chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHHY2014US039847 is an initial literature report received on 01 Apr 2014. The author discussed about the effect of influenza vaccine in asthmatic patients. This report refers to a 38-year-old female patient. She was a mother to two children aged 5 and 3 years old. Her medical history included allergic rhinoconjunctivitis with sensitization to tree, grass, dust mite, cat, alternaria species and perennial mold in addition to well controlled asthma. She managed with 2 puffs of 40 mg of beclomethasone inhaled twice daily, 2 nasal squirts of 50 mg of fluticasone propionate daily and intermittent use of over-the-counter ketotifen ocular drops as needed. She used her Albuterol inhaler before exercise and intermittently (no more than once per week). It was reported that the previous few years, she averaged approximately 4 exacerbations per year and all required oral corticosteroid courses. The patient was vaccinated with influenza vaccine (manufacturer and batch number: not reported, so conservatively coded as influenza vaccine INN (seasonal or pandemic)) on an unknown dates in the past 2 years. On an unknown date, the patient contracted influenza and had an asthma exacerbation causing her to miss a day of work despite receiving the vaccine. She reported past asthma flared up within a month of vaccination, which in part has motivated her decision to defer influenza vaccination for some years. She expressed that she does not want to get sick from the vaccine and that some years she felt the vaccine does not work. The author concluded that influenza vaccine itself was linked to causing any asthma flares or contraction of influenza virus but it need to be discussed that vaccination might not prevent influenza-related asthma complications. In past years, the main circulating strain of influenza B has not been in the vaccine, validating the patient's concern that vaccine efficacy might not be optimal in some years. However, vaccination is still the best recommendation to prevent her from contracting influenza and highlight that new quadrivalent vaccines are available that will hopefully provide more robust coverage against circulating influenza strains. It was reported that the patient was re-vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date and this time she was without any issue and neither had any asthma-related complications during the influenza season.
The patient thought his skin reaction went down after receiving hepatitis B shot; This spontaneous report was received from a 70-year-old male patient reporting on himself. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug allergies.   On an unknown date, the patient was vaccinated with an hepatitis b vaccine (manufacturer unknown) for prophylaxis (dosage schedule, route of administration, lot number and expiration date were not reported). Furthermore, the patient thought his skin reaction went down after receiving hepatitis B (manufacturer unknown) shot (therapeutic response unexpected).       The outcome of therapeutic response unexpected and the causal relationship between the event and therapy with hepatitis b vaccine (manufacturer unknown) were not reported.; Sender's Comments:  US-009507513-1610USA004936:
Severe pain in the left shoulder and have difficulty moving the left arm where a shot was given.  The pain level was 9 out of 10 (Most Severe).
A few days after the flu shot in my left shoulder, I had extremely limited arm movement. I was unable to lift my arm up to be parallel with the rest of my body. I cannot put any weight on affected arm because of pain or lift anything heavy. I am unable to sleep on side with affected arm because I wake up at night from pain and then my shoulder is extremely sore. I am unable to move arm in a certain manner with tasks such as taking off shirts or putting on socks. The pain has lasted for 3.5 weeks until I saw my doctor on November 11, 2011. Before then I was applying warm compresses, which did not improve the pain, so I switched to cold compresses which also did not help. I took ibuprofen which did not help. Then I decided to take Tylenol which helped a little. My physician prescribed me a 15-day course of Prednisone which helped and the pain subsided completely. I finished course at the beginning of this week (11/27/11) and noticed onset of pain again in left shoulder yesterday (12/02/11). Today I was unable to lift grocery bags. Pain is localized in the shoulder.
got bruising on the injection site after the booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 Immunisation. The following information was reported: VACCINATION SITE BRUISING (non-serious), outcome "unknown", described as "got bruising on the injection site after the booster dose".  Additional information: The reporter had a general concern with the booster shot. He mentioned with any other vaccination in his life, this was the first time he had witnessed slight bruising on the arm. He wanted to understand why this had occurs with the covid vaccine. Why was the booster causing bruising on arms. He also added, he did research and saw some have and refer to it as covid arm.   Follow-up(18Jan2022): This is a follow-up spontaneous report from a Pfizer-sponsored program.  Updated information included no new safety information.  The lot number for bnt162b2 was not provided and will be requested during follow up.
lots of bodyaches, headaches, difficulty swallowing,  loss of sensation on fingers difficulty walking,  cognitive problems, memory problems, fatigue, brain fog, feel like I have the flu everyday.
Cold chills, fever, headache, body ache, fatigue, nausea. This effect happened on both shots to the same intensity.
I woke up early in the morning and was hypotensive. I had severe abdominal pain. I went to the hospital. They did a CPA on my abdominal artery. They didn't find any clot. When they did a colonoscopy later they found colitis. They said that I had thrown an arterial clot from the left atrium. They said it was most likely related to my A-Fib. They kept me for 5 days. That was about 3 months after my vaccination.
NIGHT SWEATS; CHILLS; FEVER; NAUSEA; MUSCLE ACHES; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced muscle aches. Laboratory data included: Body temperature (NR: not provided) 100.1 degree F. On 04-APR-2021, the subject experienced night sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, nausea, muscle aches and night sweats was not reported. This report was non-serious.
Information has been received from a registered nurse concerning a female who had been vaccinated with 2 doses of GARDASIL (Lot# of both doses not reported). It was reported that the patient developed clostridium difficile prior to receiving her third dose of GARDASIL. The patient was being treated for clostridium difficile. The patient sought unspecified medical attention. The nurse also mentioned that the first course of antibiotics (manufacturer unknown) did not work for the patient (MSD, WAES1101USA01980), so the patient was on her second course of antibiotics. Additional information has been requested.
it gave me the flu; Initial information received on 25-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves Adult and unknown gender patient who reported it gave me the flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (strength, dose, frequency, formulation, batch number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient diagnosed with a non-serious event of it gave me the flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported "This is a social media case: I never get yhe flu. But my doctor encouraged me to get a flu shot.. And it gave me the flu.. Never get another flu shot."  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown.
Hospitalized 9/28/21.  PMH VHD, rectal carcinoma s/p colectomy (no recent chemo or XRT), remote vocal cord cancer,  cardiomyopathy, CKD stage 3B seen today for COVID 19 pneumonia.  He presented to the ED at BHL on 9/28 after a fall in his home.  In the ED, he was febrile, with temperature of 102.  Admitting labs with CRP 4.44, ferritin 175, WBC 3.75, PLT 134, PCT 0.15, Scr 2.03. CXR with patchy interstitial changes of lung bases, with a small focus of pneumonia or atelectasis in the medial left lung base.  COVID 19 PCR positive.
Returned to clinic 2 days post vaccination with swelling to right upper arm. Site erythemic.
pt called reporting arm pain, swelling, heat and redness for the last 5 days after injection on 04/07.  pt was asked to see MD.  When she saw urgent care MD, they ruled out blood clot and diagnosed cellulitis.  MD prescribed antibiotics to treat the cellulitis.
2-3 days after receiving vaccine, I noticed achyness and weakness in left arm, numbness and tingling in left hand. CPK level drawn and EMG and nerve conduction study done.
Pt received the HPV GARDASIL 9 and Influenza vaccinations and doing well. He was having his blood drawn, then had syncopal episode. The blood draw and needle stick was difficult and it made him feels sick. He was awake and alert within 45 seconds. Very pale. Pt given juice, granola bar, and saltine crackers. VSS. Waited in the exam room for 3 min. Feeling much better, awake and alert and back to baseline. His sisters have syncopal episodes after vaccinations, but never has before. VS prior to leaving were P 71, BP 106/68, resp 16. No longer pale and feeling much better.
Vasovagal syncope x3 with myoclonic jerking/ convulsions (loss of bodily control during: urination during convulsions)
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 06-MAR-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R021055 with expiration date in 01-APR-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001849: US-009507513-1907USA001848: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001832: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000952: US-009507513-1907USA000970: US-009507513-1907USA000965:
pt recv vax 21NOV97 & arm became black & blue, swelling & painful the day p/vax;pt had a lump @ the vax site that was painful & black & blue;mom applied cold compress & swelling & pain subsided;
chills, ear pain, sore throat, cough, nausea, myalgias, headaches
RASH IMMEDIATE AREA  SURROUNDING VACCINATION AND SEVERAL AREAS ON THE UPPER ARM. SLIGHTLY RAISED AND HOT TO TOUCH I took claritin reditab 10mg and a holistic Hylands seasonal allergy relief but nothing has helped
Redness, swelling, pain, hot to touch, and itchiness of whole upper left arm. Hydrocortisone 2% cream applied with cold compresses for 2 days.
Patient was found on the floor around Before arriving to the observation area, while walking with his nurse who administered the vaccine. Rapid response was called, pt refused the first set of vitals set then agreed to vitals    Spo2 98 in room air, pt refused to be taken to the ER by rapid response, he stated feel fine and does not needs medical attention, second set of vitals performed after pt was observe for 30 mins. BP 130/90 HR 103, Spo2 98 in room air, he was instructed not to leave before seing by a MD, pt refused and sted he will not stay and does not need medical attention, teaching provided to patient,  Patient verbalized undersatnding and still decided to leave. Supervisor made aware, MD Sherriff Session made aware.
Started with suspected seizure onset after 3/10/21 covid vaccine and subsequently deceased of unclear etiology on 7/12/21. Family is concerned it is covid vaccine related.
I had my flu shot and my left shoulder became sore and overtime has progressively advanced to start limiting range of motion and experiencing painful movements.  I have become concerned and had an xray performed showing mild arthritis. Nothing to explain sudden onset of pain right after shot unless its a side effect.
Began experiencing a rash about 3 inches in diameter on Left Arm below injection site about 7 days after first dose of Moderna COVID vaccine.  Rash itches and has grown in size over the last 2-3 days.
Patient stated her symptoms began on 7/3/2021 with severe muscle/body aches. Patient has experienced additional symptoms such as subjective fever, congestion, onset of a cough, shortness of breath, and nausea. Patient is still symptomatic at this time and currently hospitalized. Patient contracted COVID from her daughter(patient # Unknown
SEVERE SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced severe side effects. The action taken with covid-19 vaccine was not applicable. The outcome of severe side effects was not reported. This report was non-serious.
she is also experiencing headache with the first shot; This is a spontaneous report from two contactable consumers. A female consumer (patient) and another consumer (patient's husband) reported that a 42-year-old female patient (consumer) received bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient and her husband stated that, the patient experienced headache with the first shot as well so we were expecting that on an unspecified date. The patient passed phone to her husband because, she no longer felt like talking on the phone. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
mom reported pt vomited approx 10 hrs p/vax 12AM; fever 103.6 @ that time & remained through the morning; pt irritable, intermittant crying;
p/vax pt exp a crusty, yellow nose & red watery eyes w/a fever;pt also devel erythematous papules & blisters on torso, head & face;dx w/atypical measles;
Patient is 16 years old, and therefore should have received the Pfizer COVID vaccine, rather than the Janssen COVID vaccine.
Do not know if the symptoms were related to the vaccine. They started 4-5 days after Pfizer Covid-19 vaccination.  Intermittent Scratchy throat, stuffy sinuses, extreme fatigue felt as if I was coming down with or fighting a cold. Symptoms lasted on and off for about 4-5 days. Nothing materialized.  After that I felt fine
Tested positive for COVID; Tested positive for COVID; tightness in chest; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in Arm Right on 01Apr2021 14:00 (Lot Number: EN6207, expiration date unknown) at age of 47 years old as a single dose, 2nd dose via an unspecified route of administration, administered in Arm Right on 01Apr2021 (Lot Number: EP6955, expiration date unknown) as at age of 47 years old a single dose for covid-19 immunisation. The patient was not pregnancy at time of vaccination. There were no medical history or concomitant medications. The patient tested positive for covid and tightness in chest, both on 07Sep2021. The patient underwent lab tests and procedures which included rapid COVID-19 test: positive (Nasal Swab) on 07Sep2021. The outcome of 'tested positive for covid and tightness in chest' was not recovered. Clinical course: Tested positive for COVID on 07Sep2021. Experiencing headache, tightness in chest, stuffy nose. The patient had no other vaccine in four weeks or other medications in two weeks. The patient had no covid prior vaccination. No treatment received for the events ('tested positive for covid and tightness in chest' ). There were no known allergies.
Vaccinated during pregnancy, Pfizer two doses, shortly after admitted to antipartum care for low fetal movement and fetal heart rate. Stuck on side for her to breathe for over a month until forced c section at 34 weeks pregnant. Genetic testing on baby during nicu concluded Prader Willi Syndrome. mRNA vaccine altered and faulted 15th chromosome.  Life long syndrome.
Onset of erythema, swelling, heat over entire deltoid region on the morning after vaccine was given. Mother applied ice and topical BENADRYL. Also gave oral TYLENOL and ibuprofen as needed. Mother called our clinic for advice on how to manage. Symptoms eventually resolved. All physical findings were resolved at time of subsequent unrelated sick visit on 10/18/18.
No adverse event; Received Bivalent Booster for first Primary dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Bivalent Booster for first Primary dose) and NO ADVERSE EVENT (No adverse event) in a 22-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Bivalent Booster for first Primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Bivalent Booster for first Primary dose) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received Bivalent Booster for first Primary dose).    No concomitant medications were reported. 22-year-old patient received a Bivalent booster dose instead of the first primary Moderna COVID-19 vaccine. No treatment medications were reported.
Extreme swelling of left side of face (eye almost completely swollen shut), headache, fatigue, body aches, went to eye doctor and shingles was suspected. Prescribed antivirals and antibiotics.