chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a health professional and described the occurrence of an injection site reaction in a 2 month old male patient who received PEDIARIX. Concurrent medications included TYLENOL. On 30JULY2004, the patient received the first dose of PEDIARIX in the left leg. At an unspecified time following the administration of PEDIARIX, on 30JULY2004, the patient experienced an injection site reaction characterized as redness. The patient was seen at a physician's office. The events resolved on 9AUG2004. The health professional considered the injection site reaction to probably be related to vaccination with PEDIARIX.
Almost 12 hours after my dose I got a fever of 102.3, chills, nausea, vomiting, and body aches. I sweat through my clothes and could barely keep water down. I was sick until the next evening around 10 or 11 at night when I had a manageable headache and the other symptoms went away.
Possible 2nd dose late; This non-serious case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (1st dose received on an unknown date).   On 18-APR-2023, the patient received the 2nd dose of Shingrix. On 18-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Possible 2nd dose late). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 18-Apr-2023 The reporter reported that possible adverse event on behalf of Nurse Practitioner.   The reporter reported possible late 2nd dose of Shingrix. The Vaccine Administration Facility was the same as Primary Reporter, No additional adverse event information available. Safety emailed sales information. The reporter consented to follow up. The patient administered the second dose of vaccine at time longer than the schedule, which led to lengthening of vaccination schedule.
pt recv vax APR97 pt was dx w/status epilepticus p/vax;the recovery status of the pt was not reported;
6 to 7 minutes after vaccine felt flu like symptoms then could taste medicine.  Breathing seemed to slow down, blood pressure went to 140/90 and always have low blood pressure then tongue felt numb.   I work at a hospital so they took me to the ER
Severe nausea, vomiting, unable to keep any food or liquids down for more than 12 hours, dehydration and dizziness due to vomiting, fatigue, after approximately 12 hours continuing nausea but able to take Emetrol to prevent vomiting, past 24 hours still have slight nausea and acid in throat, but no longer vomiting
Pt exp pain, rash-mac/pap, pruritus locally-area size of half dollar when phoned for f/u phone 3 days p/given;
Pain in both hands, elbows and knees. Tingling in fingers and toes. Both hands weak, stiff, swollen and joint pain. Strange vibrations/quiver in abdomen. Generally ache and lethargic.
Fever of 100.8; body aches, headache, fatigue, injection site pain starting 11 hours after shot, lasting  24 hours
Asthma; Syncope; Dizziness; Nausea; Vomiting; Severe headache; Fever; Muscle weakness; Muscle twitching; Fatigue; Chest tightness; This is a spontaneous report from a contactable consumer (patient). A 18-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: Em9810), on right arm via an unspecified route of administration on 23Feb2021 10:30 at single dose for covid-19 immunisation. The patient medical history was not reported. There was no known allergy. Concomitant medication included sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 04:45PM on Arm Left for covid-19 immunisation. On 23Feb2021 10:30 patient experienced syncope (medically significant), dizziness, nausea, vomiting, severe headache, fever, muscle weakness, muscle twitching, fatigue, chest tightness, asthma. No treatment was received for the event. Patient not having COVID prior vaccination. Patient not tested COVID post vaccination. Outcome of the events was recovering.; Sender's Comments: Based on the strong temporal association, the association between the event syncope and the vaccine BNT162b2 administration cannot be completely ruled. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
SWELLING, MUSCLE AND JOING PAIN, SMALL KNOT AT INJECTION SITE ALL REPORTED 6 DAYS AFTER INJECTION
0835- RECEIVED FLUMIST; 0845- REPORTED TO MEIDCAL WITH C/O REDNESS/ ITCHING ALL OVER THE BODY; 0850- V/S STABLE O2 SAT AT 100% (BP: 117/73, P: 61, R:14, T: 97.2); 0900- ADMINISTERED DIPHENHYDRAAMINE HYDROCHLORIDE INJ 25ML AND ANOTHER 25ML AT 1010; 1100- PHYSICAL EXAM COMPLETED, V/S NORMAL, 100% O2 SAT.
Narrative: COVID infection following COVID vaccine series 01/04 COVID swab, result: NOT detected 03/16, Pfizer, dose #1 04/05, Pfizer, dose #2 09/07 pt cc: myalgias exposure: unknown 09/08 COVID swab, result: detected 09/08 pt admit to ED cc: Body aches, nausea, vomiting since alcohol binge dx: mild Covid illness; alcohol abuse LOS: 1 day 09/08 TROPONON I: <0.016
Redness and swelling (R) thigh > 48hr. Rx - cephalexin 100m tid, prednisone 9m daily x 5 days.
Patient received  0.1 cc of vaccine , should have received 0.05 cc as he was not yet 19 years old.
Child lost consciousness immediately after receiving the vaccination. He was diaphoretic. Pt awake in approx. 5 minutes.
Patient called me today @ the Health Department and said she has been trying to deal with this herself.  After she had her first dose of Moderna on 2/4/21 a few days later she started developing welts all over her body.  She tried treating herself w/Benadryl, her NP  tried a special soap.  She has another cream coming from the pharmacy today. She said she is hoping it helps because the welts are like dry and flaky all over from her knees up, groin, back, shoulders, face, she said she has  a huge spot on her neck that she is hoping the cream helps.   She said her neurologist told her not to get the 2nd dose.
Experience pain and muscle ache in left arm from pain originating from the hip, traveled down to the knee and now traveling down to ankle. Issues have been ongoing for 3 months now and not getting better.  Having difficulty walking and sleeping due to the pain.
i did read the disclosure and let her know concerning the vaccine I am also doing a AE for having to much vaccine; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (i did read the disclosure and let her know concerning the vaccine I am also doing a AE for having to much vaccine) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (i did read the disclosure and let her know concerning the vaccine I am also doing a AE for having to much vaccine). At the time of the report, IMMUNISATION REACTION (i did read the disclosure and let her know concerning the vaccine I am also doing a AE for having to much vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.     No treatment medications were reported.
I had bloodwork showing increased D-Dimler and that I may have a blood clot.
aPPROXIMATELY 36 HOURS AFTER INNOCULATION, THE INNOCUALTED AREA WAS FEVERED AND SORE. THE FEVERED AREA SPREAD DOWN MY ARM ABOUT 6 INCHES. THE DOCTOR DID NOT GIVE ME THE SHOT. HER NURSE DID BUT I DO NOT KNOW THE NURSES NAME. I AM REPORTING THIS BECAUSE MU HUSBAND HAD THE SAME SYMPTOMS WHNE HE HAD THE SHOT IN APRIL OF THIS YEAR. WE WERE BOTH TOLD THAT THERE HAD BEEN NO ADVERSE REACTIONS REPORTED BY THE PATIENTS AT THE CLINIC WHERE WE WERE INNOCULATED. EVEN THOUGH THIS WAS NOT A SEVERE REACTION, IT WAS INCONVENIENT AND  THIS WAS A SHINGLES VACCINE. IT IS NOT SHOWN IN THE LIST OF VACCINES.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced lupus-like syndrome. The outcome of lupus-like syndrome was not reported. No product quality complain was reported. Upon internal review, the event lupus-like syndrome was considered to be medically significant. Additional information has been requested.
No adverse reaction; Improperly stored vaccines; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 25-APR-2019 the patient was vaccinated with improperly stored 1 dose of varicella virus vaccine live (oka/merck)(VARIVAX) (1 dose, 0.5 ml) (lot # R018933, expiry date: 02-JUL-2020) subcutaneously for prophylaxis. It was not known how the sterile diluent(DILUENT MRK INJ) (lot # and expiry date were not reported) used to reconstitute the administered vaccines was stored.  The varicella virus vaccine live (oka/merck)(VARIVAX) was stored in maximum temperature of -10.3 degree Celsius (C) for 16 hours 15 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.  This is one of several reports received from the same reporter.
Bleeding from papercut won't stop.; Till this day it has not healed; delayed healing; Itching in left arm near injection site; Scratched and arm turned orange; A spontaneous report was received from a consumer concerning a 70-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bleeding from papercut won't stop, till this day it has not healed, Itching in left arm near injection site, (arm) turned orange after scratching.  The patient's medical history was not provided. Concomitant medications reported were Crestor, Zetia.  On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced itching in her left arm near injection site. The patient scratched and her arm  turned orange. On 14 Feb 2021, she got a paper cut which caused bleeding and till this day it had not healed.  No treatment information was provided  Action taken with mRNA-1273 in response to the events was unknown.   The events of bleeding from papercut won't stop , till this day it has not healed were unresolved, while the outcome of the events of Itching in left arm near injection site, (arm) turned orange after scratching were unknown.  The reporter did not provide an assessment for the event bleeding from papercut won't stop, till this day it has not healed, Itching in left arm near injection site, (arm) turned orange after scratching.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Itching; swelling / felt kind of lumpy underneath, about 2 inches in diameter/reaction continued to increase in size; redness; swelling, felt kind of lumpy underneath, about 2 inches in diameter; very painful; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), VACCINATION SITE MASS (swelling / felt kind of lumpy underneath, about 2 inches in diameter/reaction continued to increase in size), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling, felt kind of lumpy underneath, about 2 inches in diameter) and VACCINATION SITE PAIN (very painful) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013l29A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Plasma cell disorder and MGUS. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and COLECALCIFEROL (VITAMINS D3) for an unknown indication.   On 16-Jan-2021 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE MASS (swelling / felt kind of lumpy underneath, about 2 inches in diameter/reaction continued to increase in size), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling, felt kind of lumpy underneath, about 2 inches in diameter) and VACCINATION SITE PAIN (very painful). On an unknown date, the patient experienced PRURITUS (Itching). At the time of the report, PRURITUS (Itching), VACCINATION SITE MASS (swelling / felt kind of lumpy underneath, about 2 inches in diameter/reaction continued to increase in size), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling, felt kind of lumpy underneath, about 2 inches in diameter) and VACCINATION SITE PAIN (very painful) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were provided as Whole plant Multivitamins-100%, Plant calcium 905mg(oral route). No treatment details were provided. Patient stated that she did not experience any side effects after dose 2.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant follow-up received on 14-Jul-2021 contains concomitant medication information, details about both the doses of Moderna vaccine.
The reporter provided us with the information that approximately 300 people experienced a grayish black dot at injection site, i.e. deltoid, immediately after receiving Influenza vaccine (Fluzone), batch numbers U1805AA and U1839AA, vanish point syringe/needles used. The reporter stated her arm was still having grayish black dot after her dose received on 03/Nov/2005. No reports of adverse events had been received to date and no other events were reported.
Numb lower jaw; BP 163/109 (pulse 87-91). Repeat BP 169/103.
Immediately after injection Patient began to faint and clench his arms. His head tilted back and eyes were glazed over. Lips became pale and face was pale. He was clammy to the touch on the back of his neck. His blood sugar at the time of injection was 113. He had not eaten breakfast yet. This lasted about a minute or so. He was finally able to say that he felt ok, but asked what happened. This happened a second time about 4minutes after the first time. But didn't seem to last as long. I gave him some juice and saw that his blood sugar was dropping to 85. Then a few minutes later his blood sugar was at 62. He continued to drink the juice and had 3 4carb glucose tablets. He started to feel better about 15 minutes later. He states that he felt numbness in his hands and feet initially. All feelings returned and color to his face and lips. His blood sugar began to rise again and he was feeling better. No hives or rash was noted on his body and the injection site was normal.
Patient noticed body aches, chills, localized redness and swelling at injection site, nausea, fever of 103F.
Pt has localized reaction. Erythema. No warmth 2 x 1 cm.
Lower lip swelling. Vaers also filled out by Mom with first dose lip swelling. Refilled prednisone as had with previous reaction. Continue cetirizine and consider adding famotidine. Has EpiPen on hand for other allergies. Pt with hx of urticaria and family history of mast cell activation. Mom to let allergist know as well
This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 04-APR-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (dose, frequency and route were not reported) (lot # N034005, expiry date: 31-JAN-2020) for prophylaxis. No adverse effect reported. No product quality complaint involved. The LIQUID PEDVAXHIB was stored in temperature of 32 degree Fahrenheit (F) to 35 F (32 F) for 8 minutes. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.
Patient complained of fast heart rate and stated she felt like she was having a panic attack. Pt also stated she was nervous about the vaccine.  Pt was calmed by medical staff while vitals were being taken. Heart rate seen decreasing vis pulse ox. By end of vitals patient stated she felt better after talking to the nursing team. Repeat vitals taken at end of observation time, all within normal limits. Pt ambulated out of clinic.
Had shot Fri evening, woke up achy Sat AM took ADVIL and felt fine rest of day. When she went to bed she had tremor and jerky movements begin from her knees up to her shoulders and it was uncontrollable. Event lasted about 30 min and has not reoccurred.
HAVE BEEN EXPERIENCING ITCHY SPOTS ON LEFT ARM, LEFT HIP WITH HIVE LOOKING BUMPS FOR SEVERAL DAYS.
expiration date on the vial did not match the package/no AE; Initial information was received on 02-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves child patient (of unknown gender and age) who received HIB (PRP/T) VACCINE [ACT-HIB] for which the expiration date on the vial did not match the package (product label issue).  Medical history, medical treatment, vaccination and family history were not provided.  On 02-Dec-2020, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot UJ175AA, expiry date-05-Feb-2020) via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported that, after the patient was vaccinated, they realized that the expiration date on the box was 26 NOV 2020. The reporter would like to know if the patient must be revaccinated. The reporter added that the LOT, National Drug Code (NDC) numbers and expiration date on the vial did not match the package.  It was a case of an actual medication error due to product label issue.  At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
not feeling well; Headache; This is a spontaneous report received from Pfizer sponsored program. A contactable male consumer reported for his wife. This is report 2 of 2.   A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Not Provided), via an unspecified route of administration in Arm Left on 19Mar2021 at 16:30(at the age of 48 years old) as 1st dose, single dose for covid-19 immunisation. Medical history was reported none. Concomitant medication included vitamins (VITAMINS NOS). The patient experienced headache on 08Apr2021 and not feeling well on an unspecified date. Reporter stated as, "him and his wife had their first doses 19 mar 2021 second dose is today 9Apr2021, but they can't make it because both of them are not feeling well. he also said he is experiencing head cold symptoms now. Can they reschedule their second dose today and if not how can they set up their second dose, he also states that everything that they read said they shouldn't go if they are not feeling well. he wants to know if this is a reason not to have the shot and if he can go under these circumstances or not. He states his wife got Pfizer COVID-19 vaccine on 19 Mar 2021 at 1630. She has a headache that started last night. She has not taken anything for it". Outcome of the events headache was not recovered and unknown for malaise.  No follow-up attempts are needed. No further information is expected.
Syncope x2; This case was received via United States FDA VAERS (Reference number: 0958516) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Syncope x2) in an 888-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced SYNCOPE (Syncope x2) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Syncope x2) 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 Concomitant medications reported by the investigator. Treatment of these events were not reported.
Felt cold, chills, temp 99.7, eyes felt hot and body aches.    Follow up with NP told Employee that these are normal side effect to vaccine.
First dose of Pfizer extended my period from 3-5 days to 15 days followed by continuous spotting and clots. Second dose was on first day of heavy period and I got extremely hot and sweaty, non stop everyday.  Second shot I had Vasovagal syncope feeling faint and was escorted by an EMT to lay down this lasted for about 10 days
Confusion, Dizziness, Headache, Fever, Rash, UrticariaPruritus, Diarrhea, NauseaVomiting, , muscle spasms fatigue, insomnia, malaise, brain fog Narrative:
pt recv vax AUG95&7FEB96 pt exp bumps or bug bites on face&approx 12 on each arm;some of them were blistered;reporter noted that MD was hesitant to describe them as chicken pox because pt did not have the classic chicken pox presentation