chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; sweated a lot; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (sweated a lot) and FATIGUE (tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL, SIMVASTATIN, VITAMINS NOS, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), ASPIRIN [ACETYLSALICYLIC ACID], PROBIOTICS NOS and CELECOXIB (CELEBREX) for an unknown indication.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (sweated a lot) and FATIGUE (tiredness). At the time of the report, PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (sweated a lot) and FATIGUE (tiredness) outcome was unknown.            No treatment information was provided. No medical history was provided by the reporter.   This case was linked to MOD-2022-466487, MOD-2022-466462 (Patient Link).
The patient  was given a Covid19 Pfizer immunization shot around 3 pm on Saturday May 8, 2021.  The diluent used to mix with the Pfizer vaccine had a lot number of 05 111 DK and expired on May 1, 2021.   It was not discovered that the 0.9% Sodium Chloride diluent was expired until after the patient had left the pharmacy.  The patient was recommended to remain in the pharmacy for 15 minutes as every patient receive a shot is recommended to do.  The patient had no complaints of adverse reactions before leaving and has not reached out to the pharmacy since then.  We have tried contacting the patient since then with no response back.
Pt. recieved vaccine that had been drawn up greater than 12 hours. MD notified pt. regarding issue. No adverse events . Pt. declines revaccination.
This spontaneous report as received from a physician via a company representative referred to a patient (age not reported) in 2013 was vaccinated with a dose of ZOSTAVAX (dose not reported), subcutaneous injection for prevention of shingles. In 2013 the patient developed swelling at injection site after receiving ZOSTAVAX, that was tender to the touch. At the time of the report the patient recovered from swelling at injection site. Relationship between swelling at injection site and therapy with ZOSTAVAX was not reported. It was not known if the patient "received the ZOSTAVAX some time last week or some time this week" and it was also not known if this report corresponds to the "male or female patient". This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a 15 month old female with an allergy to Augmentin and a history of croup and otitis media who on 6/28/02 was vaccinated with the first dose of MMR II (639515/0897L). Four hours after vaccination, on 6/28/02, the pt became irritable and developed a temperature of 104.3 deg F. The pt was seen by her physician, had a normal exam and was treated with Motrin. The fever persisted for 4 days spiking to 103.5 deg F. teh pt had no rash. Subsequently on 7/1/02, the pt recovered. No further info is available.
Patient called on 7/3 to report that a six inch diagonal rash developed on her left arm starting at the injection site. The rash started 2 days after immunization and radiates heat according to the patient. The patient also reported  body aches and pain. I recommended that the patient use a cold compress every 15 minutes as well as a non sedating antihistamine due to insomnia therapy.
Information has been received from a physician concerning a four year old female patient who was vaccinated with varicella virus vaccine live. On 5/16/2005 the patient experienced varicella breakthrough. No other information was provided regarding the adverse experience or the patients outcome. There was no product quality complaint reported. The patient sought unspecified medical attention. Additional information has been requested.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report was received from a 72-year-old female patient of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 1 total, administered 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, after taking the vaccination, the patient became ill (feeling sick), and was diagnosed with coronavirus disease (COVID-19) (suspected covid-19 infection, and suspected clinical vaccination failure). On an unspecified date, after being diagnosed with COVID-19, she was prescribed with Xarelto (rivaroxaban). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report is associated with product quality complaint.; Sender's Comments: V0: 20210847448- COVID-19 VACCINE AD26.COV2.S- Suspected clinical 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
Headache; severe body ache; Woke up with Hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 (Lot number: FF2589) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Severe Arthritis" (unspecified if ongoing), notes: Verbatim: Severe Arthritis. Concomitant medication(s) included: OXYCODONE taken for arthritis. The following information was reported: HEADACHE (non-serious) with onset 10Sep2021, outcome "unknown", described as "Headache"; PAIN (non-serious) with onset 10Sep2021, outcome "unknown", described as "severe body ache"; URTICARIA (non-serious) with onset 10Sep2021, outcome "unknown", described as "Woke up with Hives". Therapeutic measures were not taken as a result of headache, pain, urticaria.  Additional information: The patient received 1st dose on 09Sep2021 of Pfizer vaccination and on 10Sep2021, patient woke up like severe body ache and headache. The patient woke up with Hives in area, hive, that was with lot of people.  No follow-up attempts are possible. No further information is expected.
injection site sore; headache; joint pain; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 (at the age of 57-years-old) (Batch/Lot Number: EN5318) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included penicillin (allergy). The patient did not have COVID prior vaccination. The patient received first dose of BNT162B2 on 02Feb2021 at the age of 57-years-old for COVID-19 immunization (dose number=1, BioNTech, lot number =EN5318, administration date=02Feb2021, administration time=13:30 PM, vaccine location=Right arm). On 23Feb2021 23:45, the patient experienced injection site sore, headache, joint pain. Therapeutic measures were taken as a result of injection site sore, headache, arthralgia: Tylenols were taken. The outcome of the events was recovered. The patient was not covid tested post vaccination.   No follow-up attempts are possible. No further information is expected
Began to feel ill on the day of the vaccine.  Very tired and lethargic.  The following morning the patient was very confused and had lost all short term memory.  I brought her to the hospital where she was diagnosed with Transient Global Amnesia.  She was admitted and by the next morning her memory had returned to normal.  She is still very tired from the ordeal.
Patient initially became febrile to 38 (rectal), was seen in ED evening after vaccine administration.  Discharged home, but on 4/2/13 was found to not eat with normal vigor and be sleepier.  Proceeded to have increased sleepiness, no interest in feeding when woken up x 10 hours, when represented to ED.  In ED was found to be intermittently sleepy, continued poor feeding, hypotonic (axial, +neck lag), dehydrated.  Admitted for rehydration and observation.  CBC, Chem7, VBG all normal.  Patient mental status improved at admission (roughly midnight of 4/2/13), but in AM was found to be sleepy again, persistent hypotonia on exam.  Continued with fluctuating mental status, hypotonia.  Neuro consulted.  EEG showed nonfocal asymmetry (no seizure activity), presumably due to extra or intracranial fluid as confirmed by MRI (within limits of normal; MRI was normal).  LP attempted without success.  AST/ALT were normal.  Patient began to improve significantly at ~23:00 on 4/3/13 (~60 hours after vaccine administration) and by morning of 4/4/13 (day of discharge) was almost back to baseline - alert, interactive, feeding well, hypotonia persisted, but was improved.
After my second shot, 10 hours after shot started to get body aches. They worsened and subsided within 8 hours then I was fine. After my first shot, my mental cycle was late 4 weeks. Other than that, no other side effects.
This spontaneous report was received from a physician via company representative, regarding a 3 month female patient. The patient's drug reactions/allergies included milk protein allergy. No other pertinent medical history or concomitant medication was provided. On an unknown date, the patient was vaccinated with the first dose of ROTATEQ oral, for prophylaxis (dose, strength, frequency, lot# and expiration date were not reported). On an unknown date  (reported as one and a half days after receiving the first ROTATEQ), the patient developed pale skin with bloody stools, but on the next day the patient returned to normal. Despite the patient had not received any more doses of ROTATEQ, on an unknown date, the patient experienced a second episode of pale skin with bloody stools on an unspecified date. The patient sought for medical attention. The outcome of the last events of pale skin with bloody stools was not reported. The causal relationship between ROTATEQ and the events was not reported. Upon internal review, bloody stools was determined to be medically significant.
Chest pain, was admitted to hospital on suspicion of having had a non-STEMI heart attack; determined that no angioplasty was necessary, but a nuclear stress test was performed, as a result of which it was determined that I had no "treatable" blockages
EE received immunization shot for MMR on 3/8/11 in RA. On 3/23/11 he called & stated he noticed a rash over face, arms & chest on 3/22/11. Came to EOH on 3/23/11 to be assessed by nurse. Small red like raised areas noted to both forearms & five reddish rashlike areas on face. No rash to chest. T-98.2.
Extern diluted the COVID vaccine vial with 0.3ml of diluent instead of 1.3ml of diluent. The error was noted when the remainder of the doses were drawn up for administration and there were only 6 doses instead of the anticipated 9 doses remaining.
Client received Cansino Covid vaccine with no reaction. Cansino vaccine not approved by the World Health Organization. Janssen given as an alternative
Started VERY heavy menstrual period after not bleeding for nearly a year. Also had several bloody noses.
nausea; headache; fatigue; muscle pain; feeling unwell; This is a spontaneous report from a contactable nurse who reported for herself. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in Left arm on 17Dec2020 at 11:30 am at single dose for COVID-19 immunization. Patient was not pregnant. No known allergies. Concomitant medication included unspecified drug: patient received other unspecified medication in two weeks. No other vaccine in four weeks administered. On 17Dec2020 at 11:45 am, the patient experienced nausea, headache, fatigue ,muscle pain and feeling unwell, all non serious. No treatment given. Outcome of the events was reported as recovered in Dec2020. No follow-up attempts are possible, information about batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 13-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L004754, expiration date: 10-NOV-2016 (dose and route were not reported). There was no concomitant medication provided. No adverse effects reported and there was no a product quality complaint (PQC) involved. Additional information has been requested.
Patient had severe redness, swelling and muscle hardness. Symptoms were only slightly relieved by 3 doses of Benadryl but were still bothersome 2 days after vaccine adminstration.
The night of the vaccine: body aches  24 hours later: chills, body aches  42 hours later: morbilliform rash on neck, injection site, stomach, and back
After 1st vaccine-hypotension, low heart rate, generalized fatigue, muscle aches and spasms After 2nd vaccine-increased hypotension, low heart rate, syncopal episodes, severe muscle spasms, stuttering, short term memory loss, unable to ambulate without assistance, unable to complete ADLs without assistance., chest pain, unable to speak correctly, repeative speech
enlarged and tender lymph nodes; body aches; enlarged and tender lymph nodes; Initial information received on 23-Aug-2019 regarding an unsolicited valid non-serious case received from a Physician.  This case involves a 11 years old female patient who experienced enlarged and tender lymph nodes and body aches and, while she 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.   On 21-Aug-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient had enlarged and tender lymph nodes (lymph node pain), body aches (pain) and enlarged and tender lymph nodes (lymphadenopathy) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Lab data was not reported.  Final diagnosis was enlarged and tender lymph nodes, body aches and enlarged and tender lymph nodes.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown all the events.  Information on the batch number was requested.  List of document held by sender: none.
Day 1 felt like the flu, body aches, light fever.  Day 2 left shoulder felt like I had pulled it out of socket.  Day 3 same Day 4 Same when to my doctor and got mussel relaxers Day 5 no better Day 6 pain has moved down the left arm to the left hand, fingers numb, elbow hurting, arm hurting.  Day 7 started seeing chiropractor   thinking I had a pinched a nerve.  Days 8-14, Saw chiropractor several times and no better. Let foot now going numb.  Hurts to sleep, hurts to move left arm.
GAVE 2ND DOSE OF MODERNA PER GUIDELINES AFTER 1ST DOSE WAS MODERNA AND HE WAS 17 YRS OF AGE AT HOSPITAL
left arm swollen, lymph nodes swelling headache, dizziness, generalized malaise form head to toe, chills as well.
Narrative:  Patient received J&J vaccine at an unknown outside facility on 03/30/2021 and began having symptoms on 04/16. Presented to outside ER and no issues were found and patient was sent home.
Within 20-30 minutes I had tightness in chest. I used my inhaler and it didn't really help. It never progressed. First dose, no dizzy spells same fever, flu like symptoms. I had really bad covid arm about 4 days after and lasted about 2 weeks and probably about 4-6 inches in diameter and wrapped around my arm. I went to Urgent Care of first week of march maybe around 2nd where I was prescribed a steroid cream.
Migraine; Bone pain; Runny nose; This spontaneous case was initially received on 25-Jan-2022 from other non-health care professional via Pfizer (reference number: 202200037151) with additional information received on the same day  via Agency (reference number: SEQW22-00399) (being processed together) and concerned a 46-year-old female patient.  The patient's medication included bladder infections and kidney problems. The patient's concurrent conditions included migraines, arthritis and allergy to Lyrica (pregabalin), morphine, ibuprofen and gabapentin. The patient's concomitant medication included duloxetine, Hydrocodone/Acetaminophen (hydrocodone, paracetamol), amlodipine and Salonpas (capsaicin, menthol), all used for unreported indication.  On 07-Dec-2021, the patient started using Xeljanz XR (tofacitinib citrate; dose: 11 mg daily; route of administration: oral; indication: not reported). The batch number was not reported.  On unspecified date in Dec-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On unspecified date in Dec-2021, the patient was vaccinated with non-company co-suspect Pneumovax (pneumococcal vaccine polysacch 23v; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On unspecified date, after receiving Flucelvax Quadrivalent and non-company co-suspects Pneumovax and Xeljanz XR (tofacitinib citrate), the patient experienced bone pain, described as 9/10 pain, and one severe migraine, for which she took Aleve (naproxen sodium). The patient had history of migranes but had not had one in a long time. It was also reported that the patient had constant runny nose and that she had difficulty doing daily activities.  On an unspecified date, the patient had recovered from migraine.  At the time of the initial reporting, the outcome of event 'bone pain' was not recovered.  The outcome of event 'rhinorrhoea' was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 46-year-old female patient experienced bone pain, rhinorrhea and migraine after receiving Flucelvax Quadrivalent, non-company co-suspects Pneumovax and Xeljanz XR. Elapsed time between vaccination and the onset of the events is unknown. Due to this lack of information regarding chronology, causality is unassessable.; Sender's Comments: A 46-year-old female patient experienced bone pain, rhinorrhea and migraine after receiving Flucelvax Quadrivalent, non-company co-suspects Pneumovax and Xeljanz XR. Elapsed time between vaccination and the onset of the events is unknown. Due to this lack of information regarding chronology, causality is unassessable.
Fatigue, headache, nausea, diarrhea, malaise . Symptoms still there at day 4
Woke up at midnight and had severe chills. A few hours later took my temperature and it was 101.3. Took 2 Tylenol. Few hours later temp was 99.1. For the remainder of the day had body aches, fatigue and large headaches. Finally subsided 24 hours later and now I feel relatively fine.
my eyes have been bothering me since then; This case was reported by a consumer via interactive digital media and described the occurrence of eye discomfort in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received Shingrix. In November 2020, immediately after receiving Shingrix, the patient experienced eye discomfort. On an unknown date, the outcome of the eye discomfort was not recovered/not resolved.   It was unknown if the reporter considered the eye discomfort to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. Since receiving Shingrix, the patient's eyes had been bothering to the patient. The patient was asking, if this was related to Shingrix vaccination.
03may90 pt vax hepta B. next day pt devel weakness in left extremity.  w/i 2 weeks weakness resolved. 04jun90 2nd vax. weakness reoccured w/ chest pain when leaned forward.
First 2 days, swollen and very sore.  Then a red patch (about 4 inches around) with itching.  The red patch is still on arm 2 weeks out.
I have lost my sense of taste.; Flucelvax quad: 15Nov2022, Pfizer Dose 4: 15Nov2022; Flucelvax quad: 15Nov2022, Pfizer Dose 4: 15Nov2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 10:00 as dose 4 (booster), single (Lot number: G56796) at the age of 51 years, in right arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), on 15Nov2022 as dose 1, single (Lot number: 70461032203), in left arm for immunisation. The patient's relevant medical history included: "General Anxiety" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; CLONAZEPAM; XYZAL. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Looks like ER8737, Location of injection: Arm Right), administration date: 05Apr2021, when the patient was 50-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Looks Looks like, EW0173, Prev dose vaccine location= Right arm), administration date: 05May2021, when the patient was 50-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: Unknown. Looks like, FK or HC then 9893, Location of injection: Arm Right), administration date: 08Apr2022, when the patient was 51-year-old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 15Nov2022, outcome "unknown" and all described as "Flucelvax quad: 15Nov2022, Pfizer Dose 4: 15Nov2022"; AGEUSIA (non-serious) with onset 17Nov2022 at 15:00, outcome "not recovered", described as "I have lost my sense of taste.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of ageusia.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID.
Pt complianed of intense shoulder pain from an injection too high in the shoulder (SIRVA event). Pt had pain for one month; although it is improving.