chrisvoncsefalvay/vaers-outcomes huggingface dataset:
took it twice got the flu twice; Initial information received on 05-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who stated took it twice got the flu twice while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received two unknown doses of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number; strength; formulation: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "took it twice got the flu twice" (influenza) (unknown latency).  It is unknown if there were lab data/results available.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (took it twice got the flu twice).  At time of reporting, the outcome was Unknown for the event took it twice got the flu twice.
Menstrual cycle was delayed by 4 days in January. The menstrual cycle was completely absent in February. The menstrual cycle was delayed by just over a week, with extreme cramping leading up to the bleeding in March. There was enough pain that I found it difficult to walk through the grocery store to pick up pain relief, and much of it centered in my lower back. The menstrual cycle was a day early in April.
Patient was given 2nd bivalent booster vaccine.  No adverse outcome at this time.  Prior bivalent received 9/2/22, this information was not provided prior to vaccination with 2nd bivalent booster.
Headache, Myalgia, NauseaVomiting, fatigue, chills Narrative:  had to leave work due to symptoms
Large red, hot and itchy patch or 4" to 5" diameter at the injection site
Headache, Myalgia, NauseaVomiting,  Chills Narrative:  Other Relevant History:
At 9 p.m., pt. started screaming and crying sporadically throughout the night saying his head hurt and leg hurt. He refused pain medication. His legs twitched throughout the night. In the morning, he cried his leg was sore and was limping. According to the handout received at the Health Department, these reactions can be a normal response to this vaccine. I took him to my mother who watched him the following day (8/3/23) while I worked. When I picked him up at 4:15 p.m., his left upper leg was very hard and very swollen and had red patches all over. The vaccine site was hard. His skin was hot to the touch. He continued to limp. He also continuously cleared his throat. I took him (and his older brother) home and when we arrived, my neighbor was outside; she is a nurse. I showed it to her and she said we should go to the ER. I called the pediatrician's office who also advised he should be taken to the ER. We arrived at the ER about 5:12 p.m. He was given oral steroids and I was told he was having a reaction to the vaccine and should never receive it again. We were released that night and he had a follow up appointment with a pediatrician the following day who prescribed a different dosage of steroid. He took the steroids for 5 days as prescribed. He continues to clear his throat constantly, has not slept through the night since receiving the vaccine, cries much of the night, has wet the bed every night since receiving the vaccine, and still complains of sporadic headaches. The injection site is still hard.
Coughing; blood when she spits; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing) and HAEMOPTYSIS (blood when she spits) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced COUGH (Coughing) and HAEMOPTYSIS (blood when she spits). At the time of the report, COUGH (Coughing) and HAEMOPTYSIS (blood when she spits) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-089292 (Patient Link).
This spontaneous report as received from a health professional refers to a 4 year old patient. On 26-JUN-2014 the patient was vaccinated with a dose of M-M-R II (HSA, lot # J011332, EXP date: 13-SEP-2015, dose and route not reported) and a dose of (Oka/Merck) VARIVAX (lot # J013907, expiration date: 30-OCT-2015, dose and route not reported), both vaccines were stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Rapid heartrate; Sweating; Headache; Vomiting; Pain at the injection site; I feel like I was going to die; Soreness to her other arm; This is a spontaneous report from a contactable consumer (patient). A 28-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 26Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Mar2021 around 22:00, the patient started experiencing a rapid heart rate noticing that on her watch her heart rate was up to 118 and going back down to 89 and then back up. This was accompanied by sweating, headache, vomiting, pain at the injection site and soreness to her other arm as well. The patient stated "I feel like I was gonna die". She was supposed to go to get her second vaccine dose on 16Apr2021 but was not sure if she should after having these symptoms. During the call, the patient also reported that her family had side effects but nothing like this. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Severe headache, chills, fever of 101.2 degrees, commencing 2 days after shot and lasting 3 days. Followed by severe headache for additional 6 days (total of 9 days). Treated with aspirin, no doctor called.
RN noted the client's husband asking the client if she was okay. RN responded to the client. RN noted the client seated in her seat but leaning forward. The client stated that her "heart is racing." The client reported a history of hyperthyroidism and stated that sometimes she feels her heart racing in the middle of the night. EMT responded. O2 was 99%. The client denied any shortness of breath or itching. The client reported shaking. RN noted shaking of the client's right hand. The client reported feeling "dizzy." RN left the scene to obtain the anti-gravity chair. RN responded with the anti-gravity chair. RN observed the client attempt to stand and fell back into the chair. No injury was noted by RN. RN responded. EMT prepared to assist the client into the anti-gravity chair. The client stood up partially, became unsteady, and EMT supported her into the anti-gravity chair. The anti-gravity chair was reclined to low-fowler's position. RN noted the client's eyes rolling back in her head and her head rolling to the side. The client was not verbally responsive for a few seconds. The client's husband responded. The client's husband said the client's current state was abnormal for the client. The client was oriented to person, place, time, but not situation. RN noted the client's speech was interrupted with periods of non-verbal responsiveness. RN activated EMS at 4:28PM. RN Responded. The client reported chest pressure to RN. The client and her husband denied any history of anxiety. The client reported history of allergy to "something blue." The client's husband stated the client has an allergy to contrast dye. RN  inquired if the client's current symptoms felt similar to her previous reaction to contrast dye. The client said "no." The client was intermittently squeezing RN hand and telling RN about her day in incomplete sentences. The phrases included "cooked chicken and rice" and "for kids." RN noted the client arching her neck and back intermittently trying to adjust her position in the chair. The client reported chest pressure radiating into her abdomen. Denied feeling nauseas or the urge to defecate or urinate. RN noted tears in the client's eyes. Vitals obtained at 16:35PM were as follows: HR 104, O2 99%. The client reported tingling all over her face. The client requested to be sat up and reported "I can't breathe." RN noted the client's hand on her chest and the client gasping for breath. RN noted the client's cheek and ear were cold. The client stated she felt like she was sweating. RN  recommended administration of Epinephrine per CoSD Emergency Life Support Manual. RN educated the client that she was about administer Epinephrine. The client was not verbally responsive. RN administered Epinephrine Injection, USP Auto-Injector 0.3mg into the anterolateral aspect of the right thigh at 4:37PM. RN noted the client verbally responsive. Client stated her breathing was improving. Chula Vista Fire Department assumed care at 4:38PM. RN was unable to administer Benadryl 50mg prior to the Fire Department assuming care. Client transported to. The exact time the client left the facility was not noted. VAERS completed. VAERS confirmation number.
VACCINATED WITH JANSSEN VACCINE IN MARCH OF THIS YEAR. WENT TO HOSPITAL ER ON 8/15/21 WITH A 2 WEEK HISTORY OF SYMPTOMS WHICH INCLUDED: CHILLS, RUNNY NOSE, FATIGUE, SHORTNESS OF BREATH, NAUSEA, ABDOMINAL PAIN AND DIARRHEA.  RECEIVED MONOCLONAL ANTIBODY TREATMENT WHILE IN ER AND WAS ADMITTED THE SAME DAY. SHE IS NOT IN ICU OR ON THE VENTILATOR. HER HUSBAND TESTED POSITIVE ON 8/6/21 AND HE WAS HOSPITALIZED ON 8/14/21.
Shot was Saturday at noon, late in day Rt. arm hurt, Sunday, arm hurt, but no other symptoms, by Monday, arm was swollen, Tuesday, arm still hurt, was more swollen and turned red approximately 6 x 6" and started to itch; Wednesday arm still hurt, swollen, more red - top to bottom approx 8" and sided to side 7"  in an L pattern and itching badly. Over the past couple days it was getting increasingly worse.  In addition, my eyes were now pinkish, bloodshot looking and burning and hurting, that's why I called the doctor.  I asked if it could have been from the Covid shot I had gotten as my eyes had also gotten worse Mon, Tues and Wed when I called medical facility, but Dr. hadn't heard of any adverse effects to the eyes.  I was told to put hot compresses on, and moisturizing drops which I had been doing already.  Thursday morning I work to much less itching, my arm was now only slightly red, and my eyes were now clear.  I don't know if anyone can figure out if the eye pain and redness was due to the Covid shot or not, but I was told to report it.
Patient had a near-syncope episode where he became pale, weak, had blurry vision, and was bradycardic.  He also had transient abdominal pain,paresthesias, and shortness of breath (no wheeze or stridor noted). 5/15/08-records received for DOS 4/16-4/17/08-DC DX: Reaction to vaccine. Near syncopal episode, resolved. Abdominal pain, resolved. Bradycardia. Seen in ED directly from physician's office after near syncopal episode, turned very pale and felt sick. Felt short of breath with some numbness, tingling and abdominal pain. Admitted for observation overnight. Low pulse rate of 38.
Irregular menstrual cycle: spotting 8/2-6, Extremely heavy menstrual cycle and longer than normal duration from 8/15-22, Extremely heavy cycle and longer than normal duration from 9/4-15.
No adverse effects reported; The dose of VARIVAX was inadvertently administered too early; This spontaneous report was received from a pharmacist referring to a referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 23-APR-2019, the patient was vaccinated Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) diluted with sterile diluent (dose, frequency, route, lot# and expiration date not reported) for prophylaxis. On 13-MAY-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot #R007688 and expiration date 14-MAR-2020) that was reconstituted with sterile diluent (lot# S002624 has been verified to be a valid lot number for sterile diluent, expiration date reported as May 2021, but upon internal validation established as 05-NOV-2021) (dose, frequency and route not reported) for prophylaxis. The reporter stated that the dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) was inadvertently administered too early (inappropriate schedule of product administration).
MOTHER OF PATIENT REPORTED ON 7/03/08 THAT HE HAD TINY RED SPOT ON TRUNK OF BODY AND LARGE RED RAISED AREA AT INJECTION SITE. APPT WAS OFFERED AT THAT TIME, PARENT DECLINED AND SAID SHE WOULD JUST WATCH IT OVER THE WEEK-END, CHILD WAS FEELING OK BUT HAD A LOW GRADE TEMP. PARENT CALLED AGAIN ON MONDAY AND SAID HE WAS FINE, SPOTS HAD DISAPPEARED BUT REDNESS AT INJECTION SITE WAS STILL THERE AND SHE WOULD LIKE TO BRING HIM IN THE NEXT DAY AS THAT WAS HER DAY OFF. APPT WAS GIVEN FOR 9:00 AM. THEY MISSED THE APPT BUT CALLED IN A FEW HOURS LATER AND WE GAVE ANOTHER APPT TIME FOR. UPON EXAM, INJECTION SITE WAS RED WITH A SMALL GROUPED VESICLES ON ERYTHEMATOUS BASE. EXAM BY ANP. NO TREATMENT NEEDED.
Patient complained of bieng nauseaus, clamy, and sweaty. Onsite EMS was called vitals BP 123/69        HR 59  100% O2. He said he hadn't eaten anything yet. He was offered graham crackers and water, he refused both. felt better and was released home.
Dizziness, diaphoresis post injection during observation period. Patient placed in prone position, legs elevated. Vitals assessed. After 15 minutes, patient assisted to sitting position. Declined further intervention.
Mother reported redness, swelling, pain and large hot red lump on 08/02/2017, advised to bring in for eval, which she did that day. Also reported some tingling down left arm as well. MMR injection site lower and posterior to HPV injection site. The lower site was red with large area of swelling. No "Lump" noted. Was given Rx of Cephalexin 500mg TID x5 days.
Started with the usual pain after flu shot, but one month later continues to hurt in certain positions and her left arm feels weak.
This spontaneous report was received from a nurse refers to a 6 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 03-OCT-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # N009948, expiry date: 12-OCT-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054.
Mother noticed a red blotchy rash on trunk on 12/1/03. Today (12/2/03) it had spread to the arms and legs.
Tinnitus.  The ringing in my ears has become so bad that I can?t hear and I can?t concentrate.  I don?t want to live any longer like this.
arm really hurt; stomach cramping; didn't feel well; This is a spontaneous report from a non-contactable Nurse anesthetist reporting for herself via Pfizer employee (friend). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at 08:00 at single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) received via an unspecified route of administration on 18Dec2020 at 08:00 at single dose. The patient was taking COVID-19 vaccine since is front line healthcare worker. The patient was vaccinated at hospital. Age at vaccination was 46 years. The patient's medical history and concomitant medications were not reported. The patient reported she had no problems with the first dose but after the second dose that night (08Jan2021) her arm really hurted and she had stomach cramping. She didn't feel well at all. The patient took two Advil and the next day (09Jan2021) she was fine and is still fine. The Pfizer employee stated her friend looked fine as she was exercising. Onset date of the events was also reported as 09Jan2021 with recovery date 10Jan2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
In December 2022 I was having a racing heart rate for no reason. My normal is 65 and it would be 105 or higher. It would remain consistent for several days. I visited the doctor on December 14th and wore a heart monitor for two weeks. I learned I was in AFIB about 25 percent of the time. I consulted further and will probably have an ablation.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient. A 16-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 21Aug2021 (Lot number: FC3182) at the age of 16 years as dose 2, single and administration date 21Jun2021 (Lot number: Ew0186) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "If Covid prior vaccination: Yes" (unspecified if ongoing), notes: If Covid prior vaccination: Yes; "Known allergies: Tree nuts" (unspecified if ongoing), notes: Known allergies: Tree nuts. The patient took concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Covid diagnosed between 2nd vaccine and booster". Clinical Course: Facility type vaccine was Pharmacy or Drug Store. There was no other vaccine in four weeks. There was other medications in two weeks. Covid was not tested post vaccination.
1-24-11 Vaccinated approx 11am. Taken home and after nap woke with temp approx 102 degrees. Reduces after med. Fluctuating temps (highest 102 degrees) but fine red rash appeared on stomach. Contacted health dept: report filed.
arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm sore) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm sore). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 15-Feb-2021, VACCINATION SITE PAIN (arm sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-046369 (Patient Link).
moderate pain at site of injection,  malaise, body aches, sl. nausea.  pain persistent for several days, other symptoms subsided after 48 hours
I'm fairly certain that the vaccine caused a severe fibromyalgia flare-up, about 3 days after getting the vaccine. This flare-up has been much more severe than the ones I usually get. The pain, fatigue, and brain fog has been extreme. No fever or flu-like symptoms.
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 11-JUL-2016 and 13-APR-2017, the patient was vaccinated with Oka/Merck VARIVAX (lot # L035124, expiry date: 14-SEP-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
Sensitivity to random areas of my skin.  Feels like pins and needles.  Very sensitive to touch.
Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Patient reports feeling marked presents profuse sweating and pale color. Patient is evaluated by emergency medical personnel. 66r es Pulse 68 os/06 DXT 96 R 20. He is placed on a stretcher and observed for 30 minutes. Doctor is notified by family refers family history of vagal vessel. Vitals discharge SAT 100  Pulse 76 B/P 95/60 There are no restrictions when breathing.
I woke up the next day with sore arm on left, headache, and fever 0t got 102.5, normal in 97.8, chills, and aches. My heartrate increased went 112. Went to ER that evening. They gave me IV and meds. Felt normal till the 6Nov2021 with headaches.
A report has been received from a Health Professional concerning a 44 year old, subject of unknown gender, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 17-Dec-2013. It was reported that one of the nurses gave FLUMIST to a 44 year old patient which started o 17-Dec-2013 which was expired on 25-Nov-2013. The outcome of the event of GAVE EXPIRED VACCINE is unknown. The report was considered to be non-serious.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2023 -- RECURRENCE OF SAME SYMPTOMS
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. Patients' medical history, concurrent condition and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L038503, expiration date: 18-DEC-2017, lot # M003659, expiration date: 20-SEP-2017 or lot# L043213, expiration date: 28-AUG-2017, (Strength, dose and route of administration were not reported). Patients' concomitant medication was not provided. No adverse effects were reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Few hrs p/vax pt noted to have jerky movements on & off shaking w/fever & refusing to turn to side;