chrisvoncsefalvay/vaers-outcomes huggingface dataset:
throat swelling, shortness of breath Patient given first dose of Pfizer COVID 19 vaccine at vaccine clinic. Within 15 minute observation window, patient reported shortness of breath, difficulty swallowing, and throat swelling. Epinephrine 0.3 mg IM  autoinjector was administered and emergency response team was called. Patient was transported to ED and was fully alert, with no respiratory distress or other complaints upon arrival to ED. Was given diphenhydramine 50 mg IVP, methylprednisolone 125 mg IVP, and fluids. Blood work and chest xray obtained. No notable findings. Patient was discharged from ED with prednisone dosepak, cetirizine, and famotidine outpatient prescriptions.
Hoarseness 10/24-25/2014. Bad headache 10/25/2014. 10/26/2014 2:00AM woke up with itching, burning all over body, wheals on stomach and arms self administered PO Benadry x 3 doses first dose 10:00AM 10/26/2014 wheals and symptoms cleared did not seek medical care. Reported to Health Department 10/27/2014.
0831: Patient walked up to writer and stated that she felt like she was going to pass out. Patient brought over to post vac recovery area and placed into supine position with feet elevated and vital signs obtained for patient. Vitals taken at 0832 and were 112/60 HR 64 and oxygen 98% RA. Pt grandmother at her side during occasion.  Patient states that she feels much better at this time and another set of vitals obtained from patient at this time. 0836 BP 112/66 hr64 o2 97% RA. Pt brought to sitting position and another set of vitals signs obtained. 0837 116/62 hr 62 o2 98% RA. Last set of vitals obtained at 0839 after patient was sat up into regular chair was 106/68 hr 63 o2 98% RA. @ 0842 patient brought back into regular area after incident and grandmother at her side. Patient to stay and recover for next 30 minutes prior to being able to leave, patient made aware and states that she understands. Patient walked out with all belongings in stable condition with grandmother at their side at 0900 am.
Knot above  collarbone; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old patient of unknown gender 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 11Jun2021 at 12:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. The patient previously took tetanus shot vaccine on an unknown date and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN EXTRA STRENGTH) and paracetamol (TYLENOL); both for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Jun2021, the patient experienced knot above collarbone. It was unknown whether the patient received any treatment for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event knot above collarbone was unknown at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Drug ineffective; He received a COVID booster and then got COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2023US032505_NS.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "He received a COVID booster and then got COVID". Clinical course: Event: He received a COVID booster and then got COVID.  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.
Approximately 54 hrs p/DPT, OPV administered, infant was noted to suddenly be ashen & eventually inconsistable and died in 8 hrs; pathology report = pneumonia;
2nd shot given at 14 days.  Pt reports no adverse reaction except a sore arm that is now improved.
Client reports redness immediately after injection of Td in left deltoid on 09/21/2001. Redness remains on 09/27/2001.
Patient can't perform sexually since he got the shot; This spontaneous case was reported by a consumer and describes the occurrence of SEXUAL DYSFUNCTION (Patient can't perform sexually since he got the shot) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced SEXUAL DYSFUNCTION (Patient can't perform sexually since he got the shot). At the time of the report, SEXUAL DYSFUNCTION (Patient can't perform sexually since he got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.
Patient was okay when she left our store.  The patient was not having a reaction at that time, so emergency services were not notified. Later, around 5 pm, the patient's husband called our store to inform us that the patient was having a reaction and was reporting to the emergency room to evaluated.   We were not provided with further information.
3 days 100-103 degrees temp fluctuating. Knot at site of flu vaccine.
Increased soreness in the arm that had the injection. Left side. It was found that the patient had the same vaccine less than 1 year ago. 1/27/2015 and now 9/18/2015. Administering providers mistake.
When I got home to shower noticed  3 large spots, 2 appeared(upside down snowman) red in color and felt warm to touch. I contacted my doctor when into the walk in clinic stated it might be cellulitis told to take Allegra first if not better to fill prescription for Keflex.
N17.9, N18.9 - Acute kidney injury superimposed on chronic kidney disease (CMS/HCC) E87.5 - Hyperkalemia R06.00 - Dyspnea, unspecified type R53.1 - Weakness R73.9 - Hyperglycemia E11.10 - DKA, type 2, not at goal (CMS/HCC)
This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unspecified date in 2014, unspecified number of patients received unspecified doses of M-M-R II, 0.5 ml once, subcutaneously (lot/batch number not available) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively (also reported as 15C for more than 59 hours) through 07-MAY-2014. It was reported that also GARDASIL, PNEUMOVAX, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS#1406USA000955, 1406USA000956, 1406USA00957 and 1406USA000958 respectively). No adverse effects were reported.   Follow up information was received from the registered nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013-March 2014 (previously reported as 20-MAR-2014 to 07-MAY-2014). The reporter stated they were replacing the refrigerator, freezer and the data logger and were sending the data logger for calibration to the health department.  Follow up information has been received from the registered nurse. She called back to specify that 4 patients were vaccinated with doses of M-M-R II lot J003005 expiry date: 14-MAR-2015, which was stored improperly for a period from 28-AUG-2013 until June 2014 (previously reported as October 2013-March 2014). Two patients were given doses that were stored at highest temperature 10C for 242 and 246 hours, respectively. Two patients were vaccinated with doses that were stored at highest temperature 10C for 248 hours.  This is one of several reports from the same reporter. Additional information is not expected as the correspondence was returned by the post office.
This initial spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown ages and genders. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (Lot # M003659 with expiration date 20-SEP-2017; dose, route and anatomical location were not reported). No adverse effects were reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
I received my 3rd dose of the Moderna vaccine on 12/1/21.  The following nights, I had itchy legs and scalp while trying to sleep. On 12/10/21, I broke out in hives all over my body, including eyes and ears. I experienced severe itching all over, headache, itchy throat, watery eyes. On 12/12/21, I went to Clinic. They treated it as contact dermatitis. I was prescribed a Keflex antibiotic, prednisone, and topical cream. None of this helped. I called back within 3 days, and they prescribed an antifungal pill. Again, none of the symptoms improved. When the itchiness got so severe that I hadn't slept in days and missed 5 days of work, I went to the Emergency Room at Medical Center. They couldn't determine what was wrong, but prescribed an antihistamine (Claritin OTC) and Pepcid (claiming that the Pepcid would regulate the histamine in my stomach). Within 2 days, I was back at the ER with a severe headache, chills all over my body, and vomiting. They had me on IV drugs Toradol and Zofran as well as sodium chloride drip for dehydration. They also did blood work (which came back normal besides still showing some dehydration). They referred me to a dermatologist, Dr. Dr. confirmed that the rash, nausea, etc., was due to the COVID-19 vaccine booster. He prescribed another round of Prednisone and topical cream.
About 11:50 I sat down for observation and between 12 and 12:05 I felt tachycardia, I could even hear my heart and felt my heart really racing. I could feel something on my fingertips as well. The nurse came to check on me and at 2:08 my heart rate was 109 and one minute after it was already 110. So they brought 2 RNS to observe me. I did not go to the ER. They came about 10 min later and stayed with me 20 mins. They kept taking my vitals and checking my BP and told me that my vitals were stable. I left and when I went to my car and checked my heart race and noticed that it was stable, around 83 and decided to go home. I left the hospital about 1PM. After I had the vaccine, the next day I felt body aches, I was not sure if it was my sinus issues or related to the vaccine. I also had joint pains, back pains. But sometimes I have it with my sinus but today I feel fine.  My arm the soreness increased with each day but by Friday it got better today I don't feel it anymore.
6 HOURS AFTER RECEIVING THE MODERNA SHOT,JOINTS ACHE, SEVERE DIARRHEA, FEVER OF 100. LACK OF SLEEP, SEVERE HEADACHES, LACK OF ENGERY. THIS HAS NOT STOPPED SINCE ITOOK THE SHOT.
30OCT97 pt woke up crying-temp 99.5, mom noted swelling behind rt ear;went to ER dx w/possible ear infect given biaxin;
Severe skin rash L arm induration 53x65mm, erythema 90x110mm.
Syncope, 1.5 cm chin scrape, cut on left fifth finger. BPs 92/58 (pulse 57), 100/62 (pulse 63). Given water.
Pt recvd Hep B vax JUL91 & exp burning & pain @ inject site; lot# of vax was changed & the sx did not recur;
Headache; Vomiting; Difficult seeing; Vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 (Lot number: FC3180) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, lot no: FC3180, anatomical location: Arm Left), administration date: 25May2021, for covid-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "recovering", described as "Headache"; VOMITING (non-serious) with onset 26Aug2021, outcome "recovered" (27Aug2021), described as "Vomiting"; VISUAL IMPAIRMENT (non-serious) with onset 26Aug2021, outcome "recovered with sequelae" (27Aug2021), described as "Difficult seeing"; VERTIGO (non-serious) with onset 26Aug2021, outcome "recovering", described as "Vertigo". The events "headache", "vomiting", "difficult seeing" and "vertigo" were evaluated at the emergency room visit.  Additional information: It was reported that Caller states that according to the doctor, he thinks her issues were related to the vaccination. Calle reports that she had a headache, like a knifepick in her head, and it was a debilitating, stabbing pain. Caller also reports she had vomiting, difficulty seeing and vertigo. Caller confirms that she did not have a stroke and was released from the emergency room. Adverse Event: all occurred after second vaccine. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). No, other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE(s) following prior vaccinations. Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 21 out of 25. Company comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
Extreme fussiness for >3 hours started approximately 18hrs post vaccination physical exam normal.
Rash left side of my body. Itching. Nodule under the clavicle (collarbone). Fever. Joint pain. Headache.
was scratching my legs until they bleed again; Again began having moderate to severe eczema; was scratching my legs until they bleed again; Condition aggravated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 19Feb2021, for COVID-19 immunization; BNT162b2 (DOSE 2, SNGLE), administration date: 12Mar2021, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 23Oct2021, for COVID-19 immunization, reaction(s): "moderate to severe itching on my lower legs/moderate to severe eczema/began by presenting in my lower legs and on my scalp, and has now started presenting in my forearms and my buttocks", "Scratching my legs until they bleed", "Scratching my legs until they bleed"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 16Apr2022, for COVID-19 immunization. The following information was reported: ECZEMA (non-serious) with onset Mar2023, outcome "not recovered", described as "Again began having moderate to severe eczema"; CONDITION AGGRAVATED (non-serious) with onset Mar2023, outcome "not recovered"; WOUND HAEMORRHAGE (non-serious), SCRATCH (non-serious) all with onset Mar2023, outcome "not recovered" and all described as "was scratching my legs until they bleed again". Therapeutic measures were taken as a result of wound haemorrhage, eczema, scratch, condition aggravated.  Additional information: Approximately 6 months (Mar2023) after third Pfizer Booster, Patient again began having moderate to severe eczema, and was scratching my legs until they bleed again. She decided to use Benadryl ACI 25mg tablets this time (Over the Counter), taking 2 at night, but these proved ineffective for her problem. She researched hydroxyzine HCL and discovered that another over the counter alternative was Zyrtec (cetirizine), a second-generation antihistamine, which was chemically similar to hydroxyzine, but has much less of a sedative effect. She had taken one 10mg tablet at night, as needed, and had had relief from the eczema. She had never suffer from eczema in her life, until after the Pfizer vaccinations and boosters.  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-PV202200112487 same reporter/drug/patient, different dose (Dose 3);
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2014, the patient was treated by the physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. 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.
He had covid for a whole week, felt tired, sneezing; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He had covid for a whole week, felt tired, sneezing) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Mar-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (He had covid for a whole week, felt tired, sneezing). On 16-Jul-2023, COVID-19 (He had covid for a whole week, felt tired, sneezing) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-734135 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734135:Wife case
Started with pain in the right deltoid (shot was in left deltoid). Pain cont. down arm and entire right side. Then, felt like something was stuck in her throat and she went to the prompt care when she had chest tightness/pressure, nausea, vomiting, and a fever of around 100F. The symptoms started in the early afternoon and continued through the evening/night.
Developed (L) facial numbness and pain beginning one day after typhoid vaccine. Seen in ED and MRI showed inflammation in (L) cerebellar peduncle. Seen by neurologist. DX: Trigeminal neuralgia.
From RN involved- While in observation area, pt told her son she wasn't feeling well; he spoke to me about his mother.  When I spoke with the pt, (with son interpreting) she c/o L side of face feeling hot and swelling.  I brought her and her son into an exam room to evaluate further.  on visual assessment and palpation, I could not discern any swelling of her face; L cheek felt just slightly warmer than R.  11:13AM  VS:  P 74, RR 18; sat 98%; BP 118/60 Pt continued to c/o L side of face feeling hotter and L eye getting "smaller".  Per son, he stated he thought her face was swelling; still not discernable to me.  Both other nurses also observed pt and did not feel her face was swollen.  When asked about request for prevaccination BP, pt denies being on any meds for BP; sates there is a family hx of high BP; states she "used to have BP but not anymore" 11:20AM pt continued to c/o swelling and eye closing.  With continued c/o; pt was administered 50mg Benadryl PO with her consent.  Pt sates she had not eaten so given water and graham crackers; advised that Benadryl may make her sleepy and cause her to have a dry mouth so encouraged to continue to drink. 11:30AM VS:  P 73; RR 18; sat 99%; BP 120/60. Pt sates face feels "calmer" and eye more open.  Pt appears less anxious; denies fatigue, dizziness 11:50AM  pt states she feels better, feels swelling has gone away and eye feels  fully open.  On visual assessment and palpation, face feels simetrical and cool to the touch and eyes both fully open.  VS P:  72; RR: 16; sat 97%; PB 116/62. 12:10PM  pt states she feels fine; denies fatigue and dizziness.  Advised to continue to drink fluids; if any further s&s to seek emergency care.  Advised to inform PCP of reaction at next visit.  Pt left with her son.