chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving the injection, my left upper arm was sore for 2-3 days, but nothing else. 8 days after receiving the injection, I noticed my arm was itchy, and then realized there was a 9 x 6 cm area of rash in the area of injection.  Minimally raised.   At this time I noticed I could elicit a wheal and flare reaction easily on other parts of my body (abdomen, leg).  However, for the next several hours there was no noticeable increase in the rash.   I  waited a few hours to see what would happen, and then took a  Benadryl and went to sleep.  The rash was still there in the AM, but fainter and had not spread.
Patient in 5th week of training developed widespread vesicular rash preceded by 10 URI with fever, fatigue and weakness. Rash virtually over entire body including scalp and mouth. Pruritic for the 1st 2 days, in various stages, nausea. 2 days after onset felt better, returned to training on 7/13 with some short term limitations on physical activity. Hospitalized only to achieve isolation. Bacterial and viral cultures neg.
Information has been received from a physician concerning a 17 year old female who was vaccinated with her first 0.5mL dose of Gardasil vaccine. Subsequently, the patient fainted after receiving the vaccination. The nurse caught her so she did not fall. The patient also did not eat before received the vaccination. Subsequently, the patient recovered from fainting. Additional information has been requested.Information has been received from a physician concerning a 17 year old female who on 07-NOV-2007 was vaccinated with her first 0.5ml dose of HPV vaccine in the left deltoid (lot # 658560/162U). Subsequently, the patient stated she saw black and then fainted after receiving the vaccination. The nurese caught her so she did not fall. The patient also did not eat before receiving the vaccination. Subsequently, the patient recovered from fainting and left the office with no problem.
Medication Error, dose given to 14 year old.  Parent & Patient stated pt was 16, review of paperwork post vaccination showed he was 14.
Patients came in describing knee pain (right) 2 days after administration of FLUZONE HD. Pt has hx of knee surgery a year ago. He said after the vaccine his knee felt tight and immovable. Pt's knee pain improved w/o any medication after 4 days.
No adverse event; Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 88-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster).    No concomitant medications were provided. No adverse events were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662391, US-MODERNATX, INC.-MOD-2022-662390, US-MODERNATX, INC.-MOD-2022-662385 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662391:same reporter US-MODERNATX, INC.-MOD-2022-662385:Same reporter US-MODERNATX, INC.-MOD-2022-662390:same reporter
Seizure 1.5 hr. Tactile fever - hospitalized for 3 days.
Booster dose; Enlarged lymph nodes near collar bone on same side as vaccine; noticeable lump and swelling; Slight enlarged neck lymph nodes.; Enlarged lymph nodes near collar bone on same side as vaccine; noticeable lump and swelling; painful and tender to touch; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Oct2021 at 10:15 (at the age of 37-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma and allergies (unspecified). Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any vaccine within four weeks prior to COVID vaccine. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN) and salbutamol sulfate (PROAIR); all from unknown date for unknown indication unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration; both on an unknown date as a single dose for COVID-19 immunisation. On 08Oct2021, the patient experienced enlarged lymph nodes near collar bone on same side as vaccine; noticeable lump and swelling; painful and tender to touch. Slight enlarged neck lymph nodes. Swollen area got smaller and less painful after 2 days and was completely gone in about a week. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events enlarged lymph nodes\ noticeable lump and swelling\ slight enlarged neck lymph nodes and painful and tender to touch was resolved on an unknown date in Oct2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Pain in the arm, whoever gave me the shot recommended me tylenol. However, I still have pain in the arm.
Headache, chills, diaphoresis, fever, myalgias, abdominal pain, fatigue
Chills,  fever, muscle pain, joint pain, headache, general malaise, sensitive to touch- lasted for 36 hours starting late night of injection. Swollen lymph nodes starting about 24-36 hours after injection. Increased normal treatment for chronic conditions including extra saline infusion and rest
Child given shot in R deltoid mom noticed swelling in right deltoid Wed. afternoon mom rubbed alcohol on right shoulder and applied warm compress to area.
Headache; Body aches; Fever; Nausea; Loss of appetite; Chills; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 administered on an unspecified date for COVID-19 immunization. On an unspecified date the patient experienced headache, body aches, fever, nausea, loss of appetite, chills. It was reported that all these are the side effects of the second dose of the vaccine. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Itchy rash on face, abdomen, and upper thigh that resembles shingles; scabbed and resolved in 4 days
C/O overall itchiness and throat irritation & tightness about 20 min after FLUMIST. BP 124/104. Mild inspiratory wheeze. Throat & face red. One have on neck. C/O mild throat tickle 25 mg BENADRYL given PO and improved. After BENADRYL, I did stay with patient for 30 min. Wheezing gone, CTA bilat. Per school RN patient slept after BENADRYL and was picked up by her about 1 1/2 hours later. She was symptom free.
- Immediate discomfort down right arm and into wrist and fingers upon injection. - Injection site/upper arm and shoulder pain within one hour, continued for approximately 3 days. - Extreme pain in muscles and joints within 2 hours of injection, continued for 2-3 days after, periodic recurrence for approximately 5 days thereafter. The pain was far, far worse than anything I experienced when I was infected with COVID-19 in April 2021. - Within one day of receiving the vaccine, I noticed my urine was unusually dark (typically very clear) and it got progressively darker, almost brown by the second day after injection. It has also been cloudy at times and has smelled strange at all times, without relief. The only time it has appeared normal is upon rapid consumption of significant amounts of water. On Friday 8/27/21 I went for a urinalysis labs and drank over 1.5L of water within 20 minutes so that I could take the test. It appeared normal at that time, but by the end of the evening it was again very dark. For the first 1-2 weeks after vaccination I avoided coffee and alcohol for fear of dehydration and have continued to drink a lot of liquids (primarily water, sometimes coconut water). I stopped exercising for the first 1-2 weeks for fear of rhabdomyolysis, but it made no impact. My attempts to hydrate and flush out the cause are futile, as my urine remains unusually and frighteningly dark and smelly.  This has continued for over a month without relief or sign of improvement. - Unusually heavy period 9/2021
leg pain/that her left leg kept giving out on her; back pain; difficulty walking; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (leg pain/that her left leg kept giving out on her), BACK PAIN (back pain) and GAIT DISTURBANCE (difficulty walking) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052D21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, HYDROCHLOROTHIAZIDE and Nexium for an unknown indication.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced PAIN IN EXTREMITY (leg pain/that her left leg kept giving out on her), BACK PAIN (back pain) and GAIT DISTURBANCE (difficulty walking). At the time of the report, PAIN IN EXTREMITY (leg pain/that her left leg kept giving out on her), BACK PAIN (back pain) and GAIT DISTURBANCE (difficulty walking) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment product information was not provided.
(Reported) Fever 100.2 degree F body aches/HA/pain at injection site/fatigue
For 5 days following the vaccine injection severe pain on the whole left side of the body, after that heaviness on the left arm and shoulder,  on January 31 the heaviness on the arm increased, severe headache. On February 01 noticed red bumps on  and around the vaccination site, the night before started pain on armpit that radiates downwards.
first dose of Shingrix on 12/20/2020/Due to personal reasons and COVID, she was not able to get second dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of Shingrix received  on 20th December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: This case was reported by patient. The age at the vaccination was not applicable. She did not have lot number and expiration date available.  Due to personal reasons and COVID, the patient was not able to get second dose of Shingrix within 2-6 months window was far out from the recommended schedule window and if she needs to restart the series. Therefore, the reporter do not have the following information dose, route of administration, date of administration and her date of birth and email address. The patient refused to provide any information about adverse event. The reporter does not want safety to follow-up with herself either. The reporter did not consent to follow-up.
Fever, totally immobile at torso. Had to have rescue squad take to E.R. It was like being paralyzed from neck to waist.
No thanks last time I had it I was sick for 3 weeks; Initial information received regarding an unsolicited valid non-serious case received from a consumer (patient) via social media and was transmitted to Sanofi on 09-Dec-2020.  This case involved a patient of unknown age and gender who was sick for 3 weeks (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported for prophylactic vaccination.  On an unknown date, latency unknown, it was reported patient had it and was sick for 3 weeks (illness).   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for illness.  There will be no information available on the batch number for this case.
Extremely severe & debilitating pain in sides of head & jaw.; Extremely severe & debilitating pain in sides of head & jaw.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8730, Pfizer NTEC), via an unspecified route of administration in left arm on 25Mar2021 at 07:30 (at the age of 62-years-old) as dose 2, single for Covid-19 immunization. The patient medical history included arthritis, rib injury from Aug2020 and dental emergency. The patient had no known allergies. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6202) via an unspecified route of administration in left arm on 04Mar2021 at 12:15 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient stated that, on 25Mar2021 at 22:00 the patient had experienced extremely severe & debilitating pain in sides of head & jaw. Felt like in a vise. Worst pain she had ever experienced in her life, exponentially more pain than labor contractions, dental emergency, & rib fracture. If there had been a way to quickly end my life, she was afraid she would have done it to make the pain stop - that was how severe it was & desperate she was. Had some hydrocodone pain medication leftover from a rib injury last August & after 4 hours of agony & ice packs on head & jaw with no relief she craved and took it. Each minute felt like an hour. Worried hydrocodone will interfere with immune response but had no choice. Had to take one every 6 hours to keep pain at tolerable level and she only had 5 left. Terrified of possibility of boosters. She would not do Pfizer again & do not know if she could switch to J&J after this. The patient did not receive treatment for the adverse events. The clinical outcome for the events was recovering.; Sender's Comments: Based on plausible temporality the causal role of the BNT162B2 vaccine cannot be excluded for the reported events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
aching in lt arm since vax recvd, difficulty using arm; still aches everyday cannot raise arms to reach for things up high; hx of brucitis in rt arm, arthritis & bad back (surgery 3 times);
sore arm; itchy face; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PRURITUS (itchy face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included RISPERIDONE for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and PRURITUS (itchy face). At the time of the report, PAIN IN EXTREMITY (sore arm) and PRURITUS (itchy face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       treatment medication was not provided.
Systemic: Allergic: Itch Generalized-Medium, Additional Details: Generalized/full body itching occured while pt shopping in-store after 15 min observation period (within 40-45 minutes after 2nd moderna dose). no other outlying symptoms occured. pt given 2 doses of benadryl and counseled to take prn (1-2 tab Q6hr) while at home. if worsening symptoms, advised to seek medical help.
I received my first Pfizer booster for COVID-19 on 12/3/2021. On 9/3/2022, I woke up with a cough and congestion. I took an antigen test that day and got a positive result. My symptoms worsened a little on 9/4/2022, because I was much more fatigued, plus I had dizziness. At some point, I developed a fever of about 100 or 101. On 9/5/2022, my symptoms were much worse. I normally try to shower every day, but when I showered that day, I was so dizzy after showering that I couldn't even finish putting my clothes on when I went back to bed afterwards. I checked my blood oxygen level, also, and it was 93-94%. I contacted the on-call staff at my doctor's office to see if I could get a prescription for an antiviral or something to treat the symptoms, but they didn't think my oxygen level was low enough to cause concern. They also felt that if I took an antiviral, the side effects would far outweigh the benefits, so they were hesitant to give me an antiviral. On 9/6/2022, I had a telehealth visit with my doctor, because I had a severe cough at this point and I needed relief, because the cough was keeping me from sleeping. Also, I was afraid that it could turn into bronchitis, as I am prone to get bronchitis. My doctor prescribed me codeine guaifenesin to treat the cough, plus azithromycin, because he thought that putting me on an antibiotic would probably reduce my chances of developing bronchitis. After beginning the medicine, I was able to sleep more. I spent most of the rest of the week in bed because I still had weakness and dizziness. It wasn't until about 9/10/2022 that I began to finally get out of bed and was able to shower with less difficulty. I was able to return to work on 9/12/2022, though I still had residual weakness, fatigue, and shortness of breath. At the time of this writing, I still experience some shortness of breath at occasional, random times. Aside from the occasional shortness of breath, I feel that I have made a full recovery.
Narrative:  85yo male pt with metastatic ADT-resistant protate cancer, CKD, AFib, CAD, COPD, HTN, history of EtOH abuse, Hx of colon cancer died at Hospice on 12/15/21 of cancer. Pt had received covid vaccines on 1/29/21, 2/26/21, 12/3/21. This death is not related to vaccines.
Client states that on 10/16/13, she felt swelling on the left side of her neck, in front of left clavicle.  There was tenderness at site when palpated and her upper left arm was sore.  No redness at site and no fever noted.  Client stated it "felt like a swollen gland".  Client mentioned to her primary care physician at routinely scheduled visit on 10/17/13 and physician told client it appeared to be a swollen gland.  No treatment indicated.  Swelling and tenderness gone within one week.
I feel lousy; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (I feel lousy) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     It was unknown whether the patient had any relevant medical history/conditions, allergy, concomitant diseases and risk factor. It was unknown whether the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine or not.     On 18-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I feel lousy). At the time of the report, FEELING ABNORMAL (I feel lousy) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The dosage text was reported as unknown. It was reported that the patient received the new Moderna vaccine 18 hours ago and was feeling lousy. This had happened before, normal reaction when the patient got a vaccine. No treatment medication was reported.   Reporter did not allow further contact
Information has been received from a patient who was vaccinated with a dose of ZOSTAVAX (Merck). On 20-MAY-2008, the patient experienced rashes on left thigh and leg, as well as buttocks. The patient was in extreme pain because the rashes developed into welts and yellow blistering occurred as well. The patient went to a dermatologist and a neurologist, both of whom confirmed the fact that it was shingles and prescribed oral medication, pain killers and powders to use for soaking the areas. At the time of this report the outcome was unspecified. Follow up information was received which reported that on 30-MAY-2007 the patient was vaccinated with a dose of ZOSTAVAX (Merck). Additional information has been requested.  This is in follow-up to report (s) previously submitted on 9/24/2008. Follow-up information was received from the physician's office which reported that they "had no patient with any adverse reaction to ZOSTAVAX." There was no additional information. Additional information is not expected.