chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 11 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 13-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3842AA/C3752AA received on 28 July 2011, lot number C3812BA/C3930AA received on 10 October 2011 and lot number C3967AB/C3834AA received on 29 November 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 20 July 2012, approximately seven months after the last dose. On 30 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 01 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 01 August 2012 for five days. The subject was not hospitalized. At the time of final contact on 30 August 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Pt. states received injection in (L) arm. States within a few hrs. it felt heavy. States it hurts all the time and claims to have some external swelling in (L) shoulder. States has been in therapy 3xwk for 2wks. States it hurts all the time and hurts to lift her arm.
Information has been received from a physician concerning a female (age not reported) who in approximately December 2006, was vaccinated with Pneumovax 23 (lot # not reported) 0.5 ml injection. In approximately December 2006, after the patient received the injection of Pneumovax 23 she developed shortness of breath and stiffness in upper area of the arm from the injection. The patient sought medical attention. The physician administered TYLENOL, steroids, and antibiotic to treat the problems. At the time of reporting, the patient was recovering. No other information was available at the time of reporting. Additional information has been requested.
Rashes around collar bone and partially on right shoulder. Intensive itch on left side of collar bone.
UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided.  No relevant concomitant medication provided.
During both Friday and especially Saturday, I felt "wrong" physically, very low energy, constipated, and wanting to just lie down and sleep. I must have slept at least 3 times my usual 6hrs/night both days. Also Friday and increasingly Saturday,  the injection site got much more swollen, hot and stiff than any other vaccination I have ever had. I wish I had been warned of this probability, I need to sleep on that arm due to reflux issues. Sunday morning I awoke with all health and energy back to normal. I will be sure to get my (reluctant) 2nd shot in the other arm.
Pt recv vax on 8/5/98; on 9/29/98 pt exp fever (102) & chicken pox
A nurse, in her 1st trimester of pregnancy, reported that she inadvertently injected herself with Prevnar on 5/22/01. On 1/29/02, follow-up information regarding the nurse was received from a physician. The nurse delivered her baby 4-5 weeks prematurely. The infant developed neonatal hyperbilirubinemia and was hospitalized for 2 days for treatment with phototherapy and IV fluids. The infant recovered. No further information was available at the date of this report. See HQ1264323MAY2001 for report on the pregnancy exposure. On 2/22/02, follow up information was received from the nurse. She reported that her son was born 4 weeks premature. He developed an ear infection during the first two months of life. He is doing fine now. He received his first dose of Prevnar on 2/21/02 and experienced no adverse reaction. When he was 2 months old, the infant's bowel movements became less frequent. He was intermittently treated with glycerin suppositories until 4/12/02. On 4/11/02, treatment with lactulose was begun. On 4/11/02 a barium enema was administered with the following results: no evidence of Hirschsprung's disease; colon normal. He was examined by a gastroenterologist on 4/22/02; a diagnosis of functional constipation was made. Ongoing treatment with lactulose was prescribed.
pt died of SIDS 1 day p/vax;pt recv vax 19AMR98 per mom & MD office;
This spontaneous report was received from a registered nurse and refers to a 16 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 11-OCT-2016. On 23-NOV-2016, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M023931 with expiration date of 09-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 43 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
Developed Right Branch Bundle Block in February 2022 approximately 2-1/2 months after receiving Covid booster shot.
side effects; This case was reported by a consumer and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had many of the side effects and asked, how long do they usually last.
Systemic allergic reaction to seasonal flu vaccine. Experienced generalized hives and mild wheezing after receiving shot.
T102 w/in 18hr swelling rt arm (tricep) site of inj redness & swelling rt forearm-fever aspect 2-4 days p/inject;
Information has been received from a certified medical assistant concerning a 17 year old female with hypersensitivity who on 29-Jan-2007 was vaccinated with a first dose of Gardasil (lot# 654741/1208F). Concomitant therapy included cough, cold, and flu therapies (unspecified). On 29-JAN-2007 the patient experienced dizziness and nausea and sought unspecified medical attention. Subsequently, the patient recovered from the dizziness and nausea within a few hours of vaccinations. The patient was subsequently vaccinated with her second dose of Gardasil on 16-APR-2007. Additional information has been requested.
12/5/21 approximately 3:45 PM Client  came to the COVID outreach accompanied by her mother. Client consent form was checked in and reviewed. The consent form was given to RN who took the form along with the vaccine requested by the vaccinating nurse RN. Client a 12-year-old female was given a Pfizer COVID 19 vaccine designed for 5?11-year-old (Lot # FK5127) in the left deltoid by the vaccinating nurse RN.  Client was monitored for 15 minutes and remained free from any adverse reactions or side effects.  Client's mother was made aware client received the Pfizer designed for 5-11-year-old.  12/8/21 ? A follow up call was made and spoke with client mother. The mother reports client had sore arm and no other side effects or adverse reactions. RN CCM.
Two hours after administration my right nostril opened up for more airflow than I can ever remember feeling in my life. In the morning when I blew my nose there was fresh blood. On night two the right nostril was again open in the night, left one closed. Periodic unusual snot that is white and slimy with no chunks. Mono-color.   Additionally I'm having mild flu-like symptoms.
Admitted on 10/13/21 with Acute hypoxic respiratory failure due to COVID-19 infection. He was discharged 11 days later in stable condition.
Congestion; Vomiting; Mild rash on the face; Pain in the injection arm; My fever has been from 100.6°F to 99°F and now 98°F; Head hurts so bad; Chills; Pink eyes; A spontaneous report was received from a consumer concerning a 54-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever has been from 100.6 ° F to 99 °F and now 98 °F (pyrexia), vomiting, head hurts so bad (headache), pain in the injection arm (vaccination site pain), pink eyes (conjunctival hyperaemia), congestion (nasal congestion), mild rash on face (rash), and chills.  The patient's medical history included COVID-19 infection in Mar 2020. No relevant concomitant medication was provided.  On 05 Jan 2021, on the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) in the left arm for prophylaxis of COVID-19 infection.   On the night of the same day, the patient experienced vomiting, fever, and headache, arm pain, pink eyes, mild facial rash, and chills. Her temperature was 100.6°F, down to 99°F and later reduced to 98°F. The exact time the temperatures were taken was not reported. The patient started experiencing congestion on 06-Jan-2021.  Treatment for the events included ibuprofen.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, vomiting, fever has been from 100.6 ° F to 99 °F and now 98 °, head hurts so bad, pain in the injection arm, pink eyes, congestion, mild rash on face, and chills, was unknown.; Reporter'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
Fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Additional patient notes included the relevant medical history or any additional safety information was unknown. Family history included shingles (patient's cousin).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: Fever). The outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     It was unknown if the company considered the fever to be related to Shingles vaccine.   Additional Information: GSK receipt date: 09-Apr-2023  This case was reported by a patient via interactive digital media. The patient got the vaccine, and it caused him or her fever, and stated it was better to be protected. The follow up would not possible as no contact details were available.
Patient c/o pain, swelling and erythema of area where vaccinated with Tdap. Also c/o hx of fever (not measured) the next day.
eye vision started to blur; anxiety; dizzy; super tired; achy; slept for two days; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (eye vision started to blur), ANXIETY (anxiety), SOMNOLENCE (slept for two days), DIZZINESS (dizzy) and FATIGUE (super tired) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety, Nausea, Acid reflux (esophageal) and Migraine. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), RIZATRIPTAN for Migraine, ONDANSETRON for Nausea, SERTRALINE and ALPRAZOLAM for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced VISION BLURRED (eye vision started to blur), ANXIETY (anxiety) and DIZZINESS (dizzy). In April 2021, the patient experienced SOMNOLENCE (slept for two days), FATIGUE (super tired) and MYALGIA (achy). The patient was treated with NAPROXEN for Adverse event, at an unspecified dose and frequency. On 12-Apr-2021, VISION BLURRED (eye vision started to blur) and DIZZINESS (dizzy) had resolved. At the time of the report, ANXIETY (anxiety), SOMNOLENCE (slept for two days), FATIGUE (super tired) and MYALGIA (achy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-416931 (Patient Link).
No other information given at this time.; Medical assistant calls to report a temperature excursion/ The products were administered; This spontaneous report as received from a medical assistant, concerning a 12 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 07-JAN-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S029457 with expiration date 19-SEP-2021 (dose, frequency, route and anatomical location were not provided) for prophylaxis. The excursion date was on 25-NOV-2020 with a temperature of 47.4 and duration of 1 hour and 20 minutes. No other information given at this time.  This is one of 25 reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA005178:
DIAGNOSED with COVID-19: low grade fever, increased heart rate, loss of taste and smell, fatigue, body aches, diarrhea, sore throat, cough, congestion, chest pains, nausea, vomiting.
Swollen armpit; This is a spontaneous report from a contactable nurse (Patient). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 28May2021 at 13:15, as unknown, single dose in left arm for COVID-19 immunization at Workplace clinic. The patient's medical history included hypertension, diabetes, and COVID-19. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications in two weeks after vaccination included Glipizide and Hydrochlorothiazide (HCTZ). On 29May2021, the patient experienced swollen armpit. Treatment medication for the adverse event included ibuprofen. The patient had COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event was not resolved.
After receiving the vaccine patient began to perspire profusely, turned pale, and began to tremble. Eyes rolled within eyes sockets revealing whites of eyes.  Never loss consciousness.  Stood up with the help of others and was unable to step forward.  Brought to the ground on a mat and laid down .  Was brought in front of a portable fan.  Room was warm(gymnasium at middle school) and outside temp was high 80's.  Ice pack applied on back of neck , BP 92/68, AP 65 and O2 was 98%.  Drank water and sat up on mat, talking to her mother.  No transport to EMS.  Attended to by EMS on site.  After several minutes sat in chair next to mother and ate some crackers.  Continued to sit 30 minutes after episode and waked out of gymnasium on her own.
About 7 minutes after shot, patient experienced nausea and vomiting, Episode lasted about 5 minutes and then patient felt better.  They stayed 10 more minutes and still felt fine and chose to leave.
pt recvd vax & a few hrs later exp sluggishness & fatigue, insomnia, tingling & numbness in lt arm, chest pain, nausea, stomach cramps & sick feeling; presented to MD & was found to have inc BP; sx resolved w/in a few days;
I was fine for the 15 minute observation period - but at about 20 minutes, while driving home, I experienced a distinctive tingling in my lips and around my mouth. I also felt a bit of a tightening or light tingling in the left side of my face.  No hives, no itching, no difficulty breathing. I returned to the vaccination site for further observation, where paramedics took my vitals twice over a 20-minute period (all normal).  At that point the tingling began to subside, I declined transport to the hospital, and drove home. It's now 8 hours past the time of my injection, and I feel fine for the moment - but I'm concerned that I may have experienced a mild anaphylaxis, and am wondering if I should consider not getting the follow up vaccine. I am reporting even though this is a very slight reaction, because I have read that officials are wanting to monitor side effects very closely.
About 10 hours after my booster I got acute and significant chest pain and pressure. My stomach HURT.  I also had shortness of breath. I felt like I was in labor but in my chest and in consult with a family member who is an ER doc, I went to the ER. The symptoms peaked at the 12 hour mark (1am) and I continue to experience chest pressure after ER discharge.
She got her vaccine, after 10 minutes she felt like her body was burning like fire, really hot flash.  When she got up she slid down and passed out.  She found herself in about 2-3 minutes, they took off her sweater, they put towels on her forehead and she felt like her mouth and nose were blisters and she was very shaky, hot, hot flash.  Her BP dropped, and after that she went home, had fever of 101.  Her heart rate was racing 110-120 and could not get out of the bed due to the heart racing and weakness for about 5 days.  She had chills, fever, loss of appetite.  Her main problem was her heart rate that was bumping when she tried to get up.  She called the occupational therapy clinic and reported the reactions, was told to do a COVID swab which was negative.  She had alternating chills and fever and was informed that it was a reaction from the vaccine.  She started to slowly improve which took about a week, which she was out of work for the time.  She was taking Tylenol and Motrin alternating for her fevers.
01/05/07 pt called c/p left arm still sore after 2 weeks after receiving vaccine unable to raise arm over head denies redness or swelling.
Pt had severe bronchospasm and shortness of breath 40 minutes after vaccine. No EPi needed; Stable Bp and O2 SAT, 911 to ER -discharged home.
Elevated temp & extreme irritability; given IV Ampicillin & IV Claforan;
pt recvd vax;devel a little red knot which was raised, & a warm area near inject site in the thigh;knot remained red,raised & warm for 4 days;
Rash around injection site, as well as on chest. Swelling of lymph nodes in left armpit (same arm used for vaccine)
28 days after administration of Rotateq vaccine, patient developed intussusception requiring surgical reduction. Questioned relation to Rotateq?  03/12/2007 MR received from treating hospital.  Child was transfered from local hospital for a several day history of intermittant vomiting and pain as shown by crying and curling up of his legs.  Upon admission he was somnolent and lethargic. He has had episodes of bilious emesis and currant jelly stools.  Also dehydrated. PE: revealed a soft, mildly distended abdomen with tenderness to palpation in the right mid and lower abdomen.  Hypoactive bowel sounds. No masses noted. Otherwise WNL. The child was taken to sugery for a laparoscopic reduction of intussusception. Post -operative DX:  Intussusception.
received a 3rd dose; This case was reported by a other health professional via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 3rd dose of Shingrix vaccine which led to extra dose administered. The reporter asked what were the effects if patient received 3rd dose of Shingrix. The follow-up would not possible as no contact details were available.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional Information: Reporter stated during call that her 2 sisters had sore arms after their Covid Vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021477215 Same reporter/ drug/ AE, different patient
C/o (L) deltoid warmth, redness & swelling 1 day after vaccine administration also subsequent viral illness used OTC aspirin. Symptoms resolved in arm.
This spontaneous report was received from a pharmacist refers to a patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX (lot # L048452 and expiry date 01-MAR-2017), subcutaneous. The vaccine was stored at 70F for 30 minutes. No adverse effects reported. No product quality issue reported. Additional information has been requested.
60 hrs p/inject, fever, irritability, fussiness (unconsolable); admitted w/dx acute viral illness was DTP rxn;
PT CAME TO PHARMACY AND SAID JUST GOT OUT OF ER  BECAUSE MYOCARDITIS
Sore arm at injection site and nausea started 2/8 at 12:15pm
Vaccine placed on 11/29/15. Patient started having arm pain that ultimately encompassed the whole left shoulder.
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. On 16-JUL-2015 the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml (rHA (recombinant human albumin), lot #J014876, expiration date 21-NOV-2015, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria of this vaccine was refrigerator/freezer (R/F) and the type of excursion was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
6/30/05-R leg injection site "flea bite" looking bump.  Became progressively darker red in color. 7/11/05-1/2" - 1" encrircling injection site connected "splotches".  As reported by parent.  Parent indicates no fever, activity level normal.  Parent indicates she already has appointment with Dr. today.  Advised to inform Dr.
Pt vaccinated with Engerix-B developed diarrhea, stomach flu-like symptoms, cramping.