chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; tired; achy; felt crappy/Felt very lousy; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EL9269) via an unspecified route of administration on 11Feb2021 at 10:45 (at the age of 80-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included osteoporosis, arthritis, high blood pressure, eyesight problems, heart murmur, and known allergies to shrimp and lobster, all from unspecified dates and unspecified if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications ("other medications in two weeks") included metoprolol succinate taken for an unspecified indication from an unspecified date at 100mg and ciclosporin (RESTASIS; eye drops) taken for an unspecified indication from an unspecified date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Feb2021 the patient experienced headache, tired, achy and felt crappy/felt very lousy. The clinical course was reported as follows: "All good for 4 hours, then tired, achy, felt crappy, slight headache. Continued to next day, sometimes better, other times much worse. Third day still headache. Thought this would not happen after the 1st dose. Felt very lousy." The patient did not receive treatment for the adverse events. The clinical outcomes of the events headache, tired, achy and felt crappy/felt very lousy were all recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Developed shortness of breath within 12hrs of 2nd Moderna dose along with heart palpitations and nausea. Admitted to hospital 3 days after shot and quickly developed pnemonia and died 4 days later after blood O2 fell below 80%. Had periods of mild improvements followed by more severe declines each time.
This spontaneous report was received from a pharmacy technician concerning  an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, lot # L023592, expiration date 26-JUN-2016, for prophylaxis (dose number and route of administration were unknown). The temperature reported was -1 C and the time frame was 21 days. A digital data logger was involved.  No previous temperature excursions were performed and no adverse effects were reported. Additional information has been requested.
I woke the morning after I got the shot with soreness to touch the area of the injection site, there was about 3-4" diameter red spot around site, it was hot and hard. The 2nd day was the same. The 3rd day the hardness went away, it was a little less red, it was a little less sore to the touch, but it itched unmercifully. Tylenol did not help, ibuprofen did not help, ice did not help,  Young Living Panaway essential oil took the itch away completely. Today is day 4, it is still a still sore to the touch, it is pink not red, the hardness has gone away, it is still itchy, the Panaway essential oil still relieves the itch
Rec'd vaccine at 1240, At 1245 began to feel warm and light headed. BP 120/60; AP 68; no resp distress. At 1pm had difficult in swallowing; no resp distress; 25 mg diphenhydramine administered. Contacted personal physician and received orders to observe patient for a short time and for her to "rest at home" and call if any other issues. Patient observed for an additional 30 minutes and walked for 10 minutes with nurse. Called patient the next day and she states she felt fine.
I63.9 - CVA (cerebral vascular accident)  I63.9 - Acute ischemic stroke  R29.810 - Facial weakness R56.9 - Unspecified convulsions
Itchy, red rash around the injection site which lasted 4 days plus burning down her arm and fatigue for 2 days.
Less than 12 hrs pt. had 2.5 x 4 cm induration, erythematous mass (R) thigh and tender. Pt. had fever and fussiness (T greater than 102) x 24-36 hrs. 2nd episode (1st time with Merck vaccine, 1st vaccine this was Sanofi Pasteur, 2nd dose with Some reaction).
suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles).The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient got vaccinated with Shingles vaccine, then got the shingles a few years later.  The reporter further stated that the vaccine was not always the answer.  This case was considered as suspected vaccination failure since the detail regarding primary vaccination schedule and laboratory confirmation of shingles was unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Headache, Fever, BODY ACHES, WEAKNESS, CHILLS Narrative:  Other Relevant History:
COVID-19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 at 11:00 as dose 1, single (Lot number: EL9266), in right arm, on 10Mar2021 at 11:00 as dose 2, single (Lot number: EN6206), in right arm, on 08Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 3013538A), in right arm and on 13Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9896) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Macrodantin, reaction(s): "known allergies: Macrodantin", notes: known allergies: Macrodantin. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "COVID-19 Treatment"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are needed. No further information is expected.
Flushing, dizziness, sweaty hands, bowel movement urgency within first 15 min of getting dose.  Also experienced difficulty focusing/brain fog.  Chills/shaking after 30min/1hr.  Had to take 2 benadryl and 1 aleve upon returning home approximately 10:30am.  Chills/shaking subsided by 11:30am.  Dizziness/confusion/flushing continued throughout day.  Continued taking 2x Ibuprofen 200mg and 50mg benadryl the evening of 12/17/21, as well as the morning and evening of 12/18/21.  Tinitus upon laying down both evening of 12/17/21 and 12/18/21.  December 19th, 1:30am woke up with warm sensation in back of neck and head.  Chills/shaking, warm sensation also in abdomen, fever.
First 2 doses Moderna in March/April 2021. Pfizer 11/19/2021 (booster). I started having irregular menstrual cycles. On 2/25/2022 OB/GYN found a uterine fibroid tumor. I will need surgery to remove. Surgery scheduled to remove on 3/11/2022.
The day of the injection I had lower back pain around the kidney area. Was very itchy at night. In the morning the itching had passed but I ran 100° fever for about 16 hrs. on the day after the injection. Was weak & couldn't stand without feeling like I was going to pass out. Felt nauseated when I did stand. Only able to sleep all day. 2nd day no more fever but was weak & periodically had to lie down & sleep. ( I hadn't had any reaction to the 1st shot, just the 2nd)
Starting the night of receiving the vaccine, patient began experiencing what was described as a "chicken pox like rash" that spread to her whole body (arms, chest, stomach, back, legs). Rash was described as red rash that presented as pimples that were itchy. The rash has been getting progressively worse over the last 2 days. In addition to the rash, patient felt tired and had a slightly runny nose.
From bottom of my knees all down its swollen; This is a spontaneous report received from a contactable consumer (patient).  A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number  EW0202 and expiration date: not reported), via an unspecified route of administration, on Left arm on 09Jun2021 between 08:30 - 09:00  (at the age of 47-year-old), as 1ST DOSE, SINGLE DOSE, for covid-19 immunization in the emergency room in the clinic.  Medical history included diabetes mellitus. The patient had no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The patient stated that from bottom of her knees all down its swollen on 09Jun2021  at 05:48 (as reported).The patient would like to know long will this last. The  Patient didn't take any treatment however it was also reported that all she had was some grapefruit juice, and Kool-Aid and had some rice. The outcome of the event is unknown.
Admitted 4/5/2021 with severe cdiff pancolitis, severe sepsis, multi-organ failure. DIscharged to hospice on 4/9/2021.
Pt began to have vaginal pruritus same day received the Gardasil vaccine. No discharge or redness or swelling. No fever. Pruritus improved by time seen 2 days later.
Chills fever & headache for 3 hours. Then next day May 1, 2120 body aches like I just had the flu.  & Slept most of the day.
Extreme muscle soreness/inability to move arm. Giant red raised bruising and itchy at injection site. Swollen lymph nodes under armpit. Fever, chills, sweating profusely and very cold the following night. Rash, itching and pain on arm lasted 7 days, swollen armpit lymph nodes lasted 4 days. Fever and chills for 24 hours.
10 days after immunization child developed a rash from head to toe. The initial lesions were hive like, an infuse erythema, they evolved into large lesions with purpuric centers, target lesions. All lesions were densely treated, the child looked grotesque.
I lost 30% of my hair over the summer. I had severe brain fog and short-term memory loss until roughly November. I could not concentrate to read a book. I also had restless leg syndrome which went away around October.
After second shot client complaint of being hot and lightheaded. With her eyes open her head began to shake and lost control of her bladder. Her limbs slightly shook and then she made a snoring noise. Within less than 5 minutes client was alert and orient and declined the ambulance. She did make an appointment with her family doctor for follow up.
Brief period of mental status change, lasting 10 minutes (approx. 3-4 hours post vax). Pt acted as if she didn't know who or where she was. No obvious seizure activity. Resolved on own.
Patient cried after administration.  Later, the area where the injection was given was swollen and hot to the touch.  Parents brought patient back to the doctors office in the evening.
pt recv vax & 2wk p/vax pt devel an autoimmune pancytopenia;presented w/petechiae & inc bruising, which was initially thought to be a typical rash, but then devel anemia, neutropenia & thrombocytopenia;
Received second dose of covid vaccine on 1/26 at 0930, on 1/27 at 0200 experienced fever, chills, body aches/ headache and fatigue. Temp was 100.2, fever and chills lasted until the afternoon on 1/27, headache, bodyaches, and fatigue were resolved upon waking 1/28. No meds were taken.
Redness and swelling left arm 13 cm length. Left arm 21.5 cm circumference, right arm 20 cm circumference.
Info has been received from a CMA concerning a 9 year old white female who on 7/26/96 was vaccinated, SC, with a dose of varicella virus vaccine live. On 5/19/05, the pt was seen in the physician's office and was dx'd with chickenpox. Treatment included calamine lotion and OTC ibuprofen (Motrin). The pt was reported to be recovering as of 5/19/05. There was no further info provided at the time of this report. Additional info has been requested.
Had redness at site of Hepatitis A vaccine right thigh 10/13/16, by 10/14/16 enlarged redness with warmth/hardness to 9 x 7 cm red area. Doctor gave pt cephalexin 250 mg/5cc 1 tsp BID x 10 days. No temp.
Headache for several hours. Increased joint/muscle pain. Slight pain at injection site when touched. Left arm starting locking down, could only raise 90 degrees for about 34-36 hours. Slight swelling under left arm pit. Swollen lymph node on right side of neck under chin for about 1-2 days. Slight fatigue. Rash started with red marks on skin, turning into red bumps (mainly on left arm - started about a week after this injection). No itch to rash, just bumps. They are going down in size, but not gone yet.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. An elderly (age 65 plus) patient of unspecified age ethnicity and gender started to receive PREVNAR 13, via an unspecified route of administration in Aug2017 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced nausea and sick to stomach after receiving PREVNAR 13 in Aug2017. The outcome of the events was unknown.
Significant hives & lip swelling Trmt: BENADRYL 25mg/5ml - 1 tsp po q 6 x3.
pt had sudden onset of tonic & clonic generalized sz 1 day p/vax; they were prolonged-intermittant over 4 hrs;
pt had flu shot 830AM-850 presented to clinic w/ c/o filling up; no SOB but hoarseness & drainage from nose/sinus; no stridor, no swelling,  lung CTA; given DPH;
Pt husband came in pharmacy on Monday Oct 5th and said his wife's arm was still very sore from the vaccine.  he stated she could not lift her arm over her head without experiencing pain and is having difficulty sleeping on arm.  Called pt at her house on Oct 7th and she said they were still having pain and were going to the doctor on the 15th.
A nurse reported that a 14 year old patient received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated on 08/04/00. On 08/06/00, the patient developed redness at the injection site. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Tetanus Diphtheria Toxoids adsorbed, Purogenated.
Pt complained of soreness later that evening post vax and mother noted a "lump" on his arm "about the size of 1/2 an egg." Called physician 03/03/2000 who stated that it sound like a normal reaction.
I completely lost my sense of taste and smell as a result of having COVID-19 illness in early 01/2020.  My sense of taste and smell returned almost immediately when I received my 2nd Moderna vaccine.  Within about 1 minute, I could smell and taste the actual vaccine and was able to smell and taste everything else within a few minutes.  This vaccine actually was my cure for a long-term effect of having the coronavirus.  My arm was sore at the injection site and I was fatigued for a few hours the following day.
Patient was noted to have a generalized erythematous rash on her chest, trunk, and upper exttremities bilaterally.  In addition, mother states that patient was limp and unresponsive for a brief period of time.  Per mother, the patient has previosuly received the Influenza vaccine without any known complications.
Patient received one vial of the two vial Menveo vaccine. Unknown which vial patient received. Patient reports swollen, hot, red, and very itchy reaction at the injection site. MD recommended she take benadryl at night before bed and Zyrtec during the day and ibuprofen for the pain and swelling and to go to urgent care if this does not improve over the next few days.
High fever of 103 Chills with severe shakes severe headache that lasted 3+ days where I could not get up  body ache  pain at injection site 3+ days back pain  severe muscle pain
nausea/completely nauseous; bad headache; felt really sick; arm was also sore; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number, NDC number and Expiry Date were not provided), via an unspecified route of administration on 13Jul2021 at 12:30 in the afternoon as dose 2, single dose for covid-19 immunisation. Patient history he had COVID in December, but she just feels really sick. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, on an unspecified date for covid-19 immunization. She stated that she got her 2nd dose of the Pfizer BioNTech Covid-19 vaccine yesterday 12:30 in the afternoon and on 14Jul2021, she felt really sick around 2 or 3 in the morning of the following day, her arm was also sore, it started out as a bad headache and had progressed to nausea. She took some Advil to relieve the headache, but she is still feeling the side effects of the vaccine. She states that she's just feeling really sick after the second dose. She states she's completely nauseous, she has a bad headache, she just feels really sick. She states she doesn't know what to do. She asked, is it normal to feel nauseous after? she just wanted to know if what she's feeling is normal, she just hates feeling like this. She wanted to know if feeling nausea, bad headache, and feeling unwell are among the commonly reported adverse events after getting the Pfizer BioNTech Covid-19 Vaccine. She confirmed that the product she received and is speaking of was the Pfizer Covid 19 Vaccine. She stated that it was the Pfizer 19, Covid Vaccine number two, she got it done. Reporter seriousness for nauseous, bad headache and just feels really sick was unspecified. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Shortness of breath, fatigue, headache, muscle pain, joint pain, chills, nausea, fever
Moderna COVID-19 Vaccine EUA First 24 hours - headache, tiredness, nausea  Second 24 hours - chills, headache and tiredness continued
Her father got both doses of the vaccine back in January; tested positivefor Covid-19 yesterday; This is a spontaneous report from a contactable consumer patient via sponsored program. A 90-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration on an unspecified date in Jan2021 (Batch/Lot number was not reported), as a single, second dose via an unspecified route of administration on an unspecified date in Jan2021 (Batch/Lot number was not reported) as a single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the patient experienced both doses of the vaccine back in January, tested positive for covid-19 yesterday. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 26Jul2021 tested positive for Covid-19 yesterday. The outcome of the event was reported as unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Felt a bit odd on the couch, little shiver and what felt like adrenaline. I got up and went into the bathroom where the incident occurred. I used to be on 10mg of Ramipril years ago and moved to 5 due to light headedness when standing up. Yellow tinted vision, bright and sparkly. Getting up too fast with heart pressure meds prescribed for albumin /T1D and not for heart pressure. The secondary use of Ramipril is normal for type 1 diabetes after 20+ years. So I went to 5mg and haven?t had that issue since. I should also mention that when this used to happen to me I would lay down and recover with no problem.  Back to the incident it felt exactly like that but on steroids. I was in the bathroom looking for Tylenol and I got light headed, yellow tinted vision, bright and sparkly, ringing in the ears, dizzy, and confused. I remember thinking I should probably get down on the tile floor and lay down like I?m used to from the episodes years ago with 10mg Ramipril causing the same symptoms but never anything so extreme. Next thing I know I?m on the ground waking up where I fainted and hit my head pretty hard on the way down. I probably have a minor concussion. Iced my head in the back where I hit it last night and this morning. Surprisingly 0 bumps, etc other than a little bit sore.  Trying to remember going down is impossible. There is a strange, I guess it?s not strange as I fainted, but to me being 1 moment thinking what I should do then the next moment still thinking that same exact thing but coming to on the bathroom floor with parents yelling over top of me as I was at their house is strange. I recall what almost felt like a dream while I was out but I was wondering why everyone was asking if I was ok, of course I?m ok I thought. Then I realized what happened and crawled around on the floor the rest of the night if I needed anything and was checked every hour through the night which was horrible but necessary.  Also my blood glucose was a 220 at the time of the incident according to my CGM so it didn?t have to do with low blood sugar.  In any case I feel better today but in a fog with a slight headache.
After the patient received the vaccine he developed an area of redness, warmth, and swelling approximately 2.5 inches in diameter that lasted until he presented to our clinic 1 week later. He was advised to take anti-inflammatories, the perimeter of the area was marked and he was advised to seek medical attention if the area grew outside of the marked perimeter of if he developed pain or worsening symptoms. He was seen by an MD who advised him of the same and the area resolved on its own within 2 weeks.
INR was 5.9 / INR was 4.9, INR goal is 2-3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WARFARIN. Vaccination history included: Bnt162b2 (1st dose), administration date: 22Feb2021, for COVID-19 immunisation, reaction(s): "PT-INR was 2.7, and her INR goal is 2-3". The following information was reported: INTERNATIONAL NORMALISED RATIO INCREASED (non-serious) with onset 24Mar2021, outcome "unknown", described as "INR was 5.9 / INR was 4.9, INR goal is 2-3". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient's age was reported as 66, no unit provided. Warfarin was temporarily discontinued and her INR was reported as 4.9 on 26Mar2021. The patient is going again to get it checked on Monday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vomiting, diarrhea, chills, nausea, possible fever 19 hours after vaccination Lasting 2 hours  Fatigue after the above for 12 hours