chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administrated with an expired dose of Engerix -b on April 9 2021/vaccine expired on February 22 2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number unknown, expiry date 22nd February 2021) for prophylaxis.   On 9th April 2021, the patient received Engerix B. On 9th April 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient was administered an expired dose of Engerix B, the vaccine was expired on 22nd February 2021, which led to expired vaccine used. No adverse event was reported. No patient identifier and no lot number was provided. The reporter declined to follow-up.
given expired dose, 10/1,  but stable until 10/19 accoring to pfizer.
Left arm had increasing pain starting from 9/4 from shoulder to elbow to hand with the peak on 9/6. Swelling and "welt" was also peaked on 9/6. There was a small decrease and drop on swelling/hardness by 9/6. Pain remained the same from 9/6. Pain is most prevalent in elbow area. Weakness remained in left arm and shoulder tension as well. Doctor appointment was made on 9/13 for morning of 9/14.  Pain as of 9/15 remains at a 5/10 level right above elbow area.
Information has been received from a RN concerning a 7 year old female pt who on 18Mar98 was vaccinated in the right arm with a first dose of varicella virus vaccine live. Concomitant vaccination the same day included a fourth dose of Hib conj vaccine (Crm197) (Hibtiter) (lot M260RT) given in the right thigh and a fourth dose of diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid (Tripedia) (lot 7891824) given in the left thigh. There was no illness at the time of vaccination. On 28Jun04, the reporter stated the pt now has chickenpox. Unspecified medical attention was sought, but the pt was not hospitalized and treatment was not required. A product quality complaint was not involved. Follow up information from the nurse indicated that on 25Jun04 at 10AM the pt began with varicella lesions. Subsequently the pt recovered. No further information is available.
Onset time is approximate.  Patient has developed severe nausea with vomiting (six times reported by wife of patient) and diarrhea.
My period flow have constantly been pretty normal. But this cycle I am have extremely heavy flowing and a lot of blood clots. I normally never have these.
This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 24-OCT-2013 at 09:15 the patient was administered with M-M-R II (lot number J002505, expiry date 28-FEB-2015) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date the M-M-R II was exposed to approximately for 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17:14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13:26 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
eye pain after receiving the vaccine; on stop gastro-intestinal problems; arms itches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (eye pain after receiving the vaccine), ABDOMINAL DISCOMFORT (on stop gastro-intestinal problems) and PRURITUS (arms itches) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE PAIN (eye pain after receiving the vaccine), ABDOMINAL DISCOMFORT (on stop gastro-intestinal problems) and PRURITUS (arms itches). At the time of the report, EYE PAIN (eye pain after receiving the vaccine), ABDOMINAL DISCOMFORT (on stop gastro-intestinal problems) and PRURITUS (arms itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Headache, disoriented, dizzy, trouble eating, tachycardia, labored breathing, trouble with vision
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2020 as dose 1, single (Lot number: EK5730), in right arm, on 06Jan2021 as dose 2, single (Lot number: EL3246), in right arm and on 12Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos Thyroiditis" (unspecified if ongoing); "Hypersomnia" (unspecified if ongoing); "Total Hysterectomy", start date: Oct2018 (unspecified if ongoing); "Tonsils" (unspecified if ongoing); "Adnoids", start date: 1967 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jan2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jan2023) Positive, notes: (home); (05Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.
pt who may have multiple sclerosis & may be asplenic recv vax & devel an inj site rxn described as sepsis;pt hosp & treated w/ATB;
one has documented heart changes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "one has documented heart changes".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had a headache about an hour after the vaccine. Started feeling extremely tired around 8pm. Around bedtime I was really cold, my hands were like ice and I just kept trying to get warm. I woke up feeling fine this morning. The only pain I feel is that my left arm feels sore and aches when I move the muscle around.
Rash across forehead, buttocks, elbows, knees, palms of hands, soles of feet; itching.
She got her vaccine, she had no reaction and felt something tingly on her face and disregarded it and it went away.    On Wednesday she got a spot  on her face in front of her ear and it was itchy.  By Thursday her ear was swollen and it was itchy in the front of the face where the spot firm occurred and itchy behind, tingly and itchy, and swollen the bottom part of his skull.   She called her doctor and was given an APT for Friday.  By Thursday evening it traveled down and to the crown of her head, and traveled to the back of her ear.  She went to the doctor who said that she had Shingles, and was put on medication.  She ended up only getting about 6 spots.   They have resolved, but still has the scabbed area, the ones on the head have resolved and the swelling has gone down.  She was getting stabbing pains in her scalp and top of her head, three spots down, ear and ear lobe, told it was the C2 nerve.
Fever up to 102F on both occasions and stomachache and diarrhea after 24 hrs. on both occasions.
Right deltoid-Large area redness and swelling 100-120mm not extending below elbow. Area warm to touch, tender, itching, cortizone OTC cream applied by patient, now on Tylenol prn and Benadryl OTC with effect
Body ache (8hrs) , fatigue (44hrs) , body chills (8hrs). Fully recovered from all symptoms after approximately 20hrs of sleep in the 44hr time period.
Woke up in the middle of the night with intense dizziness, nausea, followed by abdominal pain and diarrhea that lasted 4 hours.
6/28/22  I started being very short of breath. A couple of days later, I tested for COVID with an at home test and tested positive. I went to the doctor and he did not prescribe anything and if it got worse, to go to the Emergency Room.  I did have an abnormal heart rate, short of breath and still have blood clots.
missed my second shingle shot; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The patient missed second shingle shot, which led to incomplete course of vaccination. The patient asked could he/she still take it. The follow-up would not possible as no contact details were available.
From telephone contact with the reporting nurse, it was stated that a 5 year old patient (2 of 2 ) received  an IPOL, a Tripedia and a MMR (manufacturer not specified) vaccination on 05/25/01. The patient developed a large local reaction, exact site not specified. Further information requested.
This prospective pregnancy case was reported by a physician and described the occurrence of vaccine exposure during pregnancy in a 25-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included Prenatal vitamins. On 6 April 2011 at 12:04 (19 weeks gestation) the subject received a dose of BOOSTRIX at 0.5 ml in the left arm as part of a pre-employment physical. The subject experienced vaccine exposure during pregnancy. Her estimated date of delivery was 28 August 2011. The pregnancy was ongoing. No additional details were reported. Follow-up information was received from a physician on 06 May 2011. Conception was normal. The physician reported an unspecified congenital anomaly. No additional details concerning the congenital anomaly were provided at the time of reporting.
101.5 fever day one of symptoms, severe body aches/twitching, chills/shakes/chattering/sweating, severe headache, throat pain, neck and back pain, 103 fever day 2 of symptoms, 102.5 fever with above symptoms still on day 3. Tylenol and advil switched off throughout the day, does not help the symptoms.
States patient woke up in the morning and noticed some bumps on her legs, by that evening she had itchy hives covering her trunk and limbs.
HEADACHE, CHILLS, NAUSEA;  PATIENT EXPLAINED SYMPTOMS AS BEING EXACTLY HOW SHE FELT WHEN SHE HAD COVID
vaccine was administered outside of the two hour time limit for the vaccine to sit out at room temperature after first puncture.  vaccine had sat out at room temperature for about 4 hours after first puncture. no adverse events reported. called patient on 5/17 and told patient about the incident and that johnson and johnson does not recommend one way or the other regarding revaccination.
I got a nail in my hand and it cut me open so they gave me a tetanus shot after that, about 2 to 3 weeks my arm hurts like I can't hold anything in that arm the lump from the shot finally went away but my arm is still hurting and I told the nurse and they didn't do nothing for me. What can I do because I still hurt.
Patient developed red dots on right arm (2 in the area of the injection and 4 more on his forearm) one day after vaccination.  Came to our clinic for evaluation if having an allergic reaction. After looking at the red dots and patient reported some pruritis at the forearm site- sent him to be evaluated by physician.  Came back later in the day to tell us physician diagnosed erythema multiforme and he was prescribed Zyrtec.  He had documentation from the physician of his condition and treatment,
Patient warned RN vaccinating him that he did not "do well" with shots (didn't like them). Immediately after receiving H1N1 inactivated vaccine, patient said he did not "feel right." Stated he was dizzy and nauseated. Also stated that he had not eaten breakfast. Kept patient seated, gave him some juice. He continued to feel bad and was able to transfer himself to a bed in the health occupations room, where vaccinations were being given. Feet were elevated and vitals were taken. BP 121/81, P 68, R 16. Cold compress placed on anterior aspect of patient's neck. Vitals taken and stable x 4. Patient was given some crackers and was able to hold them down. Was slowly returned to a sitting position, then walked with contact guard assistance around vaccination area. Patient stated he felt fine and able to return to his class; vitals were stable, gait was stable, and he was able to walk unassisted to his class. RN inquired about patient before leaving school property at 11:00, and pt. was with his class having no difficulty.
On 5/4/2021 I awoke with pain in the muscle area at the base of my left thumb with stiffness resulting in limited motion. No prior activity or injury explained the cause. The condition persisted for several weeks and expanded to pain/discomfort when pinching my thumb together with my index and middle fingers. Some weakness and occasional pain persists to this day. In early July I awoke with stiffness and pain in the muscles on the right side of my neck. Again, no prior activity or injury explained the cause. A week later I discussed both conditions during a regularly scheduled visit with my doctor. When asked, he discounted a possible connection with the vaccine and suggested stretching exercises for my neck. The recommended neck muscle stretching exercises resulted in only limited, temporary relief of the stiffness in my neck. I began to feel additional pain and stiffness in the muscles in my right upper shoulder and arm. Discomfort, included a searing sensation in the front of my shoulder joint that sometimes persists to today along with some weakness in my right shoulder muscles. I also started to experience loud popping in my shoulder which has now diminished to some extent.
This is a spontaneous report from a contactable nurse and physician communicated to a Pfizer sales representative. This nurse and physician reported similar events for two patients. This is the second of two reports. A patient of an unspecified ethnicity and gender received TRUMENBA on an unspecified date at single dose, and MENACTRA. the patient medical history was and concomitant medications were not reported. The patient felt sick for 4 days with  nausea and fatigue, on an unknown date with outcome of unknown.
Headache, NauseaVomiting, Chills, body aches (unspecified). fatigue Narrative:
Patient fainted about 5 minutes after receiving vaccine. After being evaluated by EMTs, they recommended she go to the ER to get checked out.
PATIENT DEVELOPED LOWER LIP SWELLING.  NO OTHER SYMPTOMS DEVELOPED AND PT WAS MONITORED UNTIL HE LEFT  WITH MOM AT 6 PM.  PATIENT HAD BP, HR, PULSE OX CHECKED 3 TIMES AFTER SWELLING STARTED ALL WITHIN NORMAL LIMITS.  MOM CONFIRMED THEY HAD AN EPIPEN AT HOME IF NEEDED. CALLED MOM  AGAIN AT 7 PM NO ADDITIONAL SYMPTOMS REPORTED AT THAT TIME.
gave a child just the DTap-IPV portion of Pentacel; Initial information received on 07-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional.  This case involves a 4 months and 2 days old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB), lot number UI969AAB, expiry date 04-Apr-2020.  On 05-Jun-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U6327AA, expiry date 19-Sep-2020 via unknown route in unknown administration site.  It was an actual medication error due to inappropriate reconstitution technique.  It was reported that they gave a child just the DTap-IPV portion of Pentacel and gave ActHIB separately but not the vial that was in the Pentacel box.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Patient had episode of vasovagal syncope just before eating lunch, did not require treatment, quickly returned to baseline. Prior to event had headache, dizziness, stomachache, appeared pale. After event complained of dizziness, appeared pale. Did not eat breakfast the morning of the event. Patient received dose #2 of Pfizer vaccine the evening before the event. Presented to pediatrician the same day and at that time complained of dizziness, activity was at baseline, had normal vital signs including heart rate and blood pressure, normal exam.
Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Additional Details: Patient called pharmacy to report an adverse reaction to the high dose flu vaccine, does not typically have a reaction this severe. Reported feeling extremely fatigued and dizzy for 3 days starting approx. 12 hrs after vaccine was administered. She said she is feeling better today but was concerned because of the severity of her reaction and that it lasted beyond one day
Initial report was received from a patient on 11 November 2011. A 77-year-old female patient had received an intramuscular (IM) injection of FLUZONE HIGH-DOSE (lot number not reported) in left deltoid on 09 November 2011. On the same day of the injection, the patient developed body ache, felt itchy, head buzzing, felt exhausted and unable to sleep. The patient course of treatment was two tablets of TYLENOL, two tablets of MOTRIN and FLEXERIL and was able to fall back asleep. On 10 November 2011, the patient "felt like she was hit by a truck", body aches, headache, weakness, throat raspy and chills. No further informational was available at the time of the report. The patient outcome was reported as not recovered/not resolved but has improved. Follow-up information was received from a consumer who is also the patient. The patient had no illness at the time of vaccination. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
At 5:30 AM the morning after my second vaccine, while I was doing my normal online teaching, I felt like I was going to vomit. I got very sweaty and knew I was about to faint. I did. I was passed out for a minute or so. This happened after a miserable headache that had started about 3:30 AM. I have had headaches every night since the vaccine. As well, I am over two weeks late with my period. I track my cycle and am never, ever late. There is zero chance of pregnancy.
Aching in injection arm and shoulder, 100.4°F fever, nausea, body aches, fatigue through 11/14/15. Continuing intermittent arm and shoulder pain, muscle weakness in arm and shoulder, body aches, fatigue through present, 12/07/15. I intend to consult my physician this week as my job performance is being adversely affected.
Systemic: Rash (other than injection site)-Medium, Systemic: Other- Anxiety-Medium
I had both shingles shots. I still get shingles/ suspected Vaccination Failure; I still get shingles, not bad, but I do break out in the same place every time.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient for himself/herself. The age at vaccination was not reported. The patient had both shingles shots and still got shingles, not bad, but it broke out in the same place every time. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Sore Arm; This spontaneous report was received from a lawyer and a consumer regarding herself, a female patient of unknown age. The patient was married and was retired. The patient was a non-tobacco user. The patient's concurrent conditions included dry eye, high blood pressure (HBP), arthritis (foot), high cholesterol. The patient's historical medications included zoster vaccine live (Oka/Merck) (ZOSTAVAX), pregabalin (LYRICA), influenza virus vaccine (unspecified) and tetanus vaccine toxoid (reported as flu and tetnus vaccine). Additionally; the patient had received steroids or corticosteroids. The patient's concurrent medications included cyclosporine (RESTASIS) and metoprolol.  On an unspecified day in May 2014, the patient became aware of the symptoms of shingles and hypoaesthesia (captured in MARRS# 2002USA003299).   On unspecified dates between 2016 and 2019, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown); which caused on an unspecified date, an adverse reaction/side effects as the patient experienced sore arm (Injection site pain).   Outcome of the event was not provided, and causal relationship was reported as related to pneumococcal vaccine (manufacturer unknown); Sender's Comments:  US-009507513-2002USA003299:
Client is a walk in customer  for  his second dose of covid-19 vaccine,   he got his 1 st dose of covid-19 MODERNA vaccine at non-medical clinic , but on the 2nd dose of vaccine it was processed for a different manufacture( PFIZER) covid-19 vaccine.  vaccine mixed series