chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional also the subject and described the occurrence of not responding to therapy in an adult male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). In 1980 the subject completed two three dose series of ENGERIX B. The subject reported a negative titer after both the first and the second series of ENGERIX B. The subject had not responded to therapy. No adverse events were reported.
Shortness of breath and elevated heart rate started 09/27/21. Increased throughout that week. I visited the ER on 10/01/21 where I was admitted to the hospital for pulmonary embolism in the lower lobe of my left lung. I was discharged from the hospital on 10/04/21 with Lovenox injections and Coumadin.
A mother erported that her 4 week old son recived his dfirst doses of RotaShield, HibTiter (Wyeth),and IPV (Aventis Pasteur SA) vaccine on 05/19/99. Nine days later, the infant developed diarrhea characterized by "foamy and foul-smelling " stools. The reporter submitted this event directly to CDC. From follow up #1 phone contact on 05/25/01, the correct address for the responsible physician was provided. From mailed correspondence received on 06/13/01, it was reported that the patient recovered from this experience. This case is closed.
PATIENTS HUSBAND PRESENTED TO PHARMACY ON 2/13/09 STATING THAT HIS WIFE HAD A RED STREAK APPROX. 4 INCHES LONG AND 1 & 1/2 INCHES WIDE ON HER ARM WHERE THE INJECTION WAS GIVEN. UPON QUESTIONING, HE STATED THAT IT DID NOT HURT OR ITCH.  HE ALSO STATED THAT SHE DID CALL THE MD ON CALL LAST WEEKEND BUT HE DID NOT KNOW WHAT HE SAID. SHE RECEIVED THE VACCINE ON 2/5/09.  I ADVISED HIM TO KEEP A WATCH ON THE SPOT AND TO CALL THE PHYSICIAN IF IT PROGRESSED.
24 hours after shots my daughter was have some strange behavior. She was hitting herself in the face, digging in her mouth, bitting down on her pacifier really aggressively, crying, insomnia, loss of appetite, the next day she was have seizure like activity all morning. That night the seizure like activity lasted over 3 min and she had 3 different episodes. She stopped breathing for a moment. We took her to two different Emergency Rooms and her primary care that day but they told us it was because of a fever. There was no fever noted.
I am the epidemiologist reporting on behalf of 81 year-old male patient.  Patient received one dose of the Pfizer vaccine on 3/25/2021, according to immunization records.  The patient was found deceased at home on 3/28/2021 (3 days post first dose). The death certificate lists ?Cardiopulmonary failure? as the immediate cause of death. No additional information regarding underlying conditions that may have contributed to this death is available.
This initial spontaneous report was received from a physician referring to a 7 month-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 17-SEP-2015 at 11:26 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Initial and follow up information has been received from a physician concerning a 55 year old female professor with asthma. On 26-OCT-2006, the patient was vaccinated subcutaneously in the left deltoid with the first 0.5 ml dose of Pneumovax 23 vaccine. There were no illnesses noted at the time of vaccination. On 28-OCT-2006, "24 to 48 hours after administration", the patient developed pain, redness and swelling. It was reported that the swelling and redness progressed to the entire upper arm to the elbow (previously reported as cellulitis at the injection site). The patient went to the emergency room and was admitted for observation at an "OBS" unit stay for 23 hours. The patient was treated with unspecified IV antibiotics for 24 hours and it was reported that the patient "improved". On 30-OCT-2006, the patient recovered from the events. In follow-up it was reported from the physician that this case may be related to "pseudo-erysipelas" associated with the use of Pneumovax 23 vaccine. Additional information has been requested.
Information has been received from a health professional and a pharmacist concerning a 13 year old patient who on an unspecified date was vaccinated with a dose of Zostavax. Unspecified medical attention was sought. The patient was not experiencing any know symptoms. it was reported that the error was not a result of product confusion. The patient's vaccination history reported to include a first dose of varicella virus vaccine live on an unspecified date, but not a second dose of varicella virus vaccine live. There was no product quality complaint involved. No further information was available. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2007. Information has beenreceived from a health professional, a pharmacist and a physician concerning a 13 year old female who on 26-DEC-2006 was vaccinated with a dose of ZOSTAVAX (Merck) (reported to be an overdose) instead of GARDASIL. The treating physician reported that the patient was vaccinated with a dose of ZOSTAVAX (Merck) instead of a dose of VARIVAX (Merck). Medical attention was sought. One week after vaccination, on 02-JAN-2007, the patient developed what the physician described as a zoster rash, which was also reported to be a "raging case of chicken pox" by the office manager. It was reported that the zoster rash did not cause itching, but the patient experiecned general fatigue and pain in the muscles and joints of the knees, hips and shoulders. The patient was started on an unspecified antiviral therapy. It was reported that the physician would try to swab the lesion but the patient had already left the office. On an unspecified date the rash cleared but as of 24-JAN-2007 the muscle and joint pain continued. The patient was scheduled to have a follow up appointment on 29-JAN-2007. The patient's vaccination history was reorted to include a first dose of VARIVAX (Merck)on an unspecified date, but not a second dose of VARIVAX (Merck). It was reported that the administering employee did not follow the 5 R's, did not ask for assistance from another health care professional and "did not know what she was doing." It was confirmed that this was not a case of product confusion. There was no product quality complaint involved. No further information was available. Additional information has been requested.
He is having sinus issues with allergies which has been going on for a month; This spontaneous case was reported by a patient and describes the occurrence of ALLERGIC SINUSITIS (He is having sinus issues with allergies which has been going on for a month) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGIC SINUSITIS (He is having sinus issues with allergies which has been going on for a month). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Allergic sinusitis, at an unspecified dose and frequency. At the time of the report, ALLERGIC SINUSITIS (He is having sinus issues with allergies which has been going on for a month) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  The patient had sinus issues with allergies which had been going on for a month. The patient was treated with advil and sinus advil to the congestion.
I had an extreme sore throat, earache, runny nose with congestion. I also had fatigue.
Lump under left armpit the size of a baseball, painful arm, painful armpit. Can?t raise left arm. Treatment is rest for 2 days and Mobic.
Patient arrived at the pharmacy at 5:20pm on 02/11/2019 to report with a 4 inch diameter circle of inflammation and redness that emitted heat. Patient stated she noticed the reaction the morning of 02/09/2019. Patient stated the size of the reaction had continued to grow. Patient was advised to contact PCP for possible treatment and planned to see provider on 02/12/2019.
Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache". Therapeutic measures were taken as a result of headache.  Additional information: The patient had a headache after the vaccine for less than 1 hour. She took Tylenol. Reporter wanted to know whether it was okay to take Tylenol, benedryl and Ibuprofen after the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 2MAY97 & exp a fever, chills, nausea, dizziness & a severe h/a;further vaccination w/havirix was discontinued;pt took over the counter med w/no relief;@ the time of this report 8MAY97 pt severe h/a was still present;
Information has been received from a consumer concerning her three friends' children, who were vaccinated with MMR II and became autistic. Upon internal review, autism was determined to be an other important medical event. No further information is available.
Patient had redness at injection site and swelling. Patient states pain in the area and that swelling has gotten worse throughout the day.
it was about 3 days after when her whole face and lips swelled up; it was about 3 days after when her whole face and lips swelled up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 20-year-old female patient received bnt162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 18 years for covid-19 immunisation. The patient's relevant medical history included: "migraines" (unspecified if ongoing). Concomitant medication(s) included: TOPIRAMATE oral taken for migraine (ongoing). Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: SWELLING FACE (non-serious), LIP SWELLING (non-serious), all with latency 3 days after the suspect product(s) administration, outcome "unknown" and all described as "it was about 3 days after when her whole face and lips swelled up". The events "it was about 3 days after when her whole face and lips swelled up" required emergency room visit.  Additional information: She started taking topiramate several years ago, like maybe 3-4 years ago. The patient reported that she thinks her 1st booster when you get the 2 series it was about 3 days after when her whole face and lips swelled up and they took her to the emergency room and they called Pfizer. They assumed possibly a reaction and didn't think about it. She thought that it was maybe Oct2021 around then. She doesn't recall and she would have been out of state. She believed she had another about a year ago in Sep2022 with no issues.  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-202300333483 same reporter, patient and drug; different dose and events;
Sore arm at injection site- 7:00PM 3/24/2021 Headache - 1:00PM 3/25/2021 Swollen left armpit- 6:00PM 3/25/2022 Fatigue & body aches - 6:00PM 3/25/2021
Patient vaccinated with 2 doses of Pfizer mRNA.  Admitted to hospital for DKA on 7/2/2021 and Tested Positive for COVID-19 (Post vaccination positivity).  Did receive remdesivir when admitted.
Severe sore throat within 60 mins of receiving the shot. Within 6 hours, chills/hot flashes with muscle weakness and overall fatigue within 4 hours. Left arm felt very sore around the injection site and could not lift it above my chest line without pain, approx 6 hours in. Facial soreness, post Nasal drip, stuffy nose, Dizziness, nausea, intensely itchy eardrums, and swollen sinuses + headache persisted from 6 hours in for three days - essentially the same length+symptoms as I have experienced during a severe allergy attack. Took Advil 600mg, CBD powder 20mg (for pain), and regular sips of Children?s Benadryl round-the-clock for 3 days. I also drank many liquids and drank honey tea to soothe my throat.
Patient reports 1 hour after receiving TDAP she noticed a rash on her face, arms, and legs. Also reports her throat swelling and difficulty breathing. Reports vomiting and nose bleed.
emesis w/in 4hr p/vax devel lethargy thereafter w/significant decreased appetite;did not want to wake for feedings as had in past;adm about 36hr p/vax;discharged 52hr p/adm w/nl interaction, good appetite & waking easily;
The night of receiving vaccine, patient states that she got up in the middle of the night and tried to get up to use the bathroom and was unable to walk to the bathroom.  States that she was only able to shuffle along.  Her legs we in severe pain.  This lasted that night and the next day.  Also states that she was having frequent diarrhea.
I had regular Menstrual cycles before getting this vaccine. Now what my menstrual cycles are extremely sporadic and I am experiencing a lot of breakthrough bleeding in between periods.
Pt devel Guillain-Barre Synd subsequent to receiving Influenza Virus vax;
customers wife called Monday evening stating  patient's left arm was still hurting 3 days later,  and that he had been dizzy the evening of the 17th, the day he received the immunizations
Started w/ itching around neck in evening. by morning, had red macular rash on front of neck, worse on L than R. Was vaccinated on L arm (arm shoulder unaffected). Given Claritin/Benadryl.
Approximately 3 days after developed rash on trunk and shoulders. NP reported to pharmacy, treated w/MEDROL 4 mg hydrocortisone.
Cough; Congestion; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 5-year-old female patient received bnt162b2 (BNT162B2), administered in right arm, administration date 09Dec2021 at 14:00 (Lot number: unknown) at the age of 5 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown, Anatomical site: Right arm, Administration time: 13:00, Route of administration: Unspecified), administration date: 14Nov2021, when the patient was 5 years old, for COVID-19 immunisation.  The following information was reported: COUGH (non-serious) with onset 11Dec2021 at 12:00, outcome "recovering", described as "Cough"; NASAL CONGESTION (non-serious) with onset 11Dec2021 at 12:00, outcome "recovering", described as "Congestion". Therapeutic measures were not taken as a result of cough and nasal congestion.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient came in complaining of all over severe joint pain. The pain was to a point where she as she had trouble sitting still.
I get a temperature;  I feel temperature off and on; I feel flushed; Itching; Hives; Pain injection site; Tiredness; Headache; Muscle pain; Chills; Joint pain; Injection site is swelling; little bit of nausea the first day; Arm pain; I get a temperature; low grade temperature; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot Number: FD8448) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have the severe side effects, but the patient had it done on Sunday around 09:40 (date not reported) and had itching and hives, pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, injection site was swelling, little bit of nausea the first day and arm pain. The patient got a little bit of low grade temperature, it started out as 99.4 on the evening of 31Aug2021 then it was at 101 on 01Sep2021. The patient felt temperature off and on and suspected a temperature but it went away and patient was back to normal. The patient did not know if it was going to be on and off, patient felt flushed, then would get a temperature, then it would go away. The outcome of the event low grade temperature was recovered in Sep2021 and the other events was unknown.
Since the first dose, I have had heavy menstrual bleeding. I initially thought it was spotting in between the sugar pills in my birth control, but this problem has consisted for the last two weeks since the shot. I am not trying to get pregnant and I have not had this kind of issue before. I felt sick (like the flu and cramps) the first 24 hours after the shot as well as both my arms hurting despite only my left arm getting the shot, then felt normal other than the menstrual bleeding and persistent arm pain.
This case was reported by a physician, via a GSK sales representative, that described the occurrence of injection site hot to touch in four child subjects of unspecified genders who were vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date (s), the subjects received either their 4th or their 5th dose of INFANRIX (.5 ml, unknown). Within 24 hours after vaccination with INFANRIX, the subjects experienced injection site that was hot to the touch, and swelling at the injection site. The physician's office reported that at least four child subjects experienced the same type of reaction to a particular lot of INFANRIX (Lot #AC14B085BA). Product complaints were lodged for these reports, as the physician's office was concerned that this was a potentially a bad lot of INFANRIX. At the time of reporting, the outcome of the events was unspecified. The physician considered the events were probably related to vaccination with INFANRIX. Follow-up information received on 07 October 2008 indicated that the subject was a one year old male. The events began on 21 August 2008 and resolved on an unspecified date in August 2008. In the reporter's opinion, the events were possibly related to treatment with INFANRIX. This was the subject's 4th vaccination with INFANRIX. In follow-up a 5th case was reported. Linked cases include: A0747164A, A0747168A, A0747169A and A0752555A. A safety statement received on 19 October 2008 concluded that there was no evidence for a safety signal or safety concern for the INFANRIX lot AC14B085BA.
This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 08-SEP-2016, the patient was inadvertently vaccinated with a dose of expired VARIVAX, subcutaneously from lot # K010337 with expiry date of 22-JUL-2016. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
3AUG95 mom who asked for school certificate & stated pt had rxn past MMR & was seen @ MD ofc;
After my physical exam last Monday, March 12, she was given Pneumovax injection, a vaccine against bacterial pneumonia, about 3 PM. The person who gave her the shot and I talked jovially about the side effects which were dismissed as basically nil. About 5 PM the same day, only two hours after the shot, I began to experience malarial chills, (These were similar to malaria which I had when I was 11). These became worse as the evening wore on. So I had a warm bath and went to bed a little earlier than usual. But my sleep was extremely disturbed. The next day, Tuesday, was even worse. The chills started again, then petered out and started again. By noon I had to take a noon nap. This is extremely rare for me. My normal energetic self had been changed into a slowly walking exhausted and sick man; just as the same as when I returned from overseas several years ago. I had fish poisoning on the eve of my departure. The flight back took 14 hours flying with diarrhea all the way, waited for the connections to Washington. I walked off the plane looking ghastly sick. That's what my wife said I looked like on Tuesday last. I literally dragged myself around all day. On Wednesday, I had recovered 95%. My reaction to the vaccine was absolutely horrendous for 36 hours. Please include this report in my medical record and, in all fairness to others, the FDA should also be notified of this reaction. I wish I had been told that there may be this kind of reaction to the vaccine. May I hear from you about this matter?
Moderna COVID-19 Vaccine EUA received at 10:58 am on 1/16/21. Slight discomfort at injection site a few hours after received. Awoke at 1:25 am on 1/17/21 with chills, extreme headache, fatigue and joint pain. These symptoms continued until late afternoon on 1/17/21, then gradually subsided. Took Tylenol, rank water and finally had some soup to eat when felt better.  the headache, joint pain and fatigue resembled symptoms when I had COVID-19 in March 2020, but only lasted about 12 hours.
Left upper arm red and swollen and warm. Pt's mother was instructed to give Motrin and apply ice packs. Also was given cephalexin.
This spontaneous report as received from a healthcare worker also reported as nurse assistant refers to group of patients of unknown demographics. Information about patients' medical histories was not provided. On 04-FEB-2015, the patients were vaccinated with VARIVAX (Merck) (dose, frequency, indication and lot # were not specified) which was improperly stored. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.