chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via company representative refers to a 60 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On 24-FEB-2016 (also reported as about a week ago) the patient was vaccinated with ZOSTAVAX (dosing details were not reported) lot # L028279 expiry date of 28-OCT-2015, subcutaneously in the left upper arm. No concomitant medications were reported. The reporter stated that on 26-FEB-2015, the patient came to the pharmacy to inform that on an unknown date in February 2016, she was experiencing a rash at the left upper arm injection site. The reporter stated that the ras was red, swelling, warm (hot to touch), tender to touch and itchy, and it extends from the injection site to her elbow (injection site pain, injection site pruritus, injection site rash, injection site warmth and injection site swelling). The reporter stated that there are no bumps in the rash and the rash is not macular. The patient did not receive any treatment for the events. Patient sought medical attention by visiting the pharmacies. The outcome of the events was reported as not recovered/not resolved. The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
1630 73 year old female received Moderna COVID 19 vaccine in left deltoid administered by LPN. Patient received in post vaccination observation with difficulty breathing, diaphoresis, chills, weakness. Patient has history of asthma and HTN. Patient took 2 puffs of her Ventolin HFA 90mcg and was given water. Patient able to  breathe easier after using inhaler/ Also assessed by onsite paramedic. V/S BP 170/80 RR 16 HR 74 SPO2 98% 1700 Patient has no further symptoms, able to speak clearly and coherently. BP 170/80  Patient left observation area with husband.
No adverse event; Pharmacist reports patient was accidently administered an expired dose of PNEUMOVAX 23 on Feb 15, 2023.; This spontaneous report was received from a pharmacist and refers to an 8-year-old female patient. There was no information regarding the patient's medical history, concurrent condition and concomitant therapies details.  On 15-FEB-2023, the patient was accidently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, once, lot #U018309, expiration date: 08-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). Product had no prior temperature excursions. No further information provided. No additional adverse event or product quality complaint was reported.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 16-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA004381: Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004379: Original Case : 1808USA001261 US-009507513-1808USA004376: Original Case : 1808USA001261 US-009507513-1808USA004377: Original Case : 1808USA001261 US-009507513-1808USA004378: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261z US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004365: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261 US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA004367: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261 US-009507513-1808USA004399: Original Case : 1808USA001261 US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA004368: Original Case : 1808USA001261 US-009507513-1808USA004369: Original Case : 1808USA001261 US-009507513-1808USA004370: Original Case : 1808USA001261 US-009507513-1808USA004401: Original Case : 1808USA001261 US-009507513-1808USA004371.
I have never had the flu, but I would suspect flu-like symptoms at 12:30am on 4/22/21. Chills (I could not get warm), then hot, aching, fever of 101 when I awoke at 6:30am.  I took 3 Tylenol, but symptoms persisted the entire day on 4/22/21. I took another dose of Tylenol around 4pm. I was very tired as well, and felt weak. Then on 4/23, I awoke, feeling much better but when I got out of bed I almost fell over. I was dizzy. The dizziness has continued all day (it is now 3:09pm).  I will take a dramamine when my workday is over. I have not had to throw up, nor have I felt nauseated to that point. But it is like a vertigo, when I am sitting still, I feel like I am tilting over. (but I have never had vertigo, so I am only guessing) I plan to call my doctor if this dizziness persists, but I am hoping the dramamine will help.
tachycardia increased; Period got weird spotting in middle of month and cycle shorter with spotting before and after; Sever leg pain; migraine; Period got weird spotting in middle of month and cycle shorter with spotting before and after; chronic pain getting worse; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia increased), VAGINAL HAEMORRHAGE (Period got weird spotting in middle of month and cycle shorter with spotting before and after), PAIN IN EXTREMITY (Sever leg pain), MIGRAINE (migraine) and POLYMENORRHOEA (Period got weird spotting in middle of month and cycle shorter with spotting before and after) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LORATADINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (tachycardia increased), VAGINAL HAEMORRHAGE (Period got weird spotting in middle of month and cycle shorter with spotting before and after), PAIN IN EXTREMITY (Sever leg pain), MIGRAINE (migraine), POLYMENORRHOEA (Period got weird spotting in middle of month and cycle shorter with spotting before and after), PAIN (chronic pain getting worse) and FATIGUE (fatigue). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (tachycardia increased), VAGINAL HAEMORRHAGE (Period got weird spotting in middle of month and cycle shorter with spotting before and after), PAIN IN EXTREMITY (Sever leg pain), MIGRAINE (migraine), POLYMENORRHOEA (Period got weird spotting in middle of month and cycle shorter with spotting before and after), PAIN (chronic pain getting worse) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: normal (normal) No blood clots were found..         Patient reported that she is on IUD.
Rt. upper arm - injection site red - 1 inch from site red - hot area - arm swollen - hard to touch.
Chills; Right finger pain; Wrist pain; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730 7/21) via an unspecified route of administration in the left arm on 03Apr2021 at 10:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food or other products. Concomitant medications included levocetirizine dihydrochloride (XYZAL), from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL 9266) via an unspecified route of administration in the left arm on 09Mar2021 at 13:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 21:00, the patient experienced chills, right finger pain, wrist pain and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of chills, right finger pain, wrist pain and headache were recovered on unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Employee gave booster vaccine 23 days early. Patient was due for booster vaccine on 10/28/21.
Tdap (Adacel) vaccine administered IM to right deltoid on 2/1/2017. On 02/03/2017, patient reported reaction at vaccination site. RN observed redness and warmth to right upper extremity above and to the right of injection site. Patient reported extremity soreness. Patient self-treated with ibuprofen and ice to site at reaction onset. RN reported reaction to clinic physician, secured appointment. Clinic physician prescribed Benadryl, recommended ice to site. On 02/06/2017, patient reported redness, warmth, soreness resolved. Small knot like raised area to affected extremity at or near injection site. Clinic physician advised heat to site and activity to affected extremity to ease muscle tension.
Information has been received from a nurse practitioner concerning a 11 year old female who on 19-MAY-2009 was vaccinated with her first dose of GARDASIL (Lot#661841/0653X). The concomitant medication was not reported. On 28-MAY-2009 the patient noticed after showering that her neck was swollen. It just suddenly popped up on the clavicular region within an hour's time frame. it was unknown whether the patient sought medical attention. The outcome was unknown at the report time. Additional information has been requested.
0.25 ml of Moderna was given instead of 0.3ml of Pfizer.
Typical flu-like symptoms for 30  hours.   During that time an increasing skin sensitivity over torso and limbs.  After 36 hours, a very obvious and bad rash on hands that doctor diagnosed as dyshidrotic eczema.  Simultaneously legs were badly marked with dark red dots, especially lower legs, and much overall light red skin over upper legs and torso below neck.  The hands resolved over a few days with steroid cream.  The rest of the body continues, a month later, to feel like a sunburn.  The worst of the look of dark red dots on lower leg diminished over the first couple of weeks.  But even now, it feels like my skin is mildly burned.  I can even press it and release and see white where I pressed, surrounded by red, just like a sunburn.  Overall the skin looks mildly red, but nothing outrageous.
large lump L armpit spreading to L breast; very painful. Taking OTC Tylenol with no pain relief.
it was rpt fr pharmD concerning pt who was vax & subsequently pt exp pock marks at the inject site. no further info avail
Pt rec'd Pfizer vaccine, completed 15 minute observation period without complaint, then returned to clinic around 10:30am reporting numbness in entire left arm.  Pt states she was not able to move fingers in left arm.  Upon initial evaluation by nurse left arm was pale and cold to the touch.  Paleness and coldness resolved within a few minutes.  There was slight weakness in left hand when patient was asked to squeeze nurses hands.  Right Arm- b/p: 112/82, O2: 99%, heart rate: 91 BPM.  Left Arm- b/p: 98/77, O2: 98%, BPM: 87.  Pt was asked again to squeeze nurses hands, pt was able to squeeze slightly harder, however slight weakness compared to right arm was still noted.  Pt verbalized improvement in feeling and movement, however states still did not have full feeling or movement back.  Advised to stay with school nurse for 1 hour and re-evaluate weakness.  If weakness persisted, advised to call physician.  Upon f/up from school RN, pt remained in clinic until 11:40am when student stated she felt "much better" and strength of left hand was almost that of the right.  School nurse states "vitals remained good".
slept for about 36 hours with brief periods of being awake; aching joints; headaches; exhaustion; pain in the arm (left) where the injection was given; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA, ARTHRALGIA, FATIGUE, INJECTION SITE PAIN (pain in the arm (left) where the injection was given) and HEADACHE in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE and INJECTION SITE PAIN (pain in the arm (left) where the injection was given). On an unknown date, the patient experienced HYPERSOMNIA, ARTHRALGIA, and HEADACHE. At the time of the report, HYPERSOMNIA and INJECTION SITE PAIN (pain in the arm (left) where the injection was given) outcome was unknown and ARTHRALGIA, FATIGUE, and HEADACHE had not resolved.            No concomitant medication was provided.  No treatment medication was provided.  Action taken in response to mRNA-1273 was considered to be not applicable.   This case was linked to MOD-2021-068138.
HAD BRONCHITITS TESTED NEGATIVE FOR COVID 1-27-23 AND ADMITTED  WITH PNEUMONIA LIKE SX AND COPD EXACERBATION TO LOCAL HOSPITAL . HE PRESENTED AGAIN  2-14-23 WITH SHORTNESS OF BREATH FOR 5-6 DAYS  ,REQUIRED CPAP AND BIPAP IN ER  ADMITTED WITH ACUTE RESP FAILURE WITH HYPOXIA  , PNEUMONIA AND COVID.     DECEASED AT HOSPICE 3-12-23
Pfizer Dose #1: 3/26/21 Lot # EP6955 ? LD site, Pfizer dose #2: 4/16/21 Lot # EW0150 ? LD site.  On 04/16/2021, pt had her second COVID vaccine and she also ate room temp seafood that may have done bad. The next day, the patient had N/V/D, and pain, fever, body aches.
Feeling warm; Diarrhea; Chills; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling warm), DIARRHOEA (Diarrhea), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced FEELING HOT (Feeling warm), DIARRHOEA (Diarrhea), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING HOT (Feeling warm), DIARRHOEA (Diarrhea), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported.
pt recvd vax & devel fever, febrile react to immun, vomiting, non specific rash; Rt TM (tympanic membrane) red;
woke morning p/vax w/generalized red sl raised rash. temp 99. benadryl and allegra given
Received 3rd dose HPV 1/7/14 was symptomatic at phy later that day felt weak, nausea. Next day sweats, no fever or chills, sneezing repeatedly. Symptoms lasted 4 days. No problem 1st dose 9/2011. 2nd dose March 2012 similar symptoms but not reported.
dizziness, unsteadiness, muscle soreness and pain in legs, small blisters and rash down injection arm
patient received partial 2nd dose; leaking from barrel of syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient received partial 2nd dose) and SYRINGE ISSUE (leaking from barrel of syringe) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced UNDERDOSE (patient received partial 2nd dose) and SYRINGE ISSUE (leaking from barrel of syringe). On 25-Feb-2021, UNDERDOSE (patient received partial 2nd dose) and SYRINGE ISSUE (leaking from barrel of syringe) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Minimal pain at time of injection (8pm 7/17/2018). Worsening pain over the next 3 hours. The pain radiated down the injection arm into her wrist, around the circumference of her arm, and up into her shoulder and neck. At 11pm 7/17/2018, pt had extreme myalgia over entire body and weakness (she described as way more severe pain than she ever got while sick with the flu). In the morning her pain was as severe and she had become extremely weak. She couldn't lift her arms and had severe fatigue after only 5 minutes exertion. She was unable to go to work (fitness trainer). She called us at 3 pm. We told her the pain and weakness is a normal reaction especially for her age group but it was our opinion that the degree of her pain and weakness may have exceeded a norml outcome. We attempted to reach her Primary care physician but he was on vacation. Patient also called Dr. We encouraged her that if the pain were to worsen more, her weakness progress further, or she has problems breathing, she should immediately call 911. I followed up with the patient tonight and she said the pain had improved slightly but she was still as weak. She reports no systemic fever and no local redness, warmth or swelling at the sight of the injection.
This spontaneous report as received from a registered nurse refers to a currently 5 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 03-APR-2018, a 11 minute temperature excursion of -13.3 degrees Celsius occurred as advised by the nurse. On 18-APR-2018, the patient was vaccinated with an improperly stored dose of PROQUAD recombinant Human albumin (rHA) or human serum albumin (HSA) of lot # N015623 with an expiry date of 15-NOV-2018 (Strength, frequency, route and anatomical location were not reported) for prophylaxis. All other temperatures were in range and average temperatures remained stable. The vaccine was in the freezer at the time of excursion. The nurse advised that this was a "supported temperature excursion" since it was between -10 and -14 (Units unspecified) for a period of 11 minutes and that the supply could remain in stock and was viable. No previous temperature excursion occurred. No adverse vaccine reactions were reported. The call was because of a data logger. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 18-Apr-2022; Vaccine was expired on 01-Apr-2022 administered on 18-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 18-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 18-Apr-2022) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 18-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 18-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 18-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 18-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, However the vaccine expired on 01-Apr-2022. On 04-Apr-2022, the vial was initially stored in the refrigerator. Reportedly, the vial didn't undergo any temperature excursions.  No treatment information was reported.
This spontaneous report was received from a pharmacist refers to a currently 63 year old female patient. No medical history and drug allergies were reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). No concomitant therapy was reported. On an unknown date the patient developed an unspecified cancer. The patient would start an unspecified chemotherapy soon. The patient sought medical attention-unspecified. The outcome of unspecified cancer was reported as not recovered/not resolved. The action taken was not applicable. The causality of the reported event was unknown. Upon internal review, the event unspecified cancer was considered to be medically significant. Additional information has been requested.
personnel giving the vaccine gave the incorrect dose incorrectly at 0.5 ml (100 mcg) instead of appropriate dose for booster at 0.25 ml (50 mcg)
headache, visual disturbance, RUE numbness, expressive aphasia of acute onset 2/11/2022
Persistent Fever around 100 degrees, extreme body aches, chest pain last night only feber and extreme body aches persist)