chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered adacel and pneumovax 23 injections in the same arm, in different locations of deltoid muscle, Wednesday 05/18/2016.  Provided pt with appropriate VIS sheets and counseled patient that may have a sore arm for several days after the injections. Had patient remain in store for 20 minutes after giving injection to watch for allergic reaction.  After 20 minutes, patient reported that she felt fine.  Patient called pharmacy friday 05/20/16 to check on other meds, pharmacist checked in with patient to see how her arm was feeling and she reported no pain at that time.  Patient called pharmacy on Monday 05/23/16 stating that her arm was red, swollen, and painful.  Pharmacist on duty suspected a typical injection reaction and instructed patient to let us know if it was still hurting in a few days.  Patient called 05/26/16 stating that her arm was still painful.  When asked to describe the pain she said it was shooting from her wrist to her neck, but not getting any worse.  She had not been using any tylenol or ibuprofen for the pain.  This pharmacist recommended that she try some ibuprofen for the pain and inflammation and to let us know if the pain did not get better.  Patient said she would try that and let us know Saturday/Sunday 05/28-29 if still not better.  **Update Tuesday 05/31/16 patient has not contacted pharmacy regarding any further issues.**
This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 22 month old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-JUL-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Dose administered after more than 1 temperature excursion; Temperature excursions during a period of 33 weeks on 2021/Dose administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Dose administered after more than 1 temperature excursion) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 10:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 11:16 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Dose administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Dose administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially moved to the fridge on 09-Mar-2021 and proposed beyond use date was 08-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 30 degree Fahrenheit that has been reached by the vial. Temperature recordings were taken using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided   This case was linked to MOD-2022-566976 (Patient Link).
Patient passed out in her car after vaccine administered. Smelling salts used and client awakened and was alert. Pulse ox 99% Pulse 75. Patient was given gatorade and a snack. Patient was talking and alert, she decided to get out of the car and walk a little bit. Nurse was near her side. Patient verbalized feeling better. She called her husband and let him know to her expect her at home, as she decided to drive herself back home. Nurse advised patient to get a ride home and not drive, patient refused.
My symptoms started with muscle aches and pains. I am rarely a sick person. The next day, I tested myself for COVID-19. The result was positive. I messaged my doctor and asked what to do. I asked if I was a candidate for PAXLOVID. He prescribed PAXLOVID. I started it the same day. The pack was three pills. I experienced the symptoms for the next three days. By the 17th, I was symptom free, but I continued the PAXLOVID. Seven days after onset, I took another COVID-19 test. The result was still positive. Ten days from onset of symptoms, I took another COVID-19 test. The result was negative. On March 28, 2023, I developed a severe runny nose. The next day, I tested for COVID-19 test. The result was positive. I contacted my doctor and asked if I should consider PAXLOVID. He said it was up to me. I said I would like to take it. He prescribed it for me. The pack was 2 pills. I finished my doses. The runny nose lasted three days. I was feeling alright. On day 7, I took another COVID-19 test. The result was negative. Currently, I have head congestion, but the runny nose is gone.
TACHYCARDIA UPTO 130S ALMOST 24 HOURS AFTER 2ND DOSE OF VACCINE AND CONTINUED TACHCARDIA 100-110 WITH LIGHT ACTIVITY SUCH AS WALKING OR STANDING, CHILLS, BODYACHES, LOW GRADE FEVER.  13 WEEKS PREGNANT
BACK AND ARM STILL HURT AFTER 40 HOURS. WILL CALL HEALTH DOPT ON MONDAY
Information has been received from a physician concerning a 24 month old male with no pertinent medical history and no known drug allergies who on 9/5/03 was vaccinated in the upper left thigh with a dose of varicella virus vaccine live (lot # 642678/0761M). Concomitant therapy that day included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine administered in the upper right thigh. On 9/15/00, 10 days later, the patient developed chicken pox. The reporter indicated that the patient recovered. No medical attention was sought. No laboratory diagnostic studies were performed. There was no product quality complaint. Follow up information received on 10/13/03 indicated that the child was seen in the office on 10/1/03 and was diagnosed with keratosis pilaris. It was noted that the child had not experienced chicken pox, as his mother had described. No further information is expected.
Patient presented to the ED and was subsequently hospitalized for weakness within 6 weeks of receiving covid booster vaccination.
Patient states that her upper arm began to get sore, red, and hot the evening of 10/30/2016. She stopped in the pharmacy and showed us the area and said that the spot was increasing in size. We recommended that she see a doctor since it was getting worse.  It is located on the upper left arm, starts at middle of upper arm and spreads downwards toward elbow.
Pt recvd vax 1NOV93 & ached all over, had a heavy feeling in the chest; had rib pain, weakness, & pale & clammy skin; 17NOV93 had a recurrence of chest pain, & elevated BP; seen by MD who treated w/fluids & rest;
This child developed erythematous area (5 cm x 7 cm) where injection was given. Afebrile, no pain.
This spontaneous report as received from a pharmacist via field employee refers to a 72 year old female patient, who was a family member of the reporting pharmacist. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosing details, lot #, expiry and route of administration were not reported). No concomitant medication was reported. About 3 months later the patient developed shingles on an unspecified date in the "March to April time frame", and then on an unknown date the patient developed "numbness" at an unspecified location. The outcome of numbness was not recovered (reported as patient was still experiencing numbness) and the outcome of shingles was unknown. The reporter did not provide the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
Patient was to receive the second dose of Gardisil 9 HOV, but by mistake was Prevnar 20 was given. Patient had a dose of Prevnar 20 one month prior. At this time no adverse reactions reported and patient will receive the second dose of Gardisil 9 HPV vaccine 7/29/22
sore for several days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 27-JUL-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, it was sore for several days, but that's all.  Additional Supportive Information: The follow up would not possible as no contact details were available.
was accidentally given a third dose of Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 02-Apr-2022 Reporter's Comment: This case was reported by consumer via interactive digital media. The case was reported by the patient. The patient physician's advice was to drink fluids.  The patient was still wondering if he/she was at risk for any long term problems. Additional Supportive Information: The patient was accidentally given a third dose of Shingrix, which led to extra dose administered. The follow up would not possible as no contact details were available.
Reported dizziness approximately 15:25. Sitting 126/66-64-14 Standing 124/86 92-14. Given po fluids and rested x 30 min - symptom resolved. No other adverse reaction
Palpitation lasted for a day after the second dose of moderna. Shortness of breath occurred during ambulating and lasted for three days.  Experienced chest pain which lasted for less than 5 secs for two days after receiving moderna.
With the first and second shot, I had major arm pain, then all Covid symptoms other than the respiratory issues...even worse then when I had Covid! I had it bad. I'm a long hauler. I have Interstitial Cystitis which got so much worse with Covid, and the same with the shots. I have pigmentary maculopathy and macular degeneration, which I'm losing my vision quite quickly. After Covid and the shots, it was also severely damaged and won't get better! I'm still dealing with muscle weakness,/atrophy, shortness of breath, confusion, major brain fog, like I'm lost in space, I'm more anxious and it was all so bad that I will never get the shot again! It made stop sick
Day 1: low-grade fever, orthostasis, headache. Day 2: pharyngeal ulcers and petechiae, tonsillar exudates, weeping serous ulcers around facial hair distribution, and numerous sites of painful inflammation <0.5 cm around soles of feet and tonails.
Patient arrived for Covid vaccine, previously vaccinated with AstraZeneca covid vaccine first dose. Patient consulted with PCP who advised her to have her Moderna vaccine.  Nurse informed patient we do not have AstraZeneca currently, patient verbalized understanding and consented to receiving Moderna vaccination. Patient tolerated it well and observed for 15 minutes, with out any adverse event.
Injection site reaction (redness; about size of a quarter) developed about 48 hours after injection. Patient states it isn't as red or as large as it was.
On 04/10/2012 in the clinic the said patient came into the clinic and did a urine HCG test with negative results at 0830. At this time she requested a serum HCG to be performed and this test was ordered and drawn. At this time she was asked if there was any reason why she would think that this test would show different results then the negative urine HCG had and she said no. She had not even missed a menses at this time. She then came back at 1513 and received her 2nd Anthrax dose. At 0730 on 04/11/2012 we received the report from the lab that the serum HCG came back positive. She came into the clinic and received her counseling from the PA and the nursing staff. The chief of Preventive Medicine has been informed and the unit has been informed that the said patient cannot deploy.
Near syncopal episode with vaccine and blood draw. At 0900 after vaccines administered and lab being drawn, pt had fainting spell x 30 sec. Pt placed in supine position, vitals taken, pt assessed AAO x 3. Held for 15-20 minutes.
Pain at injection site. Severe pain about 15 minutes later in the left shoulder muscle - uppermost left arm muscle. Difficulty moving arm. This pain and movement continuous, even when tried ADVIL or aspirin. No fever. Constant and continuous pain and limited movement to date.
Delayed maculopapular rash localized around injection site starting 1 week after vaccine administration. Mild itching. Persistent 24 hours later,  larger area but still localized to the shoulder.  Had local pain starting 2 hours after the injection, lasting for about 36h. No immediate skin reaction back then.  (I am a physician)
07/01/2021 I noticed blurred vision in my left eye, and closing my eye there was a line of light, it varied depending on how bright or dark the area I as in. 07/03/2021 I saw my optometrist and he diagnosed it as Cotton-wool spot.  As of now I am waiting to see a Rheumatologist to see what the underlying cause is. I currently can see better, but the spot is still there.
Redness developed at injection site the first day.  Day 1, hard swelling developed at site about the size of a quarter,  Days 3-5 hard swelling grew to about the size of a baseball.  Swelling started going down on day 7, then itching began.  Think I read this is called COVID arm.
Pain, ecchymosis, erythema, warmth at injection site. Tylenol for pain prn.
pt recvd vax;adm to hosp w/ GBS a 1 wk & a half to 2 wks p/ vax;
Pt presents with a red rash on her right arm, in the area where she received her vaccination. Area was warm to the touch, roughly 1.5 x 1.75 inces in size, and sore per patient statement. Area appeared on the morning of 8/23/21 (12 days post vaccination). Pt stated that she had not taken any OTC medications to aleviate any symptoms.
Pt states he had a reaction 3-7 days after vaccine doses of 8/12/04. Treated at ER and hospitalized for tachycardia and arrhythmia. Treated several months with anticoagulants by cardiologist.
Information has been received from a consumer concerning her brother who received 1 dose of MMRII. The pt experienced a seizure after receiving the vaccination. Upon internal review seizure was determined to be an "Other Important Medical Event". The consumer also reported her daughter's experience following vaccination with MMRII (WAES 01021270). Additional information has been requested.
Fever, fussiness 11/1/03 to 11/3/03. Rash 11/3/03. Sx all subsided 11/6/03.
Eight days after vaccination patient reports significant swelling at the injection site. It resolve after two days. No additional treatment was needed.
Narrative: 76yo male patient PRESENTED TO COMMUNITY ER ON 9/7/2021. Pt was admitted with Admitting Diagnosis: Glioblastoma with Hemorrhage. Pt remained inpatient at this hospital. On 9/12/2021 pt had Cardiac arrest overnight 9/12/21, Pt was intubated & on multiple drips. Pt died on 9/14/2021. Pt had received covid vaccines on 2/22/2021 & 3/22/2021. Death is not related to covid vaccines.
1540 Pt c/o nauseated and almost fainted when used restroom with mother.  RN assessed and assisted pt to lay on beb with LE elevated.  Vital sign taken T.98.0 F, BP 77/49, P 64 & RR 20/min. At 1630 clinician examed and spoke to pt.  Pt denied any discomfort at that time then pt released home with parents.
Fever 99-100 F; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 99-100 F) and MYALGIA (Body aches) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 002M21A, 030M20A and 0141L20A) for COVID-19 vaccination.     The patient does not have any history of allergies and history of COVID-19 prior to or after getting the vaccine.  The patient's past medical history included Small intestinal neoplasm (Has cancer tumors in the small intestines which were removed). Concurrent medical conditions included Type 2 diabetes mellitus and Pancreas cancer (Has cancer tumors in the pancreas which were still there and still being investigated).   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced PYREXIA (Fever 99-100 F) and MYALGIA (Body aches). On 30-Oct-2021, PYREXIA (Fever 99-100 F) and MYALGIA (Body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2021, Body temperature: 99-100 (High) 99-100 F.         It was reported that the patient had both the cancers which were diagnosed in the past 3-4 years and the patient was not undergoing any chemotherapy. Co-suspect medication information included that the patient had the shingles vaccine and those were given at a clinic, the first dose of which was on 12-Oct-2021 and the second dose was on 06-Apr-2022. It was asked by the patient that if there was a way to determine if the vaccine that the patient received for his second booster dose was a real vaccine or not as the patient had not experienced any side effects post vaccination. In fact, the patient mentioned that he was more upbeat and energetic. The patient was wondering because he had fever and body aches after getting the first booster dose of the Moderna COVID-19 vaccines and included the 2 doses of shingles vaccine. The patient was told by the vaccine provider that the patient was given half dose for the two booster doses. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-541327, MOD-2022-541321 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow up received includes no new significant information.
Administration date was 8-Nov-2021 and Expiry date was 13-Oct-2021 and Date of refrigeration was 29-Oct-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Administration date was 8-Nov-2021 and Expiry date was 13-Oct-2021 and Date of refrigeration was 29-Oct-2021) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administration date was 8-Nov-2021 and Expiry date was 13-Oct-2021 and Date of refrigeration was 29-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Administration date was 8-Nov-2021 and Expiry date was 13-Oct-2021 and Date of refrigeration was 29-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information were provided. Patient didn't reported any adverse events. The vials didn't undergo any temperature excursion. The vaccine was kept in the refrigerator on 29/10/2021. No treatment information were provided.
Fever; Nausea; Headache; Chills; Ache; she wasn't feeling well; This is a spontaneous report from a contactable consumer (patient's mother).   A 19-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/lot # EL8982) at single dose at right arm on 24Jan2021 15:00 for Covid-19 immunisation, administered at school/student health clinic.  The patient medical history was none. There were no concomitant medications. The patient received the 1st dose of bnt162b2 (BNT162B2, Lot Number: EL1284 and Expiration Date: Apr2021) Intramuscular at single dose in her left arm on 03Jan2021 at around 4:00 PM for Covid-19 immunisation. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). On 25Jan2021 the patient experienced fever, nausea, headache, chills, ache, she wasn't feeling well. The patient woke up on 25Jan2021 morning, and was kind of achy. The patient underwent lab tests and procedures which included body temperature: 99.8 on 24Jan2021. Reporter checked her daughter's temperature around on 25Jan2021 an hour before this report, and her daughter has a fever of 99.8, clarifying her daughter's temperature is running about 2 degrees higher than normal. Fever was treated drinking water, and patient uncovered herself to cool her body, and was using cold compresses. The patient was able to eat something, even though, she has some nausea and headache. The patient was feeling well enough to participate in remote learning from home, and she was resting her head on a pillow. The patient had chills on 25Jan2021 morning while in bed. The patient was a healthy, active, who exercises regularly, but and did not go to the gym on 25Jan2021morning because she was not feeling well. No event required a visit to Emergency Room or physician office. No relevant tests performed. The outcome of she wasn't feeling well was unknown, of all other events was not recovered.