chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other adverse events reported; Caller reports that a patient was administered an expired MMR II today.; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drugs reactions or allergies and concomitant medications were not provided.  On 03-MAR-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-R II) subcutaneous injection (valid lot number U006489 with an expiration date on 26-FEB-2023) (dose, route of administration, strength, frequency, and anatomical injection site were not provided) for prophylaxis (expired product administered), and sterile diluent (STERILE DILUENT)  (valid lot number W010864 with an expiration date on 23-OCT-2024 or valid lot number W010871 with an expiration date on 17-NOV-2024 [conflicting information both lot number were reported, the reporter was unsure which was used]).  No other adverse events reported.
Got both doses, had a shinlges-like rash/Suspected vaccination failure; Shinlges-like rash, mild case; Shinlges-like rash, mild case; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 23-Jan-2023 Reporter's comment: The reporter spoke with the front desk coordinator and she shared with him/her that she got both doses of Shingrix and after the 2nd dose, she developed a shingles-like rash but stated it was very mild. The reporter did not consent to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.  In worst approach shingles and rash both events were coded as no clarification could be obtained from the reporter as reporter denied for the follow-up.
Extreme head pressure, headache, ringing in ears, clogged ears, chronic fatigue, hightened/more severe seasonal allergies, additional vision impairment. All symptoms lasted for months, resulting in need for hearing aids (additional hearing loss: currently at 85%, up from previous 40%--hearing aids prescribed on 02/14/2018). Also ultimately resulting in need for ear tubes to treat ear pressure (ENT tested ears, ear damage confirmed on 08/16/2018, tubes inserted on 08/21/2018). NOTE: This vaccine was given, then afterward was discovered to be a "bad batch". The shot was given again on 10/11/2017 (lot #195216), when symptoms started. Because it is unclear which vaccine caused reactions (or both), both are reported.
Patient with a meningoencephalitis of unknown etiology. She had a 3 day hospitalization at a local facility in and was transferred to hospital where she was hospitalized for an additional 5 days.
Sore arm at injection site - lasted from 5 hours after injection til more than 46 hours after injection) fever (101 F) - lasted from 8 hours after injection til 30 hours after injection) headache - lasted from 14 hours after injection til 28 hours after injection)
No adverse event; primary series vaccine/ Patient had received Moderna COVID-19 vaccines with monovalent presentation as booster doses on 10 oct 2022 who intended to received bivalent vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (primary series vaccine/ Patient had received Moderna COVID-19 vaccines with monovalent presentation as booster doses on 10 oct 2022 who intended to received bivalent vaccines) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (primary series vaccine/ Patient had received Moderna COVID-19 vaccines with monovalent presentation as booster doses on 10 oct 2022 who intended to received bivalent vaccines). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (primary series vaccine/ Patient had received Moderna COVID-19 vaccines with monovalent presentation as booster doses on 10 oct 2022 who intended to received bivalent vaccines) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (primary series vaccine/ Patient had received Moderna COVID-19 vaccines with monovalent presentation as booster doses on 10 oct 2022 who intended to received bivalent vaccines).    No concomitant medication was provided.  The patient was above 65 years of age.  The dose was given by intramuscular injection at 0.5mL between 8:30-9:00 AM on the day of this report. The patient was intended to receive the bivalent dose but were given monovalent vaccine as booster dose.  Treatment medication was not provided by the reporter.  This case contains information for the 2nd of 3 male patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-656971, US-MODERNATX, INC.-MOD-2022-656976 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-656971:(Same reporter) US-MODERNATX, INC.-MOD-2022-656976:(Same reporter)
12 year old received Janssen Covid 19 vaccine when current indication is only for 18 years and older. patient has no side effects so far
Information has been received from a nurse practitioner concerning a 73 year old female diabetic with thyroid disease and "cholesterol" and no known drug allergies who on 20-NOV-2006 at 10:00 AM was vaccinated with a first dose of Pneumovax 23 (lot # 651148/0087F) (0.5 ml), intramuscularly in the right arm. Concomitant therapy included metformin, glyburide, SYNTHROID and ZOCOR. There was no illness at the time of vaccination. On 20-NOV-2006 the patient experienced severe pain in the upper arm which persisted for four days. There was no redness or swelling. The patient took LORTAB with no relief. The patient recovered. Additional information is not expected.
pt recv vax 27MAY97 & 4 days later devel bilat joint pain & swelling of hands & wrists;tx w/OTC anti-inflammatory agent;
I could not wake up in the morning on 9/4/21, it was physically hard to get out of bed, the left side of my body was numb, my left eye would not open, I could not walk properly, my speech was slurred, I could not communicate.
only gave the liquid component of the DTAP and IPV,the ACTHIB portion was not administered with no adverse event; only gave the liquid component of the DTAP and IPV,the ACTHIB portion was not administered with no adverse event; Initial information received on 01-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient who while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and it was noticed that the patient was only given the liquid component of the dtap and ipv,the acthib portion was not administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination.  On 15-Jul-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot U7197BA, expiration date: 28-Jan-2023 via intramuscular route in the left thigh as Immunization.  On 15-JUL-2022 the patient developed a non-serious only gave the liquid component of the dtap and ipv,the acthib portion was not administered with no adverse event (incorrect dose administered) (product preparation error) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE  Nurse stated that a MA (medical assistant) was supposed to give a 2 month old patient VAXELIS, Prevnar, and Rotovirus, however the MA gave the 2 month old patient Rotovirus and PENTACEL instead. As a result the 2nd Hep B vaccine was not administered. The nurse believed that the confusion happened because they just recently switched from Glaxo Smith Klein to Sanofi. Upon attempting to give the patient PENTACEL, the MA only gave the liquid component of the DTAP and IPV. The ACTHIB portion was not administered. The nurse asked how the remaining ACTHIB portion could be administered. The nurse asked if Pedvaxhib and ACTHIB are equivalent. She asks if it safe to give PENTACEL at 18 months instead of just DTAP and HIB, because it would result in an extra IPOL injection.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
feeling light headed; sinus pressure; reports nausea; has slowed down & still constipated".; still constipated; bending down; weak and tired; This is a spontaneous report from a contactable consumer (patient herself) from a Pfizer sponsored program  Pharmacy Sutent and assistance Program. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation; palbociclib (IBRANCE), via oral route from 04Mar2021 (Batch/Lot number was not reported) and was ongoing, at 75 mg every other day (21 days on/7 days off) for breast cancer. The recommended dose was 125mg daily, 21 days on/7 days off as per the prescribing information. The patient's medical history included breast cancer and had problems with sinuses in the past. Concomitant medication(s) included fulvestrant (FULVESTRANT). On an unknown date, the patient was feeling lightheaded, a little dizzy when position changes, sinus pressure, nausea, has slowed down, still constipated, bending down. All the events were considered to be medically significant. Patient reports about a month ago, feeling very exhausted, real weak and tired. The patient went to the emergency room and was given 1pint of blood. Doctor instructed patient to restart current ibrance cycle 04Mar2021, 75mg every other day (ten tablets) + one week off to see if it improves red counts. Patient reports feeling "improved energy levels. The doctor was aware of dosing history of ibrance: 100mg dose on 18Nov2020-Jan2021; 75mg dose 21 days on/7 days off 04Feb2021. The patient underwent lab tests which included on an unknown date, blood test which was found to be low and oxygen saturation was low and on 22Mar2021, the results of red blood cells were pending. The outcome of all the events was unknown.  Information about batch/ lot number has been requested.
On Nov 17 about 10am slight rash below injection site; On Nov 19 about Noon my arm was very hot and at 1:pm Pharmacists saw that the area below the injection site was very red and hot to the touch; After 24 hours of intermittent icing location and not sleeping on that right side the redness and heat had lessened. Photos are available by request.
Patient had his WCE and immunizations 2 days ago, has been running fever since Temp 103-103.5 degrees, only goes down to about 101 degrees. Patient has been fussy, not drinking much had low grade fever with first set of shots.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   HCP stated, no AE as a result of this misadministration, patients were monitored. Date the vial was initially stored in the refrigerator: 04Nov2021 Date(s) of administration of vaccine: Some 05Nov2021 and the other doses on 12Nov2021 Did the vial undergo any temperature excursions?: No  No concomitant drug information was provided.
Fever up to 102.3 Hot flashes Chills Nausea and vomiting Sore muscles Headache
Pt received vaccine and was waiting in IMZ waiting area for approximately 30 minutes, due to waiting on mother receiving vaccine. Pt complained of headache and warm feeling in legs. BP was taken at 35 minutes post vaccine and was 97/56. Pt given 6 ounces of apple juice. BP taken again at 45 minutes post vaccine and was 97/60. Pt and mother refused for paramedics to be called and said they would go to urgent care to get checked out. pt said warm feeling in legs was just slightly "weird" but not painful or uncomfortable. Was not dizzy and gait was normal when walking around. Headache subsided after finishing apple juice.
Started with quarter size red, hard spot around the injection site.  Increased in size to more Golf ball size as week progressed.  Husband is ER physician and has been treating it at home but patient wanted to make sure it was reported via VAERS
h/a for approx 2wk p/vax;started one day p/vax given;
I woke around 06:00 in the morning to severe pain in my stomach, my deltoid muscle where I received I injection, my trapezoid muscles. My lymph nodes on both sides are swollen but the left side are so swollen, I am unable to do anything. I went to the doctor and was given pain medication and muscle relaxer, so I am able to be to be comfortable and sleep. I have tried icing the muscles this only irritates the muscles. Heat does not help either. When the contractions from the muscle spasms happen, I am rendered helpless.
Swelling of lips, outer eye, took 25 mg Benadryl. BPs 140/90 (pulse 64); 122/70 (pulse 65).
Vaccinated with 0.5ml of Janssen vaccine. At approximately 0600 became diaphoretic and disoriented. Obtained V/S: BP 110/70 HR: 55 SpO2: 95% RR: 30 AOx4 PERRLA. Patient remained with staff for 30 minutes to monitor any changes in V/S. RN arrived on scene and assessed patient. Patient cleared to return to work.
Fever (temps reached 100.2); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 18Dec2021 10:30 (Batch/Lot number: unknown) at the age of 7 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Asthmatic" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE; fluticasone propionate (FLOVENT); FLONASE [FLUTICASONE PROPIONATE]; POLYVISOL [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL PALMITATE;RIBOFLAVIN SODIUM PHOSPHATE;THIAMINE HYDROCHLORIDE] taken for vitamin supplementation. The following information was reported: PYREXIA (non-serious) with onset 18Dec2021 17:30, outcome "recovered" (Dec2021), described as "Fever (temps reached 100.2)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that the patient had a fever lasting from the day of injection through 3 consecutive days (as reported). Temps reached 100.2 but would have been higher if not controlled by ibuprofen (100 mg/5 mL) 11 mL, 6 hourly administration (orally) for 3 days. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Rt deltoid w/hard, red and edematous area about 6-8cm round, very tender. Tx: w/Benadryl cream.
Immunization given Early, Monitored patient who has reported not signs or symptoms at this time. Outcome is positive.
GAVE PATIENT MODERNA COVID VACCINE FOR THIRD SHOT(PATIENT STATES IMMUNOCOMPROMISED). PATIENT RECEIVED PFIZER COVID VACCINES FOR FIRST 2 SHOTS
Pt said that she has a silver dollar size rash at the injection site that is very itchy. It is still getting worse and not getting better.  She will be following up with her doctor.
Sore arm; They reconstituted Pfizer covid vaccine with sterile water instead of the normal saline and administered to 6 patients; They reconstituted Pfizer covid vaccine with sterile water instead of the normal saline and administered to 6 patients; This is a spontaneous report from a contactable pharmacist. This was regarding patient 2 of 6. A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3248, Expiration date: Apr2021, NDC number: 59267-1000-01), via an unspecified route of administration in left arm on 03Feb2021 at 0.3 mL, single for prevention/ COVID-19 immunisation. The patient's medical history and concomitant medications were none. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EJ1686, Expiration date: Mar2021) at 0.3 ml, single dose in left arm for COVID-19 immunisation. Calling about COVID-19 vaccination. Yesterday (03Feb2021) they mistakenly used sterile water as a diluent and administered it to six patients, so she wanted to report that and talk to someone about what needs to be done. Caller states she thinks everyone getting the COVID shot was getting a sore arm on an unspecified date. This was the second dose. Caller wanted to know if they need to revaccinate those 6 patient again, so they are protected. The caller (pharmacist) stated that they reconstituted Pfizer COVID vaccine with sterile water instead of the normal saline and administered to 6 patients. Investigation assessment was none. The events were considered as non-serious by the pharmacist. The outcome of the events was unknown. A causal relationship between bnt162b2 and sore arm was assessed as being related by the pharmacist.
Inconsolable crying soon after 4 month vaccines were given. Crying all night. Advise TYLENOL 0.8 ml - helped for 1 hour.
Fever; Migraine; Joint pain; Weakness; Swollen lymph node in an of injection; This is a spontaneous report from a contactable healthcare professional. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 07Aug2021 at 12:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, depression, chronic back pain and unspecified allergy. The patient received unspecified other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Aug2021 at 08:00, the patient experienced fever, migraine, joint pain, weakness and swollen lymph node in an of injection. The events did not result in doctor or other healthcare professional office/clinic visit/emergency visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, migraine, joint pain, weakness and swollen lymph node in an of injection were not recovered at the time of this report.  The batch/lot number for BNT162b2, was not provided and will be requested during follow up.
Myalgia, Arthralgia, Fever, Localized arm pain, sense of smell & taste changes Narrative:
Got the vaccine and was feeling tired, and her arm hurt, an all she wanted to do was lay in bed with her heating pad.  The following day she woke up with a headache, some nausea but nothing came up.  She also had diarrhea and her arm was sore.  She felt weak, and since she had COVID she has had shortness of breath.   She stayed in the bed all day unless she had to as her arm felt like it was made of metal and was extremely tired.  She was moving around upstairs and somewhere around 8:00 PM she went to the bathroom, was sweating profusely and wiping herself with tissue, and apparently turned out the light and apparently passed out as she woke up on the floor in the hallway and could not get up right away.   She could not use the left arm, was able to get herself up with the help of the door to stand on her feet.  She walked into her room and sat on the bed, and did not lay back down and greatful that she did not fall down the steps.  She went back to bed, but in the morning she was terrified and her family heard her talking to the doctor on call who told her to go to the ER.  In the ER they told her that she had syncope, seen by Dr. at Health Care.  She was admitted at 11:11 AM on 2/27/21.  She was given IV, had a CAT scan of her head, told her that it did not reveal any blood.  After several hours they discharged her.  She called her doctor and she has an appointment tomorrow morning.   She is feeling tired, not sleeping well.
General muscle soreness and body aches, chills and headaches, similar to ?coming down with the flu? - lasted 36 hours
Flublok Quad. vaccine given to patient under 18 years of age. Only 12 at time vaccine given