chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Restlessness
Clinical narrative: Lethargy; swollen and painful arm and armpit; swollen and painful arm and armpit; swollen and painful arm and armpit; chills; nausea; headache; muscle aches all over body; restlessness in muscles (feel like she had to flex everything); This is a spontaneous report received from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via unspecified route of administration in left arm on 12Feb2021 12:30 PM (at the age of 25-year-old) as 2nd dose, single for COVID-19 immunisation. Vaccine facility type was reported as hospital. The patient's medical history included depression and anxiety, both from unspecified date. No known allergies and no COVID prior vaccination were reported. The patient's concomitant medications reported as within two weeks from vaccination included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (reported as generic ADDERRAL), duloxetine hydrochloride (reported as generic CYMBALTA), both from unspecified date. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in left arm on unspecified date as 1st dose, single for COVID-19 immunisation. The patient did not receive other vaccines within 4 weeks from vaccination. On 13Feb2021 12:00 AM the patient experienced lethargy, swollen and painful arm and armpit, chills, nausea, headache, muscle aches all over body, restlessness in muscles (feel like she had to flex everything). Treatment for the events were received and reported as patient took lots of extra strength paracetamol (TYLENOL). Patient had not been tested post vaccination. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Fatigue, Hypertension, Influenza like illness
Clinical narrative: HTN; He had a sore arm at first however; Flu like symptoms; Redness on both arms, face, and various pars of his body/The redness was severe; Redness on both arms, face, and various pars of his body/The redness was severe; Fever; Tiredness; Weakness; Neck stiffness; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, in a Pharmacy, via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: EL9262) as single dose for COVID-19 immunization. Medical history included seizure from 2006 to an unknown date. The patient's concomitant medications were not reported. The patient stated that he had a sore arm at first (in Feb2021) however, 5 days later, in Feb2021, he reported flu like symptoms, redness on both arms, face, and various parts of his body, fever, tiredness and weakness, neck stiffness. He talked to a physician assistant and pharmacist and both thought it was an unusual event and said to report it to Pfizer. The redness was severe. He had to use some cream on his hands. Moreover the patient reported that he had currently hypertension. His second dose is scheduled for 25Feb2021. He isn't sure if he should get the second dose or not. He did not get a copy of the Fact Sheet for Recipients and Caregivers. The patient asked if he could get Moderna vaccine for his second dose. He also stated he would talk to his primary care physician about this, but will probably start over with the Moderna vaccine and get two doses of their vaccine. The events outcome was unknown at the time of the report.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: HTN; He had a sore arm at first however; Flu like symptoms; Redness on both arms, face, and various pars of his body/The redness was severe; Redness on both arms, face, and various pars of his body/The redness was severe; Fever; Tiredness; Weakness; Neck stiffness; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, in a Pharmacy, via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: EL9262) as single dose for COVID-19 immunization. Medical history included seizure from 2006 to an unknown date. The patient's concomitant medications were not reported. The patient stated that he had a sore arm at first (in Feb2021) however, 5 days later, in Feb2021, he reported flu like symptoms, redness on both arms, face, and various parts of his body, fever, tiredness and weakness, neck stiffness. He talked to a physician assistant and pharmacist and both thought it was an unusual event and said to report it to Pfizer. The redness was severe. He had to use some cream on his hands. Moreover the patient reported that he had currently hypertension. His second dose is scheduled for 25Feb2021. He isn't sure if he should get the second dose or not. He did not get a copy of the Fact Sheet for Recipients and Caregivers. The patient asked if he could get Moderna vaccine for his second dose. He also stated he would talk to his primary care physician about this, but will probably start over with the Moderna vaccine and get two doses of their vaccine. The events outcome was unknown at the time of the report.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; low grade fever/highest 100.7; tired; This is a spontaneous report from a contactable 64-year-old female nurse reporting for herself   A 64 Years old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included migraines, osteoarthritis and gastritis, kidney stones, mild hypertension, Hashimoto's disease. Concomitant medications included thyroid, hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), nitrofurantoin (MACROBID), galcanezumab gnlm (EMGALITY), pantoprazole sodium sesquihydrate (PROTONIX). On 04Feb2021 at 13:00 the patient experienced sore arm x 24 hours, low grade fever for 8 days , highest 100.7, didn't feel bad just tired. At the time of the reporting the patient was recovering from reported events.   No follow-up attempts are possible. Information on batch cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Inflammation
Clinical narrative: inflammation; MCP and PIP joints and SI joints started burning close to 3rd week; MCP and PIP joints and SI joints started burning close to 3rd week; This is a spontaneous report from a contactable physician reporting for himself. A 57-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, in Hospital, administered via intramuscular route in left arm on 22Dec2020 (Batch/Lot Number: EJ1685) as single dose, and the second dose via an unspecified route of administration, administered in right arm on 01Feb2021 (Batch/Lot Number: EL3249) as a single dose for COVID-19 immunization. Medical history included allergy to penicillin and benign prostatic hyperplasia from an unknown date and unknown if ongoing. Concomitant medications included tamsulosin and metoprolol tartrate, both taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with CVID-19 prior vaccination and was not tested for COVID-19 post vaccination. On 20Jan2021, close to 3rd week, the patient's MCP (Metacarpal, Carpal and Phalanges) joints, PIP joints (proximal interphalangeal joints) and SI joints (sacroiliac joint) started burning and the patient also experienced inflammation on an unspecified date. He had had some minor SI pains intermittently before but none with hands. It continued hurting enough so the patient started taking condroitin sulfate/glucosamine hydrochloride (OSTEOBIFLEX) and fish oil and more paracetamol (TYLENOL) for inflammation. After the second vaccine on 01Feb2021 the symptoms have been getting worse. Now the patient's hands burn all the time, at times bad enough that they keep him awake. The patient has red nodular areas on some of his knuckles and a distinct nodule at the proximal ulnar aspect of his left 4th finger PIP that is uniformly erythematous. Not all knuckles have the same degree of burning, but all, including thumbs, have it. The SI is more variable and at time does not bother the patient, but the hands get swollen and tight to close everyday. The patient plan to start some prednisone the following day due to the progression of the burning, moreover the events were treated with glucosamine, paracetamol (TYLENOL), ibuprofen, fish oil and turmeric. The event "MCP joints, PIP joints and SI joints started burning" had not resolved yet at the time of the report, whereas outcome of the event inflammation was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Soreness under her arm unsure if muscle or lymph nodes; Pain under the arm, under the injection site in which it was a soreness; Aching in arm; Achy; This is a spontaneous report from a contactable consumer. A 76-year-old female consumer (patient) reported that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318; Expiration Date: May2021) via an unspecified route of administration, administered in right arm on 04Feb2021 at 10:30 as first dose,single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No Prior Vaccinations within 4 weeks. On 04Feb2021, the patient experienced after is that she felt a little achy and 04Feb2021 at 8:00 pm that evening her arm was aching, patient took an Ibuprofen and had no problem afterward, On 05Feb2021, the day after patient mentioned had pain under the arm, under the injection site in which it was a soreness which had no lump. She cannot discern whether it was a lymph node or muscle, but is leaning more into it being a muscle because patient could feel a pulling sensation when patient raises her arm at the shoulder. Patient was asking if these are common side effects and for how long do these usually last. On 06Feb2021 soreness under her arm, unsure if muscle or lymph nodes. The outcome of the events achy, pain under the arm, under the injection site in which it was a soreness were unknown, soreness under her arm was recovering and aching in arm was recovered on 04Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Confusional state, Diarrhoea, Dizziness
Clinical narrative: Feeling ill; tiredness; headache; muscle pain; chills; joint pain; confused; Diarrhea; dizzy; This is a spontaneous report from a contactable consumer (patient). A 84-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in arm left on 10Feb2021 at 01:30 as 1st dose, single for COVID-19 immunization. The patient medical history included UTI and known allergies: Penicillin. The concomitant medication included fluoxetine, pravastatin and levothyroxine received in two weeks. The patient did not receive any other vaccine in four weeks. On an unspecified date, the patient experienced feeling ill, tiredness, headache, muscle pain, chills, joint pain, confused and diarrhea. Body, headache and tiredness through to Sunday afternoon. On Monday, the patient was still feeling dizzy. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Feeling ill; tiredness; headache; muscle pain; chills; joint pain; confused; Diarrhea; dizzy; This is a spontaneous report from a contactable consumer (patient). A 84-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in arm left on 10Feb2021 at 01:30 as 1st dose, single for COVID-19 immunization. The patient medical history included UTI and known allergies: Penicillin. The concomitant medication included fluoxetine, pravastatin and levothyroxine received in two weeks. The patient did not receive any other vaccine in four weeks. On an unspecified date, the patient experienced feeling ill, tiredness, headache, muscle pain, chills, joint pain, confused and diarrhea. Body, headache and tiredness through to Sunday afternoon. On Monday, the patient was still feeling dizzy. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: felt like she had the flu; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient. A female patient of an unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she saw a lady on tv got her second dose of the pfizer COVID 19 vaccine and the lady said on an unknown date, she felt like she had the flu after the second dose. The reporter wanted to know if the side effects to the second dose were worse than the first dose. The reporter wanted to know if the different phases of the vaccine distribution were the same vaccine and stated the information provided was very appreciated. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Throat irritation
Clinical narrative: coughing; throat itching; chest pain/ a pain on her chest; This is a spontaneous report from a contactable consumer or other non hcp reported for herself. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), via an unspecified route of administration on 14Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced coughing, throat itching, chest pain/ a pain on her chest. The clinical outcome of the events was unknown.     Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder discomfort, Tongue discomfort, Urine analysis, Vulvovaginal burning sensation
Clinical narrative: feel pressure on her bladder; her vagina and tongue are burning; her vagina and tongue are burning; This is a spontaneous report from a contactable consumer (Patient). A 68-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9261), via an unspecified route of administration, in left arm on 27Jan2021 as single dose for COVID-19 immunization. The patient was 68-year-old at time of vaccination. Patient relevant medical history included genital herpes (her husband cheated on her in her 20s when she was diagnosed) and allergic to hair dye (had reaction to the permanent wave in the 1980s). There were no concomitant medications. On unspecified date in 2021, the patient experienced feel pressure on her, her vagina and tongue are burning, 2-3 days after vaccine. Patient reporting adverse event to the Pfizer COVID vaccine, stated she developed a bladder infection. She went to the doctor she was prescribed antibiotics. She took the product for 2 days and her symptoms were worse. Product was Cephalexin, 500mg three times a day by mouth, dispensed in a pharmacy name vial, NDC, Lot, and Expiration date unknown. manufacturer unknown. The patient underwent lab tests and procedures which included urine analysis was negative. She performed urine tests to confirm or discard a bladder infection and the results came negative. Therapeutic measures were taken as result of feel pressure on her bladder. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Illness, Pain, Pyrexia
Clinical narrative: back that hurt; was sick for almost 5 days; threw up; body hurt; Fever; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown and expiration date: Unknown) via an unspecified route of administration in left arm on 06Feb2021 at single dose for COVID-19 immunization. Medical history included, she has to get iron infusions for years and years because her blood counts drop and her iron drops. She got the vaccine because her husband had COVID and was in the hospital for 16 days. On 27Nov2020, she lost her taste and smell, couldn't eat anything, and got diarrhea for 3 weeks. Patient was diagnosed with COVID in Nov2020. Concomitant medication included iron infusion for iron levels and blood levels drop. On 06Feb2021, patient experienced fever and diarrhea. She was sick over 5 days and scared to get the 2nd one. People have told her the second one is way worse than the first. She is wondering if the symptoms will be worse after the 2nd dose. On 07Feb2021, patient experienced body hurt. Caller stated, "They said my arm would hurt a lot, the first day it hurt but after that is was ok. It's my back that hurt. I was very sick for a week that my husband was like going crazy, because I was white as a ghost and had a garbage pail next to my bed. On 08Feb2021, patient threw up. On an unspecified date, patient was sick for almost 5 days and had back that hurt. Each time she fell asleep, she woke up and her hair and body were soaking wet. Patient stated that "It is because I didn't wait 90 days". They wouldn't give my husband because he was in the hospital with covid19. How could they give it to me? I don't understand it. My husband got covid and my daughter got covid. I was sick as a dog. I couldn't get tested because I couldn't go get tested, but when I went to get the vaccine, and when I told them they asked if I had a positive test and since I couldn't get tested I told them no. Maybe that's why I got so bad of a reaction? My husband is scheduled to get his first dose on 28Feb2021 can he get the second dose earlier? We are going to be traveling. My daughter is having a baby. He is supposed to get his second dose on 21Mar2021 but we are supposed to be there before that day." She has other Medical things going on, but the only one she knows to report is that she has to get iron infusions. She had on the day before the vaccine. She doesn't know if that made a difference or not. She has been getting the infusions for years and years because her blood counts drop and her iron drops. On 08Feb2021, event fever and diarrhea was recovered, on 12Feb2021, threw up was resolved, on 14Feb2021, body hurt was resolved. Outcome of sick for almost 5 days and back that hurt was resolved on unspecified date.    Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: back that hurt; was sick for almost 5 days; threw up; body hurt; Fever; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown and expiration date: Unknown) via an unspecified route of administration in left arm on 06Feb2021 at single dose for COVID-19 immunization. Medical history included, she has to get iron infusions for years and years because her blood counts drop and her iron drops. She got the vaccine because her husband had COVID and was in the hospital for 16 days. On 27Nov2020, she lost her taste and smell, couldn't eat anything, and got diarrhea for 3 weeks. Patient was diagnosed with COVID in Nov2020. Concomitant medication included iron infusion for iron levels and blood levels drop. On 06Feb2021, patient experienced fever and diarrhea. She was sick over 5 days and scared to get the 2nd one. People have told her the second one is way worse than the first. She is wondering if the symptoms will be worse after the 2nd dose. On 07Feb2021, patient experienced body hurt. Caller stated, "They said my arm would hurt a lot, the first day it hurt but after that is was ok. It's my back that hurt. I was very sick for a week that my husband was like going crazy, because I was white as a ghost and had a garbage pail next to my bed. On 08Feb2021, patient threw up. On an unspecified date, patient was sick for almost 5 days and had back that hurt. Each time she fell asleep, she woke up and her hair and body were soaking wet. Patient stated that "It is because I didn't wait 90 days". They wouldn't give my husband because he was in the hospital with covid19. How could they give it to me? I don't understand it. My husband got covid and my daughter got covid. I was sick as a dog. I couldn't get tested because I couldn't go get tested, but when I went to get the vaccine, and when I told them they asked if I had a positive test and since I couldn't get tested I told them no. Maybe that's why I got so bad of a reaction? My husband is scheduled to get his first dose on 28Feb2021 can he get the second dose earlier? We are going to be traveling. My daughter is having a baby. He is supposed to get his second dose on 21Mar2021 but we are supposed to be there before that day." She has other Medical things going on, but the only one she knows to report is that she has to get iron infusions. She had on the day before the vaccine. She doesn't know if that made a difference or not. She has been getting the infusions for years and years because her blood counts drop and her iron drops. On 08Feb2021, event fever and diarrhea was recovered, on 12Feb2021, threw up was resolved, on 14Feb2021, body hurt was resolved. Outcome of sick for almost 5 days and back that hurt was resolved on unspecified date.    Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Ear swelling, Erythema, Feeling abnormal, Pain
Clinical narrative: her tight feeling tight and 'weird, sore and achey'; her tight feeling tight and 'weird, sore and achey'; Throat tightness; Cough; Ear felt swollen and was red; Ear felt swollen and was red; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) intramuscularly on an unknown date at 1ST single dose for covid-19 immunization. Medical history included allergy skin disorder. The patient's concomitant medications were not reported. On an unknown date, 2 weeks after having the 1st dose, her throat felt tight and she had a cough, her ear felt swollen and was red. It was stated that this occurred twice and each time she took Benadryl and it got better. Also stated that this was what happened whenever she has an allergic reaction to something. Patient felt tight and weird, sore and achey. She did pre-medicate with Allegra and Pepcid AC and asked was that okay to do. She heard not to take Motrin before getting the vaccine, so she wanted to make sure that it was okay to take the Allegra and Pepcid AC. The outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: her tight feeling tight and 'weird, sore and achey'; her tight feeling tight and 'weird, sore and achey'; Throat tightness; Cough; Ear felt swollen and was red; Ear felt swollen and was red; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) intramuscularly on an unknown date at 1ST single dose for covid-19 immunization. Medical history included allergy skin disorder. The patient's concomitant medications were not reported. On an unknown date, 2 weeks after having the 1st dose, her throat felt tight and she had a cough, her ear felt swollen and was red. It was stated that this occurred twice and each time she took Benadryl and it got better. Also stated that this was what happened whenever she has an allergic reaction to something. Patient felt tight and weird, sore and achey. She did pre-medicate with Allegra and Pepcid AC and asked was that okay to do. She heard not to take Motrin before getting the vaccine, so she wanted to make sure that it was okay to take the Allegra and Pepcid AC. The outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: some hives/Little bit of a reaction of hives on her neck; itchy whelps on one little area of her neck; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Feb2021 (Batch/Lot number was not reported) as single for COVID-19 immunization. Medical history included chronic problem with hives on neck (continuously off and on). The patient's concomitant medications were not reported. On 03Feb2021, patient experienced some hives/Little bit of a reaction of hives on her neck, but with no wheezing or tightness, by the time patient got home after the vaccine was administered (probably about 1 hour after vaccination). Patient has had a chronic problem with hives on her sensitive areas and it was just a bit more severe this time. Little bit of a reaction of hives on her neck further described as itchy whelps on one little area of the neck, not all over the neck. Patient checked with primary care provider and he thought it was still safe for her to get the second dose of the Pfizer COVID-19 Vaccine. Patient wanted to know about recommendations regarding getting the second dose of the Pfizer COVID-19 Vaccine related to this event. Patient physician also asked her to bring some Benadryl along for her second dose and report her experience prior to vaccination. The outcome of event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: arm soreness; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A female of an unspecified age received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE: Lot number: unknown) via unspecified route of administration on unspecified date as a single dose for COVID-19 vaccination. After the first dose of vaccination on unspecified date patient experienced arm soreness, nausea and headache. The outcome of the events was unknown.   Follow- up attempts are completed and no further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Muscular weakness
Clinical narrative: she felt "very dizzy"; right arm was weak (injection arm was left arm); This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included loratadine (CLARITINE) taken for an unspecified indication, start and stop date were not reported. It was reported that the patient received the Pfizer-BioNTech COVID-19 Vaccine first dose last 29Jan2021. She took Claritin prior to getting the vaccine. Reported that last 02Feb2021 she felt "very dizzy" and her "right arm is weak" (injection arm is left arm). Patient was scheduled for her second dose this Thursday and was also concerned she would experience these again. Outcome of the events was unknown.  Information about batch/lot number has been requested.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Oxygen saturation, Oxygen saturation abnormal, Weight
Clinical narrative: involuntary gasp for air, similar to sleep apnea; my oxygen levels with a pulse oximeter and it was at 90% and then it dropped to 88%. The next morning it was back up to 90%.; headache; This is a spontaneous report from a non-contactable consumer or other non hcp. A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 10Feb2021 at 18:00 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she had no side effects until approximately 9 hours later. She reported that she had an involuntary gasp for air, similar to sleep apnea but she do not have sleep apnea, and then she had another involuntary gasp for air. She checked her oxygen levels with a pulse oximeter and it was at 90% and then it dropped to 88%. The next morning it was back up to 90%. She called her doctor and it took them 24 hours to call her back and they told her to go to the ED, but she didn't by that time. Otherwise she felt totally normal. She had a slight headache one day, but otherwise she felt fine. The caller has not experienced any more occurrences of "gasping for air" again. The patient underwent lab tests and procedures which included oxygen saturation: 90 % on Feb2021, oxygen saturation: 88 % on Feb2021, oxygen saturation: 90 % on Feb2021, weight: 40 lbs, overweight by about 40 pounds. Caller would like to know if she should receive the second dose of the Pfizer COVID-19 vaccine based on the side effect she had after her first dose. The outcome of the events were recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: headache; wasn't able to lift up his head, feels like he has a weight on his brain; This is a spontaneous report from a contactable consumer or other non hcp.A 74-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/lot number: EM9810 and expiry date: 30Jun2021) via intramuscular route administered in the region of left arm on 10Feb2021 at 13:42 as SINGLE DOSE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing diagnosed about 3 years ago.The patient's concomitant medications were not reported. Prior Vaccinations (within 4 weeks) were reported as none. On 15FEB2021 07:30, the patient  woke up in the  morning with a headache. He took some migraine headache pills. Within 3 hours, he wasn't able to lift up his head. He clarifies he couldn't even lean up on his elbows. The caller clarifies further it feels like he has a weight on his brain. Therapeutic measure was taken. When probed for product information for the migraine pills he took, he explains the bottle just says migraine relief purchased from pharmacy. It says pain reliever/ pain reliever aid. There was a number on the pill, but it does not say the strength. He makes the comment that it is all small print. When he took the vaccine, he was told the headaches would come, but he didn't understand the headaches would result in him laying down and actually not being able to function. The outcome of the events was unknown.  Therapeutic measures were taken as a result of headache.  No follow -up attempts possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea, Urticaria
Clinical narrative: shortness of breath; asthma attack; hives; This is a spontaneous report from a non-contactable Pharmacist. A 28-years-old female (pregnant: unknown) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262), via intramuscularly on 28Jan2021 as single for covid-19 immunisation. Patient took first dose of BNT162B2 (Lot number: EL3246), via intramuscularly on 07Jan2021 (at age of 28-years-old) for covid-19 immunisation. Facility type of vaccine was hospital. The patient medical history was not reported. Concomitant medications included (Other medications in two weeks) hydrochlorothiazide. It was unknown that patient had other vaccine in four weeks. Adverse event start date was 28Jan2021. Adverse event 12 hours after her second COVID-19 vaccine, the patient experienced shortness of breath that seemed to be an asthma attack (which she hasn't had in 10 years). She used a short acting inhaler. Then she experienced hives 1 hour after shortness of breath which she treated with Benadryl. Covid prior vaccination was unknown, covid tested post vaccination was unknown. Patient received short acting inhaler, Benadryl as treatment for AE. She was asymptomatic by the morning and has continued to be stable since event. The outcome of event was recovered on an unknown date in Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: The day after the vaccine the skin on the palms of my hands began to peel off.  It was the outside layer of skin, no bleeding or opening of skin.; This is a spontaneous report from a contactable consumer (patient herself). A 59-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9267; Expiration date: unknown), via an unspecified route of administration in arm Left on 03Feb2021 09:30 as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient had not chronic health conditions. It was unknown if patient had COVID-19 prior to vaccination. Concomitant medication(s) included ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE), acetylsalicylic acid (BABY ASPIRIN) paracetamol (TYLENOL), ergocalciferol (VIT D) taken for an unspecified indication. The patient previously took erythromycin and duricef and experienced nausea, vomiting. The patient experienced the day after the vaccine the skin on the palms of my hands began to peel off it was the outside layer of skin, no bleeding or opening of skin on 04Feb2021 10:00. The patient had not tested COVID-19 post the vaccination. The outcome of event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Influenza like illness, Malaise
Clinical narrative: sore throat; it "feels like sand" and "abrasive"; throat that felt raw, rough, and irritated; throat that felt raw, rough, and irritated; throat is burning; fatigue; pain in [her] joints; she wasn't feeling well; flu like symptoms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 12Feb2021 as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient historical vaccine included BNT162B2. The patient stated that she received the booster dose which she also referred to as the second dose of the Pfizer-BiONTech COVID-19 vaccine on Friday. On 13Feb2021, the patient experienced fatigue and pain in her joints. These symptoms were gone on the Sunday (14Feb2021), but a sore throat began. The sore throat was not typical, it is not a raw or a painful feeling, but it feels like sand and abrasive. On Saturday she was not feeling well, which according to the list said flu like symptoms could be a side effect, which she did have, then Sunday she felt great and better from the symptoms, but then had a throat that felt raw, rough, and irritated. The patient asked that sore throat is a part of the side effect of the COVID-19 vaccine and asked if it was safe to use a herbal throat spray that she bought at the store because her throat is burning. The outcome of the events fatigue, pain in her joints was recovered on 14Feb2021, she was not feeling well, flu like symptoms was recovering, sore throat, feels like sand and abrasive, throat that felt raw, rough, irritated and throat is burning, was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Oropharyngeal pain, Throat irritation
Clinical narrative: sore throat; it "feels like sand" and "abrasive"; throat that felt raw, rough, and irritated; throat that felt raw, rough, and irritated; throat is burning; fatigue; pain in [her] joints; she wasn't feeling well; flu like symptoms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 12Feb2021 as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient historical vaccine included BNT162B2. The patient stated that she received the booster dose which she also referred to as the second dose of the Pfizer-BiONTech COVID-19 vaccine on Friday. On 13Feb2021, the patient experienced fatigue and pain in her joints. These symptoms were gone on the Sunday (14Feb2021), but a sore throat began. The sore throat was not typical, it is not a raw or a painful feeling, but it feels like sand and abrasive. On Saturday she was not feeling well, which according to the list said flu like symptoms could be a side effect, which she did have, then Sunday she felt great and better from the symptoms, but then had a throat that felt raw, rough, and irritated. The patient asked that sore throat is a part of the side effect of the COVID-19 vaccine and asked if it was safe to use a herbal throat spray that she bought at the store because her throat is burning. The outcome of the events fatigue, pain in her joints was recovered on 14Feb2021, she was not feeling well, flu like symptoms was recovering, sore throat, feels like sand and abrasive, throat that felt raw, rough, irritated and throat is burning, was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Head discomfort, Pain, Pain in extremity
Clinical narrative: pain in arm/Sore Arm; strong pain on the left side, from the low back through the thigh; Lower Back pain; head feeling weird; she then states that it is a little dizzy; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL9264), dose 1 via an unspecified route of administration, administered in left arm on 13Feb2021 at 13:50 as 1st dose, single for covid-19 immunization. Patient's medical and concomitant medication history were not reported. The patient experienced pain in arm/sore arm, strong pain on the left side, from the low back through the thigh, lower back pain on 13Feb2021 and head was little weird, it's not dizzy, it's just not feeling normal, patient had no headache, patient then states that it was a little dizzy on 14Feb2021. It was reported that, "She took ibuprofen on Saturday and just 1 pill 600mg. She also put a cold pack on the arm because it was sore at night and she couldn't sleep well and that helped her. Yesterday morning she took another motrin. While her head feeling weird since she took medicine ibuprofen about 1-2 hours ago, right now she is a little better". The outcome of event was recovered for pain in extremity, back pain, head discomfort and unknown for the rest of the events.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea after the vaccine on day 1 and day 2 following administration. Felt better on day 3.; This is a spontaneous report from a contactable consumer (other-HCP). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) intramuscularly in right arm on 12Feb2021 12:45 as 2nd single dose and had previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) intramuscularly in right arm on 21Jan2021 10:00 as 1st single dose (at the age of 77-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient medical history included AFib. The concomitant medication included rivaroxaban (XARELTO). The vaccination facility type was reported as Other. Patient did not receive any other vaccine in four weeks. Patient did not receive prior COVID-19 vaccination. Patient was not tested for COVID-19 post vaccination. On 13Feb2021, patient experienced severe diarrhea after the vaccine on day 1 and day 2 following administration and felt better on day 3. Patient was not given any treatment for the adverse event. The outcome of the event was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site pain
Clinical narrative: pain at the injection site for 1.5 days; tired; really sore arm; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she received the first dose of the Pfizer BioNTech COVID-19 vaccine 19 days ago. She explained she had pain at the injection site for 1.5 days following the vaccine. She added yesterday she had a really sore arm that has been bothering her and she was tired. She specified she then slept for 1 hour and felt fine. Patient would like to know if these are normal symptoms to the vaccine and asked if people have reported those symptoms after the vaccine, if she can get the second dose in the same arm. Patient would also like to know if her report help benefit other people receiving the vaccine. Outcome of the events was recovered.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Pain in extremity
Clinical narrative: potential interaction between the COVID-19 virus and the virus affecting his cancer; small pain in [his] arm; This is a spontaneous report from a contactable consumer reported for himself. A 83 years old male patient received the Second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry date was Unknown) via unspecified route of administration on 12Feb2021 for COVID-19 immunisation. Patient historical vaccine included received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry date was Unknown) via unspecified route of administration on unspecified date as 1st dose single for COVID-19 immunisation. Patient medical history included has rare cancer called classic Kaposi sarcoma. Patient concomitant medication was not reported which was associated with a virus. Patient explained that this virus lived dormant in his body but last year, his immunes system became weak, and the virus activated. Patient added that it manifested as a lesion on his skin and his current prognosis is of 5 years. Patient stated he needs to start chemotherapy, yet after researching he found opposing recommendations as to when he should start his treatment following the COVID-19 vaccination. Patient added he also found a recent publication from a scientist in (publication name) stipulating a potential interaction between the COVID-19 virus and the virus affecting his cancer. Patient said based on this article the cancer virus may be activated by the COVID-19 virus; and wants to make Pfizer aware of it. Patient asked for general recommendation on how long to wait before starting chemotherapy. Patient mentioned speaking with HCP, including physicians and his wife but would like to get our perspective. He also reported having small pain in his arm after the second dose of vaccination and he took Tylenol, and it was fine now. The outcome was unknown for potential interaction between the COVID-19 virus and the virus affecting his cancer and recovered for pain in his arm.  Failed to offer warm transfer to DSU. E-transmitting AE.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pleurisy
Clinical narrative: pleurisy; This is a spontaneous report from a contactable consumer or other non hcp.     A 43-years-old female (non-pregnant) patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 12Feb2021 08:45 (Batch/Lot number was not reported) (at the age of 43-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medications (other medications in two weeks) included biotin, rosuvastatin, valaciclovir hydrochloride ,levocetirizine dihydrochloride (XYZAL). The patient did not have any known allergies. The patient did not have covid prior vaccination. The patient did not have any  other vaccines within 4 weeks. On 13Feb2021 08:00, After receiving the dose early on Friday morning, the patient woke up Saturday (8:00 AM ) with pleurisy. She had it before so she knew what it was and how to treat it. The patient had not tested post vaccination. No treatment was received for adverse event. The outcome of the event was not recovered   No further information expected.