chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 15-May-2018 regarding an unsolicited valid non-serious case from a nurse. This case involves a patient (Age and gender was not reported) who received a dose of ACT-HIB and PENTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date.  It was actual medication error due to extra dose administered (of HIB component). This was reported on 10 February 2017 that the patient had received ACTHIB and PENTACEL and staff was told to monitor the patient to report any adverse event that may occur. It was discussed that "we do not have any documentation that states that. Asked for reference number, case number for that call provided". No further questions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none.
PATIENT STATES HE WAS PLAYING VIDEO GAMES WITH HIS FRIENDS YESTERDAY WHEN HIS NOSE STARTED TO BLEED. HIS GRANDMOTHER TRIED MULTIPLE METHODS TO STOP THE BLEEDING. PATIENT'S NOSE CONTINUED TO BLEED FOR 2 HOURS WHEN HIS GRANDMOTHER CALLED EMS. PATIENT WAS TAKEN TO SCH ER WHERE A BALLOON WAS PLACED. 7/15/2021 THEY REPORT THEY WERE TOLD THE BALLOON WAS TO REMAIN IN PLACE UNTIL FRIDAY. PATIENT STATES HE HAS HAD PREVIOUS EPISODES OF EPISTAXIS, BUT NOTHING TO THIS DEGREE. PATIENT REPORTS INTENSE PAIN IN HIS NOSE, FACE AND PALATE. HE HAS HAD CLEAR NASAL DISCHARGE FROM AROUND THE BALLOON, BUT NO ACTIVE BLEEDING. PATIENT WAS PRESCRIBED ANTIBIOTIC, BUT HAS NOT FILLED THAT PRESCRIPTION YET. HE IS ASKING FOR THE BALLOON TO BE REMOVED DUE TO THE PAIN.
p/vax pt has had weakness, tingling & tightness in the joints of rt arm;states rt arm had no strength like it was paralyzed;no redness or swelling;told to come see MD;
Veteran received Pneumococcal about 9:30 AM on 9-16-09 in right arm and Influenza in the left arm.  He awoke from sleep at 2:30 AM on 9-17-09 and his arm was red, swollen, hard, and painful to touch.  He later fainted.  He was taken to hospital by ambulance where he was treated and released.
Patient is 15 YO female,  arrived to clinic with mother for third dose Pfizer on 10/09/2021 at 11:00 am. Patient's second dose Pfizer was not reviewed and verified by staff.  Patient was administered the Pfizer third dose today. Per staff, patient and mother left Clinic with no adverse events. Writer reviewed patient's prevaccination Checklist for COVID-19 Vaccines and noticed that patient's age group is not eligible for the booster COVID-19 vaccine at this time. Mother contacted and confirmed that patient's second dose was administered on 06/12/2021. Mother stated that patient is not experiences any adverse events at this time; however, it appears that patient may be catching a cold. Patient was scheduled with doctor for a post vaccination follow up to address any concerns and questions. Per patient's visit with doctor, mother stated that patient is experiencing nasal congestion. Writer follow up today and mother stated that patient is doing better and that nasal congestion has improved. Mother instructed to monitor symptoms and follow-up with PCP as needed.
I experienced a very sore arm, nausea, major headache, body chills and aches. A majority of these side effects lasted about 7 hours. The sore arm and body aches lasted about 10 hours. I took ibuprofen.
I contracted COVID-19 five months after the second dose of the vaccine. I first felt like I was coming down with something. The following day I started to develop a cough and a fever. I had muscle pain, a headache and a sore throat. The cough was severe cough. I tested positive on 08/4/2021. I was prescribed Erythromycin 250mg and Montelukast and Dexamethasone steroid. I gargled with salt water twice a day and use a Saline spray. The gargling seemed to help. The worst symptoms lasted about four days. I did not lose sense of taste or smell. I felt well by the one week check up from my doctor. I got my Booster shot and I had aches especially in my back.
Head feels cloudy; Body aches; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: El3247) via an unspecified route of administration, administered in left arm on 16Feb2021 14:00 (at the age of 43 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has had no COVID prior to vaccination. The patient has no known allergies. There were no other vaccines in four weeks and no other medications in two weeks. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient experienced head feels cloudy and body aches on 17Feb2021 12:00. No treatment was given in response to the events. The patient was not tested for COVID post vaccination. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Initial administration of the HPV vaccine on 9/2/08 was in the right deltoid and was administered without incident.  On 9/11/08 the patient was seen in the express care clinic by Dr.  At this time the patient had compaints of sharp and throbbing arm pain, as well as arm weakness (brachial neuritis).  This pain is worse at night.  The patient was given Ibuprofen 400mg #30 and Desipramine 25mg #20.  Patient was to return to the clinic in 2 weeks for follow up.  2/19/09 Received PCP & ER medical records of  FINAL DX: right arm brachial neuritis Records reveal patient experienced constant sharp throbbing pain right arm x 1 week w/decreased ROM when seen in ER on 9/11/08.  Tx w/meds & referred to PT.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 17-JUL-2016, the patient was vaccinated with improperly stored M-M-R II lot # L029266, therapy type (albumin status) rHA, (dose, strength, route of administration and expiry date were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Onset varicella November 28, 2002, sypmtoms equal vesicles 2-3 day outbreak. Sx itchy, fever 24 hours, occasional sore throat. Treatment supportive.
2 days p/vax arm sore w/redness, swelling approx 1 1/2" circular area on rt deltoid w/hard knot around;
I went to the doctor for abdominal pain that started around the time of the shot. Every time I went in they noticed that my heart rate was really high. This summer they diagnosed me with Postural orthostatic tachycardia syndrome (POTS). And they have not figured out why I have it yet. They think I might have had COVID before getting the vaccine. For treatment they gave me lots of electrolytes for hydration. They think I might have POTS before getting the vaccine.
High Blood pressure; This is a spontaneous report from a contactable other HCP. A 92-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included seronegative arthritis from an unknown date and unknown if ongoing Sero-negative Rheumatoid arthritis, hypothyroidism from an unknown date and unknown if ongoing Patient has hypothyroidism  One of my grandmother's sisters also had hypothyroid , gene mutation from an unknown date and unknown if ongoing genetic mutation (FOXC2), lymphoedema from an unknown date and unknown if ongoing Familial Lymphedema  her parents have to have passed on the mutation,  syndrome from an unknown date and unknown if ongoing this mutation is highly related to Ehlers Danlos and immune system abnormalities, immune system disorder from an unknown date and unknown if ongoing this mutation is highly related to Ehlers Danlos and immune system abnormalities, hypotension from an unknown date and unknown if ongoing , rheumatoid arthritis from an unknown date and unknown if ongoing One of my grandmother's sisters also had RA, hypothyroid, and familial lymphedema. Concomitant medication included hydroxychloroquine taken for rheumatoid arthritis, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; torsemide taken for lymphoedema, start and stop date were not reported. The patient previously took miralax and experienced drug hypersensitivity. She had the Pfizer vaccine and tolerated it very well, except three weeks post vaccine she had a few days of exceptionally high blood pressure when her blood pressure (BP) is normally very low. The patient underwent lab tests and procedures which included blood pressure measurement: increased. The outcome of high blood pressure was recovered.  Follow-up (11Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
The pt doesn't like needles.  Gave her the shot no problem. She waited 15 minutes then walked out with her boyfriend.  She said she felt faint, then passed out.  He caught her then put her in the car.  Then she passed out again.  He called 911. The ambulance came and brought them back in the store.  She got checked out and refused to go to the hospital.  She claimed she was fine and left.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT EXPIRATION DATE ISSUE (non-serious), outcome "unknown", described as "She states that the first 2 Covid vaccines there is no expiration date and wants to know why". Verbatim and Event Description: Swap from FC - first time caller/consumer is calling about Covid she received her booster Covid today and states that on the vaccine card shows expired 31Jan2021 and she states that the first 2 Covid there is no expiration date and wants to know why. She also asked how long does this vaccine stay in your system for. She states this time there was a little bit of blood on the bandaid where last 2 times there was no blood at all and what does this mean. She declined her mailing address. Provided number and transferred to PMI hold que. Faxing potential AE to Pfizer. Medical Information (MI): Were any unaddressed medical questions referred or forwarded to Medical Information: Yes. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (13Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. Follow-up (13Oct2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to non-HCP letter sent via telephonic follow-up activity which included that: Consumer Follow-up Questionnaire: Any additional information: Phone Out 4:31 PM EST, 1st attempt by phone to consumer to obtain mailing information. Phone answered by consumer who does not want to continue with the follow up process with the team. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
One day I started noticing palpitations very regularly. I could feel it in my body after every beat. I checked my pulse, and the 3rd beat was missing. I went to an urgent care then they sent me to the ER. When I went they noticed that I had PVCs. They ran tests and gave me a liter of fluids. The ER suggested that I follow up with a halter monitor. The palpitations have gradually diminished.
This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (first dose of Moderna Monovalent today but received the Moderna Bivalent instead) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    ADMINISTERED (first dose of Moderna Monovalent today but received the Moderna Bivalent instead).    No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2022: Live Follow-up  No New Information accepted
Approx 2 weeks after vaccination the patient was experiencing aches and tightness in the chest and diaphragm that goes up on the side of the chest and into the back. Patient states the pain is not constant but comes and goes and when it comes on it is very intense.
pt recv vax 1JUL97 & devel fever 9JUL97 followed by sz, tonic clonic, 1-2min x 1, w/u for infect negative;
4am 2/2/2021 I woke up with severe body aches, took Tylenol and ibuprofen, and it was resolved.   7am 2/3/2021 I woke up with large hives on the nape of my neck, head, right breast, right mid/upper back, and small ones on both lower legs, right hand, and RUQ stomach both of my ears are also very red, hot, and swollen. I have a history of chronic urticaria and they have been this bad before, however, they have not been this bad since 01/2018 and I have not needed any treatment for them since 06/2019. Since I stopped treatment in 06/2019 I have not had more than 1 or 2 small ones on my lower legs (which is where they usually occurred or 1 of my ears would be slightly warm, red, and swollen so I wanted to report it since it was so close to after receiving the vaccine. I took a Benadryl and iced the large hives on the nape of my neck and my ears which helped but did not resolve the issue.
Per the clinical lead Hepatitis B vaccine trasported to clinic in portable cooler. A vaccine excursion occurred with the portable cooler. The temperature on the portable cooler went out of range based on Engerix- B manufacturer recommendations. The portable cooler reconditioned and Hepatitis B vaccine admistered to patient. Manufacturer conatcted by representative. Per the Health Department they were advised by GlaxoSmithKline that the Hepatitis B vaccine was not viable and the patient needed to be revaccinated.
Low grade fever, diarrhea after 48 hours, lethargic, excessive sleeping, dehydration, loss of appetite, and hospitalization with positive rotavirus stool test. DC DX: Rotavirus Gastroenteritis, Dehydration. PMH: GERD recent admission DC date 9/13/06
early next morning got up to use bathroom, and collapsed on bathroom floor, went in and out of consciousness and was too weak/had no energy to pull herself up from the floor.  Severe diarrhea all over floor and self.   Was not found until Saturday afternoon, and was transported to the ER by ambulance.  Remained in hospital Saturday evening until Monday afternoon.  As of today, the following Friday the 12th, she is still weak and unsteady at times, where she was previously ambulating fine with adequate energy.  Still feels like she has no strength.
This spontaneous report as received from a register nurse refers to an unspecified number of patients of unknown age. No concomitant medication, pertinent medical history, drug reactions or allergies were reported. In 2014 (exact date unspecified) the unspecified number of patients were administered for GARDASIL (lot #, expiration date, strength, dose and frequency were not reported) that were improperly stored. Doses of this vaccines were administered after 23-JAN-2014 until an unspecified date (date approximated: 2014). No adverse events were reported. This is several reports from the same source (MARRS # 1404USA014626, 1404USA015276). Additional information has been requested.
Information has been received from a physician concerning a 16 year old female consumer with no pertinent medical history who on an unspecified date was vaccinated with varicella virus vaccine live (Oka/Merck). There was no concomitant medication. Subsequently, the patient developed cold-induced urticaria 1-2 weeks after administration of first dose of varicella virus vaccine live (Oka/Merck). Medical attention was sought, the patient was examined in the office. There was no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
This case is 1 of a cluster of 3 patients' who experienced similar adverse events following vaccination with ADACEL. The events for the other 2 patients' were captured in case number 2011-02656. An unidentified patient (age and sex not reported) received an intramuscular injection (site not reported) of ADACEL, sanofi pasteur lot number C3837BA, in April 2011. The patient developed redness and swelling larger than a quarter at the injection site. The redness covered the whole upper arm. The patient also experienced tenderness and discomfort. The patient had cellulitis and was treated with antibiotics. The outcome was reported as recovered. Documents held by sender: None.
On wednesday 2/10/21 I got a vertigo and since then I feel dizzy somedays worst than others   The extra page doesnt' work: 9. Dicyclomine, Librax
shaking chills, temp of 99.9  Diaphoretic for 48 hours,  in bed and slept 48 hours and then fatigue for a few days following  Onset of symptoms was 24 hours following the injection - tolerated well at the time of the injection
rash that traveled outside the 6x6 area; This is a spontaneous report from two contactable Consumer. This Consumer reported for a female patient.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Jan2021 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced rash that travelled outside the 6x6 area. The outcome of the event was unknown.   Follow-up attempts have been completed and no further information is expected.
Within 15 to 30 seconds post vax, the pt went limp in his chair, eyes fixed and staring, then he stiffened straight out and started shaking for 1 to 3 minutes. When he awoke he complained of headache and stomachache; appeared ashen.
This spontaneous report was received from a physician refers to a male patient of unknown age. The patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23. On an unknown date in October-2012, the patient experienced high fever of 104 degrees, aches and pain, dizziness and excruciating pain in the armpit area after receiving the vaccination. The outcome of the events were unknown at the time of this report. This is one of the several reports received by the same reporter. Additional information has been requested.
7-10 days, post vax, pt stopped breathing in his sleep, was limp and unconscious. Had to stimulate for more than 30 seconds. About 3 weeks later, the same thing happened again, only worse. Two months later had low heart rate. Uses apnea monitor constantly because apnea occurred frequently.
Girlfriend came in for her 2nd dose and reported that her boyfriend "died in my arms from a blood clot after his first covid vaccine." Patient, died suddenly at home on 7/21/2021 in the presence of Girlfriend.  She called 911 and the fire department responded. He was dead when they arrived. They did not transport him to the hospital but directly to the morgue.  No autopsy was performed. The coroner did not speak with Girlfriend.  She got the information about the blood clot from the EMTs who said "I could tell by looking at his neck that he had a clot".  Not sure why she attributed it to the Moderna vaccine?  He was vaccinated in our pharmacy on 7/6/2021. I told Girlfriend I would report this to the Pharmacy system and to VAERS.  She said no one else had reported it to her knowledge.
aching; tiredness; This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced pain and tiredness. On an unknown date, the outcome of the pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain and tiredness to be related to Shingrix.  Additional details were provided as follows: This case was reported by the reporter for his wife. The age at vaccination was not reported. The reporter reported that his wife received the 1st dose of Shingrix and the 2nd dose in August 2019. The reporter stated that after getting the vaccine, she experienced aching and tiredness. The reporter refused to provide any further information about his wife. This case has been linked with US2019206662, having same reporter.
This is a prospective pregnancy case. This 32-year-old female subject was enrolled in a study. The subject received Flu Seasonal QIV Dresden .5 ml on 4th September 2015. On 4th September 2015, an unknown time after receiving Flu Seasonal QIV Dresden, the subject developed wrong injection technique (Non-serious). Additional event(s) included injection site pain in September 2015 and vaccine exposure during pregnancy. The outcome of wrong injection technique was unknown. The outcome(s) of the additional event(s) included injection site pain (unknown) and vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the injection site pain to be related to Flu Seasonal QIV Dresden. Additional details were received as follows: The patient received FLUARIX QIV higher in the upper arm leading to wrong injection technique. In September 2015, less than a week after receiving FLUARIX QIV, the patient had more pain than usual at the injection site. The reporter was asking if the patient could be revaccinated. The reporter did not have any patient details, product details and patient's medical history.
Pt c/o stomach hurting then lost coloring in face & lips; Pt was able to hear us talk; Also felt very hot touch, BP was 90/40 @ this time;
Instead of an MMR and Varicella vaccine, patient received MMRV and Varicella, no symptoms or side effects noted.
2/23/2022 at 14:30-Left forearm numbness that progressed to  At 1600: Left lower extremity,  At 2100: Left eye blurry vision