chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Arm sore; Headache; This is a spontaneous report from a contactable consumer (patient).   A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262; Expiration Date: 21May2021), dose 2 via an unspecified route of administration on 16Feb2021 (at the age of 69-years-old) as dose 2, single for covid-19 immunisation.  Medical history included Allergies, Can't see, pollen allergies. Onset prior to being administered Pfizer COVID-19 Vaccine doses. Her allergies are so bad. The pollen count in (Name) is really high right now with temperatures in the 80s. Because of getting old she can't see. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for hypersensitivity, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for hypersensitivity and Cough medicine. Historical Vaccine included BNT162B2 as dose 1 on 26Jan2021 (Batch/Lot Number: EL1283; Expiration Date: 30Apr2021) for Covid-19 Immunisation (at the age of 69-years-old). On 17Feb2021, the patient experienced arm sore and headache. Treatment was given for the events. She had nothing the first day, on the 16Feb2021; onset of headache was when she woke up on 17Feb2021; it was a pretty good headache, the kind that hurt behind the eyes. She normally does not get headaches very often. Sore arm and headache were nothing that some Tylenol and sleep could not handle. She has taken 3 doses of Tylenol since onset of events. Injection up on the shoulder of left arm right after 09:00 was reported. She had to get a magnifying glass to read CDC vaccine record card. Patient asked if she can take Tylenol, Aspirin, Benadryl, Cough and Cold medicine (Theraflu)  and if it interfere with the vaccine if she take it. This consumer reported having had nothing but a good experience getting the Pfizer COVID-19 Vaccine injections. She called to ask if it is ok to take Aspirin, cough medicine or Benadryl after getting the Pfizer COVID-19 Vaccine. She clarified that she had preexisting allergies with onset prior to any Pfizer COVID-19 Vaccine doses; she normally would take Aspirin, cough medicine or Benadryl for those allergies but wanted to make sure it was ok to take before she took any since getting the vaccine doses. She reported height between 5ft, 7in and 5ft, 8in; she used to be 5ft, 8in but she is probably 5ft, 7.5in now. Outcome of the events were recovered on an unspecified day in 2021.   Follow up (19Feb2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported included patient's weight, relevant history, outcome of the events and clinical informations.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 30Jan2021 as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the patient had received the first dose of the Pfizer COVID-19 vaccine on 30Jan2021. Stated that, the patient developed a sinus infection on an unspecified date in 2021, which was not from the Pfizer COVID-19 Vaccine, had no connection to the vaccine-she gets these kind of sinus infections normally. Stated that, she was prescribed and taking Amoxicillin for the sinus infection until taking the last tablet last night. Stated that, she took the last dose of her antibiotic yesterday. She was scheduled for her second dose of Pfizer COVID-19 Vaccine tomorrow (on 20Feb2021). Stated that, she called to ask whether the Amoxicillin taken will interfere with the Pfizer COVID-19 Vaccine. Stated that, she just wanted her inquiry to be addressed at this time, that was to know whether there was any interaction or was it contraindicated in taking the vaccine. The reporter considered the events as non-serious. Treatment was received for the event. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Condition aggravated, Fatigue, Limb discomfort
Clinical narrative: she has been more and more tired; muscle pains; soreness; legs were so bad; she couldn't stay up and had to go to bed at 7pm and got up from bed at 11am this morning/still wanted to go to bed after that long sleep/she wanted to go back to bed; kept thinking her energy level was going to go back up but it is not; it seems to be getting worse; kept thinking her energy level was going to go back up but it is not; it seems to be getting worse; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6200) via an unspecified route of administration on 16Feb2021 (66-year-old at vaccination) as Dose 1, Single for Covid-19 immunization. The patient's medical history included high blood pressure, rheumatoid arthritis. The patient's concomitant medication(s) included prednisone; hydroxychloroquine; methotrexate and other products (unspecified) for her high blood pressure. The patient mentioned that she received the 1st shot on Tuesday. On an unknown date in 2021, she noticed that she had been more and more tired. She had muscle pains and soreness. She mentioned that her legs were so bad. Yesterday she couldn't stay up and had to go to bed at 7pm and got up from bed at 11am this morning. She had a shower but still wanted to go to bed after that long sleep. she was tired a lot now. She kept thought her energy level was going to go back up, but it was not; it seems to be getting worse. She got up at 12:00 today and all she could think of was that she wanted to go back to bed. She noticed that tiredness was a symptom listed for the Pfizer COVID-19 Vaccine. The only other symptom she thought she has had that was listed was sore muscles. She had to go up to the second floor to her apartment and it hurts. She reported she had high blood pressure and rheumatoid arthritis which was why she took medication for. She wanted an information on these events relative to the vaccine. She was asking how long these side effects are expected to last. She suffer with Arthritis, but she do not think she suffer from extra joint pain because she was taking medication for that and then she also take Prednisone, Hydroxychloroquine and Methotrexate." The patient underwent lab tests and procedures which included blood test for Rheumatoid arthritis: she had seen the results and her results are on line. She did not memorize the results." Investigation assessment was reported. She stated that no, she did not know what to take as treatment medication. The nurse said drink plenty of water, so she drank plenty of water." The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Somnolence
Clinical narrative: she has been more and more tired; muscle pains; soreness; legs were so bad; she couldn't stay up and had to go to bed at 7pm and got up from bed at 11am this morning/still wanted to go to bed after that long sleep/she wanted to go back to bed; kept thinking her energy level was going to go back up but it is not; it seems to be getting worse; kept thinking her energy level was going to go back up but it is not; it seems to be getting worse; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6200) via an unspecified route of administration on 16Feb2021 (66-year-old at vaccination) as Dose 1, Single for Covid-19 immunization. The patient's medical history included high blood pressure, rheumatoid arthritis. The patient's concomitant medication(s) included prednisone; hydroxychloroquine; methotrexate and other products (unspecified) for her high blood pressure. The patient mentioned that she received the 1st shot on Tuesday. On an unknown date in 2021, she noticed that she had been more and more tired. She had muscle pains and soreness. She mentioned that her legs were so bad. Yesterday she couldn't stay up and had to go to bed at 7pm and got up from bed at 11am this morning. She had a shower but still wanted to go to bed after that long sleep. she was tired a lot now. She kept thought her energy level was going to go back up, but it was not; it seems to be getting worse. She got up at 12:00 today and all she could think of was that she wanted to go back to bed. She noticed that tiredness was a symptom listed for the Pfizer COVID-19 Vaccine. The only other symptom she thought she has had that was listed was sore muscles. She had to go up to the second floor to her apartment and it hurts. She reported she had high blood pressure and rheumatoid arthritis which was why she took medication for. She wanted an information on these events relative to the vaccine. She was asking how long these side effects are expected to last. She suffer with Arthritis, but she do not think she suffer from extra joint pain because she was taking medication for that and then she also take Prednisone, Hydroxychloroquine and Methotrexate." The patient underwent lab tests and procedures which included blood test for Rheumatoid arthritis: she had seen the results and her results are on line. She did not memorize the results." Investigation assessment was reported. She stated that no, she did not know what to take as treatment medication. The nurse said drink plenty of water, so she drank plenty of water." The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discolouration
Clinical narrative: This is a spontaneous, non-serious report from a contactable consumer (patient). A 72-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EL9265), at the age of 72, via an unspecified route of administration, on Feb 5, 2021, single dose, for COVID-19 immunisation. There were no concomitant medications or medical history. Caller inquired about the vaccine Pfizer COVID-19 vaccine. He got the shot on Feb 5, 2021. At the point of the injection site, the skin around that area was yellow. He wanted to know if that was normal, since that area was still yellow. After waiting 2 hours, he was hoping to have some answers. He said he has time to answer some questions. He confirmed he received the first dose Feb 5, 2021 and he receives the second dose Feb 26, 2021. He does not know when he noticed it was yellow. He did not pay much attention. He thought it might have been something they put on there. He did not think much about it, but it was still yellow now 2 weeks later. He said whatever was in the needle was what they gave. He will write down the number, but he doubted he would call back. He has been on hold for almost 3 hours now because he started trying to call around noon. He will see his doctor tomorrow. The outcome of the event: unknown. No follow-up attempts possible. No further information expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site; This is a spontaneous report from a non-contactable consumer via Pfizer sales representative. A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 17Feb2021 (age at vaccination 49 years) as dose number unknown, single for covid-19 immunisation. Patient medical history and concomitant medications were not reported. The patient had no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced pain at injection site on 18Feb2021. The patient did not receive any treatment for reported events. The outcome of events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Vomiting
Clinical narrative: vomiting; diarrhea; sweats; chills; This is a spontaneous report from a non-contactable consumer. This 39-year-old non-pregnant female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 20Feb2021 at 10:00 hours in left arm (at 39-year-old), at single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. The patient did not have covid prior vaccination and was not tested for covid post vaccination. She had no allergies. About 18 hours after administration on 21Feb2021 at 06:00 AM the patient experienced intense vomiting and diarrhea, along with sweats and chills. These symptoms continued for about 5 hours. The patient received treatment with nausea medication. The patient was recovering.  Information about lot/Batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Very, very severe, widespread muscle pain; This is a spontaneous report from a contactable Consumer. A 73-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in Arm Left on 22Feb2021 07:15 as DOSE 1, SINGLE (at the age of 73-year-old) for covid-19 immunisation. Medical history included hypothyroidism, fibromyalgia, blood cholesterol increased. The patient's concomitant medications were not reported. The patient previously took vibramycin [doxycycline] and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021 08:00, the patient experienced very, very severe widespread muscle pain. AE resulted in doctor or other healthcare professional office/clinic visit. The patient did not received any treatment for the event. The outcome of the event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: had classic flu like symptoms 12 hours later after shot; tired; achy; This is a spontaneous report from a contactable other hcp (patient himself). A 60-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL3247), via an unspecified route of administration, administered in right arm on 17Feb2021 13:30 (Age at vaccination: 60 years) as DOSE 2, SINGLE for covid-19 immunisation in the workplace clinic. The patient's medical history included high blood pressure, gout, fatty liver, hepatic steatosis. Concomitant medication(s) included losartan 100mg; allopurinol 300mg. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3247) via an unspecified route of administration, administered in right arm on 27Jan2021 13:30 as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. The patient had no known allergies. On 18Feb2021 01:30, the patient had classic flu like symptoms 12 hours later after shot, tired, achy. Then lasted 24 hour later achy and tired. Then less on second day after taking Tylenol 500mg. By 19Feb2021 (Friday night), all was normal again. The patient did not receive any treatment for the adverse events. The patient was not diagnosed with covid prior to vaccination nor was tested for covid since vaccination. The outcome of the events was recovered on 19Feb2021 13:30.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain in extremity, Tremor
Clinical narrative: sore arm on the 1st day which was horrible; she felt nauseous and dizziness; she felt nauseous and dizziness; shaking, her hands were shaking and went on for quite a while; A female patient of an unspecified age (Age: 63; Unit: Unspecified) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date patient experienced sore arm on the 1st day which was horrible, she felt nauseous and dizziness and shaking, her hands were shaking and went on for quite a while. Patient would like to know if there was any interaction between Duloxetine and the pfizer covid vaccine. Patient received the Pfizer covid vaccine on Tuesday however started a new medication, Duloxetine 20 mg (generic of Cymbalta), today. She reported having a sore arm on the 1st day which was horrible. She took the new medication at 7:00 this morning, by 9:30 she felt nauseous and dizziness. increased nausea and shaking, her hands were shaking and went on or quite a while, about 45 minutes. It got so bad she had to call her doctor. Right now, she still feels a little nauseous but not as before. She also reports that she has a compromised immune system and that she is susceptible to having slight issues with medication. Patient would like to know if side effects similar to hers have been reported from receiving the Pfizer covid vaccine. The outcome of events was unknown  No follow-up attempts are possible. Information about lot/batch number cannot be obtained
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Pain in injection site; tiredness; headache; muscle pain; chills; joint pain; fever; nausea; feeling unwell; weakness; fast heartbeat; This is a spontaneous report from a non-contactable consumer reported for herself. A 42-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EN6206) via an unspecified route of administration in arm left on 10Mar2021 09:45 as dose 1, single (age at vaccination: 42 year) for COVID-19 immunisation. Medical history included thyroid, known allergies: sulfa, all from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE); duloxetine (DULOXETINE), all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No COVID prior vaccination and did not tested COVID post vaccination. On 10Mar2021 at 09:15 PM, the patient experienced pain in Injection site, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell, weakness, fast heartbeat. No treatment was received. The clinical outcome of the events on an unspecified date Mar2021 was resolved.  No follow-up attempts are possible; No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: Pain in injection site; tiredness; headache; muscle pain; chills; joint pain; fever; nausea; feeling unwell; weakness; fast heartbeat; This is a spontaneous report from a non-contactable consumer reported for herself. A 42-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EN6206) via an unspecified route of administration in arm left on 10Mar2021 09:45 as dose 1, single (age at vaccination: 42 year) for COVID-19 immunisation. Medical history included thyroid, known allergies: sulfa, all from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE); duloxetine (DULOXETINE), all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No COVID prior vaccination and did not tested COVID post vaccination. On 10Mar2021 at 09:15 PM, the patient experienced pain in Injection site, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell, weakness, fast heartbeat. No treatment was received. The clinical outcome of the events on an unspecified date Mar2021 was resolved.  No follow-up attempts are possible; No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in injection site; tiredness; headache; muscle pain; chills; joint pain; fever; nausea; feeling unwell; weakness; fast heartbeat; This is a spontaneous report from a non-contactable consumer reported for herself. A 42-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EN6206) via an unspecified route of administration in arm left on 10Mar2021 09:45 as dose 1, single (age at vaccination: 42 year) for COVID-19 immunisation. Medical history included thyroid, known allergies: sulfa, all from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE); duloxetine (DULOXETINE), all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No COVID prior vaccination and did not tested COVID post vaccination. On 10Mar2021 at 09:15 PM, the patient experienced pain in Injection site, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell, weakness, fast heartbeat. No treatment was received. The clinical outcome of the events on an unspecified date Mar2021 was resolved.  No follow-up attempts are possible; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Erythema, Hypertension
Clinical narrative: High blood pressure; Face was blood red/Went up to 150 or 160; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age (reported as age: 71, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), dose 1 via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunization. Medical history included arthritis and fibromyalgia. The patient concomitant medications were not reported. It was reported that the patient received first dose of the Pfizer vaccine last Wednesday. The patient was fine the day of, but for the two days afterwards (on unspecified date in Mar2021), she believed she had high blood pressure. Patient said her face was blood red for two days and did not have a cuff to measure. The patient thought it went up to 150 or 160. The outcome of the events was recovered on an unknown date in Mar2021.  No follow-up attempts were possible, information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Muscular weakness, Nausea
Clinical narrative: felt weakness and slight shortness of breath like she had just ran around the block; muscle weakness in the legs, knees down feel weak like the blood has been drawn out/ her lower legs just feel weak; felt weakness and slight shortness of breath like she had just ran around the block; heavy duty nausea twice- at 4pm and 9pm but did not vomit; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on 11Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated fifteen years ago she had an allergic reaction to the flu shot, with a huge amount of swelling in the arm with a very quick onset. She was given a subsequent shot and then was fine. She was fine with the pneumonia shot. She did have a cortisone shot in the knee that gave her heart palpitations and a red face. On 11Mar2021 (Thursday), patient received the first dose of the Pfizer vaccine and on the same day she experienced heavy duty nausea twice-at 4pm and 9pm but did not vomit. Then on late Saturday (13Mar2021) she felt some nausea and felt weakness and slight shortness of breath like she had just ran around the block. She experienced muscle weakness in the legs, knees down feel weak like the blood has been drawn out. She feels fine walking but that her lower legs just feel weak or "bushed." At the time of reporting, outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain, Pain
Clinical narrative: Extremely swollen lymph nodes by the left clavicle; Very painful to the touch.Even hurt to have clothes laying on them; Hurt to turn neck, pick anything up with left arm.Very sensitive; This is a spontaneous report from a contactable consumer or other non hcp. A 30-years-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6204) via an unspecified route of administration in Arm Left on 12Mar2021 08:30 (age at vaccination:30 years) as DOSE 1, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient had received other medications was NuvaRing, Zyrtec, singular within 2 weeks to post vaccination. Medical history included asthma from an unknown date and unknown if ongoing, food intolerance from an unknown date and unknown if ongoing known allergies: Egg intolerance, covid-19 from an unknown date and unknown if ongoing if covid prior vaccination: Yes. Concomitant medications included ethynylestradiol, etonogestrel (NUVARING) taken for an unspecified indication, start and stop date were not reported; Montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient experienced extremely swollen lymph nodes by the left clavicle on 13Mar2021 20:00, very painful to the touch. Even hurt to have clothes laying on them on 13Mar2021 20:00, hurt to turn neck, pick anything up with left arm. Very sensitive on 13Mar2021 20:00. Patient had Physician office visits for the events. Therapeutic measures were taken as a result of extremely swollen lymph nodes by the left clavicle, very painful to the touch. Even hurt to have clothes laying on them, hurt to turn neck, pick anything up with left arm. Very sensitive was Ketorolac 10 mg every 6 hours. The outcome of the events lymphadenopathy, pain, neck pain was recovering. No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Crying, Moaning, Nausea, Pain
Clinical narrative: a sudden "explosion" of pain/level 10 severity/a new type of pain or perhaps a huge exacerbation of existing systemic pain of some kind; fever of 100.8 at one point; nausea; I was literally moaning and crying; I was literally moaning and crying; This is a spontaneous case received from a contactable consumer (patient). A 68-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6199) via an unspecified route of administration in left arm on 05Mar2021 13:30 (age at vaccination 68-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. The patient medical history included myalgic encephalomyelitis (ME/CFS), fibromyalgia, gastroesophageal reflux disease (GERD), hiatal hernia, mild depression, limited migraine headaches, hypothyroidism, high blood pressure, high cholesterol, degenerative disc disease (DDD) and other musculoskeletal issues, irritable bowel syndrome (IBS), lichen sclerosis and systemic pain. The patient had known allergies to cipro and sensitive to milk, citrus and nuts. Concomitant medication was not reported. The patient did not take other vaccine in four weeks. The patient took other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Mar2021 18:30, the patient experienced a sudden "explosion" of pain, level 10 severity lasted for hours, a new type of pain or perhaps a huge exacerbation of existing systemic pain of some kind, fever of 100.8 at one point and nausea, the patient stated that she was moaning and crying. It was the worst pain of her life, relentless with no let-ups, despite my taking a necessary opiate 2-3 times close together. Patient was literally moaning and crying, anything to help with the pain once back at home. The patient underwent lab test and procedures which included body temperature: 100.8 and pain assessment: level 10 severity on 07Mar2021. Otherwise, a visit to the ER of her local hospital should have been done. I wished the next day I had gone there but I doubted my pain would be understood. I also feared going to a hospital in this COVID environment. Her pain was intractable and unbearable. She had a fever of 100.8 at one point and nausea, preceded byusual short-term symptoms expected to go with the first COVID shot. She was seriously considering not getting the 2nd shot, wonder whether she can tolerate this or even worsened pain, not knowing the reason for this to have occurred. Therapeutic measures were taken as a result of the events which included treatment with opiates, hot/cold packs and Tylenol. The outcome of the events was unknown.  No follow-up attempts are possible. No further information was expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, Pyrexia
Clinical narrative: a sudden "explosion" of pain/level 10 severity/a new type of pain or perhaps a huge exacerbation of existing systemic pain of some kind; fever of 100.8 at one point; nausea; I was literally moaning and crying; I was literally moaning and crying; This is a spontaneous case received from a contactable consumer (patient). A 68-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6199) via an unspecified route of administration in left arm on 05Mar2021 13:30 (age at vaccination 68-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. The patient medical history included myalgic encephalomyelitis (ME/CFS), fibromyalgia, gastroesophageal reflux disease (GERD), hiatal hernia, mild depression, limited migraine headaches, hypothyroidism, high blood pressure, high cholesterol, degenerative disc disease (DDD) and other musculoskeletal issues, irritable bowel syndrome (IBS), lichen sclerosis and systemic pain. The patient had known allergies to cipro and sensitive to milk, citrus and nuts. Concomitant medication was not reported. The patient did not take other vaccine in four weeks. The patient took other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Mar2021 18:30, the patient experienced a sudden "explosion" of pain, level 10 severity lasted for hours, a new type of pain or perhaps a huge exacerbation of existing systemic pain of some kind, fever of 100.8 at one point and nausea, the patient stated that she was moaning and crying. It was the worst pain of her life, relentless with no let-ups, despite my taking a necessary opiate 2-3 times close together. Patient was literally moaning and crying, anything to help with the pain once back at home. The patient underwent lab test and procedures which included body temperature: 100.8 and pain assessment: level 10 severity on 07Mar2021. Otherwise, a visit to the ER of her local hospital should have been done. I wished the next day I had gone there but I doubted my pain would be understood. I also feared going to a hospital in this COVID environment. Her pain was intractable and unbearable. She had a fever of 100.8 at one point and nausea, preceded byusual short-term symptoms expected to go with the first COVID shot. She was seriously considering not getting the 2nd shot, wonder whether she can tolerate this or even worsened pain, not knowing the reason for this to have occurred. Therapeutic measures were taken as a result of the events which included treatment with opiates, hot/cold packs and Tylenol. The outcome of the events was unknown.  No follow-up attempts are possible. No further information was expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle swelling, Pain in extremity, Swelling
Clinical narrative: upper right arm & right shoulder pain with right arm use; upper right arm & right shoulder pain with right arm use; swelling in right armpit and right deltoid; swelling in right armpit and right deltoid; This is a spontaneous report from a contactable Other Health Professional (patient herself). A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EM9809) via an unspecified route of administration in right arm on 10Feb2021 08:30 as dose 2, single (at the age of 50-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient medical history included asthma. The concomitant medications included aceclofenac BIOFLEX [ACECLOFENAC]) and daily multivitamins. Historical Vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9262) via an unspecified route of administration in right arm on 20Jan2021 15:45 as dose 1, single for COVID-19 immunization. Vaccination facility type was reported as other. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not COVID tested post vaccination. Patient did not receive any other vaccine in four weeks and had no known allergies. On 10Feb2021 12:00 the patient experienced upper right arm and right shoulder pain with right arm, swelling in right armpit. It was reported that since the second vaccine, she have had upper right arm and right shoulder pain with right arm use. At times, the pain occurred while resting in certain positions. The pain was not continuous, but it was persistent in the sense that it occurred every time she made specific arm movements or while resting in certain positions. There was also slight, visible swelling in right armpit and right deltoid. The patient did not receive any treatment for the adverse events. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Bursitis, Joint swelling, Limb discomfort, Pain
Clinical narrative: bursitis and arthritis; bursitis and arthritis; it got worse with pain from his shoulder down to his fingers; his elbow swelled up; discomfort in his arm; This is a spontaneous report from a contactable consumer or other non-health care professional. An 82-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: Not Reported, Expiry Date: Not Reported) via an unspecified route of administration on 04Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: Not Reported, Expiry Date: Not Reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date in feb2021 that is two weeks after vaccination, the patient experienced, some discomfort in his arm Later on an unspecified date it got worse with pain from his shoulder down to his fingers, his elbow swelled up and he couldn't put pressure on it. He had seen the doctor and had x-rays and they said he has bursitis and arthritis on an unspecified date. He was placed on Steroids and then the following week they gave him an injection in his shoulder, but he is still having some problems with it. The patient underwent lab tests and procedures which included x-ray has bursitis and arthritis on an unspecified date. Outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: bursitis and arthritis; bursitis and arthritis; it got worse with pain from his shoulder down to his fingers; his elbow swelled up; discomfort in his arm; This is a spontaneous report from a contactable consumer or other non-health care professional. An 82-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: Not Reported, Expiry Date: Not Reported) via an unspecified route of administration on 04Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: Not Reported, Expiry Date: Not Reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date in feb2021 that is two weeks after vaccination, the patient experienced, some discomfort in his arm Later on an unspecified date it got worse with pain from his shoulder down to his fingers, his elbow swelled up and he couldn't put pressure on it. He had seen the doctor and had x-rays and they said he has bursitis and arthritis on an unspecified date. He was placed on Steroids and then the following week they gave him an injection in his shoulder, but he is still having some problems with it. The patient underwent lab tests and procedures which included x-ray has bursitis and arthritis on an unspecified date. Outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea began the next morning and lasted 3 days.; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EV6205), via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 12:00 (at the age of 77-years-old) as single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension and hypercholesterolaemia. Patient had no known allergies. The patient's concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior vaccination. Patient was not tested covid post vaccination. The patient experienced diarrhea began the next morning on 11Mar2021 at 08:45 and lasted 3 days. Therapeutic measures were taken as a result of diarrhea began the next morning and lasted 3 days and patient was treated with probiotic gummies of bacillus coagulum. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Myalgia, Pyrexia
Clinical narrative: chills; muscle aches; fever; she was sick; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: not provided) via an unspecified route of administration on 26Feb2021 as DOSE,1 SINGLE for Covid-19 immunization. Medical history included meniscus tear, can't sleep, can't walk and knee pain. Concomitant medication included cortisone. The patient reported that she got the first vaccine on 26Feb2021 but has been having problems with her knee and it has been going on for over two months. She went to an orthopedic doctor today and got a cortisone shot and was supposed to get the second vaccine on Friday. She reported that was the first time she was receiving cortisone. She said she had meniscus tear and she got a cortisone shot to take the pain away and it worked. She wanted to know if the cortisone would affect the vaccine or if the vaccine would affect her treatment. She wanted to know if she would be able to do her daily activities without pain if she got the vaccine. She said she would rather not get the second dose of the vaccine if it changed the effectiveness of the cortisone because she could not sleep, could not walk, could not do anything when she had the knee pain. She asked if people taking cortisone get vaccinated. It was reported that first shot she was sick for 72 hours. On an unspecified day she experienced a lot of chills and muscle aches and fever and was very sick, but she called the nurse and she promised that it would be better in a day, and it was. She was hesitant to get the second vaccine anyway after these symptoms. It was like getting Covid all over again. She was taking Advil and Tylenol, and nothing was helping. It was pretty shocking, scary, and too much. Outcome of the event illness recovered on an unspecified date and other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Dyspnoea, Muscle tightness, Sneezing
Clinical narrative: hard time breathing; she felt her neck tied, her neck felt very tight; sneezing; I feel like my voice is kind of going; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot Number: EN6204) via an unspecified route of administration on an unspecified date (at the age of 44 years) as dose1, single for COVID-19 immunisation. The patient's medical history included hypertension, lightly elevated blood pressure, severe sinus (before patient had the pfizer vaccine she had travelled to urgent care for severe sinus) and allergies (experience having allergies) from an unknown date and unknown if ongoing. Past drug included Benadryl. She took benadryl before she got her vaccine. The patient's concomitant medication included blood pressure meds. The patient had covid 19 check out before vaccination. On unspecified date, patient received her first Pfizer shot that night and the following it felt like she was struggle like a hard time breathing like struggling to breath and was so severe that she honestly contemplated going to ER, she didn't go to the ER, she ended up not going because she thought it was her allergies, she feel like her voice was kind of going and she started sneezing, she felt her neck tied, her neck felt very tight and she don't know if the vaccine made her symptoms worst. Patient also stated that when she took benadryl and she felt 80 percent better but she just want to report it that if anyone takes it for her, her experience having allergies and then taking the vaccine it's like increased it to where she literally was having a hard time breathing. No treatment received for adverse events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Menometrorrhagia, Pain in extremity
Clinical narrative: Normal sore arm, but the next day woke up with extremely heavy and irregular menstrual bleeding.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Burning sensation, Dizziness, Erythema, Gingival discomfort
Clinical narrative: gums were enlarged/gum discomfort; teeth did not fit in them; left eye and her vision were tired; lightheaded; pressure on her entire head; redness; burning sensation on the face and gums/burning sensation on the left side of her face; hypertense; 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, Lot number was not reported), via an unspecified route of administration on 13Mar2021 (at the age of 51-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced lightheaded fifteen minutes after vaccination on 13Mar2021, on the same day after 20-25 minutes she felt pressure on her entire head, redness and burning sensation on the face and gums, where she was hypertense. The patient also felt her gums were enlarged and felt the teeth did not fit in them, for 15-20 minutes she had a burning sensation on the left side of her face and had gum discomfort, she felt her left eye and her vision were tired. The patient received treatment for hypertense. The treatment medication was chlordiazepoxide. The outcome of lightheaded was resolved on 13Mar2021. The outcome of pressure on her entire head was resolved on an unspecified date in Mar2021 and for all the other events was resolving.  No follow-up attempts are possible; information about Lot/Batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Nervousness, Tooth disorder
Clinical narrative: gums were enlarged/gum discomfort; teeth did not fit in them; left eye and her vision were tired; lightheaded; pressure on her entire head; redness; burning sensation on the face and gums/burning sensation on the left side of her face; hypertense; 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, Lot number was not reported), via an unspecified route of administration on 13Mar2021 (at the age of 51-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced lightheaded fifteen minutes after vaccination on 13Mar2021, on the same day after 20-25 minutes she felt pressure on her entire head, redness and burning sensation on the face and gums, where she was hypertense. The patient also felt her gums were enlarged and felt the teeth did not fit in them, for 15-20 minutes she had a burning sensation on the left side of her face and had gum discomfort, she felt her left eye and her vision were tired. The patient received treatment for hypertense. The treatment medication was chlordiazepoxide. The outcome of lightheaded was resolved on 13Mar2021. The outcome of pressure on her entire head was resolved on an unspecified date in Mar2021 and for all the other events was resolving.  No follow-up attempts are possible; information about Lot/Batch number cannot be obtained.