chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient tested positive for the coronavirus three days after receiving the Moderna vaccine booster; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive for the coronavirus three days after receiving the Moderna vaccine booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Dec-2021, the patient experienced COVID-19 (Patient tested positive for the coronavirus three days after receiving the Moderna vaccine booster). At the time of the report, COVID-19 (Patient tested positive for the coronavirus three days after receiving the Moderna vaccine booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Dec-2021, SARS-CoV-2 test: positive (Positive) Patient tested positive for COVID-19.         No concomitant medications were reported.  No treatment information was provided. Company comment:This spontaneous case is concerning a female patient of unknown age with no medical history reported, experienced the unexpected, AESI of COVID-19, which occurred 3 days after receiving third dose of mRNA-1273 vaccine. The outcome was reported unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case is concerning a female patient of unknown age with no medical history reported, experienced the unexpected, AESI of COVID-19, which occurred 3 days after receiving third dose of mRNA-1273 vaccine. The outcome was reported unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Case number PHHY2012US051419 is an initial literature report received on 12 Jun 2012. Authors searched VAERS for reports of adverse events (AEs) in pregnant women who received trivalent inactivated influenza vaccine from 01 Jul 1999 through 30 Jun 2009. This case refers to a pregnant female patient (age not specified). She was vaccinated with trivalent inactivated influenza vaccine (seasonal influenza vaccine, manufacturer and batch number: unknown) at an unknown gestational age, on an unspecified date between 01 Jul 1999 through 30 Jun 2009. On an unknown date after vaccination, the patient developed gestational diabetes. The outcome of the event gestational diabetes and outcome of pregnancy were not known. The causality was not reported. The VAERS system does not allow for active follow-up of adverse events among pregnant women; thus, pregnancy outcome data are not available for women who had an adverse pregnancy event. Authors concluded that no unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of trivalent influenza vaccine.
Employee received FLULAVAL vaccine on 9/19/2016 and the morning broke out in a red itchy rash and hives on arms, neck, face, back and knees.
Headache, fatigue, myalgias, dizziness, weakness, abdominal pain
Hep B outdated 1/11/04, given on 3/3/04. Vaccine to be readministered.
Swelling, pain, redness, and heat. Started at injection site, but has spread to whole shoulder and collar bone area.   Ibuprofen helps with the pain and stiffness, but not the swelling.  I have not seen a doctor, but want to report my reaction. I will see a doctor if it does not start getting better.
Pain in armpits; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain in armpits) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN (Pain in armpits). At the time of the report, PAIN (Pain in armpits) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Muscle pain; Headache; Aches everywhere; little soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis (was being treated for it).   On 17th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix, the patient experienced injection site pain. On 21st December 2020, the patient experienced muscle pain, headache and general body pain. On an unknown date, the outcome of the injection site pain, muscle pain, headache and general body pain were unknown.   It was unknown if the reporter considered the injection site pain, muscle pain, headache and general body pain to be related to Shingrix.  Additional details were reported as follows: The patient received the 2nd dose in his left arm The patient felt terrible after receiving the 2nd dose of the Shingrix. He stated that he aches everywhere, had muscle pain, headache (onset at the time of report) and a little soreness at the injection site.  He did not report fever.  On 21st December 2020, 4 days after receiving Shingrix the patient experienced muscle pain, headache and general body pain. He was unable to open the top of a jar because of the pain.  The reporter did not consent to follow-up.
Fever up to 101 degrees, Headaches, Muscle aches, joint aches, very tired, dizziness, weakness,  Nausea, Loss of appetite,
Starting the next morning after shot: fever (100.5), dizziness, fatigue, loss of appetite.
After vaccine was administered patient stated feeling a little dizzy and then patient fainted out of chair and came back to for a few seconds, hten passed out again and came back seconds after.  Patient was then transported to the Emergency Room where EKG was done.  Diagnosed with Syncope, Vasovagal.
Patient had vaccine 8/29/19, at around 1030 A patient woke up 8/30/19, with Redness and warmth @ site
Immediate stinging pain on upper right arm  site of the vaccination.  Continuing pain in upper arm (severe enough to cause sleepless nights), weakness in lower arm, inability to lift heavy items, etc. This pain has not abated even a month later.  Frequent use of Advil which does not work well.
C/o symmetric hand/wrist/ankle pain. Pain feels like a deep ache.  No rash, no sob, no respiratory symptoms.  Saw Urgent Care this morning 5/21/15.
Day 1- Chills; sleepiness; minor dizziness; tiredness; and shoulder pain. Day 2- Swollen Lymph Nodes under arm; chest pain; shoulder pain; and tiredness. Day 3- Swollen Lymph Nodes under arm and left side of the neck; neck pain; minor dizziness; and headache.
No adverse effects reported; One dose of an improperly stored vaccine, PROQUAD, has been administered to one patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients concurrent conditions, medical history and concomitant medications were not provided.   On 30-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (strength, dose, route, frequency, were not provided) for prophylaxis; the Lot No. S008578 has been verified to be a valid lot number for [Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live], expiration date reported as 16-SEP-2020, and upon internal validation established as the same.   The nurse reported that this vaccine dose was administered on this date, but the vaccine was improperly stored (incorrect product storage). It presented a temperature excursion with a temperature of 8.5 degrees Celsius for 25 minutes. And no adverse events were reported. There were no other temperature excursions presented for this vaccine and there was a data logger.   Moreover, it was stated that the sterile diluent that was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored (Lot# S026376 and expiration date 24-MAR-2022).
Pt developed wheezing, temp of 102, then sz, & collapse; Taken to ER PM on 21JUN91;Pt. had period of apnea, which responded to Father's resuscitation efforts.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown ages and genders. No medical history or concurrent conditions were reported. Since 18-SEP-2015 an unknown number of patients were vaccinated with oral ROTATEQ (lot # L008054, exp date 30-NOV-2016; lot # L006184, exp date 13-DEC-2016; lot # L008054, exp date 30-NOV-2016; lot # L010128, exp date 24-JAN-2017) (concentration, dosage and frequency were not reported) which were exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
BABY STARTED CRYING AT 1300, SCREAMING AT HIGH PITCH, FLAILING ARMS, INCONSOLABLE FOR 7 HOURS. GAVE TYLENOL BY WEIGHT, EVERY 4 HOURS. CONSTANT COMFORTING- ROCKING, ETC. BABY DID NOT EAT WELL UNTIL NEXT 12 HOURS AFTER IMMUNIZATIONS. DIDN'T REPORT TO DR. READ TODAY THAT CRYING MORE THAN 3 HOURS SHOULD BE REPORTED.
Severe hives outbreak.  Hives began on legs about 18 hours after second dose shot.  After about 4 hours, all limbs covered in hives and throat felt irritated.  Took a 5mg Claritin at that point (fearing hives would worsen during night).  Awoke with no reaction next day or thereafter.  No hives reaction after first dose. After both doses had typical sore arm for 48 hours; fatigue after second dose only.
Immediately after receiving the vaccine Pfizer at the pharmacy. I had read severe reaction. First I had horrible pain radiates up my arm to the back of my neck felt like I had whiplash. Then I had a burning pain behind my eye. Pain on the left side of my face where I felt like somebody punched me which is still going on a week later. Blurred vision that lasted on and off for 4 days. Tingling in my right leg and having brain fog for the last week and a half since receiving the shot. And a scab flash scaling at the vaccination site on my arm. that looks like the old-time back vaccination but I had when I was a child. I immediately went to the emergency room Hospital. Where I was put on the heart
I had my vaccination on 11/25/2022. On 12/24/2022 my throat was hurting and felt like I had a head cold. On 12/25/2022 I felt worse. On 12/26/2022 and the test was COVID-19 Negative. On 12/27/2022 I tested COVID-19 Positive and prescribed Paxlovid.
Panic attack; This spontaneous case was received on 16-Nov-2022 from other non-healthcare professional (reference number: SEQW22-05847) and concerned a male patient of unknown age.  The patient's concurrent conditions included panic disorder, however, he did not have actual panic attack in years. The patient's concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date, starting about twelve hours after receiving Flucelvax Quadrivalent, the patient experienced panic attack for the first time in years and was having them constantly ever since. The patient stated nothing else had changed.  At the time of the initial reporting, the patient had not recovered from the event.  The reporter did not provide a causality assessment.  Company comment: A male patient of unknown age experienced panic attack about twelve hours after vaccination with the suspect Flucelvax Quadrivalent vaccine. The patient's concurrent condition included panic disorder. Causality for event is assessed as not related to the suspect vaccine due to implausible temporal relationship.; Sender's Comments: A male patient of unknown age experienced panic attack about twelve hours after vaccination with the suspect Flucelvax Quadrivalent vaccine. The patient's concurrent condition included panic disorder. Causality for event is assessed as not related to the suspect vaccine due to implausible temporal relationship.
Patient had rainbow visual auras, followed by one episode of vomiting water she drank. Took blood pressure & pulse & they were normal.
Pt called health dept and spoke with RN on 4/15/13.  Pt reported migraine and vomiting the night of 4/10/13.  Pt stated the next day her right arm was puffy, warm, and sore.  Pt states soreness has gotten worse over time.  Pt referred to PHP for eval of complaints.  Pt went to PHP on 4/15/13 and reports to health dept that PHP thinks it was an allergic reaction and she is being treated with clindamycin, prednisone, and ibuprofen prn.
R interior deltoid ~ 3 cm oval shaped area erythema, edema + warmth + induration 0 fluctuation + tender to palpation. given Bactrim DS #14, T by mouth RID x 1 wk.
Pt. is MD. C/O marked tenderness of injection site x 7 days. "Hurts when I turn my head." Denies swelling, redness, warmth, bruising. C/O tingling and weakness bilaterally in both lower legs. C/O involuntary movement of fingers at night. Instructed to see personal physician about these symptoms.
Information has been received from a 61 year old female patient with hypothyroidism and no drug reactions or allergies who on 20-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported) 0.65ml. Concomitant therapy included LEVOTHYROXINE NA. On 21-MAY-2009 after got the vaccine she developed red hot and hard to touch bump at the injection site. At the time on the report on 22-MAY-2009 the patient had not recovered. There were no laboratories diagnostics studies performed. The patient did not seek medical attention. No further information is available.
Arm was swollen, tender, warm, and pruritic. He had marked edema, erythema, and he had a fever. Treated with prednisone and cool soaks.
He got a 4th Moderna COVID-19 booster vaccine (half dose); mild joint pain/increases during the day/quite painful as the day progresses; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (mild joint pain/increases during the day/quite painful as the day progresses), HEADACHE (mild headache) and EXTRA DOSE ADMINISTERED (He got a 4th Moderna COVID-19 booster vaccine (half dose)) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A, 031M20A and 017E21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Penicillin), Cancer since 2018 and Immunocompromised. Concomitant products included VENETOCLAX, DEXAMETHASONE and BORTEZOMIB (VELCADE) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 09-Feb-2022, the patient experienced EXTRA DOSE ADMINISTERED (He got a 4th Moderna COVID-19 booster vaccine (half dose)). In February 2022, the patient experienced ARTHRALGIA (mild joint pain/increases during the day/quite painful as the day progresses) and HEADACHE (mild headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (mild joint pain/increases during the day/quite painful as the day progresses) and HEADACHE (mild headache) had not resolved and EXTRA DOSE ADMINISTERED (He got a 4th Moderna COVID-19 booster vaccine (half dose)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It had been 7 days and patient still had the joint pain and mild headache. His doctor took him off of his oncology medications to build up his "blood members" on 04Feb2022.   This case was linked to MOD-2022-485302 (Patient Link).
HCP is administering just one dose of Shingrix after /received / Zostavax/is not providing the second dose; HCP is not providing the second dose of the Shingrix/nor indicating that / should receive it/ is being done with several patients; This case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date) and Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination and off label use. On an unknown date, the outcome of the incomplete course of vaccination and off label use were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The vaccines representative reported that, the health care professional was not completing the Shingrix schedule. The health care professional  was administering just one dose of Shingrix after the patient received a complete schedule of Zostavax. The health care professioanl was not providing the second dose of the Shingrix vaccine schedule nor indicating that the patients should receive it, which led to off label use.. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to  incomplete course of vaccination. The health care professional  wished not to be contacted for follow up. The vaccines representative agreed to follow up.
Patient fainted after receiving immunization and felt better and was fully recovered after twenty minutes of monitoring by pharmacist. Patient reported a history of having felt dizzy after receiving an immunization on Immunization Consent Form. Patient requested Advil five minutes after immunization and was advised to take with meal and took the Advil. After full recovery, patient answered no when asked if 911 should be called.
67 y.o. female admitted on 1/12/2022 with a past medical history significant for hypertension, HLD, CAD, status post CABG, COPD, DM2, and Bipolar disorder. She presents today with complaints of progressively worsening SOB going on for the past week. Dyspnea worse with exertion. There is associated non productive cough, sore throat, myalgias, and subjective fever. Onset of symptoms approximately one week ago. She took some tylenol today without much relief. Patient reports she has had to take care of multiple COVID-19 positive family members over the past few weeks.  Reports that her cousin passed away due to complications of COVID-19 on Monday.  Patient states she is vaccinated X2, but has not had a booster (which is due in March).  Of note, patient with history of tobacco abuse.  No longer smoking.  She also complains of chest pain in the substernal area that radiates into her neck and arms at times.  Chest pain at times is associated with shortness of breath.  Currently denies any syncope or lower extremity pain/swelling.  And reports decrease since that time taste, but not smell. No headache or focal weakness/parathesias.  Patient reports that she tested positive for COVID-19 on Monday.  Patient reports that due to not feeling well she has not been taking any of her medications including her basal or bolus insulin.  Upon arrival to the ED patient was noted to have a blood glucose of 577.  She was positive for COVID-19.  She was hypoxic with a pulse ox of 85% on room air.  Due to the above findings decision was made to admit patient to hospitalist service for further evaluation management.
15 month old patient was administered expired dose of Daptacel, No AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old female patient who received an expired 0.5 mL dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5254AA, expiry date- 18-Sep-2019 via unknown route in unknown administration site on 01-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccines administered.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
I was informed by the pharmacist that it was likely I would have extreme soreness at the site.  I was not informed that other common reactions were fever, chills, headache, vomiting.  I awoke with 102 fever, which persisted about 36 hours, a pounding headache, lethargy, chills.  I was home alone because I was not prepared for these symptoms.  I was lethargic, slipping in and out of sleep from about midnight Friday to around 5 pm Saturday.  During that time, I had nothing to eat or drink.  I was confused and not together enough to realize I needed someone with me.  With dehydration being a real concern for someone my age, this could have been a real risk.  In my opinion, people should be encouraged to have someone with them in the 24 hour period after taking the Shingrix vaccination.   I am a healthy, active person, and it would have been so simple for me to stay with friends, had I known about these likely reactions.  For me not to call for help tells me I was zoned out by the vaccine.  It is Wednesday and I am fine, if still a little lethargic.  I am reluctant to take the second vaccination in 2 to 6 months for fear this will happen again.  I had both my children with no pain medication, so I am not a crybaby.  In the summer of 2017, I drove alone to Lake and across to campground where I camped out a couple of weeks before driving to another city and then home.  I am not typically helpless. This episode really frightened me for my own safety.  I was told to have someone with me after I had cataract surgery, and this was exponentially much worse than that recovery.  These were listed as "common" reactions (fever, headache, chills) on the GlaxoSmithKline website but I was not informed.  I'm not reporting the vaccine as dangerous, but it should be accompanied with a more specific recommendation for precautionary action by recipients, especially elderly recipients.