chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second dose at the age of 12 years old; Mixed vaccination series - first dose Pfizer vaccine and second dose at the age of 12 years old.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Second dose at the age of 12 years old) and INTERCHANGE OF VACCINE PRODUCTS (Mixed vaccination series - first dose Pfizer vaccine and second dose at the age of 12 years old.) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and ER8736) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Mixed vaccination series - first dose Pfizer vaccine and second dose at the age of 12 years old.). On 07-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Second dose at the age of 12 years old). On 01-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (Mixed vaccination series - first dose Pfizer vaccine and second dose at the age of 12 years old.) had resolved. On 07-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Second dose at the age of 12 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  Patient received vaccine on 1-JUN-2021 from the Pfizer.   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Non Significant Follow up includes no new information.
12 hrs post injection- fever up to 102, chills, headache, nausea, sore arm 7 days post injection- small lump in left armpit, ultrasound completed, results indicated "probably" sebaceous cyst
Pain and swelling left deltoid. Started 12-24 hours after injection. No fever 4 cm x 6.5 cm with some induration. KEFLEX 500 mg TID x 10 days.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 4-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004991: US-009507513-2005USA004972: US-009507513-2005USA004992: US-009507513-2005USA004993:
Patient entered facility indecisive about which vaccine to take. Patient then decided to receive the Pfizer vaccine . An appointment was made for the patient to receive the Pfizer vaccine. Patient was escorted into the vaccination waiting area. I called, "next for Pfizer" then the patient answered and came to the vaccinating table. The patient only spoke Spanish, so I asked her to wait until the next Spanish speaking clinician was available. She was seen by the next available Pfizer vaccinating team who spoke Spanish. She received her Pfizer vaccine. After receiving the vaccine, the patient stated she did not want Pfizer, then stated she wanted Janssen.
4 hours after injection was not able to lift left arm. 3 days later am still not able to lift arm straight in front of me due to intense pain in shoulder, and it does not seem to be improving. I noted this to a medical professional who said that was not normal and I should report it.
Migraine Headache; Vertigo; could not walk or drive for 1.5 months; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine Headache), VERTIGO (Vertigo), GAIT DISTURBANCE (could not walk or drive for 1.5 months) and DIZZINESS (Dizziness) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced MIGRAINE (Migraine Headache), VERTIGO (Vertigo), GAIT DISTURBANCE (could not walk or drive for 1.5 months) and DIZZINESS (Dizziness). On 30-Jun-2021, MIGRAINE (Migraine Headache), VERTIGO (Vertigo), GAIT DISTURBANCE (could not walk or drive for 1.5 months) and DIZZINESS (Dizziness) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.  it was reported that patient had no side effects with Dose 1.   This case was linked to MOD-2022-457586 (Patient Link).
Headache inj site sore x4 days, HA, sweating, fatigue x8 days Narrative:
Patient began a fever of 101.2 degrees on Friday 4/17/2020 at 2:45 pm and her fever continued until present time. She had a seizure at 5:37 pm on Saturday 4/18/2020 which lasted 2 minutes. She was not breathing for the second minute of the seizure. She turned blue and completely limp. She eventually began to regain her usual color and was breathing on her own. Her fever after the seizure was 102.7.
injection site reaction as it occurs away from the site but I develop redness about 6-7 inches on the front of my arm; Initial information received on 05-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 77 years old male patient who had injection site reaction as it occurs away from the site but i develop redness about 6-7 inches on the front of my arm after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SAG 3V (FLUAD) for Immunisation.  On an unknown date, the patient received 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site for influenza (strength, formulation, expiry date: unknown).  On 02-Oct-2023 the patient had injection site reaction as it occurs away from the site but i develop redness about 6-7 inches on the front of my arm (injection site erythema) (unknown latency).  Reportedly, got the shot on Monday and did not develop this redness until 2 days after and don't have any fever, hives, or headache and  would think if  had a reaction to the vaccine that  would have it rather soon after the injection." Consumer stated he may be allergic to the thimerosal use in the multi-dose vials. Caller states this happened last year when he got the flu shot but it was not Fluzone HD it was Fluad Quadrivalent. He states "the redness was not getting worse and maybe a little better and last year the redness lasted a number of weeks until it went away." Consumer states "it may be a little warm but it is not swollen.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (injection site erythema).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event injection site erythema.
Information has been received from a licensed visiting nurse concerning a 77 year old female patient with no illness at the time of vaccination who on 22-DEC-2010 was vaccinated with a dose of PNEUMOVAX 23 (dose and Lot # not reported), IM, right lower deltoid, and a dose of ADACEL, IM, right deltoid. The nurse stated that on 23-DEC-2010 the patient experienced right arm pain, swelling, red and tender where ADACEL was given, patient was treated with KEFLEX 500 mg three times a day for 10 days, prednisone 20 mg daily for 5 days. There were no laboratories diagnostics performed. At the time of the report the patient had recovered from these symptoms. The patient sought medical attention emergency room / doctor visit. Additional information has been requested.
Sweats; Dizzy; Sluggish; Chills; Headache; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sweats, dizzy, sluggish, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, sweats, dizzy, headache and sluggish was not reported. This report was non-serious.
Approximately 2 hours after the injection I had  left facial numbness  Several hours later I had a  headache, fever & chills.
Redness around injection site, heat around injection area, swelling in entire arm, pain and numbness and tingling in entire arm.
Muscle and Joint pain about 24 hours after injection. Especially wrists and knees. Subsided after 6-7 hours but knees remained painful for days. Then a series of events over the last months since vaccine of muscle issues in my left leg and ongoing issues with my knees. I've been doing chiropractic, accupuncture, cryotherapy and massage. started a natural joint supplement and cbd to manage pain. This is all stuff that I've NEVER experienced and then heard another person had very similar issues since vaccine.
Hives and rashes on both arms, inner and outer side of both thighs, torso, underarm, both shoulders, lower and upper back.
Fever  fluctuating between 99 to 101 back and forth  Achey  Chills
lightheaded-couldn't think clearly slow motion, copper taste mouth; clammy, eyes dilated; did not feel well for over 24 hrs; tx at local hosp:DPH, EPI; poss allergic react to vax;
Per caller all patients, asymptomatic/ No additional AE's/PQC's reported.; Date of vaccination: 04/16/2021 / Was the vaccine resumed? Yes/ 5/12/2021; Caller reported a temperature excursion for frozen products. Caller notes PROQUAD administered to (3) patients; This spontaneous report was received from a nurse (vaccine provider), referring to a 1 year old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant therapy were not provided.  On 16-APR-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (lot # T010288 has been verified to be a valid lot number, expiration date reported as 20-SEP-2021) (strength not reported) at a dose of 1 (unit not provided), subcutaneous in the left arm for prophylaxis (incorrect product storage), which was the first dose and was administered by a healthcare professional from the reporter's institution. The healthcare professional was trained, and the vaccine was used according to the instruction leaflet. It was reported that when ordering the vaccine for state doses, digital data logger noted on 15-MAR-2021 an temperature excursion occurred at 16:58 for 3 hours and 54 minutes resulting in an elevation of temperature to - 6.8 degree Celsius. Data logger temperature was within normal limits (WNL) on 16-MAR-2021 when daily temperature was checked. There was no previous temperature excursion. On 12-MAY-2021, the vaccine was resumed (inappropriate schedule of vaccine administered). The reporter called for viability and reported that the patient was asymptomatic, and there's no adverse reaction. No additional adverse event (AE) or product quality complaints (PQC) were reported.   This is one of several reports received from the same reporter.
Low grade fever; This is a spontaneous report from a contactable consumer or other non hcp (patient's grandmother). A 14-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: FA7485, Expiration date: Unknown) via unspecified route of administration on 05Aug2021 as dose 2, single (at the age of 14-year-old) for COVID-19 immunization. Medical history included growth hormone therapy from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient had no prior vaccinations within four weeks. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: unknown, Expiration date: Unknown) via unspecified route of administration on 14Jul2021 as dose 1, single (at the age of 14-year-old) for COVID-19 immunization and experienced low grade fever. On 05Aug2021, the patient experienced low grade fever. Patient was not received any treatment. On 05Aug2021, the patient underwent lab tests and procedures which included pyrexia as 99 (he started fever about 99). The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
T.C. from mother 4/19/2006 States "arm is red, hard, itchy and swollen. Her son says that it does not hurt." Right arm where Dtap was administered. Encourage movement of arm, Benadryl and Tylenol.  Asked to call if it does not improve or go to doctors' office for evaluation. 4/20/2006 Mother took son to doctors' office state, "Arm red and swollen down to almost his wrist on his right arm."  States Doctor told her "he has a secondary infection."  Antibiotics given at that time.   4/22/2006 Right arm is not swollen, no redness and mother states "looks fine."
Patient said they had normal adverse side affects but then 5 days later her arm was still red and inflamed. After seeing a doctor she said they said it was Cellulitis. It may have been to poor shot placement and cleaning  technique.
I was feeling extreme fatigue on Tuesday  02/02/21 which I felt was just a normal outcome of the vaccine, though I had shortness of breath during a workout (I workout almost daily so this was not normal). This was already 5 days post vaccine so I also felt this was beyond the normal time frame to experience symptoms from the vaccine On Wed. I had a covid test to be sure I was ok, as I work in the clinic providing vaccine, that was resulted as neg.  I continued with some fatigue through out the week. On Saturday am, I awoke to a 3?x2?  welt that was itchy swollen and hot. I contacted my MD at that point.
Information has been received from a health professional concerning a 23 year old female patient who in November 2007, 2 months ago, was vaccinated with a second dose of Gardasil.  In November 2007, a few hours after the second dose was given, the patient felt weak and tired.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
On 5-29-13 at 9:30 pm mom reports pt appeared to be choking and spit-up clear liquid about 1/2 cup and 5-10 minutes later threw up clear yellow liquid. It appeared to mom that baby had passed out, was pale but awake couldn't hold her own head up, "rolled eyes" per dad then after this baby was quiet with eyes open, no noises, nor crying. Lasted for about 3 minutes. When paramedics got to patients home child was reacting normal. Patient was transferred to medical ctr. Chest X-ray-normal rectal temp 101.1 at hospital. Pt discharge home same nt.
I had standard side effects with the first vaccine-fatigue, headache, and soreness at the injection site. I had the same effects with the second but also had body aches, a low grade fever and facial twitches the first 2-3 days. I started feeling better but remained a bit tired. I started having episodes of  heart racing/palpitations and had dizziness about 3 weeks  after the second vaccine. I had  a feeling of syncope but did not pass out in early April and went to the ER. I?ve  continued to have episodes of light headedness/vision changes, heart racing, physical fatigue,  cold hands/feet, nausea, headaches, and anxious feelings. Episodes come and go snd are worse around my menstrual cycle. I have to lay down and elevate my feet until the incident passes.
BOOSTRIX and TD on may 18th 2021, another on May 18th 2022; MENVEO on may 18th 2022, after a year, another; BOOSTRIX and TD on may 18th 2021; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva659, expiry date 31st January 2023) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number h4y36, expiry date 12th March 2024) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and DIPHTHERIA VACCINE TOXOID + TETANUS VACCINE TOXOID (TD VACCINE) for prophylaxis.   Previously administered products included Menveo (received 1st dose on 18th May 2021 at 11 years old).   On 18th May 2022, the patient received the 2nd dose of Menveo and the 2nd dose of Boostrix. On 18th May 2021, the patient received the 1st dose of Boostrix and TD VACCINE. On 18th May 2021, not applicable after receiving Menveo and Boostrix and unknown after receiving Boostrix, the patient experienced overdose. On 18th May 2022, the patient experienced drug dose administration interval too short and extra dose administered. On an unknown date, the outcome of the overdose, drug dose administration interval too short and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 13-JUL-2022  Reporter's Comments: The health care professional reported that the patient received one dose of Menveo, Boostrix and TD-(unknown manufacturer) on same day and after a year the patient received another dose of Menveo and Boostrix. The reporter did not consent to follow up. Additional Supportive Information: The patient received the Boostrix dose earlier than the recommended interval, which led to shortening of vaccination schedule. The patient received another dose of Menveo, which led to extra dose administered. The patient received Boostrix and TD on same day, which led to overdose.
Patient was hospitalized at Facility on 5/27/2022 for COVID-19.  D/C from hospital 6/8/2022.   Death abstract indicates patient died on June 17, 2022 at hospice facility: HOSPICE/FAMILY HOSPICE. Death abstract indicates immediate cause of death: COMPLICATIONS OF INFECTION WITH NOVEL CORONAVIRUS (COVID-19) OTHER SIGNIFICANT CONDITIONS contributing to death but not resulting in the underlying cause: CONGESTIVE HEART FAILURE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, STROKE  Submitter does not have access to further medical records. If more information is needed, please contact above hospice location, or Hospital as previously listed.
Information has been received from a healthcare worker referring to a 12 month old patient of unknown gender. No relevant medical history or concurrent conditions were reported. On 15-JUN-2015 the patient was vaccinated with 0.5ml dose of VARIVAX (Merck) (unspecified lot# but could include lot # K026386, expiration date 15-DEC-2015 or lot# K020757, expiration date 31-OCT-2016) which had been exposed to temperatures outside of the recommended range, subcutaneously. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist via a company representative refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, lot#, expiration date and route of administration were not reported). On unknown dates, the patients experienced a local rash at the injection site. The patients were treated with BENADRYL and cortisone. Product quality complaint (PQC) was not involved. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
"Severe" arm pain around injection site and headache. Happens everytime I have had a tetanus shot. There has to be a solution. Luckily I don't have to work for the next few days because my arm can't be lifted up very high at all without excrutiating pain.
Left arm pain from shoulder to elbow, radiating down back and to breast. Tingling in both hands which is no longer present x 1 week. Additional info: syringe malfunction - plunger stopped at 0.2ml - patient only received 0.3ml.
small outbreak of hives on left side of stomach, roughly where waist band is.  About 10 blisters in about a 2 inch diameter area.  About another inch in diameter surrounding that area the skin is red.  Small discomfort yesterday.  Today less discomfort but a little itchy.  Used Chiggerix first yesterday because I thought it was bug bite.  Then used cortisone cream rest of afternoon and overnight.  Went back to Chiggerix at noon today after shower to help with itching.  Kept covered with gauze after applying the various creams.  24 hours in and appearance is the same.
Injection site tenderness, swelling; tiredness / low energy; intermittent nausea; feeling cold intermittently.  All of these have occurred since injection on 3/2/2021 (14 days).
Large area erythema & induration @ inject site approx 10cm diameter; Resolved p/48hrs;