chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she is pregnant; She states that she was given the vaccine right from the refrigerator, it wasn't thawed at all to room temperature, Caller states it had been 3 minutes since they left to get the vaccine, until she received the dose/not thawed at room temperature; Caller stated the second dose was delayed because she got pregnant and wanted to wait until after the first trimester; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (she is pregnant), PRODUCT STORAGE ERROR (She states that she was given the vaccine right from the refrigerator, it wasn't thawed at all to room temperature, Caller states it had been 3 minutes since they left to get the vaccine, until she received the dose/not thawed at room temperature) and INTENTIONAL PRODUCT USE ISSUE (Caller stated the second dose was delayed because she got pregnant and wanted to wait until after the first trimester) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 15-Feb-2021 and the estimated date of delivery was 25-Nov-2021. On 25-Feb-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Caller stated the second dose was delayed because she got pregnant and wanted to wait until after the first trimester). On 06-Aug-2021, the patient experienced EXPOSURE DURING PREGNANCY (she is pregnant) and PRODUCT STORAGE ERROR (She states that she was given the vaccine right from the refrigerator, it wasn't thawed at all to room temperature, Caller states it had been 3 minutes since they left to get the vaccine, until she received the dose/not thawed at room temperature). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (she is pregnant), PRODUCT STORAGE ERROR (She states that she was given the vaccine right from the refrigerator, it wasn't thawed at all to room temperature, Caller states it had been 3 minutes since they left to get the vaccine, until she received the dose/not thawed at room temperature) and INTENTIONAL PRODUCT USE ISSUE (Caller stated the second dose was delayed because she got pregnant and wanted to wait until after the first trimester) had resolved.            Concomitant medication was not provided Treatment information was not reported  Caller did not want to enroll to the pregnancy registry at the moment.   Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Follow up received on 20-AUG-2021 contains No new information.
A consumer report received concerns a male patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. On 02-NOV-2015, patient received nasal FLUENZ TETRA with batch number FJ2188. On the same day, patient experienced headache. On 03-NOV-2015, patient recovered from headache. Reporter considered headache to be non-serious.
Minor tightness/swelling for 24 hrs after 1st shot. (Not what I?m reporting here.)  Exactly one week following first shot, injection site became red, itchy and slightly swollen. Applied Eucerin skin lotion and no longer itchy, less red.
Swelling in the left eye lid. This happened after my first shot as well. About 3-4 days after.
No bad reactions luckily. The wrong moderna injection was given. Instead of giving the bivalent the original moderna was administered.
I had fever, chills, and fatigue. I went to the doctor on 11/8/2021 at Hospital and they said I had pneumonia.  They prescribed Azithromycin 250mg tablets to take 2 tablets on the first day and then 1 tablet for 4 more days. I still have a fever, chills, and fatigue. I also have back pain now.
Sore right arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right arm injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore right arm injection site). At the time of the report, VACCINATION SITE PAIN (Sore right arm injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received second Moderna COVID-19 vaccine on 14 Feb 2021 (lot number 006M20A).No Adverse reactions in her left arm. No Concomitant medication was reported.  No treatment medications were reported.
Seizure like activity, not responsive, stiffening of body and floppiness, blueness around lips fever earlier in day.
4/14/21  7:15pm arm started to hurt 4/15/21  6:10 am  vomitting  diahirra headache servere arm pain
Patient received dose 1 of the Pfizer COVID vaccine (lot ER8731, exp 7/2021) at 1230. At 1240, patient reported to EMT that he felt lightheaded, dizzy,sweaty, and anxious. EMT assisted the patient in moving to the reclining zero-gravity chair and laid him in reclining position. Vital signs: O2 97%, pulse 92, respirations 20, blood pressure 150/78. Patient reported he had not eaten in 16 hours but had been drinking fluids. Patient was offered water. Patient reported no allergies or medications, medical condition includes psoriasis. At 1247, PHN offered Benadryl, patient declined as he drove himself and did not want to feel drowsy at the wheel. Patient reported improvement in symptoms. At 1250, vital signs: blood pressure 130/78, O2 98%, pulse 98, respirations 22. Patient reported symptoms had resolved. At 1259, patient sat up monitored by EMT and PHN. At 1307, patient stood up monitored by PHN and EMT , continued to report no symptoms. PHN advised patient to call 911 and follow up with provider. Patient reported he did not have a medical provider, PHN encouraged patient to call for assistance with medical insurance and provider.
Information has been received from a physician concerning a 10-year-old male who on 03-AUG-2007 was vaccinated with a single Subcutaneous dose of ZOSTAVAX instead of varicella virus live. Subsequently, it is reported that the patient experienced no problems. It is unspecified if medical attention was sought. No product complaint was involved. Additional information is not expected. This is in follow-up to report (s) previously submitted on 9/24/2007.  Follow-up information received from a medical assistant indicated that both vaccines were in the same container in the freezer.  The wrong vaccine was pulled for use.  Since the event, the vaccines have been separated into two containers in the freezer and labeled with the vaccine names.  Regarding the patient, there has been no report of any adverse effect.  Additional information is not expected.
Following day after vac. resident had increased lethargy, nausea, altered mental stats, temp 100.1 bp 96./52, hr 107.  Sent to er 1/29, returned 1/31 diagnosis systemic inflammatory response syndrome. On 2/1 resident had temp and respiratory distress. Sent to er again.  Returned 2/3 with diagnosis CHF.  On 2/7 resident sent out again after stat labs and xray.  xray showed infiltrates.  Returned from er on 2/10 diagnosis acute encephalopathy and metabolic encephalopathy.
extreme weakness; constantly feeling that she was going to pass out; constant ringing in ears; balance issues; massive dizzy spells; can't function normally; anxiety; fullness in inner ear; A spontaneous report was received from a consumer concerning a 52-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced balance issues, massive dizzy spells, extreme weakness, constantly feeling that she was going to pass out, constant ringing in her ears, a feeling of fullness in her inner ear and cannot function normally.  The patient's medical history, as provided by the reporter, includes low Vitamin D levels Sarcoidosis.  Concomitant medication use includes Vitamin D supplements.  On 29-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A ) in the left arm for prophylaxis of COVID-19 infection.  Patient reported that after receiving the shot, she began having balance issues, dizzy spells and was extremely weak.  She stated that she constantly felt like she was going to pass out.  Additionally, she endorsed a constant ringing in her ears as well as a feeling of fullness in her inner ear.  She reported that she was unable to function normally.  Patient stated that she was hospitalized from 08-Feb-2021 through 11-Feb-2021.  She reported multiple tests were performed including an MRI (with and without contrast) that was negative. Patient complained of new onset anxiety following all of these events.   Treatment included discharge prescriptions for promethazine and alprazolam.    Action taken with mRNA-1273 in response to the events, balance issues, massive dizzy spells, extreme weakness, constantly feeling that she was going to pass out, constant ringing in her ears, a feeling of fullness in her inner ear and cannot function normally, was not reported.    The outcome of events, balance issues, massive dizzy spells, extreme weakness, constantly feeling that she was going to pass out, constant ringing in her ears, a feeling of fullness in her inner ear and cannot function normally, were unknown .; 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.
After receiving the 2nd vaccine, I have had generalized body aches, pain and weakness. My energy level is way down and I feel like every joint aches. I went to see my PCP and I insisted that he give me medication to reduce the inflammation. He gave me a prescription for a week. I took the medication and I felt great, but then it wore off. Now, I am back to feeling like I did after receiving the vaccine. I am feeling a little better after the medication, but I'm still not feeling right.
Pt states that 2 days after getting the immunization they started with a sore throat and feel like they are sick.
I experienced some pain at the injection site in the left arm. It began in the evening of the day of injection and resolved by the early afternoon of the following day.; BNT162B2, BNT162B2 OMI BA.4-5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 12:45 as dose 4 (booster), single (Lot number: GJ6742) at the age of 50 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "Known allergies: seasonal" (unspecified if ongoing), notes: Known allergies: seasonal; "Known allergies: Pet" (unspecified if ongoing), notes: Known allergies: pet; "food allergies" (unspecified if ongoing), notes: Known allergies: food allergies. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 13Sep2022 as dose 1, single; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; NASACORT; VITAMIN D [COLECALCIFEROL]; FISH OIL. Past drug history included: Robitussin, reaction(s): "Known allergies: Robitussin", notes: Known allergies: Robitussin. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FF8841, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 01Dec2021, when the patient was 49-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EK3248, Location of injection: Arm Left, Route of Administration: Intramuscular, administration time:02:00 PM), administration date: 10Mar2021, when the patient was 48-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular, administration time:02:00 PM), administration date: 19Feb2021, when the patient was 48-year-old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 29Sep2022 at 19:30, outcome "unknown", described as "BNT162B2, BNT162B2 OMI BA.4-5"; VACCINATION SITE PAIN (non-serious) with onset 29Sep2022 at 19:30, outcome "recovered" (30Sep2022), described as "I experienced some pain at the injection site in the left arm. It began in the evening of the day of injection and resolved by the early afternoon of the following day.". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: Other vaccine in four weeks: Seasonal influenza vaccine, vaccine date:13Sep2022, dose number:1, vaccine location:Left arm. Other medications in two week were allegra, nasacort, vitamin D, fish oil, multivitamin. Covid prior vaccination was no. Covid tested post vaccination was no.   Follow-up attempts are completed. No further information is expected.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. Patient's concurrent conditions included acquired immunodeficiency syndrome (AIDS), was diagnosed with AIDS in March 1999. Patient T cells were 100. He was taking his treatment for AIDS regularly and the virus had became undetected with T Cells of 1500. Four years ago in 2017, patient was admitted to the hospital due to methicillin-resistant staphylococcus aureus infection (MRSA infection) in the torso and legs and he was injected with 4 bags of vancomycin. He was going septic. The Patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, patient's antibodies test came back negative and patient experienced confirmed immunological vaccine failure. With all the past experience in mind, patient was concerned of having undetectable antibodies. He wanted to wait for the Janssen vaccine booster. His doctor recommended to take Moderna or Pfizer vaccine in order to develop antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000197220.; Sender's Comments: V0: 20211022439-Covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
I had a rash that form without 11-12 hours on the same arm after the 1st and only Pfizer shot. Then when I worked out to help the soreness in my arm 12 hrs after having the shot the rash started to itch and blister. The blisters would ache while I slept unless I drained them. They would then refill and eventually after a week and a half they started to scab. It took the process 3 weeks to get over the wounds and now I have scars on my arms to prove the issue. They change colors when I workout or am hot the scars turn bright red and when I am cold they turn purple. I went to see a dermatologist 1-2 days after the shot and she tested me for shingles which came back negative. She did not send the culture off for anything else unfortunately. She simply said she was convinced this was Shingles and that she had the same vaccine and that didn't happen to her.
Inflammation is painful as both armpits have swelled; Long-term (9 months and counting) lymphadenopathy in both armpits close to injection sites; Inflammation is painful as both armpits have swelled; Inflammation is painful as both armpits have swelled; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 11:00 (Lot number: EW0169) at the age of 33 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: AXILLARY PAIN (non-serious), INFLAMMATION (non-serious), SWELLING (non-serious) all with onset 24Apr2021 12:00, outcome "not recovered" and all described as "Inflammation is painful as both armpits have swelled"; LYMPHADENOPATHY (non-serious) with onset 24Apr2021 12:00, outcome "not recovered", described as "Long-term (9 months and counting) lymphadenopathy in both armpits close to injection sites". The events "inflammation is painful as both armpits have swelled", "long-term (9 months and counting) lymphadenopathy in both armpits close to injection sites", "inflammation is painful as both armpits have swelled" and "inflammation is painful as both armpits have swelled" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of axillary pain, lymphadenopathy, inflammation, swelling.  Additional Information: The case was not serious. At Doctor's office or urgent care facility where the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other medications the patient received within 2 weeks of vaccination. The lots of diagnostic testing were done but no treatment received. The prior vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
1/25/14 - Student c/o pain (6/10) to (R) arm where Tdap was administered. States limited movement at arm, interfering with sleep, large amount, of swelling present according to student.
Severe nausea and vomiting General body aches, but more severe lung/chest area pain, but with NO shortness of breath Overall fatigue
soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). At the time of the report, PAIN IN EXTREMITY (soreness in arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medicines were reported. No treatment information reported.    This case was linked to MOD-2021-028353, MOD-2021-005637, MOD-2021-004512 (E2B Linked Report). This case was linked to MOD-2021-028539 (Patient Link).; Sender's Comments:  MOD-2021-028353:same reporter, different patient- MOD21-040066 MOD-2021-005637:same reporter, different patient - MOD21-04067
Pt's mom scheduled appt for 2nd Moderna vaccine. I confirmed with Mom at appt to receive Moderna. When I signed off on shot later I realized patient actually received Pfizer at first dose.
can't even remember if she had even a sore arm/Doesn't even know if she got the vaccine; Sore injection arm for first and second dose; Thinks it might have been a little sore, but it was not much; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 (Lot number: EW0151, Expiration Date: 31Jul2021) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "left branch blockage" (unspecified if ongoing), notes: Verbatim: left branch blockage, Diagnosed either 2016 or 2017. The patient's concomitant medications were not reported. The following information was reported: MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "can't even remember if she had even a sore arm/Doesn't even know if she got the vaccine"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Sore injection arm for first and second dose; Thinks it might have been a little sore, but it was not much".  Additional information: The patient stated she had her first vaccine dose and only had a sore arm at 2 am then next morning. She reports that she got her second dose about 3 weeks ago and could not even remember if she had even a sore arm. The patient stated that she was watching the news and seeing other people getting their vaccines and she saw the person administering it push the needle in then they push the plunger, and her was not like that, it was just stick and that was it. The patient also stated that she was not sick at all and she do not even know if she got it. The patient was drinking aloe vera juice. The patient not had prior vaccincations wtihin 4 weeks. Relevant test was none.   No follow-up attempts are possible. No further information is expected.
HOSPITALIZED COVID DEXAMETHASONE, REMDESIVIR  BIPAP, PT WITH COPD ALSO
Client attended the flu shot clinic.  She received a 0.5cc Influenza injection, Sanofi, Lot# UH734AC, Expiration date 6/30/13, in the right deltiod muscle at 1826 hours.  Student nurse administered the dose with her instructor supervising.  After receiving the injection the client went to sit at the waiting area with her dad.  At 1830 hours the client told her dad she felt faint.  He told her to put her head on the table and called for assistance.  This nurse assisted the client to sit and then lie on the floor with her feet elevated on the seat of the table.  School nurse retreived a wrapped cold pack to apply to the client's forehead.  At 1835 hours this nurse assessed vitals: Blood pressure 110/66, pulse 72, respirations 16.  At this time the client's dad reported that the client was tested a year ago for Wolf-Parkinson-White syndrome.  Client stated she felt better after 5 minutes had past.  At that time school nurse took over for RN.  RN and this nurse then allowed the client to sit up against a pillar for support.  RN gave the client a Capri Sun juice and a fun pack bag of Skittles.  This nurse reassessed vitals at 1844 hours: Blood pressure 112/66, pulse 80, respirations 16.  Client stated she felt better, no dizziness or nausea.  She stood up without support or problems and was monitored another 5 minutes.  Client was released with her parents.  This nurse called to follow up with the client's parents the next day (11/9/12) at 0818 hours, but had to leave a message.  This nurse then called to report the incident to the client's physician at 0822 hours, but had to leave a message.
Localized reaction to immunization. 3.5 cm raised palipale, small vesicles right thigh.
pt recv vax & devel an extensive measles like rash that was flat, macular, non pruritic & red;It was morbilliform rash w/confluence over entire body;3 days p/onset of sx devel a fever of 103;dx measles;