chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About a week after I received the vaccine, my back started itching on the skin around the left bottom side of the right shoulder blade. The area was itching but then also felt numb when I scratched it.... Then the itching/numbness slowly over the  next few days spread from that area around to the front right breast. On the following Friday April 2nd a red and bumpy rash broke out on the area by the shoulder blade - then intermittent bumps - maybe 10 or so in total -  broke out in a line that wrapped around to between my breasts. That's when I suspected it was shingles...  The rash was annoying but it wasn't really painful - only maybe a day or two with intense itching otherwise the itching was bearable...
Woke up with numbness and horrible muscle pain on left side of body.  The shot had been given on right arm.
Initial report received from a health care professional on 21 June 2011. A 6-year-old male patient, medical history unknown, received an intramuscular right deltoid injection of DAPTACEL, sanofi pasteur lot number C3474AA, an intramuscular right deltoid injection of IPOL, sanofi pasteur SA lot number D1086-1, a subcutaneous right tricep injection of MMR, Merck lot number 0832Z, and a subcutaneous left tricep injection of VARICELLA, Merck lot number 1376Z, on 20 June 2011 at 10:30 AM. On 20 June 2011 at 12:10 PM, the patient's parent brought the child back to the physician's office with shortness of breath, facial edema and hives. He was given epinephrine and sent home. The patient returned again at 3:06 PM with lower extremity hives and facial swelling. He was again given epinephrine and sent home after 45 minutes. The outcome was reported as unknown. Documents held by sender: None.
This spontaneous report was received from a pharmacist referring to a 72 year old male patient. The patient's concurrent conditions included allergy to codeine. On 29-DEC-2015, the patient was vaccinated with ZOSTAVAX (Lot # L002422, expiration date 23-APR-2016) 0.65 ml once, subcutaneous in the right arm. No concomitant medications were reported. On 30-DEC-2015, the patient experienced redness, swelling and a rash at the injection site, the pharmacist also reported injection site warmth and injection site induration (also reported as the injection site was warm and hard to the touch). The patient visited the pharmacist, no treatment was given. At the time of the report, the outcome of the adverse events was reported as not recovered/not resolved. Additional information has been requested.
01/02/2022 The patient is a 46-year-old female with a history of hypertension, hyperlipidemia borderline personality disorder, schizophrenia, developmental delay that presented to the emergency due to generalized malaise, leg cramping.  She was Baker acted by the police and sent to facility.  She was discharged from facility.  States she has been at the church.  Yesterday she began to have generalized malaise and cough.  Also notes that her legs for cramping as she has been "walking a lot lately".
4 breakthrough cases of Covid 19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (4 breakthrough cases of Covid 19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (4 breakthrough cases of Covid 19). At the time of the report, COVID-19 (4 breakthrough cases of Covid 19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported  No treatment medication was reported
pt recv flu vax 13NOV96 & noticed redness, swelling & itching that evening;returned 15NOV96 w/red, indurated area @ 4x12cm w/2 1/2 cm ecchymotic area bout inj site;tx w/med; & cool compress;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a elderly female patient who received Shingrix (batch number 27J4P, expiry date 12th April 2021) and (batch number 3977A, expiry date 9th May 2021) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site rash, injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site rash and injection site erythema were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site rash and injection site erythema to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. In 2018, the patient received Shingrix subcutaneously, it reported that patient received 5 - 6 inches below bicep/couple inches above elbow - there was no muscle in this area so patient received the vaccine subcutaneously, this led to intramuscular formulation administered by other route. The patient also experiences large red rash around injection site lasting for some time and took a while to go away - the reaction at this time had recovered per pharmacist. The batch number of Shingrix was reported as 2734P or 2754P, which was corrected to 27J4P as per sales data sheet. The batch number of Shingrix excipient was reported as 3977A.
Information has been received from a health professional concerning a 5 year old male who on 24-MAR-2003 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot number 641161/0796M). On 30-MAY-2007 the patient experienced chickenpox. No further information is available.
Red itchy area noticed next day at shower.  Has gotten larger by day 2 after vaccine.  Second dose.  No other reaction.
Chills and fever began at approx. 1:30 a.m. on February 27.  Continued until late mid-day on March 1.   Extreme weakness and nausea.  Had no appetite.  Very dry mouth. Fever lessened by evening of March 1. Weakness and feeling of lightheadedness continuing as of today, March 2, morning. No more nausea today. No fever today Able to eat small amount of food
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT, UNSPECIFIED VEIN ACUTE DVT OF BILAT FEMORAL VEINS
Starting 12/08/2022, I had returned from a work conference and thought I was just fatigued from the trip. On 12/09/2022, I woke up with head congestion and feeling sick. I took an at home COVID-19 test (12/09/2022) which was positive. I called my PCP's office for PAXLOVID due to my arrhythmia and I was prescribed it. I began it on that Friday (12/09/2022). Since then, I have had gradual improvement of my symptoms. As of today, I am still having a productive cough, runny nose and head congestion. However, the body aches and the fatigue have resolved. Since Friday, I have had GI symptoms: diarrhea since the illness started but I don't correlate that to the PAXLOVID. I am currently on day 4 of PAXLOVID.
Noticed rash on thighs. States it was raised: welt-like. Denies complaints of pain, burning pruritus. Called her MD and was told to apply cortisone cream. Pt denies being seen at MD office. Treatment was prescribed over the phone by MD.
Patient complaint was that she was having loose stools and noticed bumps on her neck proximal to her clavicle area. She said the bumps were about an inch in diameter and slightly red. Stated that the bumps were not painful to the touch. She said she was on her way to the doctor's office and has yet do anything to treat any of the symptoms.
Reports dizziness and feeling light headed;  Rest, Po hydration, medical monitoring  x 30min; BP 146/90 P76 Feels better and released from facility to home
pt recvd vax 13AUG95 & 23AUG95 exp abd pain, was unable to urinate & was limping; pt hospitalized for tx;LP revealed 50 white cells w/nl glucose & protein;CSF antibodies for IgG & IgM for varicella were <1:16;dx'd encephalomyelitis
Chief complaint of worsening lower leg pain.  Initially the patient though that he had pulled a muscle however he had complaints of claudication upon ambulation.  Patient reports having J&J COVID vaccination approx 2.5 weeks prior.  Patient reported his friend informed him that he might potentially have a blood clot and that he should come to the emergency department.  Imaging consistent with acute DVT and patient taken to IR for tPA direct catheter infusion.
Bell's Palsy; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 03Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 06Apr2021, for COVID-19 Immunization; Bnt162b2 (Dose: 02), administration date: 27Apr2021, for COVID-19 Immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 2022, outcome "unknown", described as "Bell's Palsy". The event "bell's palsy" was evaluated at the emergency room visit. Clinical course: On the morning of 09Mar2022, the patient went to the emergency department at (withheld). The patient got diagnosed with Bell's Palsy. The patient read that the FDA indicated in Dec2020 that patients should be monitored for Bell's Palsy symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up.
temperature excursion, temperature reached negative -40F degrees duration of 8 hours and 25 minutes with no reported adverse event; received vaccine post-temperature excursion where the vaccines were not suitable for use with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 19 month old female patient and reporter reported that temperature reached negative -40f degrees duration of 8 hours and 25 minutes with no reported adverse event and received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] post-temperature excursion where the vaccines were not suitable for use with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Apr-2023, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE for Suspension for injection (lot: C5969AD and expiry date: 17-Feb-2024) via intramuscular route in the left arm for Immunization.   On an unknown date, the temperature reached negative -40f degrees duration of 8 hours and 25 minutes with no reported adverse event (product storage error) (unknown latency).  On 04-APR-2023 the patient received vaccine post-temperature excursion where the vaccines were not suitable for use with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Left foot tingling; Tongue and nose numb; Tongue and nose numb; Lymph node was very swollen; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 33-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in right arm on 28Jan2021 at 12:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. No known allergies. Concomitant medications included escitalopram, birth control; Both received within two weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. No COVID prior vaccination. The patient has been tested for COVID post vaccination. On 28Jan2021 at 12:00, the patient experienced left foot tingling, tongue, and nose numb, lymph node was very swollen. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test and procedure which included rapid nasal swab: Negative on 02Feb2021. No treatment medications was received for the adverse events. The outcome of the events was not recovered.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Received vaccines Wed afternoon, felt warm Thursday. Friday morning injection sites had red raised rash it spread to arms and chest in 1 hour. Mom took him to urgent care and was given BENADRYL. Rash has resolved.
Patient was given Bexsero instead of Menactra.  Patient was notified by his school that he had not had the proper vaccinations for him to return to school.  It was determined that Bexsero was ordered and given instead of Menactra.  Patient had no adverse reactions to receiving the Bexsero.  Patient was brought into the office and given Menactra on 12/29/2020.
Information has been received from a consumer concerning her 11 year old grandson who in approximately 2001, "sometime around the age of five years old" was vaccinated with a dose of Varivax (Merck) for the prevention of chicken pox. The consumer reported she was told by her daughter that her grandson developed a mild form of chicken pox after receiving the vaccine, "three weeks ago." The grandmother reported that the patient developed a fever of 103 degrees at first before developing the chicken pox. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. The reporter noted that the patient was "over it two weeks ago" (on an unspecified date in February 2007). A product quality complaint was not involved. Additional information has been requested. Follow-up information was received from the grandmother indicating that "her grandson got a light case of chicken pox. He had got vaccine when he was younger. He had low fever and some sores, not adverse. He missed school for 5 days due to fever and scabs. Additional information has been requested.
Extreme joint pain and headache beginning the day after the vaccine that lasted 48 hours. Seemed to subside but came back on 10/18/21 with the addition of headache and coughing this time. General soreness and fatigue this time. Has lasted over 24 hours and still present.
12/9/21:  Patient admitted post fall and left sided weakness.  Found to have left cerebellar infarct and left intertrochanteric femur fracture.  Covid negative on admission and no symptoms. 12/10/21:  OR for nailing of femur fracture 12/11/21:  developed aphasia and aspiration PNA 12/13-12/17:  in and out of afib with RVR treated with IV Cardizem.  Continues to have no Covid symptoms.  NPO due to aspiration risk.  For PEG tube.  Improving lung imaging post IV abx for aspiration PNA.  On 2L via NC sat >97%. 12/22/21:  Symptomatic bradycardia events.  Need for pacemacker 12/24/21:  GI bleed with transfusion needed.  Continues to have no Covid symptoms.  2L NC sat >95%.  Ferritin 235 WBC 20.8 12/27/21:  Continued leukocytosis WBC 18.2, GFR 34.  Increased resp. rate 26-32, increased oxygen need 4L NC to sat >92%.  Temp 98.6 F.  Tested Covid positive and concerns for aspiration.  CXR shows increased pulmonary infiltrates bilaterally with small left pleural effusion.  Started IV Remdesivir, decadron, flagyl, cefepime, and vitamin cocktail. 12/28/21:  Concern for PE, unable to do VQ scan due to AKI and allergies.  Started on heparin gtt.  GFR 30, temp 99.5 F, AST 39 ALT 32.  Remdesivir stopped.  Started on renal dose baricitinib.  RR 30-32 sat >92% on 5L NC. 12/29/21: @0540 patient becoming unresponsive with desaturation.  On NRBM sat 80% RR varied from 12 to 40.  Rapid response called.  ABG on NRBM 6.992 CO2 >100 unobtainable BE or HCO3.  Rhonchi and rales throughout bilateral lungs with weak inspiratory effort in acute hypercapnic/hypoxic respiratory failure.  Patient intubated and placed on Bilevel 28/20 PS 20 FiO2 100%.  CXR shows increased bilateral atelectasis and infiltrates.  GFR 29 Temp 100.0F. BP 82/41 started on Levophed.  Two hour post intubation ABG 7.298/54.6/236/26.7/-0.2. 12/30/21:  Off Levophed and sedation, minimal response to painful stimuli.  Afebrile, breathing only with vent, Bilevel 28/8 PS 20 RR 18 FiO2 45% sat 97%.  WBC 13.4, Ferritin 108, GFR 23, Ddimer 2576, AST 71, ALT 50. 12/31/21:   GFR 18 continues to be minimal nonpurposeful movement to painful stimuli off sedation.  Sputum cx negative.  End of life family meeting decide to make comfort care.  @2020 terminal extubation with rapid decline and expiration.
Initial information received on 14-Nov-2018 regarding an unsolicited valid serious case received from a consumer. This case involves female patient of an unknown age who experienced anaphylactic reaction, throat closing down, tongue swelling, while she received vaccine FLUBLOK QIV. It was reported that, patient had known allergies to: plants, mold, mildew, trees, wheat, barley, oats, rice, corn, and peanuts. Patient had mentioned previous to her FLUBLOK injection she had been getting "mild hives" on her jawline, and couldn't determine what they were from, and was taking a preventative tablet of BENADRYL each day. On 13-Nov-2018, the patient received a dose of suspect FLUBLOK QIV lot QFAA1826 via intramuscular route (dose, expiry date and site of administration were not reported). On an unknown date, patient developed a serious anaphylactic reaction following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant. Patient was then transported by ambulance to the Emergency room around at 23.00. On an unknown date, patient developed a non-serious throat closing down (choking sensation), tongue swelling (swollen tongue) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Other relevant tests included no lab data. Final diagnosis was tongue swelling, throat closing down and anaphylactic reaction. The patient was treated with BENADRYL, Steroids (in Buttock) and EPINEPHRINE for Product used for unknown indication. The outcome of the event was reported as unknown. Sender's Comments: This case concerns a patient of unknown age who presented with anaphylactic reaction after use of FLUBLOK QIV. The time to onset is not known and the events are expected with this vaccine. However, allergic history and tolerance to previous vaccinations are important points to consider in this case, which is missing at present. Based upon the reported information, the role of the vaccine cannot be assessed.
I started having trembling in my right hand a lot. I could not keep my balance and I had fallen a few times. The trembling got worse in the right hand and my left hand is started trebling as well. I was using a cane and now am using a walker but I have fallen seven times since this started. My doctor checked my walking and my balance and did a memory test as well. I have a DaT scan coming up as well. After meeting with my medical team and going over what was occurring it was diagnosed as Parkinson's.
1SEP96 devel rash (bumpy) on back;itching assoc w/rash;tired-appetite suppressed;no apparent fever;mom advised to check w/PHD;5SEP96 to f/u rash remains;no other sx;no PMD contact;
Patient Developed for purpuric, non blanchable rash  on both legs below the knee bilaterally.  24 hours  after vaccine, patient developed muscle aches and headache, no fevers.  rash developed 1-2 days after vaccine.  no abdominal pain,  no diarrhea, no joint pain.  Patient described rash as itchy. Examination of rash in clinic most consistent with vasculitis vs Henoch-Schönlein purpura.
2nd COVID vaccine: 3/31/21; 4/10/21- 4 days before my menses, I started having hives on my neck and face, which subsided 8 days later.  5/8/21 - 4 days before my menses, I started having hives on my neck and face
Information has been received from a consumer concerning her approximately 19 year old daughter with no known drug allergies and a history of infectious meningitis during infancy and epilepsy (seizure-free for eight years) who on 22-APR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). There was no concomitant medication. On approximately 22-APR-2008 the patient fainted after administration of her first dose. On approximately 24-APR-2008, "two days later", the patient experienced "panic attack" followed by two weeks of generalized anxiety. On 08-MAY-2008 patient was recovered. The patient sought unspecified medical attention via telephone. No further information is available.
Sleepiness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepiness) and PYREXIA (Fever) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced SOMNOLENCE (Sleepiness) and PYREXIA (Fever). At the time of the report, SOMNOLENCE (Sleepiness) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 105 (Inconclusive) 105 and 98.9 (Inconclusive) 98.9..         Concomitant product use was not provided by the reporter. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.
Swelling, redness, tenderness around injection site 1 day after injection. Fever, URI treated for presumed cellulitis with Keflex (DTaP given at this site).