chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that shingle shots were painful. The follow up would not possible as no contact details were available.
"Moderna arm"* aka "Covid arm" started within 24 hours: swelling in the form of a pronounced lump on should muscle, directly below injection site, red rash, slight blistering of skin Other symptoms within the same 24 hour period: nausea, throwing up/unable to keep food down, muscle soreness throughout body, dizziness, trouble focusing/slight confusion, hot sweats and cold chills, physical  restlessness, dehydration despite a lot of fluid intake, extreme tiredness  *Moderna arm also seen with vaccine #2
A 54 year old woman, with a 15-year history of Interstitial Cystitis (IC), reports she has received 4 weekly instillations of Tice BCG (on 7, 14,21, 08/28/2002), for treatment of her IC.  She states she does not have bladder cancer and that her treatments are not part of any clinical trial or study.  The initial instillation was tolerated well, but within a few hours following the second instillation (08/14/2002), she began to experience "terrible burning with urination".  Following her third and fourth instillations (08/21/2002 & 08/28/2002), her bladder irritative symptoms have progressively exacerbated, with the sensation of pressure, and the need to void, despite only small amounts or urine in the bladder and with pain so severe that she is having difficulty sleeping at night and has had to take oxydodone hydrochloride with paracetamol, dextropropoxyphene hydrochloride and oxycodone for the pain, with only partial relief from any of them (in the past her IC spin has been effectively managed by oxycode hydrochloride with paracetamil 5 mg).  She reports her pain since receiving Tice BCG is much more severe than she ever experienced with the initial IC, since her fourth instillation, she has also had blood-tinged urine (pink, no clots) with tissue particles also present.  She has advised her treating urologist of her significant symptoms, but he does not plan to discontinue her additional pending Tice BCG therapy.
1. Racing heart day of June 11. (2 days after the 2nd Pfizer shot) Following day was feeling great.  2. Crushing pain through the body on two dates June 19 & July 3. ibuprofen had no effect
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3249), in left arm, on 09Feb2021 as dose 2, single (Lot number: EM9810), in left arm and on 25Nov2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "cardiac arrhythmia" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "mild hypertension" (unspecified if ongoing); "mild scoliosis" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS, start date: Nov2021; TRIAMTERENE/HCTZ, start date: Jan2007; RECLAST, start date: 02Mar2021; GLUCOSAMINE CHONDROITIN SULFATE, start date: Apr2021; BOSMERIC SR, start date: Nov2015; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D3, start date: Jan2009; VITAMIN C [ASCORBIC ACID], start date: 11Apr2022, stop date: 19Apr2022; CENTRUM SILVER WOMEN 50+, start date: 13Apr2022. Past drug history included: Tetracycline, reaction(s): "known allergies: Tetracycline"; Xarelto, reaction(s): "known allergies: Xarelto". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Positive; (26Apr2022) Positive. Therapeutic measures were taken as a result of covid-19.  If vaccine received Yes, other medication in 2 weeks: Yes; Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes. Adverse event: My initial covid symptoms began 11Apr2022. PCR Test + on 12Apr. All symptoms disappeared 18Apr2022. On Apr2022 new symptoms began - extreme runny nose and sneezing, with slight sore throat, no fever. PCR test + on 26Apr. On 28Apr, the extreme runny nose was over, however, slight cough and nose blowing 3-4x /day persisted through 10May.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 5 min after vaccine was given patient reported difficulty breathing and stated that this is what happened last time he had a reaction to a vaccine. Patient taken back to an exam room, diaphoretic and reporting difficulty breathing. Epi pen given, 911 called, EMS on scene 2 min after being called, assessed patient and cleared patient to be transported to ER privately, instead of by EMS. Patient wheeled to ER.
Has not received the 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd vaccine) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20B) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
received first covid vaccine 1/3/21, second on 2/3/21 and booster on 8/26/21   on the 6th day after vaccine in the evening he came complained of a headache and took 4 Tylenol and went to bed.  The next day which is the day of admission he woke up with confusion/altered mental status.  He was having shaking chills and had an episode of nausea and vomiting.  He did not have any diarrhea or complain of abdominal pain.  It seemed to subside a bit.  He had some high-grade fevers and then became even more confused as the day went on and so EMS was called and he was brought to the hospital.  Patient's wife states that they have not had any recent travel anywhere.  He has not had any recent ill contacts.  He does work outside in the garden a lot.  He does have a remote history of genital herpes and also remote history of valley fever.  At any rate since his arrival here he has had high-grade fevers without a clear-cut source.  Received vancomycin, zosyn which was changed to ceftriaxone, also on fluconazole.  respiratory viral PCR panel is negative.  Urinalysis is negative and blood cultures are negative thus far.  His chest x-ray showed some atelectasis.  His CT brain was unremarkable.  His CT abdomen did not show any obvious infection.    AS of today 9/9/21 still not back to baseline, doctor's note states "Mental status somewhat improving" but also states not answering questions on orientation - remains inpatient.
Blurred vision; 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 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Apr2023 at 16:00 as dose number unknown (booster), single (Lot number: GL2042, Expiration Date: 23May2023) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE oral taken for autoimmune thyroiditis. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: VISION BLURRED (non-serious) with onset 28Apr2023, outcome "not recovered", described as "Blurred vision". Therapeutic measures were not taken as a result of vision blurred.  Additional information: The patient stated that on yesterday afternoon she got the Pfizer Bivalent Vaccine and she was having really bad blurred vision today. Patient asked if it is common, should she see a doctor. Facility type reported as Grocery store, it is a pharmacy at the grocery store. It was asked if treatment for AE patient stated she had not done anything. She just wanted to know, how do she know if this is normal or do, she need to seek treatment. Patient did not received any vaccine (4 weeks prior).
This spontaneous retrospective report was received from the registered nurse and refers to a 15-year-old female patient. The patient had no pertinent medical history and drug reactions or allergies. On an unknown date in 2002, the patient received the first dose of GARDASIL 9 (lot#, expiration date, dose, frequency and route of administration were not reported) for HPV prevention. On 28-FEB-2017, the patient received second dose of GARDASIL 9 lot# M034780 (expiration date, dose, frequency and route of administration were not reported). On 28-FEB-2017, at the time of office visit, the patient was discovered to be pregnant. The nurse completed pregnancy test to the patient and the results came back positive. The nurse stated that the last menstruation period (LMP) might have been on 27-FEB-2017 (the patient was still bleeding, as in routine menstrual cycle at the time of administration of GARDASIL 9 so it was hard to pinpoint an actual date of LMP). The patient was instructed to follow up with the office which did not happen. The patient's mother contacted the office at an unspecified time for unspecified information and advised nurse that the patient would follow up with an unspecified family doctor. The nurse stated that there was no contact from the patient or the patient's mother, therefore it was possible that the pregnancy was no longer viable. The nurse reviewed the assumption of abortion with the pregnancy registry web site. The outcome of the events: abortion and vaginal bleeding was unknown. The relatedness between the event and GARDASIL 9 was not reported. Upon internal review, the event of abortion was considered to be medically significant. Additional information has been requested.
Pt arm was swollen, warm, and tender to touch. Pt had to got to ER and got a steroid shot and BENADRYL.
Pt recvd vax 16APR92 & mom noticed 21APR92 when helping pt w/bath rt arm was swollen; 22APR92 6cm x 4cm knot noted @ inject site rt arm; warm to touch; redness extedning to 8cm x 8cm around inject site; t98.6 c/o soreness; seen by MD;
Following 2nd dose of COVID-19 Vaccine, I began having  frequent episodes of feeling that my heart was racing.  I would experience a cold sensation inside my chest that spread throughout my body and extremities.   I felt weak, short of breath, dizzy, lightheaded and nauseaous.  I began to have severe, daily anxiety and panic attacks.
Patient experienced a panic attack, patient is autistic, and it turned into a silent seizure from being overstimulated. Patient was taken to EMS room to lay down and calm. Patient given water and is able to sit back up after 15 minutes and carry on a short conversation with mom at bedside.
A spontaneous report has been received from VAERS concerning a 17 year old, male patient. Concomitant medications included hepatitis A vaccine, hepatitis B vaccine, pneumococcal vaccine and meningococcal polysaccharide. Patient had been receiving FLUMIST (intranasal) (Non AZ Product), started on 15-Jun-2009, Lot number - U2791DA. Patient was brought in for syncope. Was told he passed. States he has been having, night sweats, coughing up blood-quarter size amount of blood at night, and loose bowel movements for past 3 weeks. He has been having decrease in appetite and a 26lb weight loss since starting training. Denies of any CP or SOB. However, has been having and dysuria with increase in frequency. Patient had clinical picture consistent with meningoencephalitis. Lumbar puncture performed showed elevated protein and lymphocytes. CSF culture and gram stain were negative. Patient started on and completed full courses of vancomycin, ceftriaxone, doxycycline, fluconazole, acyclovir, TAMIFLU, steroids and IVIG. All of patients CSF lab tests for possible causes of meningoencephalitis (sent to state encephalitis project) have returned negative; tests included HSV 1 and 2, VZV, enterovirus, adenovirus, influenza, parainfluenza, WNV, EBV, CMV, and coccidioidomycosis Ag. CSF pathology negative for malignancy and parasites. Patient developed evidence of opacity of left lower lobe on 23-Jul-2009. Felt to be a result of aspiration pneumonia. Patient had following Lab test as: 18-Jul-2009- non contrast head CT- no evidence of acute intracranial hemorrhage or parenchymal mass. 18-Jul-2009 lumbar puncture: 79 WBC, 9 RBC, glucose 60, lymphocyte predominance, few PMNs, no organisms seen, culture negative. 20-Jul-2009- MRI of brain- negative MRI examination of the brain, without evidence of abnormal enhancement, specifically of the meninges or temporal horns. 20-Jul-2009 EEG: diffuse slowing which was nonspecific for cerebral dysfunction. 22-Jul-2009: testicular ultrasound: essentially normal testicular ultrasound without evidence of a primary malignancy. 22-Jul-2009: bronchoscopy: mucus plugs in left lung. Culture and gram stain negative. 04-Aug-2009: bronchoscopy for mucus plug removal. 27-Jul-09: MRI of T spine: impression: evidence of subarach. Patient treated with vancomycin, ceftriaxone, and doxycycline. Most recent CXR shows resolution of opacity. At the time of reporting, the events of meningoencephalitis, syncope and aspiration pneumonia was ongoing. The reporter assessed the event of meningoencephalitis to be serious with seriousness criteria of disability and hospitalized and events of syncope and aspiration pneumonia to be serious with seriousness criteria of hospitalized. Corrected report 16-Apr-2015: It has been confirmed by Product Complaints on 31-Mar-15 that the lot number listed (U2791DA) for case 2015SE18951 is not a lot for FLUMIST. Initial unit corrected. Name of manufacturer changed to Unknown.
Within 15 mins of getting the Vaccines he passed out. Tdap, mcv4p,. After saying I 100% did NOT want the HPV it is marked as it was given on the documentation. There were two needles and three vitals laying on her tray when she came in to the exam room to administer.  I did not want Hep A and it is also marked on the documentation. As we were leaving the department my 12 yr old got light headed, said he felt funny, started sweating, became clammy his eyes rolled back in his head and passed out. His skin was pale gray blue and took several minutes to come around. The "nurses" applied wet paper towels to his neck and wrist. No crash cart available, No O2 offered and no follow up treatment. Escorted to the car and said "this is normal". Even though they were saying this was normal they acted like this was NOT normal by their response.
I experienced  chest pressure/pain that reached a pain score of 7/10. the pressure?pain stayed at that level for 6 days and then started to decrease on day 7. It completely went away on day 10. Nothing helped with the pressure/pain
I received the vaccine 30 min. prior to starting my shift as a Nurse in the ED. About 1 hour after receiving the shot while standing I felt off balance and began to have a vertigo like dizziness. I sat down and tried to drink some water but began spitting the water back up and dry heaving after trying to drink. I did not feel nauseous if I was not drinking. I did feel the sensation of a slight lump in my throat. I did not have any shortness of breath, tachycardia,  rash or fever. I did not want to check in as a patient so I called my wife to come and pick me up from work. Before I left I had the pharmacy send me some Pepcid and Benadryl and I took 25mg of Benadryl and 20mg of Pepcid before leaving. I left work around 1400 and now at 1500 I am able to drink fluids. The slight lump in my throat seems to have improved. I still feel a little dizzy and off balance.
(R) upper arm w/firm , tender warm area w/surrounding erythema (about walnut sized) - treated with AUGMENTIN/MEDROL.
Pain in right arm since 5 days after receiving the Booster vaccine on 12/16/2022. Veins and muscles and painful when I move my arm and ongoing irritation.
Sinus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SINUS DISORDER (non-serious), outcome "unknown", described as "Sinus". Therapeutic measures were taken as a result of sinus disorder.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mild allergic reaction with swelling of airway with shortness of breath, but not to point of closure for one hour. Chills and body aches for 6 hours. If difficulty breathing had lasted longer than one hour or progressed further, I would have sought treatment, however the wait and see approach was effective and there was no need for intervention. Have had slight shortness of breath off and on since vaccination but not sure if it is related.
Patient developed red skin and started to itch. I provider her with 50mg Benadryl
I started getting extreme sensitivity to noise, especially lower frequencies, in my left year. So I sought out help.
localized indurated erythemic area 4cm around inj site;local rxn vs cellulitis;another pt had a cellulitis from some viral;
Possible early cellulitis at injection site, fever 102-103, redness, tenderness, swelling.
35 POST VACCINATION, PATIENT REPORTS ICHING PF THE RIGHT ARM.  ITCHING SPREAD TO LEFT ARM AND ABDOMEN. HIVES AND REDNESS NOTED.  MEDICATION: BENADRYL 25MG/0.5 ML IM
Received PCV13 and started methotrexate on 16 May and on May 18 went to ED with severe headache, mild cognitive changes and fatigue. She was given meds and occipital nerve block which relieved headache. Much better on discharge.
01/23/2004: Office visit-cough, congestion, URI (viral).  01/29/04: Rash, erythematous, armsl egs, face, macular rash.  Symptomatic treatment; fluids, rest.
Outbreak of shingles on mid-upper back left side. Happened within a week of getting vaccinated. First outbreak of shingles ever, had chicken pox as a kid.; This is a spontaneous report from a contactable consumer (Patient) or other non-health care professional. A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 16:00 (Age at vaccination: 35 years) as dose 2, single for covid-19 immunization. Medical history included chicken pox as a kid. Previously the patient took first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 at 04:00 PM as single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not had allergies to medications, food, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and naltrexone. The patient experienced outbreak of shingles on mid-upper back left side, happened within a week of getting vaccinated, first outbreak of shingles on 01Mar2021. Therapeutic measures were taken as a result of event which included antiviral tablets and topical cream. The adverse event result in Emergency room/department or urgent care. The outcome of the event was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Hives, then decrease in blood pressure: 110/72 (HR 66) at 6:28pm, 102/72 (HR 56, SpO2 100%) at 6:40pm, 98/66 (HR 58, SpO2 100%) at 6:52pm; 2 tabs benadryl 25mg at 6:25 pm; 125mg IM solumedrol at 6:30pm; 0.3mg IM epinephrine at 6:59pm. Called EMS, who arrived at 7:07pm and transported to ED.
After receiving vaccine  patient stated they did not feel well (complained of nausea/light headedness), before I could ask if the patient was okay the patients entire body stiffened, his eyes got very big/wide, and they started to roll back. At that point I stayed with the patient and called for my pharmacist. The patient lost consciousness, and by the time my pharmacist got there he was stable and coherent. Once my pharmacist assessed the situation she had me call 911 for paramedics.  We had him lay on the floor with a pillow under his head, feet elevated.  We provided ice water, nuts as a snack, and I dabbed sweat from his forehead while holding an ice pack to his forehead. I stayed with the patient and patients girlfriend until paramedics arrived for transport.
Red area 40 mm on left side chest above Breast open area 15mm 2 small vesicles 5mm.
Rash around face and arm some wheezing  Nebulizer treated. 0.12 epi (1:1000) Benadryl per physician order : Rash resolved by 930 V/s stable, Pt dismissed with parents @ 10:20 v/s every 15 minutes
felt wicked buzz; elmers glue on arms; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt wicked buzz) and HYPERHIDROSIS (elmers glue on arms) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were reported. .     On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt wicked buzz) and HYPERHIDROSIS (elmers glue on arms). At the time of the report, FEELING ABNORMAL (felt wicked buzz) and HYPERHIDROSIS (elmers glue on arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided. No lab data has been provided by the reporter.