chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported.; Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to patients before calling.; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-FEB-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, lot# W019627 and expiration date was estimated to 19-DEC-2023 (strength and exact dose were not provided) administered intramuscularly for prophylaxis.  Reporter called for a temperature excursion and reported measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) that had undergone temperature excursion was administered to patient (product storage error). No additional adverse event (AE) was reported.  Lot number [W019627] has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD)   This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114:
No additional adverse event; a patient was inadvertently administered an expired MMR II; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medication and drug reactions/allergies was not provided.  On 12-AUG-2020, the patient was inadvertently administered an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (strength, dose and route were not reported; lot # R014690 and expiration date 23-MAY-2020) for prophylaxis (expired product administered). The sterile diluent (MERCK STERILE DILUENT) that was used to reconstitute the vaccine was not expired. No additional adverse event. The outcome of expired product administered was unknown.
Patient passed out with associated convulsions within 2 minutes of vaccine being administered.  No previous Hx of this post vaccination but did occur once after donating blood. Patient was lowered to flat position on floor.
pt. was given Janssen covid immunization, asked pt. to sit for 15 min. in waiting area, noticed pt. pacing the floor and a little pale asked if he was ok and pt. stated yes, checked back on him 2 min later and noticed him starting to slump in his chair, ran to pt. and upon approaching pt. he started to have a seizure, pharmacist and myself stayed with pt while another employee called 911 due to seizure and pt. hitting his head on the floor. checked pt. for pulse and while checking pt. started to come to and tried to get up, had pt wait for ambulance. pt was told by EMS that his heart rate was to low and his EKG was abnormal. pt. signed against medical advice with EMS and refused to go to the hospital. from time of injection to fainting/seizure was about 5min, ambulance arrived in less than 5 min. seizure lasted about 10 seconds.
1st dose in 2021, 2nd 26Nov2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number Z7GH5, expiry date 25th January 2024) for prophylaxis.   Previously administered products included Shingrix (had received their first dose of Shingrix in 2021).   On 26th November 2022, the patient received the 2nd dose of Shingrix. On 26th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comment: The reporter called in to report that, a patient wished to know, under these circumstances, how to proceed with the vaccine schedule and if the doses were still valid.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient received the 2nd dose of Shingrix later than the recommended schedule which led to lengthening of vaccination schedule.
Patient had severe fatigue and poor appetite following vaccination for 1 month, upon having blood work done on 3/11/2021 patient was found to have pancytopenia and was sent to the hospital. Patient had a platelet count as low as 4, and required multiple platelet transfusions along with PRBC transfusion. Patient believed to be having an immunologic response to the 2nd moderna covid vaccine.
FELT A BIT WARM; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine (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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced felt a bit warm, and headache. The action taken with covid-19 vaccine was not applicable. The outcome of the headache and felt a bit warm was not reported. This report was non-serious.
G47.33 OBSTRUCTIVE SLEEP APNEA 4/3/2023 SEVERE OBESITY
MISSED TO TAKE A DOSE OF VIVOTIF ON DAY 3; This spontaneous case (PVX2019-1301) was received from a pharmacist on 22-May-2019. It describes a 12-year-old female consumer who "missed to take a dose of Vivotif on day 3". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer missed to take a dose of Vivotif on day 3 (21-May-2019).  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed to take a dose of Vivotif on day 3" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take a dose of Vivotif on day 3" was considered as not applicable.
Client experienced swollen lower lip and (L) side of face with dull pain and tingling sensation. Client took no treatment.
hospitalized following full immunization, vaccines given 2/12/2021, 3/13/2021 and 8/31/2021
pt recv vax 2AUG96 & devel redness @ inj site;w/in 6wk of vax pt became pregnant (LMP 31AUG96);estimated date of delivery is 8JUN97;
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on unknown date). On 20th February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd shingles shot and the site was red and hot to touch like a sunburn. The reporter wanted to know how long it will last.
Redness, Swelling and itching rash at the injection site 1 week post vaccination
The patient developed a painful ulcer on his tongue, presented as a raised bump on the left side of his tongue, symptoms began approximately four days after receiving the Moderna vaccine. Was prescribed triamcinolone acetonide paste two days after onset of symptoms, after visiting a walk-in clinic because of reduced ability to eat or drink due to pain. The doctor at the clinic requested we report the symptoms due to the timing after receiving the vaccine.
Injection approximately 0855 Reaction at 0900 Dizziness, blurry vision, feeling of heaviness to body. Blood pressure slightly elevated 159/82  P 88 100% Os Sat RA. Provider notice slight swelling to uvula, however airway open, slight swelling noted to face. Slight cough noted. Patient was given oral Pepcid, and IM Benadryl. After monitoring for 1 1/2 hours patient felt better BP within normal range 128/73 P80 96-100 % 02 Sat RA. No redness, swelling or pain to injection site.
Acute new onset congestive heart failure with global hypokinesis presenting as orthopnea and leg swelling. Symptoms developed over 1 week. Currently being treated with furosemide. Cardiology evaluation pending.
From telephone correspondence rec'd on 9/17/02, it was reported that a pt (L.B.) rec'd her 4th dose of Tripedia on 9/12/2002 in the thigh. On 9/14/02, the child's mother brought her to the doctor's office with a swollen and red thigh (area measured 14X13cm). Ice and warm soaks were recommended, as well as children's tylenol. A date of birth was not reported for this child and the initial source document notes 2 different ages (4 yrs and 10 mo). No additional info was provided and it was not reported whether the child recovered.
3:00pm - immediately sore arm & feeling ?high? 5:00pm- feeling off, dull headache 7:00pm - severe chills, headache, fever 99 9:00pm - fever 103  9:15pm - fever 106, took aleve, vomiting, pulsing headache 9:45pm - diagnosed with hyperpyrexia, directed by doctor to take ice bath & place ice packs around joints while sleeping, fever dropped to 103 10:15pm - directed by doctor to take Tylenol Extra Strength, fever 103 10:40pm - fever 101  7am - fever 99, extreme body aches (feeling of being hit by a bus) 9am - fever 102, ice packs , headache, took Tylenol 5pm and thru night - nausea, chills, fever 100  Extremely fatigued, extremely sore, on/off nausea, on/off headache for 2 -3 more days. Started feeling mostly better by Sunday evening.
Patient presented to the ER following allergic reaction to intranasal influenza vaccination.  Patient developed itching over abdomen and arms, but no real rash.  School nurse gave the patient two doses of liquid Benadryl 12.5mg each.  The child fle t some difficulty breathing, but no difficulty swallowing.
Error on vaccine documentation. It was documented as Pfizer 12+ lot # FL8095. This vaccine was actually not administered. Patient received Pfizer Orange cap Lot# FL8095 L deltoid. No reactions.
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 22-Apr-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.            No concomitant medications were reported. Treatment information was not reported.
vertigo; unable to walk a straight line, and his gait was unsteady; nausea; Initial information was received on 11-Sep-2020 regarding an unsolicited valid non-serious case from retired Doctor (patient) via phone.  This case involves a male patient (age was not reported) who experienced vertigo, nausea and was unable to walk a straight line, his gait was unsteady (gait disturbance), while he received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious vertigo, nausea and these were so severe that he had to lay down and was unable to walk a straight line, his gait was unsteady (gait disturbance), 1 to 2 weeks following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Magnetic resonance imaging (MRI) done on an unknown date and exact result was not reported however patient's physician thought that reactions were related to the Flu vaccine and it was a type of immune reaction.  It was not reported if the patient received any corrective treatment.  On an unknown date approximately a month after, the patient had recovered from all the events and these reactions not re-occurred to the patient.  There will be no information available on the batch number for this case.
I also had a mild headache after the first shot for a week or two; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 08:45 (Lot number: en6199) as dose 1, single for covid-19 immunisation. Relevant medical history included: "mild, cough-variant asthma" (unspecified if ongoing); "Hay fever" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN B [VITAMIN B COMPLEX]. The following information was reported: HEADACHE (non-serious), outcome "recovering", described as "I also had a mild headache after the first shot for a week or two". Therapeutic measures were not taken as a result of headache.  No follow-up attempts are possible. No further information is expected.
backache/back pain; chills; shoulder and stomach ache/joint pain; shoulder and stomach ache; Pain in arm; tired; Headache; muscle pain; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Feb2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that experiencing side effects such as backache, chills, shoulder and stomach ache on an unspecified date in Feb2021. Pain in arm, tired, Headache. muscle and joint pain and chills and back pain on an unspecified date in Feb2021. The outcome of the events was reported as unknown.
No additional AE; HCP administered VAQTA to a patient that was improperly stored overnight in the refrigerator. Vaccine had been activated the previous day and was stored with a needle attached and administered the next day; This spontaneous report has been received from a medical assistant referring to a 16-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant mediations and drug reactions or allergies were not reported.   On 15-JUN-2023, hepatitis a vaccine, inactivated (VAQTA) had been activated and was stored with a needle attached.  On 16-JUN-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (0.5 milliliter (mL), strength, lot#, expiration date, route and anatomical were not reported) for prophylaxis, which was improperly stored overnight in the refrigerator (product storage error). No additional information was provided. No additional adverse event and no PQC was reported.
I experienced  a breakthrough case of COVID-19 with fever, chills, tiredness and extreme diarrhea.
7:30 the night after the vaccine he got very lethargic and dizzy. And about thirty minutes later he couldn't he lift his right arm or right leg. He was extremely dizzy and not completely coherent. I took him to the hospital where they ran CAT scans and labeled it a TIA.
About 1.5 hours after I received both vaccines, my heart rate spiked, I got extremely dizzy and thought I was going to pass out and was rushed the the hospital.  I felt like I was having a heart attack because of the chest pains, muscle spasm and inability to talk.
Pt admitted on 7/9/2021 with cellulitis and abscess of right leg after receiving second dose of vaccine on 7/1. Per guidelines, all hospitalizations are reported.
(L) arm to hand / fingers swollen, and painful. Symptoms began within 3hr post injection per pt, sling, ice, Vicodan PRN for pain.
I tested positive on 01/22/2021 and hospitalized on 01/27/2021. I was critically ill and spent time in the ICU. I was released to rehab on 02/15/2021 and released to home care on 03/08/2021. I had care until April 04/20/2021. I had still been having some weakness and I was on Oxygen at night. I was told I did not need it anymore. My lungs were clear in early May when I saw the Pulmonologist. I got the first dose of my vaccine one week later. I had flu like symptoms for 24 hours. After I got the second dose of the vaccine my legs seemed to be weaker, and I felt very unsteady on my feet. It started one week after the second dose. I felt like it was a setback. During that week I also started to have hair loss. My hair has been coming out in clumps. I have ordered a wig. It has been four weeks and I still have back pain and weakness. I am not sure if my symptoms are due to Covid-19 or if is the vaccine. I have improved a little.
This spontaneous report as received from a certified medical assistant refers to a 14 years old female patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (lot # not reported). No adverse effect reported. Additional information has been requested.
Severe vomiting and diarrhea approximately 13 hours after injection, lasting 8 hours through the night.  Vomiting and diarrhea approximately every 30 minutes until vomiting bile.   Fever of 99.8 and  high heart rate of 98 (my normal hear rate is 72).  Occasional vomiting on day 2 after the vaccine.  Injection on Tuesday, felt well again by Friday morning.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 3:36 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021 at 3:36 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patients were given doses from vials that were stored in an ultracold freezer which was colder than should had been. Vaccine was stored in an ultra-cold freezer at minus 82 degrees Fahrenheit. Storage condition at the time of the excursion was frozen storage and excursion duration was 1 month.  Date when vials moved from freezer to refrigerator was 19-Nov-2021 and Moderna COVID-19 vials went from the super cold freezer to the refrigerator. No vaccine state changes were noticed, and vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.  No concomitant medication was reported. No treatment information was provided.   The patient was administered vaccine that was stored at temperature between minus 80-degree F to minus 84-degree F. It was unknown if patient had allergy to medications, food, and other products. It was unknown if the patient was ever diagnosed with or tested positive for COVID-19. Patient's acute illness at the time of vaccination and up to one month before was unknown. Chronic or long-standing health conditions were unknown. Prescription, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination and or at the time of the adverse event was unknown.   This case was linked to MOD-2021-402935 (Patient Link).
As reported by Employee on 6/21/2021: "Nausea, fatigue" Narrative:
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective; patient was treated with PAXLOVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
"I" have Rheumatoid Arthritis. It's been3 days since "my" vaccine and all of "my" RA symptoms are gone!!! "I" haven't felt this good for about a year!! "My" inflammation is completely nonexistent right now!; "I" have Rheumatoid Arthritis. It's been3 days since "my" vaccine and all of "my" RA symptoms are gone!!! "I" haven't felt this good for about a year!! "My" inflammation is completely nonexistent right now!; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG198) via an unspecified route of administration in the left arm on 27Feb2021 at 11:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, degenerative disc disease and known allergies to penicillin. 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 COVID vaccine. The patient received unspecified medication within two weeks of vaccination. On 28Feb2021, It was reported that the patient had rheumatoid arthritis. It had been 3 days since her vaccine and all of her rheumatoid arthritis symptoms were gone (pre-existing condition improved and unexpected therapeutic benefit). The patient had not felt this good for about a year. Her inflammation was completely non-existent at the time of reporting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events patient had rheumatoid arthritis. It had been 3 days since her vaccine and all of her rheumatoid arthritis symptoms were gone (pre-existing condition improved and unexpected therapeutic benefit). The patient hadn't felt this good for about an year. Her inflammation was completely non-existent right now was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.