chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: severe inflammation in the mouth; severe inflammation in the  eyelids; rash on head; body ache; torso with itchiness; This is a spontaneous report from a contactable consumer (Patient).   A 74 year-elderly-male received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: ER2613,) via an unspecified route of administration into arm left (at the age of 74 Years) on 20Mar2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history included Type -2Diabetes and hypertension. The patient concomitant medication included Losartan, Fish oil (OMEGA 3 EPA), Bezafibrate and Atorvastatin. It was reported that patient had no known allergies and did not take any vaccination within four weeks of vaccination. The patient underwent with covid test after vaccination. The patient previously took bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: EN6198) via an unspecified route of administration into left arm on 27FEB2021at 09:45 AM as DOSE 1, SINGLE for covid-19 immunization and experienced that I followed the recommended protocol by the responsible staff of vaccinations, applied first dose I waited 15 minutes, no secondary effects were manifested or allergic reactions; after 8 days, I noticed severe inflammation in the mouth, eyelids and rash on the head and torso with itchiness, body ache; she didn't consider a reaction to the vaccine, but an allergy for having eaten almonds although there was no background (it was a mistake having considered it an allergy);she told a known doctor about the problem, who prescribed "Loratadine" and diet without fats, strawberries, eggs, dairy and chocolates; there was improvement and symptoms disappeared. After the administration of second dose on 28 mar2021 at 14:00 pm the patient had experienced severe inflammation in the mouth, eyelids and rash on the head and torso with itchiness, body ache. On 29 mar2021, the patient underwent lab test and procedures which included SARS-CoV-2 test via Nasal swab and diagnosed with negative results. Therapeutic measures were taken for the AE and treatment included with Loratadine" and diet without fats, strawberries, eggs, dairy and chocolates. The outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: On my first shot my arm just hurt; This is a spontaneous report from a contactable consumer. This 22-year-old male consumer (patient) reported for himself that:  A 22-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in Arm Left on 22Mar2021 13:30 (at the age of 22 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing (No). There were no concomitant medications. It was reported that other vaccine in four weeks was no. Other medications in two weeks was no. COVID prior vaccination was no. COVID tested post vaccination was no. Patient had no known allergies. No Other medical history. The patient experienced on my first shot my arm just hurt on an unspecified date. Therapeutic measure were taken as no as a result of event. The outcome of event was recovered.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: Palm sized sore to touch just at the location of the shot.; Pregnant at the time of vaccination?: Yes/ Last menstrual period date 31Oct2020; This is a spontaneous report from a contactable consumer. A 32-years-old pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: ER2613), via an unspecified route of administration, in left arm on 12Apr2021 at 14:45 (at the age of 32-years-old) as a single dose for COVID-19 immunization. The patient medical history included periodontal disease. The concomitant medication of the patient was not reported. The patient had no allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19 and patient does not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient was not tested for COVID-19. On 12Apr2021 patient was pregnant at the time of vaccination and last menstrual period date of patient was 31Oct2020 with gestation period of 23 weeks. The delivery date of the patient was reported as 07Aug2021. On 13Apr2021 at 07:00 the patient experienced palm sized sore to touch just at the location of the shot which occurred next day and lasted one day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Outcome of the reported event of palm sized sore to touch just at the location of the shot was recovered on unspecified date of Apr2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: I have had a rash come up; it's come up like a hive; it itches real badly; This is a spontaneous report from a contactable consumer or other non hcp. A 84-years-old female patient received first dose of bnt162b2 (BNT162B2,Solution for injection, Lot number: unknown, Expiration date: unknown) on muscle of my right arm via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication included estradiol taken for an unspecified indication, start and stop date were not reported. The patient had first Covid-19 vaccination and she supposed to have my second one on 29th of this month but she had a small reaction, so she was little concerned. She had a rash come up, it happened about the day after that she got her first shot. It was come up, like a hive and then it had, it itches her real badly and it spread from the right side of my face, down it to her neck, behind my ear and down her throat. She was little concerned about that second shot. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Insomnia, Nausea, Pruritus
Clinical narrative: diarrhea; headaches; nausea; last night she didn't sleep much at all; couple of whelps on my arms; It looks like a rash and is hot to the touch; The swelling and itching I don't want to aggravate buy using soap or something.; The swelling and itching I don't want to aggravate buy using soap or something.; This is a spontaneous report from a contactable consumer reported for herself. A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), second dose via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient previously received Sulfamides and erythromycin and experienced allergy. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date for covid-19 immunisation and experienced diarrhea, headaches, nausea, sleep unwell and shivering. On an unspecified date, patient had diarrhea the first day, had headaches, nausea and then last night she didn't sleep much at all. She was shivering all night. But did not have a fever. Had the first vaccine a month ago and the second one on Tuesday. Thursday, she woke up with a couple of whelps on her arms and then today they were blurring together. This seems to be getting worse. The swelling and itching she did not want to aggravate buy using soap or something. It looked like a rash and was hot to the touch. It wasn't going smaller; it was getting bigger. Patient was asking what she could for it. The first time was minimal symptoms, but the second time was even worse for patient. Clinical outcome of events as unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: diarrhea; headaches; nausea; last night she didn't sleep much at all; couple of whelps on my arms; It looks like a rash and is hot to the touch; The swelling and itching I don't want to aggravate buy using soap or something.; The swelling and itching I don't want to aggravate buy using soap or something.; This is a spontaneous report from a contactable consumer reported for herself. A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), second dose via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient previously received Sulfamides and erythromycin and experienced allergy. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date for covid-19 immunisation and experienced diarrhea, headaches, nausea, sleep unwell and shivering. On an unspecified date, patient had diarrhea the first day, had headaches, nausea and then last night she didn't sleep much at all. She was shivering all night. But did not have a fever. Had the first vaccine a month ago and the second one on Tuesday. Thursday, she woke up with a couple of whelps on her arms and then today they were blurring together. This seems to be getting worse. The swelling and itching she did not want to aggravate buy using soap or something. It looked like a rash and was hot to the touch. It wasn't going smaller; it was getting bigger. Patient was asking what she could for it. The first time was minimal symptoms, but the second time was even worse for patient. Clinical outcome of events as unknown.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Headache, Heart rate increased, Illness
Clinical narrative: felt sick; fever; raising heart rate; red; swollen and itchy arm; swollen and itchy arm; dizziness/light-headedness; nausea; headache; body aches; she is currently breastfeeding her 4-week-old baby; she is currently breastfeeding her 4-week-old baby; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 37-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8737, Expiration date: unknown, NDC number: Unknown), via an unspecified route of administration on 26Mar2021 (at age of 37-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, patient had fever, raising heart rate, red, swollen and itchy arm, dizziness, light-headedness, nausea, headache and body aches. She also said that she felt sick. She also mentioned that it had only been a few weeks after she went on labor when she received the 1st dose, and that she is currently breastfeeding her 4-week-old baby. Patient had a hard time telling the difference between allergy and side effects. She did not have an anaphylactic reaction; she didn't need any help like that, but she had fever, her arm swelled up. It was red like sunburn; she had itching and she was sick for a few days and had dizziness for a few days. Also mentions she was breastfeeding and now her baby is almost three weeks old. she had the shot right after the birth. She was scheduled to receive the second dose of the vaccine 16Apr2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021442055 mother-baby case
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Off label use, Pain, Peripheral swelling, Product use issue
Clinical narrative: felt sick; fever; raising heart rate; red; swollen and itchy arm; swollen and itchy arm; dizziness/light-headedness; nausea; headache; body aches; she is currently breastfeeding her 4-week-old baby; she is currently breastfeeding her 4-week-old baby; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 37-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8737, Expiration date: unknown, NDC number: Unknown), via an unspecified route of administration on 26Mar2021 (at age of 37-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, patient had fever, raising heart rate, red, swollen and itchy arm, dizziness, light-headedness, nausea, headache and body aches. She also said that she felt sick. She also mentioned that it had only been a few weeks after she went on labor when she received the 1st dose, and that she is currently breastfeeding her 4-week-old baby. Patient had a hard time telling the difference between allergy and side effects. She did not have an anaphylactic reaction; she didn't need any help like that, but she had fever, her arm swelled up. It was red like sunburn; she had itching and she was sick for a few days and had dizziness for a few days. Also mentions she was breastfeeding and now her baby is almost three weeks old. she had the shot right after the birth. She was scheduled to receive the second dose of the vaccine 16Apr2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021442055 mother-baby case
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: felt sick; fever; raising heart rate; red; swollen and itchy arm; swollen and itchy arm; dizziness/light-headedness; nausea; headache; body aches; she is currently breastfeeding her 4-week-old baby; she is currently breastfeeding her 4-week-old baby; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 37-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8737, Expiration date: unknown, NDC number: Unknown), via an unspecified route of administration on 26Mar2021 (at age of 37-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, patient had fever, raising heart rate, red, swollen and itchy arm, dizziness, light-headedness, nausea, headache and body aches. She also said that she felt sick. She also mentioned that it had only been a few weeks after she went on labor when she received the 1st dose, and that she is currently breastfeeding her 4-week-old baby. Patient had a hard time telling the difference between allergy and side effects. She did not have an anaphylactic reaction; she didn't need any help like that, but she had fever, her arm swelled up. It was red like sunburn; she had itching and she was sick for a few days and had dizziness for a few days. Also mentions she was breastfeeding and now her baby is almost three weeks old. she had the shot right after the birth. She was scheduled to receive the second dose of the vaccine 16Apr2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021442055 mother-baby case
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood test, Circumstance or information capable of leading to medication error, Dyspnoea
Clinical narrative: Shortness of breath; made stomach worse; doesn't know if he will get the second one; This is a spontaneous report from a contactable consumer or other non -healthcare professional (Patient himself).  A 42-year-old male patient received BNT162B2 (BNT162B2 Formulation: Solution for injection Batch/Lot number: not reported Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization.  Patients Medical history included hypersensitivity bad allergies, and allergies in his blood , psoriasis. The patient's concomitant medications were not reported. On an unspecified date patient experienced shortness of breath, made stomach worse, doesn't know if he will get the second one.  The patient underwent lab tests and procedures which included blood test: allergies. Outcome of events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Swelling
Clinical narrative: It puffed up for about 4 to 5 days but now there is a bruise under the skin. It doesn't hurt or itch anymore; It puffed up for about 4 to 5 days but now there is a bruise under the skin. It doesn't hurt or itch anymore; This is an spontaneous report from a contactable consumer (patient) reported for herself via Medical Information Team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 07Apr2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation. The patient experienced it puffed up for about 4 to 5 days but now there was a bruise under the skin. It doesn't hurt or itch anymore on an unspecified date. Will that go away. This Wednesday will be 2 weeks. The outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Feeling cold, Pain in extremity
Clinical narrative: On Thursday started having some lower back pain; His legs and knees are starting to hurt/legs are aching and knees; his legs and knees are starting to hurt/legs are aching and knees; Immediately had chills/ Chills; Laid down and was kind of cold; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 41-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0162, Expiry date: UNKNOWN) via an unspecified route of administration in left arm (left shoulder) on 13Apr2021 11:45 as dose 1, single (at the age of 41-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were none. No family medical history relevant to adverse events. No investigation assessment. The vaccine was not administered at military facility. The patient experienced immediately had chills on 13Apr2021, on Thursday started having some lower back pain, his legs and knees are starting to hurt/legs are aching and knees on 15Apr2021, laid down and was kind of cold on an unspecified date in 2021. Reporter wanted to know is this normal and how long will it last. Reports chills started same date he received the shot recovered completely the same day. Caller laid down after receiving the Pfizer Covid Vaccine dose one, laid down when caller got home. Laid down and was kind of cold, that stood out to the caller. After that he hasn't had the chills again. Clarifies the lower back pains, legs aching and knees began on 15Apr2021, Lower back pains reports the lower back pains have gotten better. Legs are aching and knees: Reports this is kind of new, but it was going on a little bit. Lower back pains lower back pain is improving. Legs are aching and knees the legs are pretty much the same. Patient was not taken any prior vaccinations within 4 weeks and no adverse events following prior vaccinations. Patient was not taken any additional vaccines administered on same date of the pfizer suspect. There were no relevant tests. So far, the patient was not visited to Emergency room or Physician office. The outcome of chills recovered on 13Apr2021, lower back pain was recovering/Resolving (improving), legs and knees are starting to hurt/legs are aching, and knees was not recovered (pretty much the same) and kind of cold was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Diarrhoea, Hyperhidrosis, Influenza like illness, Pain
Clinical narrative: Flu like symptoms after the second dose; body aches; sweaty; Diarrhea; Lump under right arm; Peeling on hands and feet; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in right arm on 08Apr2021 (Lot Number: Ew0158) as dose 2, single at the age of 38-year-old for COVID-19 immunisation. Medical history included known allergies: Sulfa. The patient was not pregnant. Concomitant medications included fluconazole; cyanocobalamin (B 12); clindamycin hydrochloride (CLEOCIN); antibiotics in two weeks. Historic vaccine was bnt162b2 received via an unknown route of administration, administered in right arm on 18Mar2021 15:45 (lot number Er2613) at the age of 38-year-old for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced flu like symptoms, body aches, sweaty, diarrhea, lump under right arm, peeling on hands and feet on 09Apr2021 04:00. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment received. No COVID prior vaccination. No COVID tested post vaccination. The outcome of events was recovered with sequelae in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: Flu like symptoms after the second dose; body aches; sweaty; Diarrhea; Lump under right arm; Peeling on hands and feet; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in right arm on 08Apr2021 (Lot Number: Ew0158) as dose 2, single at the age of 38-year-old for COVID-19 immunisation. Medical history included known allergies: Sulfa. The patient was not pregnant. Concomitant medications included fluconazole; cyanocobalamin (B 12); clindamycin hydrochloride (CLEOCIN); antibiotics in two weeks. Historic vaccine was bnt162b2 received via an unknown route of administration, administered in right arm on 18Mar2021 15:45 (lot number Er2613) at the age of 38-year-old for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced flu like symptoms, body aches, sweaty, diarrhea, lump under right arm, peeling on hands and feet on 09Apr2021 04:00. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment received. No COVID prior vaccination. No COVID tested post vaccination. The outcome of events was recovered with sequelae in 2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Headache, Lymphadenopathy, Malaise
Clinical narrative: rash/rash on her body, her neck, back, and arms; diarrhea; nauseous; headache; had pain in the injection site; itching on her body/itching on her knees, feet and arms; some swelling of her lymph nodes; pain in her chest; arms and neck are aching and itching; arms and neck are aching and itching; she is not feeling well; This is a spontaneous report from a contactable consumer (patient's husband) reported that. A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 15Apr2021 vaccination in the afternoon and in the evening around 7-8pm she got nausea, a headache, and pain at the injection site. States the next day on 16Apr2021 she had diarrhea lasting to yesterday. Caller states she is a bit better, that the frequency has reduced. Caller states that last night, after 72 hours on 18Apr2021 she got a rash on her body, her neck, back, and arms. States she put moisturizer on it, and it helped a little. The patient reported that she has itching on her body/itching on her knees, feet and arms and her arms and neck are aching and itching.  He also observed some swelling of her lymph nodes and that she experienced some pain in her chest and she is not feeling well on an unspecified date in 2021. Caller states he has been reading and these are listed as common, but he is not sure if they are severe. The patient wanted to know if following these side effects, if his wife can get/take anti-inflammatory or pain-relievers. The event outcome was unknown.  Provided disclaimer: -Pfizer is unable to make any treatment recommendations for individual patients who may receive the Pfizer-BioNTech COVID-19 Vaccine.  clinical judgment made by your physician/HCP based on the medical history. Clinical status of a specific patient should dictate the appropriate actions to be taken.  PSCC Communication: Referred caller to his wife's healthcare provider for medical advice. Provided caller with phone number and hours of operation. Attempted a warm transfer to Medical Information staff. Caller disconnected before transfer could be completed. Medical Information staff states she will try to call the caller back.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain in extremity, Pruritus, Rash
Clinical narrative: rash/rash on her body, her neck, back, and arms; diarrhea; nauseous; headache; had pain in the injection site; itching on her body/itching on her knees, feet and arms; some swelling of her lymph nodes; pain in her chest; arms and neck are aching and itching; arms and neck are aching and itching; she is not feeling well; This is a spontaneous report from a contactable consumer (patient's husband) reported that. A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 15Apr2021 vaccination in the afternoon and in the evening around 7-8pm she got nausea, a headache, and pain at the injection site. States the next day on 16Apr2021 she had diarrhea lasting to yesterday. Caller states she is a bit better, that the frequency has reduced. Caller states that last night, after 72 hours on 18Apr2021 she got a rash on her body, her neck, back, and arms. States she put moisturizer on it, and it helped a little. The patient reported that she has itching on her body/itching on her knees, feet and arms and her arms and neck are aching and itching.  He also observed some swelling of her lymph nodes and that she experienced some pain in her chest and she is not feeling well on an unspecified date in 2021. Caller states he has been reading and these are listed as common, but he is not sure if they are severe. The patient wanted to know if following these side effects, if his wife can get/take anti-inflammatory or pain-relievers. The event outcome was unknown.  Provided disclaimer: -Pfizer is unable to make any treatment recommendations for individual patients who may receive the Pfizer-BioNTech COVID-19 Vaccine.  clinical judgment made by your physician/HCP based on the medical history. Clinical status of a specific patient should dictate the appropriate actions to be taken.  PSCC Communication: Referred caller to his wife's healthcare provider for medical advice. Provided caller with phone number and hours of operation. Attempted a warm transfer to Medical Information staff. Caller disconnected before transfer could be completed. Medical Information staff states she will try to call the caller back.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: rash/rash on her body, her neck, back, and arms; diarrhea; nauseous; headache; had pain in the injection site; itching on her body/itching on her knees, feet and arms; some swelling of her lymph nodes; pain in her chest; arms and neck are aching and itching; arms and neck are aching and itching; she is not feeling well; This is a spontaneous report from a contactable consumer (patient's husband) reported that. A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 15Apr2021 vaccination in the afternoon and in the evening around 7-8pm she got nausea, a headache, and pain at the injection site. States the next day on 16Apr2021 she had diarrhea lasting to yesterday. Caller states she is a bit better, that the frequency has reduced. Caller states that last night, after 72 hours on 18Apr2021 she got a rash on her body, her neck, back, and arms. States she put moisturizer on it, and it helped a little. The patient reported that she has itching on her body/itching on her knees, feet and arms and her arms and neck are aching and itching.  He also observed some swelling of her lymph nodes and that she experienced some pain in her chest and she is not feeling well on an unspecified date in 2021. Caller states he has been reading and these are listed as common, but he is not sure if they are severe. The patient wanted to know if following these side effects, if his wife can get/take anti-inflammatory or pain-relievers. The event outcome was unknown.  Provided disclaimer: -Pfizer is unable to make any treatment recommendations for individual patients who may receive the Pfizer-BioNTech COVID-19 Vaccine.  clinical judgment made by your physician/HCP based on the medical history. Clinical status of a specific patient should dictate the appropriate actions to be taken.  PSCC Communication: Referred caller to his wife's healthcare provider for medical advice. Provided caller with phone number and hours of operation. Attempted a warm transfer to Medical Information staff. Caller disconnected before transfer could be completed. Medical Information staff states she will try to call the caller back.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue
Clinical narrative: joint pain; tiredness; weakness; chill/chilly; This is a spontaneous report from a contactable consumer(patient). A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection), via an unspecified route of administration, administered in Arm Left on 17Apr2021 at 11:45 a.m (At the age of 37-year-old) (Batch/Lot Number: EW0161) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No Prior Vaccinations taken within 4 weeks. The patient wanted to know that if he had a side effect after the first dose of the vaccine, Should he get the second dose. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision, States he doesn't have a fever and he took Panadol, states it is like acetaminophen. Caller is unable to confirm spelling of product. States he just has those 2 things, weakness and chilly. He wanted to know if these are commonly reported side effects of getting the vaccine. He wanted to know if he can take paracetamol/Tylenol following the side effects that he is experiencing. On 18Apr2021 the patient experienced joint pain, tiredness, weakness, chill/chilly. The outcome of the event joint pain was unknown, tiredness, weakness, chill/chilly was recovering.  E-transmitting as potential AE duplicate.  PSCC Communication: Referred caller to contact his healthcare provider for medical advice. Provided caller with Medical Information phone number and hours of operation. Attempted a warm transfer to medical information, no agent was reached. Caller opted to be placed in hold queue.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Myalgia, Pyrexia
Clinical narrative: a little hot/ felt kind of hot; Fatigue; Chills; muscle aches; a little fever; This is a spontaneous report contactable consumer(patient). A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0161) via an unspecified route of administration in arm left on 10Apr2021 13:00 (age at the time of vaccination 72-year-old) as dose 1, single for COVID-19 immunisation at clinic. The patient's medical history included had tested positive for COVID back in November. The patient stated he believed he received vaccine for flu and shingles sometime in Mar2021. The patient's concomitant medications were not reported. The patient stated that he had the first shot a week ago Saturday and had a little reaction the day after. He stated he experienced fatigue, chills, muscle aches so nothing too serious and possibly a little fever on 11Apr2021. He stated since then he had been hearing all this chatter about the antibodies and if one had the antibodies the shot could have some sort of reaction because of the antibodies in the system. He stated as far as he knew he never had the test to see if he had antibodies and wondering since he was getting the second shot here in a couple of weeks and since he did not want complications and plan on getting the second shot if there was any definitive information about the antibodies. He stated he just had the symptoms for one day which was the day after the vaccine. He never took his temperature he just felt kind of hot and so he was not sure if he had a fever, it just seemed like he did since he was hot. He clarified that he just experienced feeling a little hot. The patient did not think he received treatment for adverse events. History of all previous immunization with the Pfizer vaccine considered as suspect and additional administered vaccines were none. Adverse events were not resulted into emergency room and physician office visit. Adverse events following prior vaccinations were none. Family medical history relevant to adverse event was none. He had not relevant tests. The outcome of adverse event was recovered on 12Apr2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: face is itchy; This is a spontaneous report received from a  Sponsored Program  Support. A contactable female consumer (patient) reported for herself that:  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: Not reported), via an unspecified route of administration on 31Mar2021 as SINGLE DOSE, for covid-19 immunisation. Medical history included known allergies: environmental allergies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that no unaddressed medical questions referred or forwarded to Medical Information. The patient experienced her face is itchy on an unspecified date. Patient stated if she can take her allergy pills. No treatments were taken for events. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: armpain (hurts like it was punched when lifting up); mild fever; severe headache; fatigue; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, 2-3 hours after second vaccination, the patient experienced armpain (hurts like it was punched when lifting up), mild fever, severe or bad headache and tiredness or fatigue for 2 days. On the 3rd day, in the noon all events were almost completely disappeared. Although the patient was reporting it to the CDC every day, for two weeks after the vaccination. The outcome of the events was recovered on an unspecified date.  No Follow-up attempts are possible. No information is expected further.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Almost had a fever; Felt fatigued; low energy; His left Arm was painful and it got swollen a bit; Unspecified arm painful; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was tested positive for COVID on 21Dec2020. One after that on 20Jan2021, they came up negative. The patient's concomitant medications were not reported. On 20Mar2021 the patient experienced arm pain/Unspecified arm painful and on 21Mar2021 said he almost had a fever and felt fatigued. The same date they took shot is when the arm pain started and on 21Mar0221 the low energy was the day after. On 201Mar2021 His left Arm was painful and it got swollen a bit and lasted for a little longer than 48 hours.  The patient underwent lab tests and procedures which included covid-19: positive on 21Dec2020, covid-19: negative on 20Jan2021. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433164 same reporter/drug, similar event, different patient
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Almost had a fever; Felt fatigued; low energy; His left Arm was painful and it got swollen a bit; Unspecified arm painful; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was tested positive for COVID on 21Dec2020. One after that on 20Jan2021, they came up negative. The patient's concomitant medications were not reported. On 20Mar2021 the patient experienced arm pain/Unspecified arm painful and on 21Mar2021 said he almost had a fever and felt fatigued. The same date they took shot is when the arm pain started and on 21Mar0221 the low energy was the day after. On 201Mar2021 His left Arm was painful and it got swollen a bit and lasted for a little longer than 48 hours.  The patient underwent lab tests and procedures which included covid-19: positive on 21Dec2020, covid-19: negative on 20Jan2021. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433164 same reporter/drug, similar event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: my body is swollen/ all my body is sore, it started last night in my foot and now all my arms, my hands and my face is sored, its sored, its swelling, its supper swollen; 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 VACCINE, solution for injection), via an unspecified route of administration on 15Apr2021 as dose 1, single for covid-19 immunisation. The patients medical history and concomitant medications were not reported. Patient states that she was calling because yesterday (15Apr2021) she got her first dose of the Pfizer shot and that night her leg was swollen and her whole body was swollen/ body is sore. It started last night placed her foot and now all her arms, her hands and her face is sored, it was sored it was swelling, it was supper swollen. She just wanted to know if this was normal or if it was something she has to worry about. The outcome of both the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort, Lymphadenopathy, Pain
Clinical narrative: felt achy; underneath her armpit was swollen (hematoma); left side of her breast was very red; stated that she could not pick up her arm; This is a spontaneous report from a contactable consumer (mother) reported for her daughter. A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient experienced felt achy, underneath her armpit was swollen, left side of her breast was very red and stated that she could not pick up her arm. Patient stated that her daughter received her first dose of Pfizer vaccine on Wednesday. Stated that yesterday she felt achy, underneath her arm pit swollen and the left side of her breast very red and could not pick up her arm. Stated that she had placed an ice pack last night and had one on it today. Stated that she took Tylenol. Therapeutic measures were taken as a result of felt achy, underneath her armpit was swollen (hematoma) and stated that she could not pick up her arm. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Ultrasound liver, Weight
Clinical narrative: itching off and on all over her body, tingling here, tingling there; itching off and on all over her body, tingling here, tingling there; This is a spontaneous report from a contactable consumer(patient) or other non hcp. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot Number: EW0150; Expiration Date: 30Jul2021), via an unspecified route of administration, administered in Arm Left on 01Apr2021 09:30 (at the age of 77-year) as dose 1, single for COVID-19 immunisation. Medical history included ongoing non-alcoholic fatty liver disease, ongoing diabetes mellitus, COVID-19 (She says she did have COVID, that was a long story, she had several hospitalizations, she thinks it was before 22Dec2020 but seemed like the effects were there for a while. She says her doctor did not have her tested for it until her isolation ended 26Jan2021 and that the COVID was about 3 weeks before that), breast cancer, mastectomy, perforated bowl, ileostomy and lost about 50 pounds. Family medical history included that her father died of brain cancer. Concomitant medication(s) included anastrozole (ANASTROZOLE) taken for chemotherapy, start and stop date were not reported; metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported; glibenclamide (GLYBURIDE) taken for diabetes mellitus, start and stop date were not reported. The patient experienced itching off and on all over her body, tingling here, tingling there on 06Apr2021. It was reported that the patient missed second dose on 27Apr2021. She says she did have an ultrasound yesterday for the liver and has an upcoming appointment on 27Apr2021. She asks should she postpone her vaccine shot until she has had her liver specialty doctor check her out. The patient underwent lab tests and procedures which included ultrasound liver with no result on 14Apr2021, weight lost about 50 pounds, weight gained some of it back but not all of it on an unspecified date. The patient did not visited to emergency room/ physician office due to events. The events outcome for itching off and on all over her body, tingling here, tingling there on was reported as recovering.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash in three places, his upper thighs and both forearms; This is a spontaneous report from a contactable consumer (patient). A male 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, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, during call consumer stated that after first injection of Pfizer COVID vaccine he got a itchy rash in three places, his upper thighs and both forearms. He stated after reading the Isreal report concerning the efficacy of the vaccine, which he states, was only 92-93% effective and after watching a Youtube video of someone who got the first shot and got a rash and then died after the second. He decided not to get the second shot. He states his rash went away after 1 - 2 months and he has been fine otherwise. Consumer states he is intrested in having an antibody test done. The outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.