chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; inadvertently adminsitered 2 doses of the Spikevax (PFS) to one patient today; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (inadvertently adminsitered 2 doses of the Spikevax (PFS) to one patient today) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch nos. 3030536 and 3030536) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer in April 2022, Pfizer in May 2022 and Pfizer in May 2023. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concomitant products included INFLUENZA VACCINE and RSV VACCINE for an unknown indication.   On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 28-Sep-2023, received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) dosage was changed to .5 milliliter. On 28-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced ACCIDENTAL OVERDOSE (inadvertently adminsitered 2 doses of the Spikevax (PFS) to one patient today). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (inadvertently adminsitered 2 doses of the Spikevax (PFS) to one patient today) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (inadvertently adminsitered 2 doses of the Spikevax (PFS) to one patient today).    They want to know if there would be any adverse events or if they need to watch out for anything on the patient. Treatment medications were not reported.
leg is peeling and is blistery; hand has blister on it and they itch; hand has blister on it and they itch; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing and she takes warfarin, allergic reaction from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took warfarin for chronic obstructive pulmonary disease (COPD). On an unspecified date, the patient reported her leg is peeling and is blistery and her hand has blister on it and they itch. The patient stated she called in to the doctor. Patient stated she told the facility of where she got the vaccine that she has COPD and she takes warfarin. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt states that she fell asleep, woke up arms was sore, was cleaning around the house, later that night, left arm started hurting, was very sore, could not lift left arm up, then woke up next morning for work and arms was very red and swollen. Went to pharmacy, was told she had a reaction to it. Put a hot rag on it last night, helped decreased the soreness. States that left arm is still sore and very warm, but it has improved.
Patient husband came in today to report patient has been extremely sick with "all the COVID symptoms" since receiving 3rd dose. Has not been able to get out of bed. Asked us to report the occurrence. States contacted the physician.
swelling/ pain in area of left armpit lymph node; Fatigue; General malaise; pain in arm where injection occurred; Headache; Chills; aches; This is a spontaneous report from a contactable consumer (patient).   This 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route in the left deltoid, on 08Feb2021 15:15 (at the age of 43-year-old) at single dose for COVID-19 immunisation, administered at Workplace clinic. No relevant medical history were provided. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), administered via an unknown route in the left deltoid, on 20Jan2021 14:00 (at the age of 43-year-old) at single dose and developed swelling/pain in armpit of injection arm on 21Jan2021; flu shot last vaccination was annual flu shot in Sep/Oct2020 with no side effects. The patient did not have a relevant concomitant medications. No other vaccine was received in four weeks. On 08Feb2021 at 18:30, the patient developed pain in arm where injection occurred, headache, chills, aches, fatigue and general malaise. On 09Feb2021 at 18:00, the patient developed swelling/pain in area of left armpit lymph node. The events did not require physician office visit/emergency room visit. The patient was not hospitalized for the events. The patient had recovered from 'headache', 'chills', 'aches', 'fatigue', and 'general malaise' on 10Feb2021. The patient had recovered from 'pain in arm where injection occurred' on unknown date in 2021 while the patient had recovered from 'swelling/ pain in area of left armpit lymph node' on 15Feb2021.  No Follow-up attempts are possible. No further Information expected.
24 hours after vaccines went to on-call doctor temp 101, dizzy, dehydrated, urticaria rash left cheek, b/p lying 113/55 sit 105/56 stand 98/50 probable vaccine reaction vs mild viral illness.
Site: Redness at Injection Site-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Vaccine site looks like a recent scab. Patient claims there is no discharge and has not scratched the area. The scab has not healed in the past 6 months since the patient got the vaccine. It does not look infected. Patient was recommended to see a doctor since it has not healed after so many days.
PT EXPERIENCED NAUSEA AND VOMITING DAY OF VACCINATION AND HAD DIARRHEA NAUSEA AND VOMITING THE DAY AFTER
got sick after 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, 'MANUFACTURER UNKNOWN'), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick after 2nd dose".  Additional Information: Reporter (Patients wife) was reporting about the Covid 19 Vaccine. Reporter stated that she got the shot last Mar and Apr. She got marble sized lumps under her arm after the 1st shot, and after the 2nd shot on 16Apr2021 she got a grapefruit sized lump and it's still there. Stated that she doesn't have any health insurance, but she did go to one doctor who looked at some cells under a microscope and said that she didn't see any cancer or anything. Caller states that she has not had any blood tests done because she can't afford it. During the call, Reporter stated that her husband got sick after his 2nd dose, but she did not.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother ph'd from cell out of country. Child developed rash on trunk mostly lt. side of body, slight temp not hot touch, rash on face and body. Will be out of country for 1 month and was concerned. C/O headache (today), advised to take child to Dr. Ph'd 6-4-07 to check on child - rec'd voice message. Called 9 more times.
Made his arm hurt; Felt bad for 48 hours; This case was reported by a consumer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and feeling bad. On an unknown date, the outcome of the pain in arm and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain in arm and feeling bad to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The case was reported via web chat. The reporter abandoned the chat before any other additional information could be provided. The patient received a shingles shot which made his arm hurt and he felt bad for 48 hours. No further information was provided.
dizzy; nauseous; slight fever; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 22Mar2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On 26Mar2021, patient woke up very dizzy, nauseous and had a slight fever. Patient asked that considering that it is 5 days after, should she be concerned that she contracted COVID-19 before getting vaccinated. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Raised Reddened Skin. area measurers 7x6 cm right deltoid Little pain, warm to Touch, very Itchy, Had Dtap, Flu, Varicella in that arm.
Pt had fevers and chilss for 24 hours, then 7 days later developed decreased hearing acuity in the R ear and R>L tinnitus which has remained unimproved for 3-4 weeks.
Dose administered beyond 30 day use by date; Improper storage of product in use; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (Improper storage of product in use) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (Improper storage of product in use). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (Improper storage of product in use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.  The vial was stored in refrigerator on 31-Aug-2021 and the date of administration was between 30-Sep-2021 to 27-Oct-2021. The vial did not undergo any temperature excursions.  It was reported that the vaccine administered between 01-Sep-2021 to 12-Oct-2021 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The vaccines administered between 13-Oct-2021 to 19-Oct-2021 likely maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration; however, some vaccine may have activity below the level studied in our clinical trials. The vaccines administered on or after 20-Oct-2021 likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.  Company Comment: This spontaneous case concerns patients of unknown age and gender (invalid case), with reported expired product administered and Improper storage of product in use and no associated events. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.  Additional information was requested.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up received: Additional information in narrative was updated.; Sender's Comments: This spontaneous case concerns patients of unknown age and gender (invalid case), with reported expired product administered and Improper storage of product in use and no associated events. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.  Additional information was requested.
4/8/15 11 PM developed headache and sorethroat. Took Aleve and slept 4/9/15 severe HA, nausea, dizzy, chills (no fever), bad sorethroat and cough. In the afternoon developed very growling stomach, aching and diarrhea. Lots of coughing and gagging. 4/10/15 Feeling better. Still sorethroat, cough and fatigue.
10/4/12 breast started itching that pm, by bedtime (11-12) noted red splotches on torso. Itching was more intense 10/5/12, realized it was hives. Thought it would go away but by 10/8/12, it was driving her crazy so she went to Dr., was treated with ATARAX tabs TID and Mometasone cream BID. Started to fade after 4th application. Stopped ATARAX after 3 days because of "brain fog"; will probably not need to use cream again - last was 10/16/12.
1/15/04 a few pox (total of 20) on abdomen. 1/18/04 pox at site and on buttocks; injection site red, hit 3.5-4"x2". 99.8 fever. 1/20/04 still slight fever; not back to self.
Subsequent to receiving 1st dose of varicella virus vaccine live on 4/19/96, the pt developed approximately 10 skin lesions with minimal itching or discomfort, on 3/16/99. Pt was treated with Benadryl.
Had red welt on arm for 7 days after the 2nd shot.  Itchy and hot to touch Never had kidney stones and no family history of kidney stones.
This spontaneous report was received from a physician via a company representative concerning a 15 month old male patient. Medical history or concurrent conditions were not reported. On 15-SEP-2015, the patient was vaccinated with a dose of MMR II, subcutaneously (lot number and expiration date was not provided. Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TE) received on an unspecified date. On 23-SEP-2015, 8 days after receiving MMR II, the patient developed a "bulls eye" type rash on the trunk of their torso (Bullous rash). He was given prednisone as treatment for the event, therefore, at the time of the report, it was unknown if the patient had recovered from Bullous rash. Additional information has been requested.
ischemic stroke  distorted vision, right arm paralysis, right side of face numbness, right arm numbness, right hand numbness, right finger numbness, inability to speak, slight facial droop
Site: Redness at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
I was positive for COVID-19 on 06SEP2022, I had only a light sore throat nothing else. I only tested because my husband tested positive but I wasn't sick. I did speak to my doctor and prescribed me PAXLOVID, I started feeling better right away but it didn't make a difference because I wasn't sick.
Patient reported immediate pain at injection site, following day reported redness, swelling, and hardness of the arm. Going on 2 weeks now currently and her MD had to prescribe her a steroid pack.
Aching/ throbbing in forearm, upper arm, shoulder, back, shoulder of injected arm. Chills, night sweats. Difficulty and pain when lifting or moving arm. Severe headache- not a migraine.
Narrative: Patient received COVID 19 vaccine in Feb/Mar 2021. The patient tested positive for COVID 19 on 17 August 2021 and was hospitalized for Covid Pneumonia. The patient was discharged on 18 August 2021, but was re-admitted on 23 August with COVID pneumonia, respiratory failure, and sepsis. The patient was treated and was discharged on 30 August 2021. The EUA requires reporting of patients that have received the vaccine and have been hospitalized with COVID 19.
Information has been received from a registered nurse, concerning a 13 year old female student, who on 10-AUG-2007 at 11:30 am, was vaccinated in the left arm with the first dose of Gardasil (lot #657868/0523U).  Following the vaccination, the patient "had a vasovagal response to injection;" her blood pressure dropped (value not specified) and she passed out.  Treatment included the administration of oxygen; her vital signs were then
Patient stayed 20 minutes at Health dept and had no reaction. Drove self to work. At work began having dyspnea and chest pain. Taken to ER and evaluated. Wife called health dept and made them aware of episode. Client also had rash 2 weeks after immunizations. Client  disoriented and couldn't speak at ER.
Redness of Left Arm Soreness of Left Arm Warm to touch of Left Arm
Pt rec'd flu shot at employer hosted worksite event on 10-4-12. Within 3 days, pt experienced seizure, went to ER, adm x1d, all tests WNL.
High pitched screaming, crying, refused to take bottle, entire body very stiff, could not be consoled, personality changed for several weeks and ended up being developmentally delayed, moans daily. Evaluation by physical therapist showed that she was developmentally delayed at 7 months of age and was equivallent to a 4 month old. 60 Day Follow Up: Sensory Integration dysfunction, ADHD, and Asperger Syndrome, and Dyspraxia. Seizure on 7/20/99 from the Tetramune injection, includiing locked joints and high pitched screaming. Sensory Integration problems soon followed, along with global developmental delay, dyspraxia, ADHD, and Asperger's. Pt is now taking medication for ADHD, and is taking occupational and sensory integration therapy.
This spontaneous report was received from a physician referring to 2-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 27-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325.
Shooting stabbing pain in right eyeball; Neck pain; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 20Mar2021 at 13:00 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history included autoimmune pancreatitis, hypothyroidism, colitis, shellfish allergy, allergy to nuts and other food allergy. Concomitant medications included mesalazine (CANASA), pancrelipase (PANCREAZE), levothyroxine (MANUFACTURER UNKNOWN) and omeprazole (PRILOSEC), all for an unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Mar2021, the patient experienced shooting stabbing pain in right eyeball and neck pain. The patient did not receive any treatment for the events. The adverse events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. The clinical outcome of the events shooting stabbing pain in right eyeball and neck pain was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
arm soreness; flu like symptoms; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.