chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (the patient's mother) and then from a contactable nurse on behalf of a physician. A 16-year-old female patient received the first single dose of TRUMENBA, (lot M37315) intramuscular in the right deltoid, on 04May2016 at 04:30 pm, for immunisation. Relevant medical history included acne, seasonal allergies and abdominal pain. Concomitant medications included oral doxycycline (unknown manufacturer, tablet) at 100 mg daily from unknown date (about 1 1/2 years before this report) for abdominal pain and acne, IMODIUM for abdominal pain, ongoing norgestimate and ethinyl estradiol (unknown manufacturer) oral at 1 DF daily from Jan2016 for acne. On the same date of meningococcal group b rlp2086 the patient also received the second single dose of MENACTRA, (Sanofi Pasteur, lot U5185BA) given intramuscular in the left deltoid (the patient had received for immunisation on an unspecified date the first dose of this meningococcal vaccine without any adverse event). The patient was vaccinated to the physician office. On 04May2016 the patient experienced soreness at injection site about an hour or two after she went home, and on the night she was extremely lethargic. She was wiped out for 2-3 days. The patient experienced gluten sensitivity in Jul2016. Due to the reported events the patient was visited, but no specific tests and/or treatment were required. The events did not require an emergency room or physician visit.  The outcome of gluten sensitivity was unknown while the patient recovered from the soreness at injection site on 07May2016 from and wiped out on 04May2016 and from the lethargy on 08May2016. The reporting nurse considered that meningococcal group b rlp2086 had a causal effect to the adverse event wiped out. Follow-up (15Aug2016): New information reported from a contactable nurse on behalf of a physician includes: suspect vaccine details (lot, route, anatomical location and time of administration), concomitant medications (meningococcal vaccine and loperamide hydrochloride were added), reaction data (new event wiped out was added), details on visit, treatment and tests, causality assessment. Follow-up (13Sep2016): New information reported from a contactable nurse includes outcome of the event. Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s): 2016364316 Legacy paper report number.
Patient experiencing pain in eyebrow radiating down to lip on right side of face. No pain on or near injection site or left side. Does not believe it is associated with vaccine technique but is afraid it is an adverse effect of the vaccine.
Tinnitus - began within the car ride home.  To date have not sought treatment as I had thought this would go away by now.    It has not.  Most extreme in morning and night when it?s quiet - however, it is present 24/7 - always there.
Pleurisy like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 at 15:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took sulfur (MANUFACTURER UNKNOWN) for an unknown indication on unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included ascorbic acid (MANUFACTURER UNKNOWN) and probiotic nos (MANUFACTURER UNKNOWN), both for unknown indications from unknown dates and unknown if ongoing. On 02Apr2021 at 14:00, the patient experienced pleurisy like symptoms. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pleurisy like symptoms was recovered with sequelae on an unknown in Apr2021.   No follow-up attempts are possible. No further information is expected.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
soreness in arm where injection given, upset stomach, diaharrea, swelling at site of injection, 3 days later entire upper arm swollen and hardened
experiencing a lot of pain in the left arm; ulcer at the injection site; there was swelling in the area where the injection was given; Patient was supposed to receive a tuberculin skin test intradermally, but instead inadvertently administered with the Adacel single-dose vial intradermally; Initial information was received on 11-Sep-2020 regarding an unsolicited valid non-serious case received from a health professional (pharmacy technician). This case involves a 40 years old female patient who had ulcer at the injection site, experiencing a lot of pain in the left arm (pain in extremity), and there was swelling in the area where the injection was given (vaccination site swelling), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] intradermally instead of tuberculin skin test.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Patient did not receive any other concomitant vaccines.  On 09-Sep-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5669AA and expiry date 09-Oct-2021) via intradermal route in the left forearm for prophylactic vaccination instead of tuberculin skin test.  On an unknown date, the patient developed a non-serious ulcer at the injection site (vaccination site ulcer), experiencing a lot of pain in the left arm (pain in extremity), and there was swelling in the area where the injection was given (vaccination site swelling) on an unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  This was an actual medication error case due to wrong vaccine administered (latency same day).  Case details: It was reported that a nurse improperly gave the Adacel vaccine and the patient was now having an adverse reaction. Patient was supposed to receive a tuberculin skin test intradermally, but instead the patient was inadvertently administered the Adacel single-dose vial intradermally, in the left forearm and patient was experiencing adverse events.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for all the events and was not applicable for wrong product administered.
This case meets criteria for vaccine breakthrough review. SxS include fever, cough, hypoxia, diarrhea.  Thought to be COPD exacerbation, COVID+.
All of the following adverse reactions were intense: Shivering, nausea, sensitivity to light, headache, runny nose, extreme lethargy, fever spikes to 102.7, extreme thirst, and extreme swelling with redness and heat at the injection site,  The symptoms began with a general feeling of nausea about 10 hours after injection. Within one hour the remaining symptoms emerged. I still have a low-grade fever of 99-100 degrees and lethargy as of this time (3/9/2020 - 4:09 p.m.)
Swelling and redness at injection site. Diphenhydramine mg qid, methylprednisolone, doxycycline 100 mg bid.
This spontaneous report was received from a registered nurse and refers to a 12-year-old female patient. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 08-JUN-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscular injection (dose, lot number and expiration date were not reported). On the same day, the patient experienced bilateral numbness in legs, which lasted for the remainder of the day (it was not specified at what time the vaccine was administered). The patient recovered from the event on 09-JUN-2017 (reported as "the next day"), without any treatment. No lab diagnostic studies were performed. No further doses of GARDASIL 9 were given to de patient. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
No additional AE; Patient was administered expired MMRII; This spontaneous report was received from an other healthcare business professional referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.     On 19-NOV-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, route of administration and anatomical location were not reported; lot number S035352 had been verified to be a valid number; expiration date 05-NOV-2021). No additional adverse event.
Chills, fever up to 101.2 F, body aches, and nausea, lasting 40 hours.
Hyperventilating, dizzy and nauseous, passed out, swollen tongue, hands curled into extremely  tight fists, sweating profusely. This 15 minute  episode is why I?m reporting (which happened about 21 hours after receiving the second shot), but I also had/have body aches, bad headache, arm is extremely sore and slightly swollen (much more than the first shot), and lethargic.
Pt observed unresponsive. Pt responded after vitals, Vitals stable A & O x4. Says she does this w/ any vaccine. Refused transport.
Patient began to feel chest tightness, tightness in throat, elevated blood pressure, itching in arm with injection, flushing, agitation, burning on administration. Patient was tachycardic (HR=151) and hypertensive (BP=173/125) on presentation to the Emergency Department. PAtient had already taken 50mg oral diphenhydramine prior to admission. Given 125mg IV methylprednisolone and 20 mg IV famotidine in the ED. Monitored until vitals normalized and symptoms improved.
Dizziness, headache, fatigue, sore throat, high fever, body ache, chills.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients who were administered vaccines which were stored improperly. This report refers to the patients who on unknown dates were vaccinated with VAQTA that were stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Follow up information was from the same registered nurse who stated that patient identifiers and dates of administration were unavailable at this time; however, lot numbers and expiration dates were available, VAQTA (Adult) lot number: J007781, expiration date: 19-SEPT-2015. Additional information has been requested.
Around 7 pm she noticed some hives on the back of her neck, and they seemed moist. They travelled down to her upper back after 2 days. The lesions seem to be drying now and they haven't migrated anymore, as of today. Treatment today involved Benadryl this afternoon around 3pm. They don't itch at all, don't burn, just noticing the lesions on the skin. The lesions are only irritating if she lays on her back.
A few hours after receiving the vaccine, I experienced chills and body aches, and a stomach ache. The chills and body aches went away after taking ibuprofen. However, the stomach ache continued and gradually moved into the lower right quadrant. This pain was severe and continued the next day and night. The next morning I went to the emergency room and they diagnosed me with appendicitis and removed my appendix.
Seriousness criteria other medically significant (OMIC). Initial report receive on 8/8/06 from a health care provider. An 81 year old female pt had received an IM, left deltoid injection of Decavac, lot number U1679DA, on 7/26/06. The pt had received the injection as a routine booster. Six days post vaccination, she experienced pain at the injection site. One week later, she had pain radiating to her left elbow which she treated with heat, ice and Tylenol. On 8/8/06, she woke up and was unable to move her left arm due to severe pain. At the time of this report, the pt had not recovered. Follow up information received on 10/27/06 from a health care professional. The pt had been vaccinated secondary to an ulcer on her toe. Physician impression of the event was Parsonage Turner syndrome. The pt was referred for physical therapy and transcutaneous nerve stimulation with gradual resolution of symptoms.
Narrative: A 69 year old male presents to ER with complaint of cough, congestion, and difficulty with urination. Patient presents with worsening symptoms for the past 4 days. Patient also has a note with him that was written by his wife. Since Monday, patient reports worsening cough productive of clear sputum, congestion, sore throat, shortness of breath. Patient is on 3 L of oxygen at baseline and reports significant shortness of breath with walking just 15 feet, which he states has been ongoing for the past year. In addition, patient reports difficulty with urination. He states that he only dribbles out small amounts of urine and does not feel like he is ever emptying his bladder. Of note patient with multiple comorbidities including HFpEF (EF 55-60%), small pericardial effusion, multiple myeloma *diagnosed 2018 off tx since 2019); CKD IV, chronic venous status and LE ulcers, DM2, HTN, HLD, CVA, Renal Cell carcinoma s/p right nephrectomy. On 9/6, patient displayed worsening respiratory distress with requirement of Oxymask. Patient was initially transferred to the PCU for HHFNC and placed on 60L 60% without notable improvement. Patient was seen by Renal who consented for tunnel catheter due to poor renal function. With his poor renal function and increase oxygen requirements that patient was deemed unstable for Medicine floor and transferred to the MICU for further medical management. Following admission to the MICU pt expressed wishes to transition to comfort measures only. Wife was able to visit and with full decision making capacity the patient opted for Palliative Care. Palliative care was consulted, pt known to them. He was started on comfort pain medications, ativan, bowel regimen. As pt was about to be transferred to medicine floor he became apneic and bradycardic and passed at 10:45am.
The client is 30 yrs. old and was given a PROQUAD in error.
1) Tender lymphadenopathy of left axilla and supraclavicular areas- started on 01-10-2021, worsened for 2 days, then began to resolve in both size and tenderness. Ultrasound performed on 01-11-2021 that was consistent with lymphadenopathy without any other findings. Most recent evaluation on 01-14-2021 with persistent lymph node swelling but decreased size and tenderness.  2) Erythema at site of injection- Patch of erythema and pain approximately 3x4cm at site of injection and just inferior to it. Symptoms  began on 01-13-2021, decreased on re-evaluation on 01-14-2021 but was still present.
Patient with questions /concerns-said she had to get vaccine because of recent dx/tx for breast cancer. She said received vaccine on 3/13- then on 3/16 she was seen for one of her breast cancer therapy sessions- they have been treating her for lymphedema - she said she has been going for breast cancer in July- no chemo just radiation- surgery of breast with removal of seven surrounding lymph nodes. She was advised to wear a compression bra- on 3/16 and ever since then her left side of neck has been sore- thought it was likely related to compression bra not fitting correctly b/c too tight & was professionally fitted on her- the straps seem very tight over the collar bone area that was damaged/irritated by the radiation she received on that side up through Oct 2020 for cancer. Now when she saw story today in news she got concerned could the neck soreness really be from a blood clot? She as been going the week for tightness in neck to physical therapy which started yesterday for lymphedema. Again her radiation ended Oct 2020 but she has had persistent swelling in breast & fluid in lymph nodes on the left side. She still has pain in on collar bone- on same side of radiation- blisters, sore, red. As well as this new compression bra having two tight straps on each side. Her COVID vaccine shot in right arm but left side where breast surgery was She went on 3/16 for consultation on breast lymphadema - that was when told her to wear tighter bra for compression on 3/16. She is going today to be fitted for new one that is not so tight. She is approx. 4 weeks post vaccination & post when started wearing that tighter bone- maybe three inches from where had radiation injury is located.
Pt had immediate localized swelling above (R) forearm injection site. Firm, sl tender, no fluctuance. Pt able to do full AROM (R) arm ice applied 10 min. Decreased swelling 10" with some residual. Saw pt 2 weeks or more later-area w/o swelling, pain.
12 hours after vaccination I got a low grade fever of 101. I had severe body back aches that were so severe I had a difficult time walking. My injection site (Left deltoid) was swollen and sore, although not more than usual after receiving a vaccine. I had no headache at all. The major concern was the fever and the backaches. I could not get warm, and I was shaking badly because I was so cold. I had ZERO relief despite taking 700 Mg of Tylenol. Side effects finally subsided after about 5 hours.
The next day following the vaccine my arm hurt slightly at the injection site, my head felt strange slight pressure maybe inflamed my face was red my blood pressure was higher for the first day.  The following days my head felt strange again and my face would get red and it would come and go. but blood pressure was normal.  Mid week the entire left side of my body felt like my body worked out but I didn't exercise.  Today  eight days after the vaccine blood was on the tissue after urinating in the morning upon waking again in the evening there was more blood on tissue.
Patient subsequently contracted one illness after another during the following six weeks. The most egregious of these adverse reactions resulted in patient putting on 40lbs within a six-month period.  Additionally, started exhibiting impulse-control issues, lack of gross motor coordination and a general disorganization and mental fogginess.  All these issues led to patient getting into trouble at school.
localised rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (localised rash) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) capsule for CLL.    Concurrent medical conditions included Thyroid disorder, Ileostomy and Hypercholesteraemia. Concomitant products included ALENDRONATE SODIUM, ALLOPURINOL, AMLODIPINE BESYLATE, EZETIMIBE, BIOTIN, FOLIC ACID, CHONDROITIN SULFATE, GLUCOSAMINE SULFATE, METHYLSULFONYLMETHANE (GLUCOSAMINE CHONDROITIN & MSM), LEVOTHYROXINE SODIUM, SIMVASTATIN, TEMAZEPAM, MAGNESIUM, THERAWORX RELIEF, TRAMADOL HCL and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and IBRUTINIB (IMBRUVICA) (Oral) 420 mg. On an unknown date, the patient experienced RASH (localised rash). At the time of the report, RASH (localised rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
sore arm; Nausea; Sedation; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date 31Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Feb2022, outcome "unknown", described as "sore arm"; NAUSEA (non-serious) with onset 01Feb2022, outcome "unknown", described as "Nausea"; SEDATION (non-serious) with onset 01Feb2022, outcome "unknown", described as "Sedation"; FATIGUE (non-serious) with onset 01Feb2022, outcome "unknown", described as "Fatigue". It was unknown if therapeutic measures were taken as a result of pain in extremity, nausea, sedation, fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt requested flu shot w/o any allergy. Shortly after administering FLUVIRIN, pt complained of dizziness. Pt's condition get worse w/swelling lips, shortness of breath, tightening her throat. Called 911. EPIPEN 0.3 mg was administered. Paramedic came and took pt to hospital.
Persistent Dizziness and Brain Fog 3 Weeks After Shot  Persistent Neck and Hip Pain After the Shot Tingling and Numbness in Hands 3 Weeks After the Shot
22 year old male patient reports feeling chest tightness, itchy throat and dizziness. Paramedic protocol is activated. Verbal medical orders via phone with Doctor R. DECADRON 4ml intramuscular. Medication is administered according to the medical orders in the right arm by nurse. Patient is referred to Hospital.
UNKNOWN DATE OF WHEN VACCINES WERE GIVEN. UNKNOWN LOT NUMBERS. PATIENT ADMITTED TO HOSPITAL AND DIAGNOSED WITH BREAKTHROUGH COVID-19
This spontaneous case was retrieved on 25-Oct-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1771491-1), reported by other healthcare professional and concerned a 13-year-old, female patient. The patient's concurrent condition included anxiety. The patient was not taking any concomitant medications. The patient had no known allergies. On 05-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration: intramuscular (IM), anatomical location: right arm (RA) below the deltoid, between the bicep and triceps muscle, dose: 'one' as reported and indication: not reported) (explicitly coded as  'Vaccine administered at inappropriate site'). The batch number reported was 308541 (reported batch number was identified as potential 308451 by Seqirus to be linked to new suspect product Flucelvax Quadrivalent). On 08-Oct-2021, three days after receiving Flucelvax Quadrivalent, the patient experienced ten cm by eight cm patch of erythema and induration just distal to the injection site on the right arm. The patient visited physician's office. The outcome of the events was unknown. The reporter did not provide a causality assessment. The case was assessed as non-serious. Company Comment: A 13-year-old, female patient, was vaccinated with Flucelvax Quadrivalent below the deltoid, between the bicep and triceps muscle (explicitly coded as 'Vaccine administered at inappropriate site'). Three days after vaccination, the patient experienced erythema and induration. Information regarding diagnostic findings was not provided. Vaccine administered at inappropriate site is assessed as not related per company's conventions. Causal role of the suspect vaccine is assessed as possibly related for other events, due to biological and chronological plausibility.; Sender's Comments: A 13-year-old, female patient, was vaccinated with Flucelvax Quadrivalent below the deltoid, between the bicep and triceps muscle (explicitly coded as 'Vaccine administered at inappropriate site'). Three days after vaccination, the patient experienced erythema and induration. Information regarding diagnostic findings was not provided. Vaccine administered at inappropriate site is assessed as not related per company's conventions. Causal role of the suspect vaccine is assessed as possibly related for other events, due to biological and chronological plausibility.