chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2016US023424, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 46 years old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, into left arm on 08 May 2016. On 08 May 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion was administered to patient. No adverse event was reported following this medication error (incorrect product storage). The case was assessed as non-serious by the nurse.
I fainted and hit my head.; I fainted and hit my head.; passing out; stomach cramps; diarrhea; chills; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20Mar2021 12:45 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation. Medical history included Thyroidectomy. Concomitant medications included pravastatin sodium (PRAVASTATIN SODIUM); levothyroxine sodium (SYNTHROID); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient received first dose of BNT162B2 on 27Feb2021 at 74-years-old for COVID-19 immunization: lot number=EN6203, lot unknown=False, administration date=27Feb2021, vaccine location=Left arm, dose number=1. On 22Mar2021 16:00, the patient fainted and hit her head. On 21Mar2021, the patient had stomach cramps, diarrhea and chills. I was wondering if passing out was an uncommon side effect. The outcome of the events was recovered. The patient received treatment for the events.
Dizzy, fever, weak, nausea for 3-4 days. No treatment from doctors office. Elective vaccination.
DEVELOPED WEAKNESS AND FEVER OF 99.5. ALSO FLUSHING IN FACE AND LETHARGY.
9 days after the vaccination mom describes an event where he was staring up at the ceiling to the side. He did not have tremors or rhythmic shaking of any limbs; he did not loose muscle tone.  He did not have a fever or any other sign of infections at the time. He was taken to the emergency room.  further investigation revealed that he had a normal MRI and but an abnormal EEG which read the following: focal discharges over the left parieto-occipital area. He is not currently on medication (mother withheld consent to begin medication). Follow up exam revealed a normal exam.
Received Pfizer vaccine (dose 1) on 01/23/21 around 2pm. At 10:30pm on 01/23/21 he stated that his chest was heavy and felt like fluid was in his lungs. He coughed up some fluid and mucous. He stated that he had shortness of breath on 01/24/21 and 01/25/21, but has no difficulty breathing since 01/25/21.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Mild
After two weeks from the injection date, my right shoulder became extremely painful and has remained that way for the past week with pain shooting down my arm.  It seems to be extremely inflamed.  Even my sweat glands are excreting a stinky perspiration only on my right side.  Much worse at night.  Advil helps.
Patient was administered with an expired Hep A vaccine. Hep A vaccine expired on 05/20/2022 and was administered on 06/08/2022,  Intramuscularly,  into patient's left deltoid.  Nursing supervisor and Vaccination physician made aware, and incident report completed. Physician  gave 1x order to repeat Hep A vaccination. Contact made with patient and she was made aware of incident and provided with education . Patient agreed to return to clinic for another Hep A vaccination.
Moderna vaccine was administered outside of facility- reported by patient  ACUTE NON ST ELEVATION MI 8/7/2021 BPH (BENIGN PROSTATIC HYPERPLASIA) HYPOTENSION 7/25/2021 BPH (BENIGN PROSTATIC HYPERPLASIA) RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/16/2021 BPH (BENIGN PROSTATIC HYPERPLASIA)
9/13/14 - Vaccine administered, 9/14 - Lump at site of administration (LA), 9/15 - weak, went to ER. Fluids were administered for dehydration 9/19/14 - Symptoms resolved accept for lump still at administration site (LA).
Developed postural osteostatic tachycardia within a couple days. Still experiencing.
Arm is very sore; sore and all joints, especially in my hands and fingers hurt; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Apr2021 at 16:45 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and sulfonamide allergy (sulfa drugs). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included elagolix sodium (ORILISSA), sertraline (MANUFACTURER UNKNOWN) and mirtazapine (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Mar2021 at 16:45 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 06:00, the patient experienced very sore arm and painful joints, especially in her hands and fingers hurt. On 16Apr2021, the patient underwent Nasal Swab, SARS CoV-2 test and the result was Negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events very sore arm and painful joints, especially in her hands and fingers hurt were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
MMR was given on 3/3/2020, after new employee had the chance to read the VIS and sign the consent. On 3/27/2020, she let us know that her arm was still sore from the vaccine. She was advised to file a report and have it seen by a doctor. She was seen by her doctor and declined recommended steroid injections at the time. She was seen by Physical Therapy and I believe is still seeing Physical Therapy as of 12/24/2020. The nurse giving the IM, did not realize that she had received the flu vaccine less than 4 weeks prior in the same arm by another nurse. The employee did not mention this after reading the VIS, which is done prior to signing the consent and being given the injection.
pt exp hypoglycemia;LMD stated feels that not related but had to report since may have been possible;pt didn't eat prior to shot either;not sure if w/in min or hr the dose were given;
Increased sensitivity; Itching in the area of injection; Circular raised left arm rash; Red oval spot around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Increased sensitivity), VACCINATION SITE PRURITUS (Itching in the area of injection), VACCINATION SITE RASH (Circular raised left arm rash) and VACCINATION SITE ERYTHEMA (Red oval spot around the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to codine), Raynauds since 1997, Systemic lupus erythematosus since 1988, Supraventricular tachycardia since 2013 and Fibromyalgia since 1988. Concomitant products included LOSARTAN, DILTIAZEM, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), OMEPRAZOLE, TIMOLOL MALEATE and CICLOSPORIN (RESTASIS) for an unknown indication.    On 05-Mar-2021 at 6:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red oval spot around the injection site). On 10-Mar-2021 at 6:00 AM, the patient experienced VACCINATION SITE RASH (Circular raised left arm rash). On an unknown date, the patient experienced SENSITIVE SKIN (Increased sensitivity) and VACCINATION SITE PRURITUS (Itching in the area of injection). On 25-Mar-2021, VACCINATION SITE RASH (Circular raised left arm rash) and VACCINATION SITE ERYTHEMA (Red oval spot around the injection site) had resolved. At the time of the report, SENSITIVE SKIN (Increased sensitivity) was resolving and VACCINATION SITE PRURITUS (Itching in the area of injection) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that on 16-Mar-2021 the patient got little better from Sensitivity. Treatment information reported included topical antibiotic cream over the counter.  Approximately five days after injection in left arm, an area below the injection begin itching and patient noticed a small size red spot. The itch continued with increased raised area spreading with an oval shape.  The rash and itch lasted for more than 7 days. Patient applied atopical itch cream which helped with the itch. It was approximately 10 days or more that the rash/raised area begin to subside. At time of this report, there was no further rashes or itching in the area.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-Jul-2021, history. Patient demographics, allergies, dose 2 details, concomitant medication, added an additional event. Updated event outcome for the Vaccination site pruritus.
Patient states the following week or sooner after receiving first  Shingrix  vaccine, he experienced injection site tingling which travelled down inside of right arm  to thumb and next two fingers. It does not hurt. He still experiences the sensation of "pins and needles" almost every day, half dozen times per day.
I?m not sure if it has anything to do with it but to me it?s very coincidental that my son that has been very healthy went in for a check up and got the HPV vaccination that was offered to him then soon after I got very sick on me I was hospitalized for almost 3 weeks and now has dermatomyositis
The pt had a generalized tonic/clonic seizure at home and then went to the ER. Then she had a second seizure in the ER.
Patient under observation for 30 minutes after having reported being hoarse or voiceless in the previous doses. She indicated that I do not need treatment at the moment. 29 minutes after starting observation, the patient cannot speak (has no voice), and presents redness and slight edema in the lower front of the neck. Effective breathing pattern at the moment, with oxygen saturation 96%. She does not have shortness of breath but indicates feeling his neck tight (makes gestures with his hands). Stable vital signs at the moment, calm patient although unable to speak.
25JUL98 613PM irritable, drowsy, afeb, eating okay;26JUL98 9:05 T99R, high pitched cry, not nl cry, not consolable;tx APAP
Still feel fatigue eight days after vaccine/Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Still feel fatigue eight days after vaccine/Fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Still feel fatigue eight days after vaccine/Fatigue). At the time of the report, FATIGUE (Still feel fatigue eight days after vaccine/Fatigue) had not resolved.            No concomitant product reported by reporter. No treatment medication reported by reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received. Reporter contact information updated. Patient Date of Birth added. Dose information added.
Pt experienced swelling and redness at injection site. The area was itching and hot to touch. Pt was treated with Benadryl.
pt recvd vax 13OCT93 & 2 hrs later devel facial & lip swelling next day (15-18 hrs p/vax) localized swelling & erythema of the entire upper arm & swelling in lower arm; resolved w/in 2 days; no tx;
Can?t move my are, fever, large red mark on are, very tired, loss of appetite
This case was reported by a healthcare professional and described the occurrence of nausea in a 19-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  On 11 February 2008 the subject received 1st dose of ENGERIX B at 1.0 ml in the left arm.  One hour after vaccination with ENGERIX B, the subject experienced nausea and dizziness.  On 15 February 2008, four days after vaccination with ENGERIX B, the subject experienced shortness of breath and had been sick for 36 hours straight.  This was considered to be a systemic reaction.  The events resolved and were considered by the reporter to be probably related to treatment with ENGERIX B.  On 25 March 2008, the subject received the 2nd dose of ENGERIX B (no other vaccines were administered)  and within a short period of time began shaking, complained of dizziness, numbness in her arm and leg and had an unsteady gait.  This was considered to be a systemic reaction.  The subject was transported to the local emergency room via EMS and was released.  The subject was still experiencing numbness at the time of reporting.  The outcome of the other events was unspecified.  No further vaccinations with ENGERIX B are planned.  Additional information received on 27 March 2008 questioned the quality of the ENGERIX B administered to the subject.  This was considered to be a product complaint.  Follow-up information received on 20 June 2008 indicated that the subject may have a history of reaction to morphine.  Details were not specified.  Both the 1st and 2nd doses of ENGERIX B were given intramuscularly.  On 25 March 2008, the day the subject received the 2nd dose of ENGERIX B, it was reported that the subject experienced an anaphylactic reaction which resolved by 30 March 2008.  The reaction was considered to be possibly related to treatment with ENGERIX B.  The subject was hospitalized and during hospitalization, an arterial venous malformation in the brain was found.  The reporter stated that the subject was "probably" born with this defect.  The subject was given medication for headaches.  Due to the subjects reactions, the 3rd dose of ENGERIX B was not given.  It was reported that the subject completely recovered from her reaction to the vaccine.  The outcome of the arterial venous malformation and headaches was not reported.
Initial report received from a health care professional on 12 October 2009. A female of unknown age received an injection of FLUZONE (lot number not reported). The site of vaccination was reported as the shoulder joint. The date and route of vaccination were not reported. The patient experienced shoulder pain. The date of onset was not reported, however the patient's shoulder pain was ongoing at 3 weeks post vaccination. The patient was seen by a health care provider. No additional information was provided. List of documents held by sender: none.
The injection site started hurting / felt sore/painful; Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received Shingrix. In April 2019, 4 hrs after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The reporter stated that four hours after receiving the Shingrix vaccine, the injection site started hurting, and felt sore. She said it was painful for two days and then resolved. Redness at the injection site started sometime on the first day, and the injection site stayed the same shade of red for the first three days. Subsequently, the redness began to fade a little every day until it was fully resolved within a week.  The reporter did not consent to follow up. The reporter would not provide any additional details.
I got shingles and COVID; Shingles outbreak following / had both vaccines for shingles and then had it, suspected vaccination failure; Shingles outbreak following / had both vaccines for shingles and then had a bad case of [it]; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 26th November 2020, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced coronavirus disease 2019. On 25th December 2020, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the vaccination failure and coronavirus disease 2019 were unknown.   The reporter considered the vaccination failure, shingles and coronavirus disease 2019 to be possibly related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient got shingles after getting vaccinated with the shingles vaccine.  The patient was scared because he had heard that people go to the hospital, get on oxygen, then the next thing is the respirator and things don't look really good after the disease.  The patient had received both the vaccines for shingles and then had a bad case of it from Thanksgiving to Christmas. The patient also had coronavirus disease. The patient stated that even though he had got shingles and coronavirus disease, if they come out with another vaccine, he would receive it. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Information has been received from a pharmacist referring to a 49 years old female patient. The patient had no concomitant medication. The patient had a history of penicillin (unspecified) allergy. On 28-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (route and dose unknown, lot # M027552, expiration date unknown). On 28-SEP-2016, the patient experienced fever and extreme soreness in the arm where she received the injection within a few hours of vaccination. The patient emailed the pharmacist to seek medical attention. Treatment had been given for the events. No lab was performed. The patient was recovering from the events. The causal relationship between the events and PNEUMOVAX 23 was unknown. This is one of two reports received from the same reporter. Additional information has been requested.
pt c/o swelling lt arm, pt stated tinkling of lt arm sl swelling noted on lt arm w/sl redness;
7:00 p.m. fever and dizziness. 8:00 p.m. vomiting chills and cough. 12:00 a.m. awoke with body aches which lasted for 72 hours. It felt like an actual live virus infection.
3-36 hours after shot: sore arm; 20-36 hours after shot: slight headache; 30-48 hours after shot: swollen lymph nodes & nasal drainage
Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: Per patient's husband, patient started experiencing shortness of breath and chest tightness starting 3-4 days ago. Pt's husband also reported of patient being immunocompromised.
Joint and muscle aches, fatigue, chills, HA, symptoms resolved within 48 hrs
FEELING SLIGHTLY TIRED; This spontaneous report received from a patient concerned a 77 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 14-MAY-2021 16:00:00 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced feeling slightly tired. The action taken with covid-19 vaccine  was not applicable. The outcome of feeling slightly tired was not reported. This report was non-serious.
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in an 89-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses. The vial did not undergo any temperature excursions.  The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received and included no significant information.
On 05-16-2021 I started to feel not well, started with a cough and fatigue. On 05-19-2021 I tested positive for Covid. I also had Covid tongue which my tongue swelled up for one week. On October and November of 2020, my household was positive for Covid. I actually had two or three covid tests performed on me and I tested negative at that time. I am a case manager nurse and am in exposure to Covid patients where I work. To this day, I still have a lingering cough and fatigue that comes and goes but my tongue has not swelled up since then.
After about 30 minutes, I noticed an itchy patch of skin on my right cheek and mild itchiness under my chin and on my other cheek. It lasted a bit over 24 hours.
No additional AE reported; improperly stored vaccine; This spontaneous report was received from a healthcare worker referring to a 14-month-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 08-FEB-2023, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) injection (1 dose, lot#: w020525, expiration date: 14-DEC-2023; route of administration, and anatomical location were not reported) for prophylaxis. This vaccine was once stored in 30F for 3 hours and 15 minutes (product storage error) and the vaccine had no previous temperature excursion. No adverse events (AE) were reported (no adverse event).
Pt has pain, swelling, redness, warmth at inj site starting 2 days after injection getting worse after 1 week.
Hives, pain in arm 4-6 hr after injection, pain radiating up to neck, no distinct calor.