chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He had the same side effects as with the first two shots (which he had in February; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (He had the same side effects as with the first two shots (which he had in February) in an 87-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (He had the same side effects as with the first two shots (which he had in February). At the time of the report, VACCINATION COMPLICATION (He had the same side effects as with the first two shots (which he had in February) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-354097, MOD-2021-354098, MOD-2021-353213 (Patient Link).
"fatigue and malaise"  day of vaccination to present Penile lesion,day of vaccination to present
Patient came in for first dose of Pfizer Covid19 shot. Upon completing the injection, it was realized that she had already received the Janssen dose on 04/12/2021. Patient called and informed.
Customer had a vasovagal rx nearly immediately after receiving vaccine at approximately 1210.    pulse of 50 when taken.   Drooling, diaphoretic.  unable to arouse when calling his name.  did sternal rub, moved patient head to upright position and customer started to waken.  asked for cold water and drank readily.  started to ask coherent questions. sat with patient approximately 20-30 min before allowing him to leave..  He told us after the fact that he has passed out before when giving blood.  Must lie down when giving blood or shots.   He was not concerned because he has experience this same reaction .  Pt left on his on accord at 1300.  Did not tell staff of this problem before he got the vaccine.
4 patients administered vaccine from 2 vials past beyond use date; 4 patients involved in vaccine administration error/deviation./1 patient was administered vaccine today from the other vial used past 30 days in refrigeration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients administered vaccine from 2 vials past beyond use date) and PRODUCT ADMINISTRATION ERROR (4 patients involved in vaccine administration error/deviation./1 patient was administered vaccine today from the other vial used past 30 days in refrigeration) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients administered vaccine from 2 vials past beyond use date) and PRODUCT ADMINISTRATION ERROR (4 patients involved in vaccine administration error/deviation./1 patient was administered vaccine today from the other vial used past 30 days in refrigeration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients administered vaccine from 2 vials past beyond use date) and PRODUCT ADMINISTRATION ERROR (4 patients involved in vaccine administration error/deviation./1 patient was administered vaccine today from the other vial used past 30 days in refrigeration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No laboratory data was provided.   No concomitant medications and treatment information was provided.
Arm soreness, swelling and tenderness of right armpit, body aches, headache
Diagnosed with Ischemic Colitis; This spontaneous case was reported by a patient and describes the occurrence of COLITIS ISCHAEMIC (Diagnosed with Ischemic Colitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Clot blood (10 days after the first booster patient got a blood clot in the lower abdomen/colon) on 01-Dec-2021.   On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COLITIS ISCHAEMIC (Diagnosed with Ischemic Colitis) (seriousness criterion medically significant). At the time of the report, COLITIS ISCHAEMIC (Diagnosed with Ischemic Colitis) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported. Patient reported that 21Nov2021 the patient got her first booster and 10 days later the patient got a blood clot in the lower abdomen/colon. A few weeks ago the patient got her second booster and the day after the patient got another blood clot. The patient was diagnosed with Ischemic Colitis.  Company Comment: This spontaneous case concerns a female patient age not specified with no medical history reported, who experienced the unexpected serious (medically significant) event of Colitis ischaemic which occurred a day after receiving the fourth (second booster) dose of mRNA-1273 vaccine. It's reported that 10 days after the first booster patient got a blood clot in the lower abdomen/colon and few weeks later she had her second booster, and a day after the second booster she got another blood clot which was diagnosed as Ischemic colitis. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.   This case was linked to MOD-2022-580272.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient age not specified with no medical history reported, who experienced the unexpected serious (medically significant) event of Colitis ischaemic which occurred a day after receiving the fourth (second booster) dose of mRNA-1273 vaccine. It's reported that 10 days after the first booster patient got a blood clot in the lower abdomen/colon and few weeks later she had her second booster, and a day after the second booster she got another blood clot which was diagnosed as Ischemic colitis. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.
Severe singles started on left side of shoulder and chest; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male 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 an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included Parkinson's disease. The patient did not have any known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 19Feb2021 at 10:30 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Around 17May2021, the patient experienced severe shingles started on left side of shoulder and chest. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with Gabapentin. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent nasal swab COVID-19 test and the result was negative. The clinical outcome of the event shingles was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Headache, dizziness, chills, body aches, extremely sore L. arm  with no swelling, and four separate incidents throughout the day of severe muscle cramps from groin to ankle in L. leg lasting about five minutes, so painful that I saw stars. The symptoms abated in 24 hours except for lingering fatigue the following two days.  I rarely have muscle cramps and have never before experienced any that involved the whole length of my leg.
DEVELOPED BODY RASH TO BREAST BACK ABDOMEN, ARMS AND LOWER EXTREMITIES.
This spontaneous report was received from a pharmacist refers to a 59 year old male patient. Patient's concurrent condition included allergy to niacin (flushing). On 04-OCT-2014 the patient was vaccinated with ZOSTAVAX (lot # K006438; expiration date: 05-AUG-2015) 0.65 ml, subcutaneous. On 13-OCT-2014, the patient experienced "intense itching all over his body". The reporter stated that the patient did not have any rash or any visible changes in his skin. No treatment was given at this time. No lab diagnostics studies were performed. On an unknown date, the patient sought medical attention by a call to pharmacy. The outcome of "intense itching all over his body" was reported as not recovered/not resolved. Additional information has been requested.
Given VARIVAX 8-19-08 redness at injection site left thigh began 8-20-08. 8-21-08 examined patient large round raised red inner area 2 1/2" in diameter circled by another lighter red area increasingly size to a total area of 4"
Woke up at 1:50AM due to bilateral kidney pain.  Also had nausea and sore arm upon waking.  Within an hour, at approximately 2:30AM, all skin became very sensitive/painful to any clothing/contact, also got chills, low back/hip/knee pain, and continued nausea and sore arm.  Took 2 extra strength Tylenol (500mg each) around 4:00AM.  Few hours later skin sensitivity and chills greatly diminished around 5:30AM.  Continued with aching pain in lower back, hips, knees, and feet (feet when walking).  Also continued with nausea, sore arm, and minor skin sensitivity.  At 8:30AM, still experiencing  aching/painful back/hips/knees/feet, nausea, and increased skin sensitivity/pain.
Bradycardia and tachycardia - heart rate dropped to 40 BPM and upon standing heart rate rose to over 130 BPM.  Symptoms started the night after the injection and continued for 3 days. Tachycardia was managed by increased salt, water, and electrolytes as well as lifestyle changes such as taking more time between resting/standing. However, I still periodically have a heart rate between 40-50 BPM while resting.
pt recvd vax; devel fever & myalgia; sx lasted short time & resolved;
On 08/02/2021 I started to feel generally sick cough, running nose, real bad headache. On 08/03/2021 I was given a COVID-19 test, the results were negative. It wasn't getting better so I went to the urgent care on 08/05/2021, I saw a NP he told me it might be pneumonia and sent me home with antibiotic, Z-pack. I started to feel a little bit better but the cough just lingered. I used an inhaler I had, and it made the cough go away eventually. Months prior to getting sick I had a blood panel done. and my liver enzymes were elevated. I don't know if that is relevant. I recovered from my AEs but as of 2 days ago, I started feeling sick again sore throat, really bad headache, stuffy congested. I have not tested for COVID-19. I will probably go today or tomorrow.
Patient states her head felt hot from the inside - her ears and eyes were hot, but she did not have a fever. She felt very tired and weak almost as if she had the flu. She took naproxen on the morning of 12/8 and again that night, and by Sunday she said she felt fine. On 12/10 the injection site was still sore, but not red or inflamed.
febrile seizure 10 days following MMR administration; family hx same event in older sibling;
I work at a mental health hospital, we are required to receive a PPD (T.B. Test) I was instructed to have this nurse (RN) that I work with on graveyard shift administer the PPD. However the nurse used Pneumovax 23 instead of the PPD serum and it was administered intradermally rather than IM or SC. In addition the injection site was hot cleaned or alcohol swiped. I contracted staff infection, within hours, and went to the hospital ER and was diagnosed with staff infection. I was put on 3 different antibiotics because my body kept reaction badly to the antibiotics. I was off work for 2 days. When I went back to work it was then that I learned from the nurse (Rn) that she had mistakenly used Pneumovax 23 instead of the PPD serum; she then asked if I had ever had this and I told her yes 4 months ago. She then said well your only suppose to get this vaccination once every 5 years or 3 year in some cases, but no in the time frame that I was dealing with. She then sent me to our local hospital. Where I was seen and prescribed a different antibiotic, However no labs were performed. But labs are to be performed this week 4-26-07. Since this event I contacted mfr to find out what I might be dealing with. Mfr sent me back all th info concerning Pneumovax 23. I was already experiencing joint swelling, itching, fatigue, and when I received the mfr info, regarding adverse reactions I felt somewhat received, at least there was a reason. I might add my employment has not assisted me in any way with this unfortunate incident. Unbelievable
Patient showing on registry as having received Moderna Vaccine 1/17/2021, 2/14/2021, 3/11/2021 and 4/9/2021 from another Vendor. After investigation by Physicians yesterday identified patient also received Pfizer on 5/21/2021 at our event at the vaccine site. This would have been patient's 5th dose of COVID vaccine.
Positive COVID-19:  5/29/2021  Admitted for scrotal cellulitis, fever, chills, headache  Was positive for COVID-19 on 2/7/2021
Patient started feeling sweaty and clammy about 20 minutes after his second vaccination. We were watching him for 30 minutes. He asked to have his blood pressure checked. He was cold and sweating and said he was having chest pain. We called 911. his blood pressure was high but his pulse was normal. The EMT took the patient to run tests.
No additional AE details available; HBP in charge of vaccine storage calling for TE evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. HBP provides initials for all patients involved.  Names of vaccines involved (including lot/e; This spontaneous report was received from a healthcare business professional (HBP) and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 06-SEP-2022, the patient was administered a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot # 1879864 with expiration date 19-OCT-2023, administered orally for prophylaxis (exact dose was not provided) (product storage error). The vaccine was improperly stored for 8 hours in the temperature above 46 degrees Fahrenheit (F) (62.8 F). It was unknown if data logger was used to capture the temperature excursion. There was no previous temperature excursion. No additional adverse event details were available (no adverse event).
Breakthrough, positive for COVID-19; Breakthrough, positive for COVID-19; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204, Expiration date: unknown) via an unspecified route of administration, administered at unspecified anatomical location on 23Mar2021 (age at vaccination was 40 years) as dose 2, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198, Expiration date: unknown) via an unspecified route of administration, administered at unspecified anatomical location on 02Mar2021 (age at vaccination was 40 years) as dose 1, single for COVID-19 immunization. The patient had had allergic reaction included hives and rash to the Regen-COV2 antibody infusion. Concomitant medications were not reported. On 02Nov2021, the patient experienced breakthrough, positive for COVID-19 (vaccination failure) showing symptoms of fever, cough, chills and head cold. The seriousness of the events were medically significant and hospitalization. The duration of hospitalization was 1 day. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab test) with positive results on 02Nov2021. The patient was treated at hospital with Rengen-COV2 antibody infusion therapy 1 day after positive test result. Patient showed allergies towards infusion and only received 70ml of the 100ml dose of antibodies. Patient was given steroids and Benadryl and monitored. The outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.
Began vomiting 11/8/12. Parents took to ER. Dr. diagnosed virus. He continued to be fussy & continued to vomit. Took back to ER 11/12/12 & was X-rayed and sent by ambulance to another hospital & had surgery for intussusception that day. Remained in hospital until 11/20/12. Had 11.8 inches of bowel removed. Patient was in Health Dept. 12/13/12 and got PEDIARIX #3 and PREVNAR #3, but I held the ROTATEQ #3. He is seeing his Pediatrician next week 12/18/12. He will discuss getting ROTATEQ with his Doctor and let me know.
I didn't sleep well night of Feb. 7, got up three times to pee.   I got up finally Feb. 8 at 6:30 and tried to stand but was too dizzy.  Finally I was able to get to the bathroom, where I had diarrhea.  I managed to make and eat breakfast, but was on and off dizzy, one more diarrhea episode.  Took my blood pressure around 10:45, not too high, but heart rate low: 45bpm.  I was ready to drive to the woods and take a walk, no further problem.
L deltoid with erythema, warmth, induration, mimimally tender to palpation. Recommended cold compressed, ibuprofen PRN for pain.
Very hot baseball size welt to right deltoid with rash + swelling from shoulder to the elbow. Lacey rash to bilateral axillary areas + inner arms. Also to bilateral groin + upper thighs.
Immediately after administration the injection site began to swell. I removed the Band Aid to monitor. It looked red, swollen and "knot-like". I drew borders around it and watched it for about 20 mins. After 20 mins. no other symptoms appeared, pt felt fine and wanted to leave and the borders of the reaction had receded slightly. Pt refused BENADRYL due to work but took 2 with him just in case he needed it. It is unknown if pt ever took these.
Syringe was 23 gauge 5/8". Afebrile, developed swelling, redness, pain L upper arm 24 hrs after injection, has increase in size and redness since then, tx'd compresses. Significantly improved post tx with compresses post 6 hrs as above.
This case was reported by a nurse via call center representative and described the occurrence of stiff neck in a 48-year-old male patient who received TWINRIX adult (batch number Z75Y2, expiry date unknown) for prophylaxis. Previously administered products included TWINRIX (1st dose) and TWINRIX with an associated reaction of injection site pain (after receiving 2nd dose on 9th January 2018, see case US2018GSK110239). On 14th June 2018, the patient received the 3rd dose of TWINRIX adult. On 15th June 2018, 1 days after receiving TWINRIX adult, the patient experienced stiff neck (serious criteria disability), throat tightness (serious criteria disability), swelling arm (serious criteria disability), joint tightness (serious criteria disability) and headache (serious criteria disability). The patient was treated with TYLENOL. On an unknown date, the outcome of the stiff neck, throat tightness, swelling arm, joint tightness and headache were not recovered/not resolved. The reporter considered the stiff neck, throat tightness, swelling arm, joint tightness and headache to be related to TWINRIX adult. Additional details were provided as follows: The patient received the 3rd dose on 14th June 2018 at 1:00 PM and the next day experienced a headache, throat tightness, arm swelling that started on the left and has now moved to both arms, joint tightening in both arms and legs and stiffness in his neck. The registered nurse made note that this was a very muscular man. The patient took TYLENOL last Friday to treat his symptoms. The reporter did not have the expiry date of the lot number. The reported TWINRIX adult batch number (SKBZ75Y2) did not exist and was updated to Z75Y2 as per sales database. Both doses (2nd and 3rd) were from same lot number.
the 10 week expiration on the pediatric vaccine was 10/31/2022 but the mfg expiration was 09/30/2022--   vaccine was expired
After the first shot my period suddenly came back after not having one since having my daughter a year before. Then I got the second shot. I became pregnant shortly after. I then had a miscarriage that started with slight bleeding on the 4th. More bleeding on the 5th. Then on the 6th I had to go to my third hospital due to extreme bleeding.  I?m now having a period every other week that starts with spotting for 3 days and then bleeding for 5.
Menstrual bleeding. I just ended the cycle of my period two days before the vaccine, and it started the day after the vaccine again.
Initial and follow-up information have been received from a register nurse concerning a 7 year old female student with no allergies and no pertinent medical history who on 17-MAY-2002 was vaccinated with the first dose of VARIVAX (Merck) SC 0.5 ml (lot # 635791/0203M). Secondary suspect therapy included the second dose of PROQUAD (Merck) (lot # 655267/0971F) SC on 26-SEP-2006. Concomitant therapy included the 5th dose of DTaP IM (lot # C2489AN) and the 4th dose of polio SC (lot # 200L8) on 26-SEP-2006. On 30-OCT-2008 (also reported as 29-OCT-2008) the patient presented with 15 insect-like lesions on her chest and abdomen and developed chickenpox. The patient was being treated with BENADRYL. On an unspecified date the patient recovered from chickenpox. The patient sought medical attention and came into the office on 30-OCT-2008. Additional information is not expected.
Information has been received from a pharmacist reported that a 51 year old female patient was administered 0.6ml of ZOSTAVAX (Merck) (lot # 669408/1384Z) subcutaneously in the upper left deltoid on 06-MAY-2011, for vaccination The consumer reported no relevant medical history, concomitant medications, or past drug history. On 07-MAY-2011, the patient had redness around the injection site. There was no relevant laboratory data. As of 08-MAY-2011, the patient continued to experience redness around the injection site and stated that the redness was worse on 08-MAY-2011, and then it was on 07-MAY-2011. Additional information has been requested.
HYPOTENSION 1/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Woke up following morning with blue spot on top side of tongue.  By Sunday morning, the underside of the tongue was a deep red and swollen, with numbness along the front and left side
Fatigued. Retired to sleep at 2/2/2021 @ 1800 hrs. Woke at 2330 hours experiencing pain in right arm, chills and RINGING IN EARS. The ringing in ears lasted 2 days. Bilateral ear ringing. Increased dramatically.  Note: In 12/2017 he experienced ringing of ears. 2020 decreased substantially to mild level.