chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given the vaccine at 10:15 Patient tolerated injection well.  She was sent to the observation area for 15 minutes.  She began to experience  tingling at the injection site. No redness or swelling noted at site.  Patient then began to have facial itching.  After 3-5 mins she began to have itching in her scalp.  She then began having itching in her throat and eyes, denies any difficulty breathing. Vital signs Blood pressure was 130/80 Patient states she does have hypertension.  Pulse 68.  911 called and informed of patients symptoms. On the way here . Patient called husband who is a retired Paramedic.  He is bringing Benadryl.   Paramedics arrive, vital signs stable.  Patient denies being transported to Hospital  Paramedics stay with Patient until husband arrives with Benadryl.  Pt advised per paramedics to take 50mg Benadryl by mouth Patient tolerated  well.  Patient leaves with husband. 3:45 pm  I called patient who states she is doing well. No further itching  and is fine.   .
Received FLUZONE (L) deltoid 11/06/08 @ 4PM. Over a period of 2 hours felt "vaccine move from upper arm to shoulder to cheek." Following morning cheek swollen and mouth full of canker sores. Saw MD 11/7/08. Advised not to have FLUZONE again.
After I got the vaccination, because I had allergies I had to sit for 30 mins at the place instead of 15. I got the first vaccination in my left shoulder without thinking. I had just recently had surgery and it hurt for several days afterwards for a while. Everything seemed fine that day. I can't remember if it was the next day or the day after, but I was sitting with my friend outside and my legs started itching. I was sitting on a cushioned chair but it had been sitting in the garage for a while. When I went inside to look there was a line of hives up my leg that itched really badly. I looked for something to put on it, I tried some baking soda, and baking powder paste. The next day it was impossible to deal with. Really red and raised, itched terribly. I initially thought it was a bite, it didn't dawn on me it was a reaction to the medication until later. I used cool compress, I did end up taking BENADRYL and another antihistamine. I did what I normally would have done if I had an allergic reaction to any other allergy. Truthfully I don't remember if it was same arm as vaccine and same leg or opposite arm leg. But it itched horribly. I looked for a chicken pox remedy bath but didn't have any. There was one night I had to put gloves on my hand to keep from breaking the skin from itching. It was one spot behind my knee, and one spot on the front of the knee and up and down my leg like a pant seam. I was going to see my doctor for my skin issues and I showed her the pictures, and initially we thought it was a tick bite because one of them looked like a target, or shingles. When I got the second dose on April 5th 2021, I had a similar reaction, and may be mixing up some of the details from the first and second dose because they were both so similar but long ago. My doctor and I both have photographs of the events, but I didn't seek her out specifically for the hives. She told me to use one of my skin ointments to help with the irritation, along with the BENADRYL. I also used a lot of cold compresses. It lasted several days maybe even weeks that it was painful and problematic.
redness/warmth/swelling on left arm from shoulder to elbow symptoms were at their worst one day after administration resolved 36 hours after administration
Pt recvd 2nd hep B vax on 04DEC90 & p/ inject devel flu-like sx,arthralgia,anxiety,nausea,malaise,blister @ inject site.
1) PINS AND NEEDLES- TOP OF HEAD TO FORHEAD; LEFT LEG DOWN TO FOOT. 2) STOMACH CHURN, INCREASED FREQUENCY OF BOWEL MOVEMENT; STOOL SOLID NOT SOFT. 3) INTERMITTENT HEADACHES 4) Drop in platelets from 184 to 174 by the 3rd week post vaccine. All persisted until just days before 2nd dose on 9/15/2021.
At 8:47 the patient complained of congestion in the back of her throat after receiving the vaccine.   8:47...Pulse 56   Resp 14...Fells congested "like constantly wants to clear throat"  Did not have when she came in to the clinic.  Lungs clear, no stridor 8:48...BP 138/86...Denies SOB, able to inhale and exhale completely.  Reports symptoms diminishing.   8:51...Pulse 60  Resp 14.  Ate breakfast this morning.  Somewhat diaphoretic.  No stridor, lungs clear.   9:00...Plan...monitor 15 minutes, recheck vitals. 9:15...BP 146/86  Pulse 56  Resp  14...Diaphoresis better.  Slight facial flushing.  Lungs clear.  No stridor.  No hives.  Feels "throat gunk" is dissipating.  Denies lightheadedness, dizziness.  Discharged home.  VSS.  No further intervention required.  4/6 call placed for follow up.  On 4/7 the patient returned call stating the congestion continued through late morning.  She then "became completely exhausted" and rested for a while.  She reports felt better after and has had no further issues
The pt experienced a hot flushed feeling with generalized redness, tingling all over, weakness, shaky tremulous feeling, heavy chest. Right deltoid ached more than left. ER visit, was given oxygen.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (not available). The reporter is the patient. A 65 year-old male patient received BNT162B2, intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; upadacitinib (RINVOQ), oral (ongoing) (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE DOSE, Intramuscular), administration date: 01Feb2021, when the patient was 64 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE DOSE, Intramuscular), administration date: 28Feb2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: DIABETES MELLITUS (medically significant), outcome "not recovered", described as "Diabetic"; HYPERTENSION (non-serious), outcome "not recovered", described as "Blood pressure high"; HYPERSENSITIVITY (non-serious), outcome "not recovered", described as "allergy"; LETHARGY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Lethargic." Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient had high blood pressure. He had allergies. He was diabetic. He was lethargic for a week after receiving the booster shot of Pfizer in 2021. The patient underwent the following laboratory tests and procedures: blood pressure measurement: high. The action taken for upadacitinib was dosage not changed.  The reporter's causality for the events of high blood pressure, allergies, diabetic and lethargic with Rinvoq (Upadacitinib) was: no reasonable possibility. Causality as per reporter for the suspect vaccine to the event lethargy was assessed as possible. The reporter's assessment of the causal relationship of the other events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   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.
3-4-08 rec'd Twinrix.  3-5-08 client states had diarrhea, stomach cramps & nausea. 3-6-08 client noticed neck was reddened, saw private doctor that day for scheduled appt. Doctor told client to take Benadryl.  Client took Claritin, but later that day developed rash with swollen eyelids.  Client called health dept, who advised her to call her physician for re-evaluation.  Client denied any wheezing or difficulty breathing, and agreed to seek emergency care if that developed.  3-7-08 Client reports did not call doctor again, and that rash is improved, and does not now have swelling.  Client states will contact doctor if condition worsens.
Ringing in Ears; Mouth Sores; Sores in skin; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in Ears), ORAL PAIN (Mouth Sores) and PAIN OF SKIN (Sores in skin) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012MZOA and 012L2OA) for an unknown indication.     The patient's past medical history included Hemochromatosis in 2021, Cirrhosis liver since 2021 and Phlebotomy. Previously administered products included for Product used for unknown indication: Hepa A vaccine (1st dose). Past adverse reactions to the above products included No adverse event with Hepa A vaccine. Concurrent medical conditions included Allergic reaction to analgesics (Dilaudid allergy), Allergy to antibiotic (Allergy to E mycin), Graves' disease since 05-Oct-2010, Allergy to antibiotic (Ciprofloxacin), Allergy to antibiotic (Rocephin), Vitamin D deficiency and Insomnia. Concomitant products included LEVOTHYROXINE SODIUM (TIROSINT) and THYROID (ARMOUR THYROID) for Graves' disease, ZOLPIDEM TARTRATE (AMBIEN) for Insomnia, VITAMIN D3 for Vitamin D deficiency.   On 12-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced ORAL PAIN (Mouth Sores) and PAIN OF SKIN (Sores in skin). On an unknown date, the patient experienced TINNITUS (Ringing in Ears). At the time of the report, TINNITUS (Ringing in Ears) had not resolved and ORAL PAIN (Mouth Sores) and PAIN OF SKIN (Sores in skin) outcome was unknown. Not Provided          Patient has taken booster dose on 03/Nov/202, lot number 039F21A intramuscular in left gluteus.  Patient had been taking tirosint concomitant medication 112 mcg orally except on Wednesday 100 mcg since 2013 for indication of graves.  Patient had been taking Vital proteins as concomitant medication 2 scoops orally since 2021 for supplemental drink. Patient stopped taking armour thyroid approximately on  May-2021. Patient was administered with Flu vaccine on unknown date   This case was linked to MOD-2021-396157, MOD-2021-396175, MOD-2021-382243, MOD-2021-396175, MOD-2021-396157 (Patient Link).
Took two doses of Vivotif on consecutive days; Spontaneous report received on 26FEB2020.  A caregiver reported that his daughter "took two doses of Vivotif on consecutive days" (PT: Inappropriate schedule of product administration). She was receiving Vivotif for immunisation. The consumer took two doses of Vivotif every day instead of every other day. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took two doses of Vivotif on consecutive days (Inappropriate schedule of product administration) instead of taking every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took two doses of Vivotif on consecutive days (Inappropriate schedule of product administration) instead of taking every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Patient stating she was feeling short of breath and some chest tightness.  Patient does have a history of asthma.  Paramedics onsite performed an 12 lead EKG and patient was transported to Hospital due to chest tightness.
One hour later of my firs dose injection, I experienced  headaches, with nausea ad vomiting. On 12-25-2020, I felt lethargic, dizzy and had rapid palpitations. I went to the ER where I was given Reglan and Tylenol. My serum creatine was 2.1. I followed up with my rheumatologist, Dr.   and PCP and an ultrasound of the kidneys was performed which within normal limits and lab-work was also done. The doctors were trying to rule out nephritis from the vaccine.  My doctor started my on Prednisone medication. I then followed up with my PCP and rheumatologist and my creatine started downwards to 1.4.
p/ pt recv vax 6/95 in 5/98 pt devel breakthrough attenuated varicella w/15 vesicles.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 17-MAY-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Soreness at injection site 3+ weeks after injection. Patient reports only occasional soreness that "comes and goes" depending on what she is doing. Mainly noticeable when the site is touched or pressure is applied. Patient has not yet seen a doctor for this.
On Friday, January 15 at approximately 6 PM while seated in a reclining chair watching television I started to develop hives below my right gluteal fold. Over the next six hours  approximately 300 hives appeared on my skin. They were very itchy. At approximately midnight my lip began to swell and being a certified registered nurse anesthetist,  who lives alone, I knew it was time to head to the ER. Prior to going to the ER  I  cleaned the lesions With alcohol, took prednisone 10 mg PO,  and applied hydrocortisone cream.    In the ER, I was given Benadryl 50 mg PO and Pepcid 20 mg and observed for one hour. The hives remained but there was no respiratory compromise. Approximately six hours later the hives were still increasing in size and number, were unbearably itchy and my swollen lips had not subsided.  I took Claritin 10 mg PO and returned to the same ER and was given Epinephrine 0.3 mg IM, prednisone 20 mg po and observed for three hours. The hives did not decrease and again there was no respiratory compromise so I was sent home on prednisone And a H-1 blocker.  Of note, both my palms and lips have been bright cherry red.     I finished a five day course of Macrobid on January 13 at 10 AM.    Final diagnosis:  Alergic  reaction
Left deltoid swelling pain, fevers 102.6, myalgias, headache, vomiting for 2 days than (L) arm swelling cellulitis, pain for one week.
Burning in throat; Fever; feeling exhausted; Had COVID; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Burning in throat), PYREXIA (Fever), FATIGUE (feeling exhausted) and COVID-19 (Had COVID) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In November 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced THROAT IRRITATION (Burning in throat), PYREXIA (Fever), FATIGUE (feeling exhausted) and COVID-19 (Had COVID). At the time of the report, THROAT IRRITATION (Burning in throat), PYREXIA (Fever), FATIGUE (feeling exhausted) and COVID-19 (Had COVID) outcome was unknown.            No concomitant medications were reported. Treatment included Antiviral Pills for 5 days. Company comment: This spontaneous case concerns a 79-year-old female patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19, approximately 2 months after the booster dose of mRNA-1273 vaccine. She took antiviral oils as treatment. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-543973.; Sender's Comments: This spontaneous case concerns a 79-year-old female patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19, approximately 2 months after the booster dose of mRNA-1273 vaccine. She took antiviral oils as treatment. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
The patient called me on 10/15/2020.  She had to go to urgent care because she had an adverse reaction to the pneumovax immunization I gave her on 10/14/20.  She said she had joint stiffness on her right shoulder (I gave her the pneumovax shot in her right deltoid and her flu shot in her left deltoid).
Some of the vaccine leaked on her arm; Some of the vaccine leaked on her arm; Some of the vaccine leaked on her arm; A spontaneous report was received from a consumer concerning a 56-year-old, female patient, who was administered Moderna's COVID-19 vaccine and some of the vaccine leaked on her arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Feb 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Batch/Lot number: 012L20A) intramuscularly in the left arm for prophylaxis of Covid-19 infection. The patient received the 1st dose of the vaccine on her left arm at Pharmacy. Some of the vaccine leaked on her arm.   No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The event some of the vaccine leaked on her arm was considered resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of Product administration error of Underdose , Exposure via skin contact, Device connection issue for mRNA-1273, lot # 012L20A, with no associated AEs.
Received dose on 10/26/22 and that evening had fever, enlarged lymph node under right arm pit, flu like symptoms.felt better next day. On 10/29/22 I started having stomach pains which continued off and on. Contacted primary doctor on 10/31 and instructed to go urgent care or emergency if gets worse.  Felt better next day but the following days pain would come and go. On 11/11/22 the pain was so intense I wen to emergency. They sent me home after giving me zofran and  toridal.  On 11/15/22 I went to follow up  with PA in primary dr. Office. She scheduled Ultrasound for 12/5. Later that evening on 11/15 the pain was so bad that I went to emergency and found that my gallbladder was inflamed. Surgery to remove gallbladder on 11/16/22.
Information has been received from a pharmacy student concerning a patient who was vaccinated with a dose of PNEUMOVAX 23 (lot # 662842/1296X). Subsequently the patient was diagnosed with cellulitis after the vaccine was given. The pharmacy student stated that the patient was hospitalized (date unspecified). At the time of reporting, the outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Pain in my upper left arm, where the vaccine was given. It started out feeling like a small animal was inside my arm gnawing at the spot. It was a burning sensation. It changed to feeling like someone was taking a dagger and digging into the spot. It didn't travel but stayed right around where the shot was injected. It started a few days after the injection and has continued to this day, although it is less frequent and less severity of pain. It was fairly constant (most days) from mid-August through late December. I have been taking Tylenol for the pain ever since and applying balm. These days I don't need the Tylenol every day but about 2 days/week.  When it started, the pain was intense at first and shifted to moderate, ongoing pain. I saw Dr on Sept. 9, 2021, at the same clinic. He diagnosed it as a reaction from the shingles vaccine and as nerve pain. He said it might go away and get better, or it might not. It is very frustrating to think that this could last the rest of my life. I am reporting it in hopes that the vaccine can be adjusted so that others do not experience this.
Ever since (a few weeks after) getting the COVID vaccine, I've had really bad, what looks like Eczema,  on my right and left forearms. My right arm is much worse than my left arm. My skin is dry and scaley and itches. I've had eczema in the past and I don't normally get it during this time of the year and certainly not this bad. It's also not been responsive to normal treatments like Cortaid or other moisturizers. I've also had pain in my chest over my heart. It feels like a broken rib and comes and goes. I suspect it's heart inflammation. I went to the emergency room and they ran EKGs, did chest X-rays, took blood and they said everything came back fine. The chest pain has subsided with the exception of a small bit of temporary discomfort/sensation every now and again.