chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unauthorized dose administered to an 11 year old due to mother and patient lying about patient age: Nurse Note for encounter 9/19/21: Pt present with her mother to the COVID-19 vaccine clinic.  Mother filled out paperwork lying about child's age & DOB.  Unauthorized first-dose Pfizer vaccine was administered to an 11 year old (11yr, 3mo).  Mother wrote on paperwork that age of child was 12, and DOB 5/27/2009.  Child told vaccinator, who properly screened patient prior to administration of vaccine, that her age was 12.  Unauthorized dose was administered and this was discovered by data-entry team. Mom admitted she gave false information for her daughter in order to get her immunized for COVID.  Mom was informed of guidelines, VAERS report to be filed and that child may not return for 2nd dose Pfizer until she turns 12 or the vaccine is authorized for 11 year olds.
A little tired; Sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:   A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "A little tired"; PAIN (non-serious), outcome "unknown", described as "Sore".  Additional information: His wife just a little tired and sore after the Pfizer booster vaccine.  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.
right facial drooping including right forehead, no other neurological deficits symptoms started on 3/13, no significant changes since onset
mom states approx 5min p/leaving MD office pt had a convulsive type rxn;pt stiffened in the car seat;then taken to ER;
Intense local swelling, tenderness, redness and increased local warmth with lymphangitic at the level of L arm where it was injected; reaction 3-4 hours after injection.
on that day 1+hour later had flushing and dizziness. had increased chest discomfort (has upcoming appointment in a few days 02/01/2022 with cardiologist for this) over sternum. had increased SOB.  felt flushes. so then "passed out." husband noted that she was pale. palpitations. had nausea but no vomiting - resolved. no current lightheadedness. had increased "esophagus spasms" (working with GI for this; s/p recent EGD) no tongue/lip swelling. no rash.  no fever/chills. no runny nose no hx of seizure and no seizure like activity. no loss of urine / stool continence.  took Aspirin 325 mg qday - with improvement
Fever; Headache; Body pain; Tingling and hot between legs and from the back to the head; Tingling and hot between legs and from the back to the head; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling and hot between legs and from the back to the head), FEELING HOT (Tingling and hot between legs and from the back to the head), PYREXIA (Fever), HEADACHE (Headache) and PAIN (Body pain) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included MIRTAZAPINE, FLUOXETINE, VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PARAESTHESIA (Tingling and hot between legs and from the back to the head) and FEELING HOT (Tingling and hot between legs and from the back to the head). On 18-Mar-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and PAIN (Body pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling and hot between legs and from the back to the head), FEELING HOT (Tingling and hot between legs and from the back to the head), PYREXIA (Fever), HEADACHE (Headache) and PAIN (Body pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Red from elbow to shoulder. Painful. Site reaction in Rt arm/Pneumovax
Patient received flu shot and immediately after it was injected, his shoulder began to hurt, feeling like he had been "shot." His arm was hanging there and reports losing about 80% of function in arm. Pain was in upper deltoid and down, couldn't flex arm or abduct more than 90degrees. Cross arm test was painful.   Had f/u visit w/ PCP on 12/9/22. Now it has "leveled off" not getting worse or better. Using tape, CBD oil, ibuprofen. Range of motion is improved.
This case was reported by a consumer via call center representative and described the occurrence of skin discoloration in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included fall (Fell and cracked head open was bleeding, got knocked out). Previously administered products included ZOSTAVAX with an associated reaction of loss of consciousness and Shingrix with an associated reaction of pyrexia (fever after receiving 1st dose, see case US2018GSK219944). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was not reported. It was unknown if the reporter considered the skin discoloration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced after receiving the 2nd shot in left arm. The skin discoloration occurred after the second shot. It did not bleed. It was about the size of a dime. It was goldfish or brownish in color. She was fair skinned. It had not resolved. It was not painful, not raised, no lesion. She did not experience a fever after the second SHINGRIX injection. This case has been linked with 1st dose case US2018GSK219944, reported by the same reporter for same patient.
One week after the first dose  for one day I had the following symptoms - temperature 100.5, chills, body aches, headaches,  horrible fatigue. Then next day I was fine. In 3 days I woke up from discomfort - body ache, trmperature 99.  After the second dose in 12 hours I developed a fever - 100.4 and fatigue . Symptoms for one day. Today - one week after the second doseQ- temperature 100.7,  horrible chills, fatigue, cough ( just a little bit. I stayed at home for a year. And now I was waiting to be fully vaccinated before socializing
Less than a minute after administration patient started to feel not well. Patient displayed symptoms of possible syncope. Eyes were unfocused and unable to sit up straight. Epipen was administered immediately. EMS was called. Patient's blood pressurewas taken multiple times and was low at each reading . Patient's blood pressure would also drop upon standing up. After about half an hour of not resolving EMS took patient to hospital for further evaluation.
Red bumps, scattered pink papules, mostly on upper back and chest, some on legs, some scabbed since 9-10-07
This spontaneous report as received from a licensed nurse refers to a 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-NOV-2015, the patient was vaccinated with the dose of GARDASIL  (lot # L010596, expiration date unknown; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse affects; two doses of MMR II were reconstitured and administered with expired MERCK STERILE diluent; two doses of MMR II were reconstitured and administered with expired MERCK STERILE diluent; This spontaneous report has been received from a pharmacist,concerning a patient of unknown age and gender.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 09-MAY-2019,  the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, anatomical location, lot and expiration date were not reported) as prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine was reconstituted and administered with expired sterile diluent (MERCK STERILE DILUENT) (lot # M010690 and expiration date 02-SEP-2018) administered subcutaneously. No adverse effects reported.This one of two reports from the same reporter.; Sender's Comments:  US-009507513-1905USA005458:
Erythema, swelling, and warm to touch at vaccination site (Right thigh). Pt prescribed BENADRYL and KEFLEX. Small lump at vaccination site.
no adverse effects; The patient received PNEUMOVAX 23 twice; This spontaneous report was received from a patient referring to themselves a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant therapies were not reported.  On an unknown day in September 2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in their arm (dose, dose number and route of administration was not reported; lot number N011491 and expiration date on 04-NOV-2018) for prophylaxis.  On an unknown day in September 2018, the patient received an extra dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in their arm (dose, dose number and route of administration was not reported; lot number R007722 and expiration date on 10-MAR-2020) for prophylaxis (extra dose administered). No adverse effects were reported.
Information has been received from a physician concerning a 21 year old female patient who on 25-SEP-2007 was vaccinated with the first dose of GARDASIL (Lot number 0530U), on an unknown date with the second dose of GARDASIL and on 01-APR-2009 with the third dose of GARDASIL.  Within a month after received the first of GARDASIL, approximately on 25-OCT-2007, the patient experienced joint pain all over her body and an auto immune response.  The physician reported that the patient was still experienced joint pain and was given PLAQUENIL, (manufacturer unspecified) but the joint pain had not gotten worse.  At the time of reporting the patient was not recovered.  The patient sought medical attention with the physician.  Additional information has been requested.
Approximately 24 hours after receiving the vaccine, I was walking in my home and my body suddenly went rigid and started to twitch, my head jerked to the side, my head felt as though it was spinning then went black, then my body suddenly relaxed and I my awareness returned, with my head still a little dizzy. About 30 minutes later I was suddenly very cold and started shivering. I laid under a sheet, 2 fuzzy blankets, and a bed spread in a short sleeve nightgown. I pulled my arms and legs into the nightgown and curled up to try to get warm, falling asleep after about an hour. During the night I began to sweat and continued to do so until morning, fitfully sleeping the rest of the night. The next day I was very tired and dozed off and on but I did not have any other symptoms.
Px states he has dull, aching,  shooting, muscle and nerve pain extending from just below shoulder where shot was administered to just above elbow on vaccination arm. Px states he has never had adverse events from any previous vaccine. Px states he has trouble lifting his left arm over his head. The pain has been constant and steady since the vaccination approximately 1 month ago. Px states he has an appointment with PCP upcoming and will report symptoms then.
Localized raised area with rash/scab areas size of silver dollar. Treated by cleansing site daily and applying triple antibiotic oint.
1st shot - no reactions same or next day after shot,  9 days later, injection spot became swollen,  warm, itchey.  Also  flu like symptoms
Transient lingual papillates; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0142) via an unspecified route of administration in the left arm on 15Jan2021 at 09:30 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medication, food or any other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Jan2021, the patient experienced transient lingual papillates that had been ongoing since January after the first dose. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event transient lingual papillates was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Severe headache that does not respond to Advil, muscle aches, chills,  fatigue, brain fog
12/01/09 6:30 pm chills, subjective fevers, 2 episodes of nausea and vomiting with myalgias and arthralgias. 12/02/09 Awoke with fever 100.4. 12/02/09 Appointment in clinic 8:55 am /no further nausea or vomiting, feels better injection site no erythema or exudate nontender. T 97.6. Plan rest, push fluids, Tylenol, return as needed.
Initial case was received from the scientific literature on 15 February 2012. The following is verbatim from the article: "The patient was born at 41 weeks gestation via Cesarean section after an uncomplicated pregnancy. The umbilical cord separated at age 1 month. Routine immunizations at birth, 1 and 2 months of age were uneventful. During the 6-month visit, a violaceous nodule was noted on the right thigh at the site of the 4-month PENTACEL injection. This was thought to be a hematoma, and the 6-month vaccines were given as usual. One week later, the patient returned to the pediatrician because the nodule had become fluctuant and expressed a purulent exudate. An abscess was suspected, so empiric antibiotic therapy with sulfamethoxazole-trimethoprim was started. Culture was negative. Two weeks after the 6-month visit, the patient continued to have drainage from the first nodule and was noted to have fever and two new nodules at the sites of the 6-month PENTACEL and PREVNAR injections. These two nodules were incised and drained, and one culture grew Clostridium perfringens. Antibiotic coverage was changed to a 2-week course of clindamycin. When the child presented to dermatology at 8 months of age, the sites of these vaccine reactions demonstrated atrophic dimpling with central hyperpigmentation. An immunodeficiency evaluation was performed because of these recurrent abscess-like lesions. Laboratory tests consisted of complete blood count, immunoglobulins, lymphocyte subsets, and nitroblue-tetrazolium test. Findings were all negative or normal. Leukocyte adhesion deficiency was investigated using flow cytometry, which confirmed the presence CD18, CD11b, and CD11c on the cell surface of the patient's granulocytes. An alternate explanation was sought, and aluminum allergy was considered. Patch testing of varying concentrations of aluminum chloride and controls was performed in a protocol similar to that previously published. Aluminum chloride 3.5%, 1.7%, and 0.35% dilutions were made from commercially obtained aluminum chloride 35% in water. Application was performed using Finn chambers coated with polypropylene. Controls of water and petrolatum were placed. Patches were read at 48 and 96 hours. There was no reaction at 48 hours. A reaction was seen at 96 hours and was graded as 3+ to 3.5%, 2+ to 1.7%, and 1+ to 0.35% aluminum chloride dilutions. The patient had positive reactions at the sites containing aluminum chloride and negative reactions at the control sites. A healthy control was tested with the same concentration of aluminum chloride to exclude the possibility of an irritant reaction to the tested solution and had no reaction. Based on these findings, the patient was diagnosed with contact allergy to aluminum." Documents held by sender: None.
Vaccine given on 07 Dec @0910 Local time. (EST)Monday- Pt felt extremely discomfort and Soreness to Left deltoid and rest of extremity. Took Tylenol for pain.Tue- Bicep inflammation, edema and itcy skin. Sought help from local M.D. in her office and was told to take Ibuprofen. Wen- Pt went to personal Physcian whom dx with infection and cellulitis and prescribed Keflex 500mg qid and Motrin 400mg three time daily. Pt. took Keflex qid till three days and is currently taking the dose three time a day. Still some cellulitis and edema but has almost resolved.
This spontaneous report as received from a pharmacist via a company representative refers to a 86 year old male patient. On 23-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported, dose not reported, "injection"). On August 6th or 7th, the patient contact the pharmacist reporting experienced "red bumps" about one inch above the injection site, the bumps were said to be "smaller than a dime and somewhat hard". The patient did not seek the medical attention. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Started with fever of 103.4 degrees the day following vaccine with headache and generalized aches.
Pt. c/o nausea after immunization. Pt denied any dizziness, pallor good. Given juice, crackers, she refused. BP 104/78, R 12, P 72.  Pt. states she was getting hot, repeatedly requested medication for pain, advised to have a seat, patient refused and left without further care. Patient returned later on 3/24/17 and subsequent call to 911 to send her to ER. When patient returned to have TST read on 3/27/17 she reported that they diagnosed her with anxiety and depression in ER and was following up with her doctor. Appeared in much improved spirits and with no observable impairment.
Bad pain in left arm the same day as injection. aching all over body .Large lump on left arm where  injection was given
Employee received second dose of Pfizer COVID vaccine on 1/13/2021 at 1400. Employee had a syncope episode on 1/14/2021 around 1300. Employee called the nurse on 1/15/2021 at 0840 to report syncope. Employee denies any current dizziness, nausea or vomiting.
Full body muscle soreness, fatigue, weakness/almost passing out several hours after injection, rash/burn feeling on thighs (no red spots)(short term), headaches
October 25-12:10PM Booster Booster of Moderna   o Headache in back of head October 26 o 8:10 AM severe chills and shaking.   o Severe headache in back of head o Fatigue-slept most of the day o Nausea o Sore Joints o 4PM chills o Sinus Congestion-very bad October 27 o Headache in back of head o Rash-chest only o Fatigue-slept on an off all day. October 28, 2021 o Rash-chest/neck/arms/some facial o Rash turning to patches o 4 PM rash patches swelling o Itchy Eyes o Called Hospital 6:10 PM o Dr. Return call immediate-expect call in AM o Take photos February 24, 2021, 7:50 AM appointment for 1st dose Moderna Vaccine-Health Department o Nausea came a few minutes after shot, and headache o Went home and napped gone after a few hours o 4PM  Headache came back, and lasted until 7PM March 2-knee pain March 3-on waking up couldn't walk March 9-Woke up with Covid Arm-Swollen arm, rash, and chills March 24-7:41 appointment for 2nd dose of Moderna-Health Department o Nausea came a few minutes after shot, muscle pain, and headache March 25th-Fever, pain, and muscle aches.  Trouble walking March 26th-Rash, and turned to red patches everywhere.  Nausea. March 27th-Rash is getting worse (like penicillin poisoning), and nausea. March 28th-Nausea March 29th-Nausea, and could not even get out of bed. March 30th-Nausea March 31st-Nausea April 1st-Nausea and chills April 2nd-Headache pain in back of head in one spot. April 3rd-Headache pain in back of head in one spot. April 5th-Headache pain in back of head in one spot. April 6th-Headache pain in back of head in one spot. April 8th-Night sweats. April 9th-Vertigo. April 10th-Hot flashes. April 11th-Hot flashes. April 12th-Vertigo and nausea. April 13th-Nausea. April 16th-Nausea, and bad headache.  Vertigo late evening. I have photos of the rash if needed.
UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
This spontaneous report was received from a pharmacist, concerning an unknown number of patients of an unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (dose, frequency and route were not reported) lot # L040053 with expiration date of 10-MAY-2017. The temperature of the PNEUMOVAX23 was 14 °C for a time frame of 3 hours; no previous temperature excursion was reported. No side effects were reported and no product quality complaint (PQC) was involved. Data logger was involved. This is one of two reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA004545:
Day after the shot on Tuesday morning woke up a little fatigue she did a little cooking and her chest started really getting tight she was sweating really bad went to bed slept all day tried walking on Wednesday put a heating pad on her legs with muscle spasms called me at 5 AM to get her to the ER she couldn?t walk her leg swelled up really bad
1/2 hr after administration of vaccine, sweating, nausea, pale, abd cramping.
Child recieved flu vaccine at 1357 on 111908 per Left deltoid IM.  Mom called CHS office back approximately 45 minutes later indicating the child was crying hard and was unconsoleable, complaining of severe arm pain, and wouldn't move arm.  Mom couldn't see any redness at injection site. RN advised Mom to take child to see her Dr.   Mom had administered 2 doses of Tylenol, prior to calling Community Health Services Office.   Mom took child to see PA at the Clinic and child was diagnosis with a sinus infection and was given antibiotics.   Note Mom reports that she had recieved a flu shot a couple of days ago and experienced tightness in her chest after being given the shot.  RN advised Mom to discuss this with the Dr. and Dr advised the flu be given in Dr's office next year.  Dad of this child also experienced a very stiff sore arm after recieving the flu shot this year.
MD reported unusual & extreme, fatigue beginning 3-4 days p/inject & persisting for approx 1mo; no treatment was given;