chrisvoncsefalvay/vaers-outcomes huggingface dataset:
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  Reporter stated that patient did not experience any adverse event.   This case was linked to (Patient Link).
Caller stated he had Pfizer first vaccine last Friday. Next day had arm pain and was tired. Then on Monday through Wednesday felt more fatigued with diarrhea. He stated feelin a bit better today.
rt arm red, hot; severely swollen around inject site; pt noticed react upon arising day p/inject 26OCT93; reported to nursing staff @ clinic 29OCT93; advised to see MD pt went to MD 1NOV93; started on Cortisone;
It was reported to this writer that the patient was being escorted by his father to the upstairs post-vaccination observation area when he slumped to the wall midway up the first flight of stairs. He appeared pale and diaphoretic; complained of chest heaviness without pain, and blurry vision. Denied nausea. He was helped to sit down. EMS was notified and came to the scene. Assessed by EMS. Vital signs were WNL and without hypotension.  Once he had a chance to sit down he accepted water and juice. Continued to be assessed by RN and EMS. Vital signs continued to be WNL. Medically cleared by EMS to leave the facility.
Following second dose of COVID 19 vaccine patient developed SOB with 4-5 word dyspnea and increased work of breathing.  Pt. also complained of tingling in bilateral lower extremities. Pt. also noted with hypertension and bradycardia (beta blocker therapy).  She was given Zyrtec 10mg po without resolution of symptoms within 30 minutes.  Pt. then received IM Epi-Pen.  Pt. remained alert and appropriate with on-going SOB when EMS arrived to transport to local ED.  Medical response was activated for this event.
Patient was administered a vaccine that had expired 3 days ago. No reaction. MMR Vaccine will be repeated at next appointment in March 2022.
This spontaneous report was received from a nurse referring to an unknown age and gender patient. The patient's medical history and concurrent conditions were not reported. On 09-JUN-2016, the patient was vaccinated with an expired dose of ZOSTAVAX vial, subcutaneous, lot # L006381 and expiration date 25-MAY-2016 (Dosage, dose number, anatomical location were not reported). No other suspect therapies or concomitants were reported. No adverse effects were reported. No product quality complain was involved. Additional information has been requested.
patient had a similar reaction (anaphylactic reaction described as entire arm swelled into her neck) but not as severe; This spontaneous report was received from a office manager, via a company representative, referring to a male patient of unknown age. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies were unknown by reporter.  On an unknown date in approximately 2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with lot number R000772 and expiration date reported as 10-MAR-2020, as prophylaxis (dose, dose number and anatomical injection site were not reported; route of administration was unknown by reporter).         On an unknown date in approximately 2018, the reporter had an anaphylactic reaction described as "her entire arm swelled into her neck" (captured in MARRS # 1908USA002148). On an unspecified date in 2018 (reported as "around the same time"), the patient had a similar reaction but "not as severe" to  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). It was unknown by reporter if the patient sought for medical attention, if any treatment was given for the event or if any laboratory diagnostics or studies were performed.  At the time of the report, the outcome of the anaphylactic reaction was unknown by reporter.  Upon internal review, anaphylactic reaction was determined to be medically significant.  This is one of two reports received from the same reporter.  Lot number R000772 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent).; Sender's Comments:  US-009507513-1908USA002148:
Caused severe arm swelling and redness, like a 6 inch band all around arm. Went to primary dr who diagnosed Cellulitis from the vaccine injection  and prescribed an oral antibiotic,  benadryl, tylenol and icing arm.
muscle aches- back, shoulders, arms chills- Body temp dropped as low as 74 degrees. excessive sweating
Information has been received from a health professional concerning a patient with diabetes who on 07-FEB-2008 was vaccinated IM with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. On 07-FEB-2008 the patient experienced injection site redness, swelling and pain. Unknown medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. This is one of multiple reports from the same source (WAES# 0802USA05540 and 0802USA05541). Additional information has been requested.
Increased heart rate. Average hr before was 68, now 99 BPM.  Hr went to as high as 105 BPM. Pressure in the chest. Tingling sensations through the body intermittently. Body aches lasting about a week.
Vaccine received 4:30 pm day before. Felt fine until 8:30 am next morning. Became extremely sleepy, could not stay awake, amnesia of events that followed. Husband took me to clinic when I said I was seeing double. Clinic called ambulance. I remember very little of this. Spent 5 hours in ED of which I remember very little. Had CT of head....negative. All blood work WNL. Urine WNL. Discharged with diagnosis of 'weakness of unknown origin'. Left arm very sore for 5 days. No induration or redness at injection site.
CHILLS; LIGHT FEVER; HEADACHE; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On APR-2021, the subject experienced chills. On APR-2021, the subject experienced light fever. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light fever, chills and headache was not reported. This report was non-serious.
Patient experienced injection site reactions. Bruising at injection site of Prevnar13. Redness, swelling, warmth, itching at injection site of Zostavax. Patient reported to pharmacy on 6/14/16 and brusing still present as well as redness/itching. Patient was treated with cold compress and Benadryl cream.
Patient had a sore right arm at the end of the day after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient had a sore right arm at the end of the day after receiving 1st dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included HYDROXYCHLOROQUINE, ENALAPRIL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Patient had a sore right arm at the end of the day after receiving 1st dose). At the time of the report, VACCINATION SITE PAIN (Patient had a sore right arm at the end of the day after receiving 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information as not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
face and hand swelling, shortness of breath, increased heart rate to 120 BPM, dizziness and nearly fainted. Lasted 3-4 minutes. Was observed, blood pressure taken and was slightly elevated. Symptoms dissipated and was released to go home. Later had lasting headache and muscle pins for approx 18 hrs along with hot flashes.   On 4/11/21 I then experienced the same episode lasting over an hour.
Rapid heart rate (about an hour after); 101 degree fever, achy body, cough
Patient was very nervous and anxious during the administration of the vaccines and after immunizations were given the patient advised to sit for 10-15 minutes. The nurse turned around and was going to walk out of the room and the patient feel from the exam table and lost consciousness. Patient came to consciousness within 10 seconds. Had blood coming from mouth which seemed to be from upper lip laceration. Pt was pale w/color returning over 10 minutes, AAO x3, PERRL. Pt denied h/a, blurry vision. Pt reports rining in ears. Pt slowly went from laying to sitting to standing without problem. Sent to ER for Eval.
Swelling in left deltoid where shot was given, approximately 10cm long x 7cm wide x 3cm deep. Red, warm to touch, extended down arm to elbow, painful to move and to touch. Instructed to apply cool compress, if increases remove compress. Referred to physician. Analgesics as needed. Saw MD, diagnosed with possible infection, Started on PREDNISONE and BACTRIM. Improved on 4/11/08, able to move and without pain, swelling and redness decreased.
PPV 23 vaccine administered on 8/15/07 in (R) arm SQ. On 8/16/07 pt developed erythema, pain, and increased heat over int. (R) arm. Pt seen today 8/17/07. (R) arm 6.4 cm L x 5.6 cm W erythema
24 hrs p/vax rt arm became extremely sore/painful as well as numbness; pt also developed lump in throat; t99.5 no loss of function treated w/Motrin and ice/heat;
Pt states that at injection site = red oval or rectangular blotch that is fading & getting better over past 2 weeks or so. (Reported to me 9/8/11).
Patient was given an expired vaccine the date of  6/13/22 and vaccine expired 5/24/22.
Patient stated her fingers in the administration arm became red, sore, and had some blisters from the fingernail to the first joint. She explained that they are improving without treatment, but she wanted us to report. She said she cannot take any sort of steroids due to steroid sensitivity and was overall ok with the improvement on its own.
I was stretching and I was transferring clothes from the washer to the dryer. There was a sharp shooting pain from my armpit down to my arm. I had bruising from my armpit all the way down. I was sore for a week from my hand all the way up and there was bruising on the arm where I had my vaccine. I took an ultrasound and they ruled out a blood clot. I wore a sling for approximately 5 days. I couldn't use my hand normally for 2-3 weeks. My hand stayed swollen for about a week as well. I took Ibuprofen. I still feel a tight tugging sensation in my armpit and I have never had this before.
Started getting hives all over his body. The hives are very itchy.  Have a dr appt on 10/12/21
Had swollen neck glands & fevers 101-104 beginning 1 wk after MMR vaccine. Treated with AMOXIL; changed to AUGMENTIN. Received ROCEPHIN IM in office. (L) neck gland tender, red, swollen. Admitted on 6/21/11. Tx with IV abx, positive abscess; drained; Dc'd home 6/23/11. Dx Lymphandenitis/Abscess.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 03-JAN-2014, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (lot number: J000360, Expiry date: 25-OCT-2015) (dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received vaccine 9/14/15. She received AFLURIA at the same time. A few days later she experienced redness and swelling at the injection site. She went to ER on Saturday 9/19 and was admitted to the hospital. She was transported to another hospital and is being treated for infection.
Got a COVID; Got a COVID; Got blind; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Got a COVID"; BLINDNESS (medically significant), outcome "unknown", described as "Got blind".  Clinical course: A caller calling on behalf of the HCP called in to inquire if we have information about the two COVID Vaccines that were administered then the patient got a COVID then got blind?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information causal association between the reported event Blind cannot be totally excluded,  as there is no conclusive information to exclude the relationship between the event and suspect drug. the case will be reassessed once new information becomes available.     The contributory role of the suspect vaccine to the reported drug ineffective cannot be excluded , as the efficacy of a drug varies individually and may be affected by different factors including drug potency.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Information has been received from a 64 year old female with no allergies and hypertension who on 22-MAR-2007 was vaccinated SC with a dose of Zostavax . Concomitant therapy included atenolol (manufacturer unknown), Klor-con. On 22-MAR-2007, the patient experienced fatigue, shortly after receiving the vaccine. On 23-MAR-2007, she also experienced a loss of appetite which still continued at the time of the report. Her energy level had improved. Unspecified medical attention was sought.  No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Additional inforamtion has been received from a physician who reported that on 23-Mar-2007 at 1:00 AM (previously reported as 22-Mar-2007), the patient experienced anorexia and fatigue. The patient recovered on 25-Mar-2007. The patient had no adverse events following prior vaccination. No further information is expected.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a non-contactable consumer (patient). A 53-year-old female patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown) via an unspecified route of administration on 13Mar2021 single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was tested positive for Covid on 29Mar2021. The patient's symptoms were mild, and she was congested and had a headache. The patient had to cancel the appointment for her second dose because she was in quarantine. These events were considered serious (medically significant). The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
waited 13/14 months to receive second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The pharmacist reported that the patient was around 60 years old. The age at vaccination was not reported. The pharmacist was looking for guidance on Havrix schedule if a patient waited 13/14 months to receive second dose, which led to lengthening of vaccination schedule. The pharmacist was in a super rush during the call, no additional info was given. The pharmacist did not consent to follow- up.
Papular skin rash blanching, no pruritic, sparse. No fever. No other symptoms.
Two hours of mild nausea followed by 7 hours of severe vomiting, diarrhea, and chills. The following morning the gastrointestinal symptoms were resolved but have a 100F fever. No treatment.
PATIENT RECEIVED VACCINATION AROUND 9:45 AM TODAY, 3-9-21. PATIENT THEN CALLED PHARMACY AT 1:09 TO LET US KNOW THAT AT AROUND 11:00 SHE STARTED GETTING A HEADACHE AND BEGAN VOMITING. PATIENT HAS SINCE VOMITED 4 TIMES AND WAS INSTRUCTED TO SEE HER PRIMARY CARE PROVIDER.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported.  On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K020181, expiration date 24-JUN-2016 and lot # L004466, expiration date 02-AUG-2016) route default as oral (dose and strength were not reported). There was no concomitant medication reported and no adverse effects were reported. Additional information is not expected as the reporter didn't consent new follow-up attempts. This is one of 3 reported received from the same reporter.
9/1/22 - Patient received 50 microgram dose of Moderna vaccine, as opposed to recommended 25 microgram dose for his age group. Provider contacted parents and reported that patient so far has not had any side effects from vaccine. Provider made follow up call today, 9/2/22, and mother reported  that patient had no fever, no redness or swelling at the injection site.
severe joint pain, fatigue, headache, general malaise, chills. they resolved about 48 hours after the vaccine was administered.
Felt like the person didn't puncture her correctly; Arm Felt really Heavy; Stiff neck; A spontaneous report was received from a consumer regarding herself, a 57-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and felt like the person didn't puncture her correctly, arm felt very heavy and stiff neck.  The patient's medical history was not provided. Concomitant medications were not provided.  On 28 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot Number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, immediately after receiving vaccine, patient felt like the person didn't puncture her correctly (A little bit over the shoulder), hence her arm felt very heavy and had stiff neck.  No treatment for the event was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events felt like the person didn't puncture her correctly was considered resolved on 28 Jan 2021. The outcome of the events, arm felt very heavy and stiff neck were unknown.; Reporter's Comments: This report refers to a case of wrong technique in device usage process (the person didn't puncture her correctly) for mRNA-1273 and concerns a 57 year-old, female patient, who experienced the events of  arm felt very heavy and stiff neck. The events occurred immediately after the first and only dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
stated arm was sore for 1 wk; arrived @ MD office 26JAN93; had 5 cm abscess lt arm; area lanced, pt put on ATB;
Pt experienced a breakthrough seizure requiring hospitalization ( pt had been seizure free for 20 years). Also experienced vertigo. Pt did not have any fever or other systemic side effects, only a sore arm after receiving the shot till the seizure occurred. Pt also reports no alcohol consummation or change in diet.