chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling very fatigue.; This is a spontaneous report from a contactable other-HCP.  A 59-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: l3249), via an unspecified route of administration, administered in Left Arm on 26Jan2021 as 2nd single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]); losartan (LOSARTAN). The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, lisinopril and experienced drug hypersensitivity. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE , Solution injection, Lot number/Expiration date: Unknown) for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination and post vaccination, patient had not tested with covid 19.On an unspecified date the patient feeling very fatigue. No treatment received for the event. The outcome of event was recovering. Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Parosmia
Clinical narrative: can't taste anything/he had an Altoid mint and "it wasn't' strong at all"; smelling things differently; This is a spontaneous report received from a contactable consumer (patient) via Medical information Team. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included altoid mint. The patient reported that after his first vaccine dose, he can't taste anything and he was smelling things differently. Patient reported that he had an altoid mint and "it wasn't' strong at all". The outcome of the events was unknown.  Information on Lot/Batch has been requested. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Circumstance or information capable of leading to medication error, Headache
Clinical narrative: Chills; Mild headache; 2 hours prior to the 2nd dose, the patient self-medicated with 2 Acetaminophen 500 mg tablets to prevent side effects.; This is a spontaneous report received a contactable pharmacist. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. It was reported that the patient received dose 1 and dose 2 (21 days later) of the Pfizer-BioNTech Covid-19 Vaccine. 2 hours prior to the 2nd dose, the patient self-medicated with 2 Acetaminophen 500 mg tablets to prevent side effects. Patient did experience chills (day 1 PM) and mild headache (day 2). No other side effects were experienced. Recent recommendations have come to light (news media) strongly advising against medicating with Acetaminophen pre-vaccine with fears that it may subdue or blunt the immune effect of the vaccine. Patient was concerned and asking what he should do. Specifically: Should he seek out a third Pfizer injection without Acetaminophen or seek out another 2 shots therapy (Moderna). The outcome of the events was unknown.   Information on Lot/Batch was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information was expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer. A 19-years-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3249), via an unspecified route of administration, administered in Left Arm on 27Jan2021 at 11:00, single for covid-19 immunisation. Medical history included tachycardia, irritable bowel syndrome, colitis, allergies to pineapple, dairy. Concomitant medication(s) included cobamamide (Vitamin B12 [cobamamide]), dicyclomine, escitalopram oxalate (lexapro). On 06Jan2021, the patient received first dose of bnt162b2 (Batch/Lot Number: EK5730) at Left arm. Facility type vaccine in Hospital. No other vaccine in four weeks. No COVID-19 tested post vaccination. No COVID-19 prior vaccination. On 27Jan2021 at 11:30 pm, the patient experienced dizziness, nausea, headache, chills, and diarrhea. The event assessed as non-serious. No treatment was received. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: a little arm pain; headache; This is a spontaneous report from a contactable consumer. This female consumer reported that:   A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3248; expiration date: unknown), via an unspecified route of administration on 15Jan2021 at 13:20 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced a little arm pain and headache. The patient wants to know if she can just get the first dose, She is worried about side effects and wants to know if it works. Reporter asked what happens if she doesn't get the second dose of the COVID-19 Vaccine. Reporter stated she had a question about the COVID-19 Vaccine. She stated she got her first COVID-19 Vaccine shot and in the next 2 weeks she will be getting her 2nd COVID-19 Vaccine shot. She asked what happens if she doesn't want to get the second COVID-19 Vaccine shot. The outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Migraine, Nausea
Clinical narrative: Shaking chills; Sweats starting 12 hours after dose while sleeping; Migraine headache for a continuous 36 hours; Nausea; This is a spontaneous report from a contactable Nurse (reporting for herself). A 37-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in right arm on 12Jan2021 09:15 as 2nd single dose and had previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st single dose for COVID-19 immunization. Patient was 37-years-old and was not pregnant at the time of vaccination. Patient Vaccination facility type was Hospital. Patient did not receive any other vaccine in four weeks. Patient did not receive any prior COVID-19 vaccination. Patient was not tested for COVID-19 post vaccination. On 12Jan2021 patient experienced shaking chills/sweats starting 12 hours after dose while sleeping, no fever. Migraine headache for a continuous 36 hours and nausea. Patient did not receive any treatment for the adverse event. The outcome of the event was recovered.   Information about Lot/ Batch has been requested.  Follow-up (16Apr2021): 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dysaesthesia, Grip strength decreased, Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: she can't grip she can still grip things but she has to shake her arm to wake it up; A feeling of pins and needles at the finger tips; Hand was numb and tingly; Hand was numb and tingly; Arm felt like it was falling asleep/felt like her arm was going to sleep; Arm is going numb; Her hand and is like it is falling asleep; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer (patient) reported that: A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982) via an unspecified route of administration in left upper arm on 22Jan2021 at 14:45-15:00 as single dose for COVID-19 immunization. Patient's Medical History (including any illness at time of vaccination) and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 she reports that her arm is going numb and her hand and is like it is falling asleep. On Monday(25Jan2021) she had to shake it to wake it up, arm felt like it was falling asleep and her hand was numb and tingly, she had the same feeling in the arm she had the injection. Tuesday and Wednesday it was ok and she had no issues but today(28Jan2021) felt like her arm was going to sleep. She had to shake it to wake it up and there was a feeling of pins and needles at the fingertips. It is not like she can't grip she can still grip things but she has to shake her arm to wake it up. She wants to know is this some known side effect and is it safe to have the shot in the same arm, her second dose is due on 08Feb2021. Outcome of the events were unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram normal, Dizziness, Electrocardiogram
Clinical narrative: I had a racing heartbeat going up to 148 beats a minute. This was 60 hours after injection. I call 911 and was taken to emergency room/ racing heart rate; Some Dizziness/ Lightheadedness; This is a spontaneous report from a contactable consumer reported herself that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL0739), via an unspecified route of administration on 02Feb2021 at 09:45 in arm right as a 2nd dose, single for COVID-19 immunization. The patient's medical history included CLL, macular degeneration ongoing, cataracts and I all allergic to Vespids (wasps, yellow jackets and hornets), heartburn and constipation. Historical vaccine included BNT162B2 on 12Jan2021 (administration time: 08:45 AM, vaccine location: right arm, dose number: 1). Concomitant medications included omeprazole DR for heartburn taken orally and ongoing, herbal remedies, ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID; ERGOCALCIFEROL; NICOTINAMIDE; RETINOL; RIBOFLAVIN; THIAMINE HYDROCHLORIDE]) and miralax (MACROGOL 3350) taken orally for constipation stopped on 01May2021. On 04Feb2021 at 09:30, the patient experienced a racing heartbeat going up to 148 beats a minute. This was 60 hours after injection. The patient called to 911 and was taken to emergency room. The events resulted in emergency room/department or urgent care. It was unknown If patient took treatment for the event. The patient underwent lab test included heart rate irregular resulted as going up 148 beats a minute. Upon follow up on 12Mar2021, it was reported that, 60 hours after receiving the 2nd dose my heart rate started increasing or a very rapid rate despite the fact that I was sitting still the heart rate reaches 148 and then went down to 108. EMT were called and suggested I go to ER. More test were done to eliminate any cardiac Rx. Nothing was found. I also had some dizziness and lightheadedness. No Prior vaccinations with in four weeks. On 04Feb2021, the patient experienced racing heart rate and dizziness. On 05Feb2021, the patient underwent lab tests and procedures included EKG was normal, Blood test was normal, CT of heart was normal, and Chest X-ray was normal. The outcome of the events palpitations was recovered, while with other event was unknown.  Reporter considered the event racing heart rate as serious (Life-threatening, important medical event) and required visit to: Emergency room. The patient was hospitalized for 9 hours.  Follow-up (12Mar2021): New information was received from a contactable consumer included: information on Medical history and lab data.  Information of Lot/Batch number was available. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Palpitations
Clinical narrative: I had a racing heartbeat going up to 148 beats a minute. This was 60 hours after injection. I call 911 and was taken to emergency room/ racing heart rate; Some Dizziness/ Lightheadedness; This is a spontaneous report from a contactable consumer reported herself that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL0739), via an unspecified route of administration on 02Feb2021 at 09:45 in arm right as a 2nd dose, single for COVID-19 immunization. The patient's medical history included CLL, macular degeneration ongoing, cataracts and I all allergic to Vespids (wasps, yellow jackets and hornets), heartburn and constipation. Historical vaccine included BNT162B2 on 12Jan2021 (administration time: 08:45 AM, vaccine location: right arm, dose number: 1). Concomitant medications included omeprazole DR for heartburn taken orally and ongoing, herbal remedies, ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID; ERGOCALCIFEROL; NICOTINAMIDE; RETINOL; RIBOFLAVIN; THIAMINE HYDROCHLORIDE]) and miralax (MACROGOL 3350) taken orally for constipation stopped on 01May2021. On 04Feb2021 at 09:30, the patient experienced a racing heartbeat going up to 148 beats a minute. This was 60 hours after injection. The patient called to 911 and was taken to emergency room. The events resulted in emergency room/department or urgent care. It was unknown If patient took treatment for the event. The patient underwent lab test included heart rate irregular resulted as going up 148 beats a minute. Upon follow up on 12Mar2021, it was reported that, 60 hours after receiving the 2nd dose my heart rate started increasing or a very rapid rate despite the fact that I was sitting still the heart rate reaches 148 and then went down to 108. EMT were called and suggested I go to ER. More test were done to eliminate any cardiac Rx. Nothing was found. I also had some dizziness and lightheadedness. No Prior vaccinations with in four weeks. On 04Feb2021, the patient experienced racing heart rate and dizziness. On 05Feb2021, the patient underwent lab tests and procedures included EKG was normal, Blood test was normal, CT of heart was normal, and Chest X-ray was normal. The outcome of the events palpitations was recovered, while with other event was unknown.  Reporter considered the event racing heart rate as serious (Life-threatening, important medical event) and required visit to: Emergency room. The patient was hospitalized for 9 hours.  Follow-up (12Mar2021): New information was received from a contactable consumer included: information on Medical history and lab data.  Information of Lot/Batch number was available. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Took a sip of water around 23:45. Found there was a strange tingling sensation on my tongue (specifically the tip area) after swallowing. Quickly fades/is not persistent after swallowing.  Not unpleasant: think fizzy drink sensation but toned  down by a tenfold, almost muted. As of writing (00:26) sensation still occurs when I drink water.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Swelling on injection site. swelling feels warm and itchy. Fever the day after vaccine and pain in body.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Confusional state, Fatigue, Feeling abnormal, Gingival swelling
Clinical narrative: Nausea, fatigue, body aches-10 days  Chronic back and neck pain completely ceased for two weeks then returned but much worse with nerve pain that makes me nauseous. It doesn?t respond to otc meds, pt exercises, stretch or rest -ongoing.  Extreme brain fog with mental confusion. For two weeks. I?m still feeling out of it and slow.  Trouble staying awake while driving or sitting still-ongoing  Swelling of the jaw on right side-10 days  Loose molars and gum swelling.-ongoing
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Loose tooth, Nausea, Neck pain, Neuralgia
Clinical narrative: Nausea, fatigue, body aches-10 days  Chronic back and neck pain completely ceased for two weeks then returned but much worse with nerve pain that makes me nauseous. It doesn?t respond to otc meds, pt exercises, stretch or rest -ongoing.  Extreme brain fog with mental confusion. For two weeks. I?m still feeling out of it and slow.  Trouble staying awake while driving or sitting still-ongoing  Swelling of the jaw on right side-10 days  Loose molars and gum swelling.-ongoing
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling face
Clinical narrative: Nausea, fatigue, body aches-10 days  Chronic back and neck pain completely ceased for two weeks then returned but much worse with nerve pain that makes me nauseous. It doesn?t respond to otc meds, pt exercises, stretch or rest -ongoing.  Extreme brain fog with mental confusion. For two weeks. I?m still feeling out of it and slow.  Trouble staying awake while driving or sitting still-ongoing  Swelling of the jaw on right side-10 days  Loose molars and gum swelling.-ongoing
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Weakness; difficult breathing; fatigue; Dizziness; general malaise; rapid heart rate; a sense of impending doom; This is a spontaneous report from a contactable consumer.   A 68-Year-old male consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route in left arm on 04Feb2021 15.15 as SINGLE DOSE, for covid-19 immunization (age at vaccination: 68-Year-old). Medical history included Heart Failure, PAD, CAD and Fibromyalgia. Concomitant medications included alirocumab (PRALUENT), aspirin [acetylsalicylic acid, hydrocodone bitartrate, paracetamol (NORCO), perna caliculata extract (LYPRINOL), ca [calcium] and diphenhydramine hydrochloride (BENADRYL). Patient was allergic to food allergy, dairy products, sulfa drugs and soy. Patient not had Covid prior to vaccination. On 06Feb2021, the patient had weakness, difficult breathing, fatigue, dizziness, general malaise, rapid heart rate and a sense of impending doom. The events resulted in emergency room/department or urgent care. The patient has tested for covid 19, nasal swab on 06Feb2021, the test result was negative. The patient had not received any treatment for adverse events. The outcome of the events was reported as not recovered.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Malaise, SARS-CoV-2 test
Clinical narrative: Weakness; difficult breathing; fatigue; Dizziness; general malaise; rapid heart rate; a sense of impending doom; This is a spontaneous report from a contactable consumer.   A 68-Year-old male consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route in left arm on 04Feb2021 15.15 as SINGLE DOSE, for covid-19 immunization (age at vaccination: 68-Year-old). Medical history included Heart Failure, PAD, CAD and Fibromyalgia. Concomitant medications included alirocumab (PRALUENT), aspirin [acetylsalicylic acid, hydrocodone bitartrate, paracetamol (NORCO), perna caliculata extract (LYPRINOL), ca [calcium] and diphenhydramine hydrochloride (BENADRYL). Patient was allergic to food allergy, dairy products, sulfa drugs and soy. Patient not had Covid prior to vaccination. On 06Feb2021, the patient had weakness, difficult breathing, fatigue, dizziness, general malaise, rapid heart rate and a sense of impending doom. The events resulted in emergency room/department or urgent care. The patient has tested for covid 19, nasal swab on 06Feb2021, the test result was negative. The patient had not received any treatment for adverse events. The outcome of the events was reported as not recovered.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Insomnia
Clinical narrative: Muscle and joint pain; Muscle and joint pain; headache; extreme fatigue; sore arm; chills; unable to sleep; Overall just don't feel well; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were not reported) via an unspecified route of administration on left arm on 08Feb2021 (at the age of 66-year-old) as 1st dose, single for COVID-19 immunization. The patient medical history included pacemaker, replacement knees and left hip. The patient had known allergy with cipro and vancomycin. The patient had COVID prior vaccination. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks. The patient was not tested COVID-19 post vaccination. On 09Feb2021 at 02:00, the patient experienced muscle and joint pain, headache, extreme fatigue, sore arm, chills, unable to sleep. Overall, the patient just did not feel well. The patient did not receive any treatment for the event. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pain in extremity
Clinical narrative: Muscle and joint pain; Muscle and joint pain; headache; extreme fatigue; sore arm; chills; unable to sleep; Overall just don't feel well; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were not reported) via an unspecified route of administration on left arm on 08Feb2021 (at the age of 66-year-old) as 1st dose, single for COVID-19 immunization. The patient medical history included pacemaker, replacement knees and left hip. The patient had known allergy with cipro and vancomycin. The patient had COVID prior vaccination. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks. The patient was not tested COVID-19 post vaccination. On 09Feb2021 at 02:00, the patient experienced muscle and joint pain, headache, extreme fatigue, sore arm, chills, unable to sleep. Overall, the patient just did not feel well. The patient did not receive any treatment for the event. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Erythropsia, Muscle spasms
Clinical narrative: florescent light in kitchen made things a pink hue; muscle cramps in legs and in arms mainly while sleeping; This is a spontaneous report from a contactable consumer.   A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) (at the age of 65) as single dose for covid-19 immunisation. No other vaccine in four weeks. Medical history included type 2 diabetes mellitus, sleep apnoea syndrome, hypertension, hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID), glipizide, metformin, potassium as supplement. The patient experienced florescent light in kitchen made things a pink hue on 10Feb2021 22:00, muscle cramps in legs and in arms mainly while sleeping on 10Feb2021 22:00. Patient woke up and went into kitchen and noticed when turning on the light the room was I hue of pink. went into computer room turned on light, no pink hue. Florescent light in kitchen made things a pink hue. incandescent light did not make things look pink. No treatment to events. No COVID prior vaccination. No COVID  tested post vaccination. No known allergies. The events outcome was recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Pain, Pyrexia
Clinical narrative: chills; body ache; feverish; feeling unwell; nose running with lots of sneezing; nose running with lots of sneezing; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Feb2021 at 13:00 (Batch/Lot number was not reported) (at the age of 70-year-old) as single dose for COVID-19 immunisation.  Medical history included blood pressure (BP) abnormal from an unknown date and unknown if ongoing. The patient did not have allergies. The patient did not have COVID-19 prior or post vaccination. Concomitant medications included regular medications for BP (unspecified). On 10Feb2021, the patient experienced chills, body ache, feverish, feeling unwell, nose running with lots of sneezing. Therapeutic measures were taken as a result of the events and included treatment with TYLENOL 500 mg. The patient outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: chills; body ache; feverish; feeling unwell; nose running with lots of sneezing; nose running with lots of sneezing; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Feb2021 at 13:00 (Batch/Lot number was not reported) (at the age of 70-year-old) as single dose for COVID-19 immunisation.  Medical history included blood pressure (BP) abnormal from an unknown date and unknown if ongoing. The patient did not have allergies. The patient did not have COVID-19 prior or post vaccination. Concomitant medications included regular medications for BP (unspecified). On 10Feb2021, the patient experienced chills, body ache, feverish, feeling unwell, nose running with lots of sneezing. Therapeutic measures were taken as a result of the events and included treatment with TYLENOL 500 mg. The patient outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Swelling face
Clinical narrative: Left side pain under left arm and into left heart region; right side facial swelling associated with lymph nodes; right side facial swelling associated with lymph nodes; This is a spontaneous report from a contactable consumer (patient).  A 68-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 10Feb2021 at 10:15, at single dose, for COVID-19 immunisation. Medical history included type 1 diabetes mellitus (for 48 years), penicillin allergy, sulfonamide allergy. Patient did not have COVID-19 prior to vaccination. Patient received unspecified medications in two weeks. Patient did not receive other vaccines in four weeks. The patient experienced right side facial swelling associated with lymph nodes (non-serious) on 12Feb2021 with outcome of recovered in Feb2021 (6 hours later), right side facial swelling associated with lymph nodes (non-serious) on 12Feb2021 with outcome of recovered in Feb2021 (6 hours later), left side pain under left arm and into left heart region (non-serious) on 12Feb2021 at 21:00 with outcome of recovered in 2021. The patient did not know if this was swollen lymph nodes or heart condition. Patient did not test for COVID-19 post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Headache; Body aches; This is a spontaneous report received from a non-contactable consumer (patient). A 48-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration in Left arm on 12Feb2021 4:00 PM at Unknown dose, single  for COVID-19 immunisation.The patient medical history included endometriosis & seizure disorder. The patient's concomitant medications included Estrogen (ESTROGEN), Lexapro (ESCITALOPRAM OXALATE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No Allergies to medications, food, or other products was reported. Facility where the most recent COVID-19 vaccine was administered at Hospital. On 13Feb2021 at 04:00 AM patient experienced headache, body aches. The patient was treated with Ibuprofen. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Constipation, Nausea
Clinical narrative: stomachache; nausea; constipation; This is a spontaneous report from a contactable consumer (patient).   A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as 2nd single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 on unknown date. A whole week after the second dose the patient experienced stomachache, nausea and constipation, all non-serious on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: sore underarm; lymph node was swollen in the axillary area. my armpit; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 11Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient received the first dose of vaccine on an unknown date. The patient medical history was not reported.  The patient's concomitant medications were not reported.  On 13Feb2021 the patient woke up the morning with a sore underarm, she noticed that her lymph node was swollen in the axillary area. Her armpit and its the same side that she received the injection. She wondered if she should take any thing like ibuprofen or put a warm compress. The outcome was unknown.    Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Pneumonitis
Clinical narrative: Severe back pain; difficulty inhaling deep breaths; lung inflammation; This is a spontaneous report from a contactable other health professional.  A 42-year-old female patient reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), into the left arm on 08Feb2021 at 05:00 PM (at the age of 42-years-old) at single dose for COVID-19 immunization. The patient had received first dose of vaccine on 13Jan2021,  at 03:00 PM, in the Left arm. The patient had history of allergies to Sulfur . Other medications included Vitiman D3. On 08Feb202 at 10:30 PM the patient had severe back pain with difficulty inhaling deep breaths She went to Emergency room/department or urgent care. Treatment received was Tylenol/Ibuprofen for lung inflammation. The outcome of the events was recovering. Prior to vaccination the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Lymphadenopathy- swollen, painful right armpit; Lymphadenopathy- swollen, painful right armpit; level of pain at injection site; Body aches; fever; chills; This is a spontaneous report from a non-contactable consumer.  This 36-year-old female consumer (patient) reported that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3247),  into the right arm on 12Feb2021 at 12:00PM (at the age of 36-years-old) at single dose for COVID-19 immunization. the patient had received first dose of vaccine on 22Jan2021 12:00 PM in right arm. Medical history was none, no known allergies. Other medications included Escitalopram. On 13Feb2021 the patient experienced  level of pain at injection site, body aches, fever, chills, Lymphadenopathy- swollen, painful right armpit. The outcome of the events was recovering  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Lymphadenopathy- swollen, painful right armpit; Lymphadenopathy- swollen, painful right armpit; level of pain at injection site; Body aches; fever; chills; This is a spontaneous report from a non-contactable consumer.  This 36-year-old female consumer (patient) reported that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3247),  into the right arm on 12Feb2021 at 12:00PM (at the age of 36-years-old) at single dose for COVID-19 immunization. the patient had received first dose of vaccine on 22Jan2021 12:00 PM in right arm. Medical history was none, no known allergies. Other medications included Escitalopram. On 13Feb2021 the patient experienced  level of pain at injection site, body aches, fever, chills, Lymphadenopathy- swollen, painful right armpit. The outcome of the events was recovering  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oedema
Clinical narrative: Right auxiliary edema extending to right pectoral muscle and lymph node swelling; Right auxiliary edema extending to right pectoral muscle and lymph node swelling; This is a spontaneous report from a contactable Pharmacist (patient)  A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 10Feb2021 15:30 (Batch/Lot number was not reported) as second  SINGLE DOSE for covid-19 immunisation.Age at vaccination :44 years. The patient received the first dose at age of 44 years on 23Jan2021 at 4:00 p.m . No other vaccine in four weeks .The patient medical history was not reported. Concomitant medication(s) included fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported.  The patient experienced right auxiliary edema extending to right pectoral muscle and lymph node swelling on 12Feb2021 with outcome of not recovered.No treatment received. No COVID prior vaccination.No COVID tested post vaccination.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Pain
Clinical narrative: pain and agony; pain and agony; This is a spontaneous report from a contactable consumer (patient).   A 77 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ),  via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced pain and agony on an unspecified date with outcome of unknown.  .  Therapeutic measures were taken as a result of pain and agony (pain), pain and agony (depressed mood).The case was reported as non serious.The clinical course was reported as follows:the patient received the 1st dose of the Pfizer covid vaccine as scheduled and was advised not take Tylenol or Ibuprofen for the next 24 hours. However, she was in such 'pain and agony' that by 4:00 AM that night, she took an Ibuprofen. Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Both lower legs extreme rash and now going to upper leg; This is a spontaneous report from a contactable consumer (patient)  A no pregnant current 66-year old female patient received bnt162b2 ( PFIZER-BIONTECH COVID-19 mRNA VACCINE) at age of 65 years via an unspecified route of administration, administered in Arm Left on 29Jan2021 14:00 (Batch/Lot Number: EN5318) as 1st SINGLE DOSE for covid-19 immunisation  . No other vaccine in four weeks;No Other medications in two weeks. Medical history included Heart attack (2 stents) , penicillin allergy, walnuts allergy from an unknown date and unknown if ongoing.     The patient experienced both lower legs extreme rash and now going to upper leg on 12Feb2021 12:00 with outcome of not recovered.The event was treated with cream Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Paraesthesia, Peripheral swelling, Pyrexia
Clinical narrative: Left arm swelling with hive; Left arm swelling with hive; left hand fingers numb; Fever; headache; Right Arm tingling; This is a spontaneous report from a contactable consumer reporting for himself.   A 65-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 14:00 (Batch/Lot Number: EL9267) at the age of 65 years as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included colectomy Colon resection 14 years ago. The patient's concomitant medications were not reported. On 11Feb2021 22:00  the patient experienced left arm swelling with hive, left hand fingers numb, fever, headache, right arm tingling all with outcome of not recovered. Therapeutic treatment: Tylenol.  No follow up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Left arm swelling with hive; Left arm swelling with hive; left hand fingers numb; Fever; headache; Right Arm tingling; This is a spontaneous report from a contactable consumer reporting for himself.   A 65-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 14:00 (Batch/Lot Number: EL9267) at the age of 65 years as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included colectomy Colon resection 14 years ago. The patient's concomitant medications were not reported. On 11Feb2021 22:00  the patient experienced left arm swelling with hive, left hand fingers numb, fever, headache, right arm tingling all with outcome of not recovered. Therapeutic treatment: Tylenol.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I had a rash on my arms, now have it on my legs and stomach; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 26Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced a rash on arms, now have it on my legs and stomach on 10Feb2021 (reported as past Wednesday) with outcome of unknown.    Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Numbness/parasthesia of the right scapula; Numbness/parasthesia of the right scapula; This is a spontaneous report from a contactable Physician (patient).  A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Jan2021 12:00 (Batch/Lot Number: EK9231), age at vaccination of 31-years-old, as single dose, for covid-19 immunisation.  The patient medical history was not reported. There were no concomitant medications. The patient had not received other vaccine in four weeks. The patient experienced numbness/paraesthesia of the right scapula on 20Jan2021 01:30 PM. No treatment was administered. The patient underwent lab tests and procedures which included sars-cov-2 test negative on an unspecified date. The patient had not recovered from the events.  The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Jan2021 12:00 (Batch/Lot Number: EL3247), as single dose, for covid-19 immunisation.  Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Arm soreness; Headache; This is a spontaneous report from a non-contactable consumer. A 24-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution or injection, Lot Number: EL3247), dose 1 via an unspecified route of administration in right arm on an unspecified date (at the age of 24-years-old) as single for COVID-19 immunization. Medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID 19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 11Feb2021, the patient experienced arm soreness and headache. Advil was received as treatment for the events. The reporter classified the events as non-serious. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Soreness arm and joint pain; Soreness arm and joint pain; This is a spontaneous report from a Pfizer sponsored program. An 85-year-old female consumer (patient) reported for herself that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient reported that her left was sore, she had soreness arm and joint pain not bad at all. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle spasms, Vomiting
Clinical narrative: severe diarrhea; cramps; vomiting; This is a spontaneous report from a contactable male consumer reported for himself. A 68-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown), via unspecified route, in left arm on 12Feb2021 13:00 (at 68-years age) 1st dose, single for covid-19 immunisation. The patient's medical history included heart disease. The had allergies to medications, food, or other products. Concomitant medications that patient received in 2 weeks of vaccination include clopidogrel (CLOPIDOGREL); losartan (LOSARTAN); rosuvastatin (ROSUVASTATIN); amlodipine (AMLODIPINE). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was Doctor's office or urgent care. On 13Feb2021 at 01:00 AM about 12 hours after the shot the patient had experienced severe diarrhea, cramps and vomiting. The patient had not received any treatment. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovering.   Information on the lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature fluctuation, Chills, Myalgia
Clinical narrative: temperature fluctuations between 98.9 up to 104.2 (normal temp is 97.9); chills; Body / muscle aches; This is a spontaneous report from a contactable consumer (patient).   A 68-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11Feb2021 03:15 PM (Batch/Lot Number: EN6201) at the age of 68-year-old; as single dose for covid-19 immunisation.   The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: E29262) on 26Jan2020 01:15 PM, administered in Arm Left for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, glucose tolerance impaired from an unknown date and unknown if ongoing.  Concomitant medications included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (METOPROLOL SUCCINATE) taken for an unspecified indication, start and stop date were not reported; famotidine (FAMOTIDINE) taken for an unspecified indication, start and stop date were not reported.   The patient experienced temperature fluctuations between 98.9 up to 104.2 (normal temp is 97.9) (body temperature fluctuation) (non-serious) on 12Feb2021 with outcome of not recovered, chills (chills) (non-serious) on 12Feb2021 with outcome of not recovered , muscle aches (myalgia) (non-serious) on 12Feb2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included body temperature: temperature fluctuations between 98.9 up to 104.2   on   temperature fluctuations between 98.9 up to 104.2 (normal temp is 97.9).     Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo 10 days after 2nd dose; This is a spontaneous report from a contactable consumer reporting for herself  A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 01Feb2021 at 13:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history were not reported. The patient received first dose of vaccine on Jan2021 at 10:00 pm, on left arm. Concomitant medications were not reported. On an 11Feb2021, 10 days after 2nd dose the patient experienced vertigo. At the time of the reporting the patient had not yet recovered from the events.   Follow-up attempts completed. No further information expected.