chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I left the pharmacy without waiting the recommended 10 minutes; they had run late and I was taking my son to an appointment; I had my first 2 shots without event and was unconcerned.  About 5 minutes after leaving I noticed my tongue felt thick and I was having trouble swallowing; a few minutes later I felt very hot and when looked in the mirror noted I was quite flushed.  I drive to the nearest , and checked in with that pharmacist around 3:35 who noted the flush and recommended I wait there until things subsided; she did not feel it was an allergic reaction.   Several minutes later my right arm lost some sensation and felt heavier / clumsier.  This increased but never to the point of significant dysfunction.  I consulted with the pharmacist who indicated Urgent Care or 911 was appropriate.  I went to  Urgent Care  where I waited about 2 hours to be seen.  My symptoms had improved by the time the APNP interviewed and assessed me.  She also seemed to feel that was not an allergic reaction.  She seemed to suggest this might have been an anxious overreaction to getting the booster.    The paraesthesia continued until  early evening the next day, when I noticed things seemed resolved.  This morning; a week later; I woke up and again feel some lack of coordination and slight numbness.  It does not appear to be impacting my strength or overall performance.   Let me reiterate that I was not at all anxious about getting the booster. The APNP's opinion of the event was informed from an assessment taking place 2.5 hours after the initial symptomatology, and seemed impacted by a very anxious nurse who admitted being terrified of getting the vaccine.   I am reporting this because I do not believe she would consider what happened to be a reportable concern.
Redness developed after received injection, continued to swell over the next 3 days. Clinic visit on day 4. Deltoid area 7cm erythema w/3cm induration.
Within minutes of giving last vaccine, patient fainted. Skin pale and diaphoretic. Patient aroused with use of ammonia inhalant. Mother present. Pt reports she did not eat prior to appointment. Food given to patient, along with sweet tea provided by mother. Transferred to w/c to private room to lie down. Observed x 15 min. with no further issues. Pt with history of seizures and will notify neurologist. Denies further issues.
PATIENT DEVELOPED RASH IN BOTH ARMS W/IN 10 MINUTES WHICH SPREAD FURTHER TO HER FACE AND BACK, FEW MINUTES LATER SHE DEVELOPED SHORTNESS OF BREATH AND SENSATION OF HER THROAT CLOSING. SHE WAS GIVEN BENADRYL 50 MG IM AND EPI 0.3 MG IM. THEN PARAMEDICS TRANSFERRED HER TO THE EMERGENCY ROOM.
Severe itching and small rash on legs about 40 hours after the vaccine was given.
A 10 yr old normal healthy male child was bitten (category 1) by a stray dog around the knee region on April 06, 1999. 10-15 mins after the bite wound, toilet  was performed with soapwater and antiseptic. Pt was administered 1st dose of Rabipur (batch number unknown) for postexposure prophylaxis. Within 5 mins after the injection he developed an anaphylactic/araphyfactoid reaction (fall in pulse rate and blood pressure, heavy breathing, sewating and redness) which lasted for 10-15 mins. The pt recovered after treatmen with Adrenaline 1 ampoule,s.c.(adrenaline bitartrale 1.8 mg) and one vial of Efcortin i.v. (hydrocortisone 100mg). The pt was kept under observation for 2 hours in a hospital and then sent home. The vaccination series was continued with a different (HDC) vaccine. The pt did not like eggs. Preliminary assessment; Seriousness-criterion; life threatening. Causality; not to exclude.
BLOOD CLOT IN LUNG; This spontaneous report received from a patient concerned a male of unspecified age. The reporter obtained the information from news/media. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient had blood clot in lung. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in lung was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210519715- covid-19 vaccine ad26.cov2.s - blood clot in lung . This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient started itching and scaling skin (no blisters) about 3 weeks ago, on extremities, hands, body, legs feels like "fire". Feet are swollen and red. She said she took Aspirin and BENADRYL. Have not seen doctor yet, told her to see a doctor.
Severe migraine after first dose. Started approx. 24 hours after injection and lasted one day.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's disease and allergy to tree nuts. Concomitant medications taken within two weeks of vaccination were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date the patient experienced severe migraine after first dose. It started approximately 24 hours after injection and lasted one day. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe migraine after first dose, it started approximately 24 hours after injection was resolved on an unknown date after the duration of one day. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 30-years-old) as a single dose for COVID-19 immunisation and experienced no side effects.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a other health professional refers to a 17 year old female patient with rubber sensitivity. On 24-APR-2016 the patient was vaccinated with GARDASIL 9 lot # L024993 dose 1, intramuscular for prophylaxis. Concomitant therapies included EPIDUO and BENZACLIN. On 24-APR-2016, 1 day after onset of therapy the patient experienced alopecia. The outcome of alopecia was reported as not recovered/not resolved. {Additional information has been requested. / Additional information is not expected.}
arm injection site pain(soreness); ran a fever of 101; Body aches; stuff nose; This is a spontaneous report from a contactable consumer.   A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route on 21Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient is not pregnant. The patient had received the first dose of the same vaccine on unknown date. On 21Jan2021 the patient experienced arm injection site pain, ran a fever of 101, body aches and stuff nose. The outcome of the events was reported as recovering. The patient did not receive any treatment for the events. The patient had not been tested for COVID post vaccination. No COVID prior vaccination. The events were assessed as non-serious.  Information on the lot/batch number has been requested.
My husband and I both had Covid for the first time in December, 2022; it could have been "Long Covid"; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (My husband and I both had Covid for the first time in December, 2022) and POST-ACUTE COVID-19 SYNDROME (it could have been "Long Covid") in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Bladder cancer.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2022, the patient experienced COVID-19 (My husband and I both had Covid for the first time in December, 2022) and POST-ACUTE COVID-19 SYNDROME (it could have been "Long Covid"). At the time of the report, COVID-19 (My husband and I both had Covid for the first time in December, 2022) had resolved and POST-ACUTE COVID-19 SYNDROME (it could have been "Long Covid") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has been going through BCG treatments immunotherapy for bladder cancer the last year and a half.  Patient had took the same vaccine shots as of his wife. Patient had Covid for the first time in Dec-2022 and it took a long time to get over. Patient had not took Paxlovid as he did not know exactly when it started. Patient thought it could have been "Long Covid". He was interested in taking new bivalent booster.   This case was linked to US-MODERNATX, INC.-MOD-2023-732537 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2023: Non-significant follow up received. On 09-Jul-2023: Non-significant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732537:Linked case ID MOD-2023-732537 Wife case
PT SAID HE RECEIVED COVID VACCINE (MODERNA) IN FEB.2021, FOLLOWED BY THE 2ND DOSE ABOUT A MONTH LATER, & STARTED HAVING SKIN PROBLEMS WORSEN AFTER VACCINATION. PT RECEIVED COVID BOOSTER ~11/11/21.
No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot number T030760, was verified to be a valid lot number with an expiration date reported and established as 08-MAR-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 17-AUG-2021, the patient was vaccinated with this improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that there was a previous temperature excursion reported of 24.8 degrees Fahrenheit (F) with a time frame of 2 hours and 41 minutes. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000271:
Initial numbness surrounding injection site extending from shoulder to elbow.  The following day nausea & redness, itching, warmth, and a hard knot at injection site.   Persisted for 3 days then subsided.  On day 8 itching, hives at the injection site that progressed to large knot, warmth, redness, and continuous itching for 3 inch diameter surrounding injection site.  Also swollen lymph node under arm on side of injection.  Symptoms improved to just mild, occasional itching to date.  Treatment with oral and topical antihistamine and ice pack
Sleepiness, a lingering headache, soreness at and around the injection sight, an extremely intense fever, with shivering so intense that my leg hurt and it was hard to move it. My fever seems to have been  between 100.6 and 100.3 degrees. I also experienced an elevated heart-rate & mild dehydration.
Husband called and said pt had typical side effects Friday and Saturday (sore arm, fatigue, chills) until Saturday a bad headache developed.  Then on Monday the elbow area was very sore and tender.  Tuesday morning the patient woke up and was very, very dizzy to the point that her husband said she couldn't walk and was very nauseous.  He called 911.  She did take  her blood sugar (type 1 diabetic) and it was about 250 tuesday morning before eating.  She did administer insulin on the way to the ER, but her blood sugar was even higher at the ER.   Husband stated patient said she felt like she was "going to die".
New information in product details regarding PREVNAR 13 was received from a nurse regarding a 3 year old male patient who experienced redness, swelling and had a ring around the injection site. The patient received a dose on 20 Sep 2010. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisatiton. Product was administered on 20 Sep 2010. Dose regimen was 0.5 mL 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced redness, swelling and had a ring around the injection site in Sep 2010 "within 24 hours of injecting the vaccine". Outcome for all events was not recovered. No additional information was available at the time of this report.
pt recvd vax; devel localized rxn that consisted of erythema, induration,localized tenderness & myalgia at the inject site;pt presented w/ low grade fever & gen body aches;
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in May2021 as dose 2, single (Batch/Lot number: unknown), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 08Jun2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing); "Previous history of long covid from Feb2020", start date: Feb2020, stop date: Feb2020, notes: likely covid, but unconfirmed as predated testing; "illness" (unspecified if ongoing). There were no concomitant medications.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient treated with Paxlovid. The patient experienced a rebound of COVID-19 symptoms with accompanying positive rapid antigen test on Day 11 of infection, after several days of improved/non-existent symptoms. The tested negative on Day 5 since positive covid test / day 5 of medication. The following days the patient had a faint positive test until Day 11 when symptoms returned, at which point the test was a clear positive. The patient had not received any other medication in two weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 24-JUN-2011, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2015, the patient was treated for a severe vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
chills, muscle aches, sore throat, swollen axillary nodes, nasal congestion
I felt very fatigues and had a sore throat on 5/18. 5/19 I had a fever and took an at home Covid test, positive. Spoke to Doctor's office in afternoon of 5/19. I got a telephone appointment for 5/20. Paxlovid prescribed and started 5/21. As of time of report, fever gone, but cough remains with nasal drainage.
Headache left arm pain Narrative: Patient experienced a headache and pain in the left arm. Both symptoms resolved within 24 hours.
pt turned very pale & quiet right p/shot (there was initial crying)-cried again p/about 2min;
Muscle spasms occurred 24-48 hours after vaccine  Muscle soreness in the neck/shoulder that did not go away.
About 2 weeks after the vaccine, my under arm started swelling. My lymph node was swollen. It couldn't rest my arm because it was so big and it was a constant pain that was very painful. It was tingly and weak. I went to my doctor and was prescribed antibiotics. My doctor didn't believe it was from the shot, he assumed it was from bacteria. Then after the 3rd shot of Moderna on 1/5/2022, lot number 028K21A that was done in my left arm, the swelling reoccurred again. My lymph node was swollen. My entire left arm hurt, I didn't not have any muscle strength, and nerves hurt. I went to my doctor again, he stated that it was possible that it was due to the vaccination. The swelling did go down eventually. I can still feel a lump that is there.
multiple Grand mal seizures; This case was reported by a consumer via interactive digital media and described the occurrence of grand mal seizure in a male patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine. On an unknown date, less than a day after receiving DTaP vaccine, the patient experienced grand mal seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the grand mal seizure was unknown.   It was unknown if the reporter considered the grand mal seizure to be related to DTaP vaccine.     Additional Information: GSK Receipt Date: 12-July-2022 Reporter's Comments: This case was received from the patient's parent via interactive digital media. The reporter said that she was lucky that her son did not die from his shot.  But what he did was, had multiple Grand Mal Seizures within 4 hours of every one of his DTP shots.  After the 3rd time his doctor wrote No Pertussis in red letters on his chart.  She also saw to it that his sister only got the TD shot. Additional supportive information:  The reporter reported that "had multiple Grand Mal Seizures within 4 hours of every one of his DTP shots" but due to limited information on number of shots and FU-no contact details, only 1 case was created.
Headache and severe muscle pain beginning at 11:30 pm on 11/3. Treated with naproxen. These symptoms lasted approx 24 hours. Redness at injection sight continued to get larger for next 72 hours. After 72 hours it was still swollen and painful and began itching. Several blisters appeared at this time.
My husband wore a t-shirt to the vaccination appointment at the mass vaccination site. Upon rolling up his sleeve to uncover the standard shoulder injection site, the person administering the vaccine asked him to roll up his t-shirt further and administered the vaccine very high and close to the shoulder bone. About 30 min after the vaccination, he started experiencing severe shoulder pain which has shown no improvement as of today (vaccine 4/7, reporting 4/9). He is unable to move his right arm without extreme pain. So far he has not sought medical care and is treating the shoulder with ice and over the counter medication. Currently ongoing with no improvement.  So far too early to determine if this will lead to disability and permanent damage.
Within 15 minutes of injection, felt dizzy. Had fever of 101 F in the evening, upset stomach, shaky. Had diarrhea and increased urination. Symptoms gone after 12 hours.
Got exposed 12/31/2020 to someone COVID positive, started feeling symptoms on the 2nd: chills and headache. Fever started the next day 01/03/2021. The highest it got was 101.7F.  I also got nausea and vomiting and cough. On 01/04/2021 got tested at my workplace and received positive result the same day.  So the nausea and vomiting I threw up every day for a week (went to the ER on 01/10 for dehydration and the headache lasted about 5 days. I also had lots of fatigue. The coughing went away after 2 1/2 weeks, fever lasted for about 1 week and the fatigue lasted 3 1/2 weeks.
Immediate swelling at injection site (~0.75" high). 30 hours later experienced extreme shortness of breath with rapid onset wich lasted for 3 hours.  Next 3 days extremely tired to the point of barely being able to get out of bed.  Following 4 days, very short of breath after climbing one story of household steps.  Currently, very low endurance before running out of breath.
No additional AE reported.; patient was accidently administered an expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist and referred to a patient of unknown age or gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were not reported.   On 27-FEB-2023, the patient was accidently administered an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, a dosage form, once, lot #U021995, expiration date: 13-JAN-2023, administered for prophylaxis (strength and route of administration were not provided) (expired product administered). The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) had no prior temperature excursions. No additional adverse event reported.