to see primary provider. Caller states will take patient to urgent care today, 3/18/21.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Moderna COVID-19 Vaccine EUA Began ~11 hours after injection with dizziness at bedtime (11 pm). Woke up around 3 am with a slight fever (100 degrees), achy muscles and joints, muscle weakness, dizziness and headache.  Drank a glass of water, put gel ice pack on forehead, back of neck, injection site (very sore.) Went back to bed around 4 am, woke up again around 6, same symptoms, drank some more water and went back to bed again - very tired.  Got up around 9 am, still feeling bad but fever was a little lower - 99.6.  Fell asleep on the couch twice that day, took 1 ibuprofen around 3 pm.  Reduced appetite that day. Fever gone by night time.  Following day, ~48 hours post-injection, only symptom was continued dizziness.  Some dizziness still  on day 3, very slight on day 4.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: Moderna COVID-19 Vaccine EUA Began ~11 hours after injection with dizziness at bedtime (11 pm). Woke up around 3 am with a slight fever (100 degrees), achy muscles and joints, muscle weakness, dizziness and headache.  Drank a glass of water, put gel ice pack on forehead, back of neck, injection site (very sore.) Went back to bed around 4 am, woke up again around 6, same symptoms, drank some more water and went back to bed again - very tired.  Got up around 9 am, still feeling bad but fever was a little lower - 99.6.  Fell asleep on the couch twice that day, took 1 ibuprofen around 3 pm.  Reduced appetite that day. Fever gone by night time.  Following day, ~48 hours post-injection, only symptom was continued dizziness.  Some dizziness still  on day 3, very slight on day 4.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: woke up Sunday morning [2 days after] with a swollen left arm pit ;same side as vaccine was given. Area was tender, not discolored or warm to touch. Irritation the more I moved around. swelling  was soft and pliable, no hardness. Monday morning swelling had  decreased significantly. Email my care team on Sunday, Monday response was that swelling may have been attributed to the vaccine and I should file a report with CDC. No other symptoms other than soreness at injection site and body aches that lasted 24 hours.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Full blood count abnormal, Gait inability, Physical disability, Red blood cell sedimentation rate
Clinical narrative: Patient developed Severe INflammatory response syndrome .  Was hospitalized as her cbc was abnormal and no infection could be found, could not walk or take care of herself
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Systemic inflammatory response syndrome, Troponin, Urine analysis
Clinical narrative: Patient developed Severe INflammatory response syndrome .  Was hospitalized as her cbc was abnormal and no infection could be found, could not walk or take care of herself
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red ring around the injection site, red area going down about 3 inches. No pain or itching. (have photo if interested). By evening started to lighten in color. noticed it was slightly raised.  By next morning, faded to light pink.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event---administration error only. Patient needed to be 16 to receive vaccine, but was only 15 yrs old
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: NAUSEA AND VOMMITING AND FEVER AND HEADACHE AND CHILLS  STARTED  3/19/21,  DIAHHREA CALMED DOWN YESTERDAY 3/21/2021
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urine analysis, Vomiting
Clinical narrative: NAUSEA AND VOMMITING AND FEVER AND HEADACHE AND CHILLS  STARTED  3/19/21,  DIAHHREA CALMED DOWN YESTERDAY 3/21/2021
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperaesthesia teeth, Pyrexia
Clinical narrative: Chills, fever and intense headache.  Started at 9:30 PM and lasted through the night.  8:00 Am next day felt much better but did have the upper teeth sensitive to cold and heat.  This lasted half a day.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: After receiving the Moderna vaccine and about 5 minutes later, the customer became dizzy and blacked out for a few seconds and fell.  She was then transported to the hospital.