chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye pruritus, Eye swelling, Fatigue, Feeling hot
Clinical narrative: eyes irritated; left arm a red lump that's been red and warm to touch/the spot where they gave vaccine is swollen with large, hot, red, hard lump; left arm a red lump that's been red and warm to touch/the spot where they gave vaccine is swollen with large, hot, red, hard lump; left arm a red lump that's been red and warm to touch/the spot where they gave vaccine is swollen with large, hot, red, hard lump; numbness in both arms left and right(from elbow down)/arms from the elbow down were completely numb, states if felt like they were asleep, like the tingly numbness; tiredness/tired; both of her arms from the elbow down were completely numb, states if felt like they were asleep, like the tingly numbness; itching/eyes were irritated, itchy and swollen; swollen/ her eyes were irritated, itchy and swollen; left arm a red lump that's been red and warm to touch/the spot where they gave vaccine is swollen with large, hot, red, hard lump; This is a spontaneous report from a contactable consumer. This 23-year-old female consumer (patient) reported that she received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EL9265) as SINGLE DOSE for covid-19 immunisation. Medical history included polycystic ovaries from an unknown date and unknown if ongoing. Concomitant medication included metformin (METFORMIN) taken for polycystic ovaries from 2018 and ongoing. Patient reported side effects after the first dose of the Pfizer vaccine. She experienced "numbness in both arms left and right (from elbow down), tiredness, eyes irritated, itching and swollen, left arm a red lump that's been red and warm to touch since Saturday. The second dose, should I get?" Caller wants to report the side effects from vaccine, clarifies the Covid vaccine. States she received the vaccine on Friday, 29Jan2021 at 9:05AM. Caller states both of her arms from the elbow down were completely numb, states if felt like they were asleep, like the tingly numbness, that she was tired, her eyes were irritated, itchy and swollen, and the spot where they gave vaccine is swollen with large, hot, red, hard lump. States she got the vaccine in her left arm. Caller would like some information about these side effects. NDC and Expiration date are unknown. Caller declined to provide HCP information. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events injection site redness, Feeling hot, Limb mass was not recovered for events itching/eyes were irritated, itchy and swollen, swollen/ her eyes were irritated, itchy and swollen, Injection site swelling, Paraesthesia was unknown for event tiredness was recovering and for events numbness in both arms left and right(from elbow down)/arms from the elbow down were completely numb, states if felt like they were asleep, like the tingly numbness, eyes irritated was recovered.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling, Limb mass, Paraesthesia
Clinical narrative: eyes irritated; left arm a red lump that's been red and warm to touch/the spot where they gave vaccine is swollen with large, hot, red, hard lump; left arm a red lump that's been red and warm to touch/the spot where they gave vaccine is swollen with large, hot, red, hard lump; left arm a red lump that's been red and warm to touch/the spot where they gave vaccine is swollen with large, hot, red, hard lump; numbness in both arms left and right(from elbow down)/arms from the elbow down were completely numb, states if felt like they were asleep, like the tingly numbness; tiredness/tired; both of her arms from the elbow down were completely numb, states if felt like they were asleep, like the tingly numbness; itching/eyes were irritated, itchy and swollen; swollen/ her eyes were irritated, itchy and swollen; left arm a red lump that's been red and warm to touch/the spot where they gave vaccine is swollen with large, hot, red, hard lump; This is a spontaneous report from a contactable consumer. This 23-year-old female consumer (patient) reported that she received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EL9265) as SINGLE DOSE for covid-19 immunisation. Medical history included polycystic ovaries from an unknown date and unknown if ongoing. Concomitant medication included metformin (METFORMIN) taken for polycystic ovaries from 2018 and ongoing. Patient reported side effects after the first dose of the Pfizer vaccine. She experienced "numbness in both arms left and right (from elbow down), tiredness, eyes irritated, itching and swollen, left arm a red lump that's been red and warm to touch since Saturday. The second dose, should I get?" Caller wants to report the side effects from vaccine, clarifies the Covid vaccine. States she received the vaccine on Friday, 29Jan2021 at 9:05AM. Caller states both of her arms from the elbow down were completely numb, states if felt like they were asleep, like the tingly numbness, that she was tired, her eyes were irritated, itchy and swollen, and the spot where they gave vaccine is swollen with large, hot, red, hard lump. States she got the vaccine in her left arm. Caller would like some information about these side effects. NDC and Expiration date are unknown. Caller declined to provide HCP information. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events injection site redness, Feeling hot, Limb mass was not recovered for events itching/eyes were irritated, itchy and swollen, swollen/ her eyes were irritated, itchy and swollen, Injection site swelling, Paraesthesia was unknown for event tiredness was recovering and for events numbness in both arms left and right(from elbow down)/arms from the elbow down were completely numb, states if felt like they were asleep, like the tingly numbness, eyes irritated was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid-19 2 weeks after 1st dose; Tested positive for Covid-19 2 weeks after 1st dose; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced tested positive for covid-19 2 weeks after 1st dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.  Information about Lot and batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: post injection moderate increase in tinnitus noted about 5-7 days later and currently unresolved; increase in hearing difficulty due to tinnitus ongoing; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1284) via unknown route of administration on 31Dec2020 08:30 AM at single dose in right arm for COVID-19 immunization at Hospital. Medical history included hearing loss and ongoing tinnitus. Allergies to medications, food, or other products included penicillin, sulfa, levoquin. The patient was not pregnant at time of vaccination. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant other medications the patient received within 2 weeks of vaccination included multivitamin. It was reported as post injection moderate increase in tinnitus noted about 5-7 days later in Jan2021 and currently unresolved. Also increase in hearing difficulty due to tinnitus ongoing in Jan2021. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse events. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Tongue discomfort
Clinical narrative: her mouth and lips begin to tingle and her tongue feels like she has eaten something hot an burned it; her mouth and lips begin to tingle and her tongue feels like she has eaten something hot an burned it; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (Solution for injection, Lot# EL9264), via intramuscularly on 29Jan2021 11:40 at single dose in the upper right arm for covid-19 immunization. Medical history included ongoing blood pressure abnormal, ongoing Vitamin supplementation, Complete Hysterectomy and ongoing blood thinning. A long time ago she had a reaction to flu shot and has not had any reactions to ones she has received 2-3 years since. Manufacturer, dose, lot and expiration are unknown. She just got the flu from it. She had Polio when she was younger, and she was concerned. Concomitant medication included estrogens conjugated (PREMARIN), on an unknown date in 1983 at 0.3 mg, daily for Complete Hysterectomy, and reported as, taking it for 30 years at smallest dose. If she does not take it, she has migraine headaches, lisinopril at 20-25mg, once daily for Blood pressure and reported as taken it for quite some time, vitamin d3, vitamin c [ASCORBIC ACID] and zinc at 1 DF, daily for Vitamin supplementation and reported as started 6 months ago to build immune system, when everything started coming out about COVID, acetylsalicylic acid (COATED ASPIRIN) 81 mg, every other day for Blood thinning and reported as takes it because at one time they thought she had a blockage, but she did not. The patient previously took Penicillin, Biaxin, Crestor, Sulfa drugs, adhesive tape and experienced drug hypersensitivity. No manufacturer for Penicillin and sulfa drugs. She does not have a lot or expiration for any of them. Received call from consumer regarding the Pfizer COVID vaccine. On 29Jan2021 12:15, Friday and her mouth and lips begin to tingle. "It was like her tongue had eaten something hot and felt like how you burn your tongue." Saturday, it was not any different. She took Benadryl and it was still the same way. She wondered if she had a reaction to the vaccine. She did talk to family doctor and he told her to take Benadryl, Tylenol and drink fluid. He still recommended she take second vaccine. Benadryl dose was 25 mg, Lot P115109, Expiration May2022. It was sealed and intact. She would be willing to send a sample. Therapeutic measures were taken as a result of her mouth and lips begin to tingle and her tongue feels like she has eaten something hot an burned it. The outcome of the events was not recovered.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Feeling abnormal
Clinical narrative: king size belly ache; pooped all over herself; weak and too through; severe diarrhea; This is a spontaneous report from a contactable consumer (patient, self-reported) via medical information team. A 82-year-old female received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262, expiry dates not provided, NDC#; unknown), via an unspecified route of administration, in arm left, on 27Jan2021 14: 00, as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were none. It was reported that the patient experienced severe diarrhea on an unknown date in 2021, also reported that She got a king size belly ache the following Saturday and pooped all over herself. She is weak and too through; all events on 30Jan2021. The outcome of the event diarrhea was unknown and other events were recovering.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Vaccination site pain
Clinical narrative: Tingling and numbness of tongue about 2 hrs after injection; Tingling and numbness of tongue about 2 hrs after injection; Soreness at site of injection for 1 day; This is a spontaneous report from a contactable consumer reported for an adult male patient of an unspecified age that he started to receive bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration from 26Jan2021 to 26Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Jan2021 the patient experienced tingling and numbness of tongue about 2 hrs after injection (paraesthesia oral), tingling and numbness of tongue about 2 hrs after injection (hypoaesthesia oral), soreness at site of injection for 1 day (vaccination site pain). The action taken in response to the events for bnt162b2 was not applicable. The outcome of the event was reported as recovered.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Severe night sweats; body aches; low grade temps continuing growth off and in; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231), via an unspecified route of administration (left deltoid) on 09Jan2021 at single dose, for COVID-19 immunization. Medical history included celiacs, hypertension (HTN), thyroid disease, gastrooesophageal reflux disease (GERD), migraines, allergies: celiacs (gluten), and allergies: culturelle. Concomitant medications included levothyroxine and prednisone which was stopped 4 days prior. The patient previously took dilaudid and experienced allergies and received first dose of  bnt162b2 for COVID-19 immunization on 18Dec2020, 13:15, left arm (lot ELO140). On 11Jan2021, the patient experienced severe night sweats, body aches and low grade temps continuing growth off and in since second vaccine. Patient reported to have missed work. This has been going on for 3.5 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab: negative on 27Jan2021. Outcome of events was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality product administered, Product preparation error
Clinical narrative: Sore arm; They reconstituted Pfizer covid vaccine with sterile water instead of the normal saline and administered to 6 patients; They reconstituted Pfizer covid vaccine with sterile water instead of the normal saline and administered to 6 patients; This is a spontaneous report from a contactable pharmacist. This was regarding patient 2 of 6. A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3248, Expiration date: Apr2021, NDC number: 59267-1000-01), via an unspecified route of administration in left arm on 03Feb2021 at 0.3 mL, single for prevention/ COVID-19 immunisation. The patient's medical history and concomitant medications were none. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EJ1686, Expiration date: Mar2021) at 0.3 ml, single dose in left arm for COVID-19 immunisation. Calling about COVID-19 vaccination. Yesterday (03Feb2021) they mistakenly used sterile water as a diluent and administered it to six patients, so she wanted to report that and talk to someone about what needs to be done. Caller states she thinks everyone getting the COVID shot was getting a sore arm on an unspecified date. This was the second dose. Caller wanted to know if they need to revaccinate those 6 patient again, so they are protected. The caller (pharmacist) stated that they reconstituted Pfizer COVID vaccine with sterile water instead of the normal saline and administered to 6 patients. Investigation assessment was none. The events were considered as non-serious by the pharmacist. The outcome of the events was unknown. A causal relationship between bnt162b2 and sore arm was assessed as being related by the pharmacist.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Disorientation, Dizziness, Emotional disorder, Fatigue
Clinical narrative: Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM; Felling Dizzy; Disoriented, Could not finish the drive home due to disorientation; Emotional; Crying; Nausea; Tired; Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in left arm on 04Feb2021 10:30 am at a single dose for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 on 12Jan2021 (at 04:30 PM, Right arm, dose 1) for covid-19 immunisation. The patient experienced felling dizzy (dizziness), disoriented, could not finish the drive home due to disorientation (disorientation), emotional (emotional disorder), crying, nausea, tired (fatigue); all on 04Feb2021 11:00 am and Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM (inappropriate schedule of product administration) on an unspecified date and (off label use) on 04Feb2021 10:30 am. No treatment received for the adverse events (felling dizzy, disoriented, could not finish the drive home due to disorientation, emotional, crying, nausea and tired). All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM (inappropriate schedule of product administration) and (off label use) was unknown and for all events, not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nausea, Off label use
Clinical narrative: Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM; Felling Dizzy; Disoriented, Could not finish the drive home due to disorientation; Emotional; Crying; Nausea; Tired; Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in left arm on 04Feb2021 10:30 am at a single dose for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 on 12Jan2021 (at 04:30 PM, Right arm, dose 1) for covid-19 immunisation. The patient experienced felling dizzy (dizziness), disoriented, could not finish the drive home due to disorientation (disorientation), emotional (emotional disorder), crying, nausea, tired (fatigue); all on 04Feb2021 11:00 am and Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM (inappropriate schedule of product administration) on an unspecified date and (off label use) on 04Feb2021 10:30 am. No treatment received for the adverse events (felling dizzy, disoriented, could not finish the drive home due to disorientation, emotional, crying, nausea and tired). All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM (inappropriate schedule of product administration) and (off label use) was unknown and for all events, not recovered.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blood test, Laboratory test, Limb discomfort, Myalgia
Clinical narrative: Reported after receiving the first COVID-19 Vaccine dose she had muscle pain that lasted about 2 weeks; I couldn't lift my arm for 3 weeks; Exacerbated her arthritis in her left shoulder; This is a spontaneous report from a contactable consumer. A 78-year-old female patient (consumer) received first dose BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, lot number: EJ1284, expiry date: 30Apr2021) via Intramuscular, Arm Left on 12Jan2021 at 13:00 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. States she received her 1st Pfizer vaccine on 12Jan2021. "she couldn't lift her arm for 3 weeks on an unspecified date in Jan2021." When she received her 2nd dose 02Feb2021 the Pharmacist at the vaccinating site told her it was "ok to get her shot subq." Was this ok to not get the injection IM? "she even went back and asked the Pharmacist again if this was allowed and he said yes." Reported she received her first Pfizer COVID-19 Vaccine about 3 weeks ago (clarified as 12Jan2021, between 1:00-1:30PM, intramuscularly, in her left arm). She said she received her second COVID-19 Vaccine dose 2 days ago (clarified as 02Feb2021 between 1:00-1:30PM, subcutaneously, in her left arm). She said the COVID-19 Vaccines were administered by (Speciality pharmacy name). Reported after receiving the first COVID-19 Vaccine dose she had muscle pain that lasted about 2 weeks on 12Jan2021. She clarified she couldn't lift her left arm. She said the first COVID-19 Vaccine exacerbated her arthritis in her left shoulder on an unspecified date in 2021. She said the funny thing was when she received her second COVID-19 Vaccine dose subcutaneously on 02Feb2021, her left shoulder now feels better, like the second COVID-19 Vaccine treated her left shoulder arthritis. Treatment: Reported she started physical therapy for her left shoulder about 2 weeks after getting her first COVID-19 Vaccine shot. Reported she was a healthy individual and takes no medications. Reported she recently had routine blood tests performed. She said she tested for negative for Rheumatoid Arthritis. Outcome of event Muscle pain and Limb discomfort was recovered on an unspecified date in Jan2021, while with other event was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Headache, Underdose, Vaccination site bruising, Vaccination site mass
Clinical narrative: Headache; The needle had not been completely secured; I felt fluid rushing down my arm/solution ran down her arm/It ran to her elbow, she saw a collection of fluid at her elbow/ Two drops of medication leak down her arm; I had a lump on my arm the size of a large jaw breaker in my arm/hard lump at injection site/she had a hard lump the size of a large jawbreaker for about 5 hours; bruising at the site; This is a spontaneous report from a  contactable  consumer  reporting for herself and a nurse.    A 82-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine, via an unspecified route of administration in the left arm  on 29Jan2021 13:30 at single dose  for Covid-19 immunisation .  Medical history included anticoagulant therapy , bone disorder, vitamin D deficiency (vitamin supplementation), probiotic therapy, rhinorrhoea, lung congestion, dry eye .  Concomitant medication included acetylsalicylic acid (ASPIRIN 81), calcium carbonate, colecalciferol (CALCIUM 500+D3), colecalciferol (D3), ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS), bifidobacterium infantis (ALIGN) , guaifenesin (MUCINEX), macrogol 400, propylene glycol (SYSTANE), metronidazole (METRONIDAZOLE).  The patient experienced the needle had not been completely secured  on 29Jan2021 with outcome of unknown ,  felt fluid rushing down her arm/solution ran down her arm/it ran to her elbow, she saw a collection of fluid at her elbow/ two drops of medication leak down her arm  on 29Jan2021 with outcome of unknown , i had a lump on my arm the size of a large jaw breaker in my arm/hard lump at injection site for about 5 hours  on 29Jan2021 with outcome of recovered , bruising at the site  on 29Jan2021 with outcome of not recovered , headache on 30Jan2021 with outcome of recovered.  The patient took Tylenol for her  headache. The patient stated that states her injection site was already black and blue when she got home and removed the bandage. Adds in her photo her whole shoulder is yellow and it looks jaundiced.  The nurse stated that the incident occurred on Friday 29Jan2021 , so they had multiple different type of syringes and needles that was using to administered and they had a vaccinator who was using a lower lock syringe in which you case you know you have to secure the needle by twisting in to that lower lock and when he went to administer the vaccine to the patient two drops of medication leak down her arm, so of course we are at that point the vaccinator realize the lower lock and that the needle had not been completely secured so we don't know how much vaccine the patient actually received.  Information about Lot/Batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Headache; The needle had not been completely secured; I felt fluid rushing down my arm/solution ran down her arm/It ran to her elbow, she saw a collection of fluid at her elbow/ Two drops of medication leak down her arm; I had a lump on my arm the size of a large jaw breaker in my arm/hard lump at injection site/she had a hard lump the size of a large jawbreaker for about 5 hours; bruising at the site; This is a spontaneous report from a  contactable  consumer  reporting for herself and a nurse.    A 82-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine, via an unspecified route of administration in the left arm  on 29Jan2021 13:30 at single dose  for Covid-19 immunisation .  Medical history included anticoagulant therapy , bone disorder, vitamin D deficiency (vitamin supplementation), probiotic therapy, rhinorrhoea, lung congestion, dry eye .  Concomitant medication included acetylsalicylic acid (ASPIRIN 81), calcium carbonate, colecalciferol (CALCIUM 500+D3), colecalciferol (D3), ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS), bifidobacterium infantis (ALIGN) , guaifenesin (MUCINEX), macrogol 400, propylene glycol (SYSTANE), metronidazole (METRONIDAZOLE).  The patient experienced the needle had not been completely secured  on 29Jan2021 with outcome of unknown ,  felt fluid rushing down her arm/solution ran down her arm/it ran to her elbow, she saw a collection of fluid at her elbow/ two drops of medication leak down her arm  on 29Jan2021 with outcome of unknown , i had a lump on my arm the size of a large jaw breaker in my arm/hard lump at injection site for about 5 hours  on 29Jan2021 with outcome of recovered , bruising at the site  on 29Jan2021 with outcome of not recovered , headache on 30Jan2021 with outcome of recovered.  The patient took Tylenol for her  headache. The patient stated that states her injection site was already black and blue when she got home and removed the bandage. Adds in her photo her whole shoulder is yellow and it looks jaundiced.  The nurse stated that the incident occurred on Friday 29Jan2021 , so they had multiple different type of syringes and needles that was using to administered and they had a vaccinator who was using a lower lock syringe in which you case you know you have to secure the needle by twisting in to that lower lock and when he went to administer the vaccine to the patient two drops of medication leak down her arm, so of course we are at that point the vaccinator realize the lower lock and that the needle had not been completely secured so we don't know how much vaccine the patient actually received.  Information about Lot/Batch number has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: prolonged numbness in left pinky finger and occasionally the adjacent finger/first noticed this on left shoulder/numbness radiated to shoulder maybe once or twice, but has been more prolonged in pinky finger; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on 26Jan2021 at 15:45 pm (at the age of 28-years-old) on left arm at single dose for covid-19 immunisation. Medical history was none. No Known allergies. Allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included linoleic acid (CLA), l-carnitine [levocarnitine] (L-CARNITINE [LEVOCARNITINE]), cocos nucifera oil (MCT OIL [COCOS NUCIFERA OIL]) as dietary supplements. The patient reported that, I noticed mild numbness on my left side the same night I had received the vaccine on 26Jan2021 at 20:00 PM. This has quickly faded over the course of the next day, however a week later (about 2 days prior this submission) I noticed prolonged numbness in my left pinky / sometimes adjacent finger. On occasion (once or twice) I have felt slight pain in my left shoulder and left foot. Pinky finger is currently still numb. I am unsure if I pulled a nerve while exercising or if this is an adverse reaction to the Pfizer Covid vaccine. He will be scheduling a checkup with his PCP to get a diagnosis, but informed me as his manager and I'm hereby reporting it as an adverse event. The event was considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was not recovered from the event.  Information about lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Joint swelling
Clinical narrative: finger joints swollen stiff; finger joints swollen stiff; joint painful; This is a spontaneous report from a contactable other-HCP for herself (non pregnant). A 59 year old female patient received first dose BNT162B2 (Solution for injection, lot_number:EL3246) via an left hand of arm on 15Jan2021, at single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After vaccination Patient experienced finger joints swollen stiff and painful on 18Jan2021. Facility most recent COVID-19 vaccine was administered at Hospital. Due to event doctor or other healthcare professional to visit the clinic. There was no treatment for the events. The event outcome was not recovered.  Information on Lot/Batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Was scheduled to have Moderna vaccine which is given 28 days apart however, when they went to the vaccination center they received Pfizer BioNtech Covid 19 Vaccine which is 21 days apart; This is a spontaneous report from a Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 12Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced was scheduled to have moderna vaccine which is given 28 days apart however, when they went to the vaccination center they received pfizer biontech covid 19 vaccine which is 21 days apart (inappropriate schedule of product administration) on an unspecified date. There was not treatment received for the adverse events. The events were considered as non-serious by the other healthcare professional. The outcome of the event was reported as unknown. Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Chest discomfort, Dizziness, Head discomfort
Clinical narrative: Light-headed; Pressure in my chest; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Arm was sore; Had light headache; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982) via an unspecified route of administration on 22Jan2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]) taken daily. The patient experienced light headedness and pressure in her chest that went to her left shoulder and jaw. Patient had light headache, pain in chest, and pain in jaw. She woke up this morning feeling better but still had slight pain in jaw. Wondering if side effects are from vaccine and will she be ok. Patient stated, "I have the first dose of the vaccine on 22Jan2021, I didn't have any side effect, my arm was sore but nothing big. But yesterday I feel light headed, like pressure in my chest, kind of pressure on my jaw and shoulder, my left shoulder, and my vitals were okay like my blood pressure, my heart rate and everything was normal. Further she explained this morning I felt better I didn't have pressure on my chest or anything but the pressure on my jaw that go up to my head. Is that related to the vaccine or is something that I have to worry about?" Consumer stated, "The second one is going to be on 12Feb2021, this Friday." Patient stated, "No, I was calling because today I feel better, I don't have the pressure on my chest. But I still have the pressure on my jaw and on my kind of my head. But no I have not called anybody. It's not like an emergency, I am calling because I was not sure about this is related to the vaccine." For treatment consumer stated, "No, today I took some Tylenol, that's all." No investigation assessment. The outcome of the event 'Light-headed' was recovering, the patient recovered from the event 'Pressure in my chest' on an unspecified date, was not recovered form Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head and was unknown for other events.  No follow-up attempts needed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Pain in extremity, Pain in jaw
Clinical narrative: Light-headed; Pressure in my chest; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Arm was sore; Had light headache; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982) via an unspecified route of administration on 22Jan2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]) taken daily. The patient experienced light headedness and pressure in her chest that went to her left shoulder and jaw. Patient had light headache, pain in chest, and pain in jaw. She woke up this morning feeling better but still had slight pain in jaw. Wondering if side effects are from vaccine and will she be ok. Patient stated, "I have the first dose of the vaccine on 22Jan2021, I didn't have any side effect, my arm was sore but nothing big. But yesterday I feel light headed, like pressure in my chest, kind of pressure on my jaw and shoulder, my left shoulder, and my vitals were okay like my blood pressure, my heart rate and everything was normal. Further she explained this morning I felt better I didn't have pressure on my chest or anything but the pressure on my jaw that go up to my head. Is that related to the vaccine or is something that I have to worry about?" Consumer stated, "The second one is going to be on 12Feb2021, this Friday." Patient stated, "No, I was calling because today I feel better, I don't have the pressure on my chest. But I still have the pressure on my jaw and on my kind of my head. But no I have not called anybody. It's not like an emergency, I am calling because I was not sure about this is related to the vaccine." For treatment consumer stated, "No, today I took some Tylenol, that's all." No investigation assessment. The outcome of the event 'Light-headed' was recovering, the patient recovered from the event 'Pressure in my chest' on an unspecified date, was not recovered form Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head and was unknown for other events.  No follow-up attempts needed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: husband had chills and nausea after the first dose; husband had chills and nausea after the first dose; This is a spontaneous report from a contactable consumer (patient herself)  male patient of an unspecified age received first dose of bnt162b2  (PFIZER-BIONTECH COVID-19 Vaccine ,Formulation : Solution for injection)dose 1 via an unspecified route of administration on an unspecified date 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 husband had chills and nausea after the first dose (chills) , husband had chills and nausea after the first dose on an unspecified date and The events were considered as non-serious by the other healthcare professional. The outcome of the events was unknown.  No follow-up attempts are needed. No further information expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hot flush
Clinical narrative: Severe fatigue; headache; chills; hot flashes; This is a spontaneous report from a non-contactable other healthcare professional. A 31-year-old (age at the time of vaccination was 31-year-old) male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via intramuscular route of administration on 03Feb2021 12:00 PM at single dose in right arm for COVID-19 immunisation at clinic. The patient medical history and concomitant medications were not reported. It was reported that the patient had not received COVID prior vaccination. The patient experienced severe fatigue onset 24 after receiving shot on 04Feb2021; duration 48 hours. Included headache, chills, and hot flashes on 04Feb2021. Treatment was not received for adverse events. No other vaccine in four weeks. The patient was not tested for COVID post vaccination. The outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: stuffy nose; body aches; sore throat; swollen glands in the throat; general not feeling well; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL-9265), intramuscular in left arm on 04Feb2021 at 04:30 PM at single dose for COVID-19 immunization in pharmacy or drug store. Medical history included penicillin allergy. Concomitant medications included bupropion, buspirone and several different vitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL-1283) in left arm on 14Jan2021 at the age of 42 years for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced stuffy nose, body aches, sore throat, swollen glands in the throat, general not feeling well on 05Feb2021 at 05:00 AM. No treatment was received for the adverse events. Patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Influenza like illness, Insomnia, Nausea
Clinical narrative: Fever; Chills; Achiness; nausea; flu-like symptoms; waking up over night; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), on Left upper arm via an unspecified route of administration on 27Jan2021 2:30/3 PM at single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient previously took first dose (lot number: EJ1685, EXP: 31Mar2021) at 4:30 PM for covid-19 immunisation. Caller says she got this number from the pamphlet that was given to her when she gotten her first dose of the Pfizer COVID Vaccine. She got the second dose yesterday. Early this morning (around 2 or 3 AM this morning 28Jan2021) in the middle of the night she started having flu-like symptoms. She was calling to make sure to report them and she wanted to know if it was okay to take Tylenol. She cannot remember if the people who gave her the vaccine said if she could take Tylenol if she needs it. She had a fever this morning of 100.6. She also has chills and achiness. She volunteers at a healthcare facility, which is where she got the vaccine. She will call them about it. Got the second dose yesterday 27Jan2021. She kept waking up overnight and could not get warm. She just was unable to get warm. It was early this morning. She had went to be around 11:30 PM and felt perfectly fine. She tried to drink OJ and keeps trying to drink lots of water. She ate some protein, some cheese. She was concerned not to eat because she did not want to counter balance the nausea and it get worse. She had a tinge of nausea this morning. Outcome of the events nausea and flu-like symptoms was unknown, Outcome of the event waking up over night was recovering. Outcome of the other events was not recovered.   Information on the Lot/Batch number has been requested
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever; Chills; Achiness; nausea; flu-like symptoms; waking up over night; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), on Left upper arm via an unspecified route of administration on 27Jan2021 2:30/3 PM at single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient previously took first dose (lot number: EJ1685, EXP: 31Mar2021) at 4:30 PM for covid-19 immunisation. Caller says she got this number from the pamphlet that was given to her when she gotten her first dose of the Pfizer COVID Vaccine. She got the second dose yesterday. Early this morning (around 2 or 3 AM this morning 28Jan2021) in the middle of the night she started having flu-like symptoms. She was calling to make sure to report them and she wanted to know if it was okay to take Tylenol. She cannot remember if the people who gave her the vaccine said if she could take Tylenol if she needs it. She had a fever this morning of 100.6. She also has chills and achiness. She volunteers at a healthcare facility, which is where she got the vaccine. She will call them about it. Got the second dose yesterday 27Jan2021. She kept waking up overnight and could not get warm. She just was unable to get warm. It was early this morning. She had went to be around 11:30 PM and felt perfectly fine. She tried to drink OJ and keeps trying to drink lots of water. She ate some protein, some cheese. She was concerned not to eat because she did not want to counter balance the nausea and it get worse. She had a tinge of nausea this morning. Outcome of the events nausea and flu-like symptoms was unknown, Outcome of the event waking up over night was recovering. Outcome of the other events was not recovered.   Information on the Lot/Batch number has been requested
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Heart rate, Heart rate increased
Clinical narrative: Rapid Heart Rate - between 120-150bpm for more than 6hrs; diarrhea; This is spontaneous report received from a contactable consumer (patient herself). A 29-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL3248) via an unspecified route of administration on left arm on 14Jan2021 06:45 at Single Dose and then second dose via an unspecified route of administration (lot number: EL3248) on left arm on 03Feb2021 06:45 at Single Dose for COVID-19 immunisation. Medical history included hypothyroidism and COVID.  Concomitant medication included levothyroxine and unspecified Birth control (received within two weeks of vaccination). The patient previously took cefaclor (CECLOR), amoxicillin sodium/ clavulanate potassium (AUGMENTIN) and experienced known allergies with both. It was reported that, the patient experienced rapid heart rate between 120-150bpm for more than 6hrs in 2021. Went to the ER (Emergency Room). Beta blocker was given to lower heart rate. This started about 6hrs after vaccine was administered. Also had diarrhea for 3 days after vaccination. The patient had COVID-19 prior to the vaccination. The patient not tested for COVID post vaccination. The outcome of the event diarrhea was recovered in 2021 whereas recovering for another event.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer reported for herself. A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number Batch/Lot number was not reported, via an unspecified route of administration on 24Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and Concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient experienced shingles (herpes zoster) on 26Jan2021. Outcome of the event was recovered. The reporter considered the events as non-serious.   Information on the lot/batch number has been requested.