chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 3 days after receiving SHINGRIX, the patient experienced shoulder pain and pain in elbow. On 27th August 2018, the patient experienced pain in arm, tingling, weakness of arms, injection site swelling and injected limb mobility decreased. On 28th August 2018, the patient experienced fever and pain. On an unknown date, the patient experienced tenderness muscle. The patient was treated with ADVIL. On an unknown date, the outcome of the pain in arm, fever, pain, injection site swelling and injected limb mobility decreased were recovering/resolving and the outcome of the shoulder pain, tingling, weakness of arms and pain in elbow were not recovered/not resolved and the outcome of the tenderness muscle was unknown. It was unknown if the reporter considered the pain in arm, shoulder pain, tingling, fever, pain, weakness of arms, pain in elbow, injection site swelling, injected limb mobility decreased and tenderness muscle to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. About an hour later after receiving SHINGRIX, the patient's arm hurt at the injection site and was a little swollen. About 4 hours later, at bedtime, the pain in the arm became worse, and the patient could barely move her arm. The next day after receiving SHINGRIX, the patient felt achy and feverish. The arm pain increased. On the third day after receiving SHINGRIX, the pain spread to the elbow and shoulder. The patient experienced muscle tenderness in the right arm. The patient also reported that the thumb on the injection side feels like an electric charge and tingling was going through it. The patient took ADVIL, and it did not help. The patient saw her physician, but was just advised to wait and see. Clarification raised regarding event onset date.
Approximately 5 minutes after receiving vaccine, pt felt like passing out and c/o of involuntary shaking and numbness-decreased speech from numbness noted. Red area noticed around the base of throat and upper chest. No c/o SOB or dyspnea. Pt lay down on cot and BP taken. Transferred to ER. Called pt at home at 2:45 PM. Pt nervous and anxious, states she had no breakfast. Had some sips of water and resting. Husband with her. Felt better, set up on cot again felt like passing out and face was flushed. She was given Motrin, Benadryl, and epinephrine but is doing fine. to call if noticed anything at all happening. Not to get any more flu shots. Pt stated she had felt a rush when she had received former flu shots.
Severe allergic reaction, I still have the allergy, I have been treated with prednisone, which altered the blood sugar, I have thin skin syndrome and my fingers break making my work difficult.
SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via other manufacturer (Pfizer) concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and tetanus vaccine allergy. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 10-MAR-2021 13:00 for covid-19 prophylaxis. No concomitant medications were reported.  It was unknown whether patient had any adverse events following vaccination (Dose number in series 1).  The patient received additional non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 034F21A expiry: UNKNOWN) dose was not reported, administered at right arm on 17-NOV-2021 14:30 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2). On unspecified date in 2023, the patient experienced suspected covid-19 infection (Dose number in series 2) and received treatment medication paxlovid (nirmatrelvir/ritonavir) from 13-SEP-2023 to 17-SEP-2023. On 18-SEP-2023 after taking paxlovid, covid symptoms reappeared for approximately 2 weeks. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
6.5 X 4.5 cm raised erythematous dermatitis over right deltoid.  Treatment:  BENADRYL elixir.
Symptoms began about 3 hours after shot, Flue like symptoms including  sore throat, ached all over and felt worse than I have ever felt in my life, Went to urgent care, nose was swabbed for flu and came back negative. Slight cough and nasal drip. Heavy fatigue. Slight fever, redness at injection site. Day 2 - felt better but still hurt and fatigued.
Malaise; Lightheadedness; Pain at the injection site / sore arm; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), DIZZINESS (Lightheadedness), VACCINATION SITE PAIN (Pain at the injection site / sore arm), CHILLS (Chills) and NAUSEA (Nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.  On 16-May-2022 at 3:30 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022 at 5:00 AM, the patient experienced MALAISE (Malaise), DIZZINESS (Lightheadedness), VACCINATION SITE PAIN (Pain at the injection site / sore arm), CHILLS (Chills) and NAUSEA (Nausea). On 17-May-2022 at 8:00 AM, MALAISE (Malaise), DIZZINESS (Lightheadedness), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain at the injection site / sore arm) had not resolved.     Concomitant product use was not provided by the reporter.  The patient received second booster on 16-May-2022 at 3:30 PM afternoon and experienced several AEs on 17-May-2022 between 5:00 AM to 8:00 AM morning. They were the most significant of all 4 shots. The patient experienced pain at the injection site, chills, malaise, nausea and lightheadedness. Events had subsided, except for a sore arm.  Treatment information was not provided.
Prolonged arm pain and limited ROM for 3 months. Multiple PT and massages appointments required to alleviate pain and resume ROM.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 17-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna COVID-19 Vaccine EUA  injection site was red and rashy-looking approx. 9 days after the shot. Additionally, it was hot to touch and the tissue under the skin was hardened. On day 10 or 11, the rashy look turned to a light purple bruise.
This study case was received from the investigator in a trial on 15 April 2014. A 19 year old male subject, medical history reported as no, developed chest pain, considered mild in severity, 2 days after he received an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) on 24 March 2014 and concomitantly, an injection of TYPHOID VACCINE, (manufacturer, lot number, route, site and side not reported) on 24 March 2014. On 26 March 2014, 2 days post vaccination; the subject experienced three episodes of chest pain lasting about 30 seconds, each improved when he "paused" for a second. The subject did not take any meds for it or seek medical attention. On 08 April 2014 the Troponin I result was reported as normal, less than (<) 0.10 ng/mL. On 08 April 2014, electrocardiogram (ECG) was reported as normal. The subject was referred for care. According to reporter, no further information was expected to follow. The chest pain was considered resolved on 07 April 2014. The patient's outcome was reported as recovered. According to the investigator, the event of chest pain was considered other important medical events and possibly related to the trial product. Documents held by sender: none.
No adverse reaction; Got expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Got expired vaccine) and NO ADVERSE EVENT (No adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Got expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Got expired vaccine) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Got expired vaccine).    Concomitant medication was not reported.  Patient and her husband received expired vaccine. They did not experience any side effects. Treatment details were not reported.   This case was linked to MODERNATX, INC.-MOD-2022-662400 (E2B Linked Report).
L  upper arm had some tenderness at site of injection--normal.   Exactly one week after receiving the vaccine, the injection site began itching, reddening and swelling.  I felt mildly fatigued but otherwise OK.   There was an area of reddening and swelling about 6 inches by 3-4 inches.  Benedryl 25 mg po relieved the symptoms and by the following morning the swelling & itching had subsided some but the redness had slightly expanded.  We took photos of my arm.
Patient was given MENACTRA IM in RD. Patient was then given the Flu and HPV9 in LD. A minute later patient's father opened the door and stated to me (vaccine administrator) that his son was dizzy. Dr. was informed and acted immediately asking patient to lay down and take fluids. 5 minutes later 4:21 PM, patients BP was 98/56.  Dr. was informed. The Doctor then examined the patients' heart, then asked him to remain laying down and to take more fluids. 12 minutes later, 4:33pm BP was 105/60. Dr. was informed. The Doctor again asked him to remain laying down for a few more minutes. 20 minutes later 4:53pm, BP was 105/64. Dr. was informed. The Doctor examined him again before releasing him.
Child febrile (temp unknown) per parent report on 5/20/10, arms painful to touch, child brought to health department on 5/21/10--afebrile at the time, bilateral arms red, swollen and warm to touch, child playing and acting appropriate.
Patient passed out for 30-45 seconds shortly after receiving the shot. He recovered with low BP (62/31) shortly after EMS was contacted. After monitoring, patient recovered BP to 112/61 under supervision. He left with parents afterward.
Erythematous macular rash to torso and upper extremities - 18 hours later was examined. Antihistamine Benadryl RX, Observation
Los of ROM in left arm very painful at injection and about an inch down. Can't reach back without causing extreme pain can't even raise my arm all the way up to put deodarant on.
Severe fatigue lasting through at least 4/13,  barely able to get out of bed.  Light headed
-Arm soreness began a few hours after vaccination, lasted about 24hrs -Headache, slight fever noticed after waking up on 9/18, minor body aches  -Period began a few days earlier than expected (was stressed about vaccine, understand the possibility that this was because of stress)
Patient described tongue tingling in approximately 30minutes after receiving the vaccine. She opted to be evaluated in the ED where she reported that her tongue/mouth felt swollen.  SHe was assessed and no immediate intervention was necessary.
Pt's. (L) arm swelled from elbow to shoulder where she rec'd the SQ injection.
Pain while breathing,  2 inch diameter raised welt on arm near injection site (treated with Benadryl), feverish for 24 hours, soreness in joints, pain in arm and lymphnode near injection site, migraine lasting 2 days.
This spontaneous report was received from a medical assistant concerning herself, a female patient of unknown age. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. On 19-MAY-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, lot# and expiration date were unknown), which was administered with a properly stored sterile diluent (lot# and expiration date were unknown) subcutaneously for prophylaxis. It was reported that the VARIVAX had a temperature excursion, which was detected by a data logger, of -9°C to 8°C for 1 hour and 14 minutes, and -14°C to -10°C for 7 days. On 20-MAY-2017, the patient experienced general body aches (pain). On approximately 21-MAY-2017, the recovered from the event of pain (reported as "which lasted about 24 hours). The causality between the event of pain and VARIVAX and sterile diluent was not assessed. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015757: US-009507513-1706USA000283:
22 cm x 15 cm area of redness without fluctuance (R) upper arm. Mild TTP. Iced at home. Topical BENADRYL applied.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-APR-2016, the patient was vaccinated with an improperly stored dose of MMR II (dose and route were not reported, lot # L011528, expiration date 30-APR-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
28NOV95 for cellulitis 5cm-given Keflex back to MD 11DEC95 lymph node rt groin enlarged 1/2cm x 2 no script;induration cont rt thigh
Pt. from tent 3 at observation lane was complaining of light headedness + generalized weakness.  Paramedics assessed.  Once symptoms subsided paramedics released pt. to leave.
Patient started feeling ill 3-4 hours after receiving the vaccine. She had a fever, body aches, fatigue/decreased strength, and a lot of pain at the injection site. This was her second dose in the series, but her side effects were more severe after the second dose than after the first dose. Her symptoms were most severe the day after receiving the vaccine (8/2/18) and resolved 3 days later (8/4/18). She felt too ill to drive herself to a doctor's office but said she would have called an ambulance if her symptoms worsened.
DEATH; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death. The reporter stated that "My sister's coworker dropped dead at work the next morning after her shot". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220233703.  Version created to amend previously reported information on 14-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1- Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event.  20220233788-Covid-19 vaccine ad26.cov2.s-Death. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
No effects for first 4 days. The evening of May 3rd around 7PM PDT I was stuck with severe nausea/vertigo. This lasted for several hours. Also experienced weakness for duration, cold sweat for first half hour.  For first couple of hours any movement caused extreme nausea/vertigo, gradually fading. (my insomnia was not effected!). As I type this, May 4th at 742 AM I feel tired, very slightly nauseous. No other symptoms noted at this time.
Rash on arm; Looked and felt like shingles; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash and vesicular rash. On an unknown date, the outcome of the rash and vesicular rash were unknown.   It was unknown if the reporter considered the rash and vesicular rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient broke out in a rash on arm he/she received Shingles vaccine in after 1st dose. The patient reported that there was no live virus, but it was sure looked and felt like Shingles. The patient stated that the doctor said did not take the next dose, so the patient guess that he/she was only partially protected. Additional supportive information: Follow-up would not possible as no contact details were available.
Developed large red like rash below the injection site. Very hot to touch 2 days after injection. Returned to Clinic on 8/28/2019 and was prescribed to take Cephalexin 500 MG twice a day for 10 days and Triamcinolone Cream 0.1 % 30 GM twice a day.
Pt has had no history of receiving PCV13 or Tdap. Pt receive vaccine on 10/12/2018 denies any reaction until 10/18/2018 saw provider complaining of heat, pain and redness at both injection sites. Pt denies shortness of breath or hives since injection. Pt states does apply BIOFREEZE to arms daily.
Initial report received from a pt (who is a nurse) on 10/18/05. A 51 year old, female pt experienced burning upon administration of 0.5ml of Fluzone given inadvertently in the left forearm Intra dermally. She also received Tubersol in the right forearm. Within 10 minutes, she developed redness and a rash covering her entire forearm. The injection site was warm to touch, swollen and itchy. At the time of the report, the rash had disappeared. The reaction site was not specified. It was not known if the other symptoms had resolved. She has not recovered.
I had sinus infection, I had respiratory infection and double ear infection (Inner and Outer) and ran a fever for 1 week. I went to Urgent Care twice, the first time they gave a prescription for the ear infection. After the second time I got another prescription, and everything was better. No need to see a doctor again.
Anaphylaxis/Angioedema Patient was given EpiPen 0.3 mg IM; Methylprednisolone 125 mg once; Diphenhydramine 25 mg IV push once; Famotidine 20 mg IV push once; Dexamethasone 10 mg IV push once Patient was intubated and put on propofol and midazolam drips for sedation
Information has been received from a licensed practical nurse concerning a female patient who on an unspecified date was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain, numbness, and a tingly feeling all the way down to her fingertips. The events occurred in the arm in which the patient received the vaccination. Unspecified medical attention was sought. The patient subsequently recovered from the events. Additional information has been requested.
How intense is the side effect of second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How intense is the side effect of second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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, the patient experienced VACCINATION COMPLICATION (How intense is the side effect of second dose). At the time of the report, VACCINATION COMPLICATION (How intense is the side effect of second dose) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.