chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a prospective pregnancy case. This adult female subject was enrolled in a study. The subject received the 1st dose of BOOSTRIX on an unknown date. Co-suspect products included BOOSTRIX. The subject received BOOSTRIX a week 21 of the pregnancy and during the second and third trimesters of pregnancy. On an unknown date, not applicable after receiving BOOSTRIX, the subject developed extra dose administered (Non-serious). Additional event(s) included vaccine exposure during pregnancy. The outcome of extra dose administered was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. Additional details provided as follows: The nurse reported that the pregnant patient received 1st dose of BOOSTRIX at 21 weeks pregnant and then again at 38 weeks pregnant. Follow-up information received on 12 June 2015: This pregnancy was a normal conception. The subject details were provided (age, weight, height and ethnic origin). It was not known if the subject had allergies or relevant medical history. The subject's last menstrual period was on 12th August 2014 and estimated date of delivery was 19th May 2015. The subject received BOOSTRIX at week 28 and 3 days of the pregnancy and during the third trimester of pregnancy. From 01 December 2014, the subject took Prenatal Vitamins. On 22nd May 2015 after 40 weeks and 3 days, the subject gave birth to a live neonate with no apparent congenital anomaly via unknown delivery. The subject was discharged home on postpartum on day 2 with the baby. Follow up information received by a nurse on 22nd July 2015: The subject is non-smoker and non-alcoholic. The subject's current condition included anemia during pregnancy. The subject did not have any other known medical conditions. The subject did not have any previous pregnancies. On 17th April 2015, the subject underwent group B Streptococcus culture, which was found to be positive. So the subject received prophylactic treatment with Penicillin during labour. The subject gave birth to live male neonate via normal delivery method. The infant had an APGAR score of 9 and 9 (the reporter was unsure of hospital timeframe). Upon internal corrections received on 24th August 2015, Group B streptococcus culture positive event was updated in this case.
A sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (A sore arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (A sore arm). At the time of the report, PAIN IN EXTREMITY (A sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-352622, MOD-2021-352623, MOD-2021-352994, MOD-2021-352991 (Patient Link).
Pt has history of CLL and stage IV uterine carcinoma with recurrent malignant ascites.  Pt was found to be COVID positive and to have COVID-19 pneumonia.
Temperature 103 F, headache, muscle aches, nausea, fatigue developed day 1 after the second vaccine , day 2 temp down to 101 F, headache and muscle aches less and nausea gone
About 2 hr. noticed some pain which got worse every hr for 3 or 4 hr. arm started swelling and getting hot which remained for 3 days. Didn't want to use or lift arm for 2 days which let up on 3rd; on 4th day swelling started going down that I could use and pain had let up starting on 3rd day, another person getting shot pneumococcal had same adverse reaction at same time I did.
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Started getting sick), VACCINATION SITE WARMTH (Injection site is hot), HYPERHIDROSIS (Sweating), FEELING HOT (I am hot) and PYREXIA (Ran a fever of 99.9) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 037K20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Breast cancer, Diabetes, Cholesterol, Depression and Anxiety. Concomitant products included BUSPIRONE for Anxiety, LETROZOLE for Breast cancer, ATORVASTATIN for Cholesterol, VENLAFAXINE for Depression, METFORMIN for Diabetes.On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced ILLNESS (Started getting sick), VACCINATION SITE WARMTH (Injection site is hot), HYPERHIDROSIS (Sweating), FEELING HOT (I am hot), PYREXIA (Ran a fever of 99.9), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, ILLNESS (Started getting sick), VACCINATION SITE WARMTH (Injection site is hot), HYPERHIDROSIS (Sweating), FEELING HOT (I am hot), PYREXIA (Ran a fever of 99.9), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2021, Body temperature: 99.9 (High) 99.9.
Pt received imm on 8/11, first time ever receiving imm. Pt came on 8/23 c/o 4 days h/o rash that started in (R) leg but later covered all his body (urticaria like). Treated with PEDIAPRED. Pt improved. Unsure of causality.
Mom brought her 2 mth old son for immunizations at clinic. Nurse administered the vaccines, one of which was a HIBERIX (a brand of HIB authorized for the booster dose only).
This spontaneous report was received from a registered nurse referring to a 34 year old female patient. The nurse noted that patient, was administered her first two doses in the GARDASIL vaccination series on unspecified dates several years ago before she was 25 years of age (approximately in 2005). She was now in the office, is 34 years of age, and wants to get her third dose of GARDASIL today. No adverse effect reported. Additional information has been requested.
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant medication were not informed. On 25-JAN-2018, the patient was vaccinated with a improperly stored dose of Oka/Merck VARIVAX lot # M008171, expiration date 16-FEB-2018, for prophylaxis (route of administration and dosage information were not informed). Concomitant therapies included MERCK STERILE DILUENT. No adverse effects reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1802USA004853.
Patient was in usual state of health when received first Covid Moderna vaccine on 2/2/21 and did fine until about 2/17.  He started c/o discomfort and appetite decreased.  2/18/21 had low grade fever.  2/22  fever and generalized weakness and abnormal labs (elevated potassium).  2/22 hydration was started.  2/25 antibiotic started for UTI for 7 days.  Patient seem to improve except appetite.  Since vaccine, patient remained on frequent IV hydration and had poor appetite through February into March.  On 3/2/21, patient received 2nd dose of  Moderna Vaccine while on Augmentin for UTI, issue with dehydration and appetite.  By 3/4/21, patient was noticed to have trouble chewing and swallowing.  Speech was ordered.   On 3/5/21, it was noted patient had continued poor appetite, weakness, dehydration risk, debility.  On 3/8/21, it was noted patient had intermittent confusion.  By 3/10/21, patient was more alert.   Patient remained fairly consistent from that time with poor appetite, dehydration issue, weakness and dysphagia management.  Then on 3/27/21 he became disoriented, wheezing, labored breathing,   Vitals were 92% oxygen on room air, Temp 97.5, 158/62, pulse 94.  Oxygen started and sent to ER.  Family reported patient is admitted to hospital with mild stroke and UTI.   The vaccine seemed to change patient's state of health about 2 weeks post first dose with multiple sequelae.  This seems similar to timing of actual COVID infection pattern when it is the actual virus.
pt recvd vax, stood up & immed stated would faint; was put in chair; seemed to faint for about 2 sec but responded to questions p/that head bent to floor; cold towels head & neck; color came back to nl; nail beds color good; no swe;
This spontaneous report was received from a pharmacist via Pfizer company representative regarding a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 (dosing details, lot# and expiry date not known). On an unknown date in October 2016, the patient experienced inflammation and swelling. The outcome of inflammation and swelling was unknown. The reporter considered inflammation and swelling to be related to PNEUMOVAX 23. Additional information has been requested.
Site: Pain at Injection Site-Severe, Additional Details: Reached out to patient to gleam more information 1/2/23 left voicemail.
Patient is not showing or exhibiting any sign or symptoms of any adverse reaction. No changes from the patient baseline. Based on the record she received Pfizer 1st dose vaccine on 4/27/2021. (We don't have a record on file). We gave her 1st dose Moderna vaccine on 5/10/2021.
Mtallic taste in mouth; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSGEUSIA (Mtallic taste in mouth) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced DYSGEUSIA (Mtallic taste in mouth). At the time of the report, DYSGEUSIA (Mtallic taste in mouth) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications were not provided. The treatment information was not provided.  The action taken with mRNA1273 for the events were considered as not applicable.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Additional Details: immunization given on 5/12/2021 at pharmacy at approximately 5:25p.  about 3 minutes later patienst complained of lightheadedness and black spots covereing her vision.  in an attempt to help her lie down, when patienst was reposistioning, she went limp and passed out for a few seconds.  vitals were checked by rph.  911 was called.  patienst was cleared and went home on her own record.  patienst has driver friend
Information has been received from a physician who received the information from a consumer that provided him a link to a forum concerning a female patient who was vaccinated with the first dose of GARDASIL in May 2007, and the second dose in July 2007. The patient started to experience side effects immediately but the doctor did not think it was an issue when it came time for her second dose. Right after the second dose the patient experienced fainting, dizziness, nausea, weakness, body aches. In November 2007, the patient experienced seizures described by the patient as brain fog. By the time of this report (August 2010) the patient still had seizures that were  being controlled with medication and she still complained of brain fog and found it difficult to concentrate and retain information. The patients symptoms included seizures, fatigue, irritability, depression, muscle and joint pain, headaches, painful menstrual cramps, hair loss and rash. The reporting physician considered seizures to be an other important medical event. No further information is available.
Pt. was given all 3 vaccines and within 2 minutes went into a shock like state and then had a seizure that lasted less than 5 minutes.
Severe burning and tingling in mouth, outer vaginal area, tops of feet. After one month tingling moved to hands arms legs, then face. Tingling of mouth and vaginal area subsided. Feet burning and tingling worsened with swelling of tops of feet lasting continually  now for 4 months, ongoing.  Bloodwork  and tests were ordered by doctor.
This is a prospective pregnancy case. This 42-year-old female subject was enrolled in a study. The subject received Flu Seasonal QIV (unknown) .5 ml on 29th September 2014. The subject's past medical history included no adverse event. Previously experienced adverse reactions included malaise (The patient always experienced malaise after vaccinations). Previously administered products included Tdap with an associated reaction of no adverse event. Concomitant products included Prenatal Vitamins. Th subject's last menstrual period was on 15th January 2014 and estimated date of delivery was 22nd October 2014. The subject received Flu Seasonal QIV at week 36 of the pregnancy and during the third trimester of pregnancy. On 30th September 2014, 1 days after receiving Flu Seasonal QIV the subject developed malaise (Non-serious). Additional event(s) included vaccine exposure during pregnancy. The outcome of malaise was recovered/resolved. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. The investigator considered the malaise to be possibly related to Flu Seasonal QIV. Additional information received on 07 October 2014: The patient received a Tdap vaccine about one week before the FLUARIX Quadrivalent vaccine. She had no adverse events.
Right after the vaccine I had major swelling in my face and lips and a burning sensation as well. I went back into the urgent care i had received the vaccine and they immediately took me to the ER. I was admitted and they gave me prednisone and benadryl and they gave me an epipen to take home. They sent me home and told me to use the epipen and call 911 if I couldn't breathe. My face was still swollen, red, and burning when I left the hospital. I still have the facial burning and swelling. I am putting cold compresses and taking benadryl. My neck and chest are also red and hot.
Sore arm, slight muscular aches and headache with minimal fatigue began 9 hours after dose and became profoundly exacerbated by the following morning (02/25/2021) with severe arm soreness, increased muscular discomfort, throbbing headache, and severe fatigue affecting mobility. There was no fever or chills but I was cold and could not get warm. The symptoms appeared consistent with a flu. These side effects began to dissipate slowly the following day (20/26/2021) and were completely resolved by 02/27/2021.  The side affects from the first dose were insignificant by comparison. Other than the usual sore arm there was minimal muscular aches and slight fatigue and was not debilitating at all like the second dose.
Swelling at injection site started 3/18/2021. Around 3/21, swelling grew to about 2? circular red raised area. Increased over the next week to about 3?, with bold red outline at margins. As of 4/1/2021, area is still about 3? in diameter. Also flulike symptoms from 3/17/2021 to 3/19/2021, but none since.
She had redness and hives the size of a nickel at the site of the Varicella vaccine within 2 minutes of receiving the injection. She was given Benadryl (2tsp) observed in our for 30 minutes with no difficulties.
Immunized 10 am on 11/09/05 with DTaP, IPV on right arm and MMR on L arm. Parents noted next day evening raised, reddish blue rash on dorsal surface R arm extending entire arm to elbow. Welt noted at site of injection. Patient felt sore and itchy. On 11/14/05 noninduration nontender erythema noted 3.25 X 2.25 inches dorsum R arm. Also noted raised area R arm.
About 10 hours after injection, experienced arm pain at and around injection site, headache, nausea, weakness, chills, very low energy, loss of appetite. Lasted 18-20 hours. After 7-8 days a raised rash appeared at and near the injection site. It is still there.
the worse headache of my life; made me throw up; This is a spontaneous report received from a contactable consumer or other non hcp. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 09Feb2021 at 10:50 (Age at vaccination: 44-years-old) as DOSE 1, SINGLE for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient stated that "Approximately 10pm-2am, caller experience, "the worse headache of my life", "made me throw up". Caller says, "I feel better this morning. little headache, but not as bad as it was" Caller says, "I'm scared to get 2nd dose, will the 2nd dose symptoms be worse?" on 11Feb2021. Caller stated that she received Pfizer Covid vaccine yesterday at 10:50AM. Stated that last night from 11Feb that she had the worst headache ever in her life where she was throwing up/vomiting. Stated still has headache but nothing like it was. Wanted to know if this is a side effect. Stated that she was afraid to get the second one because she does not want to go through that again. The outcome of the event headache was not recovered, and event vomiting was unknown.  Follow-up attempts completed. No further information expected.
Patient presented to hospital on 11/7/2021 with stroke like symptoms, 11/6/2021. Stroke work up positive for Acute ischemic stroke, right thalamus, precentral gyrus. Patient discharged home with family after 2 day hospital stay.
Cardiac Arrest with in an hour of receiving Covid vaccine; Brought into ED by EMS doing CPR; resuscitation continued in ED for 20 minutes before ROSC was achieved.  Pt admitted to Critical Care.
5:22PM Developed headache followed by tingling in tongue.  5:25PM BP 192/90, P 92. Administered Benadryl 25mg PO.  5:35PM 182/94, P 88 Symptoms persist.  5:44PM BP 182/90, P84.  5:50PM BP188/98, P 84 Second dose of Benadryl 25mg PO. 6:00PM BP 204/106, P88 C/O headache worsening, Lips feel "funny" Called for ambulance for assistance 6:10PM BP 222/98, P 88. Transport to Health Center via ambulance.
Very inflamed under neck; Severe rash/rash started up around my neck and spreading/rash took over neck and chest; front and back; severe pain in left hand; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FSA RX 0884468; Expiration date was not reported) on the left arm on 19May2021 (16:30) as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. The patient had no relevant medical history. Concomitant medication included ibuprofen (ADVIL 12 HOUR). The patient was not pregnant at the time of vaccination. On 20May2021, the patient had severe pain in the left hand. On 21May2021, the patient had severe rash; the rash started up around the neck and spreading. On 22May2021, the patient's rash took over the neck and chest, front and back; and the patient was very inflamed under the neck. The patient had received diphenhydramine (BENADRYL) and ibuprofen (ADVIL) as treatment for the events. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
No additional AE reported; PROQUAD and VARlVAX were inadvertently administered; This spontaneous report was received from a medical assistant concerning a patient of unknown age. No concurrent condition, medical history, or concomitant therapy was reported.  On 21-OCT-2021, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength and route were unknown; recombinant Human albumin; 0.5 (unit not provided), lot # T032147 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 20-MAR-2022) and varicella virus vaccine live (oka/merck)(VARIVAX) (strength and route were unknown; 0.5 (unit not provided), lot # T41503 was evaluated and changed to the valid lot # T041503, expiration date reported and confirm upon internal validation as 09-DEC-2022) for prophylaxis (accidental overdose).  No adverse event was reported.
Information has been received from a certified medical assistant concerning a male with hypertension and sleep apnea and no allergies reported who was vaccinated SC in the upper arm with a dose of ZOSTAVAX (Merck) (Lot number 663894/0129Y) (dose not reported). Subsequently the patient experienced injection site redness, injection site warmth and injection site swelling on an unknown date. The patient sought medical attention by calling to the office. Additional information has been requested. Follow up information has been received from a physician concerning a 62 year old male with hypertension, sleep apnoea and asthma and no known drug allergies and no illness at the time of vaccination, who on 23-FEB-2009 was vaccinated SQ in left deltoid with first dose of ZOSTAVAX (Merck) (dose not reported) (lot number 663894/0129Y). Concomitant therapy included ADVAIR, albuterol, PROTONA 40mg QID, enalapril maleate (manufacturer unknown) 10mg QID, LIPITOR 10mg QID and AGGRENOX 25-200mg BID. The physician reported that on 24-FEB-2009 the patient had redness, warmth and swelling at injection site. The patient went to the office on 28-FEB-2009 and was evaluated no medical information available. The patient went for a follow up on 18-MAR-2009. The patient reported that still had small red spot at the injection site, but no other symptoms or problems. Subsequently, the patient recovered from injection site warmth and injection site swelling. The patient's injection site redness persisted. Additional information is not expected.