chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse referring to an unspecified patients of an unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unspecified dates, the patient's were vaccinated with an approximately 6 doses of PROQUAD, lot # M032498 and an expiration date of 02-JAN-2018 (strength, dose number, and anatomical location were not provided) for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 7 hours and 41 minutes: 1.9 grades Centigrade. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. Additional information has been requested. Sender's Comments: US-009507513-1612USA010857.
Stiff neck, swollen area near collar bone, dizziness , tingling pain on left side.
UTI; This is a spontaneous report from a contactable consumer or other non HCP.     A 16-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EP7533), dose 1 intramuscularly, administered in Arm Right on 08Jul2021 11:00 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient experienced UTI on 15Jul2021 with outcome of recovered. Therapeutic measures were Ciprofloxacin taken as a result of UTI (urinary tract infection).   Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.
patient feinted about 5 minutes after dose. She regained consciousness almost immediately but feinted again a few minutes later. We called EMS which arrived on scene and she continued having dizziness and was taken to hospital for evaluation.
This case was reported by a healthcare professional (nurse practitioner) via sales representative and described the occurrence of injection site abscess in an infant subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included PREVNAR (non-gsk); non-GSK manufacturer; unknown; right thigh given on an unspecified date; unspecified vaccine; manufacturer unspecified; unknown; right thigh given on an unspecified date. On an unspecified date the subject received 2nd dose of PEDIARIX (unknown, left thigh) as the 4-months series vaccination for PEDIARIX. At an unspecified time within months of 2nd vaccination with PEDIARIX, the subject experienced injection site abscess and nodule injection site. The infant subject received the full 2, 4 and 6 months series of PEDIARIX; the specific age of the baby was not provided. After each injection of PEDIARIX on unknown dates, the baby had nodules from on the leg. All three doses of PEDIARIX had been injected in the left thigh. All of the nodules formed on the same thigh and were localized to the exact same area where the PEDIARIX was injected. Other vaccines, included PREVNAR, had been administered on the right thigh with no nodules. The infant subject was scheduled to have surgery to have pus taken out/ drained of the little abscesses that have formed. The reporting nurse practitioner was not certain that this was even related to PEDIARIX. This case was assessed as medically serious by GSK. The immunization series with PEDIARIX was not discontinued. At the time of reporting the injection site abscess and nodule at injection site were unresolved. Please see cases A1059527A and A1059527C for the subject's experience with previous and subsequent doses of PEDIARIX.
Metallic taste in mouth; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DYSGEUSIA (Metallic taste in mouth) in a male patient of an unknown age 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 DYSGEUSIA (Metallic taste in mouth). At the time of the report, DYSGEUSIA (Metallic taste in mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Itching and red circle appeared.  Did not report , because I thought this was so minor.        redness gone, itch a little still.
Skin reddened. light blisters, swelling, itchy, slightly warm.  Overlays my small pox vaccination scar from childhood (I had a keloid at that time).
Information has been received from a physician concerning a 12 month old male with no past medical history who on 06/26/03 was vaccinated with a dose of varicella virus vaccine live (site unknown) (0.5mL) (Lot # 641155/0793M) (SC). Concomitant therapy included MMRII and Prevnar. On 07/08/03 the pt developed "red, botchy lesions on trunk, face and scalp. The child came back 24 hours later and those lesions were crusty on his face and scalp." The total number of lesions reportedly "may have reached 50." The pt sought unspecified medical attention. Additional information has been requested.
I started off with a sore throat.  As the day progressed I became congested.  I tested for COVID-19.  I had a horrible cough, constantly blowing my nose, and weakness. I then contacted  Telehealth line and the nurse prescribed the Paxlovid for me.  I started taking it the same day.  I did five days of Paxlovid and 5 days of masking up.
This has nothing to do with the vaccine which I received in November 2021. Nearly six months after last boosted, I was exposed to COVID at a family gathering on a 05/15/2022 and subsequently contracted COVID (positive home test) confirmed on the following Saturday 05/21/2022. My symptoms began three days after exposure with a minor sore throat, drainage, congestion, and mild headache. This progressed over a few days. After three days of mild symptoms, I developed severe headache, fever, chills, and fatigue on Friday and into Saturday.
Each time the lymph node under my armpit swelled up like a kiwi; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Known allergies: tetracycline, reaction(s): "known allergies: Tetracycline". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Each time the lymph node under my armpit swelled up like a kiwi". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated she got her flu shot 16Oct2022 in her left arm no problem. She had received 3 COVID shots 2 Pfizer 1 moderna. Each time the lymph node under her armpit swelled up like a kiwi. On 21Oct2022, she got the new COVID vaccine. Felt fine, not even a sore arm until 12 pm 22Oct2022. All of a sudden, she felt sore all over, chills and checked her temp 103.7. She took a shower and went to bed. She slept for 4 hours. When she woke up the lymph nodes under her arm, right breast and neck were all swollen and painful. Her husband called out doctor. She took Tylenol and Motrin and tandem for the next 48 hours. This was the most extreme reaction she had yet to have in getting any of the COVID shots or boosters. The swelling in the lymph nodes still persist but was improving. She no longer had a fever. She have never improved. She have never tested positive for COVID. If other vaccine in four weeks was yes, and If covid prior vaccination: No. If covid tested post vaccination was yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Case number PHEH2014US025113, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 75-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 29 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event report following this medication error.
Clients states rash about 11:00 PM on 11/24/2014.
received the first dose of the Pfizer covid vaccine and subsequently tested positive for covid; received the first dose of the Pfizer covid vaccine and subsequently tested positive for covid; This is a spontaneous report from contactable consumer (patient's wife).  A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 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. The patient received the first dose of the Pfizer covid vaccine and subsequently tested positive for covid. The patient experienced received the first dose of the Pfizer covid vaccine and subsequently tested positive for covid on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The event was assessed as medically significant. Outcome of the event was unknown.  Information on the lot batch number has been requested.
HORRIBLE REACTION TO THE JJ COVID VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced horrible reaction to the jj covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from horrible reaction to the jj covid vaccine. This report was non-serious.
Felt off like I had bad allergies since. About 5-6 days later started feeling flu symptoms. I?m feverish, body aches, super fatigued, head hurts, difficulty breathing.
Headache, Myalgia, Nausea Vomiting, FATIGUE
Injection site was tender but gone the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Injection site was tender but gone the next day".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Reports chest tightness and anxiety. Evaluated by EMT.  BP in 200's.  Pt states she forgot to take her BP meds. EKG normal.
Patient states that she felt tightness and soreness in the left side from her shoulder going up to her neck, possible swollen lymph nodes.
Redness and swelling of arm. Fever [over 101]; body aches, shivering.
Arm soreness, left body swelling (leg, arm, back/shoulder, neck), chest pain, shortness of breath, inability to make it through a workout like before the vaccine, inability to exercise arm without pain, headaches, dizziness, hair loss, fat loss around injection site, arm deformity,  fatigue, mood changes, bowel issues, no desire to do anything/no motivation/depression, constant soreness/pain in arm around injection site, frequent infections, breast lumps/pain
Trouble swallowing at 5pm after injection administered at 9am. Woke up and 4am the following day with swollen lips and mouth and around 9am noticed rash on legs and arms and a small amount on my belly.
No adverse event; if there was any flexibility in efficacy of Moderna bivalent if it was given three days after its manufacturer expiration date/HCP confirms this is an actual situation; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (if there was any flexibility in efficacy of Moderna bivalent if it was given three days after its manufacturer expiration date/HCP confirms this is an actual situation) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 046H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (if there was any flexibility in efficacy of Moderna bivalent if it was given three days after its manufacturer expiration date/HCP confirms this is an actual situation). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (if there was any flexibility in efficacy of Moderna bivalent if it was given three days after its manufacturer expiration date/HCP confirms this is an actual situation) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (if there was any flexibility in efficacy of Moderna bivalent if it was given three days after its manufacturer expiration date/HCP confirms this is an actual situation).    It was unknown if the patient receives any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Individual vial was multi-dose vial. Vaccine was initially stored in the refrigerator on 15-Jun-2023. Vial did not undergo any temperature excursions. Suspect vaccine dosage text was reported as unknown. Expiry date of the suspect vaccine was 12-Jun-2023 reported as three days after its manufacturer expiration date.  Treatment information was not provided.
urine turned brown with purple sediment in the bottom of my urine bag. My urine is always yellow.
Got red hot bump on arm at injection site. It was very large and itchy. First appeared 7 days after shot. Today on day 11 is still there but have greatly reduce in size. I've been taking allergy medicine,  two doses of Claritin and 2 doses of benadryl a day. Also the same day i  recieved the shot I got a large bump on my arm at the same location but it did not itch and was painful instead but it went away by day 5/6 so only had one day where my arm was fine.
Tetanus toxoid/MMR vaccine: Acute Disseminating Encephalomyelitis (ADEM) reported one week post vaccination in a 24 yo female; presented with generalized tonic/clonic seizures. EEG and MRI of brain, which showed scattered multiple white matter lesions, were indicative demyelination. Patient improved after treatment with prednisolone and levetiracetam; the case was self-limiting.
Induration, warmth, redness and rash at injection site 1 week after injection
Narrative: COVID infections following completion of COVID vaccine series 03/16/21 COVID vaccine dose #1 04/06/21 COVID vaccine dose #2 07/28/21 Pt presents to screening reporting cough and fever x2 days; he reports close exposure to COVID positive person; COVID POSITIVE 08/01/21 Pt presents to ED and reports painful headache, cough, poor appetite, mild shortness of breath, and fever, chills, loss of taste/smell, muscle pain, nausea; CXR bubasilar pulmonary opacities concerning for COVID pneumonia; treated with albuterol/ipratroprium neb, fluids, and dexamethasone; admitted inpatient 08/02/21 Pt reports feeling improved; being treated with dexamethasone, remdesivir, zinc, ascorbic acid, vitamin D, ipratropium/albuterol inhaler, benzonatate, acetaminophen; CTA negative for PE 08/03/21 Pt discharged home with rx for albuterol/ipratropium, benzonatate, dexamethasone, fluticasone/salmeterol, guaifenesin 08/06/21 Pt reports cough is improving; clinically resolved
Not able to exercise as much as he normally does; more muscle weakness than usual; Chills; Achiness; Fever of 100.5 (his normal temp is 96.5); Shakes; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), EXERCISE LACK OF (Not able to exercise as much as he normally does), MUSCULAR WEAKNESS (more muscle weakness than usual), CHILLS (Chills) and MYALGIA (Achiness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 326289) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DICLOFENAMIDE (KEVEYIS) and SERTRALINE for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced TREMOR (Shakes), EXERCISE LACK OF (Not able to exercise as much as he normally does), MUSCULAR WEAKNESS (more muscle weakness than usual), CHILLS (Chills), MYALGIA (Achiness) and PYREXIA (Fever of 100.5 (his normal temp is 96.5)). At the time of the report, TREMOR (Shakes), EXERCISE LACK OF (Not able to exercise as much as he normally does), MUSCULAR WEAKNESS (more muscle weakness than usual), CHILLS (Chills), MYALGIA (Achiness) and PYREXIA (Fever of 100.5 (his normal temp is 96.5)) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 °F and 101 °F.         The patient advised that he had a reaction to his 2nd COVID-19 vaccination. He had fever around 101 degrees and chills for 2 days and they went away only to return 2 weeks later and last another 30 hours. The patient stated he also had an autoimmune response to the vaccine during this time. No other details provided.  Company comment: Based on current available information and the temporal association between product date and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Based on current available information and the temporal association between product date and the start date of the events a causal relationship cannot be excluded.
8/3/04 to 5/05, had abdominal pain and pressure, flu like symptoms. Resulted in visit to clinic. Saw liver and GI doctors. Ending diagnosis: liver damage from adverse event from hepatitis B vaccine. Additonal terms aded from Medical record rec'd 12/28/2005: Abnormal liver function, hepatomegaly, abnormal lab values, splenomegaly. Per 60 day follow up report-Ongoing liver problems according to client. He is still seeing a doctor.
MILD ILLNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced mild illness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild illness was not reported. This report was non-serious. This case, from the same reporter is linked to 20220624624.
nervous; whole body itching; tongue was itchy and burning; tongue was itchy and burning; cough; headache; fever; lower back pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 20 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Oct2021 11:00 (Lot number: 301258A) at the age of 20 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Small adenoma" (unspecified if ongoing), notes: Illness/AE: none.  Small adenoma. , Onset Date: 3 years ago.; "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing), notes: including diabetes; "obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: TONGUE DISCOMFORT (non-serious), TONGUE PRURITUS (non-serious) all with onset 11Oct2021, outcome "recovering" and all described as "tongue was itchy and burning"; PYREXIA (non-serious) with onset 07Oct2021, outcome "recovering", described as "fever"; COUGH (non-serious) with onset 10Oct2021, outcome "unknown", described as "cough"; PRURITUS (non-serious) with onset 13Oct2021, outcome "not recovered", described as "whole body itching"; BACK PAIN (non-serious) with onset 07Oct2021, outcome "recovering", described as "lower back pain"; HEADACHE (non-serious) with onset 08Oct2021, outcome "recovering", described as "headache"; NERVOUSNESS (non-serious), outcome "unknown", described as "nervous". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, back pain, headache.  Additional Context: Received call from consumer regarding the Pfizer COVID vaccine.  She received first dose 8 days ago and after that she has a fever.  She checked for COVID and it was negative. She also checked for other viruses and that was negative. She was also coughing a lot and has whole body itching.  She did not have an address, phone, or email for her primary care provider. When asked to provide outcome of the fever, she stated that her fever was getting higher and she got pills to reduce it, and it lowered it.  When asked to provide outcome for cough, she stated that the cough also was sometimes better, but sometimes worse. If she coughs once it may continue for 15 minutes. It does not stop. She gets nervous sometimes. She took Tylenol for the lower back pain and maybe Ibuprofen for headache. No further details provided. She checked for COVID twice and it was negative.  She also did a RPP test and it was negative. She has no viruses. The patient was not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine within 4 weeks.  No follow-up attempts are possible. No further information is expected.