chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving vaccines, patient got dizzy and lightheaded. Patient sat down and waited 5 minutes and began to feel better.
I was self diagnosed with a home test on June 25. I was wiped out with body aches, headaches, sinus problems, chest congestion. I contacted our family physician on Monday the 27. The NP called in a prescription for Paxlovid that I went and picked up. I took 2 doses per day through the first of July. I felt better on the 2nd, 3rd, and 4th. July 5th, I started experiencing severe body aches and was really wiped out on that night. I was up using the restroom every 15 minutes. I couldn?t stand up straight, my skin hurt. I took a shower on the 6th and the water l felt like it was burning my body. This went on for probably 3-4 days until the 10th. The body aches started to go away, and I just experienced sinus issues and congestion issues. The last two days have started to subside in symptoms. During this time period, I experienced some of the weirdest ailments for 10-15 seconds at a time. For one instance, my Achilles heel randomly hurt. Another time, a random pain in my left toe left like an intense sharp pain that lasted 10-15 seconds then went away. I also had this feeling twice in my arm where there would be intense pain for 10-15 seconds in random parts of my body then go away. Due to the myelodysplasia, I have to get monthly IVIG infusions. I have to get immunoglobulin infusions for 4 hours at a time, and I was fortunate enough to get an infusion yesterday and feel a lot better today. Still experiencing some sinus issues and chest congestion, but they are a lot milder than they were initially. Not fully recovered, better than I originally was. Still experiencing some symptoms with decreased energy level being a significant symptom.
Vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 03-Oct-2022; No adverse event; Administered a vaccine after the beyond-use-date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a vaccine after the beyond-use-date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 03-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Oct-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a vaccine after the beyond-use-date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 03-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a vaccine after the beyond-use-date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 03-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered a vaccine after the beyond-use-date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 03-Oct-2022).    No concomitant medication was reported. No treatment medication was reported.  The reporter asked about the next steps since a patient was administered a vaccine (monovalent, first dose) after the beyond-use-date.  The vial was of 5.5 ml size and was stored in a box. The vial did not undergo any temperature excursions.  No further information was available with the reporter.
PFIZER BIONTECH COVID-19 VACCINE,BIVALENT. Patient 5 years of age. Received Pfizer bivalent booster for 12+ years
Received Tdap Wed, 08/15/07. Returned to clinic on Fri, 08/17/07 with red raised macular rash with itching on head and trunk. Treated with Prednisone 20mg po daily x 5 days. 08/20/07 - have place a f/u call to mother to check on status of patients' rash. 8/21/07 Spoke with father, and rash is almost gone; hardly see any spots.
At approx 3 am on 1/29 I woke up shivering uncontrollably. I got a bunch of blankets to warm myself up in my already toasty house and took some Tylenol. It was a fever I?m pretty sure. At the time of this writing I still don?t feel perfect but am doing much better.
Patient reported a rash on his arm from latex, but the vaccinator did not use any latex product. He went to his physician on 9/17/15 and was diagnosed with latex allergy and given a prescription for a steroid.  The latex exposure came from a different source but he wanted to report the reaction as being attributed to his vaccination.
Feels like I have the flu. Body aches and hurts to the touch, huge headache
This case was reported by a consumer via sales rep and described the occurrence of rash in a 60-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid and experienced rash on both shoulders that went to the patient's hands.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 07-SEP-2016, the patient was vaccinated with a dose of improperly stored M-M-R II (rHA, once, lot # K012473 with expiration date 26-AUG-2016, dose and route were not reported). Additional information has been requested.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 09-JAN-2019, the patient was vaccinated with an extra dose of VARIVAX for prophylaxis, lot # R018143 and expiration date 25-JUN-2020 (dosage schedule, route and anatomical location were not reported). The vaccine were reconstituted with MERCK STERILE DILUENT, lot # N0126286 and expiration date 06-FEB-2020. No adverse symptoms were reported.
dry throat, dry nose, itchiness/scratchy feeling in throat  Narrative: Employee seen at Urgent Care by Staff Physician, reports no shortness of breath or trouble breathing.
A medical assistant reported VARlVAX was administered after undergoing a temperature excursion.; This spontaneous report has been received from a Medical Assistant and refers to a 4-years old patient of unspecified gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 15-JUL-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (lot number T035400, that was verified to be valid, with an expiration date reported and established upon internal validation as 16-OCT-2022) (concentration, dose number, vaccination scheme frequency, route and anatomical site of administration were not provided). It was reported that the vaccine was administered after underwent a temperature excursion of 0.4 degrees Celsius (+ 0.4 ° C) with a time frame of 13 hours and 10 minutes, which was detected by data logger (product storage error). No previous temperature excursions were reported.  This is one of several reports received from  the same reporter.; Sender's Comments:  US-009507513-2107USA007000: US-009507513-2107USA007007: US-009507513-2107USA006981: US-009507513-2107USA007009: US-009507513-2107USA007049: US-009507513-2107USA006957: US-009507513-2107USA007004:
experienced shortness of breath; pain all over his body; This is a spontaneous report from a Pfizer- sponsored program via a contactable consumer (patient's partner/wife). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14Aug2021 at 15:00 hours as DOSE 1, SINGLE (at the age of 48-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shortness of breath, and pain all over his body on 14Aug2021. The patient underwent lab tests and procedures which included pulse rate: 68 on 14Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Woke up 4/6/21 with minor, dull cramping feeling in my left calf.  Pain increased each day and occurred during rest and activity, although walking was the most painful.
fully vaccinated (Pfizer, 3/25/21, 4/15/21).  symptom onset 7/19/21
Received ROTATEQ 10/15, developed progressive diarrhea 10/16 and hospitalized 10/22/07.  11/5/07 Vax record received and info updated in VAERS database. 12/07/2007 Hospital records received for DOS 10/22/-27/2007 with DX: Diarrhea & Dehydration.  Child presented to ER with 6 day hx of frothy, pale diarrhea and dehydration.  Sunken anterior fontanelle and eyes noted on PE. Labs indicated metabolic acidosis.  Txd with IVF. Stool decreased in frquency and quantitiy by D/C.
16 days post vax pt started running a fever of 101-102 & his neck glands are swollen; Taken to MD who said pt had mumps; Did not do lab work, given APAP;
7 days post injection I developed inflammation accompanied by extreme itching at injection site. The inflamed area is ~4" diameter. The itching spread up neck and down arm, but redness, raised area if inflammation remained local. I understand that this is within normal expectations and did not seek medical care, but did report it to PCP.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzines), DYSPNOEA (short of breath), POLYURIA (Polyuria) and VERTIGO (whole bathroom was spinning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concurrent medical conditions included Diabetes. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced DIZZINESS (Dizzines) and DYSPNOEA (short of breath). On an unknown date, the patient experienced POLYURIA (Polyuria) and VERTIGO (whole bathroom was spinning). At the time of the report, DIZZINESS (Dizzines), DYSPNOEA (short of breath) and POLYURIA (Polyuria) had not resolved and VERTIGO (whole bathroom was spinning) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications and treatment information were not provided. Patient reports feeling extremely dizzy the day after her vaccination, 7Feb2021 and noticed shortness of breath. Side effects are ongoing. Patient reports feeling better as of 8Feb2021, with less dizziness, but she still has frequent urination and shortness of breath. Reporter did not allow further contact.
This case was reported by a other health professional via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional information received as follows: The healthcare professional reported that, the pharmacist mentioned his patient had pain following the administration of SHINGRIX and refused to receive the 2nd dose because of it. The reporter was unsure if this had been reported previously. The reporter was not able to provide any demographics of the patient or vaccine lot number and expiry date. The reporter did not give consent to follow up.
headache; myalgia; fatigue; This is a spontaneous report from a contactable nurse. A 53-year-old adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK923), intramuscular on 08Jan2021 16:15 (reported as "04:15 PM") at single dose on the left arm for COVID-19 immunisation. There were no medical history and concomitant medications. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscular on 18Dec2020 04:30 PM on left arm. COVID-19 vaccine was administered in the hospital. The patient experienced headache, myalgia and fatigue on 09Jan2021 at 8:00 AM. No treatment received for the events. The events were assessed as non-serious. Outcome of the events was recovered in Jan2021. The patient has not been tested for COVID-19 since the vaccination.
Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 29 months old male patient who received a third dose on 19-May-2017 and fourth dose on 24-Aug-2017 of ACTHIB and a fourth dose on 19-May-2017 and fifth dose on 24-Aug-2017 of DAPTACEL (Batch number, expiration date, route and site of administration was not reported). The patients medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate schedule of vaccine administered (given fourth dose of DAPTACEL on 19-May-2017 and fifth dose on 24-Aug-2017 and given third dose of ACTHIB on 19-May-2017 and fourth dose on 24-Aug-2017). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. 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. List of documents held by sender: none.
Information has been received from a physician concerning a 15 year old female patient who on unspecified date was vaccinated with a dose of GARDASIL. After three hours of GARDASIL vaccination, the patient developed myoclonic seizures. The patient sought medical attention at the office and emergency room. Upon internal review, myoclonic seizures were determined to be an other important medical event. At the time of reporting, 20-NOV-2008, the outcome of the patient was unknown. Additional information has been requested.
12/31/02 After both immunization with Fluzone, patient developed high fever to 104 degrees within 24 hours after vaccination. Fever persisted for 4 days with cough, congestion, malaise, irritability, diarrhea, vomiting. 1/2/03 Still with high fever 104 degrees. Treated with Rocephin and Suprax.
Symtoms: Severe headache, bodyaches, chills, and extremely high fever as high as 104.5 starting around 11:30 pm and not ending until 1/25/2021 around 1400.
2nd COVID-19 vaccine late afternoon 3 days ago on Friday, 5/7/21. As soon as injection occurred, pt had increased saliva (mild), metallic taste, tingling tongue. She did not advise pharmacist at pharmacy/administrator of sxs, she stayed another 10 minutes & did not tell anyone of her "mild" sxs, left. On the way home, started to get tingling in her throat (points to suprasternal notch), itching started on soles of both feet, then started feeling itching all over. Called pharmacy, was advised she should call 911. Called a nurse friend, advised to take Benadryl immediately, took 50 mg by mouth after she could get to the pharmacy to get it, then felt it start working 18-20 min later, noticed when it started that she
Gout symptoms in feet, ankles, left wrist, elbows, lower right leg - sore knee joints and finger joints
The pt had been instructed at the time of MMR administration to prevent/avoid pregnancy for 3 months after receiving the vaccine. The pt unintentionally became pregnant. LMP 3/12/01, MMR given on 3/15/01. The pt had a positive pregnancy test on 4/16/01. Pt unsure of plans regarding pregnancy. The pt did not have an adverse reaction.
Information has been received from a registered nurse concerning a female who in approximately 2000 was vaccinated with varicella vaccine. "Recently" in 2001, the pt was titered and did not show seroconversion. No further details were provided. Additional information has been requested.
Stored beyond-use-date. Moderna analysis requested. Full vaccine efficacy not shown. Recommended patient receive an additional vaccine.
induration, erythema, tenderness @ vax site noted 3DEC94; pt recvd vax 25NOV94;
Adverse event: Frozen shoulder in left arm presented a few days after 1st COVID-19 Pfizer vaccine. No prior illness of COVID-19. Treatment: Home physical therapy exercises. Outcome: Healed after a few months of home exercises.
Approx 1 hr after vaccine developed flu like symptoms chills, body aches, abd pain, diarrhea, eye's itchy and red, fever. Had to leave work. Symptoms improved 10 hrs post onset.
This is a spontaneous report from a contactable pharmacist from a non-clinical study program, Pfizer First Connect. A 67-year old female patient of an unspecified ethnicity received PREVNAR13; Lot number: J53435; Expiration Date: NOV2015), intramuscular on 23FEB2015 at 16:15 at 0.5 ml, single dose in the right deltoid muscle. The patient's medical history and concomitant medications were not reported. On 23FEB2016 at 16:15, the right arm of the patient instantly started to swell. On 23FEB2015 at 16:20, the site of the vaccination was hot and swollen to the touch. The events did not require treatment or hospitalization. The clinical outcome of the events, right arm of the patient instantly started to swell and site of the vaccination was hot and swollen to the touch, was unknown.
Pt does not c/o pain. Site is swollen, warm to touch, and redness noted. Borders of redness were marked to view any changes. Swelling and redness are to the left arm from shoulder to 2 inches away from the bending of elbow. Swelling reduces towards the elbow. Pt sent to PCM. Injection site edema or warm and tender within 24 hours. Exhaustive fatigue/malaise within 24 hours.
Pt received wrong manufacturer for second dose. Vaccinator was educated and had remedial training.    Who:  What: Received wrong manufactured dose for second Covid-19 Dose (was suppose to receive Moderna, but instead received Pfixzer) Where: State  vaccine site When: 1300 on 9 April 2021 Why: Mistake by vaccinator
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt said experiencing difficulty swallowing 10min post injection, consulted mom and decided to give benadryl, administered 37.5mg benadryl, mom also had pt use her inhaler, after about 10 more minutes pt said still having difficulty swallowing and now said also little trouble breathing, numbness in arm, and vision changes. Consulted mom and she said to go ahead and call 911. Monitored pt, did not appear in respiratory distress. EMS arrived minutes later, Pt walked out on own with mom and EMS.
Itching and a red area around the injection site.  Swelling and hardness in a 2-3 inch circumference around the injection site.  It was painful to the touch.  The symptoms lasted for four days (Thurs-Sunday) with the swelled area decreasing in size each day.  The itching subsided around day 2.  I did not take any medications during this time as I did not want to interfere with the vaccine's efficacy.
PATIENT GOT MODERNA SPIKEVAX VACCINE ON 10/02/23 ABOUT A MINUTE OR 2 MINUTES. PATIENT PASSED OUT. PATIENT DECRIBED IT AS "VASOVAGAL" PER PATIENT WORD. HE WAS LIGHTHEADED AND EVERYTHING WENT BLACK. HE WAS FEELING DIZZING AND EVERYTHING IS SPINNING. HE SAID HE TRIED TO FIGHT IT AND MOVE HIS BODY UNTIL HE STARTED SEIZING UNTIL HE FAINTED.  I IMMEDIATELY PUT HIM TO THE GROUND  ON A RECOVERY  POSITION. PATIENT WAS TRYING TO GET UP AND INSTRUCTED TO REST. ABOUT 2 MINUTES HE WAS ABLE TO REGAIN HIS CONCIOUSNESS. PATIENT LOOKING PALE FOR 15 TO 20MINUTES AND STARTED GETTING BETTER. PER PATIENT HE HAS TWINS WHO HAD THE SAME REACTION WITH THE VACCINE ABOUT A WEEK OR 2 AGO.
headaches; achy feeling; nausea; felt hot; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3249) via an unspecified route of administration in the left arm on 12Jan2021 09:15 AM at a single dose for COVID vaccine. Medical history included rheumatoid arthritis. Concomitant medications included leflunomide, paroxetine, and ergocalciferol (VITAMIN D) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient had known allergies to sulfamethoxazole/trimethoprim (SEPTRA) and mefloquine. It was reported that the patient had 4 days of headaches and achy feeling on 12Jan2021. During her 30-minute wait after the injection, she experienced some nausea and felt hot on 12Jan2021. Treatment was not received for the events. The patient had no COVID prior vaccination. She did not have COVID tested post vaccination. The outcome of the events was recovering.
shoulder was slightly sore; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of arthralgia (For tolerance of 1st dose, refer case US2022AMR122458).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shoulder pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:US2022AMR122458   Additional Information: GSK Receipt Date:13-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter stated that, sorry to hear that happened to you and he/she took the shots for shingle and it did not affect him/her at all might be his/her shoulder was slightly sore for 1 day only. Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR122458:First dose case/Same reporter
Significant pain in arm/muscle after injection. Pain continued and increased over next 5 days. Unable to lift arm, very limited motion without significant pain, interfered with sleep, pain radiates down to hand with some numbness. Used Ibuprophen with no relief. On 3/21 used Naproxin Sodium for pain, minimal relief.  On 3/22 re-visited clinic regarding symptoms. Was provided with MethyIPREDNIsolone 4mg dosepak and Tylenol w/ codeine for night time to sleep.