chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist regarding an 18 year old male patient. The patient did not have any pertinent medical history or drug reactions or allergies. On 09-APR-2018, the patient was vaccinated with VARIVAX (lot # N028713, expiry date: 13-OCT-2019) (dose not reported) with sterile diluent (manufacturer unknown) subcutaneously for varicella prevention. His concomitant therapies included hepatitis a vaccine, inactivated (manufacturer unknown), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown), influenza virus vaccine (unspecified), hepatitis b vaccine (recombinant) (manufacturer unknown), poliovirus vaccine inactivated (unspecified), meningococcal conj vaccine (unspecified), and tuberculin purified protein derivative. On 12-APR-2018, the patient broke out in varicella rash. The patient sought medical attention. The patient denied any exposure to varicella. On 15-APR-2018, the patient was treated with TYLENOL, BENADRYL and calamine lotion for the events. The patient was not hospitalized but on an unknown date in April 2018, the patient was transferred to medical intensive care unit at the detention center in order to prevent any spread of varicella to other inmates. On an unknown date in April 2018, the patient was tested for Human immunodeficiency virus (HIV) which was negative. The patient recovered from the events on 18-APR-2018. On an unknown date, the patient was discharged and returned to the general population of the detention center. Causality for the events was not reported but the patient considered that he got the event from the shot. Product quality complaint (PQC) was not filed.
This spontaneous report was received from a physician and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (concentration, dose, route and anatomical place of vaccination were not reported) which had the following lots # of M009377 and M011839 with expirations dates of 17-JUN-2017 and 13-SEP-2017 respectively. Which were reported because a data logger and were exposed to 31F for 124 Hours, 51.F 2 hours for 30 minutes and 28.2F for 28.25 hours. This is one of several reports from the same reporter. Additional information has been requested.
2 days ago I had a pain in lower back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 83-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Feb2021 10:00 (Lot number: EN6203, Expiration Date: 30Jun2021) at the age of 83 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Osteoporosis" (ongoing); "Arthritis" (unspecified if ongoing), notes: Caller states Her hands hurt because of arthritis, she goes on to mention she has salve she uses. Caller reports she Osteoporosis. The patient took concomitant medications. The following information was reported: BACK PAIN (non-serious) with onset 25Feb2021, outcome "recovering", described as "2 days ago I had a pain in lower back". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of back pain.  Additional information: The patient stated I had the vaccination a week ago, then 2 days ago I had a pain in lower back." Caller wants to know if she can take Advil. Caller wants to know if the back pain is related to arthritis or the vaccine. Caller states She only take vitamins.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a 80 years old female patient reporting on herself with penicillin allergy, K-flex allergy and morphine allergy. The patient's medical history included carotid artery surgery and shingles in the past. On 05-SEP-2012, the patient was vaccinated SC with a dose of ZOSTAVAX (lot #, dose and site of administration were not provided). No other co-suspects were reported. Concomitant medications included FLUZONE, losartan potassium (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), MAXIDE, simvastatin (manufacturer unknown), naproxen, omeprazole and aspirin. On 06-SEP-2012, the patient experienced that her face was swollen, and her right eye was droopy. She also experienced intermittent numbness on the right hand of her cheek, her tongue, her right arm and right hand. Her skin was itchy at times too. The patient was admitted to a hospital from 07-SEP-2012 to 07-SEP-2012. On an unspecified date, unspecified blood work, electrocardiogram (EKG) and Computerised axial tomography (CAT) was performed (results not provided). The patient sought medical attention by a phone call. At the time of the report, the outcome of her skin was itchy, intermittent numbness on the right hand of her cheek, her tongue, her right arm and right hand, her right eye was droopy and face was swollen was reported as not recovered/not resolved. Additional information has been requested.
Pt complains of numbness and tingling in arm with limited range of motion. Still warm. Pt reports arm hurt for 2 weeks.
Pt developed chills and shivering that started at 21:00 and continued all night.
I can scape my self lightly and eventually get Welt if I scratch it I would get more welts just from a small cut; my skin is also red and very itchy
Information has been received from a physician and a 29-year-old female with no drug reactions / allergies and with a history of rubella, measles and chickenpox and a history of pneumonia at 1-year of age, who on 17-APR-2006 was vaccinated with a dose of MMR II. Concomitant therapy included tetanus toxoid and tuberculin purified protein derivatives (MANTOUX SKIN TEST). It was noted that the patient may have previously been vaccinated with rubella vaccine. There were no other concomitant medications. It was noted that the patient became pregnant on approximately 01-APR-2006. Since the time of vaccination, on 17-APR-2006, the patient had a temperature of between 99 and 101 degrees on and off. ON 26-APR-2006, the patient presented to the physician's office. It was noted that she did not know she was pregnant at the time of vaccination. The outcome was reported as not recovered. No lab diagnostic studies were performed. There was no product quality complaint. No other information was available. Additional information has been requested.
Erythema, itching, warmth developed next day and persisted, but improved with Benadryl.
Case number PHEH2014US025047, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 63-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 16 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
Tiredness; joint pain; feeling un well; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration on 16Mar2021 at 1400 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was allergic to cephalexin and zithromax Z-Pak. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not tested positive for COVID-19. On 16Mar2021 at 2100, the patient experienced tiredness, joint pain and feeling unwell. The patient did not receive any treatment for the events experienced. The clinical outcome of the events tiredness, joint pain and feeling unwell was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Very stiff neck muscles, onset 24 hours later. No other physical events to potentially cause this no fever or constipation symptoms. Rx: muscle relaxants.  No fever or constitutional symptoms.
headache on the right side of the head and above the eye; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache on the right side of the head and above the eye) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Milk allergy. Concomitant products included AMLODIPINE for BP raised, CALCIUM CITRATE for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache on the right side of the head and above the eye). At the time of the report, HEADACHE (headache on the right side of the head and above the eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-251199 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up received and contains second dose information
Pt recvd 1st dose of Hep B vax 13DEC89 &later devel a rash, arthritis, fever & fatigue.On 02JAN90 arthritis persisted & pt. tx w/ ibuprofen. F/U lab tests revealed inc SGOT & SGPT;
Dizziness  exactly 7 days after shot.  I NEVER have dizziness.  And suddenly, I am feeling dizzy at time throughout the day.  It's worse when getting up out of a chair or bed, but also feel it when just staying still.   I can still function, but it is strange.  Also: a  day after the second shot (Day 2), I got "sick" for two days  (Day 2 and 3)-- sluggish, exhausted, unable to focus.  Spent two days in bed.  But was fine by Day 4..  Then the dizziness started on Day 8.
Patient had fever, cough, sore throat, shortness of breath, fatigue, chills, headache, and runny nose
Varicella Zoster (shingles) activation on Neck and Face days after Pfizer booster; The patient received third dose/Pfizer booster; The patient received third dose/Pfizer booster; This is a spontaneous report from a contactable physician (patient). A 45-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0183) via an unspecified route of administration, administered in arm left on 27Sep2021 14:15 (age at vaccination 45-year-old and non-pregnant at the time of vaccination) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient's medical history allergy. Concomitant medication was not reported. Historical vaccine included second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3246) via an unspecified route of administration, administered in arm left on 07Jan2021 11:00 AM as DOSE 2, SINGLE for COVID-19 immunisation and the patient also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EK5730) via an unspecified route of administration, administered in arm left on 17Dec2021 02:00 PM as DOSE 1, SINGLE for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19. On 27Sep2021 14:15, the patient received third dose/Pfizer booster. On 30Sep2021 16:00, the patient had varicella zoster (shingles) activation on neck and face 4 days after Pfizer booster. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with Valaciclovir and Gabapentin for the event varicella zoster (shingles) activation on neck and face 4 days after Pfizer booster. The outcome of the event varicella zoster (shingles) activation on neck and face 4 days after Pfizer booster was not recovered.
Experienced numbness in index & middle finger distal phalanx as well as redness; Experienced numbness in index & middle finger distal phalanx as well as redness/right ear was hot and red; Swelling of hypothenar & palm at the base of the index finger.; Index finger was still numb/tingly; Right ear was hot and red; This is a spontaneous report received from a contactable consumer (Patient). A 45-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0150), Solution for injection, via an unspecified route of administration, administered in Arm Right on 09Apr2021 14:00 (at the age of 45-year-old) as single dose for covid-19 immunisation. Medical history included sulfa drugs allergy, neomycin allergy and milk allergy. Concomitant medications included venlafaxine hydrochloride (VENLAFAXINE HYDROCHLORIDE), cranberry (CRANBERRY), loratadine (LORATADINE), ergocalciferol (VIT D). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since vaccination. On 10Apr2021 at 07:30, the patient experienced numbness in index and middle finger distal phalanx as well as redness and swelling of hypothenar and palm at the base of the index finger. Started the day after the 1st vaccination. Right ear was hot and red on the day after the vaccination as well. Swelling and redness stopped 2 days after vaccination. Middle finger was numb for 1 week. Index finger was still numb/tingly. No treatment was received to treat adverse events. The outcome of event experienced numbness in index and middle finger distal phalanx as well as redness, right ear was hot and red and Index finger was still numb/tingly was not recovered, experienced numbness in index and middle finger distal phalanx as well as redness/right ear was hot, red and swelling of hypothenar and palm at the base of the index finger was recovered on 11-Apr-2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
rash all over his body; This is a spontaneous report from a contactable nurse (patient's spouse). An 80-year-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular at the age of 80-years-old, administered in Arm Left on 17Feb2021 13:30 (Lot Number: EN6201) as a single dose for COVID-19 immunization. Medical history included recently, the patient had retinal detachment and had surgery for that on 18Jan2021, then he had to go back 26Feb2021 to have surgery on the same eye, he has a pacemaker. Concomitant medication included unspecified eye drop. The patient previously received bnt162b2 (BNT162B2), dose 1 intramuscular at the of 80-years-old, administered in Arm Left on 29Jan2021 11:00 (Lot Number: EL9263) as a single dose for COVID-19 immunization. The patient experienced rash all over his body on 19Feb2021. Reporter's husband (patient) has a rash all over his body. The rash has not bothered him. Reporter noticed the rash 3 days after he received the second dose, clarified as she noticed the rash 2 days after he received the second dose. Reporter just happened to walk into the room while patient's shirt was off. She was like "Oh my goodness, what is that." She has looked a couple of more times at patient's rash. After patient first gets out of the shower, his rash is more pronounced. She is not sure if it is because of the warm water or washing up that makes it more pronounced. She can run her hand over the rash and still feel it. The rash had gotten slightly better. Reporter stated that the rash has not concerned her until it has not gone away. Reporter is trying to decide whether or not to take patient to the doctors office since the rash has not went away. The outcome of the event rash was unknown. The event was considered as serious (medically significant).; Sender's Comments: Based on available information, a possible contributory role of  subject product, BNT162B2 vaccine cannot be excluded for the reported event of  rash, based on temporal relationship and the known product safety profile. There is very limited information provided in this report.  This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt received GARDASIL #2 on 7/10/09.  No complaints at visit.  Phone call to clinic Mon 7/13/09 08:10am.  Pt reported to RN pains swelling and unable to move (L) arm, neck (L) side, pain to back area since 7/11/09 sat.  Appt @ clinic 7/14/09 Pt states also felt short of breath sat 7/11/09 along with pain back, neck, arm.  Shortness of breath went away, + weakness + pain (L) arm + (L) neck.  No edema no erythema.  Recommended ibuprofen 600g massage, heat.
This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a 63-year-old female patient who received SHINGRIX (batch number 79N59, expiry date 30th January 2020). Concurrent medical conditions included skin cancer. Concomitant products included Vitamin B12 injection. On 1st February 2018, the patient received SHINGRIX (intramuscular). In February 2018, less than a month after receiving SHINGRIX, the patient experienced Guillain Barre syndrome (serious criteria hospitalization, disability, GSK medically significant and other: as per reporter) and sores lip (serious criteria hospitalization, disability and other). On an unknown date, the outcome of the Guillain Barre syndrome and sores lip were unknown. The reporter considered the Guillain Barre syndrome and sores lip to be probably related to SHINGRIX. Additional details were reported as follows: The patient answered a question concerning her immune system as having skin cancer. The patient received SHINGRIX on left arm. Within 4 weeks of vaccination, the patient received B12 shot. The healthcare professional had no further details at time of reporting. The pharmacist stated he would let the pharmacist who had administered the vaccine to the patient, make the decision whether to provide his details. The reporter might call back with additional details.
About 20 days after the second Moderna Covid-19 vaccine Pt started with acute arthralgias, myalgias, and extreme fatigue. Treated with Hydroxychloroquine 200 mg, B complex and Traumeric.
Arm soreness at injection site; This is a spontaneous report from a non-contactable consumer or other non hcp.  A 28-years-old female (not pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3247) via an unspecified route of administration on 28Jan2021 13:45 as 1st dose single for covid-19 immunisation.  Medical history was not reported. The 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 was not tested for COVID-19 since the vaccination. Concomitant medications included spironolactone (SPIRONOLACTONE) 100 mg. On 28Jan2021 09:00, the patient experienced arm soreness at injection site. The outcome was recovered.    No follow up attempts are possible. No further information is expected.
Second dose schedule 49 days later; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose schedule 49 days later) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included TETANUS VACCINE from 29-Mar-2021 to an unknown date, LEVOTHYROXINE and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose schedule 49 days later). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose schedule 49 days later) outcome was unknown.            No treatment medication was reported by the reporter.   This case was linked to MOD-2021-060938 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received: contains NNI, thyroid medication and dose number was added from the initial
Severe nausea, severe body aches (lower), severe kidney pain, weakness, chills, sweats, fatigue, low grade fever for 48 hours.
Menstrual cycle has dramatically changed.  Unexpected one time bleeding occurred five days before cycle and again three days before cycle.   This month I am 5 days late on my period, which has never happened. Took a pregnancy test today and results are negative.
Patient slumped over almost immediately after receiving her first covid vaccination.  She was unresponsive but breathing and hearbeat for 30-45 seconds.  At that point she became responsive and asked for water.  We gave her bottled water and some candy.  She sat for about 20 minutes and appeared alright.  Her mother was present and said that the patient has had this type of reaction before.  She also said that the patient hadn't eaten or drank much previously during the day.  It was in the high ninties outside.  The mother said that she would make sure that the patient ate something when she got home and she would be home with her all day.
Pt. stopped in today to notify us of a continued sore arm in the spot of vaccine, no redness or other rxn just off and on soreness -> recommended heating pad and massage and follow-up with PCP if necessary.
1/13/21 had pain in R arm and employee woke up 1/14 with cramping, chest pain and feeling of heaviness from belly button down to the legs. Advised to go to the EC for evaluation. Update 1/15: Seen in ED and had EKG with inverted T wave. Still has heaviness in legs. Will get a referral to cardiology after speaking with PCP.