chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm became extremely swollen; Arm hot to the touch; Exactly one week after I received the vaccine, I started to feel sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 12:00 as dose 1, single (Lot number: HH7595) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "breast cancer" (unspecified if ongoing); "melanoma" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. Past drug history included: Taxotere, reaction(s): "Known allergies: Taxotere". Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, All others have been Moderna.), for COVID-19 immunisation. The following information was reported: FEELING HOT (non-serious) with onset 05Oct2023 at 16:00, outcome "not recovered", described as "Arm hot to the touch"; PERIPHERAL SWELLING (non-serious) with onset 05Oct2023 at 16:00, outcome "not recovered", described as "arm became extremely swollen"; ILLNESS (non-serious) with onset Oct2023, 1 week after the suspect product(s) administration, outcome "not recovered", described as "Exactly one week after I received the vaccine, I started to feel sick". The events "arm became extremely swollen", "arm hot to the touch" and "exactly one week after i received the vaccine, i started to feel sick" required emergency room visit. Therapeutic measures were not taken as a result of peripheral swelling, feeling hot, illness.  Additional information: Patient arm became extremely swollen, and hot to the touch and patient felt sick for several days. Exactly one week after patient received the vaccine, Patient started to feel sick. Patient went to urgent care and was still ill. This was patients first Pfizer vaccine and all others have been Moderna.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300329590 same patient, drug and different events;
1st dose on 28Dec2021, 2nd not received/2nd dose not administered due to supply shortage; This case was reported by a pharmacist via call center representative and described the occurrence of product supply issue in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 28th December 2021 with batch number 5D753 and expiry date 23rd April 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.   Additional Information: GSK receipt date: 10-Jan-2023 Reporter's comment: The pharmacist called in to report that a patient received the first dose of Shingrix but unfortunately, the second dose was not administered due to a shortage in the supply. Information about the vaccine and patient was relayed. The vaccine administration facility was the same as the primary reporter. The call was transferred to second line. The reporter consented to follow-up. Additional supportive information: The details were reported for the first dose.
102 temperature started around 11pm on the 17th. Fever went back to normal evening time on the 18th- treated with ibuprofen. Body aches started same time as fever and lasted until the 19th- treated with ibuprofen. Severe fatigue started the night of the 17th  and has lasted until the 20th. Severe headaches started the night of the 19th.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: pt was feeling a little dizzy, but she informed me that she didn't eat.
Patient given Moderna 50 mcg Booster dose instead of Pfizer 30 mcg Booster dose.
I had the H1N1 vaccination. I started getting a tingling sensation in my chest area and my breast. My breast started swelling 2X as large, with excrutiating pain. Since then I have been to my Gynecologist. We have done all kinds of labs (CBC, Prolactin, Thyroid, Estrogen, etc.), these have all came back normal. We have had a breast ultrasound. Then we had a MRI of the breast. Where they found all the nodes were dilated. The breasts specialists was contacted where she thought also that this could have been a reaction to the shot and everything was inflamed. A chest x-ray was done last night.
Patient is a staff member at nursing home in her area. Facility requested dose to be sent (per our LTC provider agreement for COVID-19 vaccines)  without informing us (Pharmacy) that patient was under 18 years old. Dose was administered on 8/11/21. To our knowledge, the patient did not have any major adverse effects from the vaccine but we needed to report due to wrong age group for Moderna.
Started on Thursday (two days after vaccination) as a mild headache with soreness around injection site after the pain had gone away. Lethargy and full body aches with low grade fever on Friday with sensitive neck lymph nodes. Same symptoms on Saturday with the addition of hives on the neck and itchy scalp. Sunday morning woke with armpit adjacent to injection site's lymph node tenderness, and nausea that persisted all day with continuous low grade fever. Random "bug bite"-like lesions on arms, legs, back, and abdomen. Tightness in chest, almost similar to heartburn, with no phlegm or cough.
1 day p/shot pt ran fever 104 w/APAP mild sz-head jerking movements-distant look in eyes;went to MD 4JUN96;said rxn to vax give ped DT next visit;
patient was inadvertently given 2 doses Flulaval; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 65-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) for prophylaxis.   Previously administered products included FluLaval Quadrivalent (received on an unknown date).   On 15-SEP-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On 15-SEP-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced extra dose administered (Verbatim: patient was inadvertently given 2 doses Flulaval).  The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-SEP-2023 The patient was inadvertently given 2 doses Flulaval, which led to extra dose administered. No symptoms reported. The HCP did not have date of birth or lot/expiry at time of report. Healthcare professional (HCP) consented to follow-up via email.
This case was reported by a consumer via call center representative and described the occurrence of osteoporosis in a elderly female patient who received SHINGRIX for prophylaxis. In January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced osteoporosis (serious criteria hospitalization) and back disorder (serious criteria hospitalization). On an unknown date, the outcome of the osteoporosis was unknown and the outcome of the back disorder was recovering/resolving. The reporter considered the osteoporosis and back disorder to be unrelated to SHINGRIX. Additional information was received as follows: The patient stated that she presented back to the pharmacy to receive the second shot and the pharmacist denied stating that she was beyond the timeframe. The patient stated that the cutoff date he noted was 22nd July 2018. The patient noted the reason for the delay was due to medical reasons. She noted that about 3 months before the reporting date, she began having back problems. She was hospitalized twice and seen in the emergency room. She noted that the first hospitalization was for 2 days and the second was for 3 days. The patient stated it was due to osteoporosis and she denied any relationship to the SHINGRIX vaccination. The patient would have the pharmacist call back to GlaxoSmithKline for discussion on the delayed time. This case has been linked to the case US2018142991 (husband's case), reported by the same reporter.
Red, rash, blotchy on legs (both) and abdomen. Itchy? Resolved in 48 hours completely. Mother gave cool bath, ibuprofen.
Information has been received from a physician concerning a 15 year old female patient with no known allergies, no concurrent conditions and no pertinent medical history who on 20-JUL-2010 was vaccinated with a dose of VARIVAX (Merck) (lot# 657194/0364U). Suspect secondary vaccination administered on the same day included an IM 0.5 ml dose of GARDASIL (lot# 666929/0331Z). It was noted that VARIVAX (Merck) was administered first and GARDASIL last. On 20-JUL-2010, immediately after GARDASIL was administered, the patient, who had been in a sitting position, turned her head, her eyes started to roll, and she had fainting/seizure like activity; body reeling was also reported. The physician stated that there were no tonic/clonic movements and no incontinence. The physician felt that by having the patient lie down, a full blown seizure was prevented. The physician called the event "atypical syncope". No "neuro" consult warranted. The patient sought unspecified medical attention. On an unknown date the patient recovered. No laboratory or diagnostic tests were performed. Upon internal review, "seizure like activity" was considered to be an other important medical event. No further information is available.
She had an injury; This is a spontaneous report received from a contactable consumer (reporting on herself). A 35-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an un-specified route of administration on 21Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient received the first dose of the BNT162B2 vaccine on 21 April2021.  She had an injury and got a medically necessary tetanus shot last night.  She understands you are supposed to wait 14 days before and after. she was asking if she able to get the second dose in two weeks. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
pt recv vax; devel a mild rash, about 10 bumps on trunk & face;
pt recv vax; T 101 all eve;cold cloth use;pt was out all eve, no intake; T inc at noc; to er & did blood test; on ATBs; sent home & T gradually down & was nl at 12 noon;
I didn't feel good; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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, Event verbatim: I got really sick), administration date: 18Jan2021, for COVID-19 immunization, reaction(s): "sickness", "Hypertension", "Tremor". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I didn't feel good".  Additional information: The patient wanted to know if the three vaccines were identical or if anything had changed and also didn't knew if the event was a drug reaction or normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a health professional concerning a 15 month old white male, with an azithromycin (Zithromax) allergy, who on 11Jul05, at 10:30AM, was vaccinated with a first SC dose of varicella virus vaccine live (lot 648554/0584P). There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that the pt developed a rash on his back, described as a cluster of bumps with a white center, the day after receiving his varicella virus vaccine live vaccination, on 12Jul05. It was noted that the pt did not have a fever. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a woman working in a physician's office indicated that the day after receiving varicella virus vaccine live, on 12Jul05, the pt developed about 10 raised, red lesions with white centers extending from the base of the right scapula extending to the middle of his back. Follow up information from a woman working in a physician's office indicated that they had no further information. Additional information is not expected.
Difficulty breathing; He got sick he got Fever, Chills; He got sick he got Fever, Chills; He got sick he got Fever, Chills; This is a spontaneous report from a Pfizer-sponsored program. A male consumer (patient) of an unspecified age received bnt162b2 (BNT162B2), first dose via an unspecified route of administration on 29Mar2021,single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got sick he got Fever, Chills and difficulty in breathing, all on 2021 and he got hospitalized because of those adverse events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Pt given vaccine on 5/10/01. On night of 5/11/01, started with fever, little cough, runny nose and rash on both arms and legs. Still with rash on 5/14/01. Went to ER on 5/12/01. Had negative throat culture.
Information has been received from a physician concerning a female patient who in "the week of 22-JAN-2007" was vaccinated IM with a 0.5 ml dose of HPV VLP vaccine (yeast). After vaccination, the patient fainted.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a registered nurse concerning a 15 year old female patient who on 23-FEB-2007, at 3:35PM, (previously reported as approximately 22-JAN-2007) was vaccinated IM, left arm, with a 0.5 ml of GARDASIL (lot # 653735/0688F). That same day, the patient was leaving the office when she complained of dizziness; she was extremely pallor, perspiring and had tingling in both hands and subsequently fainted. The patient's blood pressure was 110/70 mmHg, pulse 116bpm, and her oxygen saturation was 98%. The patient was given oxygen and she stayed at the office for 45 minutes. Subsequently, the patients symptoms subsided and the patient recovered. No product quality complaint was involved. Additional information is not expected.
I did not have an adverse reaction to the Moderna vaccine. I had a preexisting problem with sleeping for unknown amount of time. I was diagnosed with sleep apnea in 05/2023.
Pt states that approximately 14 hours after the shot was given she was working in her closet. Pt says she started seeing spots and tried to get to her bed when she passed out.
Patient reported a high fever (104 degrees F) followed by Aphthous ulcers (canker sores) all over her mouth. She saw a dentist on 7/12/21 and will be seeing her PCP on 7/15/21. She said that she is treating the canker sores with salt water rinses.
devel "bout of coughing" described as "an explosion w/in the body disrupting the nl function". exp "degradation of sight" as a result of coughing; prior to oct 04, he only required reading glasses;
flu like symptoms incl fever with first dose,  Dec 20th severe hive outbreak after booster.  Continuing
She already had her period this month and yesterday she started bleeding; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUATION IRREGULAR (She already had her period this month and yesterday she started bleeding) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034B21A) for COVID-19 vaccination.     No Medical History was Provided by Reporter.     On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced MENSTRUATION IRREGULAR (She already had her period this month and yesterday she started bleeding). At the time of the report, MENSTRUATION IRREGULAR (She already had her period this month and yesterday she started bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medicine-Birth control meds No Treatment information provided
My injection was on a Monday at 1pm. I had no issues for about a day and a half. On Wednesday afternoon I started having itching and redness on my forearms and top of both hands. Both arms on Wednesday evening were swollen, quite red and sore (a bit of a burning sensation). It almost feels like a bad sunburn at times. I took an antihistamine to help with the itching and swelling and this morning actually put calamine lotion on my arms to help soothe the burning feeling. It is more irritating that painful and nothing needing medical attention but I thought it should be reported.
Swelling on entire left arm, enlarged lymph nodes, fever for 5 days as of today, swelling of left face / ear.  Headache, nausea, vomiting
Extra dose of measle mumps rubella   vaccine given. Child  had received  2nd dose of MMR  and varicella vaccine  in another  state . no immunization reminder  information system report. 2nd doses of MMR and varicella received earlier than CDC's recommended schedule 4-6 ry. of age.
body aches, headache, vomiting, stomach ache, excess air in stomach, no energy, tired, cold chills, sweating, sore arm . Most lasted for 60 hours.  Couldn't eat without neusea for 4 1/2 days.  I had covid in Jan 2021.  The shot was worse than the illness.  Thinking about not getting the ain2nd none.  I do not want to get ill like that again.
Systemic: Seizure-Mild, Additional Details: pt was given child pfizer vaccine. vial and syringe verified by pt's mom. pt was nervous at time of injection.  proceeded to give brother child pfizer vaccine. came out of room and pt states she had blurred vision. i asked if she felt dizzy and her eyes rolled back and she starting to convulse. place patient on floor laying down with mom and by that time she came back to and went to sit on chair. states she doesn't remember anything besides sitting on chair and waking up on floor.  fed h20/food
3/24/16 5:00 PM - pain at the injection site;  9:00 PM - nausea; 3/25/16 4:00 AM - nausea, chills, weakness; 6:00 AM - severe weakness (difficult to stand up), extreme nausea; 8:00 AM - 9:00 AM diarrhea 3 x, severe weakness/feeling faint; 10:00 AM - vomiting, diarrhea, hives, fever; 11:00 AM - 8:00 PM - nausea, diarrhea 10 x; treatment - ice chips throughout day, could not tolerate food (tried jello at 5 PM and had nausea/diarrhea); 3/26 - nausea but beginning to tolerate food (rice, banana), extremely weak/dehydrated from vomiting/diarrhea on 3/25; 3/27 - 3/29 nausea persists but able to tolerate food (BRAT diet)
Patient is a 25 yo woman who just had her second Pfizer vaccination approximately twenty-five minutes earlier. She reports "tightness" in her throat, but no evidence of stridor or difficulty breathing. She remarked that she had similar symptoms after her first dose and was treated with diphenhydramine 25 mg orally with relief. She requests and was given, diphenhydramine 25 mg and a bottle of water. After approximately thirty minutes, she reported the resolution of her symptoms and requested to leave the extended monitoring section.  6/14 ED visit for nausea and SOB - zofran given
A nurse reported that a 27 y.o. female did not respond to the Hep B vaccine recombinant (Engerix-B) immunization series. The subject's medical history, concurrent conditions, and concurrent medications were unknown. The subject experienced no adverse events following previous immunizations. The subject received Engerix-B on 1/3/02 (lot ENG5214A2), 2/9/02 (lot ENG5214A2), and 7/23/02 (lot ENG5313A2; expiry, Dec. 03). An unspecified titer, measured on 9/17/02, 52 days after the 3rd injection of Engerix-B, was "negative for antibodies". The reporter considered the event to be probably related to Engerix-B administration.
Patient was found unresponsive the morning of March 14, 2021. She was pronounced dead at 5:33 AM. The medical examiner quoted natural cause of death.
had a lump and breast issues; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRna VACCINE, solution for injection, date (Batch/Lot number was not reported)), via an unspecified route of administration on an unspecified as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a lump and breast issues. At the time of this report, the outcome of events was unknown.  The lot number for, the vaccine, BNT162B2, was not provided and will be requested during follow up.
First 3 hours tongue tingling numbness Within 3-4 hr moderate lower back pain. Chills first night Itching on back and chest.  Severe Stomach pain  and right side 3 days. Extreme fatigue. Bed rest 2 days. Feel normal on day 5.
Short of Air Narrative:  Patient transported via ambulance to ER for further evaluation and treatment.
pt recvd vax; was wierd, dizzy; 1:30am throbbing h/a; blurred vision; cough; dyspnea; congested nose; vomited x 3; chills; 3am able to sleep in recining chair; ok by noon 31oct94 h/a last sx to go;
Information has been received from a health professional concerning a 1 year old Hispanic male who on 6/12/02 was vaccinated with varicella virus vaccine live. It was reported that while hospitalized in the ICU, the child broke out with less than 5 chicken pox lesions. At the time of this report, the outcome of the chicken pox was unknown. Conflicting follow-up from an RN reported that the child required hospitalization for 11 days. Further conflicting follow-up received from an RN at a physician's office revealed that the pt was 1st seen in the practice on 3/26/02 for a 1st visit for an ear infection. At that time, there was no history of any allergies and there was no significant past medical history of problems with previous vaccinations. The child's next visit was on 6/6/02 which was a well visit and the child received vaccinations with MMRII (lot 640913/1117L), Haemophilus B conjugate vaccine + hepatitis B vaccine recombinant (yeast) (lot 637096/1173K), and varicella virus vaccine live (lot 641594/0200M). The child's next visit to the clinic was on 7/2/02, which was documented as a post hospitalization check-up. In the child's chart, it was documented that the child was in the hospital for 1 and half weeks for seizures. The child was reported to be stable at this visit and was to be followed up in 2 weeks which was a failed to show appointment. No further information was available pertaining to the hospitalization. Additional information has been requested.