chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluid in lungs; Positive COVID test; Feeling poor; Dehydration; Loopy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY OEDEMA (Fluid in lungs), COVID-19 (Positive COVID test), DEHYDRATION (Dehydration), CONFUSIONAL STATE (Loopy) and FEELING ABNORMAL (Feeling poor) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PULMONARY OEDEMA (Fluid in lungs) (seriousness criterion hospitalization), COVID-19 (Positive COVID test) (seriousness criterion hospitalization), DEHYDRATION (Dehydration) (seriousness criterion hospitalization), CONFUSIONAL STATE (Loopy) (seriousness criterion hospitalization) and FEELING ABNORMAL (Feeling poor) (seriousness criterion hospitalization). The patient was hospitalized from 22-Mar-2021 to 23-Mar-2021 due to CONFUSIONAL STATE and DEHYDRATION. The patient was treated with Surgery for Pulmonary oedema. On 23-Mar-2021, PULMONARY OEDEMA (Fluid in lungs), DEHYDRATION (Dehydration), CONFUSIONAL STATE (Loopy) and FEELING ABNORMAL (Feeling poor) had resolved. At the time of the report, COVID-19 (Positive COVID test) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Blood Thinners (unspecified). The reporter did not mention any treatment medications for the events.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
A little weak at bedtime (Saturday) Next morning  Strong toothache upper back left teeth, slight swelling/itching  lower left side of mouth/chin area (Sunday) Pain all day (Monday) Feels like teeth are in a vice, swelling left side of roof of mouth
Injection site and arm up to elbow turned purple-black with burning sensation. After 4-5 days skin color improved but skin is charred and rough. Treating with aloe plant gel
Patient called the same day as she got her vaccine with us reporting that she believed to have not gotten the full Janssen vaccine. We use circular adhesive bandaids that we vaccinate directly through and patient reported that after having removed the bandaid, "a bunch of liquid ran down her arm". She reported it not being blood and too much to just be some condensation underneath the bandaid. Therefore, she thought it was the vaccine that didnt entirely get into her arm. Unclear how this could have happened, I directed the patient into looking into getting an antibody test in 2 weeks to see if her body produced any post vaccination. She called back two weeks later and said her test came back negative. I called the CDC confused and they reported that antibody tests would not show antibodies produced through vaccination and would only show that produced naturally through previous infection. The CDC then suggested that if there was a device malfunction and that the full dose was not administered, that the dose should be readministered. Patient was adamant that she did not get full dose and after talking to her Dr, it was the pharmacy's decision to revaccinate due to full dose not being administered. We didnt have any Janssen vaccine at that time so we put patient on our waitlist. Patient found vaccine elsewhere and pharmacy readministered there.
1st dose in 2019, never completed the series; Pain at the injection site; Chills; Fever; bad headaches; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 30-OCT-2019, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 30-OCT-2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at the injection site), chills (Verbatim: Chills), fever (Verbatim: Fever) and headache (Verbatim: bad headaches). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in 2019, never completed the series). On 31-OCT-2019, the outcome of the injection site pain, chills, fever and headache were resolved (duration 1 day). The outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain, chills, fever and headache to be related to Shingrix.     It was unknown if the company considered the injection site pain, chills, fever and headache to be related to Shingrix.   Additional Information: GSK receipt date: 28-Mar-2023  This case was self-reported by the patient. The patient started with bad headaches on day of vaccination, and then the following day had fever, chills and pain at the injection site.  The next day, all the symptoms were disappeared.  The patient never completed the vaccination series. Details were reported for 1st dose. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
She is experiencing extreme fatigue and is still experiencing a fever; She is experiencing extreme fatigue and is still experiencing a fever; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included at the age of 76 received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19. On 2021, The patient reported she is experiencing extreme fatigue and is still experiencing a fever. Patient has received both doses of the Pfizer BioNTech Covid vaccine. After the first dose she experienced fatigue. However, after the second dose on 4Feb2021 she had a "fairly large response." She is still dealing with these side effects over six weeks later. She is experiencing extreme fatigue and is still experiencing a fever. Her temperature is usually normal in the morning and then raises to 100.5 to 101.2 in the evening. She has already seen her HCP several times and they have no recommendations. She has been tested for Covid and different viruses but they've all been negative. She's had a chest Xray, urinanalysis, put on antibiotics just incase there was something latent. She has had blood work done several times, her WBC was 5.4 and was only slightly anemic. Her doctor may start her on iron supplements. The patient underwent lab tests and procedures which included, body temperature: 100.5 to 101.2 on 2021 (100.5 to 101.2 in the evening), body temperature: normal in the morning on 2021, sars-cov-2 test: negative on 2021, urine analysis: unknown on 2021, viral test: negative on 2021 and x-ray: unknown on 2021 (She's had a chest Xray) and white blood cell count: 5.4 (Her doctor may start her on iron supplements). The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was unknown.  Information on the lot/batch number has been requested.
9/6/21: The patient is a very pleasant 58 year-old female who presents to the ED with worsening shortness of breath after recent diagnosis of acute COVID-19 infection. Patient developed symptoms on Tuesday and received antibody infusion on Wednesday. She later developed severe shortness of breath yesterday and sought medical attention in the ED. Upon initial evaluation patient was tachypneic with SpO2 on room air of 90%. Serologic analysis was fairly benign only notable for elevated creatinine 1.22. Chest x-ray showed no acute cardiopulmonary findings. Due to high D-dimer a CT angio chest was done ruling out acute embolism but showing right pleural effusion. Patient received first dose Pfizer vaccine on 2/24/2021 Lot # EN6203, the second dose on 3/18/2021 Lot # EN6200 and the booster shot on 10/29/2021 Lot# FH8028
Inflammation, itchiness, and minor pain at injection site. Began 3/21 and resolved by 3/29
12 hours after vaccine--fever, chills, body aches, headache lasting for about 30 hours
received the vaccine after the 6 hour vial puncture expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the vaccine after the 6 hour vial puncture expiry) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received the vaccine after the 6 hour vial puncture expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received the vaccine after the 6 hour vial puncture expiry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Concomitant medications was not provided.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 012M20A)  with no associated AEs.
Shortly after vaccines were received, pt developed hives on back, wheezing, difficulty breathing, nausea. Pt given BENADRYL, DECADRON IM, and epinephrine IM, and albuterol neb with improvement in symptoms. Pt taken to ER by EMS.
pt devel redness, itching, swelling w/red, lacy rash bordering inj site (about 5 inches diameter);stated pain was great enough to prohibit raising arm above shoulder height;9/11/99 pain in rt upper chest episodes lasting about 10min;
Patient passed away on 10-22-2021 after receiving 2nd shot on 9-3-22
Itching and tingling of the face. Took Benadryl and symptoms resolved.
Severe Vertigo lasting about a month, periodic meclyzine prescrided to help with nasuea.  Physical Therapy helped reduce vertigo.  Continuation of periodic dizziness.  Pressure in both ears, more in right ear.  Tried antibiotices, steriods.  Saw Earn Nose and Throat Specialist, remove alcohol and caffinne.  No impact on feeling of waves and unclearness.  Like getting off a boat onto solid ground...As of June 23rd, still experiencing dizziness daily.
Female patient 25 years old refers to nurse with feeling dizzy and blurry vision after the vaccine administration. She gets transferred to the evaluation area. We take her vitals 110/70, 98% Spo2, 103 pulse and 76 glucose. We consult with Doctor R. and she indicates to leave patient in the observation area for 30 minutes and to reevaluate vitals. After 30 minutes we retake her vitals BP 120/70, Spo2 99%, 97 pulse and 90 of glucose. Patient refers feeling better and free of dizziness. Patient leaves the cent of vaccines.
Pt seized lost consciousness, became apneic and was without a pulse, ambu bagged pt. 0.4 mg epi given & pt regained pulse & consciousness. A&Ox3. Paramedics came. Pt did not hit his head. HR: 100 BP: 116/70 when paramedics arrived. Total seizure length: 1.5 minutes.
Joint pain, limited range of motion, mild numbness and tingling down arm to right index finger. Swelling and inflammation in entire shoulder.
discomfort in arm for two days, minor  headache one day, felt tired for approximately six days.
Information has been received from a medical assistant (M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 25-JUN-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23, lot # K018528, expiration date 14-APR-2016 (dose and route not reported). No adverse effect was reported. Additional information has been requested.
Pt reports fever with general malaise.  She noticed that her R deltoid at injection site was warm, red, swollen.  Wound was draining 2 days later.  Pt required 2 visits to physicians office.
Pt had a local rash at the site of her MMR injection. Mom noticed the rash the next morning after injection.
Pt woke up the following morning with a swollen lt arm and lt side of face. She also developed diarrhea, but symptoms resolved within 24-48 hrs.
About 36hours post vaccination patient reported one large area (large apple sized) area of bruising around injection site as well as area being somewhat swollen and warm to the touch. As days progressed smaller, less intense areas of bruising appeared on the injection arm not connected to initial swelling
dizzy spells; Muscle aches; Headaches; 4 months pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (4 months pregnant), DIZZINESS (dizzy spells), MYALGIA (Muscle aches) and HEADACHE (Headaches) 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 11-Feb-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) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (4 months pregnant), DIZZINESS (dizzy spells), MYALGIA (Muscle aches) and HEADACHE (Headaches). At the time of the report, EXPOSURE DURING PREGNANCY (4 months pregnant) had resolved and DIZZINESS (dizzy spells), MYALGIA (Muscle aches) and HEADACHE (Headaches) outcome was unknown.            No relevant concomitant medication was reported. Treatment information was not provided. Patient is 4 months pregnant.; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on the current available information and temporal association between the use of the product and the start date of the events other than the exposure during pregnancy, a causal relationship cannot be excluded
at first I had the expected reaction and feeling of being "hungover" on night after vaccine, 7pm on 1/29/2021.  I felt better overall in 24 hrs, but I've continued to have mild arm pain at injection site. Now, over a week and a half later, on 1/8/2021, I have mild itching at injection site and moderate arm pain. V-safe check-in site I was using has stopped actively sending my daily checkins after a week, switching to weekly check-ins instead.
On 9/16/2022 I had a sore throat and a cough. I felt a little achy like a cold or flu was coming on. I threw up a little bit, fever 102 +, and chills. I just did not feel good at all. It lasted for a good day and a half. On Sunday, 9/18/22, I started feeling a little bit better. I called my doctor on Monday he prescribed antibiotics, BIAXIN, and steroids, prednisone. Typically, I develop bronchitis and I was trying to get ahead of it. I was prescribed antibiotics, Z-PAK and another course of steroids, prednisone by another allergist, 10/18/2022. The steroids I am still taking the prednisone until I am done. I have 2 days' worth. The only symptom remaining is the cough.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 01-APR-2017 the patient was vaccinated with GARDASIL 9 for prophylaxis. On 01-APR-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA004161: US-009507513-1708USA004162: US-009507513-1708USA004160:
SM developed redness, swelling, pain at injection site approx 24 hrs post vaccination during deployment. Resolved over 2 week period. Symptoms: Edema @ injection site 50-120mm, Erythema, Pain
Local redness at injection site and swelling, LA. Tingling in (Lt) middle finger.
Around 11 pm on 2/20/21 I had a sore neck. I began to get achy in the middle of the night and could not sleep. On 2/21 around 9:00am I had a fever of 101F and was very achy, tired and had a mild headache. At 7:00pm on 2/21 I had a fever of 101F and was still achy and had a headache. I took two regular strength Tylenol at 9:30pm on 2/21 and that took the edge off so I could sleep. I woke up on 2/22 feeling better but still had a sore neck and arm. The whole time I had a sore arm starting on 2/20 around 3pm.
Injection was high on the left arm, patient did not experience discomfort until a couple of hours later. Patient had a hard time going to sleep due to discomfort. Patient cannot lift up arm after 4 days. Patient will contact orthopedic doctor on Monday to schedule a possible office visit.
nauseous for several days; This is a spontaneous report from a non-contactable pharmacist.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at unknown single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if the patient was pregnant. The patient stated she was nauseous for several days after getting vaccine on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Chills; Fever; Swelling on her arm and down to her elbow; Swelling on her arm and down to her elbow; Dizziness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced chills, fever, swelling on her arm and down to her elbow, dizziness. Therapeutic measures were taken as a result of fever which included treatment with unspecified medicine. Clinical course: Patient wanted to know if the side effects that she was presenting with the Pfizer COVID-19 vaccine would go away prior to her second dose. She received the first dose of the COVID-19 vaccine on Saturday and had developed the following side effects: chills, fever, swelling on her arm and down to her elbow (currently the swelling was going down), dizziness so bad she could not drive. Patient also wanted to know if it is known what ingredients of the vaccine could cause an allergic reaction. Patient believes that the second dose is "worst" than the first one in terms of the severity of the side effects. She took medicine for the fever. Patient also wanted to know if the second dose would provoke her the same adverse reactions as the first one or more. Response: Per attached CONS, according to the CDC some of these side effects are normal signs that the body is building protection and should go away in a few days. No specific information on the duration of her side effects. Per attached CONS, Dizziness and weakness could be signs of a severe allergic reaction. Per attached CONS, there is information for the purpose of the vaccine on the formulation, no information on what ingredients could cause an allergic reaction. Per PI, 6.1 Clinical Trials Experience, LAB-1457-7.0, Revised: 06Apr2021, the incidence of side effects are higher with the second dose, no information on the severity of the side effects. Patient wanted to know for how long would she have the side effects that she is presenting and why is her second dose of the vaccine "worst" than the first one, when she was provided with the information available she stated that she had already received this information from her doctor and that she did not received any "other answers" by calling to the Medical Information line. Patient was informed that she should consult her case with her physician. Patient wanted to know if the first and second dose of the vaccine contain the same ingredients and have the same dose, and was informed that each dose is a 0.3 mL dose containing the same ingredients. Outcome of the event swelling on her arm and down to her elbow was recovering, of the other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
woke up in the night with a "thick tongue" on 2/10/21. this resolved by morning, patient has body aches now but will take tylenol. advised to take benadryl and call 911 if tongue swelling returns or any other signs/symptoms of allergic reaction
pt recvd vax 28APR94 & that evening a swollen gland in back of neck; ran in track meet on Saturday; c/o joints aching & puffiness; pt took advil for discomfort; slept more than usual & still aching on Sunday;
Pt vaccinated with DTP/OPV developed onset of swelling & erythema over injection site spreading up thigh.
I gave a pediatric dose of Hep B instead of the adult dose.  The patient did not suffer any adverse reactions.  I contacted the patient and reported my error.  He will come in tomorrow to receive the adult dose of Hep B as recommended by CDC.
high fever; Initial information received on 23-Apr-2019 regarding an unsolicited valid non-serious case received from a physician by phone.  This case involves adult patient of unknown demographics who experienced high fever, while received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On an unknown date, the patient received a booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number, expiry date, dose, dose in series, route and site of administration were not reported).  On an unknown date, the patient developed a non-serious high fever (pyrexia) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was reported that the patient almost went to hospital.  No Lab data was reported.  Final diagnosis was high fever.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for high fever.  Documents held by the sender: none.