chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The 2nd dose of the Pfizer vaccine was given earlier than the recommended 21-day interval. Dose 1 was given on 5/24/21 and dose 2 on 6/9/21.
Cold sweats; Body aches; Dehydrated; Sore arm; Headache; This is a spontaneous report from a contactable pharmacist. A 26-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route on an unspecified date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient woke up in middle of the night after receiving vaccine the previous day (as reported) with cold sweats, body aches, headache all morning, sore arm and dehydrated. The adverse events were starting to subside then. The clinical outcome of the event cold sweats, body aches, headache, sore arm and dehydrated was recovering at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Raynaud's attack in finger about 5 minutes after injection; Raynaud's attack in finger about 5 minutes after injection; This is a spontaneous report from a contactable consumer, the patient. A 63-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), dose 1 via an unspecified route of administration, administered in arm left on 12Mar2021 12:15 as dose 1, single (at the age of 63-yaers-old) for covid-19 immunisation. Medical history included rheumatoid arthritis, raynaud's disease, autoimmune dysfunction and bee allergy. It was unknown if patient had covid prior to vaccination. Concomitant medications included levothyroxine sodium and cyclobenzaprine. The patient did not receive any other vaccine in four weeks. On 12Mar2021 at 12:15, the patient experienced raynaud's attack in finger about 5 minutes after injection. The patient did not visit the emergency room and physician office. Patient did not receive treatment for adverse event. The patient did not test for covid post vaccination. The outcome of the event was recovered in Mar2021.  No follow-up attempts were possible; information about lot/batch number could not been obtained
Information has been received from a lawyer regarding a case in litigation concerning an approximately 83 year old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2006, at approximately 72 years of age, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician. On an unknown date in 2017, the patient was treated by the physician for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to herself and economic losses. Additional information has been requested.
Onset of fever (38.4 degree C) and tinnitus on the right ear 13 hours following the second vaccination.  The fever broke after 23 hours from the onset but the tinnitus persists up to date.
Initial misuse report received from a healthcare professional on 23 July 2013. A 30-year-old patient (no other information was provided regarding the patient) had received DAPTACEL vaccine instead of ADACEL. No adverse event was reported. Documents held by sender: None.
This spontaneous report as received on 12-JUL-2017 from a licensed practical nurse (LPN) refers to a male patient of unknown age. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The female LPN reported that the patient was administered a dose of VARIVAX (Dose, route of administration, site of administration, Lot number and expiration date were not reported) for prophylaxis on 01-MAY-2006. The female LPN reported that the patient was administered a dose of M-M-R II (Dose, route of administration, site of administration, Lot number and expiration date were not reported) for prophylaxis on 23-MAY-2006 and 29-JUL-2010. No adverse effects reported.  No further details provided. The outcome of the event of product use issue was unknown. Additional information is not expected as there was no consent for follow-up.
ringing in the ears, nausea, numbness in extremities BP: 124/62 HR: 70 Sp02: 98% Seen and cleared by EMS
Third dose was inadvertently given. Nursing facility reported needing to start the series unaware of his doses he had already received. Failure by us to check vaccination records prior to giving the injection. Have instructed our team to look up each patient prior to giving doses.
Vaccinated with pfizer in 02/2021. Has only cough. No fever.
Reporter indicated that currently about 50% of pt who completed series tested as nonresponders or inadequate response;
Fever (99 to 100°F); Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever (99 to 100°F)) and HEADACHE (Headache) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VENLAFAXINE for an unknown indication.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced PYREXIA (Fever (99 to 100°F)) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever (99 to 100°F)) and HEADACHE (Headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
tiredness; muscle and joint aches; muscle and joint aches; chills; swollen underarm lymph node; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:15 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation. Other medical history was none. Concomitant medication(s) included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported; biotin (BIOTIN) taken for an unspecified indication, start and stop date were not reported. Other medications in two weeks also included oral birth control. The patient had no other vaccine in four weeks. No covid prior vaccination and not tested covid post vaccination. The patient had no known allergies. The patient previously received first dose of BNT162B2 (COMIRNATY, Batch/Lot number EL3247), in Arm Left on 22Jan2021 14:15 as single dose for COVID-19 immunization. Since 13Feb2021 10:00 AM, the patient experienced tiredness, muscle and joint aches, chills, swollen underarm lymph node. The patient did not receive any treatment for AE. Outcome of the events was recovering.
A patient came back with negative tier on just the Mumps; This spontaneous report was received from a nurse and refers to a 44-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced came back with negative tier on just the Mumps (Mumps antibody test negative). At the time of reporting, the outcome of the event was not known.   The causal relationship between the event and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
vaccine created a local breakout of atopic dermatitis right thigh For Atopic dermatitis  Use cream once or twice a day   Can use other emmollient creams
Large injection site reaction- redness, swelling, itching about 5-6 inches in diameter.  Reaction has persisted and worsened over 3 weeks since injection.
large raised bump on injection site; injection site itchy; injection site red.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8730), via an unspecified route of administration in the left arm on 23Mar2021 at 09:00 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN) and valsartan (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 30Mar2021 (also reported as 8 days after vaccination), the patient experienced large raised bump on injection site, itching and redness. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events large raised bump on injection site, itchy and redness were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Chills- Started Saturday continued until Tuesday Feeling weak-Started Saturday ,still feel very tired Feeling "out of it"- Saturday until Tuesday (feel a little more with it Tuesday) Soreness and redness at injection site- Sunday, continuing on Tuesday Diarrhea and abdominal cramping- Began Sunday evening, continuing on Tuesday
initially pain, redness, swelling-sl dec followed by inc swelling, pain ( wks post) seen 28NOV rx Keflex-inc swelling, pain-referred to dermatologist-rx Cipro x 1 wk; 25DEC pain, red lump @ site tx 2JAN95 I&D abscess, Cipro x 1 wk;
Booster 10/31/2021 Moderna, breakthrough case of Covid-19. Started feeling unwell on 01/20/2022. Positive COVID-19 PCR on 01/21/2022. COVID acute sickness for about 10 days, feeling flu like symptoms, low energy, fever, loss of smell and taste, runny nose, sore throat and cough. While over the acute illness as of 02/23/2022, but still having symptoms. After a month later fatigue, bad headaches, and brain fog that impacted ability to work more than a couple of  hours per day.
Slight headache, sore arm at injection site, stiff neck. & chills  (same as first 2 shots)
swelling/soreness of left axillary lymph nodes, starting 2 weeks after 1st dose.  Subsided within a few days. Reoccurred starting 3 days after the 2nd dose. Subsided after almost 2 weeks.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 26-DEC-2015 at 18:11, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 7.4 and 6.5 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports from the same reporter. Additional information has been requested.
The pt began crying around 2 am, which developed into a high pitched scream and squirming around constantly. She had one incident of vomiting around 04:30 AM and a few incidents of diarrhea. He fever ran around 102F until 13:00 PM on the 18th. Her screaming continued off and on throughout the next day. The doctor ordered Motrin and Benadryl.
Body rash occurred after  COVID-19 Booster. rash on torso & back. occurred    8 days after vaccine
Severe Weight loss, Dizziness, Blurred vision, Loss of appetite, Shakiness and no balance, Joint pain. Blood clot.
Antibody test negative. Information has been received from a physician concerning a 38 year old airman with no allergies and no pertinent medical history, who in February 2000, was vaccinated with a first dose hepatitis A virus vaccine inactivated (646789/0753N) and according to patient's chart shows that possibly, he was administered a 0.5ml dose of hepatitis A virus vaccine inactivated. In July 2004 he was vaccinated with a second dose (1.0ml) of hepatitis A virus vaccine inactivated. There was no concomitant medication. On 02-SEP-2005 a titer was non-reactive. The physician reported that he is unsure whether the first dose was incorrect or was charted incorrectly. It was noted therapy stopped after the July 2004 dose and the patient's outcome is not recovered. There was no product quality complaint reported. The patient sought unspecified medical attention. Additional information has been requested.
Swollen lymph nodes in neck and above right clavicle resulting in waxing and waning discomfort on same side of body as injection, first noticed 12 days after injection. Time course is ongoing, reported 2 days after symptoms noted.  PCP notified.
Subject is nearly a 6 year old female child who received FluMist through our school-based influenza vaccination program on October 17, 2008. On November 10, 2008 she was seen at the clinic for a 2 day history of fever, rhinorrhea, sore throat and cough. PE was notable for slight erythematous throat without exudates. Chest was clear to auscultation and she was assessed to have an intercurrent viral illness. She was seen in the emergency room on November 11, 2008 for progressive symptoms which now included conjunctivitis, left sided pain, headache, nonbloody and nonbilious emesis, inability to eat without throwing up and decrease urination. PE was remarkable for ill appearing child with moderate dehydration. Her vital signs were Temp 104.3, BP 104/65 Pulse 146 with an oxygen saturation of 92%. Her oral mucosa was dry, chest was clear to auscultation, abdomen was soft and nontendor. Chest X ray revealed a left lower lobe infiltrate. The child had fluid resuscitation and was started on rocephin 75 mg/kg once per day, and was admitted to the hospital. Lab test: Strep screen was reported negative, WBC: 12,000 with 90% PMNs; and urine analysis was unremarkable except for ketones. Blood culture was obtained prior to starting rocephin and it remained sterile. Repeat CXR on Nov 12, 2008 was consistent with a left pleural collection which increased compared to Nov 11 study, a dense LLL consolidation and a small focus in the lingual (left lung). Patient gradually improved and was discharged on November 14, 2008 on omnicef (14 mg/kg twice a day for 10 days). She was seen for a follow-up visit on December 5, 2008. She had done well since discharge except for a slight cough that was resolving. Final diagnosis: Community acquired pneumonia and dehydration. Past Medical History: none. Medication: none. School: kindergarten. Smoke exposure: none. Influenza vaccine: FluMist. Date of Vaccination: 17 Oct 2008. Date of SAE:  November 11, 2008. SAE: Event was serious and not related to FluMist (This SAE was reported to the agency).  12/19/08 Reviewed hospital medical records of 11/11-11/14/2008. FINAL DX: LLL pneumonia Records reveal patient experienced HA, fever, cough, emesis.  Had rhinorrhea, watery eyes, fever, decreased activity, reduced oral intake approx 3-4 days prior to admit & diarrhea x 1 day, left rib/flank pain x 2 days.  Seen by PCP where strep tests neg & dx w/viral illness.  Did not improve, cough worsened & admitted.  Diarrhea & fever continued in hospital.  Gradually improved on antibiotics & d/c to home on continued antibiotics.
arms are sore; fever of 100.3/back down to 101.4/103.2; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (arms are sore) and PYREXIA (fever of 100.3/back down to 101.4/103.2) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 14B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2022, the patient experienced PYREXIA (fever of 100.3/back down to 101.4/103.2). On an unknown date, the patient experienced PAIN IN EXTREMITY (arms are sore). At the time of the report, PAIN IN EXTREMITY (arms are sore) and PYREXIA (fever of 100.3/back down to 101.4/103.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jun-2022, Body temperature: 100.3 degree (High) Body temperature is  100.3 degree.         Concomitant mediations were not reported Treatment information was not reported   This case was linked to MOD-2022-592100.   Reporter did not allow further contact
Client complains that right side of face and tongue are numb He states that his right eye will not close and that the right side of his face does not move normally. He also reports that his left arm got the shots is numb. He says this numbness moved up into his neck. The fingers in his left hand, he states, feel swollen. All symptoms started reportedly 11/14/09. Client's aunt states that at MD visit later today (11/16/09), the doctor did not know if the symptoms had to do with immunizations. The doctor treated client with an injection of diphenhydramine in the office, and sent him home with a prescription to take diphenhydramine orally that night. Client's aunt reports that his symptoms did ease since the injection. 11/19/09 client's aunt reports that client went to MD again today as "his lip dropped even more today." She states that MD is doing tests and will call them back with results. When asked how client's arm and neck were she reported that those symptoms were gone. Aunt called me back at 1:20 pm today and reported that MD diagnosed him with Bell's Palsy and wrote a prescription for a steroid for 7 days.  11/20 and 11/23/09 Medical records received for DOS 11/16- 11/19 Final DX: Angioedema. Bell's Palsy Presets w/facial swelling unilat, cannot shut eyes, facial burning. RTC w/sweats shaky. R Facial paralysis.   ICD9 Code: 996.1
twenty minutes after injection I  got dizzy for about three to five minutes two hours later I had difficulty breathing as an asthma issue not short of breath treated with homeopathic phosphorus 30C  Friday night and Saturday  and it was resolved by Saturday evening three hours after injection abdominal pain,  no treatment no dietary change,s still ongoing  Sunday. although less severe
This case was received from a health professional on 17 January 2008. A 58-year-old female patient received an injection of FLUZONE (lot number U2444AA) on 12 December 2007. The patient had a history of allergies to egg, penicillin, pollen, and  other food. On 16 December 2007, four days after vaccination, the patient developed constant muscle aches, which she described as being worst in her arms and legs. She also complained of extreme fatigue. She was treated with prednisone, with little effect, and was later seen in the emergency department. Laboratory work-up, including CBC and ESR, were performed in the emergency department, but results were not provided. She was seen by an ENT (ear, nose and throat specialist) and diagnosed with a sinus infection. On 17 January 2008, she underwent protein electrophoresis testing, the results of which were not provided. At the time of the report, the events had not resolved. Per the reporter, the patient had experienced a "similar event following last flu vaccine". Concomitant medication included PROZAC, Avista, Vitamins, Calcium, and monthly flu shots. In addition to allergy history, the patient also had a medical history of osteoporosis.
Extremely itchy; hives, bad rash all over body; Skin and subcutaneous tissue disorders; Bad Rashes; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Extremely itchy), URTICARIA (hives, bad rash all over body), CONTUSION (Skin and subcutaneous tissue disorders) and RASH (Bad Rashes) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced PRURITUS (Extremely itchy), URTICARIA (hives, bad rash all over body), CONTUSION (Skin and subcutaneous tissue disorders) and RASH (Bad Rashes). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 22-May-2021 to 26-May-2021 for Allergy, at a dose of 10 milligram once a day. On 27-May-2021, PRURITUS (Extremely itchy), URTICARIA (hives, bad rash all over body) and RASH (Bad Rashes) had resolved and CONTUSION (Skin and subcutaneous tissue disorders) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After a week of taking the first shot of the Moderna vaccine, patient got hives, bad rashes all over my body which included the chest area, arms, underarms, hips, and the thighs, it was extremely itchy. The patient took one tablet of Zyrtec for Allergy with Cetirizine HCl 10mg/tab per day, 5 days from May 22 to May 26, and the symptom is mostly gone on May 27 but left some large bruises on my hips.  No concomitant medication was provided by the reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received 2 immunizations (HAV/Tdap); after getting both patient became quiet and started leaning out of his chair. Nurse attempted to catch patient, and slow his fall to the floor. Patient quickly regained consciousness and sat up, nurse assisted him to recliner to lie down. Patient stated he had "passed out" before, when giving blood. VS B/P118/60, P86, R16. Patient drank a Gatorade and waited 30 minutes before leaving. Stated he felt fine. Patient seen by physician immediately after incident.