chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 25-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
COAGULOPATHY, UNSPECIFIED TYPE 3/26/2023 ATRIAL FIBRILLATION, PAROXYSMAL
Patient stated that after first vaccination the only reaction she had was feeling dizzy. After second vaccine patient stated that symptoms started around the first of August. Symptoms include  received headaches, nausea, throwing up, sweating, get cold real easily, loose stool dizziness, cramps in feet, and could hardly walk
Fever or Chills  New loss of taste or smell  Sore throat  Congestion or running nose
Severe chills, fever, abdominal pain, injection site rash, itching, and pain.
2.5 cm x 1.5 cm bruise at injection site, 6cm x 7cm area of erythema, firm, inflamed. Treated with Ibuprofen 150 ng Q 6H x 48H and cool compresses PRN.
MAGNETS ARE STICKING TO HIS LEFT SHOULDER; CHILLS; HEADACHE; MUSCLE ACHES; VERY TIRED; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Concomitant medications included vitamins nos, and zinc. On 03-MAY-2021, the subject experienced chills. On 03-MAY-2021, the subject experienced headache. On 03-MAY-2021, the subject experienced muscle aches. On 03-MAY-2021, the subject experienced very tired. On 25-MAY-2021, the subject experienced magnets are sticking to his left shoulder. The action taken with covid-19 vaccine  was not applicable. The patient recovered from chills, headache, muscle aches, and very tired on 04-MAY-2021, and had not recovered from magnets are sticking to his left shoulder. This report was non-serious.
CHIEF COMPLAINT Cough, shortness of breath, hypoxia  COVID positive   HISTORY OF PRESENT ILLNESS Patient is a 67 y.o. female who presents with Cough, SOB and hypoxia and COVID 19.   Background -Initially presented to OMC ED on 10/29 with cough and weakness- tested positive  For COVID -HFpEF (echo 2019 EF 53%, grade 2/4 left ventricular diastolic dysfunction) -Segmental PE August 2020 -heterozygous prothrombin gene mutation -Atrial fibrillation on Warfarin -Left total knee arthroplasty infection status post debridement June 2020 on chronic suppression with Augmentin and levofloxacin -obesity -hypertension   Hx   The patient started having symptoms on 10/20 5th and they started with dry cough shortness of br Additional information for Item 18:  CHIEF COMPLAINT Cough, shortness of breath, hypoxia  COVID positive   HISTORY OF PRESENT ILLNESS Patient is a 67 y.o. female who presents with Cough, SOB and hypoxia and COVID 19.   Background -Initially presented to OMC ED on 10/29 with cough and weakness- tested positive  For COVID -HFpEF (echo 2019 EF 53%, grade 2/4 left ventricular diastolic dysfunction) -Segmental PE August 2020 -heterozygous prothrombin gene mutation -Atrial fibrillation on Warfarin -Left total knee arthroplasty infection status post debridement June 2020 on chronic suppression with Augmentin and levofloxacin -obesity -hypertension   Hx   The patient started having symptoms on 10/20 5th and they started with dry cough shortness of breath and shortness of breath on exertion has as well as muscle aches and pains.  She did not complain of any chest pain and no fevers.  She initially presented to Olmsted Medical Center ED in 10/29 when she had a positive COVID test.  The patient did not require oxygen at the time and was discharged home.   Over the past few days assistant symptoms of cough and shortness of breath.  She also reported feeling feverish however she did not measure her temperature.  She also had significant shortness of breath on exertion had stop after walking 5.  The symptoms gradually worsened and until today where her daughter made her come into hospital.    On presentation to ED she was requiring 2 L via nasal cannula to maintain her O2 sats she was also tachycardic with heart rates in the 130 blood pressure has been stable on above 100 systolic.  She was a pyrexial.  She had CT scan of the chest which out rule pulmonary embolism Bilateral perihilar and peripheral predominant groundglass pulmonary opacities compatible with patient's known COVID-19 infection. She received a dose of IV Dexamethasone  6mg in ED and a 500ml Bolus of Lactate ringers.    On presentation to the floor the patient was maintaining his oxygen sat her oxygen saturations on room air.  Her tachycardia resolved.  She is still complaining of cough and shortness of breath.
After the Pfizer vaccine she got more headaches; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. Medical history included stroke patient and headache from an unknown date. After the Pfizer vaccine she got more headaches. Inquiring if she should take the second covid vaccine. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Pt recvd 1 dose of Engerix-B & exp immed inject site rxn (red, hot); 24-48 hrs later malaise, dec appetite, chills & bruising on legs; nausea, fever, vomited, lost weight, low back discomfort, crampy pain in inguinal areas, muscle cramps;
Injection site pain, onset 6 hours after injection, lasting  for 24 hours; slight headache, onset after 24 hours, lasting 1/2 hour; slight fever on second day; muscle aches on second day
Patient expressed redness at the injection site along with swelling, and a warm pain.  This redness encompassed most of the deltoid region of her upper arm.
This spontaneous report as received from a pharmacist refers to a 3 unspecified infants of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 29-JUN-2015, the patient were vaccinated with a dose of improperly stored RECOMBIVAX HB (doses and routes of administration were not reported, lot number K010535 and expiration date 27-AUG-2016, lot number K020216 and expiration date 17-SEP-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
REDNESS, PAIN AND SWELLING OF THE WHOLE UPPER RIGHT ARM, 3-DAY COURSE OF PREDNISONE , BENADRYL PRN PAIN AND SWELLING AND COLD COMPRESS ON DAY 1 THEN WARM AFTER TODAY.
Swollen arm; numb hand; red , nausea, headache, diarrhea.
74yr old female who presents to the clinic today for congestion, headache, and sinus congestion.  She has had symptoms since 12/15/2021 in the afternoon.  She has taken Zicam and ibuprofen.  She has also bee taking Emergen-C for her symptoms.  She denies any fevers, sore throat, or cough.  She is fully vaccinated for COVID and influenza.  BREAKTHROUGH COVID+
MODERNA VACCINE HAS NOT YET BEEN APPROVED FOR USE IN PATIENTS UNDER THE AGE OF 18. PATIENT IS 17 YEARS OLD; PATIENT DID NOT HAVE ANY ADDITIONAL ADVERSE EVENT
10 minutes after 1st dose of moderna vaccine, employee began experiencing palpitations. Examined by on-site physician. Denied chest pain, dyspnea, throat tigetening, angioedema, dizziness, nausea/vomiting, rash/hives. Employee did report warmth on roof of mouth without metallic taste. No acute distress or angioedema noted as time passed. Blood pressure (BP) 150s/100s, heart rate (HR) 120s, which dropped down to 100, then 96 during examination. By 12:31 PM palpitations and mouth warmth resolved. BP 125/86, HR 93. 12:45: BP 130/89, HR 80. Hypertension, tachycardia, mouth warmth resolved. Employee was observed for a full hour and was directed to continue to self-monitor. Employee was directed to see PCP for worsening or recurrence of symptoms.
About 4:00 p.m. symptoms began-extreme fatigue but couldn't sleep, low fever: 98.8 temperature, chills,  achiness,  and upper arm pain.  Took Aleeve at 8:00 a.m. and 6:30 p.m. on 2/3/21, and 8:00 a.m. on 2/4/21. By 4:00 a.m. all symptoms but arm pain were gone.
Pt spiked temp 4-5 hrs p/inject w/crying, crankiness partially controlled by APAP; temp was >104; Seen @ ER Hosp for 2 days w/fever & tremors extremities; EEG scheduled 16JUL91;
COVID-19 Treatment; COVID-19 Treatment; 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.  An 82-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm and on 29Aug2023 at 10:30 as dose number unknown, single (Lot number: GL0087) at the age of 82 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex"; Macrobid, reaction(s): "Known allergies: Macrobid"; Ciprofloxacin, reaction(s): "Known allergies: ciprofloxacin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19 included Paxlovid from 10Oct2023 to 15Oct2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Circular area of redness, left upper arm, below vaccination site. Area also warm to touch. Approx 10 mm x 8 mm area.
Following administration of Influenza vax, pt 80+ devel nausea & general feeling of illness;
Information has been received from a health care student who reported that on unspecified date a friend's child was vaccinated with a dose of MMR II (lot number, dose and site of administration not reported). On unspecified date, after administration of MMR II, the patient had autism. It was unknown if the patient sought medical attention. At the time of the report the patient's outcome was unknown. Upon internal review, autism was determined to be an other important medical event. This is one of several reports received from the same source. No further information is available.
Fever vomiting aches pains  just like having covid again(Had month of Dec.)
Arms are killing me; mildly headachy/tired; mildly headachy/tired; Product use for unapproved combination; Booster; This is a spontaneous report from a contactable consumer (patient). A patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 01Nov2021 DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation and influenza vaccine on 01Nov2021 as DOSE NUMBER UNKNOWN, SINGLE for Immunisation. The patient previously received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for covid-19 immunisation. Got Pfizer booster and flu shot yesterday (01Nov2021). Arms are killing me, feel mildly headachy/tired, but mostly just grateful to be benefiting from science in such a positive way. Outcome of the events was unknown.  No follow-up attempts are possible; information
2 days after receiving immunization, pt woke up with swelling on her left side. Her ankles and hands were swollen. When she weighed herself, she had gained approximately 5 lbs in 2 days.
Patient received first dose of Hepatitis A vaccine 3/14/07.  He developed fever of 102 that evening.  He had a febrile seizure 3/15/07 and a CBC done at that time revealed pancytopenia. He was hospitalized to monitor labs until 3/18/07. At discharge he was well, with resolving pancytopenia.  CBC 11/7/07 was normal.
This spontaneous report was received from a patient's father refers to a 14-year-old female patient with no pertinent medical history and no drug reactions/allergies. On 18-SEP-2012 the patient was vaccinated with dose 1 GARDASIL (lot # not reported). No concomitant medications were reported. Patient's father stated that a few minutes after his daughter had gotten the first shot of GARDASIL she fainted. She was woken up with smelling salts. She was still experiencing dizziness and nausea, however she was recovering. The reporter was unsure if the patient would receive the next doses of GARDASIL. No further adverse event (AE) information was provided. Patient sought medical attention in the doctor's office. Additional information is not expected.
Information has been received from a medical assistant concerning a 11 week old male pt who on 10/16/98 or 10/19/98 was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant (625231/1598E is invalid for this product). Concomitant medication administered on 10/16/98 included doses of poliovirus vaccine inactivated, and diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. The reporter stated that on 10/23/98 the pt developed symptoms of swelling of the hands, feet, face and tongue, and also had a "pimple rash" on his upper back, but did not have any difficulty breathing. The reporter confirmed that the pt was diagnosed with an "anaphylactic reaction" at the hospital, and not a "prophylactic-like reaction" to Haemophilus B conjugate vaccine (+) hep B vaccine recombinant, as previously reported. The reporter stated that the pt received his 2 month vaccinations at another facility. At the time of the report, the pt was "four and a half years old." He had not received anymore of his childhood immunizations since the 2 month vaccines and his parents wanted to get him "caught up" on vaccinations. The medical assistant questioned whether there was a suggested "skin testing technique, to see if he will react adversely again." She also reported that she was contacted "other pharmaceutical companies" in reference to this case and requested any protocols for allergy testing of their vaccines. Upon internal review, anaphylactic reaction was determined to be an other important medical event (OMIC). Additional info has been requested.
punctured a medical assistant's thumb / medical assistant noticed pain in her thumb while administering the vaccination and realized a piece of the finger flange broke off during the injection of a patient.; RECOMBIVAX HB broke; This spontaneous report was received from a registered nurse referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 17-NOV-2022, the patient noticed pain in her thumb while she was administering hepatitis B vaccine (Recombinant) (RECOMBIVAX HB) injection (lot number W016842 which has been verified to be valid, expiration date reported and validated as 19-NOV-2023) as prophylaxis (dosage, route of administration, and anatomical site of injection were not reported); and realized a piece of the finger flange broke off during the vaccination and punctured her thumb (wound and syringe issue). The patient sought medical attention, and as treatment the wound was cleaned, and glass was removed. On 18-NOV-2022, the patient recovered from the event.   The causal relationship between wound and hepatitis B vaccine (Recombinant) (RECOMBIVAX HB) was not provided.    This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2211USA006547:
Hospitalized (9.22.21);  COVID-19 positive (9.21.21);  fully vaccinated  Discharge Provider: DO Primary Care Provider: PA-C Admission Date: 9/22/2021 Discharge Date: Sep 29, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxia [J96.01] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 79 year old woman who presented for evaluation of fever, productive cough, weakness and shortness of breath. Found to be hypoxic, septic and covid positive. She was started on Remdesivir and Decdaron. O2 was used to maintain adequate saturations. O2 needs increased early in here stay so her admission was a bit prolonged. Gentle diuresis was employed to maintain euvolemia. As the admission progressed, o2 needs leveled out. Currently, she is using 1-2 L and will go home with oxygen as she is eager to go home. I do have concerns about medical non-compliance as many of her listed home medications have not been filled in 10 + months. For her PVD, she is advised to take ASA/Plavix and statin. Her HTN appears to be controlled off home medications Lisinopril, Triamt/HCTZ. Additionally, we resumed Levothyroxine- she had not filled this in 10+ months. I recommend checking outpatient TSH in 4-6 weeks. Two additional days of Decadron will be prescribed to complete 10 days total. Probiotic and fiber for her diarrhea. Close follow up with her pcp is recommended. A follow up cxr is advised per pcp.
Patient developed a rash on multiple locations of his body. It developed most on his face, predominantly his left, and swelled one eye completely shut and the other partially shut. The rash started developing on Monday Aug 8th and by Wednesday his left eye was swollen shut and by Thursday his right eye was partially swollen shut.   After evaluation by his doctor, who thought it might be contact dermatitis, we put him on a prednisolone course of treatment, and about 24 hours after starting that, the symptoms slowly abated. Today, Aug 18th, he still has a few skin irritations left but is mostly recovered.  This was Patient's 2nd reaction to a Covid shot. In December, he also developed a rash on his body, again largely on the left side of his face. This developed 3 weeks after his shot. This current reaction came more quickly and was more severe.
Initial misuse report received from a healthcare professional on 29 October 2013 and on 21 March 2014. This case concerns first patient of the two patients with 63 year of age. A 63 year old patient who had received FLUZONE HD on an unknown date. The patient received FLUZONE HD at the incorrect age. No adverse event was reported. The list of documents held by sender: None.
Information has been received from a medical assistant referring to a 16 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Prior to donating plasma donor "felt blah", mild headache, diarrhea 2-3 times, didn't tell anyone. Rabies shot given approx 2 hrs after leaving headache worsen, vomited x4 diarrhea x4. Left arm very sore, no areas of swelling, redness, rash noted today. Left arm still very sore, no further vomiting or diarrhea noted today, no fever 6/21 or today at home. Slept well last noc eating and drinking normally today. BP 112/76, pulse 72, didn't take temp as just drank can of soda.
Temp of 105, fussy began the evening of 4/5 awake all night screaming. Refuses solid foods not nursing well, increasing lethargy.
Patient presented to the ED on 4/11/21, which was 4 days after her 2nd Moderna COVID-19 Vaccine, with bilateral hip pain that patient reports started after getting the vaccine. The bilateral hip and thigh pain was very severe and she was unable to ambulate and perform her ADLs like usual. Vaccine received on 4/7/21.
Started having terrible Chills; Very tired; fever; inflammatory response from the vaccine; This is a spontaneous report from a contactable consumer reporting on daughter. A 14-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 23Aug2021 (Batch/Lot Number: FC3182) (at the age of 14 years old) as dose 1, as a single dose for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to an unknown date, described she was positive for antibody before a week of the Covid-19 vaccination because she had mild cold due to Covid-19 infection back in December. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Aug2021, the patient experienced fever and inflammatory response from the vaccine. On 25Aug2021, the patient was very tired. On 29Aug2021, the patient started having terrible chills. The patient visited the physician's office and treatment was received due to these events. The doctor determined that it was definitely some type of inflammatory response from the vaccine. The patient underwent lab tests and procedures which included body temperature 99-100F on an unspecified date, body temperature 102.4F on 30Aug2021, body temperature 100.3F on 30Aug2021 gave her some more ibuprofen and fever went to be like 100.3, body temperature 102.7F on 30Aug2021 we went to home by the afternoon around 2 and her fever was like 102.7, body temperature 100F on 30Aug2021 gave her some more ibuprofen and it lowered her fever at about 100, body temperature 102F on 30Aug2021 fever got elevated 102 by 8 o'clock, her fever was like 103.3 overnight, body temperature: 103.3F on 30Aug2021 fever got elevated 102 by 8 o'clock, her fever was like 103.3 overnight. The patient took ibuprofen, Motrin and Tylenol as treatment for fever reducing but started again to have fever and becoming difficult to control. The reporter stated that these side effects are actually worse than the Corona Virus right now she has like-Corona virus and now she is going sick for a week and it actually got worse and it didn't get better. She was some better today and hoping that may be the side effects completely go away by tomorrow. The outcome of the events fever, inflammatory response, very tired and chills was not recovered.  Follow-up (02Sep2021), Follow-up attempts are completed. No further information is expected.
by next day after vaccination pt reports started to feel very achy all over body, especially joints namely neck and L trapezius, headache on L side which is unusual for pt, increased eye pressure in L eye, sharp L eye pain especially with computer use and driving, rated pain as 6/10 , all symptoms have improved, achiness has resolved but L head and eye pressure has continued and can be painful with rating of 3/10.
2 weeks 8 days after vaccine, patient suffered which sent pt to emergency room. Husband states she had a "blood clot" to brain with skull fracture and traumatic brain injury. Transferred to Medical Center, then to long term facility. Has not recovered to date. Husband states unable to speak or move.
left arm was real red and hot, started feeling bad about 30 min after, pain went up the shoulder, neck and to other shoulder and arm. Stomach pain, headache. Felt all over with back and body muscle ache.