chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; Headache; muscle spasms; extreme weakness; body aches; fever; sinus congestion; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 09:45 at single dose for covid-19 immunisation. Medical history included hypertension (HTN), high cholesterol. Concomitant medication included lisinopril, levocetirizine dihydrochloride (EURO ZYSOL), ezetimibe (ZETIA) and stool softner. No other vaccines within 4 weeks prior to the COVID vaccine. No diagnosed with COVID-19 prior to vaccination. The patient experienced woke up with chills, headache, muscle spasms, extreme weakness, for 24 hours continued with body aches, fever, sinus congestion. Still have sinus congestion, all other symptoms ended in 24 hours from onset. Events onset date reported as 09Jan2021 01:00. No treatment received for the events. Outcome of events was recovered with sequelae. Since the vaccination the patient has not been tested for COVID-19.   Information on the lot/batch number has been requested.
Redness, swelling of the left arm to slightly below the elbow, Tx: with Vioxx and Atarax
This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021) in a 97-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were not reported. No treatment medications were not provided.
Initial information received on 27-Jun-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA177770, 2018SA177771 and 2018SA177772. This case involves a 36-years old patient (gender not reported) who experienced redness, swelling and lump at injection site, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that the patient did not receive any other vaccine on the date of administration. On 19-Jun-2018, the patient received a dose of ADACEL (lot C5541AA, expiry date: 13-Nov-2020) via intramuscular route in the deltoid NOS. On an unknown date, the patient developed a non-serious redness, swelling and lump at injection site, following the administration of ADACEL. Relevant tests were not reported. Final diagnosis was lump at injection site and redness, swelling at injection site. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. List of documents held by sender: none.
Information has been received from a healthcare worker concerning unspecified number of patients of unknown age and gender. On unknown dates the patient received GARDASIL (lot#, expiration date, dose and route not reported), after being improperly stored for one month. No adverse effects were reported. Follow up information has been received from the medical assistant on 16-MAR-2015. On unknown date the patients received GARDASIL (lot# J006236, expiration date:25-FEB-2016), which was improperly stored. No adverse events following administration of the vaccinations. It was reported that the reporter does not have patient identification information readily available at the time of the call. This is one of several reports received from the same reporter. Additional information has been requested.
patient was coming in for his second dose of COVID-19 and instead of receiving the 12 and older vaccine, he received the pediatric dose for the 5-11 year olds
Client presents for Flu vaccine per her Employer. Client states she has a severe egg allergy. Components of Flucelvax printed and reviewed by Client and her mother, education provided. Client states that she has until the 15th to receive her flu vaccine, otherwise she will face corrective action by her employer. Client states her employer refused her medical exemption. Client reviewed and signed HIPAA and Vaccine Consent. Client was insistent to receive Flu vaccine. Flu vaccine administered at 9:39. Client complained of throat warmth at 9:44. Client complained of throat tightness at 9:51. EMS contacted at 9:52. Benadryl 1mg IM administered at 09:56. Client able to speak in full sentences and did not complain of SOB. Minimal emesis by client. Client remained alert and oriented, in an upright position. EMS arrived shortly after and began assessment/symptomatic treatment. Client independently got onto gurney and was transported.  Spoke with Nurse Hotline a few times during appointment.
Information has been received from a physician concerning a 75 year old female who was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient developed a rash resembling chicken pox on one arm and diffused over other parts of her body, which was not unilateral like zoster.  The physician did not see the patient and only spoke to her on the phone.  She was prescribed an anti-viral and within two weeks the vesicles were gone. Additional information has been requested.
Feeling Odd; Bowel Changes; Lightheadedness, dizziness; trouble sleeping; Extreme Chills; Fatigue; some soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling Odd), ABDOMINAL DISCOMFORT (Bowel Changes), DIZZINESS (Lightheadedness, dizziness), INSOMNIA (trouble sleeping) and CHILLS (Extreme Chills) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), VITAMIN D3, MULTIVITAMIN [VITAMINS NOS] and FLUOROURACIL for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling Odd), ABDOMINAL DISCOMFORT (Bowel Changes), DIZZINESS (Lightheadedness, dizziness), INSOMNIA (trouble sleeping), CHILLS (Extreme Chills), FATIGUE (Fatigue) and VACCINATION SITE PAIN (some soreness at the injection site). At the time of the report, FEELING ABNORMAL (Feeling Odd), ABDOMINAL DISCOMFORT (Bowel Changes), DIZZINESS (Lightheadedness, dizziness), INSOMNIA (trouble sleeping), CHILLS (Extreme Chills), FATIGUE (Fatigue) and VACCINATION SITE PAIN (some soreness at the injection site) had not resolved.            Treatment information was not reported.
More than a week after my vaccine the arm near the injection site started getting sore and my body was achy. The next morning I woke up with it swollen, red, warm to the touch, huge knot covering most of my upper arm. I was also nauseous and a little bit of body aches.  Later that day the area that was red also began getting hives. I massaged it, applied a warm compress, and took Benadryl. The next day it was still sore but the redness wasn?t as bad or the arm wasn?t as swollen.  Later that night the redness and warm to the touch was completely gone .
Around June 14 2021, I experienced tingling/numbness in my neck, head, the two fingers in my left hand, and left foot. It would start in the evenings and at various times. I would get a lot of pressure in my head and then when that went away, the rest of the symptoms would disappear shortly. But I tend to experience these symptoms sporadically and at different times of the day. I've also been dealing with unusual, but noticeable head bopping and shaking for a couple of months.  I will be seeing a neurologist in October 2021 for a follow-up.
Fever 102.8 ax on day 3, large local reaction-12cm x 14cm erythema induration on Day 1.
Patient c/o sl swelling rt upper eyelid without uticaria. No pain, no trauma, no discharge, PERLA, cornea sclera clear.  No respiratory distress, VSS WNL.  Tx - Diphenhydramine 25mg cap - take one tablet TID.
local reaction in leg (mom unsure which leg) p/vax of 25JUn93-t104-105 starting that day in afternoon; then w/in 24 hrs temp dec gradually for couple of days & edema of leg;
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium
Redness at injection site. Rash about the face with swelling when Pt returned the following day. Gave pt some Benadryl and advised her to contact her physician.
At unspecified time, the patient received her first two injections with Lymerix for prophylaxis, with no untoward effects.  On 04/01/00, she received the third dose  and the next day experienced a bull's eye red mark the size of a softball and arm swelling on her injected arm. Approximately two days after the injection, she experienced joint pain in her knees and ankles so bad she could not walk. Three days afterward, she had back pain. No treatment given, the information received on 04/06/00 reported the arm swelling went down and the joint pain continued but was improved.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 31-AUG-2015, the patient was vaccinated with an expired dose of PROQUAD (Merck) lot # reported as K02996, expiration date 27-AUG-2015 (strength, dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
8 days straight now of nausea, muscle ache, extreme fatigue, stomach ache, chills, hot from inside out, nasal congestion  taking Flonase
Patient not experiencing additional symptoms.; patients received unspecified dose in ROTATEQ immunization series that was improperly stored; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 05-NOV-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot # R017955, expiry date 05-MAY-2020) (exact dose was not reported) for prophylaxis. Storage temperature was 10.57 Celsius degrees (C) during the time frame of 15 minutes. Previous temperature excursions were: 9.94 C for 15 minutes, 10.1 C for 15 minutes and 13.29 C for 45 minutes. The digital data logger was involved. The patient did not experience additional symptoms. The outcome of product storage error and no adverse event was unknown.
8/08-High fever-102, chills, body aches, mild headache. Soreness in arm. Symptoms lasted 48hrs, although fever lowered to 100 on 2nd day.11/08-palpitations, hypertension(hyperthyroid sx), found to have subacute lymphocytic thyroiditis 3/26/09.
This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), non-Hodgkin's lymphoma (serious criteria GSK medically significant), shingles, neoplasm, unable to walk and shingles. The patient was treated with chemotherapy, NOS. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the non-Hodgkin's lymphoma, neoplasm and unable to walk were not recovered/not resolved and the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure, non-Hodgkin's lymphoma, shingles, neoplasm and unable to walk to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the friend of the patient. The age at the vaccination was not reported, however patient could be either 63 or 64 years old. The reporter reported that the patient developed shingles after getting the 1st dose of SHINGRIX. The patient developed second case of shingles after getting the 2nd dose of SHINGRIX. The reporter stated that sometime after receiving the 2nd dose of SHINGRIX, the patient could not walk and went to see a physician and the physician found a tumor wrapped around his spine. The patient was diagnosed with non-Hodgkin's lymphoma. The emergency room visit was required. The patient was currently undergoing chemotherapy to shrink the tumor and the reporter stated that the prognosis did not look good for the patient. The reporter stated that the patient had been in a rehab facility and was receiving physical therapy. The reporter did not have any additional details regarding this event. This case was considered as suspected vaccination failure as a primary vaccination schedule, TTO (time to onset) of event and laboratory confirmation test were not reported.
The Covid vaccine was Pfizer-BioNTech (would not let me choose it from drop down) The patient did not have an allergic reaction. The patient was given a single dose from an expired Lot. The Lot expired 1/27/23 and was given today, 1/30/23. Our pharmacist at the hospital advised our office to file a report.
Pt. got pneumonia vaccine RA, IM, lot #15414 on 10-6-08. Pt stated and showed nurse on 10-8-08 where shot was given. Pt. stated it was given too high. Went to private Dr, 10-7-08. Dr. gave him Hydrocodone for pain. Nurse gave him DEPO-MEDROL, 40 mg, LD, IM. Advise to use heat packs, rest x 2 days, then start gradual ROM exercises.
Patchy Ulcers on the Tongue after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TONGUE ULCERATION (Patchy Ulcers on the Tongue after vaccination) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TONGUE ULCERATION (Patchy Ulcers on the Tongue after vaccination). At the time of the report, TONGUE ULCERATION (Patchy Ulcers on the Tongue after vaccination) 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 medications were mentioned. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Non-Significant Follow-up
Start w/ Joint pain, pain at injection site.  Developed flu like symptoms, fever, cough, body ache, Mid grade headache. 8 days later, swollen R upper arm, at injection site, proximal and distal  and anterior/ posterior about 3"-5"   about 3/4th around upper arm.,redness, hot to touch, itchy.  Inflamed R side lymph nodes along clavical, and cervical and axillary (arm pit)
Severe burning, aching pain in entire shoulder area 30 minutes following injection given high in left shoulder at 5:00pm 10/13/03. Took acetamenaphen with codeine at 6:00pm, with very little relief. By midnight, slightly improved but extremely sore in shoulder area, unable to lift arm. After approximately 54 hours, severe relapse with constant burning, aching pain in entire shoulder joint area and stiff neck. Two days post-injection, cannot lift injection site arm. However, no visable inflamation or swelling present. Mild to moderate general body aches and headache starting 18 hours post-injection and continuing to present time (72 hours post-injection).
She had the shot in the afternoon at about 4 pm. It was Halloween. She was fine for trick or treating, home by 8pm and in bed by her normal 9:45 or so, but the fatigue she experienced for the Wed, 11/1 and Thur, 11/2, was like I had never seen in her since she was a sick as a small child. She was so tired, she slept on the floor in the bathroom at school for 45 minutes. She slept during class (this is extremely uncharacteristic of her). She slept whenever she had the slightest opportunity. I didn't think much of it at the time meaning that I wasn't worried about her, figuring that she was tired from having had the shot. I had the vaccine on 11/11/17, and then I was far more empathetic to her experience. The exhaustion and fatigue made it so napping was not something you just consider, there was no choice in the matter.
severe headache; body aches; Mild pain at the injection site; This is a spontaneous report from a contactable other healthcare professional via Pfizer Sales Representative. A female patient of an unspecified age received BNT162B2(COMIRNATY, Solution of injection, Batch/Lot Number: was not reported) via an unspecified route of administration on an unspecified date as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe headache, body aches, mild pain at the injection site on an unspecified date. She experienced a severe headache that lasted 1 week. She also had bad body aches that lasted for about 3 days. Mild pain at the injection site. Outcome of the event was unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Pt recvd vax approx 9AM 1200hr fever?, hypotonia, diarrhea & vomiting; 2200hr ER hosp t105 above sx;
Bumpy rash developed 4/20 on arm. Sunburn like redness on arms and legs 4/20-present and then right armpit pain 4/24. On 4/25 the day was normal and then a sudden bought of vertigo like dizziness happened. Nausea and vomiting occurred. I called the dr and they didn?t have much treatment except drinking fluids and resting. The entire rest of the day I couldn?t get up, lift my head, or roll over in bed without getting sick.  I researched and found vitamin c and d would help along with ibuprofen as it appeared for some as an adverse response by immune system causing inflammation in the inner ear.
This spontaneous report was received from a pharmacist regarding a 23-year-old patient of unknown gender. Information on pertinent medical history, drug allergies and concomitant medications were not reported. On 06-OCT-2017, the patient received the first dose of GARDASIL 9 intramuscularly for prophylaxis. The pharmacist reported that on 30-MAR-2018, the same patient returned to pharmacy to receive the 2nd dose of GARDASIL 9 lot# N019104 with expiry date of 03-FEB-2020 for prophylaxis. No adverse effect was reported. No product quality complaint was reported.
Very red, nontender area. Warm to touch with inflammation of (L) upper arm from shoulder to elbow on outer aspect. Instructed with Benadryl/Tylenol.
Swollen lymph node in left armpit/same side as injection. Additional symptoms include fatigue, joint pain, overall aching.
pt recv vax 9AUG95 & 27JUn97 pt mom reported to MD office that child broke out w/chickenpox 26JUN97;child not seen by office & later recovered;
Fever to 101.2.  deltoid muscle swollen, hot to touch and painful.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient received BNT162b2 (BNT162B2), on 05Jul2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 66 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1st, Date: 26Apr2021, Anatomical site of injection: (withheld), Route of administration: Intramuscular, Batch/Lot number: Pfizer EN5318), administration date: 26Apr2021, when the patient was 64-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose: 2nd, Date/ Time: 12May2021, Anatomical site of injection: (withheld), Route of administration: Intramuscular, Batch/Lot number: ER8735), administration date: 12May2021, when the patient was 64-year-old, for COVID-19 Immunization, reaction(s): "COVID-19", "Dose 1: 26Apr2021/Dose 2: 12May2021"; BNT162b2 (Dose: 3rd (Booster), Date/ Time: 13Dec2021, Anatomical site of injection: (withheld), Route of administration: Intramuscular, Batch/Lot number: FJ8762), administration date: 13Dec2021, when the patient was 65-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2022, outcome "unknown", described as "lymph node swelling". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Additional information: Patient age at time of vaccination: 65, then 66 years. Patient had no prior reaction. Patient was later told this was reductant due to actual immunity. Develops Safeway should tall. This staff who was informed of my prior covid reaction to this booster. Lymph node swilling. Specific relevant test for thromboembolic events with thrombocytopenia is None. Comments/ Narrative: Following (positive) covid test, was given Paxlovid. No positive effect- I worsened later that it is for serious case, but mine was not: no fever, no breathing difficulty. No patient dude with doctor with list in hand-told to take the sheets of paper and go home and read them. (After administration of Paxlovid). Probably not Paxlovid had no positive effect. I found the drug to be hassle on my body. (I normally was natural healing and health maintain products). At the end of Paxlovid I returned to the same urgent call and pay temp. and respiration were tested both not serious (Although I felt worse than before when diagnosed) and was told to go to home and rest, was given nothing. I self-started zinc for immune with occasional supplement of olive leave immune. I was unsure about zinc and olive leaf did not wish further complications. To date (11Aug2022). I continue the zinc to finish the bottle and will return to my natural method afterwards. My covid brain frog coded fully 01Aug2022 (7Weeks) and fall energy returned 11Aug2022 for normal activity. Please excuse the dirty condition of this envelope and interior sheets, it came to me this way. No follow-up attempts are possible. No further information is expected.