chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 3/18/22, patient presented to office for immunization update. DTaP and Polio vaccines both due verified by provider and MA. Kinrix was administered. Provider was unaware that Kinrix is invalid if administered as the initial dose of DTaP and Polio. Patient had not received any immunizations prior to age 4 years of age, Thus, Kinrix is invalid and child will need further immunization prior to being up-to-date for school this fall. I have called mother and explained the situation to her and she verbalizes understanding. She is appreciative of the call and agreeable to the plan to have patient return for immunization update (he is scheduled to return on 4/22/22 for this already, as he did not receive his infant/toddler vaccinations required for school and is due for several vaccines). Mother will bring patient to the office for immunization update as planned. There was no adverse event, no harm to patient.
patient got the flu; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case involves patient of unknown demographics who experienced flu (influenza), while patient received INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site prophylactic vaccination.  On an unknown date, the patient developed a non-serious got flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.   At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 69-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020) for prophylaxis. On 29th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 29th May 2018, 2 hrs after receiving SHINGRIX, the patient experienced fever, malaise and muscle pain. On 30th May 2018, the outcome of the fever, malaise and muscle pain were recovered/resolved. It was unknown if the reporter considered the fever, malaise and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the registered pharmacist (Rph). The patient received SHINGRIX in left arm. The events resolved after about 1 day. This case was linked with the case US2018147989, reported by the same reporter.
Patient received her first dose of Moderna on May 6th in the late afternoon called our office on May 10th explained that she developed headache and body aches the evening of May 6th and woke up on May 7th with pain/swelling on the left posterior head and then noticed a painful lesion on her scalp.  Dr advised patient to come in for evaluation.
AE: patient felt nauseous  15 minutes post vaccine administration and vomited, felt faint but did not pass out. Treatment: no medication was given. patient was under observation.  Water improved symptoms Outcome: symptoms resolved and patient was sent to POV/Home.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 at 12:00 as dose 1, single (Lot number: ew0153), in left arm, on 29Apr2021 at 11:00 as dose 2, single (Lot number: ew0172), in left arm, on 24Nov2021 at 12:00 as dose 3 (booster), single (Lot number: fh8128), in left arm and on 01Jun2022 at 18:00 as dose 4 (booster), single (Lot number: fm9992) at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZYRTEC R; B12 1000 SR; MOTEGRITY; PRILOSEC [OMEPRAZOLE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Adverse event: Covid rebound. After testing negative 7 and 8 days after day zero patient began showing symptoms a few days later (1 week after paxlovid was finished). The patient again tested a strong positive and was sick with fever and cold symptoms, lethargy etc.
Patient was seen in Berlin office 4/23/03 for a rash. He was diagnosed with chicken pox - under 50 vesicles. He had the varicella vaccination on 9/7/95. Has chicken pox at this time.
- a lot of pain in shoulder/around socket/lymph node/armpit area - complete numbness down entire arm that will last a few minutes before feeling returns
pt devel a fist-sized local rxn p/vax;no further details known as of the date of this report
Painful, swollen, bruised injection site. Swollen lymph nodes in injection side armpit. Painful, bruised line on skin of bicep ending at armpit. Fever of 102+ for 56+ hours following injection. Overall muscular soreness.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with four doses of GARDASIL (Lot #, dose and route not reported) respectively on 16-JUN-2009, 17-DEC-2009, 26-JUL-2010 and 29-JUN-2012. It was not known if the patient sought for medical attention. No adverse reaction reported. Additional information has been requested.
On 08/22/2000 the patient developed a varicella like rash with less than 100 lesions on her chest, abdomen and buttocks. No other symptoms were noted.
Headache, Myalgia, Arthralgia, Fever, left arm- vaccine arm hurt Narrative:
Information has been received from manf for Diphtheria toxoid (+) pertussis acellular 3 component (+) tetanus toxoid (INFANRIX) and Diphtheria toxoid (+) hep B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3 component (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX) and was assigned manf report number A0510670A. This was originally reported by a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. It was noted that following administration of Diphtheria toxoid (+) pertussis acellular 3 component (+) tetanus toxoid (INFANRIX) or Diphtheria toxoid (+) hep B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3 component (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX) the pt developed an injection site characterized by a rash and golf ball size knots. The pt developed same injection site reaction following varicella virus vaccine live. The outcome was unk. Additional information has been requested.
pt had several urticaria lesions beginning several days after each of his first 3 doses. after he had 4th dose, he had urticaria over much of his body beginning 1 to 2 days after injection.pt had requested steroids initially. sx's improving
cellulitis in her upper chest area; pain at the injection site all the way up to her jaw; redness all over her right shoulder; pain at the injection site; This spontaneous report was received from a female patient in her 60's, referring to herself. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (formulation, exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis and subsequently experienced pain at the injection site all the way up to her jaw and redness all over her right shoulder. After a few days, she developed cellulitis in her upper chest area and had to go to urgent care for treatment. It was unknown whether any lab diagnostics/studies were performed. The outcome of the events was unknown.  The relatedness between the suspect therapy and the events was not provided  Upon internal review, the event of cellulitis was considered medically significant.
pt recv vax 11APR97 & it was reported that w/in 11hr of vax pt exp glassy pupils, listlessness, nausea, vomiting, stomach pains & cramps & fever 101.5;pt was seen in ER;
2 separate reactions Tdap 6x4 1/2" area hot to touch. Induration of biceps upper arm started day of injection given seen in office 9/28/06, Gardasil 3 1/2 x 3" hot to touch started 3 days after shot for both ice and Ibuprophen.
No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication information was provided. Patient age was 22 years and 6 months. Beyond use date was reported as 17-Feb-2022. Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 days beyond use date. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Significant follow up received: Patient information and vaccination details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
I started getting symptoms of fever of 102 - 102.5 that lasted for 5-6 days. I had a bad headache, nauseous, fatigue, cough, and  chills. I did an at home COVID-19 test that was positive. I went did a virtual visit with the urgent care and was prescribed a cough medication benzonatate for the daytime and then a nighttime cough syrup promethazine. The cough medication does help some. I was told that I was too healthy for antiviral medications. The last 2 days I have had shortness of breath in the mornings. I also still have headache, cough, and fatigue. I retested on 6/19/2022 and was still positive.
Administered after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The vial was moved to fridge on the date of administration. The vial did not undergo temperature excursions. No adverse events reported by the patient after the administration error.  No treatment medication was provided.
This case was reported by a other health professional via call center representative and described the occurrence of local reaction in a unk patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was unknown. It was unknown if the reporter considered the local reaction to be related to FLULAVAL QUADRIVALENT. Additional information: Sales representative was told by a medical assistant today that a patient had a reaction to FLULAVAL QUADRIVALENT. She said it was a local reaction. No further details provided. Patient purchased the vaccine from a pharmacy. No further details provided. No lot number provided. No patient information provided.
20 minutes, post vax, the pt had uncontrollable crying. He threw up during this fit. He had a shaking episode for a few minutes where his arms were quivering.
PT STATES HER LEG WENT NUMB AND SHE HAD CRAMPING IN HER TOES
Mother reported that patient went to sit down in a chair in the waiting room.  Mother became concerned with patient was not responding to her voice and asked for assistance.  This RN noted that pt had a change in mental status and pale coloring.  Pt had her eyes open, but answering questions or making eye contact with this RN.  Pt was breathing shallow.  EMS notified.  Pt laid on the floor and airway protected with head tilt chin lift.  Pt remained breathing on her own.  Pt spontaneously made eye contact and began talking.  Pt brought to a sitting position, then to a standing position with assistance, and walked with assistance to the ambulance.  Report given to EMS responders.
Headache, fatigue, mild but constant left sided chest pain and nausea. Increased redness and local swelling at the injection site with warmth and then pain and tenderness in to her left trapezius and in to her neck and left anterior chest.
I was experiencing severe abdominal pain and daily migraines. A few weeks after receiving the vaccine, I experienced very heavy clotting in my menstrual cycle. The bleeding lasted for about 3.5 months straight. Throughout this time, I was also very nauseous and in a lot of pain. Also constantly fatigued and overly tired for no reason at all. Occasional vomiting as well.
Patient with moderate to severe pain, swelling, and warmth in arm w/in 24 hours after receiving Pneumovax. Am treating with Keflex, ice (alternating w/ heat), Vicodin, and benadryl prn.
States on 12/9/08 around 6:00 p.m. pain to R deltoid injection site.  States she has been using warm compresses and ice packs.  States last night 12/14/08 states pain better.  Started itching this morning, area reddened and slightly swollen.  Is going to see her PCP.  Temp 97.8.
Day 8-10 post moderna vaccine a red rash developed on my entire lateral upper arm of injection site, Area red, burning, itchy. I am breastfeeding 17 months and first time had breast pain that came not sure if related or not but same days the evening of day 8-10 after the rash started in the morning. Both came and returned to baseline but wanted to report to help for clinical data. I have had a history of allergic reactions.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 27Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin, shellfish; "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Penicillin, shellfish. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Sep2022) Negative, notes: Tested negative on last day of Paxlovid treatment; (25Sep2022) Positive, notes: Tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: It is unknown if other medication taken in 2 weeks of starting COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Severe fatigue , headache, chest / heart discomfort and blood pressure issues. my body still feels fatigue to this day. Was in ER twice within two weeks, didn't feel well for over a month, still not feeling like myself.
Patient felt faint shortly after immunization during 15 minute observation. Upon first presentation, patient was clammy, sweating and lightheaded. EMS was notified and patient verbalized feeling better after drinking fluids. EMS came and evaluated the patient further.
Nausea, Shortness of breath, low grade fever 99-100, sore throat
Pt with vaccines two weeks prior, presented with numbness and weakness in both legs, had urinary incontinence, fever 101 degree F, clonus.
Approximately 45 minutes post vax, the pt complained of left arm hurting at the injection site. That evening the arm still hurt but was now red, and swollen and hot to the touch. The pt experienced a high fever with sweats and shakes. He states his head felt like it was going to "explode". Like a migraine headache. Her chest felt like a weight was on it. She could not breathe easily, was breathing fast and deep. The pt experienced muscle spasms.  They felt like convolutions in her body. She could not control them. She had light sensitivity and was sensitive to loud noises. She was weak, had trouble walking, sore throat, ear ache, loss of appetite, dizziness and tired. The lymph gland under th left arm pit was very painful and swollen. The left side of mer neck and down her shoulder blade was sore and achy.
Client had hx of dementia, she appeared alert and oriented and answered questions clearly. When registering for the vaccine client provided incorrect first name which in turn prevented her previous vaccine records to appear in our system. She denied having been vaccinated previously so the staff proceeded to vaccinate. After vaccine administration clients case manager informed the team that she had in fact completed her 2 doses on 3/24/21 & that she received her 3rd dose that day (4/14/21).
Extremely severe flu symptoms; terrible testing cough in his chest; This is a spontaneous report from a non-contactable consumer (patient).  A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported, no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extremely severe flu symptoms, terrible testing cough in his chest, had to go to the emergency room (ER) on an unspecified date with outcome of unknown. The adverse event resulted in ER/ department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), hospitalization duration was 2 days. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.  No follow-up attempts are possible, information about batch number cannot be obtained.
Has not received the 2nd vaccine; Covid-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 positive) and PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd vaccine) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced COVID-19 (Covid-19 positive). On 30-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd vaccine). On 30-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd vaccine) had resolved. At the time of the report, COVID-19 (Covid-19 positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided. Treatment information not provided.    This case was linked to MOD21-12105 (E2B Linked Report).; Sender's Comments:  MOD21-12105:
Burning at injection site,  then elevated heart rate, flush, and light headedness. I was kept and observed for another 30 minutes at the hospital and everything returned to normal. Then,  I developed severe dry mouth and congestion, post nasal drip,  headache,  and nausea. I drank 3 liters of water with continued dry mouth,  intermittent feelings of flush and light headedness for the next 3 hours, but no fever.  After that subsided,  I had only chills and headache that were resolved by the next morning.  Now I have only arm soreness and mild fatigue.
Left under arm lymph node swelling; dyspnea on exertion; lower body edema; This is a spontaneous report from a contactable other healthcare professional (patient, nurse). A 50-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL0142, expiration date: not reported), via an unspecified route of administration in left arm on 12Jan2021 (at age of 50-year-old) as dose 2, single for covid-19 immunization. Medical history included asthma, drug hypersensitivity (Known allergies: Sulfa). Concomitant medication(s) included bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported; rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EJ1685, expiration date: not reported), via an unspecified route of administration in left arm on 23Dec2020 (at age of 50-year-old) as dose 1, single for covid-19 immunization. On 17Jan2021, the patient experienced left under arm lymph node swelling, dyspnea on exertion, lower body edema. The adverse events resulted in doctor's clinic visit. No therapeutic measures were taken as a result of the events. The outcome of events were recovered with sequel.  No follow-up attempts are possible. No further information is expected.
I took the vaccine at 11:20 a.m. on Thursday 3/25/21.  About 3:00 a.m. I awoke with a splitting headache, my night gown was soaked with sweat, I ached all over and I was nauseated.  Walking to the bathroom was painful.   I took two Tylenols  These symptoms continued throughout the day on Friday.  I awoke Saturday free of symptoms.
About 5 days after TDAP (9/10/12), pt. claims hives to back, abd., unclear if related to vaccine. Pt. still having hives.