chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain-Barre syndrome; Initial information received on 03-Oct-2021 regarding an unsolicited valid Social Media serious case from a consumer/non health care professional.  This case involves a patient (unknown age and gender) who had guillain-barre syndrome after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past  medical treatment(s), vaccination(s), Concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious guillain-barre syndrome (unknown latency) following the administration of vaccine. This event was assessed as medically significant.  It is unknown if the patient experienced any additional symptoms/events  No laboratory data reported.  It was reported that "Hard no here. Gramps got guillain-barre syndrome from flu shot. I haven't had a flu shot in YEARS!"  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.; Sender's Comments: This case concerns a patient (unknown age and gender) who had guillain-barre syndrome after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is compatible. However, patient's medical condition at the time of vaccination and other relevant laboratory data were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.
I did not have an adverse reaction to the vaccine. On 02/01/2023, my ears began to hurt. On 05/07/2023, I was diagnosed with an ear infection in both ears and I sinus infection. I am taking an antibiotic for the infections.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "85-year-old recently widowed male with past medical history significant for coronary disease status post remote stenting, primary hypertension, borderline Type 2 diabetes mellitus, and hyperlipidemia presenting with a several day history of generalized weakness with significant chills with progressive decreased activity tolerance.  His weakness got so bad at home and he could get out of his chair today.  Therefore, his family brought him to the ER for evaluation.  On interview patient also reports some last about loss of appetite over the past few days and some recent weight loss since passing of his wife within the last month.  Patient denies had   On presentation to the ER patient was found to be COVID-19 positive.  He also was found to have a fever of 40° Celsius, mild sinus tachycardia, lymphopenia to 300, thrombocytopenia to 118 and blood sugar of 154.   CXR showed possible early left lower lobe infiltrate.  He was also found to have hypoxia to 85% and was titrated to 4 liters by nasal cannula.  He had some mild intermittent hypotension with a lactate of 2.2 which improved to 1.7.  I had them add on a CRP which was 11.7 with D-dimer of 1,00 and fibrinogen of 473.    Patient was started on treatment for Covid-19 including supportive management with O2 and dexamethasone and Remdesivir. He was further treated with CAP coverage for LLL pneumonia for possible concomitant bacterial pneumonia. Patient responded very well to therapy and did not require supplemental O2 for the remainder of his hospitalization. He continued to receive both antiviral and antibiotic medication. Patient was discharged after working with therapies and reassurance from family and patient that he was near his baseline. "
larger than nl areas of redness & swelling;this is one of three pt from this site who exp the above rxn;
pt exp fever & rash & stuffy nose & sl cough;seen in MD office 12DEC97;rash petechial, fever 99.3ax; sent to hosp adm d/t platelet count of 6,000;hosp stay from 12DEC97 to 15DEC97;
Had a sore arm almost immediately (did not happen until the day after with the first one), cold sweats, complete body ache and headache, and 100 degree fever the morning following the 2nd vaccine dose.
Dizziness; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), NAUSEA (Nausea) and VOMITING (Vomiting) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, DIZZINESS (Dizziness), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Concomitant medications was not reported. Treatment history included Anti-nausea medication .
07/08/23 @ 4:06PM SX: PALE, SWEATING, DIZZINESS, BREATHING HEAVILY, ALMOST FAINTING 07/08/23 @ 4:06PM: VITALS: BP: 117/79; P 66.  INSTANTLY AFTER THE ADMINISTRATION OF THE VACCINES. PT WAS SEATED AT THE PHARMACY WAITING AREA. EMS WAS CALLED TO THE PHARMACY. PT WAS CONSCIOUS AS TO PERSON, PLACE, AND TIME. PT WAS COLD TO TOUCH. WHILE WAITING FOR EMS TO COME, PT HAS RECOVERED. SUCH AS HIS SKIN WAS COMING BACK TO BE PINKISH AND HE CAN TALK MORE.
double vision / woke up with double vision; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (double vision / woke up with double vision) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. No Medical History information was reported. On 25-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced DIPLOPIA (double vision / woke up with double vision). At the time of the report, DIPLOPIA (double vision / woke up with double vision) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Blood test: normal (normal) Normal. In November 2021, Magnetic resonance imaging: normal (normal) Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product reported by reporter. No treatment medication reported by reporter. Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Added reporter information. Added patient information. Added lab data information. Added product details. Added onset date and outcome of event.
This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A female patient, of an unspecified age, received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, Apr 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unknown route of administration, on an unknown date, single dose, for COVID-19 immunisation. Patient stated, she experienced adverse reaction after her second dose of Pfizer-BioNTech COVID-19 vaccine. She did not give a specific date she just said she got it in Apr. She said she has been tired all the time. She is over-heating. She is getting very hot. She has a fever and has not gone away since she got the vaccine Apr 2021. The outcome of the events reported as unknown. The lot number for (BNT162B2) not provided and will be requested during follow-up.
This spontaneous report as received from a nurse practitioner refers to a 6-week-old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 22-JAN-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # 008874, dose, strength, route of administration and expiration date were not reported) which had temperature excursion. The lot source was public. No information on patient's concomitant medication was provided. There was no adverse event experienced. This is one of several reports received from the same reporter. Additional information has been requested.
Subsequent to receiving the first dose of Lymerix the pt developed tennis ball size sebaceous cysts which were cut and drained on the genital area. The cyst on her nose was very painful and the pt refused for it to be drained. It was treated with Augmentin for 10 days. The cysts resolved. The following month the genital cysts returned. It was treated with Augmentin and the cyst resolved. Physician did not feel that the cysts were related to Lymerix.  Pt was found to be pregnant subsequent to receiving the second dose of Lymerix. The most recent information reports that the cysts resolved and that the pregnancy is ongoing.
Pt reports with redness, resembling a bulls-eye, dark red in the center measure 2 cm in diameter, swelling and redness surrounding this dark red center measuring 9cm in diameter. Pt has some burning, itching, and warmth, no fever (97.6 tympanic). And swelling, warmth, itching. Aspirin 325 mg.
This spontaneous report was received from a health professional via Pfizer (manufacturer report # 2018433973) concerning a currently 48 years old female patient. The patient was allergic to COMPAZINE. Information on patient's medical history and concomitant medications were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, strength, dose number, therapy type, # lot and expiry date not provided). It was reported that, the patient had allergy to PNEUMOVAX 23. The action taken with suspect therapy and outcome of the event was unknown. Causality assessment was not reported. Sender's Comments: US-PFIZER INC-2018433973.
The next day after the vaccine the injection site got a big round red circle around the injection side which began to get black and blue under the skin which lasted about a week.  I felt bad and was vomiting and super tired for about 3 or 4 days.
Besides the usual expected side effects, on the day of vaccination 1/8/21 I had chest pressure on the sternum area and back pressing together that became more and more uncomfortable as the day progressed. Vaccine was  at 2pm and an hour or two later I noticed it. By evening very uncomfortable and at bedtime even worse. Almost went to the hospital for heart check/tests.  The chest pressure worsened when reclined so it was very difficult to fall asleep.  It got too uncomfortable to lay down so I had to keep getting up to walk around to feel better during the night.  I couldn't fall asleep because as I was about to fall asleep the chest pressure would worsen and I'd wake up as I was about to doze off.  I felt like I had a strong intense heartbeat, like it was working hard, and I could hear irregular beats.  I did get a little sleep finally. Next morning pressure still there but not as bad because I was up walking around more. Always worse whenever reclined or in bed laying down.  It was very uncomfortable at the end of exhaling big or at the end of a large inhale.  I did not feel comfortable exerting myself aerobically.  As the day progressed it got a little better.   On the 2nd night as I was about to fall asleep I would get a sharp radiating pain across my chest. This happened a few times with the first one being the worst.  Again I almost went to the hospital.  I finally was able to fall asleep.  Each subsequent day the pressure slightly improved.  By Monday I almost went to the hospital to get some tests done on my heart but as each day progressed it improved just a little bit.  I did not feel comfortable doing aerobics until about 2 weeks later and still took it easy.   Night  #3  I did not have any sharp painful zingers, and I was able to fall asleep better, but the chest pressure remained.   Each day it keeps improving but I  still have the pressure, still able to feel a stronger intense heartbeat, irregular beats at times  and uneasiness about overexerting myself.   At a month after vaccination, still have some slight chest pressure but minimal.
HYPOTENSION 2/13/2023 LIVER MASS HYPOTENSION 2/13/2023 PANCREATIC CANCER, UNSPECIFIED SITE  HYPOTENSION 2/13/2023 COVID-19 TEST POSITIVE BY OUTSIDE LABORATORY HYPOTENSION 2/13/2023 IRON DEFICIENCY ANEMIA
Patient did not receive the vaccine at our facility, but reported to the ED.  ED notes as follows.   59 y.o. female who arrived and presented to the emergency department for Left arm rash. Onset was Friday. Patient received her second dose of the Moderna vaccination on Thursday. Friday, she noticed some swelling of her left arm and so she applied some ice to it and the swelling went down. She also felt chilled and achy in general. Saturday, she went out shopping and was feeling tired and achy and noticed the upper arm was swollen again and red. She started taking benadryl. She took that a few times, the last was Saturday at 0300. Today, she went to work, her arm felt a little like it was burning and there was still some redness so she went to Employee Health and was referred to the ED for further evaluation. The patient is on minocycline for acne. She is not a diabetic. She denies any tongue, lip, or throat swelling during this.  Patient's left deltoid region is slightly erythematous, minimally edematous compared to the right. It is also slightly warmer than the adjacent, non-erythematous skin. No area of induration or fluctuance. No streaking.  Diagnosis management comments: 59-year-old female presents to the ED with left deltoid area erythema, swelling, burning pain following her 2nd Moderna vaccine in the same arm. She has not had any respiratory issues. She has taken benadryl and applied ice which have helped, however, the benadryl makes her really tired. She was instructed that she can switch to zyrtec which she has at home and can take that up to 2 times a day. A three day course of steroids was also prescribed.
Miscarriage- baby had no heartbeat- at 9 weeks (May 2021),  Miscarriage- baby had a heartbeat at 8 and 10 weeks, none at 12 weeks (September 2021)- testing done, Trisomy 15. Miscarriage at 20 weeks (May 2022)- baby had Anencephaly and wouldn't survive. Successful twin pregnancy and birth- 5/29/18 at 38 weeks. Successful singleton pregnancy and birth- 12/XX/19 at 39 weeks.
Patient presented to the ED and was subsequently hospitalized for rapid atrial fibrillation on 4/17/2021. Patient hospitalized for intermittent atrial fibrillation on 4/21/2021. These visits are within 6 weeks of receiving COVID vaccination.
Potential AE because of use against local labelling with no AE; Initial information received on 18-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who reported potential ae because of use against local labelling with no ae while receiving vaccines DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2016, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE at a dose of 1 DF(dosage form) lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event "potential ae because of use against local labelling with no ae" (product use issue) (latency-Same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE) was not applicable.  At time of reporting, the outcome was Unknown for the event potential ae because of use against local labelling with no ae.   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 the guidelines. 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.
PT WAS SEEN IN CLINIC ON 1/27/2010 WITH A 2 DAY HISTORY OF COUGH, CONGESTION, RHINORRHEA, WATERY EYES AND A RASH ON ANTERIOR AND POSTERIOR CHEST. RED, ERYTHEMATOUS, MACULOPAPULAR RASH
Dizziness - feeling she will "pass out" if doesn't lie down.  Nausea, weakness, headaches.  9/23/08 Reviewed PCP medical record of 8/15/08. FINAL DX: adverse reaction Record reveals patient experienced dizziness, HA, feeling like passing out daily x 3 wks but now 3-5x/week, nausea/vomiting if doesn't rest & general weakness.  Instructed to increase oral fluids.
Throat closing - cough, red, watery eyes, headache, aches (body).
He cried for 7 hours after receiving Dtap at 2 months/ shots visit.
Extreme pain in arm for 7 days with ongoing current pain in arm; constant headaches, overall body and muscle aches, nausea and lack of appetite, have to take Tylenol or Advil every two hours in order to try to get through the day and am constantly feeling sick.
Body rash, itching from 2-23 until now. Received medical treatment 2-28-11. Symptoms improving.
No adverse effects were reported; Multiple patients were administered improperly stored PROQUAD. Temperature -3 C; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions/allergies, concurrent conditions and concomitant medication were not reported.      On 06-JUN-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rha) (dose number, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot #, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA010323: US-009507513-1906USA010324: US-009507513-1906USA010325: US-009507513-1906USA010327: US-009507513-1906USA008695: US-009507513-1906USA010326: US-009507513-1906USA010329: US-009507513-1906USA010330: US-009507513-1906USA010331: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662:
This case was reported by a other health professional and described the occurrence of swollen arm at the injection site in a 57-year-old female patient who received FLULAVAL (batch number 4597B, expiry date June 2015). This case was associated with a product complaint. Concurrent medical conditions included diabetes. On 17th October 2014, the patient received the 1st dose of FLULAVAL (intramuscular). On 18th October 2014, 1 days after receiving FLULAVAL, the patient experienced swollen arm at the injection site, soreness at the injection site and redness at the injection site. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the swollen arm at the injection site, soreness at the injection site and redness at the injection site were recovered/resolved and the outcome of the pharmaceutical product complaint was unknown. The reporter considered the swollen arm at the injection site, soreness at the injection site and redness at the injection site to be probably related to FLULAVAL. It was unknown if the reporter considered the pharmaceutical product complaint to be related to FLULAVAL. Additional information about the product complaint received on 19 November 2014: The events required a doctor visit (or an emergency room visit). This is one of the 5 cases reported by the sane reporter for the same vaccine (with the same lot number).
RECEIVED BOTH DOSES OF PFIZER VACCINE. (01/23/21 & 02/13/21) AFTER 1 DAY (02/14/21) WENT TO ICC REPORTING SUDDEN HEARING LOSS IN RT EAR, LIGHT-HEADEDNESS, AND FEELING UNBALANCED. DIAGNOSED WITH HEARING LOSS OF RT EAR AND HYPERTENSION AND INSTRUCTED TO GO TO ER. WENT ER ON 02/14/21 AND WAS DIAGNOSED WITH ACUTE HEARING LOSS OF RT EAR.
chills and shivering for about 5 hours, then sweats for a few hours.  Fatigue for one day.
Low grade fever, Pityriasis rosea rash on back neck, torso. Patient reporting itching, no pain.
RIGHT FOOT LEG AND INNER THIGH HAS BRUISES; Right foot, leg and inner thigh has bruise and soar with tightness; Right foot, leg and inner thigh has bruise and tightness; Right foot, leg and inner thigh has bruise and tightness; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021 at 08:00 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. Medical history included sarcoidosis. Concomitant medications were not reported. The patient did not have any known allergy to any medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had been tested for COVID-19 since the vaccination. On 30Mar2021 at 07:00 the patient was not sure but experienced right foot, leg and inner thigh had bruises and sore with tightness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events right foot, leg and inner thigh had bruises and sore with tightness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Really fatigued and my muscles were really sore, chills, low grade fever. I couldn't grasp anything. Flu like symptoms. Doctor said to follow up in two days if not better but was better by then.
I started having signs of Crohn's flare after the fever that started around 11pm the 17th. My symptoms continued to get worse over the next 3 days. I was having sharp GI pains, nausea, headaches, pain during and after urgent BM, strong cramps and tender abdomen. The pain in my lower abdomen got so bad yesterday afternoon I could hardly stand and had a very strong headache. My crohn's had been in remission since the end of last year. I have had several tests this year to prove this. I had been doing very well with no issues until having this second dose. My Dr's had to put me on steroids to stop the progression of my disease.
Patient's leg swollen, large welt at least 3 inches in width, red & irritated. Bruising