chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea for two weeks, upset stomach and on and off nausea. Went to ER and they did a work up of blood tests , urin and stool.  Everything was good. Said to see my doctor especially if the diarrhea lasted more than a week and so I had a video chat with doctor and she sent me for more blood work and stool and that also came back normal . Now I have to go to a GI doctor in a couple weeks. Still have diarrhea. And upset stomach.. I missed work a couple days .
This spontaneous report was received from a Registered Nurse, referring to an unspecified number of patients of unknown demographics. No medical history nor concurrent conditions were reported. On unknown dates, unspecified number of patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L006381, expiration date 25-MAY-2016) (strength, dose, route and frequency were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaints were reported. This is one of several reports from the same source.  Additional information has been requested.
very sick; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious social media case from the patient.  This case was linked to case 2020SA292550 (same report).  This case involved an adult patient (age and gender were not reported) who was very sick (malaise), after he/she received INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor but he/she had not been sick for a number of years and the patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination as the patient was a volunteer at a hospital.  Since the comment received from a public post on the internet, they are assuming that the consumer was referring to the Sanofi flu vaccine.  On an unknown date, the patient became very sick (malaise) (non-serious event and unknown latency), following the administration of INFLUENZA VACCINE.  Hence reportedly the patient decided to not get flu shot this year (at the time of reporting).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome of the event was unknown.   There will be no information available on the batch number for this case.
Information has been received from a female medical office manager who on 22-OCT-2007 was vaccinated with a "normal single dose" of PNEUMOVAX 23.  Concomitant vaccination on 22-OCT-2007 included influenza virus vaccine (unspecified) in the same arm.  On 22-OCT-2007, "right after vaccination", the patient developed red, swelling in a three inch diameter around the injection site.  It was reported that the rash became raised and hard and hot to touch.  The physician at the office administered the vaccine.  Unspecified medical attention was sought.  At the time of this report, the patient had not recovered.  Additional information has been requested.
Information has been received from a medical assistant concerning a female patient who on 11-SEP-2008 was vaccinated with GARDASIL was administered subcutaneous instead of intramuscular into the right upper arm. On an unspecified date, the patient experienced knot at injection site post vaccination. In September 2008 the patient recovered from knot at injection site post vaccination. Additional information is not expected.
Information has been received from a nurse practitioner concerning a 17 year old male who on unspecified dates was vaccinated with first and second doses of Varivax. Subsequently, "1.5 years ago", in approximately April 2006, the patient developed a case of shingles. No further information is available.
Woke up day after receiving 2nd shot very achy, tired, flu like symptoms, nauseous stomach, low grade fever 101.6 F.  Took Aleve at night and fever came down.  Slept 10 hours and felt better (90%).  Injection site still sore BUT not as bad as first dose received in Mid-September 2020.  Note:  Only had bad arm pain at injection site after first dose.  Did not experience the above symptoms.  Second dose experienced worse symptoms.
developing a rash this morning covering both sides of his chest, his neck, his head and scalp and below his eye.; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2020, the patient received the 1st dose of Shingrix. On 30th January 2020, 3 days after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was recovering/resolving.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were received as follows: The patient developed rash covering both sides of his chest, his neck, his head and scalp and below his eye after vaccination. The patient reported that the rash was red but not raised and was not itchy. The patient consented to follow up.
Had Intranasal Flu vaccine at around 2:00 p.m. and went back to school, after receiving 2 tsp. Ibuprofen syrup.  Mother brought him back about 4 p.m. saying he got off the bus itching and with hives on neck, chest, abdomen, back, no difficulty breathing.  We gave him Zyrtec 7.5 ml. and kept him about 40 minutes.  He developed no further symptoms but remained with hives.  Sent him home with Benadryl chewable tablets to take at bedtime for hives. Called mother this morning, she said he was fine, hives were gone by time they got home yesterday.
Joint pain, primarily in the hips and knees, was severe following vaccination. This pain has since decreased but is still significant enough to cause distress.
Systemic: Allergic: Itch Generalized-Mild, Systemic: Joint Pain-Medium, Additional Details: One hour after vaccination, patient felt itchy all over and it resolved after taking Benadryl. Two days later, she noticed pain in her hands that worsened gradually. It came and went. She felt like the joints in both hands hurt. She took ibuprofen and that resolved the pain. Hand pain came and went and it permanently went away two weeks after vaccination.
This spontaneous report was received from a licensed vocational nurse referring to multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA injection (strength, dose, route, lot# and expiration date were not provided) for prophylaxis. It was reported that the vaccines were exposed to a temperature excursion between 44 Fahrenheit degrees and 77 Fahrenheit degrees for 2 hours and 45 min. The call was placed because of a Digital data logger. No previous temperature excursion and no adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009061:
Information has been received from a health professional concerning a 16 year old female who in June 2007, was vaccinated with the first dose of Gardasil (lot # 657617/0384U). In December 2007, the patient was vaccinated with the third dose of Gardasil (lot # 659437/1266U). Subsequently the patient experienced rash. The reporting nurse was from the dermatologist office who reported the patient had a rash from the GARDASIL. The rash was on both arms of the patient, the triceps, and back. The office did not administer the vaccine, it was given at a different office. The patient sought unspecified medical treatment by speaking to the physician. A biopsy of the rash showed it was viral and a drug related eruption. The patient reports this is the only medication she has had since the rash. The patient received all three doses, however information pertaining to the second dose is missing. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow-up information has been received from a health professional concerning a 16 year old female with tiny red bumps with keratosis pilaris on the triceps and a mother with malignant melanoma, who on 15-JUN-2007 at 10:50 was vaccinated with the first dose of GARDASIL (lot # 657617/0384U). Subsequently, the patient developed a rash on both of her legs. On 15-AUG-2007 at 11:05 the patient was vaccinated with a second dose of GARDASIL. Concomitant vaccination included BOOSTRIX. On 18-DEC-2007 at 09:35, the patient was vaccinated with the third dose of GARDASIL (lot # 659437/1266U). Subsequently the patient experienced rash on her trunk. The reporting nurse was from the dermatologist office who reported the patient had a rash from the GARDASIL. The office did not administered the vaccine, it was given at a different office. The patient sought unspecified medical treatment by speaking to the physician. On 15-JAN-2008 the patient was seen in the physician's office. The patient had 3 tiny papules on her upper lateral thighs, with 2 on the right and one on the left. The patient had a few tiny papules and pustules on her upper back and a few infected comedones on her face. The physician reported that she did not believe the reaction was related to the vaccination at all. It was reported that the tiny spots on her legs looked like irritated hair follicles from shaving. The patient was advised to stop shaving for a few weeks to she if the symptoms would resolve. The rash on the patient's upper back was diagnosed as very mild inflammatory acne. The patient was treated with EXODERM 2%, and was referred to a dermatologist. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Patient was tested for COVID19 d/t preop for knee surgery. Patient tested positive on 4/6/2021. She states she had minimal symptoms from COVID19 and there were no complications. Patient quarantined at home for 2 weeks before receiving her 2nd shot of the Moderna vaccine. Patient did not have symptoms at the time of vaccination for second vaccine.
Infant found listless, poor muscle tone AM following vaccination.  Parent felt he had a seizure while sleeping.  Was taken to ER.  Dx with pneumonia, temp of 102.  Neurologist did feel infant had seizure while sleeping but did not feel it was related to vaccinations he had received.
24 hours after 2nd shot fever of 101.9 for 24 hrs and extreme body aches.  4 days later hives on face, neck, both arms, hands, and chest.
This spontaneous report was received from a 55 year old female patient regarding herself. The patient had diabetes, thyroid and high blood pressure. The patient had AUGMENTIN allergy. On 24-OCT-2016, the patient was vaccinated with ZOSTAVAX and unspecified flu, hepatitis C and whooping cough vaccines. On 24-OCT-2016, the patient reported that the area around injection site became red on the evening. It started out small and got larger since 25-OCT-2016. The affected area looked like a welt and was the size of a small apple. The area was red, itchy and uncomfortable. The outcome of the events were unknown. No lab tests were performed. The patient did not seek medical attention. Additional information has been requested.
Arthralgia injection site tenderness, chills, swollen lymph nodes, fatigue. Had sxs for 3 days Narrative:
Unevaluable event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On 17-Apr-2021, the patient experienced UNEVALUABLE EVENT (Unevaluable event) (seriousness criterion disability). At the time of the report, UNEVALUABLE EVENT (Unevaluable event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Red circle at injection site. BENADRYL, Ibuprofen, ice, ZYRTEC. Fatigue, face flushed.
Information has been received from a consumer and a physician  concerning his 63 year old wife with no pertinent medical history and no drug reactions or allergies who on 03-OCT-2008, was vaccinated with a 0.5 ml dose of ZOSTAVAX (Oka-Merck) (lot number not provided).  Concomitant therapy included vitamins (unspecified).  On approximately 07-OCT-2008 ("October 7th or 8th") the patient experienced an outbreak of shingles on her legs and has been in severe pain since.  The patient still had blisters on her legs.  No lab diagnostics studies were performed.  Therapy with ZOSTAVAX was discontinued on 03-OCT-2008.  At the time of reporting, the adverse events were ongoing.  The patient has been to the dermatologist twice.  Additional information has been requested. 03/27/09 This is in follow-up to report(s) previously submitted on 12/23/2008. Follow up information was received from a physician who reported that the patient had typical zoster of the right lower leg with pain. The patient stated that she received ZOSTAVAX (Oka/Merck) approximately 5 days prior by her family physician. The patient was placed on VALTREX 1 gm TID for 7 days and resolved except for some granulation at one persistent lesion. Additional information is not expected.
Patient c/o dizziness, flushed feeling, and syncope 10 min post-vaccine. Hx of same related to vaccines/venipuncture in past. Epi-pen given prior to obtaining vasovagal syncope hx. Patient awoke and symptoms improved.
Information has been received from a physician concerning a 20 year old female patient who on an unspecified date was vaccinated with the third dose of GARDASIL (lot # not reported).  1 1/2 weeks later the patient developed an abnormal Pap smear showing "inflammation" and a positive test for HPV (type not specified).  At the time of reporting, the outcome was unknown.  Additional information is not expected.
Started feeling more tired, lethargic, not as hungry, falling asleep at work, lost interest in activities within several days after vaccine. Went to ER with more acute symptoms on 10/29/16 of pain between shoulder blades, chest, down left then right arms, led to paralysis of hands, lower body. Transverse myelitis.
unpleasant GI issues; unpleasant GI issues made her vomit like crazy; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an unknown date (at the age of 47-years-old), as a single dose for COVID-19 vaccination. Patient's medical history included active Epstein-Barr virus and had high cortisol levels. The concomitant medications were not reported. The patient reported that when she received BNT162B2, she experienced unpleasant GI issues and she also stated that unpleasant GI issues made her vomit like crazy. The patient has not had this in over 20-25 years. The outcome of the events was unknown.   No follow-up attempts are possible.   Information about lot/batch number cannot be obtained. No further information is expected.
Erythema at the injection site for 3 days, beginning 10 days post vaccine.  Brief erythema at other sites on limbs, not raised or itchy.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: Er8733), in left arm, as dose 2, single (Lot number: Er8735), in left arm and on 21Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Costochrondritis" (unspecified if ongoing); "low blood pressure;" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive; (08May2022) Negative; (17May2022) Positive; (2022) Positive. Therapeutic measures were taken as a result of covid-19. Clinical course included: The patient had taken full course Paxlovid starting 01May2022 to 05May2022 after positive COVID test. Symptoms improved slowly but felt worse on 07May2022 and tested positive. Negative COVID test on 08May2022 as symptoms subsided. On 16May2022 COVID resurged. Tested positive on 17May2022 with sudden onset fatigue, chills, tiredness, congestion.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-OCT-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB injection (lot # L048208, expiry date 15-SEP-2017 and dose not reported) intramuscularly. The administered dose experienced a temperature excursion of 50 Fahrenheit for a cumulative of 16 Hours and 45 Minutes and 33 Fahrenheit for a cumulative of 24 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Headache, Sedation, Myalgia, Arthralgia, Fever & Nausea Vomiting Narrative: Six hours after receiving the 2nd dose reported onset of headache, fatigue, myalgias, arthralgias, fever, diarrhea and nausea. Symptoms lasted 72hours. Pt missed work x 3 days due to severity of symptoms. No known prior COVID infection.
pt returned home p/MD visit pt napped; awoke stopped breathing for a few seconds; aunt shook pt; pt started breating cried & stopped breathing; cyanosis around mouth was noted; called for ambulance; pt brought back  to MD; t102.5;
Severe unrelenting  underarm pain (7 out of 10) on same arm as Pfizer booster; Very tired, cold, somewhat dizzy, listless, overall aches.
After couple hrs of receiving the flu vaccine pt. felt involuntary movements in his arms often. Also he felt weird whole day.
Patient was given 2 doses of Fluzone High Dose.  One dose given on 9/7/22, second dose given on 10/14/22.
SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; LUPUS SYMPTOMS WERE GONE; This spontaneous report received from a patient (retired nurse) via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's past medical history included that she had rods, pins and donor bone implantation, was paralysed on her left side, had broken her neck twice and was very athletic. The patient's concurrent conditions includes lupus, but only a form in her in abdomen, cancer in both eyes, and premalignant tumor in breast for which she was supposed to have a double mastectomy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, with frequency time 1 total, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included cortisone for an unknown indication which is given into her SI periodically. The patient stated that, on an unspecified date her lupus symptoms were gone (unexpected therapeutic benefit from vaccine) after the vaccination. She had been undergoing extensive antibody testing which concluded zero antibodies, this indicates suspected immunological vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lupus symptoms were gone and suspected immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority 90000202779.; Sender's Comments: V0: 20211134666-Covid-19 vaccine ad26.cov2.s- suspected immunological vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Patient presented to the ED and was subsequently hospitalized for Acute on chronic combined systolic and diastolic CHF within 6 weeks of receiving COVID vaccination.
Fever (<102.8), chills, general body and head ache and soreness, lasting until morning of August 26. Fatigue gradually lessening as of 8/29.
Symptoms began roughly 12 hours after vaccine was administered. Flu-like symptoms. Headache, extreme fatigue, body aches, fever, chills. For the following week, extremely watery diarrhea numerous times a day along with headaches and fatigue. Eight days later, Saturday February 3rd - symptoms progressed to vomiting, diarrhea, headache, fatigue, nausea, stomach cramps, stomach pain, dizziness. These symptoms continued until February 23rd. Blood results showed bacterial infection and an allergic response. Ultrasound normal. X Ray normal. Symptoms began to slowly improve on their own February 24th.
Night of injection had very restless sleep, felt strange and had generalized discomfort.  Day 1 and 2 after vaccine had severe headache, body aches, joint pain, chills, brain fog, weakness,fatigue, waves of severe weakness followed by severe pain over varying body parts/areas, SOB/chest pain w/activity, took 5 min to recover. Middle of day 2 all symptoms started to improve slowly.  By the end of Day 2 the waves of severe weakness/then pain stopped.  Day 3 after vaccine continued to have headaches,body/joint pain, occasional chills, weakness, fatigue,some SOB w/activity, and brain fog. Since then symptoms have slowly improved. Still have slight tiredness/fatigue, brain fog, headaches,occasional SOB, ankle/foot pain.
12AUG91 w/in 12hrs post admin of immunes, slight fever; swollen eyes; fine, unraised rash-prominant on bottom of feet; 13AUG91 w/in 24 hrs post admins of immun, high fever (degree unk); dx coxsackie syndrome;
No Adverse event occurred, but patient in retrospective review of data was discovered to have incorrectly been given Moderna vaccine while under 18 year old as approved in the EUA. The manufacturer was contacted and they provided information about an ongoing clinical trial in patients 12-18 years old receiving the same (100mcg) 2 dose series of Moderna COVID-19 vaccine, however this age group is not currently approved. This is being reported as an error having occurred with the Moderna COVID-19 vaccine. Patient/Guardian will be contacted by a prescriber to inform the patient of the historical event and explain when a 2nd dose can be given.