chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Called patient 1/6/22: Patient reports receiving boost 1/5/22. The following morning reports "swollen body, achy, headache, hard area at site of injection, pain through shoulder and elbow". Denies shortness of breath, wheezing. Reports actual swelling in hands, feet.   Called patient 1/7/22 with no answer.
On day of vaccination: Heart Palpitation,  malaise, which lasted about 3-4 hours, when patient went to bed at 7pm. Two days later: visible redness about three inches across, one inch high, mild itching. warm to touch. Resolving redness, itching continues,
Sore arm; mild fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the parent.  An 8-year-old male patient received BNT162b2 (BNT162B2), in Jun2022 as dose number unknown (orange cap; booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "Sore arm"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "mild fever".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201318850 same product, different patient/event;
Pt received flu vaccine on 10/3/13. The following day 10-4-13 she developed enlarged supraclavicular and posterior cervical lymph nodes. This prompted an urgent care visit and she was placed on AUGMENTIN and lab/CXR was done. She continues to have swollen nodes and it seeing PCP.
Fever 103.2, fatigue, sore joints, swollen arm, horrible arm pain - used heat pack to ease pain to sleep, itchy arm, headache, tingling in face
her face feels a little warm and flush; headache; injection site pain in my left arm; This is a spontaneous report from a non-contactable consumer (parent). A 32-year-old female patient(daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, reporter 32 y/o daughter had the Pfizer covid vaccine today, her face feels a little warm and flush, she doesn't look red, she's had reaction, no temperature, doesn't look flushed. reporter gave her Tylenol and advil, she took one of each. Daughter states that, she have a headache at this point, a little flush, injection site pain in my left arm. Her arm feels a little better. Her head is still in pain. Is it normal, can she take an antihistamine or what you would recommend. Can she take a Benadryl. Therapeutic measures were taken as a result of her face feels a little warm and flush, headache, injection site pain in my left arm. The outcome for event injection site pain in my left arm was recovering, outcome for event headache was not recovered and outcome for event her face feels a little warm and flush was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 14-APR-2016, the patient was vaccinated with 0.5 ml dose of improperly stored (Merck) VARIVAX (which had a lot # of L040419 and an expiration date of 14-OCT-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of (Merck) VARIVAX (which had a lot # of L043624 and an expiration date of 03-NOV-2017) had also been improperly stored but it was not reported whether it had been administered. The vaccines experienced the following temperature excursions on the following dates: 10 F for 2 hours and 15 minutes on 24-MAR-2016; 12.4 F for 2 hours and 15 minutes on 26-MAR-2-16; 10.4 F for 2 hours and 15 minutes on 30-MAR-2016; 10 F for 2 hours on 03-APR-2016; and 9.3 F for 1 hour and 45 minutes on 07-APR-2016. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
12:30 vital signs 118/70-86 and O2 Sats on RA 97%. Child complained of visual disturbances. No respiratory distress noted. Eyes dilated and sluggish blurred vision. EMS called and child taken to ER. ER physician did assessment and noted to have visual disturbances and referred to Optomotrist. Full eye exam done and no specific dx identified.
Death - Hospice patient with metastatic CA admitted to facility and received vaccine during stay. No adverse sequelae noted from vaccine administration, but reporting as required because pt died 7 days later. Narrative: Reporting this event because patient died 7 days after receiving vaccine in the facility where he was in hospice care for metastatic cancer. Vaccine was administered by protocol without complications. The patient had been asked and denied any prior severe reaction to this vaccine or its components and gave permission to receive it. No vaccine adverse sequelae were documented after the immunization as monitored for 15 minutes nor in facility notes for 7 days after the immunization. The patient's death was felt to be due to underlying terminal illness.
In the afternoon, I started feeling cold. It wasn't too bad, but it continued. Later when I tried going to sleep, I started shivering uncontrollably for a few hours. I developed a fever and vomited. I was given hydrocortisone, but I was unable to keep it down. I called my endocrinologist who recommended I go to the ER. At the ER I was given fluids and IV hydrocortisone as well as Tylenol. I also had a fever of 100.7. I was also given anti-nausea medication. I felt a lot better and released around noon the next day. I came home and slept. For the next 2 days I doubled my hydrocortisone dose and then returned back to my usual dose of with no problem. It was assumed this was just a reaction to the vaccine.
Sore throat with slight swelling sensation a minute after vaccination along with sore arm, dizziness, feeling unwell.  Afterwards, myalgia, joint pain.
WHILE SPEAKING WITH THE PATIENT, HE BECAME PALLOR IN COLOR AND DIAPHORETIC. HE BEGAN COMPLAINING OF CALF PAIN AND EXPRESSED PREVIOUS SYNCOPAL EPISODE AFTER RECEIVING THE FLU VACCINE LAST YEAR. I ASSISTED PATIENT TO RECLINE IN HIS SEAT IN THE CAR, PROVIDED A COLD BOTTLE OF WATER, PLACED AN ICE PACK ON THE BACK OF HIS NECK, AND BEGAN TO FAN HIM. PT REMAINED CONSCIOUS AND ABLE TO ANSWER NEUROLOGICAL QUESTIONS WITHOUT HESITATION. AFTER 2 MINUTES, PT BEGAN TO REGAIN COLOR AND WAS ABLE TO SIT UP. AFTER ANOTHER 5 MINUTES, PT WAS ABLE TO STAND AND WAS FEELING MUCH BETTER, SKIN COLOR RETURNED TO NORMAL.
TINNITUS bilateral, loud, persistent Joint soreness Foggy thinking Pain at injection site Headache Weird twinges all over body randomly
Gout flare-up; ~42h after second dose of Moderna COVID-19 vaccine
Initial health care professional report received on 01 Dec 2009: This child was inadvertently received 0.25L IM dose of FLUVIRIN (batch no: unknown) on an unknown date. No adverse event was reported. No more information was available.
patient didn't report adverse reaction until today 5/28/22. But, patient had dark purple and yellow bruising from her shoulder down to her elbow. it started a few days after vaccination. this purple and yellow bruising has lasted almost a month now.  patient is still having some pain at the injection site.
Pt called 5/6/21 reporting symptoms of swollen eyelids, pain in facial bones especially jaw, change in voice (raspiness, hoarseness, etc.), with no difficulty breathing or itching/swelling of the throat. Patient received vaccination on 5/5/21 and relayed that symptoms began roughly 5 hours post vaccination. She stated no allergic reactions in the past to vaccination, medication, environmental triggers, or food. Patient was advised to seek medical attention at urgent care or local ER since the symptoms were affecting her throat; potential airway involvement should be avoided. Patient verbalized intent to seek medical attention and advice on whether or not to continue with 2nd dose.
sought medical care for severe cough, SOB- thought it was asthma but it didn't improve with asthma meds. Also had sinus congestion and cold symptoms covid test negative chest xray (clear) treated with prednisone & zpac and asthma meds Took about a month to shake the
It started out with lower BP, my blood pressure was lower, dizziness and headaches. I was in the process of getting a new PCP at the time. I was diagnosed with arrhythmia, left ventricle node not firing like it should, and ascidia
Patient describes headache that is excruciating soon after the injection. On the fourth day post injection, he states he had pressure in the left side of his chest, the left side of his nose swelled up and is very painful, he had a "slight" temperature, and decreased appetite. He states he is still feeling bad and the headache and his nose is what bothers him the most. He called his cardiologist and the cardiologist advised him that the doctor did not think he needed to be seen for the chest pain. The patient states that if the pain does not improve he is going to the Emergency Department. He noted that the injection was done in his left arm and the left side of his body is what is reacting so strongly.
Missed period after booster dose.; booster; This is a spontaneous report received from a contactable reporter(s).   A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 08:00 (Lot number: FD0809) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Hyperlipidaemia (unspecified if ongoing). Concomitant medication(s) included ATORVASTATIN; WELLBUTRIN. Vaccination history included Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3302, Location of injection: Arm Left), administration date: 28Jan2021, when the patient was 34 years old, for COVID-19 immunization, reaction(s) Lighter periods after first two doses; Bnt162b2 (Dose Number: 1, Batch/Lot No: EJ1686, Location of injection: Arm Left), administration date: 07Jan2021, when the patient was 34 years old, for COVID-19 immunization, reaction(s) Lighter periods after first two doses. The following information was reported IMMUNISATION (non-serious) with onset 24Nov2021 08:00, outcome unknown; MENSTRUATION IRREGULAR (non-serious) with onset 01Dec2021, outcome unknown. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination was birth Control. Prior to the vaccination, patient not had COVID-19. The patient was not tested positive for COVID-19 post vaccination. The patient had no known allergies. The patient was not prolonged hospitalization. Previously always regular periods on schedule. Two pregnancy tests taken and both negative on an unspecified date in Dec2021.  Follow-up attempts are completed. No further information is expected.
Whole body itchy (except for hands, feet, and head) for the last 2 days.
This was 2nd dose of this vax. She went to her car and felt dizzy, trembling, weak. Found to be bradycardic, later learned she has had              bradycardia in the past. Patient improved after 1 liter normal saline We observed in ER for several hours & symptoms resolved
Got the shot / got a mild case/Suspected vaccination failure; Got a mild case of them; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received shingle shot and got a mild case of shingles. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and time to onset and laboratory confirmation for shingles were unknown. The follow up would not be possible as no contact details were available.
This spontaneous report has been received from a consumer, a mother of a male patient who was health of new born and was later diagnosed with autism via a survey of Merck vaccine website. On an unknown date, the patient was vaccinated with Hepatitis B Vaccine (manufacture unknown) and Hepatitis A Vaccine (manufacturer unknown). Reported consumer stated that she know that "the only thing he received that was dangerous to him from his third day of life until he was two half was the nasty chemical filled vaccines". The reporter stated also that "Your hurting child destroying people's lives" and "I never would have used a single shot especially Hep B and Hep A. I can't thru blood my baby wasn't out having sex or using injectable drugs on his third day of life. Or at any time since." The action taken, outcome and relatedness was not reported. Additional information is not expected.
Got shot 2/5/21. Woke up 2/9/21 L arm tingling and painful. Red, warm/hot to touch. Redness & Swelling below injection site. Concerns for cellulitis
Mother states child began c/o tenderness under left arm in axilla area approximately on 2/6/03. Has now noted "hives" x 20 to axilla area and to side x 1 day (2/7/03). Child is afebrile. Advised mother that s/s probably not related to vaccine since it was given 7 days ago, but instructed mother to call pediatrician and describe symptoms. Instructed mother to call clinic back after MD advise. Child recovered. Doctor stated probaly viral illness.
Patient presented with his upper arm black and blue (slight black and blue around the site of injection, more black and blue leading to the elbow). It appears he may have suffered a hematoma from the shot. He stated that it didn't hurt and it appears to be resolving because of the yellowing color. The patient was reluctant to see the doctor but I suggested that he still go see his doctor to have it evaluated. He has an appointment with his physician on Monday Nov 5th to evaluate it.
I noticed that same afternoon one side of my mouth/throat was sore, in the back on the left. I tried gargling with salt water, then later with baking soda in water. Ate some yoghurt later. No real difference.  Today (next day) I see white blotches on side of tongue in back.  I feel fine other than this, no other adverse reactions. Hurts....bothersome still in the back of my throat  when talking or eating.
The pt experienced rotavirus three months after vax. He was hospitalized twice. He almost died. No medical history and no further details were provided. Follow up info received on 11/9/01, upon review of the case, the recovery status was changed to "unknown."
This spontaneous report was received from a registered nurse via a company representative concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot number, expiry date and dose unspecified) in her butt muscle. No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Patient reported uncontrollable shivers that started in the middle of the night. Which then gave him trouble breathing. He believes because of his lung condition he got tired from the shivering and had trouble breathing. Then the following day had Flu like symptoms fever. But the next day all symptoms were gone. Reported to me on 08/13/18.
1 Week after the shot patient started to have erythema (red and warm) at the injection site.  This continued for a few days which alarmed patient who then called the pharmacy to report adverse event.
Where vaccine was given it was red and tender to the touch about 2 in by 2.
A non-serious spontaneous report of FLUMIST administration to pregnant female (14 weeks pregnant) was received from a physician concerning herself, a 33-year-old female. FLUMIST was administered on 21-Sep-2009. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
28Jan91 pt vax w/ MMR; vax was IM rather than Subcutaneously.  No adverse reaction.
Information has been received from a licensed LPN concerning a female with no allergies who in October of 2003 "was just vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and had more more serious reaction of itching, swelling, hives and was treated with an antihistamine. There was no illness at the time of vaccination. It was noted that the pt was being monitored in the office at the time of this report. Unspecified medical attention was sought. There was no product quality complaint involved. Subsequently, the pt recovered. The reporter expressed concerns about the particular lot of vaccine and requested a lot check on 1026M. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned that three other pts were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and experience a similar reaction. Additional info has been requested.
This spontaneous report as received from a registered nurse refers to a 12 year old female patient. The patient had none medical history, none drug reactions nor allergies and none concomitant medications. None of lab diagnostic studies were performed. On 16-04-2015, the patient received the first dose of GARDASIL (Lot number: L001442 and expiration date: 22-JUN-2015) and on 15-JUN-2015, the second dose of GARDASIL (Lot number: L001442 and expiration date: 04-NOV-2016). On 19-NOV-2015, the patient received GARDASIL 9 (Lot number: L028083 and expiration date: 23-SEP-2017) intramuscular as the third dose in the series. On 19-NOV-2015 (five to ten minutes after receiving GARDASIL 9), the patient developed a headache, blurry vision and became nauseous. The patient sought medical attention as she was in the office at the time of the adverse event. The patient was given Ondansetron (manufacturer unspecified) and Ibuprofen (manufacturer unspecified) as a treatment. On 20-NOV-2015, the patient was still groggy and was seen by the physician on the same day. The physician completed a neurological exam and determined the patient was very tremulous in the legs and arms, she had clonus of the ankles, both hands were weak with the left hand being a little weaker than the right hand, the patient's knees were hyper reflexive and the patient had optical neuritis. The outcome of headache, blurry vision, nausea, optic neuritis, hyperreflexia, muscular weakness, clonus and tremor was unknown. The relatedness between the events and GARDASIL, GARDASIL 9 was not reported. Additional information has been requested.
This spontaneous report as received from registered nurse refers to an unspecified patients of an unknown age and unknown gender. On an unknown date in 2015 (reported as past week), the unspecified patients were vaccinated with improperly stored M-M-R II (Lot# K006141 and expiry date: 29-APR-2016) (dose, frequency and route were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported for M-M-R II. This is one of the several reports from the same reporter. Additional information is not expected as the reporter did not wish to contact.
The day after I took the vaccine, I had the worst headache I have ever had in my life and fatigue. I thought it was a reaction to the shot, even though the first shot I had. I always have a reaction to the flu shot so I thought it was just that. However, the fatigue and headaches kept coming and going. I had blood work done and nothing came of it, it showed nothing wrong. I contracted COVID in December of 2022 as well. We are now in January and I still get the headaches and fatigue. I did have a chiropractor appointment for my back and they did a CT scan of my back and neck but also found nothing.
PATIENT ARRIVED 05/14/21 AT 12:00AM TO RECEIVE HER 2ND MODERNA COVID 19 VACCINE. I HAD 2 OTHER VACCINES WAITING AT THAT TIME. PATIENT COULD NOT COME INSIDE THE PHARMACY DUE TO IMMOBILITY. I WENT OUTSIDE AND ADMINISTERED THE VACCINE INTO RIGHT DELTOID MUSCLE. UPON ARRIVING BACK INTO PHARMACY TO GO TO NEXT SHOT I NOTICED THE VACCINE SHEET I WAS LOOKING AT WAS NOT FOR THAT PATIENT AND WAS FOR THE NEXT PATIENT. I WAS TOLD TO GET ONE JOHNSON & JOHNSON SHOT READY AND DID NOT REALIZE THE PATIENT REQUIRED THE MODERNA VACCINE AND I HAD ADMINISTERED THE JOHNSON & JOHNSON VACCINE. I HAVE SPOKE WITH THE PATIENT EARLIER AND ALSO A FEW MINUTES AGO SHE SAID SHE IS FINE.
Information has been received from a patient services representative at a health clinic concerning a 19 year old female who In the "middle of August" 2007 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included "birth control" (therapy unspecified) and cetirizine hydrochloride (ZYRTEC). On 13-OCT-2007, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot #655324/0088U). On 15-OCT-2007, the patient developed hives on her head from which she was recovering. Additional information has been requested.
pt recvd vax & 1 day later exp itching all over & a fine rash on arms & chest; treated w/DPH for itching; The itching & rash lasted 2 wks;
One week after receiving the Covid vaccine, pt was seen by telemedicine in our clinic with symptoms of local cellulitis. The area was red, swollen and warm to touch.
The tetanus booster shot (Adacel) gave me a very bad stiff neck, which I still have now, a year later at this point. Reported to Dr., I had X-ray, MRI and throat ultrasound - all came back normal, but this terrible stiff neck continues.  Also earache from the stiffness, and ringing in the ear. Have stiffness in throat, under jaw, around ears, and back of neck.  Also, the same Dr's office gave me a SECOND Tetanus Booster shot(Adacel) by mistake on Dec. 4, 2014, because they didn't understand that I already had a tetanus booster on Sept. 4.  And I didn't even need the tetanus booster; I was only getting it as a precaution. After the Dec. 4, 2014 shot, I had an immediate adverse reaction that evening of even greater tightness in my throat that was extremely painful and frightening.