chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; This is a spontaneous report from a contactable pharmacist, the patient. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date at 15:00 (at the age of 65-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, 8 hours after the vaccination at 11 PM, the patient experienced headache and was treated with Excedrin. Event continued till Sunday. The reporter assessed the event as non-serious.   Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Unexpected incontinence struck mid morning, continued a full day: Bladder urgency despite not eating or drinking all night. 4AM - had violent bile-only dry heaves  5:30 AM through 8 AM - able to sip 1/2 Cup of plain water and ate a half Saltine cracker plain 10:30 AM - bladder urgency went on and off all day about every 45 minutes, 90 minutes at most, even if the urine output was very minor. Repeatedly couldn't make it to the toilet on time, had to change pants. Remained home a full additional day to be sure it wouldn't continue. Stopped happening as suddenly as it began.
12/09/2023 I started feeling symptoms of a Sinus Infection. I went to Urgent Care and was prescribed antibiotics, nasal spray and Sudafed for 10 days.
After 1 hr of vaccination - patient Arm is sore , swelling developed a red patch and few days later experienced the Nausea , vomiting and Diarrhea .  Her MD thinks she might have developed a local  infection at injection site .
This case meets vaccine breakthrough criteria review with +COVID test >14 days post vaccination series. Presented to ED with shortness of breath, myalgias, fatigue, nausea, abdominal pain, cough, vomiting, diarrhea
patient received a Ipol vaccine after an excursion, no adverse event; Initial information received on 08-May-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to case 2019SA129834 (same reporter).  This case involves a 17 years old male patient who received a IPV (VERO) [IPOL] vaccine (vial lot P1A17, Box Lot # P1A171M, and Exp. Date 24-Apr-2020) via intramuscular route in the left arm after an excursion, on 03-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) and INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) for Immunisation.  It was an actual medication error case due to incorrect product storage.   It was reported that MA wanted to gather stability information on ActHIB, IPOL(open), Penatcel and Tdap vaccines exposed to a temp of 46.6 degrees F for 30 mins. This Happened on 03 Apr 2019.  No adverse event was reported.  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.
On 6/15 I began heavy menstrual bleeding with large clotting. I am on oral contraceptives and this bleeding occurred 4 days earlier than it should have. The oral contraceptive keeps me regular and my bleeding is of a medium flow lasting no more than 4 days. I had extremely heavy bleeding for 8 days with continued spotting.  I'm also experiencing large bruising from the slightest injury. I even bled and later bruised at the injection site on 6/26 when receiving my second Moderna dose. This was in addition to fatigue, muscle cramping and headaches. But I expected that. The bleeding is extremely unusual.
Received 1st dose of the vaccine on 10/2/2020.  By 5:30 AM the next morning, on 10/3/2020, I felt very weak, my muscles ached, I had a quarter size hard lump at the injection site that was very sore and tender to touch.  I also felt nauseous and had a headache.  The symptoms of feeling weak with muscle aches lasted throughout the day.  I took Advil 200 mg for the headache and it was partially relieved.    By that evening the symptoms were subsiding.   The redness and soreness of my left arm lasted for 4 days before it began to resolve.
This spontaneous report as received from a nurse refers to her sister, a 62 year old female patient. Approximately in August 2011 ("2 years ago") the patient was vaccinated with ZOSTAVAX (dose, route, indication, lot#, expiration date not reported). Approximately in August 2013 (currently) the patient had a mild case of what appeared to be shingles. The patient sought medical via physician examination and communicated with her physician. The outcome of the event was reported as not recovered. Additional information has been requested.
12 hours after receiving a shot I woke up from a sleep and when I went to walk her right leg collapsed under her. She hit her head at that point. Her leg remained unable to bear weight and Monday morning we went to the emergency room  where they diagnosed her with a stroke. Her right leg is paralyzed and her right side weak.
patient inadvertently receive a Pentacel vaccine at 7 months of age with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare Professional. This case involves a 7 month old male patient who receive 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ384AAA and expiry date 09-Oct-2021) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) (not produced by Sanofi Pasteur) ( lot number and expiry date not reported), patient inadvertently receive a pentacel vaccine at 7 months of age (accidental exposure to product).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEP [HEPATITIS B VACCINE]) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE SHANTHA) for  prophylactic vaccination.  It was a potential medication error case due to accidental exposure to product.  The caller stated that a patient inadvertently receive a pentacel vaccine at 7 months of age. See the additional event details field for more info. Additional Description of event Adverse events :The patient was given a pentacel vaccination at 7 months of age. Staff person SH administered 0.5 ml of penticacel in the patient's right thigh. He also received prevnar, Hep B and the Roto virus vaccines on this visit. NP wrote the orders.  At the time of reporting, no adverse event was reported.  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.  There will be no information available on the batch number for this case.
Vertigo-No health issues/Never had Vertigo before.  Woke up 8:00 am on Sunday (few weeks after 1st shot) with dizziness.  Went about my day.  Evening, went to lie down on couch and went into an extreme Vertigo attack.  It would not stop.  After about 30 minutes, my husband called 911.  I could not even get onto the stretcher.  They had 3 guys pick me up off the couch.  I was vomiting for about 4 hours.   Hospital immediately admitted me.  Ran MRI and CT Scan.  Spinning stopped about 5 hours later from onset.  I was hospitalized for 2 days.  Since this attack, I continue to have Vertigo attacks for about 20 seconds every time I lie down.  I've gone to ENT and they don't see any issues with crystals in my ears.  I'm having more tests run and seeing a neurologist.  My head has to be elevated at night .   Various times of the day, I experience a brief dizziness.  I went to PT with no success.  This appears to be continuing on and not stopping.
Over a 103 degree fever, hard time breathing, weakness in muscles so I couldn't walk or stand. Those symptoms went away after day 2, but my arm stayed hot and swollen for 3 weeks. On week two, I was having chest pain and left arm pain. My upper left arm was inflamed, hot, and swollen for weeks. Due to getting SVT from my bout with COVID in January, I went to the ER. They said the pain was from the muscles in my chest wall. The pain from the injection TWO weeks prior was still causing me issues by radiating out. 6 weeks later, I am still having muscle weakness in that left arm and pain in my shoulder. When I got my second vaccine in my right arm, my left arm was hurting worse and was hot again.
Redness right upper arm 19 x 22 cm warm to touch, hard to touch treated with AUGMENTIN, BENADRYL; ZYRTEC.
experienced "severe reactions; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   On 21st June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication Several patients received the first dose of Shingrix and did not receive the second dose after a two to six months period. Pharmacist mentioned that 4 patients received the first dose in the pharmacy where she works but she only provided the details of one patient.  She did not provide his initials.  After call was transferred, the pharmacist told second line agent the reason patients delayed taking the second dose was because they experienced severe reactions which she described as having problems getting out of bed for three days. She stated she had already provided the information to the first line agent. No further details or information provided, other than what was documented. This case is one out of 4 cases reported by the same reporter.
Pain, swelling redness 8 inch area where shot was given. Chills, body aches, sore joints mild headache, mild nausea, extreme tiredness.
Temperature of 100.7; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature of 100.7) and CHILLS (chills) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PYREXIA (Temperature of 100.7) and CHILLS (chills). At the time of the report, PYREXIA (Temperature of 100.7) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature increased: 100.7 Unit not specified.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided.   Patient took two ibuprofen for his symptoms.
11:15 patient seated in observation area reported a "burning sensation in her stomach" and feeling hot Water given, encouraged to remove her coat  RN offered to move to private observation area  1117 patient confirmed she was able to stand and ambulate independently.  Patient walked with adult son to private observation area. Door opened for fresh air and patient seated next to door.  EMT and RN assessing patient 11:18 VS: 150\88, HR 70, PO2 97% Patient stated she feeling better and shared she really thinks it was nerves Last blood sugar 142 taken at 8:30 before daily medications 11:22 apple juice offered and declined by patient. another water provided. patient stated she is feeling fine 100% better.  11:28 patient discharged from observation area. Self ambulated with adult son at side.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 31-JAN-2017 at 10:57, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA00045.
Patient presented to Hospital ED on 3/14/21 with respiratory distress. Patient was tested for COVID-19 and found to be positive on 3/14/21 in the hospital ED. Patient was a DNR. Hospice was consulted (this writer is employed by Hospice). The patient passed away on 3/15/2021. Per family patient had recently received COVID-19 vaccine. Vaccine information verified in portal.
Following my 2nd dose of the 2 part series vaccine in August I have had intermittent pain that comes from the injection site (Left Arm)/ The pain is locateddirectly at the injection site.; When the pain presents itself it is deep and sore and it inhibits me from having full range of motion because of the discomfort.; When the pain presents itself it is deep and sore and it inhibits me from having full range of motion because of the discomfort.; Additionally, I can no longer lay on my side ( Lt. Arm) at night for long periods of time without having a gnawing pain that occurs throughout my whole Lt. arm.; This is a spontaneous report from a contactable nurse, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via intramuscular route of administration in the left arm on 27Aug2021 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic back pain and known allergies to sulfa and penicillin (PCN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via intramuscular route of administration in the left arm on 23Jul2021 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date in Sep2021, following 2nd dose of the 2-part series vaccine in Aug2021, the patient experienced intermittent pain that came from the injection site (Left Arm). As of 29Oct2021, it had occurred on 4 occasions. The patient reported that, when the pain presented itself, it was deep and sore, it inhibited the patient from having full range of motion because of the discomfort. The pain was located directly at the injection site. Additionally, the patient could no longer lay on her side (left arm) at night for long periods of time without having a gnawing pain that occurred throughout her whole left arm. The patient was concerned that this would not go away and potentially get worse over time. The pain that patient experienced felt like she just got the vaccine yesterday and it was almost 3 months since vaccination. 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 not been tested for COVID-19. The clinical outcome of the events had intermittent pain that came from the injection site (Left Arm), when the pain presented itself, it was deep and sore, it inhibited the patient from having full range of motion because of the discomfort, the pain was located directly at the injection site, additionally, the patient could no longer lay on her side (left arm) at night for long periods of time without having a gnawing pain that occurred throughout her whole left arm was not resolved at the time of this report.
TONGUE AND FACIAL SWELLING THAT EVENING CONTINUED TILL THE AM WHEN THE TONGUE WAS EVEN MORE ENLARGED WHERE THE PT AND HER MOTHER WENT TO THE LOCAL ED. WAS GIVEN STEROIDS IV, BENADRYL, PEPCID AND HELD FOR 2 HOURS. THEN SENT HOME ON A ORAL STEROID TAPER FOR 2 DAYS. MOTHER STATED THAT THE DAUGHTER COULD SWALLOW SALIVA AND PILLS BUT NOT LARGE BOLUSES OF FOOD. THE SYMPTOMS RESOLVED BY THE END OF DAY 1.
Several minutes after administering a Pneumovax 23 to a patient she began to have severe difficulty breathing and chest pain. We called EMS, and a code and I administered 1 dose of epinephrine 0.3mg to the patient. Patient remained conscious and sitting in the chair but was clearly in distress.  EMS came shortly after, assessed the patient, and took her to hospital for evaluation/treatment.
Patient stated that around 8 pm he started having violent tremors. Later at 1:00 am he got up to go to the bathroom and when he went to return to bed he could not walk. He had to be carried by his son.  Later at 7 am he got up and was able to walk around. Then at 8 am when eating breakfast he (according to his son) completely froze, he couln't move, talk, and had no eye movement. His son had to scream at him to tell him to breathe. They called 911 and we ended staying in the hospital for 4 days. They checked his vitals, which were ok. He had an MRI, CAT scan, and EEG which all came back normal. He was diagnosed with seizures and prescribed Keppra. He had a bad reaction to the Keppra and stopped taking it. He went to a neurologist who diagnosed him with Guillan-Barre and that his reaction was due to the vaccines. (He also received pneumovax 23).
Pt got her 1st dose of Covid -19 vaccine, Pfizer brand at 06:35 PM. Pt  sat down at the post vaccine area for the observation, pt stated that 5 mins after getting the vaccine, she felt warm and sweaty and light headed. Pt called the admin staff attention and reported what she is feeling. Staff assisted staff on duty and post vaccine RN checked pt. Staff and RN assisted pt in a laying position on the ground. Initial vitals was checked and recorded as BP 100/70 mmhm; PR 85 ppm; RR 20 cpm; Temp 97.3 F; oxygen sat of 99% at room air.EOA was notified as well and assessed pt.  Pt is alert oriented to self, place, time, location and date. NO Chest pain noted, No SOB noted. quick skin assessment done and no hives or redness noted. Pt was monitored every 15 mins by RN until stable. Pt refused to call 911. Pt was assessed by EOA after 15 mins and pt verbalized feeling better and stated that she had history of being anxious. Pt was gradually transitioned to sitting position. Pt was advised to have someone pick her up but she refused. Pt was also advised to get an appt with primary doctor for follow up check but anything like chest pain or SOB at home to call 911 right away.  Pt was checked once again before discharging pt. Pt is stable and no more complaints of lightheadedness. At 07:28 PM RN accompanied pt to her care. Pt verbalized appreciation and abrupt interventions of her concerns and reaction. EOA made incident report as per protocol.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 16-year-old male patient who received MENVEO for prophylaxis. Co-suspect products included TRUMENBA for an unknown indication. On 30th May 2018, the patient received MENVEO. On an unknown date, the patient started TRUMENBA at an unknown dose and frequency. In May 2018, less than a day after receiving MENVEO, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to MENVEO. Additional details were provided as follows: The reporter was not a healthcare professional but a very concerned parent. The reporter's son received Meningococcal vaccines last Wednesday and had suffered from a fever since. The reporter had taken the patient to emergency room on Saturday due to a 106 temperature. All labs were normal. No sign of viral or bacterial infection were found. The reporter had been doing some research on vaccines to determine if this was an adverse side effect. He was asking was a 7 days temperature normal. The reporter agreed to be contacted for follow up. The reporter provided contact details of his son's physician and mentioned there were several doctors in facility, there is no main doctor he sees. The patient also had an appointment on the reporting date with the physician.