chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My friend's son is in the hospital with anaphylaxis; If for example my friend's son who is in the hospital now with  anaphylaxis, he may die; He got very, very high asthma and anaphylactic asthma; This is a spontaneous report from a non-contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: unknown), via an unspecified route of administration 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 my friend's son is in the hospital with anaphylaxis; if for example my friend's son who is in the hospital now with anaphylaxis, he may die; he got very, very high asthma and anaphylactic asthma on an unspecified date. The patient was hospitalized on an unspecified date for the event anaphylaxis. Reporter stated, Okay, I am calling I mean, I myself, I am fine. I have taken the vaccine from Pfizer but my friend's son, he got very, very high asthma and anaphylactic asthma and he has severe issues . My child is over the age of 12-13 but she has severe anaphylaxis and severe asthma and is allergic to like so many things, certain things that are in vaccine (further not clarified). So, the problem is if we give it to her she can have a bad reaction and she can die from anaphylactic shock (further not clarified). So, I need to know from you, are you still thinking it's okay because from the data it's showing anaphylactic issues and my friend's son is in the hospital with anaphylaxis. I also want to tell you I spoke to you guys about five months ago on the same issue and you guys advised, not to take it. So, I need to ask again here, because that will be her. Reporter stated, I wanted to ask you a question. If for example my friend's son who is in the hospital now with anaphylaxis, he may die (further not clarified). Product details (LOT, NDC, UPC and Expiry date) cannot be probed. Reporter reported about friend's son who is in hospital going through asthma and anaphylaxis, was referring to vaccine. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
rapid onset of erythema, swelling, bruising, aches, pain, no fever tx ice, DPH;19OCT97437Pm had 8cm area of erythema w/5cm area of bruising-no induration-warm to touch;
lethargic; weakness; sore arm, really big and black and blue around it; muscle pain; felt wiped out, tired; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), ASTHENIA (weakness), PAIN IN EXTREMITY (sore arm, really big and black and blue around it), MYALGIA (muscle pain) and FATIGUE (felt wiped out, tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu. Past adverse reactions to the above products included Pain in arm with flu.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LETHARGY (lethargic), ASTHENIA (weakness), PAIN IN EXTREMITY (sore arm, really big and black and blue around it), MYALGIA (muscle pain) and FATIGUE (felt wiped out, tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargic), ASTHENIA (weakness), PAIN IN EXTREMITY (sore arm, really big and black and blue around it), MYALGIA (muscle pain) and FATIGUE (felt wiped out, tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant Medication was provided   This case was linked to MOD-2021-262346 (Patient Link).
Erythema and warmth below area where DTAP was given. Small nodule beneath the skin at injection site.
About 2 hours after receiving her flu vaccine at 0800 patient noticed redness, swelling, itching, and warmth at the site.  She was advised to complete a visit with an employee health practitioner.
PT had a Hep B shot in May 2007. This was not reported due to the time of onset and the recovery. The Pt received the recent Hep B shot and was in and out of consciousness and was going into shock. She was transported to the local emergency room. She was observed and released after 24 hours.
for 24 hours I was drained of energy and unable to get out of bed.  My legs were especially painful, but my whole body was achy and uncomfortable.  I was dizzy when I had to get up and feared fainting.  I am a healthy 53 yr old and usually nothing keeps me from being productive and working hard each day.  This is a feeling I never want to experience again.
Sudden Death.  8/12/09 Autopsy records received. CAUSE OF DEATH - SUDDEN UNEXPLAINED INFANT DEATH. Infant found prone with head between the mattress and netting wall of the porta-crib.
Have had a little, very light, tinnitus before, but it became noticeably louder after 2nd Moderna Vaccine. I am 6 days post 2nd vaccination and it is still very loud. Still thankful for the Covid vaccine and would do it again, but would have a little concern if booster might make it worse. Might consider Pfizer for a booster.
took all 4 capsules; 11MAR92 pt started taking VIVOTIF Berna; pt was in Brazil 1JUN92 - 6JUL92; 28JUL92 had stool & blood checked & on 3AUG92 had typhoid;
Rashed red rash about 2 inches in diameter at injection site. Still present and itching a week later. Now appears to be blue around the edges.
This spontaneous report was received from a licensed practical nurse referring to a 12 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, during a well check, the patient was vaccinated with PROQUAD, subcutaneously, Batch #M027637 and expiration date: 02-JUN-2018 (dose not reported); VARIVAX subcutaneously, Batch #M035140 and expiration date: 03-AUG-2018 (dose not reported) and hepatitis a vaccine, inactivated(VAQTA) intramuscularly (dose, Lot # and expiration date were not reported); all three vaccines for prophylaxis. The nurse reported that the patient received PROQUAD instead of M-M-R II. The Nurse no reported adverse effects after administration. There was no product quality complaint involved. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 4:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 4:15 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 40.45  Concomitant products were not provided.  On 12-Feb-2021, Excursion time was 10 AM, 11 AM and temperature was 35, 35 respectively. Total doses given for the day was not provided, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021 and vial was moved to clinic on 12-Feb-2021. 3 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
1.) Redness 2.) Itching 3.) Warm to touch. 4.) Severe coughing 5.) Thick mucus coughing at the back of my throat - to constant clearing & hard to get out. stress incontinent increased I am sending you this form regarding my experience of receiving a vaccine of (1.) Prevnar (2.) Boostrix of TDAP syringe which I develop all the symptoms of having whooping cough at thick mucus coating behind my throat & experiencing until this time. I had been suffering fr this vaccine. I would like to have this be resolved of my experience coughing & with so much mucus coming out when I cough constantly.
No adverse effect reported.; a patient was inadvertently administered an expired dose of PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 10-APR-2019, the patient inadvertently administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type: recombinant Human albumin (rHA), lot # N028444 with expiration date 09-APR-2019; strength and dose detail were not provided) subcutaneously for prophylaxis(expired product administered). No adverse effect reported. The causality of the event was not provided.
Patient under age 18 was vaccinated with Moderna, which is a vaccine error.  He is age 17 and will be 17 when he gets his second vaccine. Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn away on a Moderna-only day.  All parties ignored the age restriction/confirmation of birthdate that was put in place to prevent this type of error, and the scribe and vaccinator ignored the note in the computer system instructing them to redirect him to a Pfizer day. Parent signed consent, did not respond to an email sent by the reporter prior to vaccine date redirecting to a Pfizer only day.
has been sick; throwing up for two weeks; having diarrhea; in a daze; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient. A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (first Booster, manufacturer unknown), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "has been sick"; VOMITING (non-serious), outcome "unknown", described as "throwing up for two weeks"; DIARRHOEA (non-serious), outcome "unknown", described as "having diarrhea"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "in a daze".  Additional information: Agent with the Pfizer Call Center has a reporter on the line calling to report after he took the Pfizer COVID booster shot, he had been sick and throwing up for two weeks. Reporter verified the information provided by the transferring agent and clarified it was his second booster dose and he was in a daze for a week throwing up and having diarrhea and thought this was not a live virus asks if it is a live virus and how is he sick like this. He was fine with the first shots. He was sick and missed work and this is two weeks and asks if there is help for him being sick and out of work regarding compensation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
April 15- second Covid shot April 22 - first big vertigo spell. Deafness then ringing in right ear April 23 - mild ringing in both ears and thumping, pressure in head May 4th - very noticeable ticking in right ear May 9th - felt sick, off, hard to take a deep breath, pounding head, fullness in ears, ringing, emotional May 11th - ENT visit. Ears clear, hearing fine May 18th - May 23- off and on headaches, difficulty breathing May 24th - Headache that didn?t go away with medicine. Fullness in ear. Nausea May 25th - Sleepless night, stiff neck, very full head. Medicine providing no relief(Excedrin, Sudafed, Flexeril) can feel fast heartbeat, ringing, and pulsation in ears, stiff jaw May 26-28 -  light head congestion May 29- headache returns May 30- head congested even after Sudafed. Ears feel ?wet? hard to take a deep breath, lots of yawning. Flushed face and blotchiness on neck.  May 31 - Difficulty breathing, ringing in both ears
pt to ED with c/o headache, frontal sinus congest, sore throat, mild cough, denies SOB; positive for COVID; per death certificate pt died in the ED
patient was sore at the site of injection initially (1st couple day) then the pain went away.  Three days later (total 5 days from vaccine administration) patient complains of redness, pain in whole arm and fever of 100.4F.
Severe constant pain to left mid/upper back and left shoulder area - radiating to entire left arm. Also weakness in left shoulder and arm. Prescribed Cyclobenzarine 10 MG Q day, Torodol shot 1st visit and otc motrin/Tylenol. Massages and heating pads.
Lack of efficacy.  Fully vaccinated for COVID19 with symptoms and confirmed positive PCR test result on 9/27/21.; Lack of efficacy.  Fully vaccinated for COVID19 with symptoms and confirmed positive PCR test result on 9/27/21.; This is a spontaneous report from a contactable Pfizer colleague (Nurse) reported for a patient. A 46-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247), dose 2 via an intramuscular route of administration, administered in Arm Left on 04Mar2021 (at the age of 46-year-old) as DOSE 2, SINGLE and dose 1 via an intramuscular route of administration, administered in Arm Left on 11Feb2021 (Lot Number: EL3247), (at the age of 46-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. It was unknown prior to vaccination, the patient diagnosed with COVID-19. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 27Sep2021, the patient experienced COVID19. The reported stated that Lack of efficacy, fully vaccinated for COVID19 with symptoms and confirmed positive PCR test result on 27Sep2021. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures, which included PCR test: Positive on 27Sep2021, Nasal Swab. It was unknown if the patient received treatment for the events. The patient outcome of the event was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and covid-19 and the suspect drug BNT162B2.
sick due flu vaccine; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a 54-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The experienced sickness due to flu vaccine.
This spontaneous report as received from a Medical Assistant refers to a 3 patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 12-MAY-2015, the patients were vaccinated with doses of improperly stored (exposed to 47 degrees F for 34.5 hours on 07-MAY-2015) MMRII (dose and route were not reported) lot # J008533, expiration date: 12-JUL-2015. There was no adverse reactions report or PQC involved. There was no concomitant medication provided. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. During 2015, the patient was inoculated with ZOSTAVAX at a hospital for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, she was treated by a physician for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
4/7/21 6am - woke up with moderate muscle pain in left arm at injection site 8am - injection site pain gone, mild nausea and dizziness, body aches and joint pain started and got worse throughout the morning 9:30am -took 1000mg acetaminophen 12pm - nausea and dizziness gone 3pm - joint pain went away, moderate all-over soreness of joints and muscles, moderate fatigue, mild headache, took another 1000mg acetaminophen, small red spot around injection site (less than half an inch diameter) 9pm - all symptoms gone except for mild muscle soreness 4/8/21 10am - redness at injection site gone, 2x1 inch rectangle and quarter sized circle of redness a few inches below injection site, very defined outlines 10pm - both red spots are slightly raised, feel hot to the touch, and outlines are blurred
Hurt bad when injecting. Hurt afterwards. Still hurts 2 days later. Shoulder started hurting yesterday. Today I have a big knot under armpit.
4/20/06 Noticed redness at injection site. 4/26/06 Woke up with hives 3" X 2" at injection site with itching and lo grade fever.  Presented at ER, sent home with advil and benedryl and reassurance. Mother c/o "this is a bad reaction and wants VAERS filled out" 4/28/06 Public Health notified by parent.  I counseled parent on local effects of 4th DTap injection site reactions.
itchy/dry throat; Feverish; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (itchy/dry throat) and PYREXIA (Feverish) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included Anti Depressant and Cholesterol Medication for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (itchy/dry throat) and PYREXIA (Feverish). At the time of the report, THROAT IRRITATION (itchy/dry throat) and PYREXIA (Feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Client received 1st dose of Moderna on 03/05/2021 with no known acute illness. He later tested positive for Covid-19 after a direct exposure in his household and was asymptomatic. His positive test date was 03/10/2021. He quarantined at home without symptoms, complications, or need for medical treatment. His quarantine ended on 03/10/2021, although he chose to quarantine until 03/24/2021. He was scheduled to receive his 2nd dose of Moderna on 03/29/2021. He had not reported a positive test previously. After reviewing the CDC guidelines, he was given his 2nd dose of Moderna on 03/29/2021.
Patient reported "not feeling right" shortly after receiving vaccine. Patient experiencing audible wheezing, mild cyanosis, and was nonverbal. pharmacist responded with epi-pen at 2:48pm. Patient immediately responded to epi-pen (no wheezing, lips/nailbeds pink, verbalizing "I'm ok" after 15-30 seconds. Patient was monitored and experienced no further distress.
Heart palpitations starting shortly after the COVID vaccine.  Patient called EMS to take her to emergency room.  Patient states heart rate has been consistently around 124-125.  Associated intermittent diaphoresis, a flushed appearance, and fatigue.  Similar episodes of tachycardia in the past that resolve independently.  Patient transferred to a facility with Cardiology.
Patient was given yellow fever vaccine at the infirmary last 05/09/2005. Did well,and about 1:00pm of 05/11/2005 she started to have numbness periorally and gradually extended to the anterior neck area and tips of fingers.Patient arrived around 3:00pm and symptoms did not get worse nor get better in the next 1.5 hours. Denies any shortness of breath, rash, pruritus, sore throat, headache, weakness,panic attacks/anxiety. Patient has been very calm all throughout. Denies any new medications,foods, skin products. CDC was consulted and he recommended to continue observation and to go to ER if worsening. No medications given. Patient advised to return to infirmary to report these event. Patient has not started taking her malaria medications yet.
Pt developed rt thigh reaction with erythema, mild induration and warm about a size of 7 1/2 of diameter.
Information has been received from a nurse concerning a 7 year old female who on 14-APR-2008 was vaccinated with the second dose of VARIVAX (Merck) (lot# 660280/1997U). The date of the first dose was unspecified. There was no concomitant medication. Subsequently the patient developed an injection site reaction in the left arm. The arm developed a 5/10th of an inch diameter area that is hot, very red and swollen surrounded by a 4 inch in diameter area of pink, tender and swollen area. The patient was seen by the physician on 16-APR-2008 and was placed on therapy with KEFLEX prophylactically. As the time of the report it was unknown if the patient had recovered fro the injection site reaction. The nurse also mentioned that this patient is the third patient that had developed an injection site reaction after the second dose. No information on other patients mentioned. This is one of the several reports received from the same source. Additional information is not expected.
MOM STATES PT WAS C/O PAIN ON 08/26/19 AND WAS LIMPING. MOM GAVE IBUPROFEN FOR PAIN ON 08/26/19.