chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: Reaction started Sunday, August 22, 2021 morning.  I woke up with Tachocardia,my heart rate was 125bpm.  I went ahead a took my Diltazem and hour later I was up to 165bpm so I took my Propanolol and still could not get it to lower so I had to repeat DIltazem but only lowered to 130.  This continued for the rest of the day. For the next three days it was still more elevated than normal anywhere from 120-150 bpm.  During this time I also experienced intense burning all through my body like it was on fire. This lasted only on Sunday and Monday.  I had severe body aches  and headaches, fever, and diarrehea from Sunday thru Thursday.  On Friday both my left and right arm elbow down from 12:00 pm to 6:00 p.m.  I did contact my family doctor but she told me that these were normal symptoms after receiving the vaccine but no one else I spoke with that had received the vaccine had my reaction.  I feel that this is not normal for me.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Reaction started Sunday, August 22, 2021 morning.  I woke up with Tachocardia,my heart rate was 125bpm.  I went ahead a took my Diltazem and hour later I was up to 165bpm so I took my Propanolol and still could not get it to lower so I had to repeat DIltazem but only lowered to 130.  This continued for the rest of the day. For the next three days it was still more elevated than normal anywhere from 120-150 bpm.  During this time I also experienced intense burning all through my body like it was on fire. This lasted only on Sunday and Monday.  I had severe body aches  and headaches, fever, and diarrehea from Sunday thru Thursday.  On Friday both my left and right arm elbow down from 12:00 pm to 6:00 p.m.  I did contact my family doctor but she told me that these were normal symptoms after receiving the vaccine but no one else I spoke with that had received the vaccine had my reaction.  I feel that this is not normal for me.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Dysuria, Feeling abnormal, Vaginal haemorrhage
Clinical narrative: By 7pm the day I received the vaccine, I started to feel bad. I went to the bathroom and was bleeding. I would fill the toilet bowl with blood the entire night until the next morning. It was discharging vagina my and through urine.  I had bad cramping each time I had to pee.  The next day the blood went away but the cramping continued and is still severe on Friday 9/3.  I have wondered if I have a UTI.  It feels like I?m going into labor.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Head injury, Pallor, Syncope
Clinical narrative: A few moments after the patient received his second dose of Pfizer vaccine, he collapsed onto the ground and hit his head on the right side. His mom immediately called for help. He was responsive shortly after while laying on the floor. I (pharmacist) brought him a bottle of water and he was able to sit up slowly to drink some water. He gradually felt better but appeared to be pale and veins on the sides of his head were apparent, more apparent than usual per his mom. The patient felt dizzy and lightheaded throughout. He rested on the ground for a few minutes and then we moved him to the open waiting room area by the pharmacy to sit down. After talking to the patient, he mentioned that he only had a snack to eat all day. The store called EMS on the mom's behalf, the fire rescue team and EMS arrived shortly. His blood pressure was low per the EMS's observation. They took him to the hospital for further analysis.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: Reports significant left upper arm pain after 2nd COVID vaccine for 6 months Slowly improving. 7/10 at times. given 2/26/2021
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient Recieved covid 19 vaccine second dose. It was noted that he recieved 0.1 mL vs 0.3 mL of the dose. No adverse events noted.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: Bump @ injection site within 2-3 hours that lasted 1 week
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin irritation
Clinical narrative: irritated rash that lasted about 1 & 1/2 weeks-required no treatment
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Vaccine administered in 9/1. Patient took a shower & washed hair on 9/3 & noticed a bald spot that she did not notice before. Although lamotrigine can cause 4% alopecia, she believes moderna caused the bald spot She has been on lamotrigine for >9 years and has seen routine normal hair loss. She has not noticed any "hair clump" loss on 9/1 or 9/2 but noticed the bald spot on 9/3.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Dysphonia, Full blood count, Laryngitis, Pain
Clinical narrative: 12yo receives COVID vaccine on 8/19/2021 w/in 12 hours starten t hoarse voice, body aches, fever SXS. worsening over 1 week, tested to COVID negative. RequireD Prednisone for laryngitis sxs. persisted x 2 weeks seen in ER 9/2/2021
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, X-ray
Clinical narrative: 12yo receives COVID vaccine on 8/19/2021 w/in 12 hours starten t hoarse voice, body aches, fever SXS. worsening over 1 week, tested to COVID negative. RequireD Prednisone for laryngitis sxs. persisted x 2 weeks seen in ER 9/2/2021
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received the Pfizer COVID vaccine on 7/27/2021. When the patient presented for her second Pfizer COVID vaccine on 8/23/2021, she was given the Moderna COVID vaccine in error.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site warmth
Clinical narrative: Swelling of L Leg & warm to touch no redness.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Gave 3rd HPV9 0 needed as had 1st B4 15 yrs old  Extra HPV9 PT aware.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Feeling of body temperature change, Paraesthesia, Syncope
Clinical narrative: Patient fainted after receiving Covid vaccine;  reported tingling in arms & being hot & cold compress Applied to forehead; no injuries; symptoms resolved w/ patient remained in pharmacy for 30 minutes; VARS stated no history of syncope but mom lateR sAid  shots  make patient anxious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin abnormal, Dermatitis bullous, Pemphigoid
Clinical narrative: Pt has no previous history of skin issues 10 days after 2nd Moderna vaccine developed bullous lesions which gradually worsened until over most of 4 extremities
Age: 11.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: After injection next day arm was purple,  Red and Hot to touch. Pt. was scheduled  Doctor prescribed Augmentin.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Cough, Diarrhoea, Nausea, Respiratory tract congestion, Urticaria
Clinical narrative: MMRV vaccine rec'd 8/20. Mom 1st noticed hives 8/21. Given Benadryl a few times which helped. Also had nausea/diarrhea. No vomiting. Has had cough/congestion on/off for a while- in daycare. Seen in office 8/24- hives on exam but overall less since started. Advised Zyrtec if not controlled w/ that will add pepcid
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Electrocardiogram, Laboratory test, Malaise, Tachycardia
Clinical narrative: Chills, malaise, Tachycardia  All tests done at hospital  We have no records
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age
Clinical narrative: Determined that this patient was 16 yrs of age and given a Moderna Vaccine-which has the  recommendation for 18 yrs and up. She is also pregnant and her OB physician recommended the vaccine. (didn't have Pfizer in stock- Modern given without realizing age.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 12cm x 8cm area of erythema and induration to upper arm at site of injection
Age: 17.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Product preparation issue
Clinical narrative: 1st shot was given with the mixture of sterile diluent and normal saline. 2nd shot was given with the correct mixture (covid + normal saline diluent) No reaction.
Age: 1.08
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Right thigh red, swelling area 3cm withd x 4cm height, Dr prescribed cephalexin 250mg/5ml and Bactroban ointment was on the right thigh that prevnar was  given
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Patient states severe pain  in left  arm  radiating to  shoulder area.   Kept arm in sling then had pain in  wrist.    Spoke    with  patient  -  using gentile movement  and massage.  Doing much better per call to patient.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: I diluted the MMR vaccine with the wrong diluent. I used lidocaine instead of the specific sterile water diluent.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Blood ethanol, Blood ketone body, Blood lactic acid, Blood magnesium, Blood thyroid stimulating hormone
Clinical narrative: Patient's mother reports that since patient has received her series of the Covid vaccine she's had 3 syncope episodes with unknown cause.  Currently, cardiac monitoring is being conducted.  Labs have been normal.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Chest X-ray, Drug screen, Electrocardiogram, Fibrin D dimer
Clinical narrative: Patient's mother reports that since patient has received her series of the Covid vaccine she's had 3 syncope episodes with unknown cause.  Currently, cardiac monitoring is being conducted.  Labs have been normal.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Glycosylated haemoglobin, Haemoglobin, Laboratory test normal, Lipase
Clinical narrative: Patient's mother reports that since patient has received her series of the Covid vaccine she's had 3 syncope episodes with unknown cause.  Currently, cardiac monitoring is being conducted.  Labs have been normal.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, N-terminal prohormone brain natriuretic peptide, Syncope, Troponin, Urine analysis
Clinical narrative: Patient's mother reports that since patient has received her series of the Covid vaccine she's had 3 syncope episodes with unknown cause.  Currently, cardiac monitoring is being conducted.  Labs have been normal.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Nodule
Clinical narrative: 1 day post vaccine knot on left collar bone. Palpable lump left axillary under clavicle, lobes soft and tender. Lymphadenopathy.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Biopsy skin, Computerised tomogram head abnormal, Insomnia, Pain
Clinical narrative: 2 days after receiving 1st dose pt developed facial swelling, arthralgias, diffuse rash, pain, not sleeping well. Rash biopsied by dermatology, concern for rheumatologic process.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling face, X-ray
Clinical narrative: 2 days after receiving 1st dose pt developed facial swelling, arthralgias, diffuse rash, pain, not sleeping well. Rash biopsied by dermatology, concern for rheumatologic process.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain, Rash erythematous, Swelling face
Clinical narrative: 2 days after receiving 1st dose pt developed facial swelling, arthralgias, diffuse rash, pain, not sleeping well. Rash biopsied by dermatology, concern for rheumatologic process.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Patient noticed red blotch on right eye at 5:10pm. He came back to us at around 5:39pm because he was worried the blotch has expanded the length of his lower lid. First thing the patient was asked if he wanted us to call 911. The patient refused. The pharmacist asked if he was okay, he stated he was fine & felt no different, just the spot on his eye. The pharmacist asked again if he wanted us to call 911, he refused a second time. The Pharmacist ask if he's ever gotten a red blotch in his eye and patient said he rarely gets them, about three times a year. He was asked if this has ever happened with getting vaccines, he said he doesn't get vaccines. He was asked if this has happened when he takes any medication, the patient said he doesn't take medication. The pharmacist asked if he has told his doctor about this, the patient stated he has not told his doctor because it goes away on its own
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Extra dose of measle mumps rubella   vaccine given. Child  had received  2nd dose of MMR  and varicella vaccine  in another  state . no immunization reminder  information system report. 2nd doses of MMR and varicella received earlier than CDC's recommended schedule 4-6 ry. of age.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: patient came to take a covid shot on 9/3/21. He didn't have an appointment. patient said that he got his 1st shot in the same store (Not accurate information) pt didn't have his card.  After pt left he sent the card with his sister. upon checking, the 1st dose was Moderna shot. Upon trying to call patient himself (Because the incident was discovered when his sister had her card with her and had Moderna first dose). when trying to call the patient, the patient's father picked up saying that his son is not at the house , gave us the patient's cell phone number then the father said we should start discussing compensation. *Upon calling the patient's cell phone, he said that someone from the company should contact him about compensation.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Skin reaction
Clinical narrative: Cutaneous skin reaction to injection, possibly suggestive at delay hypersensitivity reaction, particularly with second dose Adverse reaction first reported 9/2/21 and patient examined by provider that day
Age: 38.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: WITHIN 5 minutes of BoTh vaceinations ,  patient fainteD  to flooR.  RegaineD consciousness  after   a Few seconds (approx). patient  states  she   Doesn't think  she  hit any- thing on way Down DenieD amBulance , was proviDED wateR.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip swelling, Pain in jaw, Pruritus
Clinical narrative: Lips swelling, itchy face, jaw pain and HA. Patient also received allergy shot 3 days prior to  vaccine at allergist office.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, C-reactive protein, Dyspnoea, Full blood count
Clinical narrative: Pt recv'd Covid19 vaccine on 8/6/21, on 8/8/21 pain in both feet started. Pain radiated from knee to feet and felt like pins and needles. He also complained of pain when exhaled.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Pain, Pain in extremity, Paraesthesia, Red blood cell sedimentation rate
Clinical narrative: Pt recv'd Covid19 vaccine on 8/6/21, on 8/8/21 pain in both feet started. Pain radiated from knee to feet and felt like pins and needles. He also complained of pain when exhaled.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Resuscitation
Clinical narrative: Pt recv'd Covid19 vaccine on 8/6/21, on 8/8/21 pain in both feet started. Pain radiated from knee to feet and felt like pins and needles. He also complained of pain when exhaled.
Sex: M
Vaccine: PPV
Symptoms: Scar, Thermal burn, Visual impairment
Clinical narrative: still having problems with his face it burnt his face.; it scarred his face really bad around his eye; This is a spontaneous report from a contactable consumer (patient).   A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) dose 1 via an unspecified route of administration on 06Dec2020 (Batch/Lot number was not reported) as DOSE 1, SINGLE for immunisation.  The patient's medical history and concomitant medications was not reported. The patient was still having problems with his face it burnt his face, it scarred his face really bad around his eye. He got the shot at withheld pharmacy. Patient had to go to the hospital and doctor.  He needs to speak to someone about compensation in regards to his face and eyes, terrible scarring. He does not have the exact name of the pneumonia shot or the flu shot and cannot provide any details. States the pharmacy has that information and he can get it. Its been bothering him for a while. He has been to the eye doctor and had to get new glasses and it left a terrible scar on his face. Therapeutic measures were taken as a result of events. The outcome of events was unknown.  The lot number for pneumococcal 13-val conj vac (dipht crm197 protein) was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: enlarged lymph nodes under right arm; the underneath of her arm was swollen and hurting; the underneath of her arm was swollen and hurting; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-year-old female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EM9809), via an unspecified route of administration in arm right on 08Feb2021 (at the age of 49-years-old) as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL3247), via an unspecified route of administration on 19Jan2021 (at the age of 49-years-old) as single dose for COVID-19 immunisation. On 10Feb2021, the patient experienced enlarged lymph nodes under right arm, the underneath of her arm was swollen and hurting and the underneath of her arm was swollen and hurting. The reporter asked the information on side effects didn't mentioned enlarged lymph nodes was this a side effect. The outcome of the events was reported as not resolved.  Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: enlarged lymph nodes under right arm; the underneath of her arm was swollen and hurting; the underneath of her arm was swollen and hurting; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-year-old female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EM9809), via an unspecified route of administration in arm right on 08Feb2021 (at the age of 49-years-old) as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL3247), via an unspecified route of administration on 19Jan2021 (at the age of 49-years-old) as single dose for COVID-19 immunisation. On 10Feb2021, the patient experienced enlarged lymph nodes under right arm, the underneath of her arm was swollen and hurting and the underneath of her arm was swollen and hurting. The reporter asked the information on side effects didn't mentioned enlarged lymph nodes was this a side effect. The outcome of the events was reported as not resolved.  Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Injection site pain, Pyrexia
Clinical narrative: chills; fever; joint ache; injection site soreness; sweating; This is a spontaneous report from a contactable physician. This 31-year-old male physician (patient) reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER7231) via an unspecified route of administration on 11Jan2021 at 11:30 AM on left arm (at 31-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history included scoliosis and anxiety. Concomitant medications included vitamin D3, emtricitabine, tenofovir disoproxil fumarate (Truvada); fish oil (Omega 3 Fish Oil, all were taken for an unspecified indication, start and stop date were not reported. It was mentioned that no other vaccine was received in four weeks. The patient did not have COVID prior vaccination and was not tested for covid post vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EH9899) via an unspecified route of administration on 21Dec2021 at 11:30 AM on left arm (at 31-year-old), as dose 1, single for COVID-19 immunization. On 11Jan2021 at 11:00 PM approximately 12 hours after vaccine administration the patient experienced fever 102 F, chills, sweats, joint aches and injection site soreness. Naproxen alleviated the symptoms and the symptoms resolved approximately 10 hours after onset. The patient received treatment with Naproxen. On an unknown date in Jan2021 the patient recovered Follow-up (14May2021): Follow-up attempts were completed. No further information was expected.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Hyperhidrosis, Pyrexia
Clinical narrative: chills; fever; joint ache; injection site soreness; sweating; This is a spontaneous report from a contactable physician. This 31-year-old male physician (patient) reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER7231) via an unspecified route of administration on 11Jan2021 at 11:30 AM on left arm (at 31-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history included scoliosis and anxiety. Concomitant medications included vitamin D3, emtricitabine, tenofovir disoproxil fumarate (Truvada); fish oil (Omega 3 Fish Oil, all were taken for an unspecified indication, start and stop date were not reported. It was mentioned that no other vaccine was received in four weeks. The patient did not have COVID prior vaccination and was not tested for covid post vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EH9899) via an unspecified route of administration on 21Dec2021 at 11:30 AM on left arm (at 31-year-old), as dose 1, single for COVID-19 immunization. On 11Jan2021 at 11:00 PM approximately 12 hours after vaccine administration the patient experienced fever 102 F, chills, sweats, joint aches and injection site soreness. Naproxen alleviated the symptoms and the symptoms resolved approximately 10 hours after onset. The patient received treatment with Naproxen. On an unknown date in Jan2021 the patient recovered Follow-up (14May2021): Follow-up attempts were completed. No further information was expected.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: chills; fever; joint ache; injection site soreness; sweating; This is a spontaneous report from a contactable physician. This 31-year-old male physician (patient) reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER7231) via an unspecified route of administration on 11Jan2021 at 11:30 AM on left arm (at 31-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history included scoliosis and anxiety. Concomitant medications included vitamin D3, emtricitabine, tenofovir disoproxil fumarate (Truvada); fish oil (Omega 3 Fish Oil, all were taken for an unspecified indication, start and stop date were not reported. It was mentioned that no other vaccine was received in four weeks. The patient did not have COVID prior vaccination and was not tested for covid post vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EH9899) via an unspecified route of administration on 21Dec2021 at 11:30 AM on left arm (at 31-year-old), as dose 1, single for COVID-19 immunization. On 11Jan2021 at 11:00 PM approximately 12 hours after vaccine administration the patient experienced fever 102 F, chills, sweats, joint aches and injection site soreness. Naproxen alleviated the symptoms and the symptoms resolved approximately 10 hours after onset. The patient received treatment with Naproxen. On an unknown date in Jan2021 the patient recovered Follow-up (14May2021): Follow-up attempts were completed. No further information was expected.
Age: 30.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: severe acute allergic reaction skin rash spread all over body; minor rash spread on arms; small bumps skin rash occur on small area of upper back; minor itchy ears; This is a spontaneous report from a contactable consumer (reported for self). A 30-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EK9231, Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 29Jan2021 at 08:00 (at the age of 30-years-old) as dose 1, single for covid-19 immunisation at Pharmacy. Medical history included food allergy from an unknown date and unknown if ongoing and food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced minor itchy ears on 13Feb2021 at 10:00, small bumps skin rash occur on small area of upper back on 16Feb2021, minor rash spread on arms on 17Feb2021 and severe acute allergic reaction skin rash spread all over body on 20Feb2021. The reporter stated the events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of events included treatment with Steroid's shots, benadryl and anti-itchy cream. The clinical course was as follows: No lifestyle, habit nor food change during second dose to event occurred. The outcome of the events was resolved.  Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Ear pruritus, Hypersensitivity, Rash
Clinical narrative: severe acute allergic reaction skin rash spread all over body; minor rash spread on arms; small bumps skin rash occur on small area of upper back; minor itchy ears; This is a spontaneous report from a contactable consumer (reported for self). A 30-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EK9231, Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 29Jan2021 at 08:00 (at the age of 30-years-old) as dose 1, single for covid-19 immunisation at Pharmacy. Medical history included food allergy from an unknown date and unknown if ongoing and food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced minor itchy ears on 13Feb2021 at 10:00, small bumps skin rash occur on small area of upper back on 16Feb2021, minor rash spread on arms on 17Feb2021 and severe acute allergic reaction skin rash spread all over body on 20Feb2021. The reporter stated the events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of events included treatment with Steroid's shots, benadryl and anti-itchy cream. The clinical course was as follows: No lifestyle, habit nor food change during second dose to event occurred. The outcome of the events was resolved.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry throat, Dysphagia, Heart rate irregular, Lip swelling, Paraesthesia oral
Clinical narrative: anaphylaxis; I looked at my lips and tongue and they were swollen.; . I started to feel something in my throat, but not severe at that time. So I went to bed. My heart was beating irregularly so I took my pulse with my monitor and it showed Irregular and 50-57 bpm.; I was more concerned by the time, but laid there and took my blood pressure. It was normal but irregular.; I looked at my lips and tongue and they were swollen.; I was injected at 5:30pm. I waited the advised 15 minutes time in a chair and another 15 minutes for safety. I left and shortly started to feel tingling in my lip; I was injected at 5:30pm. I waited the advised 15 minutes time in a chair and another 15 minutes for safety. I left and shortly started to feel tingling in my lip, then in my tongue.; My heart was beating irregularly; started to feel something in my throat /It got harder to swallow; This is a spontaneous report from a contactable consumer (patient herself).   A 75-year-old non pregnant female patient received first dose of BNT162B2 (Solution injection; Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 17:30 as single dose for covid-19 immunisation. Medical history included atrial fibrillation and allergies to penicillin, contrast dye. Concomitant medications included verapamil, losartan and warfarin sodium (COUMADIN). The patient previously took advair disc and experienced allergy. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior vaccination. Patient was not tested for covid post vaccination. Patient reported that she was injected at 5:30pm. She waited the advised 15 minutes time in a chair and another 15 minutes for safety. She left and shortly started to feel tingling in her lip, then in her tongue. She was concerned and stopped at a fast food restaurant to get a large Sprite to get fluids in her. She kept driving home for another 30 minutes. She started to feel something in her throat, but not severe at that time. So she went to bed. Her heart was beating irregularly so she took her pulse with her monitor and it showed Irregular and 50-57 bpm. She was more concerned by the time but laid there and took her blood pressure. It was normal but irregular. She looked at her lips and tongue and they were swollen. It got harder to swallow so she took a menthol cough drop. At 3:30 she went to sleep. At 6:00 am she called her primary care's office and the nurse told her to immediately go straight to the ER. She was diagnosed with anaphalaxis. Therapeutic measures were taken as a result of the events and patient was treated with prednisone and benadryl. The outcome of the events was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: anaphylaxis; I looked at my lips and tongue and they were swollen.; . I started to feel something in my throat, but not severe at that time. So I went to bed. My heart was beating irregularly so I took my pulse with my monitor and it showed Irregular and 50-57 bpm.; I was more concerned by the time, but laid there and took my blood pressure. It was normal but irregular.; I looked at my lips and tongue and they were swollen.; I was injected at 5:30pm. I waited the advised 15 minutes time in a chair and another 15 minutes for safety. I left and shortly started to feel tingling in my lip; I was injected at 5:30pm. I waited the advised 15 minutes time in a chair and another 15 minutes for safety. I left and shortly started to feel tingling in my lip, then in my tongue.; My heart was beating irregularly; started to feel something in my throat /It got harder to swallow; This is a spontaneous report from a contactable consumer (patient herself).   A 75-year-old non pregnant female patient received first dose of BNT162B2 (Solution injection; Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 17:30 as single dose for covid-19 immunisation. Medical history included atrial fibrillation and allergies to penicillin, contrast dye. Concomitant medications included verapamil, losartan and warfarin sodium (COUMADIN). The patient previously took advair disc and experienced allergy. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior vaccination. Patient was not tested for covid post vaccination. Patient reported that she was injected at 5:30pm. She waited the advised 15 minutes time in a chair and another 15 minutes for safety. She left and shortly started to feel tingling in her lip, then in her tongue. She was concerned and stopped at a fast food restaurant to get a large Sprite to get fluids in her. She kept driving home for another 30 minutes. She started to feel something in her throat, but not severe at that time. So she went to bed. Her heart was beating irregularly so she took her pulse with her monitor and it showed Irregular and 50-57 bpm. She was more concerned by the time but laid there and took her blood pressure. It was normal but irregular. She looked at her lips and tongue and they were swollen. It got harder to swallow so she took a menthol cough drop. At 3:30 she went to sleep. At 6:00 am she called her primary care's office and the nurse told her to immediately go straight to the ER. She was diagnosed with anaphalaxis. Therapeutic measures were taken as a result of the events and patient was treated with prednisone and benadryl. The outcome of the events was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure abnormal, Dysphagia, Heart rate, Heart rate irregular
Clinical narrative: anaphylaxis; I looked at my lips and tongue and they were swollen.; . I started to feel something in my throat, but not severe at that time. So I went to bed. My heart was beating irregularly so I took my pulse with my monitor and it showed Irregular and 50-57 bpm.; I was more concerned by the time, but laid there and took my blood pressure. It was normal but irregular.; I looked at my lips and tongue and they were swollen.; I was injected at 5:30pm. I waited the advised 15 minutes time in a chair and another 15 minutes for safety. I left and shortly started to feel tingling in my lip; I was injected at 5:30pm. I waited the advised 15 minutes time in a chair and another 15 minutes for safety. I left and shortly started to feel tingling in my lip, then in my tongue.; My heart was beating irregularly; started to feel something in my throat /It got harder to swallow; This is a spontaneous report from a contactable consumer (patient herself).   A 75-year-old non pregnant female patient received first dose of BNT162B2 (Solution injection; Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 17:30 as single dose for covid-19 immunisation. Medical history included atrial fibrillation and allergies to penicillin, contrast dye. Concomitant medications included verapamil, losartan and warfarin sodium (COUMADIN). The patient previously took advair disc and experienced allergy. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior vaccination. Patient was not tested for covid post vaccination. Patient reported that she was injected at 5:30pm. She waited the advised 15 minutes time in a chair and another 15 minutes for safety. She left and shortly started to feel tingling in her lip, then in her tongue. She was concerned and stopped at a fast food restaurant to get a large Sprite to get fluids in her. She kept driving home for another 30 minutes. She started to feel something in her throat, but not severe at that time. So she went to bed. Her heart was beating irregularly so she took her pulse with her monitor and it showed Irregular and 50-57 bpm. She was more concerned by the time but laid there and took her blood pressure. It was normal but irregular. She looked at her lips and tongue and they were swollen. It got harder to swallow so she took a menthol cough drop. At 3:30 she went to sleep. At 6:00 am she called her primary care's office and the nurse told her to immediately go straight to the ER. She was diagnosed with anaphalaxis. Therapeutic measures were taken as a result of the events and patient was treated with prednisone and benadryl. The outcome of the events was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Paraesthesia oral, Swollen tongue
Clinical narrative: anaphylaxis; I looked at my lips and tongue and they were swollen.; . I started to feel something in my throat, but not severe at that time. So I went to bed. My heart was beating irregularly so I took my pulse with my monitor and it showed Irregular and 50-57 bpm.; I was more concerned by the time, but laid there and took my blood pressure. It was normal but irregular.; I looked at my lips and tongue and they were swollen.; I was injected at 5:30pm. I waited the advised 15 minutes time in a chair and another 15 minutes for safety. I left and shortly started to feel tingling in my lip; I was injected at 5:30pm. I waited the advised 15 minutes time in a chair and another 15 minutes for safety. I left and shortly started to feel tingling in my lip, then in my tongue.; My heart was beating irregularly; started to feel something in my throat /It got harder to swallow; This is a spontaneous report from a contactable consumer (patient herself).   A 75-year-old non pregnant female patient received first dose of BNT162B2 (Solution injection; Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 17:30 as single dose for covid-19 immunisation. Medical history included atrial fibrillation and allergies to penicillin, contrast dye. Concomitant medications included verapamil, losartan and warfarin sodium (COUMADIN). The patient previously took advair disc and experienced allergy. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior vaccination. Patient was not tested for covid post vaccination. Patient reported that she was injected at 5:30pm. She waited the advised 15 minutes time in a chair and another 15 minutes for safety. She left and shortly started to feel tingling in her lip, then in her tongue. She was concerned and stopped at a fast food restaurant to get a large Sprite to get fluids in her. She kept driving home for another 30 minutes. She started to feel something in her throat, but not severe at that time. So she went to bed. Her heart was beating irregularly so she took her pulse with her monitor and it showed Irregular and 50-57 bpm. She was more concerned by the time but laid there and took her blood pressure. It was normal but irregular. She looked at her lips and tongue and they were swollen. It got harder to swallow so she took a menthol cough drop. At 3:30 she went to sleep. At 6:00 am she called her primary care's office and the nurse told her to immediately go straight to the ER. She was diagnosed with anaphalaxis. Therapeutic measures were taken as a result of the events and patient was treated with prednisone and benadryl. The outcome of the events was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Dysgeusia, Headache
Clinical narrative: asthmatictype cough; cough; metallic taste in her mouth; This is a spontaneous report from contactable consumer.  This female Consumer (Patient) reported.  A female patient with unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 04Feb2021 11:40am as dose 1, single for COVID-19 immunization. The patient medical history includes NSAID induced Drug hypersensitivity and concomitant medications were not reported. On 04Feb2021, after the vaccination, the patient experienced a metallic taste in her mouth afterward. The next day (Friday) she developed an "asthmatic-type cough", on Saturday she didn't cough as much. She wants to know if it is safe for her to receive the second dose and could it, she be reacting to an ingredient/are there any that are similar to NSAIDs. The events assessed as non-serious. The outcome of the event dysgeusia was unknown and asthmatic cough was resolved on 06Feb2021.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (02Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Cough, Dysgeusia
Clinical narrative: asthmatictype cough; cough; metallic taste in her mouth; This is a spontaneous report from contactable consumer.  This female Consumer (Patient) reported.  A female patient with unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 04Feb2021 11:40am as dose 1, single for COVID-19 immunization. The patient medical history includes NSAID induced Drug hypersensitivity and concomitant medications were not reported. On 04Feb2021, after the vaccination, the patient experienced a metallic taste in her mouth afterward. The next day (Friday) she developed an "asthmatic-type cough", on Saturday she didn't cough as much. She wants to know if it is safe for her to receive the second dose and could it, she be reacting to an ingredient/are there any that are similar to NSAIDs. The events assessed as non-serious. The outcome of the event dysgeusia was unknown and asthmatic cough was resolved on 06Feb2021.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (02Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Normal, expected injection site soreness; Aches; chills; low grade fever (99.0 degrees, which is high for me); This is a spontaneous report from a contactable consumer (patient). A 27-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in arm left on 16Feb2021 at 12:45 PM (at the age of 27-years-old) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in arm left on 26Jan2021 at 12:45 PM (at the age of 27-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medications included ibuprofen, clindamycin phosphate pledgets, adapalene and levonorgestrel (MIRENA) taken for an unspecified indication and unknown start, stop date. Patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 17Feb2021 at 07:00 AM, the patient experienced normal, expected injection site soreness, aches, chills and low grade fever (99.0 degrees, which is high for me). Patient had not taken any treatment for reported events. The patient underwent lab tests and procedures which included body temperature: 99.0 degrees (low grade fever) on 17Feb2021. The outcome of all the events was recovering.   Follow-up attempts completed. No further information expected.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Normal, expected injection site soreness; Aches; chills; low grade fever (99.0 degrees, which is high for me); This is a spontaneous report from a contactable consumer (patient). A 27-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in arm left on 16Feb2021 at 12:45 PM (at the age of 27-years-old) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in arm left on 26Jan2021 at 12:45 PM (at the age of 27-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medications included ibuprofen, clindamycin phosphate pledgets, adapalene and levonorgestrel (MIRENA) taken for an unspecified indication and unknown start, stop date. Patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 17Feb2021 at 07:00 AM, the patient experienced normal, expected injection site soreness, aches, chills and low grade fever (99.0 degrees, which is high for me). Patient had not taken any treatment for reported events. The patient underwent lab tests and procedures which included body temperature: 99.0 degrees (low grade fever) on 17Feb2021. The outcome of all the events was recovering.   Follow-up attempts completed. No further information expected.