chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second dose swelling and redness from from shoulder to elbow and exhaustion for two days after.; Seconddose swelling and redness from shoulder to elbow and exhaustion fortwo days after; Second dose swelling and redness from from shoulder to elbow and exhaustion for twodays after; Sixth and seventh days,exhaustion is back with fever, nausea,and swelling getting bigger; Sixth and seventh days,exhaustion is back with fever, nausea,and swelling getting bigger; This is a spontaneous report from a contactable consumer. This female consumer reported for herself that a 71-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration, in left arm on 27Feb2021 12:00 (at the age of 71-years-old) as 2nd dose, single for covid-19 immunisation and first dose (Batch/Lot Number: EL9269) via an unspecified route of administration, in left arm on 04Feb2021 12:00 as 1st dose, single for covid-19 immunisation. Medical history included diabetes and high blood pressure. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Concomitant medications were not reported. Other medications in two weeks reported. No known allergies reported. The patient did not receive any vaccines within four weeks prior to the vaccination. No reaction with 1st dose. After second dose, the patient experienced swelling and redness from shoulder to elbow and exhaustion for two days after. Third, fourth, and fifth days, exhaustion gone but swelling and redness still there but area getting smaller. Sixth and seventh days, exhaustion is back with fever, nausea and swelling getting bigger. The patient did not receive any treatment for the event. Outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
APPROXIMATLY 45 MIN AFTER VACCINIATION PT REPORTED DIZZINESS AN DPRESENTED WITH HYPERTENSION AND TAHYCARDIA
Pt had swelling and redness 3.5 cm by 3.5 cm around injection site left thigh one day after DTaP dose 4 was administered.
Extreme redness, swelling, hot to touch, itching... treated as Cellulitis with high dose of Clindamycin. This is the second year in a row with severe reaction.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "SLE" (unspecified if ongoing), notes: Other medical history: Yes - SLE; "normocalcemoc hyperparathyroidism" (unspecified if ongoing), notes: normocalcemoc hyperparathyroidism. Concomitant medication(s) included: MYCOPHENOLATE MOFETIL; PREDNISONE; PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]; ESCITALOPRAM; OMEPRAZOLE; METOPROLOL; ESTRADIOL. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin", notes: Known allergies: Yes - amoxicillin; Clarithromycin, reaction(s): "Known allergies:clarithromycin", notes: Known allergies: Yes - clarithromycin; Metronidazole, reaction(s): "Known allergies:metronidazole", notes: Known allergies: Yes-metronidazole; Ibuprofen, reaction(s): "Known allergies: ibuprofen", notes: Known allergies: Yes-ibuprofen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in 2weeks. The patient received Paxlovid for COVID 19 Treatment, Treatment start date was 26Nov2022, Treatment stop date was 30Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 (COMIRNATY) to the reported events Drug ineffective and COVID-19 cannot be ruled out.
This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 22-DEC-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received concerning an 8 year old female with reactive airway disease and seasonal allergies who on 8/7/96 was vaccinated SC with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 10/31/03 in the PM (also reported as in the afternoon), the patient broke out with a rash. It was noted that the patient was exposed 2 weeks prior to breaking out. The patient had a fever of 102 degrees F for 3 to 4 days, and she continued to break out until the rash covered her body, inside her mouth, and the palms of her hands. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations of the patient or her siblings. The outcome was reported as recovered on 11/10/03. No additional information is expected.
feels sick; food won't go down to her throat; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE.), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "feels sick"; OROPHARYNGEAL DISCOMFORT (non-serious), outcome "unknown", described as "food won't go down to her throat". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient complained of bilateral injection site soreness, nausea, vomiting, fever, and headache that lasted for approximately 2 days and began about 6 hours after receiving the vaccine.
Information has been received from a nurse concerning a female who was vaccinated with dose of MMR II (lot# 663099/1639X, 0.5ml, SC) on an unspecified date. The patient experienced a red, hot and swollen area the size of a golf ball on her arm, at the injection site, about 2 weeks after receiving the vaccine. The patient sought medical attention by phone. At the report time the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Initially  pain/swelling/red/hot localized (1/2 baseball). Rash began day 3 (again baseball size), Rash swelling spread from shoulder to 3" above elbow . Currently at 2 week post vaccine, Itchy, red bumpy rash, & swelling unchanged.  No issues with resp, temp, or "covid-like" symptoms
Pt recv vax on 10/22/98; immediately post vax pt exp vax site burning, tingling of LA, aching x 45 min
Extreme Swelling of the Breast and Lymph nodes. Lasted several weeks. Very painful.  After not having my period for almost a year it brought my period on with very painful ovary pain Taste of metal in mouth leading to ulcers. Very tired Nausea Headache
-t2 pm  :one hour post injection: itiching arms torso and thighs -3 pm : 2 hours post injection : red flat rash to arms , torso and thighs  ,  hives to arms and torso , severe headache, scratchy throat, stuffy nose , sore throat , running nose , lethargy and stomach upset, slight dizziness awakened at 3 am with fever and all of the above, headache worse. new onset nose bleed x 3/ blisters inside nares  -48 hours post injection: severe hip joint pains, pain in knees elbows and ankles, all of the above 3 pm day of injection  symptoms  continue .  - joint pain severe for 48 hours and slowly resolved by 7 days post injection
Loss of balance and  musculature in lower limbs, waist down up to 72 hours Right arm where injection was received numb and loss of use for 48 hours Inability to sit up, had to lie prone for 48 hours Knee pain and all joint pain up to 72 hours Incoherent and cognitive obstruction for first 24 hours High fever, chills, shivering, and spasms up to 72 hours Persistent joint and neck pain/stiffness for up to 96 hours Abdominal cramps and pain upto 48 hours Increased sensitivity to sounds for about 96 hours
This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. On 19-NOV-2007 the patient was vaccinated with (Oka/Merck) VARIVAX dose 1, 0.5ml, subcutaneous (lot # was not provided). On 23-SEP-2011 the patient was also vaccinated with (Oka/Merck) VARIVAX dose 2, 0.5 ml subcutaneous (lot # was not reported). Concomitant medications were not reported. In Dec-2012 the patient developed chicken pox after receiving two doses of (Oka/Merck) VARIVAX. The outcome of patient developed chicken pox was reported as recovered/resolved on unknown date. Additional information has been requested.
Shot was administered too high causing arm pain/weakness.  She cannot raise arm or have normal range of motion.
A report has been received from a Health Professional concerning a Child, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced Influenza A which started on 20-Dec-2012. The patient recovered from the event of Influenza A on an unspecified date. The report was considered to be non-serious.
No adverse event; Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022) 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 WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022).    Concomitant product use was not provided by the reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was provided.   This case was linked to MOD-2022-691256 (E2B Linked Report).; Sender's Comments:  MOD-2022-691256:Original Case : MOD-2022-691256
Child had received vaccine and was sitting in monitoring area when he fainted. His father got him.  Child placed on floor and seen by EMS.  He vomited liquid and white pieces of meat. He felt better.  Initial P57 BP 110/84 lying, sitting BP110/78,BP 108/78. Child stood and sat in chair. Stated he felt better.
Pt recvd 1st dose of Engerix-B & exp anxiety, cramps in stomach & difficulty breathing; Reporter indicated that the signs were similar to an anaphylactic rxn; no tx was given;
Felt ill; Low grade fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt ill), PYREXIA (Low grade fever) and CHILLS (Chills) in a 68-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced MALAISE (Felt ill), PYREXIA (Low grade fever) and CHILLS (Chills). At the time of the report, MALAISE (Felt ill), PYREXIA (Low grade fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provider by the reporter.  Treatment information was not provided.    This case was linked to MOD-2021-090192.
11/7 7:00pm- "severe arm stiffness-could not move her arm at all" per patient. 11/7 10:30pm- "severe tremors-needed help up the stairs" per patient. 11/8 12:30am- "drenched in sweat- fever of 100.3" per patient. Morning of 11/8- "called md to report fever- fever had gone down to 100.1- md told patient to take TYLENOL for fever and come to the office if fever persisted or got worse" per patient.
Fever; Weakness; Pain at injection site; Injection site Stiffness; Itching at the injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced fever, weakness, injection site pain, stiffness and injection site itching. On an unknown date, the outcome of the fever, weakness, injection site pain, stiffness and injection site itching were recovered/resolved.   It was unknown if the reporter considered the fever, weakness, injection site pain, stiffness and injection site itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 50 or 51 years. The patient received the first dose of the Shingrix vaccine on a Wednesday. The patient had pain, stiffness and itching at the injection site. He also experienced a fever, and weakness. All symptoms resolved by either the following Saturday or Sunday. The patient would not provide any additional information.
After his vaccination, child started to run a fever.  Vaccination site was red and warm to the touch.  Injection site redness spread past 5 x 4.5 mm circle.  Required ER visit; MD diagnosed cellulitis and prescribed Omnicef.
Chest pains, high blood pressure, high heart rate, shortness of breath, constant headache got sent straight to the ER from work. Now I?m seeing a cardiologist and neurologist.
14APR swelling of entire lt thigh p/DTAP;15APR inc swelling adm  w/ cellulitis; (60day f/u: 4/19, more induration & almost entire leg rosy red, knee swollen, redness travel up into groin & above groin crease.)k.h.
DTP/OPV/HIB given 22JUL91  & on 23JUL91 pt cried inconsolably for 24hr period; Screaming episodes over 48 hrs; F/U had resolved 25JUL91;
After receiving vaccine TD in (R) arm and another vaccine in the same arm c/o (R) side neck pain x 3 days. C/o migraine headache and nausea. Arm red, painful, warm to touch and swollen 1/2" red spots on (L) arm red in color. Went to doctor 10/22/10 red spots increased & c/o blurred vision doctor prescribed MOTRIN 800mg x 3 days. Missed days at work.
Fever, chills...body aches...nerve pains all  after 8 or 830pm monday ...and all day tuesday....
I got the flu; Initial information received on 21-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional (patient).   This case involves patient [age and gender unspecified] who got the flu (influenza), while patient received INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, every time patient taken the flu shot. Patient got the flu.   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Pt vaccinated with DTP/OPV developed screaming beginning 1 hr after vaccination lasted several hrs. Resolved completely by 12 hrs after.
Nausea, vomiting, rash on face, back and shoulders.  Low grade fever and fatigue.  Twin brother also had Tdap given the same day and had similar reaction.
I took my second dose of the phizer vaccine in October because my work required it. I didn't want to get it, but it was out of my hands. I noticed a month or so after, that I started breaking out in hives on my hands and wrists. They hurt and are very itchy, but nothing leaks from these spots. I would also occasionally break out around my neck and inner thighs. Nothing would cause the reaction and I've never had such a thing happen before. I'd wake up with the hives and they'd last for days. They'd eventually go away on their own and come back a day or two later. My feet also started itching, but no hives there. I've been tested for syphilis with negative results and I've been to an allergist. He diagnosed me with a condition basically saying I have persistent urticaria that will eventually go away on its own. He prescribed with with a bunch of meds and creams to help them subside, but they haven't gone away. I'm enraged that a vaccine I was forced to take has caused such a side effect. I've read articles and similar circumstances and I'd like to report it to the FDA so perhaps something better can be done other than just throwing meds at me and saying it will eventually go away. Well it's been a year and my hands are still covered in hives.
Noticed nausea and slight fever upon waking. Vomited at 9:30 and 10:30 am, fever and chills from 8:30am-4:30 pm when this report was completed, still nauseous and vomited at 4:15 pm. Cannot eat or drink anything.
PATIENT WAS GIVEN BOTH DOSES OF COVID-19 PFIZER VACCINE AND TESTED POSITIVE TO COVID ON 8/19/21.
Face had numb feeling; Face tingly feeling; Chills; Slight swollen feeling in upper cheek; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E130) via an unspecified route of administration in the right arm on 04Apr2021 at 13:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 18:30 the patient experienced that her face had a numb feeling in both of her upper cheeks. She could still feel her face but had numb/tingly feeling. Developed chills and numbness when away. The patient took Advil and chills went away but face numbness returned but not as prominent and more scattered. She reported she feels mostly better this morning just slight swollen feeling in upper cheek on right side occasionally but face looks normal. Therapeutic measures were taken as a result of events and included treatment with Advil. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The clinical outcome of the event face had numb feeling, face tingly feeling, chills and slight swollen feeling in upper cheek was recovering at the time of report.   No follow-up attempts are possible. No further information is expected.
expired dose administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2022-449355 (Patient Link).
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 22-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported the vaccines was stored in freezer, we take out to two vials and place in fridge each day as needed.  No treatment information was provided.
My son woke up with red hives all over him, fingers were a little swollen. While changing his diaper I noticed that his bowel movement had a little mucus. Took him to the doctor and doctor said it could've been an allergic reaction to food. So he put my son on the BRAT diet. He did not improve. I took him back because he then had a low grade fever and then there was more red spots (face, butt, private area, neck, ears, hands, feet) and he wasn't acting like his self. It took about 5 days for my son to improve. His doctor quarantined us when I took him back the second time. We were given prednisone and was told to keep him on the BRAT diet.