chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial case was retrieved from the scientific literature on 28 November 2012. This case is linked to 2012-11464 and 2012-11465. An 18-month-old child received injection of DTAP and PREVNAR (lot numbers, routes, sites, and date of vaccination not reported) and developed nodules at the injection site 1-2 days following administration, which persisted for six years. The intensely pruritic nodules led to bleeding from excoriated lesions. Nodules were increasingly pruritic, erythematous, sore and larger at times of illness. Patient was found to have hypersensitivity to aluminum, neomycin, and formaldehyde by patch testing which were present in these vaccines. Antibody titers showed that patient was not adequately protected to tetanus vaccines without aluminum, neomycin, or formaldehyde. Patient received his initial infant vaccines of DTAP, Hib, and PREVNAR without incident. The patient's outcome was not reported. Documents held by sender: None.
Received her injection at 3 pm. She awoke at 1:30 am the next day with intense whole body shaking and rigidity - like chills but she was not feeling cold and did not have a fever. She had a general feeling of anxiety and apprehension. No other symptoms.
Severe edema, erythema, firmness, ecchymosis, warm and severe tenderness to touch. 2 hours past vaccination are ecchymosis, firmness, edema and warmth set, later progressing in severity around vaccination site and around arm, reaching a diameter 6.5in x 3.5in
Pt went to ER about 21:27, Dx with localized reaction to pneumonia vaccine. Pain started about 2 hours after inj. Contusion at shot site & swelling, tender warmth, erythema from elbow to delt. noted by ER doctor. Home to rest. NORCO - pain. Apply warm moist cloth TID. Pt improved 70% 2315, pt not found in room at 2310.
Patient woke up this morning 2/17/22 with a red blotchy rash on bilateral upper arms.
Approximately 3 days following the vaccine, I developed a severe migraine (aura, severe headache and nausea) that lasted for about 4 hours followed by 24 hours of fatigue and weakness.
Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
vaccinated while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccinated while pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011J20A) for COVID-19 vaccination.     no medical history provided.  The patient's past medical history included Pre-eclampsia (In her previous pregnancy in 2018). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccinated while pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (vaccinated while pregnant) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information provided
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a six-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Post receiving the vaccine, child was waiting on site with his mother & brother for 15 minute observation. Received vaccine at 9:02 am, had syncope at 9:20 am. Syncope lasted 1-2min. EMS contacted at 9:21 am and arrived at 9:28 am. Child alert & oriented upon their arrival, sitting up. EMS and mother did not express need for child to f/u at or be taken to hospital at that time. Child remained on site at clinic until 9:45 am. Walked out to car on his own, with mom & brother.
Systemic rash total body with arthralgia in 56 yo. female. (Papular rash, throat clear, negative edema in joints.)
pt recv vax 28JUL95 & began cranky unusual cry @ 4PM;t102 APAP given 4 hrs; crying -temp down @ 10-11AM 29JUL95;inj site appeared painful; ask a nurse called-advised to observe
i got sick as shit; Initial information was received on 21-Oct-2021 regarding an unsolicited valid social media non-serious case received from a consumer/non-health care professional (under reference number: US-SA-SAC20211026001521).  This case involves an adult patient with an unknown gender who got sick as shit while receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   It was unknown if the patient had any concomitant disease or risk factor.  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 unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event I got sick as shit (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Last time I took a flu shot I got I got sick as shit. "  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was reported as unknown.  There will be no information on lot number for this case
Within couple hours of receiving flu shot, started with hives, neck, head and stomach. Chest heaviness.
Horrible shoulder pain which was unbearable and moved throughout body; Horrible shoulder pain which was unbearable and moved throughout body; C reactive protein jumped to 8.6; Polymyalgia; Could not walk; This is a spontaneous report from a contactable consumer (the patient). This consumer reported similar events under the same suspect product for two patients. This is one of two reports.   A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 09Feb2021 10:15 (at the age of 67 years old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283) on 18Jan2021 10:30 AM, administered in left arm, for COVID-19 immunization. The patient has no history of COVID prior vaccination. He was not COVID tested post vaccination. 1 month later on 01Mar2021, the patient experienced developed horrible shoulder pain which was unbearable and moved throughout body. C-reactive protein jumped to 8.6 and ended up with polymyalgia. The patient was treated with Prednisone. It was also reported that the patient could not walk until treated with steroids. The events required a visit to the physician's office. The patient underwent lab tests and procedures which included c-reactive protein: 8.6 on 01Mar2021, Immune tests: ok on Jun2021, Basic metabolic panel (BMP): ok on Jun2021 and sedimentation rate: ok on Jun2021. The patient was recovering from the events.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021677122 Same reporter and drug, similar event, different patient
1/2 DOLLAR bill  redness c some swelling and itching on Left Upper Arm subcutaneous
Severe myalgias started during sleep the night of the vaccine administration.  Next day myalgias persisted & worsened and brain fog started (difficulty/inability to perform ADLs, memory lapse, difficulty thinking, concentrating, forming sentences, functioning very slow, etc).  Throughout the day severe headache set in, myalgias persisted and brain fog worsened.  By 8-9pm symptoms were extreme, took about 1000mg of expired Children's Tylenol. By 11pm myalgias improved. Slept through night. Next morning all symptoms had resolved.
Pt sat down after receiving her vaccine and felt a burning in her chest that was creeping up to the base of her throat and down her arms. Pt denied trouble breathing, drooling, speaking, or swelling.  Paramedics on scene escalated the situation. Pts pulse was 98 bpm with a regular rhythm (12 lead EKG was performed). Pt was hypertensive (BP 177/104). Paramedic on scene continued to use medical language and amplify the situation. An ambulance was called. I offered to have pt wait 10 minutes and then recheck bp, as the rest of her symptoms had resolved. Paramedics encouraged patient that it was "her decision to take the ambulance, however they were concerned about a stroke with a bp that high". Pt left in an ambulance. Will f/u in a couple days.
Right arm sore; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the right arm on 16Mar2021 at 08:30 (at the age 54-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol from an unknown date. Prior to 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 have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included simvastatin (ZOCOR) from an unknown date. On 17Mar2021, 22 hours post vaccination the patient experienced sore in right arm and had slight headache. The patient did not receive any treatment for the events. The clinical outcome of events sore in arm and headache were resolving at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Immediate injection site swelling (nodule). No pain/discomfort. Swelled to nodule site w/in 2 min. No redness. No dizziness/light headed. Swelling began to clear in size after 12 min.
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. In approximately 2015, the patients were vaccinated with improperly stored doses VARIVAX (Merck) lot # K011804, expiration date 21-AUG-2016 (route of administration was not reported) since a previous temperature excursion on 19-MAY-2015. No adverse effects were reported. Additional information has been requested.
Injection site pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 30-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in Arm Right on 23Mar2021 11:45 (at the age of 30-year-old) as dose 2, single and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration, administered in left arm on 01Mar2021 10:30 (at the age of 30-year-old) as dose 1, single for COVID-19 immunization at Workplace clinic. The patient medical history was not reported. Patient had no allergies. Concomitant medication(s) within 2 weeks included ethinylestradiol, norgestimate (NORGESTIMATE AND ETHINYL ESTRADIOL). The patient was not pregnant at time of vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021 13:00 The patient experienced injection site pain. The patient had injection site pain approximately 2-3 hours after vaccine. Patient did not received any treatment for the event. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Chronic urticaria started about two weeks (~12/9/21) after COVID-19 MODERNA booster (11/23/21). Hives/areas of hives would randomly appear throughout the day on body, including legs, arms, core area, back. Did not notice any on face. The hives would start out small and be intensely itchy and get bigger. They appeared at random times during the day and I could not pin down anything that may have been causing them, other than the booster. Dermatographia as well, scratching would cause raised welts. Topical hydrocortisone helped somewhat in the short-term. Zyrtec seemed to keep symptoms away for about 2-3 days. I stopped Zyrtec in about mid-Feb 2022 after seeing an allergist. No tests were run but we went over the symptoms and possible causes (food, detergent, seasonal allergies, etc).Based on my analyses and prior medical history, he thought it was likely my immune response to my vaccine was causing the hives and advised treatment with Zyrtec since that was generally working for a few days. He thought I was on the downslope from the hives based on how long Zyrtec was working. Today, about 4 months after the booster, symptoms have mostly subsided but dermatographia still is there a little bit. I no longer have patches of hives thankfully.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications. On or about 07-NOV-2012, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention of shingles and zoster-related injuries. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the events was unknown. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, Plaintiff had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The event shingles was considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.
Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. On unknown dates these patients were vaccinated with improperly stored ROTATEQ (dose and lot# were not reported) orally. No adverse effects were reported. This is one of several cases reported by the same reporter. Additional information is not expected because the reporter would not like to be contacted.
2/26/05 Left center went home (1 hr) then fitness gym, during weight lifting became nauseous, vomited once (approx 2 cups), left gym at approx 5:45 still nauseous, went home, bed, next morning donor felt fine. Nausea began approx 3:00.
p/ pt recv varicella vax in 4/1/98 then 12 days later pt devel ``erythema @ inject site that resembled chickenpox
7 days after MMR, DTaP, Pedvax, PCV7, Varicella, child developed fever 102 F, red dots on legs. Fever broke after 4 days. Medicated with Tylenol and Motrin.
Nausea Chill - Bone Chilling/Chattering Teeth/Cold more at extremities/cold to the touch Headache Achy All over Achy joints Exhausted/Extremely Tired Diarrhea
Constant clear runny nose, teary eyes day after injection. Progressively worsened. 5 days post injection, facial swelling with continuois runny nose and watery eyes. Treated symptoms with non-drowsy sinus medicine with some relief. 10 days post injection large amount of swelling at injection site with warmth, more soreness than expected, and red blotchy skin. No fever. Congestion has subsided.
Patient experienced redness and swelling on  his arm. Started to run a  fever on 3/16/2016., Felt hot to the touch. Went to Doctor office, and was prescribed an antibiotic.
No additional AE reported; Caller was Healthcare Business Professional who was in charge of vaccine storage/stability. Caller reported AE for Patient.  As confirmed by Caller at current call time, Patient who was previously seen by Separate Facility, This spontaneous report was received from Healthcare Business Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 29-JAN-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, unk, lot #K010209, expiration date: 17-JAN-2016, administered for prophylaxis (strength, and route of administration were not provided).  On 29-JAN-2023, as confirmed by caller at current call time, the patient who was previously seen by Separate  Facility, was administered expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) by Unknown Healthcare Professional from Corresponding, Separate Facility, (Expired vaccine used). Caller was unable to further clarify these statements at current call time. Caller was unable to confirm whether or not Affected Product had encountered any Temperature Excursions prior to or at event time. No AE Letter was sent since Caller did not wish for Caller to be contacted in future regarding event. No additional AE reported. No PQC reported. No further information provided.
Unable to read lot and exp number on card. Symptoms started 2 weeks later. Woke up early morning to my legs and head being itchy.  Not sure if I was scratching but my feet and hands were swollen. Took Benadryl and eventually fell back asleep. Next morning hives kept closing and going all over my body. I had welts and was itchy. Went to urgent care that evening and when I went it felt like it was my head. My throat was scratchy my ears were swollen. They gave me a steroid injection and medrol dose pack and said to continue taking benadryl
About 10 minutes post vaccine I was just talking to my husband and I immediately felt ?drunk? . I got extremely hot & started sweating out of every pore in my body.  I could barely hold my head up & I was very nauseous. I was drenched in the matter of minutes. I was back to normal about ten minutes later.  I was not anxious about the vaccine. I was fine . I was literally just sitting there .
A non-serious spontaneous report of administered expired FLUMIST was received from a health professional concerning a four-year-old male. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 27-Nov-2011. On 01-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age.
Initial report received on 03 February 2010 from a health care professional. A four year old female patient with an allergy to pertussis and amoxicillin developed a fever of 39.3 degrees celcius and painful right knee one day after receiving IPOL subcutaneously in the right deltoid (lot number B0475), TUBERSOL intradermally in the left forearm (lot number C3269AA), MMR, and Varicella (lot and manufacturer not reported) on 01 February 2010. At the time of the report, the patient was awaiting a hospital admission. Tests were completed in the emergency room, however no further information was provided. The patient had not recovered. List of Documents held by Sender: none.
Client has shooting pain down arm and hand gets numb at times.  Seen nurse practitioner at health care.  Took Methy/Pred for six days (started it on 7-8-08).  Went back to health care on 7-15-08 and seen nurse practitioner and is currently taking Naproxen, Skelaxin and BUT/APAP/CFSO.  If she skips a dose, her arm still has shooting pain.
From telephone contact received at manufacturer on 11/05/02, it was reported that a 49 year old female pt had been vaccinated with Fluzone on 10/24/02.  The pt's liver function tests are abnormal.  The pt started taking cholesterol-lowering medications 6 months ago.  Her liver function tests were normal until last week.  No systemic symptoms after receipt of dose.  The pt's doctor did not locate the lot number of the product while reporting this event, but will provide it when completing a VAERS form for the manufacturer.  The MD also stated that she felt most likely that this event was not due to the Fluzone vaccine, but because it occurred in such close proximity to the receipt of dose, she felt it should be reported.
I95.9 HYPOTENSION 3/23/2023 LARYNGEAL CANCER, UNSPECIFIED SITE
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 at 16:00 as dose 1, single (Lot number: EN6208), on 02Apr2021 at 16:00 as dose 2, single (Lot number: ER8734), on 05Nov2021 at 17:00 as dose 3 (booster), single (Lot number: FH8027) and on 27May2022 at 16:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION, start date: 06Jul2018; ATORVASTATIN, start date: 03Aug2018, stop date: 07Jul2022; VITAMIN C ACID; VITAMIN D NOS; ZINC; CBD OIL. Past drug history included: Codeine, reaction(s): "Known allergies: codeine", notes: Known allergies: codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Unknown Result. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The Patient took PAXLOVID from 08Jul2022 to 12Jul2022 for the COVID-19 treatment and 8 days after finishing PAXLOVID symptoms returned and tested positive again on 20Jul2022 at 06:00 PM. No treatment was received.
Health Dept went off-site to jail to provide H1N1 to employees and in-mates. Patient were asked prior to vaccination if they had received H1N1 vaccination previously. All answered no. Vaccination provided to patient. As clerks keyed dates into system realized patient had received H1N1 vaccination previously 12-09. patient had no problems from vaccination, just received 2 doses.
Johnson & Johnson COVID-19 Vaccine Chills Headache Nausea Fever 102
Aside from the typical fever, body aches, headaches, and muscle pain, I have incredibly swollen and painful lymph nodes. Specifically, two in my neck, and my armpit on my right side (same side as injection site). My neck and armpit are both also visibly swollen