chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TERRIBLE HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the patient experienced terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible headache on 15-APR-2021. This report was non-serious. This case, involving the same patient is linked to 20211145086. This case, from the same reporter is linked to 20211145488, 20211145086 and 20211144980.
covid test date: 11Feb2022 / covid test result: Positive; covid test date: 11Feb2022 / covid test result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 (Lot number: Fl3198) at the age of 35 years as dose 3 (booster), single, administered in arm right, administration date 30Apr2021 (Lot number: Ew0176) as dose 2, single and administration date 09Apr2021 (Lot number: Er8734) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Corn" (unspecified if ongoing); "Known allergies: lamb" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Feb2022, outcome "unknown" and all described as "covid test date: 11Feb2022 / covid test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Feb2022) positive.
upper arm hurt; plain lousy; Headache; queasy stomach; minor/elevated temp; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in January 2019, refer case US2019GSK086392).   On 7th May 2019 20:00, the patient received the 2nd dose of Shingrix. In May 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, feeling bad, headache, queasy and body temperature increased. The patient was treated with acetylsalicylic acid (Aspirin). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, feeling bad, headache, queasy and body temperature increased were unknown.   It was unknown if the reporter considered the pain in arm, feeling bad, headache, queasy and body temperature increased to be related to Shingrix.  Additional details were provided as follows: The patient didn't know if the actually had chicken pox or the measles. The patient was an adult at the time in married student housing during grad school. The patient had the follow up vaccination and reported that the patient had normal activity after vaccination except upper arm hurt, feel just plain lousy with headache (not migraine) and queasy stomach. The patient asked about the events lasts 2 to 3 days. This was worse than first dose. The patient also had minor elevated temperature. The patient took 81 mg Aspirin.
about a 5 inch area around the injection site became swollen, red, itchy, and hot to the touch
This spontaneous report was received from a nurse prescriber referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 07-SEP-2017, the patient was vaccinated with an expired dose of GARDASIL 9 (route of administration and frequency were unspecified) lot # L028083 (expiration date: 03-SEP-2017) for prophylaxis. No adverse effects reported.
I felt tired couple hrs in the afternoon felt better after laying down.. I started to feel completely around 5 pm. I did not miss any work.
Right thigh cellulitis/urticaria 24-48 hours after HAV and Dtap vaccine. Treated with antibiotics (Rocephin, Keflex) and antihistamines.
Thursday 04/05/07 noticed a rash on my arms Friday went to ER and was prescribed Benadryl Saturday arms and legs were completely covered by rash as well as ears and neck, Sunday 11pm I was prescribed Prednisone since the rash has stopped itching and started to go away
On 11/17 staff reported that they had been exposed to COVID-19 over the weekend.  We performed rapid & PCR COVID-19 tests in the parking lot.  rapid test came back positive, we are still awaiting PCR results.  No symptoms to date.
Unable to eat without wanting to vomit after every meal. Gone from being a healthy kid who ate heaps to now unable to eat small amounts without wanting to vomit. Lack of energy. Gone from an energetic teen to a kid who struggles to get out of bed. Her periods prior to vax, normal 4-week cycle, 4-5 day regular flow. Now she has severe cramping and has been hospitalized for pain relief, on 1 occasion. Her bleeding is now lasting, since the shot, 3 weeks, and changing her pads hourly. This has badly impacted to the ability to stay in mainstream school.
Patient developed urticaria with itching that lasted 2 weeks at time of being seen at ER on Feb. 14.  Patient treated with Hydroxyzine for itching and 5 day course of Prednisone.
injection site is warm; injection site is a hard bump; This case was reported by a consumer via interactive digital media and described the occurrence of injection site warmth in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site warmth and injection site induration. On an unknown date, the outcome of the injection site warmth and injection site induration were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth and injection site induration to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-JUL-2022 Reporter's Comments:  This case was received from patient via interactive digital media. The patient received Shingrix and his/her injection site was a hard bump and warm. The follow-up would not possible as no contact details were available.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 16 month old female patient who experienced injection area warm to touch, tender injection site area and red welt on right thigh measuring 8x5 cm. At 16 months of age, the patient received the fourth dose on 9/6/2005. Relevant medical history was not found. Indication for Prevnar was immunization. Product was administered on 9/6/2005. Dose regimen was 1 dose 1 time per day intramuscular. Concomitant medications were nor reported. The patient was taken to the pediatricians office on 9/9/2005 with a red welt on right thigh measuring 8x5 CMS injection site urticaria. The area was also warm to touch (injection site warmth) and tender (injection site pain). No fever was noted at the time of the visit. Outcome was unknown. No additional information was available at the time of this report.
Information has been received from a physician concerning a 6 yr old female who in approx 2000, between the ages of 12 and 15 months, was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt developed breakthrough varicella. The number of lesions was not reported. Unspecified medical attention was sought. It was not reported if treatment was necessary. There was no product quality complaint involved. Additional information has been requested.
Fever (100.4F), body aches, headache, nausea, and overall fatigue from 10 hours post to 36 hours post injection. Mouth sores inside lips, roof of mouth and throat, 24 hours post - puffy and itchy, resolved within 36 hours.
About 2 hours after receiving her vaccine the patient returned to the pharmacy and complained of chest pain, rapid heartbeat, and feeling faint and said she thought it was caused by the vaccine. We called 911 and had the patient sit in the pharmacy area until paramedics arrived. Upon arriving, paramedics determined that the patient needed to be transported to the hospital in order to rule out a heart attack.
felt tongue swelling very soon after injection, starting under and to one side of tongue then all of tongue.  light headedness a few minutes later.  Subsided within 30 minutes.
Information has been received from a nurse concerning a patient who was inadvertently vaccinated with a dose of VARIVAX (Merck) (lot # 663941/0262Y) instead of ZOSTAVAX (Merck) due to nursing error. No adverse reaction. Follow-up information has been received from the nurse on 10-JUL-2009 who indicated that the label was intact. She said both vaccines were stored in the freezer, one on one side, one on the other. However, the sides were recently switched. She added that the vaccines "sound alike". She suggested making labels totally different colors would be helpful. Additional information has been requested.
stiff & sore joints (ie. elbow, shoulder & knee joints) past 6 mon, treated as tennis elbow, did not seek tx for knee & shoulder sx come & go w/o cause;
Immediate headache Soreness in arm Nausea within 1 hour Fever lasting 48 hours, spiking to 103f & breaking 10/9/21 Violent Vomiting- 12 hours after receiving jab Persistent Headache- migraine status to 72 hours Chills, aches, night sweats to 72 hours post jab  Nausea past 72 hours post jab  Unsteady when standing -- 24 to 60 hours Dizzy, blurred vision-- immediately to 60 hours post jab Extreme soreness at injection site-- lasted beyond a week post jab
acute psychosis resulting in 3 hospitalizations from 4/30-6/4, PHP, IOP
Local reaction at the site of the injection/ delayed reaction that started a week after getting the vaccine; Pain comes with pressure / Pain when moving the arm; Pain at the injection site and when moving the arm / local reaction at the site of the injection that is painful/ is painful when she touches it or lays on it at night/ when she rubbs it, feels pains in the whole area; Glands were sore under arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (Local reaction at the site of the injection/ delayed reaction that started a week after getting the vaccine), PAIN IN EXTREMITY (Pain comes with pressure / Pain when moving the arm), VACCINATION SITE PAIN (Pain at the injection site and when moving the arm / local reaction at the site of the injection that is painful/ is painful when she touches it or lays on it at night/ when she rubbs it, feels pains in the whole area) and LYMPHADENOPATHY (Glands were sore under arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE REACTION (Local reaction at the site of the injection/ delayed reaction that started a week after getting the vaccine), PAIN IN EXTREMITY (Pain comes with pressure / Pain when moving the arm), VACCINATION SITE PAIN (Pain at the injection site and when moving the arm / local reaction at the site of the injection that is painful/ is painful when she touches it or lays on it at night/ when she rubbs it, feels pains in the whole area) and LYMPHADENOPATHY (Glands were sore under arm). At the time of the report, VACCINATION SITE REACTION (Local reaction at the site of the injection/ delayed reaction that started a week after getting the vaccine), PAIN IN EXTREMITY (Pain comes with pressure / Pain when moving the arm), VACCINATION SITE PAIN (Pain at the injection site and when moving the arm / local reaction at the site of the injection that is painful/ is painful when she touches it or lays on it at night/ when she rubbs it, feels pains in the whole area) and LYMPHADENOPATHY (Glands were sore under arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had vaccine 5 and a half weeks ago and had a local reaction at the site of the injection that was painful when she touched it or laid on it at night. At the time her glands were sore under her arm and had pain at the injection site and when moving the arm. That was delayed reaction that started a week after getting the vaccine and it's been going on for weeks. The pain comes with pressure, when she rubs it, felt pain in the whole area.   No concomitant medications were reported.  No treatment information was reported.
flu like symptoms; felt like shit; cannot sleep as long through the night; temperature was 100 for 4 days; been more tired; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (felt like shit), INSOMNIA (cannot sleep as long through the night), PYREXIA (temperature was 100 for 4 days) and FATIGUE (been more tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 058H21A, 007C21A and 038B21A) for COVID-19 prophylaxis.     He had no history of myocarditis or pericarditis.  The patient's past medical history included Cardiac ablation, Pacemaker insertion (cardiac) in 2003 and Cardiac ablation (In the past 2 years). Family history included Hypertrophic cardiomyopathy (with maternal family history (his mother's father)). Concurrent medical conditions included Hypertrophic cardiomyopathy. Concomitant products included AMIODARONE for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (felt like shit), INSOMNIA (cannot sleep as long through the night), PYREXIA (temperature was 100 for 4 days) and FATIGUE (been more tired). In 2022, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, FEELING ABNORMAL (felt like shit), INSOMNIA (cannot sleep as long through the night), PYREXIA (temperature was 100 for 4 days) and FATIGUE (been more tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.         After receiving the 4th dose of the vaccine experienced flu like symptoms for 4 days with no high fever. Temperature was 100 for 4 days though it normally was 98 and felt like shit. Patient had also been more tired and cannot sleep as long through the night: Would put 8 hours down at night but in the morning at 10:00 tired. The last couple months patient was been going down for 4 to 4.5 hours. Patient wake up, cook something healthy fish and vegetables,  go online. Dead tired at 9:00 PM. Took second batch of cardiac medicine at 10:00 which patient needed to stay up for.  Concomitant medications included stomach medication for colitis and cardiac medicine.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2022: Follow-up received included no new information. On 11-Aug-2022: Follow-up received included no new information.
A non-serious spontaneous report of FLUMIST to 2 kids under 2 years-old was received from a registered nurse concerning a 14-month-old female. Neither medical history nor concomitant medication was reported for this patient. On 14-NOV-2010, the patient received FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 24-Mar-2011 and incorporated into the narrative: no late occurring adverse event was reported.
Mild rash over entire  body.  Headache.  Cough that developed and worsened over several days similar to an asthmatic  cough following bronchitis.  Severe fatigue.  Sluggish focus Slight dizziness.  Slight difficult if reading after a brief time of reading.  Slight nausea.  Swelling over entire body.
I experienced pain moving my ring finger and middle finger in my left hand followed by extreme swelling of my veins causing me not to be able to bend my fingers and make a fist. I also experienced along with these symptoms pain and swelling with redness and rashes at the injection site of my left arm. This swelling was raised up and it appeared to look like a bullseye appearance on my arm.
Today December 11, 2021 around 8:15am parent and child proceeded to my vaccination table number 12. Data entry personnel asked parent for information. I started to ask mom and child prescreening questions. I asked child if she was left handed or right handed. Child mention she was right handed. I made mom and child aware that I will be administering the child first dose of Pfizer in the left deltoid muscle. both agreed As I was preparing to administer the vaccine the child started to get upset and nervous about the vaccine. I stopped preparing the vaccine to calm the child down and make her comfortable. After the child was calm I administered the vaccine.
Flu like symptoms after the second vaccination which lasted for three days. After recovery was left with very loud tinnutus episde which has persisted.
This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unspecified. On an unknown date, the patients were vaccinated with improperly stored GARDASIL, lot # K014191, expiry date 10-MAY-2017; K009202, 17-DEC-2016 expiry date (number of doses unspecified). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Pt developed a sore area on her thigh at the injection site and then developed a rash. Pt has a scattered papular rash with lesions with some crusting. the lesions were red and slightly raised. The physician also noted a varicella like rash secondary to the injection.
The pt experienced severe pain, swelling, redness at the site of injection 2 days post vax. A 7cm round area to the right deltoid was warm to the touch and swollen. The pt was treated with Benadryl, Motrin and Atarax.
I started to have headaches the day after the first dose of the vaccine.  It was a headache that went from one temple to the other all day. Ten days after because the headaches had not gotten better checked my blood pressure was high diastolic 115 to 125. The headaches seemed to improve in the third week but then came back when I got the second dose. They were worse than after the first shot. I saw my doctor two weeks after the second dose. I had to start taking additional medication for my  blood pressure Coreg 25mg/2Xdaily PRN Metoprolol for Diastolic Blood Pressure for a week. The headaches started to improve three weeks after the second dose. It was a gradual improvement. I got the second shot in the other arm and had ghost pain in the arm where I got the first shot. My blood pressure has still been difficult to control than it was before the vaccines.
Post vax, the patient developed pain in the left arm radiating up to the neck. The patient was treated with ice.
I have had a headache for 3 days and my arm is swollen and warm and red.
- November 6, 2020:  facility confirmed patient previously had Covid-19 without symptoms, and was confirmed via antibody test:  SARS-CoV-2 IgG Index = 6.56;  - March 25, 2021:  Patient had 1st Moderna Covid-19 Vaccination shortly after 9:00am.  No post vaccine symptoms; and  - April 28,2021:  Patient had 2nd Moderna Covid-19 Vaccination shortly after 9:00am.  Symptoms (e.g. both leg calves very tight and additional pain in both knees when calves become extremely tight) began approximately 48 hours after vaccination and have persisted 4+ months.
Mattery eye, nausea, weakness and fatigue. Eye Sx abated end of day; other Sx X 36 hours.
Onset of rapid heart beat and sweats about 12 hours after injection lasting about 30 minutes. Severe head ache, neck pain, upper back pain and skin sensitivity in upper back and left shoulder area lasting for 2 days. Stomach cramps and body aches lasting for 1 1/2 days. Mild ear pain and tinnitus still present after 3 days. Injection site swelling and pain still present after 3 days.
My first period immediately after the vaccine began 4 days earlier than expected. Since I?ve been on NuvaRing birth control (since 2009), my periods always begin exactly on schedule. Then after my most recent period ended, I experienced a breakthrough bleeding day, which has never occurred any time I have been on NuvaRing. My period ended on June 26, the break through bleeding episode occurred beginning around dinner time on July 4 and ended in the evening of July 5.
Left arm was sore all day Sunday and Monday. Monday night I noticed a lump in my armpit. It is painful and still there.
Sugar starting spiking and overnight it got up into the 500s; Not feel well; This case was reported by a nurse via call center representative and described the occurrence of blood sugar increased in a 46-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 9579P, expiry date 30th June 2020) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On 17th September 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. In September 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced feeling unwell. On 17th September 2019, the patient experienced blood sugar increased. On an unknown date, the outcome of the blood sugar increased was not recovered/not resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the blood sugar increased and feeling unwell to be related to FluLaval Tetra 2019-2020 season.  Additional information received were as follows: The employee health nurse on the line with a type I diabetic employee who received a dose of FluLaval, pre-filled syringe, a day before reporting date. By 7:00 pm, less than a day after receiving Shingrix, the patient's sugar starting spiking and overnight it got up into the 500s (his monitor can not monitor levels higher than what it reached). The employee took 12 extra units of insulin, which brought their glucose into range, but it was wearing off this morning and his glucose was now back into the 300s and the employee does not felt well The reporter consented to follow up.