chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Maternal exposure during pregnancy; Arm was sore; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and PAIN IN EXTREMITY (Arm was sore) in a 27-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included DOXYLAMINE SUCCINATE (UNISOM 2) and PYRIDOXINE HYDROCHLORIDE (B6) for Nausea, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 30-Dec-2020 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in May 2020 and the estimated date of delivery was 11-Mar-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and PAIN IN EXTREMITY (Arm was sore). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 31-Dec-2020, PAIN IN EXTREMITY (Arm was sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jul-2021, Pregnancy test: positive (Positive) Positive. On an unknown date, Glucose tolerance test: normal (normal) Normal. On an unknown date, Trisomy 21: low risk (Borderline) Low Risk.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details was reported.  The patent's estimated date of conception was 20-Jun-2020.  The patient's previous pregnancy included a full term birth on 25-Jan-20219.; Sender's Comments: This is a case of product exposure during pregnancy with one reported AE for this 27-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the arm pain, a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Patient fainted about 10 minutes after receiving vaccine. Upon regaining consciousness patient was pale, sweating, and light headed. After about 30 minutes the patient was feeling well enough to leave with her sister.
Flublok that was frozen was administered in error, no AE; Initial information received on 15-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked with case 2020SA253162 (same reporter).  This case involves a 40 years old male patient who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] that was frozen in error (product storage error).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Sep-2020, the patient received 0.5 (unit not specified) of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2006 and expiry date 22-May-2021) via unknown route in unknown administration site for prophylactic vaccination.  This was an actual medication error case due to product storage error temperature too low.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
day after the vaccine I developed atrial fibrillation, went to ER at hospital and was observed for about 8 hr. The fibrillation subsided with Rx but recurred in short episodes over the next week.
Pediarix & Hib given to pt at 11:30AM. By 16:00 child started crying and cranky. Tylenol given with relief. Child felt better next day. Tylenol helped crying to stop.
On Feb 3, 2020 I was given the first Shingles shot in my upper right arm. It was painful and remains painful to this day. For the last two months  I have suffered from  limited use of my left arm if I try to dress, reach or move my arm in a certain direction. I also have a non-stop tingling sensation as if the needle where still in my arm. Very annoying. After 2 months of pain I thought it was best to report it to my doctor and the Pharmacy located on
should have two injections; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date, few years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comments: The case was reported by the patient via interactive digital media. The patient just found out that he/she should have received 2 injections. The patient asked if he or she should take second dose now. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
COVID-19; COVID-19; 26Dec2020-Pfizer (DOSE 01); 15Jan2021-Pfizer (Dose 02); 03Sep2021-Moderna (Dose 03); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 26Dec2020 as dose 1, single (Batch/Lot number: unknown) and on 15Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 26Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Is the patient a smoker/former smoker? No" (unspecified if ongoing), notes: Is the patient a smoker/former smoker? No. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2021, outcome "unknown", described as "26Dec2020-Pfizer (DOSE 01); 15Jan2021-Pfizer (Dose 02); 03Sep2021-Moderna (Dose 03)"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Aug2022, outcome "recovered" (2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
6 hours after receiving H1N1 inactivated vaccine left arm developed pruvitic hives left arm, right arm, and chest.
Patient was scheduled to receive the bivalent moderna booster covid vaccine but was provided with improper dose.  Received 0.25ml rather than 0.5ml. No adverse events reported.
Pain at injection site, redness, swelling. Fever of 101 degrees 5 hours later, rash hives, muscle aches, lightheaded, headache, vomiting, diarrhea.
A little bit of a sore arm; This is a spontaneous report from a contactable consumer (Patient). This is the master case and one of the two reports.   A 69-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9263, expiration date reported as 202021), via an unspecified route of administration, administered in arm on 02Feb2021 (at the age of 69-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included a very inflamed sciatic nerve for which patient was taking ibuprofen and Tylenol and stopped prior vaccination. The patient concomitant medications were not reported. On an unspecified date, the patient experienced a little bit of a sore arm. The patient was having a very inflamed sciatic nerve and was taking Ibuprofen and Tylenol for it but read that patient needed to stop that prior and after the vaccination. So, patient did that because it interferes with something with immune system. Patient questioned when it was appropriate to resume taking those drugs (Tylenol or Ibuprofen) again. Patient was taking both of those drugs prior to the vaccination but stopped taking them because all advise said not to take them prior or after the vaccination because it would interfere with the vaccination to work, so now patient was trying to find out how long patient need to wait after the vaccination before resuming Tylenol. When asked to confirm the two drug Ibuprofen and Tylenol query, consumer stated as yes (Ibuprofen and Tylenol), Tylenol was an Aspirin medication another name for (Tylenol). Consumer was informed about Pfizer Medical Information Department. When asked if have any problems with vaccine, consumer stated absolutely none. The outcome for event little bit of a sore arm was unknown.  Follow-up attempts are completed. No further information is expected.
I've always had problems with my sinuses so I gave little thought to the  constant sniffles . Until recently when I was at the movies with a friend and they really  expressed how much noise I was making. That's when I got the Allegra  Nothing  improved then I  was frying some chicken and noticed I could not smell it that much or anything else .. Unless I'm being over whelmed by a smell I won't  smell it but yet my taste buds are just fine.
Patient stated that her arm was very sore and swollen - she called the pharmacy and informed us of this approximately 4 days after the vaccines were administered
CDC reports: 2 yo child immunized 19FEB90, 26FEB90 developed fever 103 & convuls. Dx Strep throat @ E>R>;
Pt was seen on 10/5/09 after receiving FLUMIST and varicella vaccine on 10/2/09. She c/o B both arms and both leg weakness. She describes a feeling of a weight on them. The arm symptoms improved through the day but leg symptoms persisted and weakness. Was not stable on exam. Lower extremity reflexes were normal.
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female patient who on 16-SEP-2010 was vaccinated with her first dose of GARDASIL (lot #660387/1967U) and subsequently was determined to be pregnant by a pregnancy test. Concomitant therapy included PROVENTIL. No adverse effects were being experienced by patient. Last menstrual period (LMP): 15-JUL-2010. Her estimated date of delivery (EDD) was 21-APR-2011. The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. Follow up information was received from the physician and reported that the patient with a history of asthma and obesity, 5 previous pregnancies, 3 full term deliveries, 2 spontaneous abortions (miscarriages), birth defects in previous pregnancies unknown and infant complications in previous pregnancies unknown. The patient took PROVENTIL every 4 hours as need for short of breathiness, and on 16-SEP-2010 the patient was treated with cyclobenzaprine hydrochloride (manufacturer unknown) 10 mg TID as needed for back pain. It is unknown if any tests are done for this patient. Follow up information was received from a registered nurse and reported that the patient with diagnosis of abnormal Phenolsulfonphthalein (PSP), chlamydia, Trichomoniasis, Gonorrhoea and no birth defect in previous pregnancies. On 17-SEP-2010 ultrasound showed single live fetus. On 10-FEB-2011 ultrasound showed normal fetal survey. On 02-MAR-2011 ultrasound showed no bleeding, normal pregnancy. On 13-APR-2011 the patient had ultrasound due to weight loss which showed  normal amniotic fluid (AFI). During pregnancy on unknown date, the patient experienced pressure which was treated with ZOLOFT, and experiencing nausea which was treated with PHENERGAN. On unknown date during pregnancy, it was found the size was less than dates (WAES # 1009USA03595B1). The patient also took prenatal vitamin during pregnancy. On 23-APR-2011 the patient had a liveborn male baby on 38 weeks from LMP who is 3505g, length 20.5 inch, Apgar score 9/10, head circumference 14inch. The baby is normal, and no congenital anomalies and no other complications. Ultrasound also showed weight loss, depression and size <dates. The baby's adverse event was captured in WAES 1009USA03595B1. Additional information has been requested.
Patient inadvertently given duplicate dose of Polio vaccine. One dose was from a multi-dose vial of single antigen IPV and the other dose was given from a combination vaccine, KINRIX. Both vaccines were given simultaneously in opposite arms. Parent was notified of duplicate dose and patient was observed for 30 minutes in the office before leaving. Dr. followed up with patient and her mother 24 hrs after the dose was given. Mother reports patient generally not feeling well, headache and warm to touch (no temperature obtained). Mother gave the patient a dose of Tylenol.
ringing in ears (for 1 mon); lt sided body numbness (for 1mo); had MRI to have spinal tap & blood work;
localized swelling of the arm and muscle spasms, headache, very painful arm/back/neck soreness, fatigue, nausea, and flu like symptoms all appearing within a few hours of injection and lasting for 48 hours. The swelling, muscle spasms and soreness still apparent after 48 hours.   (experience a similar reaction as an infant, but that the doctor assumed it was from the pertussis).
Pt. received two vaccines, I gave the first vaccine (flu) at 11 am then I gave her the Pneumovax 23 at 1102 am.  Pt. c/o of backache, pain shot up from from her leg to her back.  I gave her the epinephrine in the right thigh at 1110 am.  She kept moving and moaning with pain for about 10-15 minutes.  After that she settle down.  During that time we took vital signs and called the ambulance.  Pt did not have any rash, skin warm and dry, no nausea or vomiting, LE's no swelling.  I noticed pt. was shaking all over about 1/2 hr. after this all happened.  She stated, her chest felt tight, she felt like she could not breath.  This was after she calmed down, I asked her these questions.  The ambulance came and took her to medical center at 12 pm.
Administered DTaP, MMR, IPV and flu vaccines at approx 2:15pm. By 4:15pm was breaking out in tichy rash on trunk. By approx 5pm when sought medical attention at local ER was experiencing urticaria over entire body, including face, neck, extremities, and trunk.
30 MINUTES after receiving flu vaccine he had hives to arms, neck,face, itching, and slight itchy feeling to his throat. No SOB/chest pain or nausea/vomitting. He works in ED so he was seen there. received 1 liter normal saline IV fluids. 1 gram of tylenol, benadryl 50mg IV push. Pepcid 20mg IV push. solumedrol 125mg IV push. Had improvement of rash/itchiness and was released home with. Rx for benadryl/prednisone/H2 blocker.   Was re-evaluated by me the following morning, and had not filled Rx. Still with multi form wheels to arms with itching. NO angioedema, respiratory sx, No nausea vomiting. Reinforced the importance of continuing RX for sx resolution. Has appointment followup scheduled on 9/30/19.  Patient notes that last year he received the flu blok on 10/10/18 without any issues. Previous 10/10/2017 regular influenza IIV vaccine he also experienced hives.
Tingling in feet and legs that lasted x 15 minutes later in the day after receiving the vaccine.  Also had tingling in left arm where she received vaccine. Experienced aching in legs and fatigue for several days after receiving vaccine.
symptoms included pleuritic chest pain and shortness of breath; diagnosed with bilateral subsegmental pulmonary emboli and popliteal deep venous thrombosis, currently being treated with lovenox with plan to bridge to warfarin
Patient was younger than 50; Slight pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 46-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had outbreaks of shingles 2 to 6 times a year for the past 10 years or so).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain and inappropriate age at vaccine administration. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 45 or 46 year. After receiving the 1st dose of Shingrix, the patient felt an immediate difference and got slight pain for 2 months and they felt as if the body was fighting off. The reporter consented to follow-up. For tolerance to the 2nd dose of Shingrix, refer case US2021AMR033905; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR033905:Same reporter, same suspect, same patient, 2nd dose
rash had spread down lhe arm past the elbow. The rash has the appearance of "tiny papules (little fine raised bumps)".; lhe patient developed a "rash" at lhe "injection site"; This spontaneous report has been received from a medical assistant referring to a 12 years old female patient. The patient was not pregnant. The patient had administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) on 15-MAY-2015, rash developed after first dose. Concomitant drug included meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) administered in the left arm on unknown date. The allergies included poison ivy, poison oak and unspecified sunscreen.       On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: R032767, expiration date: 31-AUG-2021, dose 1, intramuscular in the right arm) for prophylaxis.         On 18-JUL-2019 the patient developed a rash at the injection site. On 20-JUL-2019 the patient stated the "rash had spread down the arm past the elbow", the rash had the appearance of "tiny papules (little fine raised bumps)" (rash papular). The patient had "refused treatment" from her Physician. The reporter also mentioned the patient had a similar reaction after being administrated the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (unknown lot # and expiration date).      The outcome of injection site rash and rash papular were reported as not recovered. The causality between injection site rash, rash popular and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not provided. No Product Quality Compliant (PQC) was present.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA014034:same reporter
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 20-year-old female patient received TRUMENBA (0.5 ml), via an unspecified route of administration on an unspecified date at 0.5 ml, single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient's arm began to swell several hours after receiving the vaccine. Eighteen hours later, it resulted in a golf ball size swelling surrounded by redness around the injection site area. The swelling lasted for three days. She also experienced headache, tiredness, soreness and pain on an unspecified date. Outcome of the event 'Vaccination site swelling' was recovered on an unspecified date; outcome of the other events was unknown. Information on the batch number has been requested.
Period came uncharacteristically early; The cramps were more severe and breasts were tender for a couple days prior; The cramps were more severe and breasts were tender for a couple days prior; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 06May2021 at 15:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. 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. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 15Apr2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 19Jun2021, a couple days prior to her period, the patient experienced cramps which were more severe and breasts were tender, which was not something that has happened for the patient before. On 21Jun2021, the patient experienced period which came uncharacteristically early. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period came uncharacteristically early, the cramps were more severe and breasts were tender for a couple days prior which was not something that has happened for the patient before was unknown at the time of this report.
This spontaneous report as received from a pharmacist refers to a 60 years old female patient. The patient did not have any drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, left arm, lot # was reported as H098038, expiration date was in January 2014) on 31-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The patient developed a headache three hours later after vaccinated ZOSTAVAX on 31-DEC-2012. No treatment information was reported. The patient sought medical attention via calling pharmacy. The outcome of headache was reported as not recovered/not resolved. The relatedness for headache is unknown for ZOSTAVAX. Additional information is not expected.
10/20/2014 THE PATIENT REPORT A HARD RED AREA SIZE OF QUARTER THAT ITCHES AND IS HOT TO TOUCH, NO FEVER OR CHILLS NO OFFICE VISIT NECESSARY. ADVISED COOL PACK INTERMITTENTLY, TYLENOL FOR DISCOMFORT, AND BENADRYL FOR ITCHING AT BEDTIME. SHE IS TO REPORT FURTHER SYMPTOMS.
Swelling, itchy reaction (28.5 cm circumference around arm) area 10x10 hot to touch. Painful. Swelling was better per mother but hotter to touch.
About 2 hours after the 3:30 pm injection, around 5:30-6:00 pm, I began feeling nauseous followed almost immediately by tingling in my mouth and tightness in a band circling my upper abdomen and back. I also felt tightness in my upper back. I felt it was challenging to draw breath, though I had no swelling in my face or throat. The symptoms got worse for about an hour and then began to fade. I went to bed about six hours after the injection and by then I had milder nausea and much less tightness.