chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 025L20A, 041L20A and 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:master case
This spontaneous report was received from a healthcare worker concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 05-JUN-2017, the patient was vaccinated with PROQUAD (rHA) lot number M029599, expiration date 10-DEC-2017, and with VARIVAX lot number M034583, expiration date 27-JUL-2018 (dose, frequency, lot number and expiration date were not reported) both for prophylaxis. The patient's concomitant medication included STERILE DILUENT. No adverse effects were reported. Additional information has been requested.
Pt stated before getting vaccine that she might "pass out". 20-30 seconds after vaccination, she stated, "things are going dark" and then lost consciousness. BP was 122/80, and pt woke about around 40 seconds later. After approx 3 minutes later, she was able to sit up. Water was given and she left after a 30 minute observation, walked out on her own.
Approximately seven days following second dose of Pfizer COVID vaccine, I began experiencing heart palpitations, elevated heart rate, chest pressure, difficulty breathing, shortness of breath, and dizziness.  Multiple "episodes" each day would occur without warning, did not relate to physical activity, or any other stimulus - would just happen throughout the day, often multiple times per hour.  Even to this day, more than 90 days following the second dose of Pfizer, there are multiple times each day when I feel chest pressure, heart palpitations, and slight shortness of breath.  It is not as common, or as severe as it was early on, but some symptoms remain.
Extreme vertigo, double vision, room spinning. Tingling, coldness and numbness in feet, and toe twitching. Swollen lymph nodes in breasts, bleeding & menstrual period after 13 days (from start of last period)
Several hrs after vaccine she developed severe HA, dizziness and shaking. Evaluated in office. TYLENOL given after 30 min symptoms improved. Back to normal approximately 4 hrs later. But had persistent HA, dizziness, nausea x 2 more days.
Rotator Cuff & Bicep Tear. Bacteria in Urine Developed neurological issues: Posterior leukoencephalopathy.
Received shots 3/13. 6:45AM 3/14 had seizure. No history of illness prior. Diarrhea followed seizure. Dehydrated in ER for IV on 3/16. 3/18 check up with the doctor to see how he's doing. Start of ear infection; put on antibiotic. 3/24 EEG. 3/25 results and check up with neurologist. All tests normal. had another seizure 3/30/03.
3 pm injection, 3:10 ears hot, 3:40 flush around mouth and swollen, 4 face starts to recede/improve, 4:30 hands very cold and mottled
patient had second shingrix vaccination yesterday.  patient called today and reported she had been out riding her bike earlier in the day, but then 3 hours later started to experience chills and fever.  Patient was advised to take a fever reducer to calm fever and discomfort and to follow up with her doctor if there were no improvements.
Tongue swelling and sore throat.  Patient took an Allegra with some partial sx relief.
he has sinus headache; This is a spontaneous report from a Pfizer-sponsored program via contactable consumer (Patient). A male patient of an unspecified age received BNT162B2 (Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergies. The patient's concomitant medications were not reported. The patient got 1st dose of the vaccine he was cautioned to not take any kind of pain medication day before or after, which he did not need/want to do. But now wants to know if ok to take something for his allergies, like a Sudafed because he has sinus headache. The outcome of event was unknown.   Information about lot/batch number has been requested.
This spontaneous report was received from a registered nurse refers to an actually 60 years old female patient with allergy to thimerosal. On 06-AUG-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number 0565AE, Exp. Date: 23-MAR-2013) (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that the patient went on vacation after receiving ZOSTAVAX on 06-AUG-2012, and at an unspecified time, in approximately August 2012, the patient developed a rash. It was stated that the patient was in contact with poison ivy and a wasp sting while she was on vacation but when the patient went to see a physician at an unspecified urgent care facility, the physician diagnosed the rash as a varicella-like rash in approximately August 2012. The patient called to registered nurse on 21-AUG-2012 and informed her of this occurrence. The registered nurse did not know if any treatment was prescribed for the experience and she did not known if the patient had recovered, however it was reported that the patient was recovering. The relatedness for patient was diagnosed with varicella-like rash on her back was unknown for ZOSTAVAX. Additional information has been requested.
Patient inadvertently received a 0.5 mL flu vaccine rather than a 0.25 mL flu vaccine. No adverse effects were noted afterwards.
Please note: I had similar symptoms after the first dose but after the second dose they are more intense.  Persistent headache pain 5/10 Body weakness/fatigue- difficultly going up stairs that I usually don?t have an issue with. SOB upon exertion.  Nausea&vomiting- persistent feeling of nausea; intense urges to vomit.  Loss of appetite- related to N&V Pain at injection site (right deltoid)- unable to raise arm, minimal ROM, pain 6/10 SOB- periods throughout the day of SOB, sometimes even while sitting simply doing desk work  Cough- non productive cough throughout the day   **please note- I recently had a COVID PCR completed through my work on Friday, January 29th.  I have no known exposure. I live alone and have not been out and about. We receive a daily antigen test upon arrival to our shift- these have all been negative as well.
Rash on the outer part of my right thigh, covering an area 3 inches by 3 inches, approximately.  Quite itchy.  Applied over-the-counter Hydrocortisone cream to the area.  The rash cleared up after two days.
On 1/23/21 at approximately 3:30pm I began to develop headaches.  Approximately 2-3 hours later I began to feel nauseous and began to vomit.  I then was taken to the Emergency Room where I had begun to suffer from an Addisonian Crisis where I was given Stress Dose steroids. The stress does steroids where given through 1/24/21 and medicine for the headaches are still be used to relieve the pain from the headaches. I was released from the hospital the late morning in the late morning of 1/25/21
Patient developed olecranon bursitis a day after Moderna injection in left arm.  Non infectious bursitis.
Immediately after the 2nd shot, Pt got extremely ill, tired no energy, over the next few days, she gained 20 pounds of fluid, and needed to go to the emergency room, where they gave her Lasix and drained 9lbs of fluid off in one evening. They then prescribed her 40mg of Lasix daily to keep the fluid off,  she has had cardiac appointments, needed two blood transfusions, blood counts at 4 and 7, and received an endoscopy to try and see if she is losing blood somewhere. Nothing has been diagnosed as of today, she has a cardiac appointment again on August 31st to see if her heart is damaged. In mid-August Pt needed to go to the ER again as the fluid retention has not stopped, we are going on 6 months and she continues to take Lasix. Fluid-like water now drains from her arms at all times. Pt now walks 100% with a walker can not stand to cook or get in the shower, she needs assistance with everything. She was fully functional prior to the 2nd vaccination.
Information has been received from a physician concerning a patient who started oral ROTATEQ. It was reported that the patient is over 12 weeks old. No adverse event reported. Unspecified medical attention was sought. No product quality complaint involved. Additional information is not expected.
On 12/3/99, approximately 48 hours post vax, the pt experienced 15 large marks on his palms and knees, and a prickly heat rash. He was scabbing over at the time of the report. No further information
20 Minutes after Rabies #3 injection pt had facial swelling, hives, rhinitis, threatening. Benadryl 50mg, PO given, 0.3ml epinephrine IM, O2 and transported to local ER via EMS.
Information has been received from a physician via Pfizer referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot#, dose and route were unknown) and experienced a arthus reaction with this vaccine. The patient's concomitant medication was not reported. The outcome of the event was unknown. The reporter considered the event to be related to PNEUMOVAX 23. Additional information has been requested.
onset 7MAR AM of pinpoint rash later becoming hive-like on arms, neck, inner thighs-over body itchy; called ER & told to take DPH (during noc); next day saw personal MD given cortisone; ?poss allergic rxn to ampicillin vs adverse rxn to MMR
Headache (severe), fever (102), body aches, fatigue - lasted approximately 24 hours. Rash was noted after symptoms abated (do not know if it had been there before).  Largest portion of rash is located not at injection site but below it. Rash measures approximately 4.5 X 3 inches and is warm to the touch.
Retired patient received routine ZOSTAVAX vaccine on July 9, 2015 (manufacture - MSD and lot #K015311) subcutaneously to left tricep region. He reported no adverse reactions until wife noted site red on Friday evening (1 day after vaccination). This site was pink and warm to touch. Over the next 24 hours this site became bright red with paler pink area surrounding the vaccine site to encompass 1/3 of his arm. He complains of intermittent tingling to his entire left hand - mostly in fingertips depending on arm position for 1-2 days. He has no tingling at this visit. He stated both the redness and tingling are already better by Sunday (yesterday). He denies any loss in ROM, weakness to left arm/grip, neck/shoulder pain, fever, headache, rash/hives, difficulty breathing, or any other systemic symptoms. He denied any trauma to area and was doing routine yard/pool maintenance when reaction occurred. He denied being bite by mosquitoes, or any insect. General overall feeling. No pain, no fever, and no chills. Neurological symptoms intermittent tingling left hand-fingertips depending on arm position. Skin symptoms rash, redness, swelling to left triceps region at vaccine site.
Pt injected / when needle retracted, most of) the content still in needle; This case was reported by a consumer via sales rep and described the occurrence of accidental underdose in a 2-month-old patient who received Hib (Hiberix) (batch number AF3TY, expiry date 20th May 2021) for prophylaxis.   On 4th May 2021, the patient received Hiberix. On 4th May 2021, unknown after receiving Hiberix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The patient was injected with Hiberix but when needle retracted, most of the content was still in the needle which led to accidental underdose. The reporter consented to follow up.
Pt stated, "feeling dizzy and hot" at 1:20pm while waiting at the observation area. Escorted pt to EMS. Had pt on the bed and took VS  BP 118/78, HR 75, 98% O2. Gave pt water and an ice pack.
-Right arm is sore and unable to move comfortably during daily routine and work. -Full body fatigue for 48 hours.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated 03/19/21 and has since received his second dose 04/09/21.
Light-headed at time vaccine administered twelve hours later severe stiff neck two days after shot back pain, feeling "out of it" and uncoordinated. On 6/18/07 reports she is improving.
On Saturday 9/19/2015 our daughter became really tired and slept 14 hours (which has never happened).  Then later on Sunday 9/20/2015 she was sleepy all day and around 3:30pm she woke up from her nap and started getting hives that started the size of mosquito bites and then morphed into the size of an egg. They were red and warm to the touch from her knees up to her rear.  We gave her Benadryl at 4:30 pm and the hives/rash went away.  By 7:30pm it was completely gone.  We took her to daycare and after she woke up from daycare at 1:30pm the teachers noticed the hives back again on her legs and arms.  I went to pick her up and by 2:45pm they were starting to go away without any medicine.  I went to the walk in clinic because her pediatrician could not see her and the rash/hives were all gone.  The nurse said she obviously couldn't really tell without seeing it in person (I had a picture) but to give her Benadryl again if it came but to then request allergy testing if they came again as its obviously something she is allergic too.  Neither the nurse or the pediatrician nurse thought it was related to the flu vaccine but I think it is as I saw that the reactions can be 7-10 days later.  There is just nothing else we can contribute the two episodes too where there is anything in common... Especially since she was so tired.  We think the effects just hit her later.  It would be nice to know if Benadryl is enough.
Was lightheaded, felt like I was drunk or high for 3 days, should not have been driving to and from work. Felt like sleeping all day. Could not go to work for a day and a half.
doses administered after excursion; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No concomitant medications were reported. It was reported a temperature excursion that occurred several days ago in the Freezer. It was found that vaccines were viable. The patient received the booster dose. No treatment medications were reported.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot # M000768, expiration date 05-JAN-2018) (dose and route unknown). The vaccine was exposed to 47.1 F for 160 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Stroke after receiving vaccine/multiple strokes after receiving; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke after receiving vaccine/multiple strokes after receiving) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke after receiving vaccine/multiple strokes after receiving) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke after receiving vaccine/multiple strokes after receiving) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment medication information provided.  Company comment: This case concerns a female patient of an unknown age no reported medical history, who experienced the unexpected events of multiple strokes after receiving the vaccine. The events occurred following an unspecified duration after the unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as details about dosing and scheduled was not disclosed. Causality for the reported events was not provided by the reporter. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Stroke is an adverse event of special interest.   This case was linked to MOD-2021-345450 (Patient Link).; Sender's Comments: This case concerns a female patient of an unknown age no reported medical history, who experienced the unexpected events of multiple strokes after receiving the vaccine. The events occurred following an unspecified duration after the unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as details about dosing and scheduled was not disclosed. Causality for the reported events was not provided by the reporter. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Stroke is an adverse event of special interest.
Blood blister; hands, feet, torso are covered and painful/soreness and tenderness of palms; has trouble with ambulation; torso are covered and painful; This is a spontaneous report from a contactable nurse (patient's daughter). An 86-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry: Mar2021), intramuscular in the left upper arm on 25Jan2021 13:30 at a single dose for protection against virus. Medical history included COVID from 18Nov2020 and ongoing (recovering/resolving). The patient's concomitant medications were not reported. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry: Mar2021) intramuscular in the left arm on 04Jan2021 for protection against virus with no problem. On 26Jan2021, patient had one tiny blood blister but now was covered in them. Her hands, feet, and torso are covered and are painful. The patient has trouble with ambulation and using her walker since. The palms of her hands are covered front and back too. The patient was also covered on her toes and areas of the abdomen around the umbilicus area. Had the first dose on 04Jan2021 and the second on 25Jan2021. Her mother has an appointment on 03Feb2021, and caller wanted to know if this is uncommon or a rare side effect. The reporter has found a couple of articles, but most of them refer to pediatrics and rashes and she didn't see any side effects about blood blisters for her mother's age group. Further stated that areas covered are progressively worse and disabling since her mother was using a walker to ambulate. Has not been able to really use the walker due to the soreness and tenderness of palms. Her mother had the disease (COVID) back on 18Nov2020 and was symptomatic and was mild. No other vaccines received the same time. No history of problems with vaccines in past. They can't think of nothing that was new, no new medications, lotions, creams, or detergents, nothing new. The events did not require a visit to emergency room nor a physician office. Onset date of events reported was on 26Jan2021 with outcome of not recovered. The reporter assessed the seriousness of events as disability. The events were assessed as related to vaccines.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.