chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light and sound sensitivity/head pounding; light and sound sensitivity; light and sound sensitivity; nausea; lightheadedness; My arm was sore; Felt absolutely terrible; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 01Apr2021 13:30 (1:30 pm) as single dose for COVID-19 immunization in a clinic. Medical history included autoimmune hypothyroidism, gastrooesophageal reflux disease and don't tolerate NSAIDs but not allergic all from an unknown date. Concomitant medications included levothyroxine; esomeprazole magnesium (NEXIUM); cetirizine hydrochloride (ZYRTEC ALLERGY); gabapentin; and estradiol (ESTROGEL) all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin and experienced drug intolerance but not allergic on an unspecified date. The patient previously received the first dose of bnt162b2 (lot number: EN6204) on 11Mar2021 1:30 pm administered in left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. On 01Apr2021, it was reported that the patient experienced tachycardia (avg. 125 bpm), dry mouth, low sodium, low potassium, excruciating headache/head pounding, light and sound sensitivity, nausea, lightheadedness, arm was sore, and felt absolutely terrible. The patient was hospitalized for tachycardia (avg. 125 bpm) for 1 day. The events required physician office and emergency room visit. the patient was treated with IV saline, IV anti-nausea, and IV morphine. The patient underwent lab tests and procedures which included blood potassium: low, blood sodium: low, and heart rate: 125 bpm - tachycardia all on 01Apr2021. The outcome of the events was recovered.
severe reaction with Moderna vaccine; hair was falling out; skin was falling off on his hands and feet; one time he did hit a tender spot on his tummy; he can feel it when he gives himself the injection and it is slightly uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (severe reaction with Moderna vaccine), ALOPECIA (hair was falling out), SKIN EXFOLIATION (skin was falling off on his hands and feet), VACCINATION SITE PAIN (one time he did hit a tender spot on his tummy) and VACCINATION SITE DISCOMFORT (he can feel it when he gives himself the injection and it is slightly uncomfortable) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concurrent medical conditions included Atopic dermatitis.   On 13-Jun-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. In 2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram. 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 IMMUNISATION REACTION (severe reaction with Moderna vaccine), ALOPECIA (hair was falling out), SKIN EXFOLIATION (skin was falling off on his hands and feet), VACCINATION SITE PAIN (one time he did hit a tender spot on his tummy) and VACCINATION SITE DISCOMFORT (he can feel it when he gives himself the injection and it is slightly uncomfortable). At the time of the report, IMMUNISATION REACTION (severe reaction with Moderna vaccine), VACCINATION SITE PAIN (one time he did hit a tender spot on his tummy) and VACCINATION SITE DISCOMFORT (he can feel it when he gives himself the injection and it is slightly uncomfortable) had resolved and ALOPECIA (hair was falling out) and SKIN EXFOLIATION (skin was falling off on his hands and feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided.  No treatment medication information provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
hair loss; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 21Dec2020 at 08:00 as dose 1, single (Lot number: EL9231) at the age of 65 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "hair loss". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Received all 3 doses at [hospital name withheld]. Hair loss started to [Illegible] bad and worse in Feb2022.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not reported. On 13-AUG-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX, lot # L007227, expiration date: 03-MAR-2017  (administration route was not reported). No concomitant therapies were reported. No adverse effects were reported. According to the reporting nurse the dose were exposed to a temperature excursion from 12-AUG-2015 to 13-AUG-2015 for a total of 17 hours at 5.5C. This is one of several reports from the same reporter. Additional information has been requested.
12 hours After second dose I had fever, body aches, chills and nausea that lasted approximately 12 hours.
Patient was immunized with Pfizer vaccine as a minor with consent from mother. Patient had no issues initially with vaccine. Following 15 minutes after administration, patient noted flank pain and both sides of abdomen and also labored breathing.  We called a code white in the store had management as well as pharmacist offer ambulance to patient and also monitored the patient. Mother and son left AMA and went to call patient's doctor.
Pt received HEP A & VARIVAX on 7-29-09.  On 7-30-09 Pt went to ER for a 5 X 2 cm wheal where VARIVAX was given.  Pt was afebrile.  It resolved the next day.
Friday night felt hot to the touch at bedtime 9 pm and gave Tylenol. Began crying around 10:30 and still felt hot to the touch. Did not want bottle. Mom massaged legs and gave another warm bath. Began crying again after bath. All day Saturday and Sunday he slept a lot and when he was awake he cried and looked like he hurt and was hot to the touch. Patient usually wakes once in the night for a bottle and this weekend he woke five to six times during the night. Monday morning mom took temperature orally and it read 99.7 and he is still weak and cries a bit. Mom plans on calling the pediatrician today.
Patient feeling dizzy. Denies pain, She has a history of anaphylaxis x8 from shellfish. As talking to patient, lips began to feel tingly. No SOB, no rash or swelling. Patient refused transport to ED.
Development of Left  Occipital/Trigeminal neuralgia type symptoms that later subsided to left facial and chin numbness
Neurological problems: - muscles twitches - restless leg syndrome - myoclonus - ear pumping  - muscle weakness in hands and legs - restlessness in upper back - blurred vision
Claims felt "drained" on the afternoon following vaccination with severe headache lasting 19 hrs. Seen by PMD for headache.
patients came in to get Adacel and the nurse accidently gave TD, no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 59 years old female patient who received vaccine DIPHTHERIA AND TETANUS TOXOIDS lot number not reported via unknown route in unknown administration site instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], on 19-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered.  It was reported that one of the patients came in to get Adacel and the nurse accidently gave TD or is there a pertusis vaccine.  At the time of reporting, no adverse reactions were 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.  Information on the batch number was requested.  List of documents held by sender: none.
within 12 hours:  sleepiness (very), pain at injection site & around to muscles in right shoulder; slight pain in moving injected arm above 45 degrees, slight generalized muscle aches.
Prior to the vaccine my PSA lab results were below 2.0 but in July it had jumped to 25.8 per my internal medicine doctor  and urologist. This resulted in a biopsy which found Prostrate Cancer with a Gleason score of 9.  I have received hormone shots on 9/7/2021, will consult with radiologist 9/16/2021, undergo Scan and Screening on 9/22/2021. I am to expect 9 weeks of radiation treatment and insertion of radioactive isotope seeds/pellets into my prostrate. That is all I know at the current time.
left arm pain / arm pain at the injection site; pain spread around shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 95XF7, expiry date 29th October 2021) for prophylaxis.   On 22nd August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 22nd August 2019, 1 hr after receiving Shingrix, the patient experienced pain in arm and shoulder pain. On an unknown date, the outcome of the pain in arm and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter reported that, after vaccination, the patient experienced pain at the injection site. On 12th September 2019, the patient informed to pharmacist that, the arm pain continued and had spread to the back of the arm and around the shoulder and still persisted The reporter consented to follow up.
Hives on my face, neck and back. The hives spread and were only alleviated with Benadryl (liquid). The hives on my back and neck have continued to flare up from time to time since the vaccine was given. My doctor advised that I NOT get the 2nd dose because of my body's reaction to the 1st dose.  I had a fever above 102 degrees for the first 2 days, accompanied by body aches and headache.
Patient was a 77 year old, resident, past medical history of dementia, hypertension, schizophrenia, hyperlipidemia, Parkinson's disease. Patient presented to the ED with altered mental status and a potential seizure. In the morning of 3/24, patient reportedly had an episode of seizure that lasted 30 seconds, generalized tonic/clonic. It is unknown if she fell  or hit her head. Per manager, patient is following Neurology, recent work up for possible syncopal month ago. Patient received her 2nd dose of Moderna Vaccine recently on 3/19. At baseline patient is independent, ambulates by her self. Patient has been ill after receiving a COVID vaccine last week. Patient has progressive weakness of the bilateral lower extremities and progressive difficulties with talking , had had multiple falls.
In Saturday 7/24/21 woke up with what i thought was a knot  behind the left side of the bottom Of my hairline.  7/25/21 pain was still there, Monday 7/26/22 noticed pain was still there but now it was on the left said if my clerical neck  and randomly throughout the day i would get a quick ?zing? feeling in my head by my temple and, again i still thought i has slept wrong, and was just stretching to try and relieve it. Sat 7/31/21 i noticed swelling in my lymph nodes on the left side of my neck and left side of chest.  Monday i went to urgent care where they diagnosed me with Shingles. I had a rash at the spot i first started having the pain and it aches,  itches off and  on.
Pregnancy loss; Vaginal bleeding; Vaccine exposure during pregnancy; A spontaneous report was received from a nurse practitioner who was 31-year-old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine exposure during pregnancy, pregnancy loss (abortion spontaneous), and vaginal bleeding (vaginal hemorrhage).  The patient's medical history was not provided. Concomitant medications reported as taken since conception included magnesium, prenatal vitamins, vitamin B and vitamin C.  On 10 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011LZ0A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 10 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine.   On 02 Feb 2021, the patient developed vaginal bleeding, so she went to her obstetrician and had an ultrasound exam. The patient reported that there was no heartbeat at fifteen weeks and five days. No treatment information was provided.  The patient's prior positive pregnancy test, last menstrual period, conception and due dates were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event,  pregnancy loss and vaccine exposure during pregnancy, was considered resolved. The outcome of the event, vaginal bleeding, was unknown.; Reporter's Comments: This case concerns a 31 year old, female subject, who experienced a spontaneous abortion and drug exposure before pregnancy. Very limited information has been provided at this time. Further information has been requested
Pt. woke up the morning  after flu shot with left arm paralysis. Unable to lift arm past 45 degrees. No pain, swelling or redness at site. Site warm to touch but patients temp was 97.7 on exam.
On 4/20/99, 5/12/99 and 5/12/00, the pt received his 1st, 2nd and 3rd doses of Lymerix vaccine. Nine months after the 3rd dose, on 3/10/01, the pt experienced headache, facial pain, general malaise, alternating stiff joints and photophobia. A spinal tap was performed. CSF, reportedly, contained elevated protein. An ELISA and Western Blot were "positive for 3 bands but not the same as for the vaccine". The pt was seen by his PCP and a neurologist. A 20 day course of doxycycline was started on 4/27/01. The reporter was not sure of the causality of the adverse events with regard to Lymerix. As of 5/10/01, the outcome of the adverse events was unresolved. The adverse events of 'headache' and 'stiff joints' do no meet serious criteria, but are being submitted as an expedited report by special FDA request per the 6/28/00 letter. Additional info was received from the vaccine provider, who is the vaccinee's primary care physician, on 08/03/2001. The physician reported that the vaccinee began to experience vertigo on 02/12/2001, this was described as "equibilrium off each AM." On 04/12/2001 the vertigo persisted and the vaccinee began to experience frontal headache and weakness. The physician discontinued terasosin therapy on 04/12/2001. The headache, vertigo, and weakness persisted. On 06/07/2001, triamtergne/hydrochlorothiaside therapy was discontinued, and the vaccinee's hypertention was treated with candesartan and hydrodhlorothiazide. The frontal headache, vertigo, and weakness resolved on 06/24/2001. The physician did not confirm the spouse's report of stiff joints, photophobia, or elevated CSF protein. The physician did not report findings of an ELISA or Wetern blot analysis. The physician indicated that the vertigo, frontal headache, and weakenss were of mild intensity and not related to LYMErix administration. The physician stated, "pt had no adverse reaction to vaccine administration." As of 08/03/2001, the vertigo, frontal headache, and weakenss had resolved. The outcomes of the stiff joints and photophobia were unknown, since these events were not confirmed by the physician.
Some target lesion right thigh with blanching urticarial like lesions on legs and some blanching papules on abdomen with hypopigmented halos; rash starting 9/4/03. Currently no rash.
urticaria rash along the rt & lt side of trunk;no wheezing or resp sx;treated w/Atarax & resolved w/in 24hrs;
I started getting symptoms Friday night. I had fatigue and exhaustion and was enough to have me unable to walk 35 feet for about 5 days; and I'm used to walking 7 miles a day. I was really congested, sinus, nasal and some coughing for 5 days. I loss sense of smell on Sunday and it returned on Friday. I had a headache that started on Friday and lasted the full week; TYLENOL didn't make it go away. I started PAXLOVID on Sunday. The majority of my symptoms have resolved but I'm not back to my regular energy level and stamina. There is still some lingering fatigue.
Patient received (age 3) Flu vaccine, watched his sister get several vaccines and subsequently became diaphoretic, pastly, glassy eyed with episode of vomiting, No loss of consciousness. O2 by mask give, juice given. Color came back and after observation for about  30 - 4d days back to normal.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 04-AUG-2016, the patient was treated for the onset of a vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Raised rash 3" x 1.5" w/aching, itching, and warmth at the site of inoculation.
(All hx obtained from the mother)A few hours after the administration of the DTaP vaccine and IPOL, the patient developed fever and continued to have fever for 3 days.  The Tmax was 104.  The day following the vaccination, the patient also had several bouts of vomiting, and was listless. Then on the third day after the vaccine, the baby developed a total body rash which resolved after three days.  I saw the baby on day 7 after the vaccine and the physical exam was completely normal.
This spontaneous report as received from a pharmacist refers to one or two patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, improperly stored ZOSTAVAX doses (dose number, dose, route, anatomical location and lot number were not reported) were administered to one or two patients. No adverse effects were reported. Concomitant medications were not specified. Additional information has been requested.
Rash, pain, swelling, purple at injection site; Body chills, fever, malaise; Herpes outbreak; Terrible nausea, weight loss.
06/30/09 MT REPORTS CHILD FELT HOT, COMPLAINED OF HEADACHE & PAINFUL LEFT ARM. ARM SWOLLEN &HOT 6/30 & WORSE 07/01/09.GAVE TYLENOL & USED ICE ON IT. TODAY 07/01 LEFT DELTOID AREA IS WARM TO TOUCH, RED, & SWOLLEN 4 1/4" X 4".CHILD DOES NOT HAVE ANY FEVER TODAY AND IS PLAYING AND ACTING OKAY. DOES REPORT PAIN IN HER LEFT ARM.
sudden onset abd pain and nausea s vomiting causing him to go to ER.  Required IVF and morphine.
Client received vaccinations on 10-11-11 at 3:00 pm. The following evening on 10-12-11 client displayed pea-sized red raised itchy welts on her chest and abdomen. Client's mother called health dept today to report same type of welts on her (R) side scattered. Mother is taking client to family physician.
Before I had my second COVID shot, I had my teeth cleaned on March 4, 2021. They did not notice any change of my gum disease. This was at Dr.; June 10, 2021 - I went down to another cleaning with Periodontist Dentist and his Hygienist was very concerned about how deep my pockets had gotten. I had to have  - LANAP Procedure done - that was two days to get that done and then I was going for 2 weeks for every week and now it's to once a month. Then next month, I should be cleared before I go to see them again in three months. I spoke to Dr and he said that I had been stable with the gum disease for so long - he was thinking it was either from the COVID shots or the Reclasp Infusion. The Reclasp Infusion was January 18, 2021. The LANAP seems to have worked.
I got the vaccine around 3:45 PM.  I felt completely fine all day until around 10PM that night. I started feeling really cold, then suddenly my whole body started shaking uncontrollably.     I also got a fever (close to 102). I paged my dr to let  her know what was going on.    She told me to take tylenol (and advil a few hours later IF needed).  After taking  2Tylenol, the shaking stopped after a few minutes and the fever went down.   During the night i felt slightly nauseous, but i did not throw up.   I also had some stomach pain.    By the next morning, my temperature was around 99-100 throughout the day, but no more shaking.   I still had some intermittent stomach pain but it wasn't severe enough to keep me down. I was able to shower, get my kids ready for school and go about my day for the most part.   By later that day, the temperate was normal .  I am getting some headaches now, but it's been a week since the vaccine and I do periodically get headaches, so i would not say for certain it's from the vaccine.  I am also still very intermittently getting some stomach pain. I can go for hours with no pain and then some random pains that come and go.
Received vaccine at 1100 on 1/29/21. No symptoms noted during 30 minute post-vaccine observation period. Symptom onset at 0300 on 1/30/21 (16 hours after vaccine administration). Symptoms included chest pain, dyspnea on exertion, weakness, nausea/vomiting, decreased appetite, and diarrhea. Patient presented to Medical Center Emergency Department around 1130 on 2/1/21. Found to have NSTEMI 2/2 Takotsubo's cardiomyopathy with acute congestive heart failure. (of note,  coronary angiography in 11/20 showed no coronary artery disease). Patient has never had a reaction to a vaccine or component despite receiving many vaccines due to extensive travel history.