chrisvoncsefalvay/vaers-outcomes huggingface dataset:
singular Pustular rash which began to Left upper shoulder. Then to R upper shoulder. Increasing number of singular small approx 3 mm pustular rashes to abdomen, torso, dorsal aspect of hand, anterior and posterior neck, Left ankle medially, bilateral medial thighs. I began taking cetirizine 10 mg daily 3 days ago due to eruptions. Began taking diphenhydramine last night to help with itching. I don't believe any new foods, nor shampoo, nor detergents, nor soaps. The eruptions are not like I have seen for other patients, since I do Primary Care. Usually, patients get an immune rash to the injection site and arm. These are pustular, singular, small 3mm, non tender, but intensely pruritic. I did have significant fatigue, nausea, abdominal soreness for 3 days after the vaccination, which I attributed to the vaccination. I am fine other than very itchy; I just want to make sure I report it just in case, and since it is mandatory due to EAU.
Headache, Myalgia & Fever missed work due to flu-like symptoms after second dose
Reports that his arm still hurts after 2nd dose vaccination.  Sometimes has to take tylenol to sleep.
Information has been received from a pharmacist concerning a 20-year-old female patient, who on 28-OCT-2008 was vaccinated with a dose of PNEUMOVAX (lot number, route and injection site unknown).  Subsequently the patient developed fever, chills and local reaction.  It was unknown whether the patient sought medical attention.  The patient's outcome was unknown.  Additional information has been requested.
Patient described extreme muscle soreness, tingling in fingers, 1/2 grip strength, cannot lift arm or move across her body.
itchy rash - hips , thighs after vaccine #1 12-23-20 rash developed on 1/8/20  had vaccine #2 - 1/13/21 - rash progressed to include upper back, elbows, axilla
Case number PHEH2012US016273 is an initial spontaneous report received from a medical assistant on 15 Aug 2012. This case refers to a child patient (age and gender not reported). This patient received only the MenCYW-135 liquid conjugate component of MENVEO (batch number: A10054) intramuscularly on 04 Aug 2012, and did not receive the MenA lyophilized conjugate component of MENVEO. The reporter stated that few children were vaccinated 04 Aug 2012, and they could not tell which child received only the partial dose. No adverse event was reported following vaccination.
2 days p/inj,  pt's arm became sore @ the site;site warm to touch w/hardness felt @ site;shooting pain began extending to fingers;rt side of neck became sore;no redness @ site;no fever of 101 x 1 days;d,tender ax adenopathy;
Pt reported itching at injection site immediately following injection. Pt was given 50mg BENADRYL to be safe. Pt reported no further itching that day or next day.
Pre medicated with 100 mg PO benadryl 10 minutes before injection. Immediate lip swelling, and throat scratchiness. Cough and mild wheezing. Administered additional 50 mg IM benadryl, Lip swelling continued but did not need to have epinephrine administered.Discharged to home with epi pen.
Information has been received from a nurse practitioner concerning a male with no pertinent medical history, allergies or drug reactions who on 05-OCT-1998 was vaccinated with VARIVAX (Oka/Merck) (Lot no. 637876/1241H) 0.5 mL, route and site not reported. It was reported by the physician that the patient experienced shingles. On an unknown date, the patient recovered from shingles. Follow up information has been received from a nurse practitioner on 12-MAR-2009. It was reported that the 11 year old student was vaccinated subcutaneously with a one time 0.5 mL dose of VARIVAX (Oka/Merck) at age 1 year. On an unspecified date, the 11 year old was diagnosed with shingles. On an unknown date, the patient had recovered. Additional information is not expected.
This spontaneous report as received from a registered nurse concerning to a patient who, on an unspecified day, was vaccinated with an improperly stored dose of MMR II which was exposed to 67 F for 63 hours. No adverse effect reported. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
Redness appeared 1-2 hrs after administration 22 hrs after redness, heat, itchiness 2 1/2 x 1 1/2 diameter ring of inflammation.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 7-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
large, red itchy rash developed seven days after injection.  injection received on Friday, January 15th--rash appeared on the evening of Thursday, Januaruy 21.  Rash approximately 5" x 2".  Pictures available.
Aches, chills, nausea, vomiting within 24 hours lasting 3 days.  Took 2 advil 600 mg  every 12 hours or so. Rested.
Pt recvd MMR 05NOV90; On approx 07NOV90 devel morning pain & stiffness, & erythema on rt, 2nd & 3rd metacarpophalangeal joints; tx Anaprox w/no relief of sx; Lab eval positive for rheumatoid factor;
Redness & swelling in entire upper arm area. Presented at pharmacy 6 days after receiving vaccine.
SM developed raised, red, itchy lesion on arms, neck, upper legs. A few days later, he noted fatigue and malaise, one episode of SOB on 7/7/08 as well as arthralgias.
Rash-papular, diffuse-3 days after vaccinations. Second occurrence. Treated with antihistamines. Child's mom called office 4-4-10 stating child had rash for 2 days.
This spontaneous report as received from a consumer via Clinic refers to a currently 2 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-MAY-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M008589, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Pt. rec'd Hep A, Hep B and Quad FLULAVAL at O.V. on 10/04/17. Seen again on 10/05/17 for reported S/S "hives/rash on trunk/arms/legs. Afebrile. Mom gave BENADRYL and rash resolved after 10/05/17 O.V. Mom provided phone pics to PCP of rash/hives.
This spontaneous report as received from a physician refers to a 22 year old male patient. On 17-JUL-2012 and on 11-JAN-2013, the patient received the first and the second dose of GARDASIL respectively. On 05-APR-2013, the patient was vaccinated with a third dose of GARDASIL (lot # 0459AE, expiry date was 13-DEC-2013, route and dose were not reported) that was improperly stored at temperatures 29 Fahrenheit (F) to 29F. No adverse reactions were reported. The patient remained healthy. This is one of the four reports received from the same reporter (MARRS# 1305USA017145, 1306USA003145 and 1307USA014754). Additional information is not expected.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/31/2022,  11/25/2022,  11/27/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Woke next day with sore arm, chills and temp 99.6.  Tired and chill all day.  Took tylenol.  Much better today.
On same day of vaccination, I experienced severe and almost unbearable ringing in both ears.  On same night, I experienced a watery discharge from my right ear which fortunately, alleviated the symptoms after several hours. The closest ENT appointment was given for March 8. Currently, I am still experiencing the noise from my left ear which is traumatizing. Difficulty sleeping and concentrating.
Narrative:  Patient presented with complaints of fever/fatigue/cough/shortness of breath. -Patient has been having several COVID-19 complaints such as headache, fatigue, cough, shortness of breath particularly on exertion. Symptoms have been occurring for appx 1 week. Patient's longterm partner was recently admitted to Medical Center for PNA which she was found to be COVID19 positive. Patient's partner was having a cough for appx 3-4 weeks and was worsening the last several days. -No complaints of anosmia, loss of appetite, diarrhea, CP, pleuritic CP -Patient had Pfizer COVID19 PNA vaccination in Jan/Feb 2021 -Patient has former tobacco hx 1ppd for 30 years in past and Substance abuse history including cocaine, IV heroin, marijuana Admitted to hospital, administered oxygen and dexamethasone and supportive care. Remdesevir administered once renal functino improved to Cr<1.5. Discharged home after revovering.
discomfort in the injection arm; her left hand is warm; her left hand is red; her left hand hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (discomfort in the injection arm), INJECTION SITE WARMTH (her left hand is warm), INJECTION SITE ERYTHEMA (her left hand is red) and INJECTION SITE PAIN (her left hand hurts) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE for an unknown indication.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE DISCOMFORT (discomfort in the injection arm), INJECTION SITE WARMTH (her left hand is warm), INJECTION SITE ERYTHEMA (her left hand is red) and INJECTION SITE PAIN (her left hand hurts). At the time of the report, VACCINATION SITE DISCOMFORT (discomfort in the injection arm), INJECTION SITE WARMTH (her left hand is warm), INJECTION SITE ERYTHEMA (her left hand is red) and INJECTION SITE PAIN (her left hand hurts) outcome was unknown. Not Provided          Treatment information was not provided.
a delayed reaction, rash at injection site which looks like cellulitis; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (a delayed reaction, rash at injection site which looks like cellulitis) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (a delayed reaction, rash at injection site which looks like cellulitis). The patient was treated with PREDNISONE for Vaccination site rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (a delayed reaction, rash at injection site which looks like cellulitis) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Age of patient was corrected; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from an office manager via field representative refers to an approximately 12 months old female patient. Pertinent medical history was reported as none. On 23-APR-2014, the patient was vaccinated with VARIVAX, lot # J009167, 1 single shot, subcutaneously for the prevention of varicella. Other suspect therapies included PREVNAR received on 23-APR-2014 and ACTHIB received on 23-APR-2014. On approximately 01-MAY-2014 (also reported as eight days after administration of VARIVAX), the patient was diagnosed with herpes zoster. Patient sought medical attention and visited the physician. Action taken with respect to VARIVAX, PRENAR, ACTHIB was not applicable. No product quality complaint was involved. The outcome of herpes zoster was unknown. Causality was not provided. No further adverse event information was provided. Additional information has been requested.
sore arm; muscle ache; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PAIN IN EXTREMITY (sore arm) and MYALGIA (muscle ache) in a 29-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013821A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension in January 2017, GERD in 2005, Sleep apnea in August 2019, Anxiety in October 2010 and Pregnancy (spontanous  misscarriage) in May 2017. Concurrent medical conditions included Shellfish allergy (shell fish, Peptose). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN C [ASCORBIC ACID], VITAMIN B NOS and ZINC for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 17-May-2021. On 24-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and MYALGIA (muscle ache). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 24-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) and MYALGIA (muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, Pregnancy test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided Patient estimated conception is on 29-08-2020.
Starting 12 hours after receiving vaccine: chills, 2 degree fever, sore arm, tired, headache  Starting 18 hours after, nausea, 1 incident of vomiting, dizziness, weakness,  This lessened as day went on. Still had headache and small fever. Morning of next day - headache gone, body temp back to normal.  Felt only a little less energetic; otherwise, back to normal.
Severe Headaches, severe swelling at injection site, body chills, extreme irritability, stomach ache...all symptoms have been constant for 3 days now starting from the first day of the vaccination. Before hospitalization, I gave her 10mg doses of vitamin c, as well as Tylenol for the body and headache pain.
Significant persistent pain at site of injection. Pain later presented at various sites (unassociated) of body leg/foot, others.
This spontaneous report was received from a medical assistant and refers to an unknown number of unspecified patients. Since August 2015 (reported as "for the past two years"), the patients were vaccinated with improperly stored doses of PROQUAD (dose, route of administration, lot# and expiration date were not reported) for prophylaxis reconstituted with sterile diluent. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA013509: US-009507513-1708USA013510:
I spoke with patient at 2:15 pm on 8/30/23, patient states that after she left clinic yesterday, her left arm started feeling full, as if her blood pressure was being taken. She also c/o pain/achiness to back of head and neck, left shoulder. She later felt as if she was chilled, so she took tylenol or ibuprofen, and went to bed. When she woke up on 8/30, she if feeling better.
Pt was given vaccination (Fluzore). In 10 minute pt was flushed skin warm to touch and slightly nauseous. Sat for 10 minutes and felt slightly better and wanted to leave. Returned in 1/2 hour still queasy and flushed. Administered Epipen. Felt better in 5 minutes. Pt remained better on 11/08/2001 as well.
Irregular heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 08Mar2021 at 11:00 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included food allergy. 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 COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 15Feb2021 at 11:00 as a single dose for COVID-19 immunisation. On 10Mar2021 at 06:00, the patient experienced irregular heartbeat. No adverse symptoms with this. Felt fine, blood pressure (BP) and Pulse normal. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient underwent blood pressure and the result was normal. On an unknown date in Mar2021, the patient underwent pulse rate and the result was normal. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event irregular heartbeat was recovered on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Patient had received 2 doses of Moderna prior, 2nd dose being some time in April. Patient is not immunocompromised and received a 3rd dose of Pfizer in error. No adverse event is apparent at this time.
Patient was given booster dose of Moderna. Lot 023C21A was found to be expired on 10/24/21 and dose was given on 10/25/21. No adverse reaction was noted. We have reached out to Moderna for guidance and vials were put in quarantine.
Pt recv vax on 3/11/99; 2 hr post vax pt exp painful vax site, cold sensation, sore lt leg at pelvic joint; tx=Tylenol
I am not even getting 3 ounces every 12 hours and my breast are not full and have not felt full in over a day; I am breastfeeding. I was pumping a minimum of 25-30 ounces a day to feed my baby, and if I didnt pump every 4 hours I would feel very full and hard on my breasts. 2 days after receiving the first do; I am breastfeeding; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Batch/Lot number: unknown) at the age of 25 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications.  The following information was reported: OFF LABEL USE (non-serious) with onset 05Oct2021, outcome "unknown", described as "I am breastfeeding. I was pumping a minimum of 25-30 ounces a day to feed my baby, and if I didnt pump every 4 hours I would feel very full and hard on my breasts. 2 days after receiving the first do"; PRODUCT USE ISSUE (non-serious) with onset 05Oct2021, outcome "unknown", described as "I am breastfeeding"; SUPPRESSED LACTATION (non-serious) with onset 07Oct2021, outcome "not recovered", described as "I am not even getting 3 ounces every 12 hours and my breast are not full and have not felt full in over a day". Therapeutic measures were not taken as a result of suppressed lactation.  Additional Information: Patient previous pumping a minimum of 25-30 ounces a day to feed her baby, and if she didn't pump every 4 hours she would feel very full and hard on her breasts. On 07Oct2021 at 00:00, 2 days after receiving the first dose, patient was not even getting 3 ounces every 12 hours and her breast were not full and have not felt full in over a day. Patient had to buy formula for baby in order to feed the baby. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had no known allergies. 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.  Concomitant medications included unspecified pre-natal (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing for an unknown indication. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101488763 baby case