chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizzy; Nauseous; Headache; Tired; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Aug2021 at 11:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient medical history included COVID-19 respiratory infection from unknown date and allergy to sulfur drug. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and unknown if ongoing. The patient previously received pethidine hydrochloride (DEMEROL) and experienced drug allergy. On 26Aug2021 at 11:00, the patient felt dizzy right after the vaccination and 6 days later still the patient felt nauseous, tired and experienced headache. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy, nauseous, tired and headache was not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Slight fever, cold chills, body aches. Took ibuprofen and slept until 05:00 pm
Soreness at site of injection - not too bad. No other symptoms. On the 15th, I had a loss of taste and smell. That night, I had fever, body aches, chills and headache. I had a loss of taste and smell a good month. I went to urgent care the 15th of January. I tested positive for COVID. Just symptom treatment at home - OTC. The worst of it was about 24 hours long and by the 18th, Monday, I was starting to feel better.
On 3/14 I woke up with a sore arm and burning at the injection site. The injection site also felt hard. On 3/15 I woke up with the injection site being sore and also two red patches on the arm near the injection site.
Locked shoulder joint within 48 hrs after flu shot given. Undergoing physical therapy and prescribed MEDROL DOSE PAK.
Paresthesia of left foot and left hand, along with fatigue, apathy, dysphoria, some myalgias. Normal neurological examination, strength, sensation, reflexes. Symptoms were intermittent and transitory. No specific treatment.
Strong but became subdue headache in the frontal lobe region; Extreme fatigue; Sore left arm and under shoulder blade; Sore left arm and under shoulder blade; Feelings of clinical depression are amplifies compared to prior vaccine; Significant loss of appetite; It feels like I'll vomit if I do; This is a spontaneous report from a contactable consumer or other non hcp. A 25-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot Number: ER8735) via an unspecified route of administration, administered in Arm Left on 25May2021 12:00 pm as dose 2, single for COVID-19 immunisation. Medical history included Clinical depression and Recovering alcoholic (Recovering alcoholic (last drink was Jan31)). Concomitant medications included sertraline hydrochloride (ZOLOFT) and etonogestrel (NEXPLANON). The patient received first dose of BNT162B2 on 27Apr2021 at 12:00 pm (Lot number:EW0173, Left Arm) for covid-19 immunization and experienced Temporary headache in frontal lobe area. 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. On 26May2021 the patient experienced Strong but became subdue headache in the frontal lobe region, Extreme fatigue, Sore left arm and under shoulder blade, Feelings of clinical depression are amplifies compared to prior vaccine, Significant loss of appetite and It feels like Ill vomit if I do. Therapeutic measures were taken as a result of Strong but became subdue headache in the frontal lobe region. The outcome of all the events was resolving. Follow-up attempts are completed. No further information is expected.
Hot flash, tightening to throat, tingling to tip of tongue and lips. Mild to moderate.  Began 5 minutes post injection.  Increased for about 10 minutes, then leveled off but did not resolve.  Seen in ER and given Benadryl 50 mg IV and Solu-Medrol IV, dose of Solu-Medrol not listed on ER visit summary. Observed for about an hour and a half symptoms resolved,and discharged. Rx for  Prednisone 40 mg po x 4 days and Epi pen given.
Stiff and sore neck 01/08/2021  10:00am to approx 2:00pm
was Covid + 2 weeks ago; was Covid + 2 weeks ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 23Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 57 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "was Covid + 2 weeks ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive; (19Jun2022) Negative; (28Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Patient experienced soreness stiffnes to left arm, chills and headaches x 3 days. Patient no longer has symptoms.
On 1/24 I developed a fever, the highest noted was 101.8 however, I did have Tylenol on board. I pre-medicated with Tylenol and continued taking it every 4 to 6 hours for about 40 hours. I also had chills, body aches, nausea, decreased appetite, and headache.
Pt. stated she had to see a MD on Sat., Oct. 24,2009 d/t discomfort in her left arm. Pt. had heat, erythema, and swelling on L arm. Area raised.She states the MD told her she had cellulitis in hr left arm. She states that it is still read and raised and that the upper part is now brown color. She states MD gave her a deadron shot: Rocephin shot, and augmentin antibiotics. She states she has had a low grad fever. 11/04/2009- P/c to pt. today. She states she has recovered & her arm is fine.
On 4/8/21, experienced crushing chest pain.  911 called, EKG findings concerning for STEMI.  Was rushed to cardiac cath lab.  Diagnosed with Takotsubo cardiomyopathy.
This child's right deltoid was red, swollen (entire deltoid), fever of 101, onset within 24 hours.
Excruciating pain in lower back, spasms and pressure. Unable to stand, walk, sit or sleep normally before second shot.
loss of taste and sense of smell; loss of taste and sense of smell; This is a spontaneous report from a contactable other hcp.  A 14-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), via an unspecified route of administration on 17Aug2021 (age at vaccination 14-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Aug2021, the patient experienced loss of taste and sense of smell. The patient was scheduled for 2nd dose of the vaccine on 07sep2021 whereas patient completed the ten days of quarantine. The clinical outcome of the event was unknown.  The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1/8 12:00 vaccination 5:30 I started to notice my body was itching. No rash marking the skin. Itching progressed,  made me nervous because I am allergic to other things and its the same symptoms. As my temperature would change slightly, no fever, but elevated for me I feel uncomfortable. Persisted into the week. Made appt with my immunologist. Put on weeks worth of antihistamines; night and day. It did help and gradually help. The itching lasted for quite a while,  2nd dose was recommended to take a antihistamine before vaccination. No itching with the second dose.  RASS test in a month
I have received both Moderna vaccines.  After the first shot the tinnitus began and only got worse after the second shot.
Body ache; Fever; Chills; This is a spontaneous report from a contactable consumer (patient) via Pfizer- A 45-year-old male patient received First dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN5318 and Expiration Date: 31May2021), via an unspecified route of administration on 05Feb2021 as DOSE 1 SINGLE for covid-19 immunization.  Medical history and concomitant medications were none. Patient was calling because after he got the first dose of the vaccine, the COVID Vaccine. He is experiencing body ache, fever and chills on 10Feb2021. He wanted to know if that is coming from the Pfizer first dose of the vaccine or it was symptom of the COVID virus. Patient stated the chills he do not have that much, the body ache was only when patient stressed and fever went down a little bit, it was 101.7 yesterday and about 100.1 about half an hour ago. The event outcome was unknown.  No follow up attempts are possible. No further information is expected.
Pt was 12 years old at the time of this second COVID vaccine, but was mistakenly administered the Youth Pfizer vaccine. She had received, correctly, the Pfizer adult dose as her first COVID vaccine, on 10/11/21.
patient administered an expired dose of Pentacel/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Agency via call-center (Reference number- 00339146) and transmitted to Sanofi on 30-Oct-2020.  This case involves a 6-months-old female patient who received expired 0.5 mL DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (frequency: once, strength: standard, lot number: UJ065AAA and expiry date: 16-Oct-2020) (expired vaccine used) on 23-Oct-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B) and Menvale (study drug) for prophylactic vaccination.  This site is part of the vaccine study.  It was an actual medication error case due to due expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
10/7/11 1345 employee c/o left deltoid swelling, mottled & tenderness. States it "appears bruised". Advised she ice area & take ibuprofen prn & return to Occ Med clinic Monday 10/10/11 appears IM given in mid-deltoid area.
5 yr. immunizations given 05/08/12 at WCE. C/O H/A. 5/9/12 AM & 'not feeling well'; fever began that afternoon at school & hive patch (Lt) cheek - (resolved before exam). No rashes. Tx with Ibuprofen q6-8 hours. Call for F.U. appt. if s/s increase.
she felt on concrete; face got injured; This spontaneous case was reported by a consumer and describes the occurrence of FALL (she felt on concrete) and FACE INJURY (face got injured) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced FALL (she felt on concrete) and FACE INJURY (face got injured). At the time of the report, FALL (she felt on concrete) and FACE INJURY (face got injured) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Reporter causality updated.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Patient states he fell off chair, but did not strike his head. No aches or pains, no head or spine deformities.
Exactly seven and a half hours after the vaccine, I started to shake uncontrollably, similar to extreme shivering. I then started to feel as though someone injected ice into my veins and tried to sleep with my winter coat on in addition to many blankets, but I was unable to get warm. My arm was in so much pain I could not move or use it from the injection. It was incredibly weak and essentially useless. For the next two days, I had a four-degree fever, my temperature is usually 96.5 and it rose to 100, significant for me. I didn't eat and slept for approximately 48 hours. This lasted for two days then I started to feel better. However a week later, I still don't feel as though I'm at 100%. I have never in my life felt this horrible, it was as if I had a severe flu, I would have gone to the hospital but I was too weak to drive there.
SHORTLY AFTER COMING HOME AROUND 4 PM, PT.STARTED VOMITING SEVERAL TIMES...WONDERED IF THIS WAS A SIDE EFFECT OF COVID VACCINE #2...HAVE NOT RECEIVED TREATMENT...
Pt was diagnosed cellulitis by ER doctor, and pt stated it is due to flu shot.
Patient came in 3/9/17 complaining of arm hurting from flu shot given on 2/11/17. There was a lump from shot (approximately 1" from top of arm/shoulder). Pain was associated with the lump. Patient was advised to go to doctor who referred to orthopedic.
Patient received vaccine on 8/7 and came in on 8/10 with a size of a tennis ball in diameter injection site RXN that was mid tone pink in color with a smaller deep red inj. site. No pain or itching, but started on 8/8 was feeling better but after physical therapy when she laid on that arm the intensity of color increased. Patient called back after an hour saying she took BENADRYL and the color was fading.
Pt. mother, called on Monday, 9/13/2010 and reported on 9/12/10 son had c/o welt to Left arm at injection site area.  Was sore to touch.  Instructed over the phone that it sounded to be in the area of MCV4 injection and to apply cold compress and take 600mg Ibuprofen q 6 hours.  To call MD if not relieved, worsens, or new symptoms appear. 9/14 Dr. office calls to inform that they believe pt. has cellulitis of left upper arm.  Tx with Keflex and Zyrtec. 9/15/10 Called pt. mother.  Reports fever broke through night and arm seems to be improving.  States pt. c/o headache this am.  Instructed to call MD to report headache and provide update.  To return to MD/ER for worsening or new symptoms.  Mom verbalized understanding.
This spontaneous report was received from a medical assistant, referring to a 13 month old patient of an unknown gender. The patient's medical history, concurrent conditions or concomitant medication were not reported. On 30-MAY-2018, the patient was vaccinated with improperly stored doses of Oka/Merck VARIVAX lot # N024568, expiration date 07-SEP-2019 or lot # N029631, expiration date 23-OCT-2019, for prophylaxis (dosage information and route of administration were not informed). Other suspect therapies included MERCK STERILE DILUENT lot # M029682, expiration date 12-JAN-2019. No adverse effects were reported. It was also reported that the temperature and time frame were -14°C to -10°C (-12.7°C) for 20 minutes. There was no previous temperature excursion. A "data logger" was involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1806USA012318: US-009507513-1806USA012317: US-009507513-1806USA012319: US-009507513-1806USA012316.
Herpes flare up; This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (Herpes flare up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Herpes NOS.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES VIRUS INFECTION (Herpes flare up). At the time of the report, HERPES VIRUS INFECTION (Herpes flare up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  Patient reported that he is under Antiviral treatment for a herpes flare up.  Patient wanted to know if he should reschedule his second dose vaccination appointed for tomorrow 7-APR-2021 to a few days later.
Fussy, afternoon, post vax. The next day, had 3 episodes (25 seconds) of eyes rolling up, no loss of consciousness, no tonic-clonic activity. Resolved spontaneously. Temp max to 101.5, rectally.
This is a spontaneous report from a contactable pharmacist communicated to a Pfizer sales representative. This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age (65 but was unsure) and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date (several years before reporting) at single dose for pneumococcal immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient developed a rash around the injection area under the arm a few days after receiving on an unspecified date with outcome of recovered. The rash went away quickly so the patient thought it may have been due to deodorant or something.
Patient's mother called and stated the patient is feeling worse today after the second dose which was expected, but patient is now having EXTREME pain behind her eyes that will not let up.
15 minutes after vaccine patient was very sleepy. VSS patient became progressively sleepy and c/o eyelids and tonge with slight swelling. transported to ED via wheelchair
itching all over face, eyes, ears, hair; itching all over face, eyes; itching all over face, eyes, ears, hair; hives all over bidy; Lightheaded; This is a spontaneous report from a contactable consumer. A 47-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in Arm Left on 05Mar2021 13:15 as DOSE 1, SINGLE (at the age of 47-year-old) for covid-19 immunisation. Medical history included hypersensitivity. Concomitant medications included metoprolol; buprenorphine hydrochloride (BELBUCA); baclofen; omeprazole; cefixime (FLEXERIL [CEFIXIME]). The patient previously took codeine, morphine, amoxicillin, lexapro. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Mar2021 at 13:45, patient experienced lightheaded; itching all over face, eyes, ears, hair; hives all over body. Therapeutic measures were taken as a result of events. Patient received the treatment of 2 Benadryl, 1 chewable antacid. The outcome of the events was recovered with lasting effects on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Prescheduled eye exam (every 6-7 weeks) and and shot in right eye on 2/3/20 for macular degeneration showed a new large wet macular degeneration in left eye which had been stable for over 2 years.  Consequently, shots are now scheduled for both eyes every 6 weeks.
Terrible mensuration cramps began in June, didn't think anything of it, went away. In July terrible shooting pains in left hip/uterine area, assumed it was mensuration related until I couldn't walk because the pain moved down my legs and I couldn't sleep. Really bad bloating, fatigue, cervix extremely painful to touch during exam. Diagnosed with Pelvic Inflammatory Disease and a Yeast infection.
9 yo male with 15cm of erythema and edema and 3cm vesicular reaction after varicella vaccine administered 5-18-10.
Headache body aches, chills Narrative:  employee states: dhe had problems sleeping due to headache, body aches, and chills. She came into work but then had to leave. She then had a low grade fever of 99.5 F
EMPLOYEE CAME AFTER RECEIVING VACCINE. LEFT UPPER ARM RED HOT AND EDEMATOUS. COMPLAINT OF FOREHEAD AND NOSE ITCHING.CALLED PHARMACY AND DISPENSED BENADRYL 50 MG. ICE PACK TO LEFT UPPER ARM. HAVE EMPLOYEE CHECKING IN WITH NURSE MANAGER TO CHECK UPPER ARM AND STATUS OF EMPLOYEE. EMPLOYEE INSTRUCTED TO COME SEE ME IF SYMPTOMS BECOME WORSE AND WILL ALSO CHECK IN FIRST THING TOMORROW MORNING.
Beginning at 10:30 pm, I had severe chills and body aches through the night. It felt like the flu but no fever. I slept until 1:30 the next day (1/6)  I noticed a rash on the outer border of my left shoulder blade around 1:30 on 1/6. I was tired but ok the rest of 1/6. I felt totally normal on 1/7.
Severe rash covered 25% of body --head to mid-chest/back.; Face swelled; Lips swelled/tingled; Lips swelled/ tingled; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Apr2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC), vitamin d nos (VIT D), ascorbic acid (VIT C), sodium ascorbate, vaccinium macrocarpon, lactobacillus acidophilus, lactobacillus rhamnosus, bacillus coagulans, fructooligosaccharides (VH ESSENTIALS PROBIOTICS WITH PREBIOTICS & CRANBERRY) and withania somnifera root (ASHWAGANDHA ROOT) for unknown indication from an unknown date.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 00:00, the patient experienced severe rash covered 25% of body - head to mid chest/back, face swelled, lips swelled and tingled. No apparent stimulus for reaction, the patient last ate 6hrs before event and had only drank water since. Managed to get it under control after 2 days of regular Benadryl dosing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with 2 days of regular diphenhydramine (BENADRYL). The clinical outcome of the events severe rash covered 25% of body - head to mid chest/back, face swelled, lips swelled and tingled was recovered on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.