chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients received TENIVAC today and she is having a baby in November with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from nurse and consumer/non-health care professional via Medical Information (Reference number- 00742649) and transmitted to Sanofi on 26-Aug-2021.  This case involved unknown age female patient who was exposed to DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] while she was pregnant and having a baby in November (exposure during pregnancy)  Data regarding this pregnancy were received prospectively, i.e., before pregnancy outcome was known.   The date of last menstrual period was not reported.  The estimated due date was not reported.  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination while she was pregnant and having a baby in November (exposure during pregnancy)  It was reported,"Nurse states one of their patients received TENIVAC today; she had wanted to receive ADACEL for protection against pertussis. How long must the patient must wait before receiving ADACEL after receiving TENIVAC? How long does primary dose of ADACEL provide protection against pertussis? If she received ADACEL 10 years ago, will she still be protected now? How much tetanus and diphtheria toxoid is there in TENIVAC vs. ADACEL? Nurse states that the provider has told the patient that she is unable to receive ADACEL at this time, however nurse states she wanted to call to gather additional information to see if there's any way this patient can receive ADACEL before her baby is born in November. Nurse declined to provide information for an AE/safety report. Nurse states the patient has not received any extra vaccinations yet. Nurse states if they decide to administer ADACEL, she will call back and provide information for AE (adverse event)/safety report".  This case was vaccine exposure during pregnancy  At the time of reporting, no adverse event  There will be no information available on the batch number for this case.
numbness on the arm where she got the vaccine; numbness in the place of the vaccine, started to go down her arm to her fingers; vertigo/two days after the vaccine she had vomiting that triggered an episode; vomiting; pain in the left arm; couldn't sleep all night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient in her 60's received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 11:00 (Lot number: FH8028, Expiration Date: 31May2022) at the age of 7 decade as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (unspecified if ongoing), notes: Verbatim: Vertigo. There were no concomitant medications. Vaccination history included: Pneumonia vaccine, administration date: 2018, for Immunization, reaction(s): "redness". The following information was reported: HYPOAESTHESIA (non-serious) with onset 18Dec2021, outcome "recovering", described as "numbness on the arm where she got the vaccine"; VERTIGO (non-serious) with onset 17Dec2021 23:00, outcome "recovering", described as "vertigo/two days after the vaccine she had vomiting that triggered an episode"; VOMITING (non-serious) with onset 17Dec2021 23:00, outcome "recovering", described as "vomiting"; PAIN IN EXTREMITY (non-serious) with onset 16Dec2021 23:00, outcome "recovering", described as "pain in the left arm"; HYPOAESTHESIA (non-serious) with onset 18Dec2021, outcome "recovering", described as "numbness in the place of the vaccine, started to go down her arm to her fingers"; INSOMNIA (non-serious) with onset Dec2021, outcome "recovering", described as "couldn't sleep all night". The event "vertigo/two days after the vaccine she had vomiting that triggered an episode" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of hypoaesthesia, vertigo, vomiting, pain in extremity, hypoaesthesia, insomnia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not admitted to emergency room.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant reporting about unable to confirm the exact number or identities of the patients may involve more than 20 patients of unknown age and gender who on an unknown date in the last couple of months were vaccinated with an improperly stored doses of VAQTA (dose route and not number not provided). No adverse effects were reported. Additional information has been requested.
Information has been received from an unspecified reporter referring to a 4 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 23-SEP-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Patient reported that the morning after receiving the vaccines, she woke up with achey joints and fever. She said the site of the injection had a lump and was warm to the touch. She said over the next day, she developed a hives only on the arm where the vaccine was given (left arm).
Hospitalization: 1/8/2023 - 1/12/2023 (4 days) Presentation to the ED: GENERALIZED WEAKNESS.  COVID + date: 1/8/2023 Treatment: No indication for therapy.  Discharge to: HOME.   038K20A 2/3/2021 03M20A 3/3/2021
About 18 hours post H1N1 vaccination, patient (employee) developed red, raised rash left antecubital; under both eyes and upper back. Rash lasted 5 days. Received no treatment.
Within a couple of hours of the first vaccine, after a long walk, my R hip/leg became weak and unreliable to the extent that I was limping and it has continued to be a problem.  I'd had no problem at all with that since recovering from the surgery done in April 2019.  I delayed the second vaccine until 5 weeks, and after some gradual improvement, it did get somewhat better during that fifth week -- though still not normal.  Prior to the first vaccination, I was accustomed to walking 1 to 2 miles almost every day with no difficulty at all.   The initial reaction to the second dose was less than with the first.  (I didn't walk for two days after that one.)  However, it worsened over the next couple of weeks so that again I could barely walk 1/4 mile without making things worse again.  Now it's about 3 1/2 weeks since dose #2 and it does seem to be starting to improve, but slowly.  (And I took ibuprofen for 5 days last week, 400 mg 2x/day, which helped.)   The only other reaction I had to either dose was the usual sore arm.  Neither affected the L hip which still has severe arthritis.   I have kept a day-by-day journal with details.
There was a temperature excursion on 4/21/2020. This dose came from an open multi dose vial of Polio. Per manufacturer and health department, the open multi vial was compromised by the excursion and deemed unusable. Per recommendation from the health department and and manufacturer, the child should he re vaccinated. The patient's physician or Dr. will be reaching out to the parents today or next week to inform them of what happened. They will scheduled to come back to receive their polio vaccine. At this time the parents have not reported any adverse reactions to the vaccine that was given.
1/13/10 Recieved shots at 3:15 PM, 5:30 PM Noticed becoming VERY Hoarse and eyes a bit pink, feeling "run down", 7:30 PM Lip became swollen, felt like "prickly heat - pins and needles", By 6:30 next morning lips not swollen any more, but eyes were crusted shut. 1/14/10 still very run down and not myself, but no other sympyoms.  1/15/10 feeling pretty good.
30 min post vaccine - itchiness at vaccine site & headache.  1hr post - tennis ball size swelling at vaccine site. Hot to the touch. Administered Prednisone 10mg and Aleve. 12/2 swelling still present. Cold packed. 12/3/15 golf ball size swelling at vaccine site still hot to the touch.
Left shoulder pain  Limited movement Left arm Right hand finger joint swelling  Dizziness  Headache
Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 30-Mar-2022; Received vaccine past its 30-days Exp date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 30-Mar-2022) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.     On 30-Mar-2022 at 2:32 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Mar-2022 at 2:32 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 30-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 30-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Ethnicity was reported as black or African American.   No concomitant medications information was reported.  It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. It was unknown if other vaccines were given on the same day or within one month prior to any dose of Moderna COVID-19 Vaccine to the patient.  Patient received the booster dose.  It was reported that vaccines went into 2-8 C thaw state on or above 24-Dec-2021 and were administered up until the expiry date of 04-Apr-2022.  No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
No adverse reactions noted.  Pt received Moderna and is only 16 y/o.  Spoke with mother at 1640 on 8/4/21 states pt has had no reactions since vaccine.
SHAKING; FEELING VERY COLD; This spontaneous report received from a patient concerned a female of unspecified age. 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, batch number: Unk) dose was not reported, administered on 18-MAR-2021 14:00 on left arm for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 18-MAR-2021, the subject experienced shaking. On 18-MAR-2021, the subject experienced feeling very cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking, and the outcome of feeling very cold was not reported. This report was non-serious.
Patient received immunization for well check visit on the 1st of July. Presented on 7/12 with bilateral inguinal node swelling turn to rubbery with no tenderness no fever.
This spontaneous report as received from a pharmacist refers to a 71 year old female patient. No medical history provided. On 09-MAY-2013 the patient was vaccinated with ZOSTAVAX (vial; dosing unknown; lot # J000432). No concomitant medications were reported. On 20-MAY-2013 the patient experienced a rash with pain and mild itching. The patient sought medical attention by going back to the pharmacy. No lab diagnostic studies were performed. The event was treated with a dose of BENADRYL (dose unspecified). The outcome of the rash with pain and mild itching is unknown. Additional information has been requested.
very constipated since vaccine injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 90 year-old male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 90 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONSTIPATION (non-serious), outcome "not recovered", described as "very constipated since vaccine injection". Therapeutic measures were taken as a result of constipation.  Additional Information: The patient said that he took prune juice and everything as treatment but no matter how much he squeezes he can't go.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient rolled to side, after he regained consciousness, moved to a reclining chair, Vitals taken and juice given PO. Held him for about 25 min. Orthostatic BP taken. patient stated he felt fine, vitals good, no dizziness prior to discharge home.
called today with itching all over her body starting early afternoon the day after the covid shot as of saturday afternoon was still having itching, has been taking  zyrtec  or claritin and has had improvement in  symptoms
Patient stated she got her covid shot and it knocked her out for hours; This is a spontaneous report received from contactable reporter (Consumer) for a Pfizer sponsored program (134184). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: LYRICA. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Patient stated she got her covid shot and it knocked her out for hours".  Additional information: patient stated she can't go without her medicine (as reported). The lot number for bnt162b2 was not provided and will be requested during follow up
Head Ache starting on 4/6/2022 through 4/8/2022 Fever 100.5 starting on 4/7/2022 through 4/8/2022 Diarrhia starting on 4/7/2022 through 4/10/2022
This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (itching, tiredness and muscle ache after receiving 1st dose on 20th October  2018, see case US2018231048.). On 20th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 21st December 2018, 1 days after receiving SHINGRIX, the patient experienced headache, pruritus, tiredness and muscle pain. The patient was treated with ibuprofen (Advil). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the headache, pruritus, tiredness and muscle pain were not recovered/not resolved. It was unknown if the reporter considered the headache, pruritus, tiredness and muscle pain to be related to SHINGRIX. Additional information was provided as follows: The patient received the second dose of SHINGRIX vaccine and experienced headache, itching, tiredness and muscle ache. She took Advil today morning. Did not consent to follow up. No further details were provided. This case linked with US2018231048, by same reporter for the same patient.
CHIEF COMPLAINT:   Pt BIBA, pt has had trouble urinating for the last few days. Pts family states he has been a little more confused than usual lately and might possibly have UTI. Pt has hx of BPH. Pt denies any pain. EMS states he urinated on stretcher upon arrival.   HISTORY OF PRESENT ILLNESS:     87 years old male with past medical history of BPH, hypertension, hypothyroidism, diabetes mellitus insulin-dependent with long-term insulin use, chronic kidney disease stage IV, history of bradyarrhythmia status post pacemaker placement, coronary artery disease status post PCI, patient presents to the ER brought in by ambulance he was referred by his primary care physician after calling him, family reporting altered mental status slightly from baseline, and having trouble urinating.  Patient is alert and awake and oriented x2, is answering my questions appropriately slightly slow, he admits to pain in the lower chest and epigastric area mild discomfort, no radiation, comes and goes, currently present.  He denies diarrhea admits to constipation, admits to cough productive unknown color, patient is wheelchair bound, denies shortness of breath at this time, he is states that he has no control of his urine baseline
Information has been received from a licensed practical nurse and a consumer concerning a 12 year old male who on an unspecified date was vaccinated with the first dose of VARIVAX (Oka/Merck) and was well tolerated. On 4-AUG-2008, was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot # 660079/0331X) (in follow-up, the lot 3 was reported as 661445/0525X). On 04-AUG-2008, the patient was vaccinated with a second dose of VAQTA in the deltoid (OKA/MERCK). There were no illness at time of vaccination. On 05-AUG-2008, the patient experienced redness, itching and swelling at the injection site. The patient may have also experienced fever and/or pain and burning while getting injected with the vaccine. On 07-AUG-2008, the patient recovered. The reporter has requested a lot check due the patients have adverse experiences. The patient sought medical attention by calling the office. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released. This is one of several reports provided by the same source. No additional information is expected.
Flu-like symptoms consisting of myalgias and malaise started on 6/4/21 at 1300. Overnight into 6/6 around 0230, he began having chest pain that felt like severe heart burn and shortness of breath. Tried to sleep through it but was unable and sought care. Found to have elevated troponin level and transferred to our facility pediatric ICU for higher level of care. Currently hospitalized in Pediatric ICU.
severe itching, wheezing, coughing, severe chills, severe nausea, vomiting, not able to really eat, hives, rashes, small bumps frpm scalp through entire body. fash and lips swollen
Symptoms of anaphylaxis: tingling/swelling of lips and tongue, dizziness, weakness, itching, constriction of smooth muscles beginning at throat continuing downward and through urethra, leg and stomach cramps, rapid heart rate, difficulty in breathing.
Adverse effect to sense of smell. Patient states that some but not all foods smell like decaying flesh. Most meats but also other foods. She also notices the smell at random times. It has caused her to gag as well.
arm redness; swelling / arm swelling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm redness) and PERIPHERAL SWELLING (swelling / arm swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (arm redness) and PERIPHERAL SWELLING (swelling / arm swelling). At the time of the report, ERYTHEMA (arm redness) and PERIPHERAL SWELLING (swelling / arm swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient had declined Consent for follow-up.
approx 3 hrs p/vax pt became very gray colored around eyes, mouth & quite flaccid over body, breathing never stopped, never devel a fever lasted 90 seconds & then began to arouse;
65 yrs old female. Patient was seen for Annual PE and received the PCV 13 vaccine on right deltoid on 02/20/2019. Patient c/o pain, swelling and redness on right deltoid area one day after vaccine was received, on 02/21/2019. Patient seen at the office 5 days later on 02/26/2019. At the exam, she presents on right deltoid area, erythema 12x19 cm and tender, warm, induration area of 4x6 cm, also right axillar lymphadenopathy. 2019-02-28 at 09:40 PM On f/u visit 02/28/2019, Patient feeling better, less pain, less swelling and less redness. She denies fever or chills. Patient currently taking BACTRIM DS 1 po bid and Cephalexin 500 mg 1 po QID. Right, arm, deltoid area with faded erythema 11 x 18 cm and less tender, induration decreased to 4 x 5 cm. Recommended to continue with present treatment and f/u visit scheduled on 03/08/2019.
Pt presented to clinic 8/8/16 w/ father, reported "rash" was noticed (L) upper back 8/6/16; pt was taken to Dr. and prescribed "ZYRTEC, BENADRYL, and "some cream", pt reported that "rash" spreading to (R) upper back later (after 8-6-16) and treated w/same meds. At inspection 8/8/16  redness noted to (R) upper back.
Patient came in the store to receive a Flu vaccine (above information).  However, a Covid vaccine was administered (Pfizer Bivalent Booster GH9697 12-02-22 in the left arm).  No adverse effects at the time of the incorrect vaccine.  Flu vaccine was administered right after since that was when the error was noted.
got covid after getting the first dose of the vaccine; got covid after getting the first dose of the vaccine; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer sponsored program.  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, 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. Reporter stated that she was getting off quarantine was scheduled to get her second dose thursday April29th, she got COVID after getting the first dose of the vaccine, wanted to know if it is safe for her to go ahead and get the second dose of the vaccine. Patient took down medical number for future references and she knows that there are a few ahead of her in Que. No unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknow.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Approximately 3 weeks after getting the shot, I had really bad lower back pain and a fever of 100.2. The fever lasted one day and the back pain for about a week until it started feeling better. I also had pain on the left side of my stomach area and a rash under my breasts. Rash and stomach pain gone.
Baby received prevnar on 02/16/01; there was no adverse reaction noted.  On 02/23/01 mother noted inter costal retractions.  Work-up for cardiac, pulmonary and reflex negative