chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 23-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and DOCOSAHEXAENOIC ACID (DHA) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Oct-2020 and the estimated date of delivery was 02-Aug-2021. On 17-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  On 17-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided      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.   Tests done was Ultrasounds, Anatomy scan and urinalysis (test results unknown).  On 26 Nov 2020, Pregnancy test was Positive. No treatment medications reported.
49-year-old female client  presents to Covid Vaccination location and requests a Pfizer first booster. Client reports to RN  that she developed a rash on abdomen and right leg 12 hours after Pfizer first dose Lot# EW0167 on 5/12/2021. Client states it went away 12 hours after and no medication was taken. Client reports it was the first time she has had a rash, and that it was not painful nor itchy. Client did not report this when getting her Pfizer second dose Lot#EW0168 on 6/2/2021 nor report it to her primary care provider. Client states no rash or adverse reactions occurred after Pfizer second dose. Per client, NKA, no health conditions, and no medications taken at this time. At 1551 medical consult sent to Dr. if Pfizer first booster could be given today. At 1552 Dr.  approved for Pfizer first booster. Client received a Pfizer first booster Lot#FP7138 today at 1555. Client was asked to stay 30 minutes in the observation area by RN. Lead nurse educated client to seek medical care if an adverse reaction occurs as well as to check in with their primary care provider if any changes occur. Client tolerated Pfizer vaccine first booster well and reported no rash after the 30 minutes. Client left the facility in a steady gate.
10 wk old infant vaxed 14JUN94 & w/in 24 hrs devel generalized urticarial rash; seen by MD 16JUN; tx w/DPH; recovered;
Pneumonia; Pneumonia; This is a spontaneous report from a contactable pharmacist. A 82-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at single dose for immunization, pneumococcal vaccine polysacch 23v (PNEUMOVAX 23), via an unspecified route of administration on an unspecified date at unknown dose for immunization. Medical history included high blood pressure, pneumonia in past years. The patient's concomitant medications were not reported. The patient experienced pneumonia on an unspecified date. The pharmacist reported that his mother (the patient) was vaccinated both pneumococcal 13-val conj vac (dipht crm197 protein) and pneumococcal vaccine polysacch 23v on unknown date. This year alone his mother had had pneumonia 3 times. She had had pneumonia in past years also, but he was not sure about relative information about those events. His mother did not have any underlying medication condition, only high blood pressure. The last time she got pneumonia he thought she was going to die because it was really bad. He asked for information about reimmunization with pneumococcal 13-val conj vac (dipht crm197 protein) because he felt like his mother may not have been well vaccinated. At the time his mother weighed more and had bigger arms and wondering if maybe at the time the needle did not go deep enough. The outcome of the event was unknown.  Information on the batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results are needed for full medical assessment.
myalgia; fever; fatigue; flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of myalgia in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced myalgia, fever, fatigue and influenza-like symptoms. On an unknown date, the outcome of the myalgia, fever, fatigue and influenza-like symptoms were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, fever, fatigue and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of Shingrix and two days after experienced myalgia, fatigue, fever and flu like symptons ongoing for 8 days.  The reporter did not consent to follow up.
Patient reported nausea, vomiting, and fever beginning about 12 hours after receiving the vaccine and lasting for about 3 hours.
Was 7 weeks pregnant, due Aug 30, nothing adverse happening to pregnancy. Shortly after that shot i had a sore arm and left armpit lymph nodes for a few days. I noticed yesterday, a week after the shot, the lymph nodes were still a little sore. Then yesterday afternoon, my left shoulder started itching like crazy at the injection site, lasting for a couple hours. I looked and it was red where it itched, like three splotches the size of quarters but not very defined. This morning it is red over a larger swath, like a palm and a half on my shoulder. Feels sore and slightly hard under the skin, rather than itchy.
COVID breakthrough cases where the 2 individuals had received Pfizer vaccine; the individuals were surprised they tested positive since they were vaccinated; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two different patients. This is the first of two reports.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 2, single, for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single, for covid-19 immunization. It was reported that there were recent COVID breakthrough in patient who received the vaccine; that was mild case of COVID, and the patient was surprised that tested positive after vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date.  It was unknown whether the patient received any treatment. The outcome of the events was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101376953 same reporter/drug/event and different patient
Pt recvd 3 doses of Engerix-B & 31OCT91 it was determined that pt did not respond to the vax series;
This spontaneous report as received fro a pharmacist refers to a 71 year old female patient with hypertension, irritable bowel syndrome, migraine headaches and drug reactions/allergies to sulfonamides. On 26-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 0.5 ml in the left arm (lot # K004487 and expiry date: 21-AUG-2015) (route not reported). On 27-AUG-2014 the patient developed a large area of redness and warmth at the injection site. The area of reaction started 2 inches below the left shoulder and extended to the elbow. The patient visited an emergency room and on 27-AUG-2014 was diagnosed with an allergic reaction. She was prescribed BENADRYL, MOTRIN and ice compresses as a treatment. The outcome of an allergic reaction and a large area of redness and warmth at the injection site was unknown. Relatedness between the events and PNEUMOVAX 23 was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Immediately after shot patient lightheaded, pale, no LOC, no nausea, but felt shaky. Given orange juice and better but reported 7-10 minutes post vaccine a "strong sensation" (R) hand side of vaccination. No paresthesias or weakness. Left office on own.
About 7-10 days after injection patient started with a headache and pain behind knees.  The pain went to lower back, shoulders and jaw.  When pain behind knee and lower back began he went to a chiropractor.  Pain did not get better.  His foot doctor suggested him go to a neurologist where they sent him for x-rays and MRI's and sent him to physical therapy, which did not help and he was released.  He returned to chiropractor and still did not get better. He saw his primary care physician and he sent patient for blood work.  The blood work came back showing patient had very low iron. His primary sent him to Dr.  She sent him for a biopsy of the Temporal artery, which came back positive for an autoimmune disease called temporal arteritis.  He was treated with prednisone and slowly began feeling better.
chronic cough; smell and taste have been altered /losses; smell and taste have been altered /losses; heavier menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (chronic cough), PAROSMIA (smell and taste have been altered /losses), TASTE DISORDER (smell and taste have been altered /losses) and HEAVY MENSTRUAL BLEEDING (heavier menstrual cycle) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in December 2021. Concomitant products included ZINC and VITAMIN B COMPLEX (VITAMIN B CO) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced COUGH (chronic cough), PAROSMIA (smell and taste have been altered /losses), TASTE DISORDER (smell and taste have been altered /losses) and HEAVY MENSTRUAL BLEEDING (heavier menstrual cycle). At the time of the report, COUGH (chronic cough) had not resolved and PAROSMIA (smell and taste have been altered /losses), TASTE DISORDER (smell and taste have been altered /losses) and HEAVY MENSTRUAL BLEEDING (heavier menstrual cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   It was unknown if the patient experienced any additional symptoms/events. The patient had no medical history, concomitant disease or risk factor. It was unknown if there were additional lab data/results available.
Extreme debilitating body aches for over 72 hours.  Extreme swelling of lymph nodes in arm pit of injected arm with extreme pain unable to use arm.  Injection site does not hurt.
Within 2 minutes of injection left thigh developed 2cm wheal at site. No respiratory sxs. Treated patient with Zyrtec syrup. Patient left our office after approx 45 minutes - wheal almost completely resolved.
?COVID arm?: 4? x 2? oval area- red, itchy, somewhat firm, swollen, increased in size since initial vaccine response, very noticeable one week post vaccine, contacted primary care physician via phone yesterday, he is concerned, but I don?t want to go to an urgent care facility
Pt awoke from nap on day of receiving vax screaming that his left ear was hurting. The health care provider treated him with "drops" and oral antibiotics (not specified). Later that evening child again complained of ear pain and was seen in the ER. He was given a diagnosis of "mild" pharyngitis. The following day he was seen by his health care provider with no signs of ear pain and was found to be "fine." He recovered.
Fever of 102; Severe nausea; chills; This is a spontaneous report from a contactable consumer reporting for herself. A 69-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration, administered in Left arm on 25Feb2021 at 18:45 as single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus. Concomitant medication(s) included metformin (GLUCOPHAGE); levothyroxine sodium (SYNTHROID); atenolol; simvastatin and QUIN. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. On 01Mar2021 at 07:00 the patient had Severe nausea, chills, and fever of 102. No treatment was received. The patient underwent lab tests and procedures which included body temperature: 102 (unit not reported) on 01Mar2021. The outcome of the events was resolved on unknown date of Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from an RN concerning three pts who in approximately January 2004, within the last three weeks and two of those within the last two days, who were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The nurse did not provide specific pt details but reported that the pts developed local reactions that were very bothersome for them, including temporary loss of the full use of the arm, pain, erythema an hardness. Unspecified medical attention was sought and no treatment was required. No further details were provided. No product quality complaint was involved. It was noted that all the reactions came from the same lot number but upon inspection the vaccine "appears" to be fine. Information has been received from an RN concerning a 69 year old male with allergies to codeine, amoxicillin and Keflex who on 14JAN2004 was vaccinated IM in the left upper arm with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included ASA enteric coated 81 mg 1 PO daily, Lipitor, Wellbutrin 100 mg PO BID, Toprol XL 50 mg PO daily and Nitrolingual 0.4 mg/dose one under tongue as needed for chest pain. On 15JAN2004 the pt was seen in the physician's office for an allergic reaction to the vaccine. It was reported that the pt was "now" on Bactrim for a respiratory infection. The pt had developed increasing pain and redness at the left shoulder. There was no shortness of breath. The pt was in no acute distress. Her vital signs were: Temperature 99.0, BP 112/70, pulse 84, and respirations 18. The pt developed a local reaction that was very bothersome for her, including temporary loss of the full sue of the arm, pain, erythema and hardness. The pt had tenderness at the upper outer extremity especially over the deltoid region but also spreading circumferentially almost completely around the upper arm. There was no substantial tenderness and a mild amount of swelling associated with this. her lungs were clear. The pt was given an injection of 10 mg of Benadryl which produced no response, and 25 mg which also produced no response and the pt was not drowsy.  A prescription was given to the pt for prednisone 10 mg, two now, then one tonight, and then one BID starting on 16JAN2004. Side effects were discussed. Benadryl 50 mg which the pt could obtain in an over the counter form was noted. On 16JAN2004, the pt was to be seen for follow up to see how she was doing. Subsequently, the pt recovered. No product complaint was involved. It was also noted that 2 other pts wee vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also developed adverse reactions. It was noted that all the reactions came from the same lot number but upon inspection the vaccine "appears" to be fine. No further info is expected.
Within a few days after receiving the vaccine I (the patient) began experiencing severe nocturnal pruritus. This was severe enough to awaken me several times during the night. This is a new event for me - I have never experienced something like this before. The pruritus is localized to the anterior/lateral thigh on my left leg (L4 dermatome). There have been occasional itches elsewhere but this is the predominant one that awakens me on a nightly basis.I have ended up take Benadryl 25 mg on a regular basis to try to prevent a recurrence. Last night (on the advice of my non-medically-trained wife) I tried applying a topical Peppermint oil which did provide some relief. I am hoping that this is a self-limited relatively short-term adverse reaction!!! I have had no other exposures recently to account for symptoms similar to this.
severe pain, tingling sensation in both feet/not able to walk/neurologist suspects neuropathy; I am not able to walk/I have to use crutches to walk; severe pain; Tingling sensation in both feet; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 14-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0187), via an unspecified route of administration, administered in Arm Right on 06Jun2021 16:00 (at the age of 14-years-old) as dose 2, single for covid-19 immunisation at Pharmacy or Drug Store. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: EW0177), via an unspecified route of administration, administered in right arm on 16May2021 at 04:00 PM (at the age of 14-years-old) as single dose for COVID-19 immunisation. The patient stated 4 weeks after booster dose, on 06Jul2021 at 08:00, he woke up one morning with severe pain, tingling sensation in both feet. He was not able to walk, he saw a podiatrist who referred me to a neurologist and the neurologist suspects neuropathy. He has to use crutches to walk and was on gabapentin. She has had these indications for 3 weeks now, its not getting better. Patient is otherwise very healthy with no other medical issues. Therapeutic measures were taken with gabapentin as a result of all event. The outcome of all event was not recovered.  Follow-Up (03Aug2021): Follow-up attempts are completed. No further information is expected.
Infant developed very high fever (sepsis ruled out) hours after vaccine. Despite maximal medical support, infant died. No explanation for fever could be found.
Swollen glands in armpits, body aches. All the nerves in head and neck were burning, mouth and lips were on fire like a cold sore outbreak was about to happen.  Did not seek treatment beyond taking acetaminophen.  Day 3 was the worst, then gradually improved over 7 days.
giant red swatch on left arm at injection site; injection site with redness; rash on the arm; injection site with some swelling; sore arm; feeling of malaise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feeling of malaise), VACCINATION SITE REACTION (giant red swatch on left arm at injection site), VACCINATION SITE ERYTHEMA (injection site with redness), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE RASH (rash on the arm) in a 72-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.     No medical history was provided by the reporter.     On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION COMPLICATION (feeling of malaise) and VACCINATION SITE PAIN (sore arm). On 21-Jan-2021, the patient experienced VACCINATION SITE REACTION (giant red swatch on left arm at injection site), VACCINATION SITE ERYTHEMA (injection site with redness), VACCINATION SITE RASH (rash on the arm) and VACCINATION SITE SWELLING (injection site with some swelling). On 28-Jan-2021, VACCINATION SITE REACTION (giant red swatch on left arm at injection site), VACCINATION SITE ERYTHEMA (injection site with redness) and VACCINATION SITE SWELLING (injection site with some swelling) had resolved. At the time of the report, VACCINATION COMPLICATION (feeling of malaise), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE RASH (rash on the arm) had resolved.        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.
Female patient oriented in time and space.  In the recovery area she notified that she feel itchy in all her body. We call the paramedic and he take the vitals; BP 130/70; HR 90, SO2% 99; RR 18. Paramedic indicated if he administrated a medication she need to go to the hospital; but patient denies go to hospital. We oriented the patient to go to her doctor. Patient was  accompanied to speak we the supervised; patient was evaluated cephalocaudal, the patient do not present with any topical reaction, patient was observed for inflammation or erythema wish they're no findings. At the moment of evaluation the patient indicated to have the same sensation of itching t  like the first dose of Moderna vaccine.
This spontaneous report as received from a pharmacist via company representative refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (lot number reported as H021710, expiry date was 07-MAR-2014), 0.65 milliliter (reported as standard dose), subcutaneously. On an unspecified dates, more patients complained of burning and stinging with their current lot of ZOSTAVAX. No treatment was provided. The outcome of the reported event was unknown. Additional information has been requested.
55 paramedics were vaxed w/ series of 3 doses of Engerix-B & 18 were non-responders when tested 30 days to 4 mos p/last inject; reporter indicated plans to revax the non-responders;
sx's local erythema, tenderness, low grade fever per pt; unk of actual temp due to (not taken); tx hot compresses, soaks, relafen (rx-anti inflammatory;
Widespread hives all over body which started the day after getting vaccines. Pt seen in office on 10/26 and 10/27. Also on amoxicillin to treat strep. On 10/27 told to stop that and start azithromycin.
approx 30-45 minutes after administration, pt complained of racing heart/chills.  Pt placed on O2 & monitored.  BP was elevated, pulse was elevated & O2 was low.  EMS was contacted & pt was taken to ER.  After vaccination, patient noted she had previously experienced substantial side effects from previous COVID Vaccine administrations.  Pt also has extensive allergy history including Benadryl & oral steroids.