chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on chest, back, wrist - itchy; Took a dose of benadryl around 10:40AM, no other action taken. Recommendation: Can continue use of OTC anti-histamines (in this case benadryl) if rash continues to itch. Hydrocortisone cream may also be applied to rashes.  These rashes can start a few days to more than a week after the first shot and are sometimes quite large. These rashes are also known as "COVID arm." If you experience "COVID arm" after getting the first shot, you should still get the second shot at the recommended interval if the vaccine you got needs a second shot. Tell your vaccination provider that you experienced a rash or "COVID arm" after the first shot. Your vaccination provider may recommend that you get the second shot in the opposite arm.
Migraine; This is a spontaneous report from a contactable consumer (patient). A 45-years-old, non-pregnant, female patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine in a Pharmacy or Drug Store, administered via an unspecified route in right arm on 06Mar2021 15:30, at 45 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. Concomitant medications included ibuprofen and naproxen sodium (ALEVE), both taken for an unspecified indication, since an unknown date. The patient previously took amoxicillin and experienced drug hypersensitivity. On 07Mar2021 06:00 AM the patient experienced migraine. She didn't receive any treatment. At the time of the report the reported event was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
52 y/o (M/F) with PMHx of chronic lower back pain began to feel lightheaded 1 minute after receiving the Covid vaccine (2nd dose). He LOC for 10 seconds. He became diaphoretic and pale. Denies headache, vertigo, seizures/PMHx of seizures, numbness/tingling/parasthesias, throat irritation, throat tightness, SOB, dyspnea, palpitations, chest pain, chest tightness/heaviness, hives, rash, peripheral or facial edema, nausea, vomiting. Patient was immediately assessed by EMT and clinical leads. Vitals were taken immediately. Given oral fluids (water/orange juice) and cookies. Vitals @ 8:48 AM  BP: 124/73 HR: 63 bpm SpO2: 98%  Vitals @ 9:00 AM BP: 134/86 HR: 76 bpm  SpO2: 99%  Orthostatic Vitals Laying Vitals: BP: 124/78 HR: 72 bpm  Sitting Vitals: BP: 160/82 HR: 74 bpm  Standing Vitals:  BP: 164/86 HR: 77 bpm   Physical Exam:  General: NAD, pale, diaphoretic  HEENT: NC/AT, EOMI, PERRL, airway patent, no trismus, no facial swelling Lungs: CTA B/L, no wheezes/rales/rhonchi, no accessory muscle use Cardiac: clear S1, S2, no murmurs/gallops/rubs Abd: soft, NT, BS x 4 Skin: no rashes, hives, no peripheral swelling  Patient was observed for a total of 95 minutes. Patient was reassessed and is stable. He took an uber home. Advised patient to call 911 or go directly to ER if he/she experiences continued dizziness/lightheadedness, LOC, seizures, headache, ataxia, SOB, dyspnea, chest pain/tightness/heaviness, nausea, abdominal pain, rashes, swelling or hives.
After receiving the Covid-19 Moderna vaccine, patient was able to walk to the observation area.  after few minutes reported throat tightness and dizziness.  Lower extremities were elevated.  BP 122/80, P-104, pulse ox 99%.  Did report tingling in lips and throat. 122/90, HR 119, Resp 18.  pulse ox 99%.  Administered 50 mg liquid  diphenhydramine, per standing order. 18 min later-  VS improved. 124/80, HR-81, pulseox 99%, dizziness resolved, throat tightness resolved
Significant increase in neuropathic pain lasting over 45 days.  Breathing difficulties, daily nausea episodes, upper right abdominal pain, muscle weakness, increased pain to all areas below T6, inability to breath without pain.  Fatigue.  Lasted acutely for over 30 days.  Symptoms including breathing difficulty, nausea, and increased peripheral nerve pain continue to linger.
Patient developed a itchy, painful rash on her back on May 4th. May 5th she was given a cortisone injection and prescribed Triamcinolone cream 1% and benadryl.
pt recv vax & devel an arthus type rxn;LMD is concerned that children in the area may have a viral infect @ the time of vax causing this to happen;
Fever; Shivering; This case was reported by a nurse via sales rep and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and shivering. On an unknown date, the outcome of the fever and shivering were unknown.   It was unknown if the reporter considered the fever and shivering to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced fever and shivering.
very weak; couldn't stand or walk; couldn't stand or walk; fever; could barely speak; lethargic; fell into a deep sleep; This is a spontaneous report from a contactable consumer (patient). A 95-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9261) via an unspecified route of administration on the left arm on 19Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included AFIB, chronic anemia, hip surgery in Aug2020 (recovering) and diagnosed with COVID-19 (prior to vaccination). Concomitant medication included levothyroxine sodium (L-THYROXINE), omeprazole (PRILOSEC), calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS); sodium chloride; ferrous sulfate; folic acid; vitamin D3; guaifenesin (MUCINEX) and clarithromycin (CLARITINE) reported as 'Claratinde'. Approximately 22 hours after injection, on 20Jan2021 03:30 PM patient became very weak, couldn't stand or walk, had a fever, could barely speak, lethargic and fell into a deep sleep. No treatment was received for the events. Events were reported as non-serious. Patient was not pregnant. The facility where the vaccine was administered was in a clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was unknown.
patient left observation period without reporting any adverse event.  After shopping in the grocery store, the patient returned and stated that she felt some pressure in her chest area and a tingling sensation on the roof of her mouth.  Patient denied sweating, rapid heart beat,  warmth, nausea vomiting.  Patient did not seem flushed or short of breath.  I took the patients blood pressure and it was 172/101.  Patient stated she has high blood pressure but does not like needles and was very anxious about the vaccination.  I had the patient wait under observation for another 15 minutes and took blood pressure again.. the reading was 151/91.  Patient stated she felt much better and was ready to leave.  The patient denied any nausea, sweating, itching, or other unusual sensation.
On 09/14/2000 the patient developed a mild case of chickenpox which consisted of greater than 50 varicella lesions and a fever of 100.7 axillary. Subsequently, the patient recovered. Additional information is not expected.
This spontaneous report was received from a patient of unknown age and gender. The patient had a question about the GARDASIL vaccination. If the patient had received the first dose back on an unknown date in 2009, then the patient recently got the second dose of GARDASIL on an unknown date in May 2013 and my last one coming up on 16-OCT-2013. Patient asked is there any chance it could still work the same even though the dates are spread apart? Additional information has been requested.
Detached Retina left eye; experiencing dark floaters; This is a spontaneous serious report from a contactable consumer (patient herself).  A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jul2021 (Batch/Lot Number: EW0180) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration, administered in Arm Left on 09Aug2021, at noon (Batch/Lot Number: GN0191) as DOSE 2, SINGLE, (age at vaccination was 51 years old) for covid-19 immunisation. Medical history included broken thumb from 07Aug2021 to an unknown date. The patient's concomitant medications included allergy shot, current frequency every 3 weeks for allergy (last dose was on 29Jul2021, has received on and off for the last decade). Patient reported receiving second dose of Pfizer covid vaccine 09Aug2021 and a couple of days after (unspecified date in Aug2021) she started experiencing dark floaters. She developed a detached retina of the left eye with 2 tears. She had an eye exam on 17Aug2021 and was referred to a specialist. She had surgery that same day due to having the detached retina with 2 tears. The events required a visit to Physician Office. She had no AE(s) following prior vaccination (first dose). Patient stated she has not had any trauma to her eye at all prior to this. She would like to report this experience. Unable to provide outcome of event for dark floaters. She is still is unable to see out of her left eye. Patient adds that she read where others have reported this and ocular issues. Details are unknown to her. One was a science article. She forgot where she read the other one. They were different articles but with the same issues. She is unsure if this has been reported. The patient underwent lab tests and procedures which included eye exam (ophthalmological examination): two tears and a detached retina left eye on 17Aug2021. Treatment for the events was eyesurgery performed on 17Aug2021. The outcome of detached retina left eye was recovered/resolved with Sequel on 17Aug2021 and outcome for experiencing dark floaters in eye was unknown.
pt devel very swollen lt arm w/in 2-3 days;was dx as cellulitis;fainted on 14JUN97 & had severe nose bleed on 15JUN97;checked again by MD;
Extreme, prolonged tiredness and feeling of bodily heat persisting since vaccination 2 weeks ago.
BRIGHT RED CIRCULAR SPOT AT SITE OF INJECTION. APPROXIMATELY 2 INCHES IN DIAMETER.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On  unspecified dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L048849, expiration date 04-FEB-2018, strength, dose and route were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected since it was not allowed to contact the reporter.
Sick to stomach, chills, muscular pain throughout the next day.  Woke up next morning w/headache
Hives starting on 11/19/17 @ 10-11am. Mom initially noted few hives on face/chin, then changed diaper & realized legs were covered as well. Eventually spread to arms, trunk, scalp. Parents took patient to ER (11/19/17 @ 1pm), where he was given BENADRYL PO & told to follow up with his PCP. Hives improved with BENADRYL, but returned after approx. 12 hours. Seen today at clinic (11/20/17 @ 10am); hives still present & confirmed by this writer as true hives, not other type of rash that parents identified as "hives." Instructed mom to continue BENADRYL prn for hives until resolved.  Afebrile at both ER & clinic visits No respiratory symptoms, SpO2 100% at both ER & clinic visits
Information has been received from a physician concerning a male who on 14-MAY-2007 was vaccinated with Zostavax. On 27-MAY-2007 the patient experienced a sharp shooting headache on the right side of his head. The patient went to the hospital where he was evaluated and diagnosed with trigeminal neuralgia. The patient was prescribed Tegretol and discharged from the hospital. A few days later, on approximately 30-MAY-2007, the patient experienced confusion and shortness of breath. The patient went to the emergency  room where it was noted that the patient was too weak to stand on his own. The patient has a prior history of shingles. Unspecified medical attention was sought. There was no product quality complaint. Lot number was not available. Additional information has been requested.
I had the vaccine I urinated in my sleep; my urea nitrogen was high; I had excess protein in my urine; GFR decreased; my kidneys are having some issues; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Dec2021 (Lot number: FL3197) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "immune compromise issues" (unspecified if ongoing), notes: I still don't have a diagnosis.I just have seen a lot of doctor I just have some immune issues some sort, I have had some problems like other viruses like Epstein-Barr virus really severely complications because its my immune system. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: 30Apr2021, when the patient was 33 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2), administration date: 21May2021, when the patient was 33 years old, for Covid-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 26Dec2021, outcome "unknown", described as "booster"; DYSURIA (non-serious), outcome "not recovered", described as "I had the vaccine I urinated in my sleep"; BLOOD UREA INCREASED (non-serious), outcome "not recovered", described as "my urea nitrogen was high"; PROTEIN URINE PRESENT (non-serious), outcome "not recovered", described as "I had excess protein in my urine"; GLOMERULAR FILTRATION RATE DECREASED (non-serious), outcome "not recovered", described as "GFR decreased"; RENAL DISORDER (non-serious), outcome "not recovered", described as "my kidneys are having some issues". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysuria, blood urea increased, protein urine present, glomerular filtration rate decreased, renal disorder.  Follow-Up (19Jan2022):Follow-up attempts are completed. No further information is expected.
Area red and blotchy; Injection site sore; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jul2021 at 19:00, the patient had injection site sore, felt like right after got the first and second vaccines, area was red and blotchy.  Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events injection site sore and was red and blotchy were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning an 18 year old female who on 09-AUG-2010 was vaccinated with 0.5 ml GARDASIL (lot # 666118/1539Y). Concomitant vaccination included ADACEL. The patient hadn't eaten when she got the vaccination, and then immediately she began having abdominal pain, she became pale, felt faint and dizzy and nauseous. Within an hour she had recovered (it was also reported that the patient recovered on 16-AUG-2010). Unspecified medical attention was sought. Additional information has been requested.
Patient went to Pharmacy for Tdap and Varicella vaccine on 02/13/2023. patient  received only Tdap vaccine from Pharmacy on 02/13/2023. Pharmacy referred her to another Pharmacy for varicella vaccine however patient showed up at Pharmacy on 02/14/2023 and asked for Tdap vaccine Pharmacy gave her Tdap at this point and realized the next day that patient received Tdap twice. We called patient and she is feeling ok only arm site soreness. We will give her refund and will give her follow up call.
I went to the hospital to get my flu usually yearly flu shot. It was not available at the hospital. They advised me that I could go to my local pharmacy to have it done. I went to the pharmacy. The Pharmacist did it. However, since receiving the shot in my right arm, I am having pains in the arm and is unable to use the arm to the full capacity. I have to be taking ALEVE and rubbing it with alcohol, ointments and I have to use my left hand to lift the right hand into place. The pain is excruciating and limit me to what I can and cannot do. I went to the ER and they xrayed the hand and said everything looks fine and it will take time to go away but 2 months later I am still in pain. Is that really normal?
A few months after the final shot in June I started becoming very weak. I could barely stand, was in constant pain, doctor thought it might be lupus since bloodwork was crazy.
Patient reports she developed erythema, swelling that turned to purple within 24 hours. She did not return to the clinic for evaluation and had no other adverse reactions.
rash on my arm; shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE , lot number and expiration date: not provided), for COVID-19 Immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "rash on my arm"; HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles". The events "rash on my arm" and "shingles" required physician office visit.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110146 same patient/drug, different dose number/event;US-PFIZER INC-202300111130 same patient/drug, different dose number/event;
Immediate feeling of medication running down arm into hand.  Muscle pain in right arm, right shoulder and right side of neck.  Later in the evening noticed right sided throat discomfort, rapid heart rate and shallow breathing.  Difficulty sleeping. Next day muscle pains continued and additional muscle pain in right leg and right foot.  Walked with limp due to pain in right foot.  4/22/21 partially recovered from condition.
A week after receiving 2nd shot. I started noticing pain in my left arm at the injection site. Pain radiates to the back of my neck and the entire left shoulder.  Went to see my PCP. She requested I get an Xray. When I sit down in my recliner I do not feel pain. I'm still feel a dull ache. The pain comes and goes.
Pt c/o of dizziness as the only symptom s/p vaccination.  She denied any chest pain, shortness of breath, vision loss, or pain. Pt's mother stated that she previously gets dizzy after vaccinations, and seeing needles. Pt stated that she had a "fear" of needles, but wanted the vaccine anyway. The nurse moved the pt to the private area, and helped her onto the stretcher, where she laid down.  After the pt was lying down, the nurse assessed her. The nurse then took vital signs every ten minutes, listened to her lung sounds, assessed the radial pulse, assessed her vision, and mentation. After 15 minutes the pt sat upright with her feet dangled. With the nurse and the mother ten minutes later, the pt was walked down the hall. No issues were noted and the pt was stable.  All the vitals were within normal limits throughout the entire time. The previous dizziness was gone, and the mother stated that she looked great.  Pt stated a total of 40 minutes and then was safely discharged.
Dose 4; Pfizer, Dose 5: Moderna; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Apr2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Oct2023 as dose 5 (booster), single (Lot number: 80777010293), in right arm 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 included: "COPD" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, start date: 01Jan2023, stop date: 30Oct2023; METOPROLOL, start date: 01Jan2023; FAMOTIDINE, start date: 01Jan2023. Past drug history included: Lisinopril, reaction(s): "Known allergies: Lisinopril". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Oct2023, outcome "unknown", described as "Dose 4; Pfizer, Dose 5: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid start date on 30Oct2023 and stop date on 03Nov2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300366019 Same reporter/patient, different drug/event;
Initial unsolicited report received from a consumer (patient's mother) on 05-Oct-2016. This case involves a three-months-old male patient who was vaccinated with a dose of Acthib (batch number: UI265AA, expiry date: 17 May 2016), DAPTACEL (batch number C4754AA, expiry date: 23-Jun-2017), MMR (manufacturer: other, batch number K011317) (dose, site and route of administration: not reported for all vaccines) on 15-Aug-2014. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions included egg, dairy allergy. On 15-Aug-2014, 10 to 30 minutes after vaccination, patient experienced coughing, facial swelling and throat swelling shut. The patient was transported to the hospital ER and on an unspecified date, was then admitted to the hospital. Relevant diagnostic tests were not reported. Patient was treated with Benadryl and "epi" on advice from doctor's office. On an unspecified date, patient recovered from the events. Documents held by sender: none. Sender's Comments: This case concern 3 month old male patient who received HIB (PRP/T) VACCINE simultaneously with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and MEASLES, MUMPS AND RUBELLA VACCINE . After 10 to 30 minutes patients experienced coughing, facial swelling, throat swelling shut and treated with benadryl and epinephrine. Time to onset is compatible. Events are consistent with hypersensitivity reaction. Based on available information role of vaccines cannot be excluded. Role of a particular vaccine cannot be assessed since multiple vaccines were administered simultaneously.
I awakened this morning with significantly compromised vision in my right eye.   It has improved slightly since awakening, but only slightly in the approximately 4 hours.