chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 72-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date unknown) for prophylaxis. On 18th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 3 days after receiving SHINGRIX, the patient experienced injection site bruising. On 19th September 2018, the patient experienced injection site lump, injection site erythema and injection site warmth. On an unknown date, the patient experienced injection site itching. On an unknown date, the outcome of the injection site lump, injection site erythema, injection site warmth and injection site bruising were unknown and the outcome of the injection site itching was recovering/resolving. It was unknown if the reporter considered the injection site lump, injection site erythema, injection site warmth, injection site bruising and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the right deltoid. The pharmacist stated 24 hours after receiving the vaccine, the patient developed a knot at the injection site, along with redness and stated that the area was warm to the touch. Three days following the injection, the patient developed bruising at the injection site. In 2018, the patient reported to the pharmacist that the area was itching as it was healing. This was 1 of the 3 cases reported by the same reporter.
This spontaneous report as reported by a nurse refers to an unspecified number of patients (no demographic information was provided). The nurse reported that a physician's office may possibly have administered VARIVAX (Merck) and M-M-R II that were not stored properly. The nurse was not sure if this was correct information and would investigate. No symptoms were reported. Additional information has been requested.
This spontaneous report was receive from a Licensed Practical Nurse concerning to an unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history, historical drugs a concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot number M038216, expiration date 09-MAY-2018 dose, route and anatomical location were not reported) for prophylaxis. The temperature was between 0 Centigrade degrees and 2 Centigrade degrees, the time frame was 33 hours and the previous temperatures excursion were: 4 previous excursions: 1. between 0 Centigrade degrees and 2 Centigrade degrees for 32 hours; 2. between 0 Centigrade degrees and 2 Centigrade degrees for 30 hours; 3. between 0 Centigrade degrees and 2 Centigrade degrees for 29 hours; 4. between 0 Centigrade degrees and 2 Centigrade degrees for 36 hours. Data logger was involved. No adverse effect was reported. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1701USA008611:Original Case : 1701USA008041; US-009507513-1701USA008610:Original Case : 1701USA008041; US-009507513-1701USA008608:Original Case : 1701USA008041; US-009507513-1701USA008041:Original Case : 1701USA008041.
Mom noted a red bumpy rash on the abdomen the day after vaccines administered. One day after that area was very red and hyperpigmented, burn-like rash.
no adverse event; Incorrect product storage; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 24-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose/ frequency: 1,  lot # T010310, expiration date 24-MAR-2022, for prophylaxis (route were not reported).  The temperature involved was 16.5 degrees F for 4 hours. The previous temperature excursion was 14.5 degrees F for 2 hours and 45 minutes, 15.6 degrees F for 3 hours and 21 degrees F for 5 hours and 30 minutes. A data logger was involved. No adverse events.   This is one of multiples cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA003878:Original Case : 2104USA003483 US-009507513-2104USA003885:Original Case : 2104USA003483 US-009507513-2104USA003880:Original Case : 2104USA003483 US-009507513-2104USA003881:Original Case : 2104USA003483 US-009507513-2104USA003882:Original Case : 2104USA003483 US-009507513-2104USA003883:Original Case : 2104USA003483 US-009507513-2104USA003884:Original Case : 2104USA003483 US-009507513-2104USA003483:Original Case : 2104USA003483 US-009507513-2104USA003876:Original Case : 2104USA003483 US-009507513-2104USA003879:Original Case : 2104USA003483
What has been described now as "COVID Arm." About a week after the injection, the injection site started itching and when I looked at it, it had swelled slightly and had a rash about two inches in diameter.  It lasted for about 6 days and then subsided.  I often react to injections with swelling, etc. since I have a lot of allergies, and didn't think too much about it until I read about COVID arm and decided to report it.
Sore arm initially. Started to feel all around muscle ache and fatigue during the day after I received the shot. I went to bed early and woke up with hives. Taking over the counter allergy medicine.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant therapies, drug reactions/allergies and medical history was unknown. On 14-JUL-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose and route unknown, lot # M039453 with expiration date at 19-DEC-2017; for prophylaxis) reconstituted with sterile diluent (STERILE DILUENT) (incorrect product storage). No adverse event was reported. The vaccine had been exposed under temperature 15 Fahrenheit (F) to 46 F for 1 hour, but did not undergo previous excursion. Data logger was used.; Sender's Comments:  US-009507513-1706USA007264:
The day after getting the vaccine my arm had redness, moderate pain, and was swollen at the injection site. I also developed a fever of 100.6 degrees the day after receiving the vaccine. I also had muscle pain throughout my body and a headache. I took Tylenol for the headache and fever.
Patient's husband is acting as primary historian.  He reports that his wife tried to get up around midnight to use the bathroom and she fell on the side of their bed.  He states that around 4:00 a.m. she had another fall.  She has had increased urinary frequency thinking that she had a urinary tract infection over the past 2 weeks.  He states this morning when she had her 2nd fall she did feel quite clammy.  He denies any seizure activity, facial droop or slurred speech.  He states it was difficult to get her off the ground because she was so weak.  He reports that yesterday she complained of being fatigued.  She is recovering from a stroke but did not have any residuals from this.  She has been actively participating in physical therapy.  He notes that she has some tremors that may be associated with a Parkinson's diagnoses.  They arrived in the emergency room for evaluation.  Patient tested positive for COVID.  Her husband states that they both has had a cough for the past couple of days.  He associated this with allergies.  They both have received the COVID vaccine.     Her procalcitonin was 0.12, lactic acid of 2.05.  Glucose level 164. No leukocytosis appreciated.  She had an abnormal urinalysis.  She is pending a urine culture.  The remainder of her labs were unremarkable.  Patient's vitals are stable in the emergency room.  She had a negative chest x-ray.  Her CT of her head just showed bilateral old lacunar infarcts otherwise her CT of her head was negative for any acute abnormalities.   Interventions in the emergency room include COVID protocol being initiated.  Patient is not requiring any supplemental oxygenation.  She received Rocephin IV and Lovenox 40 mg subcutaneous. Admitted on 9/18/2021. CEftriaxone continued inpatient x 2 days. Discharged on 9/20/21
Right upper arm swollen from shoulder to elbow, warm to touch.  Not painful, not open or weeping.  Small bruise (size of penny) at site of DTaP injection.  Benadryl, cold compresses, advil for children.
Had a knot and it was tender for 2 to 3 days; Had a knot and it was tender for 2 to 3 days; Patient got full dose instead of half dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (Had a knot and it was tender for 2 to 3 days), VACCINATION SITE PAIN (Had a knot and it was tender for 2 to 3 days) and ACCIDENTAL OVERDOSE (Patient got full dose instead of half dose) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product SUNITINIB MALATE (SUTENT) for Secondary malignant neoplasm of kidney.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and SUNITINIB MALATE (SUTENT) (unknown route) 37.5 milligram. On an unknown date, the patient experienced VACCINATION SITE NODULE (Had a knot and it was tender for 2 to 3 days), VACCINATION SITE PAIN (Had a knot and it was tender for 2 to 3 days) and ACCIDENTAL OVERDOSE (Patient got full dose instead of half dose). At the time of the report, VACCINATION SITE NODULE (Had a knot and it was tender for 2 to 3 days) and VACCINATION SITE PAIN (Had a knot and it was tender for 2 to 3 days) had resolved and ACCIDENTAL OVERDOSE (Patient got full dose instead of half dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  Pateint stated that patient and his wife received moderna booster few days ago. Patient will go for his next scan soon. This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna
Patient was given  2 doses of Moderna Bivalent Once on 11/03/2022 and one on 02/21/2023.
Patient presented requesting a Pfizer booster dose and mistakenly received 0.3ml of Janssen J&J COVID-19 Vaccine instead of 0.3ml of Pfizer COVID-19 Vaccine.  CDC was consulted and the recommendation is the smaller Janssen dose is invalid and to repeat with a full dose of any age appropriate vaccine authorized for a booster.
Vomiting/diarrhea x 2 days requiring 2liters iv fluids for rehydration. Negative liver/pancreas/kidney injury. Pt released with no further treatment.
Vomit on 8/24/2020. Upon calling the pediatrician?s office, instructed to go to the ER. No significant findings at the ER; told to come back in case of projectile vomiting, blue lips, etc. On 8/25/2020,  patient had blue lips at 3pm first then again at 6pm along with low oxygen desaturation levels per home pulse oximeter. Upon taking him to ER, he had an episode of Low oxygen level of 30-40%, and was admitted to the ICU. Multiple episodes of desaturation led to EEG monitoring which showed seizure activity. Bacterial and viral infection tests, metabolic diseases tests and epilepsy genetic panel tests came back all negative. MRI, echocardiogram, ekg showed no significant findings related to seizures.
pt recv vax 6SEP96 & 10JUN97 pt devel server varicella consisting of more than 50 lesions that were disseminated;
Mild flu-like symptoms; beginning with sleeplessness; headache; fatigue; waves of mild nausea; muscle/joint aches; muscle/joint aches; waves of muscle spasm in right groin area; This is a spontaneous report from a contactable Other Health Professional reported for herself that a 63-year-old Female (no pregnant) patient received 2nd dose of Pfizer COVID-19 vaccine BNT162B2 (lot/batch number: EN6201) at Left arm on 02Mar2021 at single dose for covid-19 immunization. Medical history was Fibromyalgia, Arthritis, Lumbar disc bulge. Allergies to medications, food, or other products: PCN, codeine, ephedra, gluten. Concomitant drug included Progesterone, estradiol (ESTROGEN), minerals nos/quercetin/thioctic acid/vitamins nos (EMERGEN-C), ergocalciferol (VIT D), zinc. No other vaccines within 4 weeks prior to the COVID vaccine. Historical Vaccine was 1st dose of BNT162B2 on 09Feb2021 (lot/batch number: EL9269) at Left arm for covid-19 immunization. Patient experienced Mild flu-like symptoms: beginning with sleeplessness, headache, fatigue, waves of mild nausea, muscle/joint aches and waves of muscle spasm in right groin area. All lasted less than 24 hours from 03Mar2021 02:00 am with outcome was Recovered. No treatment. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
5 minutes after receiving HPV, felt dizzy, unresponsive x 2-3 seconds. Started to fall and mother grabbed her. Rt arm was twitching for few seconds. Pulse and BP.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 16-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
Swollen throat, difficulty swallowing and breathing within 30 minutes of infection. Swallowing became easier after two hours. Severe lower back pain symptoms began 48 hours after injection.
Nausea and headache at 0200 on 1/21. Myalgias, rigors, and fever to 1pp developed at 1000. Resolved by 1500.
Nine days after the shot, I noticed a red rash at and around the injection site. The area is warm and slightly raised. I had nothing at the injection site immediately after the shot, nothing but a small bruise for several days after, and then I stopped monitoring my arm. This red area appeared sometime between 8 days post-vacc and 9 days post-vacc. It is now 3 inches long and 2 inches wide.
This case was reported by a pharmacist, who is also the patient, and described the occurrence of loss of sense of smell in a 73-year-old male patient who received LOVAZA capsules over a period of 1 year as an antioxidant. The patient's past medical history included open heart surgery. The patient noted that his lipids and triglycerides are fine. Concurrent medications included CRESTOR, COREG and LOTREL. In 2009 the patient started Omega-3-acid ethyl esters (oral) at 1 gram per day. On an unknown date the dose was increased to 1 gram twice per day. An unknown time after the dose increase, the patient experienced loss of sense of smell, loss of taste and has a sensation of smelling burnt toast. The onset of these events was in April 2010. The pharmacist considered the events to be disabling. Treatment with Omega-3-acid ethyl esters was discontinued. At the time of reporting, the outcome of the events was improved. The reporting pharmacist considered the events were almost certainly related to treatment with Omega-3-acid ethyl esters. A male patient, who is also a pharmacist, reports that he lost his sense of smell and taste after going from 1 gram of LOVAZA per day, to 2 grams per day. The patient notes that he has a sensation of smelling burnt toast. He was seen by an otolaryngologist, and the visit was unremarkable. He notes that food is "non-palliative", but he is eating. The patient discontinued LOVAZA about 3 days ago and he has noticed a slight improvement. Follow-up information received on 28 September 2010: Co-suspect flu shot. The pharmacist said he plans on having a magnetic resonance imaging (MRI) shortly and a complete blood test performed. He said he eats because he was hungry but "imagination plays a big part when trying to taste food". He said the events were possibly related to LOVAZA and could also have been associated with the flu shot and his condition of influenza because "I did have the flu". Follow-up information received on 28 September 2010, via pharmacist who is also the subject. An additional event of upset stomach occurred on an unspecified date. The subject reported "I eat because I am hungry but have difficulty tasting any food substance. Total lack of smell. Imagination plays a big part when trying to taste food". The subject stated he plans on having a magnetic resonance imaging (MRI) shortly and a complete blood test performed. It was also reported that "any and all doers manifest as the same- burnt coffee or toast". The pharmacist reported the events were possibly related to LOVAZA and could also have been associated with the "Flu shot and I did have the flu" [vaccination failure]. At the time of the report the events of loss of taste and smell, burning smell had improved but were still present; the outcome of upset stomach and flu were unknown.
Covid symptoms started on 12/30/21. I initially had fever, chills, and body aches and specifically my back was really hurting and that lasted for 4 days. The fever was on and off for 4-5 days as well. It was kind of your typical symptoms and I was better during the day than night time. On the 4th day I started experiencing a high heart rate when standing and the only reason I knew that was because I was checking my pulse ox because I was getting bad pain behind my shoulder blade and I could see my heart rate was jumping really high, but if I sat back down it would return to resting heart rate of 52 BPM. As soon as I would get up it would go to 130-140 but I never got dizzy. I went to the ER and they did an EKG and blood work and said it wasn't an emergency and to go home. That was day 5. On Day 6 I felt a little better and wasn't getting as high of a heart rate, and by day 8 and 9 I was back to normal. The whole time I had fatigue and I had probably had it for probably a month.
been on Paxlovid since Friday 17Jun /had 2 Pfizer vaccines and 2 Pfizer booster; been on Paxlovid since Friday 17Jun/had 2 Pfizer vaccines and 2 Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; cilgavimab, tixagevimab (EVUSHELD), 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), outcome "not recovered", described as "been on Paxlovid since Friday 17Jun /had 2 Pfizer vaccines and 2 Pfizer booster"; COVID-19 (medically significant), outcome "not recovered", described as "been on Paxlovid since Friday 17Jun/had 2 Pfizer vaccines and 2 Pfizer booster". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Patient had been on Paxlovid since Friday 17Jun. Patient didn't feel better. Patient did think a second round of another 5 days would work. Maybe just wishful thinking. Patient had 2 Pfizer vaccines and 2 Pfizer booster s plus the Evusheld.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I was exposed on 05/01/2022. By 05/03/2022 I started to not feel well. I was running a fever and I had a headache. On 05/04/2022 I went to Urgent Care because I was running a temp of 102. They tested me to COVID-19 using the Rapid and PCR and both came back negative. The Doctor stated that I might have COVID-19 and advised I should test again in a couple. On 05/06/2022 I took a home rapid test and it came back positive. I contacted the doctor I saw in Urgent Care and she prescribed Paxlovid. I took that for 5 days. By the following week I felt good again.
Red raised area extending from shoulder to just above elbow. Cephalexin 500 mg TID.
Child with fever, irritability. Dx with otitis, but irritability worsened and child started having seizures - continues with temporal lobe seizure activity and deviation of eyes. Symptoms started 3 weeks post last set of IZs. Pt treated with anti-seizure medications and acyclovir. Unknown association of illness as related to vaxs.
Patient came to vaccination clinic with father, father stated she needed her second covid vaccine. When billing out after clinic it was noted patient had already received Pfizer vaccinations on 05/17/21 and 6/08/21. It was also noted that patient received Moderna which is not approved for 13 years of age.
FLUZONE HD was administered. Pt did not have adverse events on follow up 10/10/14 AM.