chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Registered Nurse concerning a female patient with no known drug allergies who on 07-FEB-2011 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 (lot #667995/1150Z expiration date: 04-MAR-2012). Subsequently the patient experienced injection site reaction of pain, swelling and warmth. Patient was given antimicrobial (unspecified). At the time of the report patient's status was unknown. By nurse's request, a lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
The next day, patient was found down by children (lives alone.) Was confused, had had fecal incontinence many hours earlier (dried) . Neither syncope nor fecal incontinence had occurred before. Previously  managed to walk w walker or holding on, do her own basic ADLs (toilet, use microwave, eat.) Now bed bound  and requires 24 hour care, unable to stand even with assistance/PT. Mental state has returned to baseline. Spent a week in rehab but could barely comply w PT instructions due to pain/dizziness.
This spontaneous report as received from a healthcare worker refers to a patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of PROQUAD (Merck) (dose, frequency, route of administration and indication were not reported),  which were exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported similar events for 3 patients. This is the 3rd of 3 reports. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13 on an unspecified date, at single dose, for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a red blotchy rash in the area surrounding the injection site, not directly at the injection site. This rash lasted approximately 7 days and resolved on its own. There was no itching or pain associated with the rash. No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017492902 same reporter/drug/event, different patient;US-PFIZER INC-2017492889 same reporter/drug/event, different patient
Approximately half an hour after receiving the vaccination, the patient (me) became extremely dizzy while standing still and lost her balance. She nearly fell into a display case at the pharmacy location, and experienced extreme brain fog and balance issues following the vaccination and up until this day.
pt recv vax 21AUG95 & on 3FEB97 pt devel chickenpox;It was reported that two other pt WAES #97021046 & 97021048 who recv varicella vax;
would come down with the flue every time; Initial information received on 15-Oct-2020 regarding an unsolicited valid non-serious case from a consumer via media.  This case involves patient of unknown demography who would come down with the flue every time (influenza), after receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient would come down with the flue every time (influenza, non serious) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was not reported for the event influenza.  There will be no information on the batch number for this case.
Arm soreness itching at injection site. Extreme tiredness and sleepiness. Brain fog flu like symptoms chills.
Hearing loss; Tinnitus; Aural fullness; This is a literature report.  A 69 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Meniere's" (unspecified if ongoing), notes: 2 years - stable. The patient's concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss"; TINNITUS (non-serious), outcome "unknown", described as "Tinnitus"; EAR DISORDER (non-serious), outcome "unknown", described as "Aural fullness". The events "hearing loss", "tinnitus" and "aural fullness" were evaluated at the physician office visit.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
5 days following receipt of the MedImmune Live attenuated H1N1 monovalent vaccine, child developed raised itchy painful welts on her lower limbs, that rapidly spread to cover her entire body.  No fever.  Notified physician and treated with OTC Benadryl with resolution of symptoms.  Had gradual resolution of symptoms over the following 5 days.  Completely well by 11/19/09.  Spoke with child's pediatrician, who verified information.
On 3/10/2021 the patient presented to the ED with fatigue and diarrhea. The patient had been constipated and then started taking magnesium citrate and Colace. Since starting the laxatives the patient had been experiencing diarrhea. Once at the hospital, the patient was routinely tested for COVID-19. She had one COVID antigen that was positive and one negative, and the COVID PCR negative. Chest xray shows no pneumonia and he WBC was 11,000. Reason for admission: diarrhea and weakness.
The day after the shot I started getting a sore throat, achy, itchiness/pain at site of injection, and began getting fatigued.  The next day after that 11/8/21, I was very fatigued so I had to call into work.  The next day I started getting a very sore neck and getting even more tired.  I began getting a great deal of abdominal pain and bloating as of 11/14/21 the abdominal pain and bloating is getting better, however, the neck pain  and pressure along with sever fatigue is continuing to persists.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of RECOMBIVAX HB (lot # M000442, expiration date 31-MAR-2018; dose and route were not reported). No adverse effects were reported. The vaccines were stored in 33 F for 60 days. The call was made because of the data logger. No previous temperature excursion was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Good morning after the shot I woke up with a fever of  99.6, chills bodyaches headache total body fatigue. Are use Tylenol to bring the fever down but aches and pains in body continued as well total fatigue to date
Immediately  after injection face and neck turned red, throat felt scratchy, after 15 minutes lost moisture in my mouth, for about 20 minutes, Arm was red, very sore, and swollen.  Arm stayed red for 2 weeks after injection.     One week after injection began to have dizzy spells,  and lightheaded.   EMT on site told me flushing was normal.   When to my doctor and allergist who both advised not to get second shot.   Doctor is treating me for vertigo.    Still having dizzy spells and lightheaded after 5 weeks.
15 year old given a booster dose which is currently approved for patients 16 years and older
Nurse reported medical assistant administered PROQUAD and VARIVAX to the same patient on the same day. See request case 02477482. No additional AE/no PQC.; medical assistant administered PROQUAD and VARIVAX to the same patient on the same day.; No additional AE; This spontaneous report was received from a nurse and  refers to a 1 year old male patient. The patient's concurrent conditions, medical history, concomitant medication, drug reaction or allergies were not reported.  On an unknown date, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # U0239723, expiration date: 15-DEC-2023) and one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # X005167, expiration date: 15-AUG-2024) (strength, frequency, route of administration, anatomical location not provided for both) on the same date (inappropriate schedule of product administration, overdose). No additional adverse event was reported.   Lot number U0239723 is an invalid lot number for varicella virus vaccine live (oka/merck)(VARIVAX)
Information has been received from a health professional concerning a patient who on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced fever, redness, soreness and swelling at the injection site and was hospitalized. At the time of the report the patient's outcome was unknown. No product quality complaint was involved. This is one of two reports for the same source. Additional information has been requested.
At about 10 p.m. I decided to go to bed. When I stood up out of my chair I got chills. I walked to the kitchen to get a glass of milk but I couldn't drink the milk because I started shaking very badly. I put the milk into the sink with a very very shaky hand and then stood there a while in the kitchen because I couldn't move my muscles. They were so tight from shaking. I started not being able to breathe very well. I was gasping for breath. I started moving into my bedroom to try to lay down. But that made it harder to breathe. So I would sit up and that was hard. I kept gasping for breath. I kept trying to relax myself and to get warmer but the shivering and the shaking kept going for about 10 minutes. I thought I should call 911 but I remembered from my first booster shot I had a similar shivering experience. However that time before I did not have problems breathing. Not that I remember. In hindsight, I should have called 911. I didn't know when this was going to end. The episode lasted about fifteen minutes overall. I was able to calm down and breathe a little. I was in the bed under the covers because I had been so cold. I soon fell asleep. I woke up about 2:15 in the morning and had a fever of 101. And my lungs were filled with congestion. I was wheezing pretty heavily. My whole body was aching as well. I took some ibuprofen and morphine and went back to sleep in a little while. When I woke up at 7:30 in the morning on Sunday I was much better. I did not have a fever but I still had congestion in my nose and chest. I continue to feel better.
Diffuse punotate papular macular erythematous rash.  12 days after MMR/Varicella.
Breakthrough case of varicella. Parent called office to confirm case of varicella. Sibling had varicella illness 04/03/02 (onset) on 05/23/02.
I have got lump under my left arm and it's rather sore; I ache from head to toe; I have got a temperature of 102; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. Medical history included none. There were no concomitant medications. The reporter stated that I am experiencing some side effects, I ache from head to toe, I have got lump under my left arm which is where I got the injection (Clarified as Covid-19 Vaccine by Pfizer) in my left arm and it's rather sore and I have got a temperature of 102. The patient not received any treatment for the events. The outcome of the events was reported as unknown.
Patient complained of a sore arm at the site of injection. No swelling or redness at the site.
Started blacking out at the gym.  Thought perhaps blood pressure was high but it was extremely low. 70 over 45.  Stayed with nurses and they had me eat packets of sugar and got me to eat some food in cafeteria.  I am not certain the shot caused the black outs or low blood pressure,  but the gym thought the shot did factor into what happened.  Perhaps a combination of coming off Agumentin for the dog bites, Tetanus shot, and then the flu shot. I have had a flu shot every year without any issues. Pressure came back up later in the day.
Mom called on 02/28/2002 and stated that the child complained of left arm red, swollen and hot to the touch (area size of golf ball). Mom notified to use ice to site and Benadryl. Mom called on 03/01/2001 stating that the pt was getting worse. Pt seen by the doctor, he was placed on Prednisone. Seen in follow up on 03/04/2002.
Information has been received from a physician concerning a 9 weeks old male, who on 19-DEC-2008, was vaccinated with the "normal dose" of ROTATEQ (Lot # was not available), orally. Concomitant therapy included PREVNAR, IPV, PEDVAXHIB, and DTaP. On 23-DEC-2008, the patient experienced vomiting and dehydration and was hospitalized. Patient was tested for rotavirus and test result came back positive. Physician noted that the patient recovered and was released from the hospital on 28-DEC-2008. "Hospital demographics are unspecified." Additional information has been requested.
Painful arm for 2 days.  On day 3 and 4, sick with headache, bodyaches, general tiredness.   Day 6 back to normal.  Day 7-8 pain in left arm deeper muscle or tissue than shot area.  Day 11 or 12 noticed itchiness in the area and redness and slight swelling about the size of a softball.  Still on day 14, red, itchy and slightly raised.
FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms. This report was non-serious.
This is a spontaneous report from a contactable pharmacist who reported the same event for 2 patients (husband and wife). This is the 1st of 2 reports. A 62-year-old female patient received the first dose of PREVNAR 13 (Lot number R41774, Expire date Apr 2018, NDC number 0005-1971-01), via an unspecified route of administration at 0.5 ml single in the left deltoid on 04Mar2017 for immunisation. No other vaccines were administered on the same date. The patient medical history and concomitant medications were not reported.  The patient previously took Z-pak in Jan2017. Within 24 hours, on an unspecified date in Mar2017, the patient experienced nausea. It was mentioned to her doctor and to the pharmacy on 14Mar2017 and when the pharmacist was able to get back in touch with her on 24Mar2017 the nausea had abated. The reporter stated that it sounded as though she just spoke to her doctors office over the phone and did not receive care or treatment for the nausea. No physician office or emergency room visit were required. The event resolved on an unknown date in Mar2017. The reporting pharmacist did not believe that the nausea was related to Prevnar 13. He believed that it sounded more as though the patient picked up a GI bug.; Sender's Comments: Though the event nausea is possibly related to the suspect product based on the know safety profile, per reporting HCP company agrees that nausea may not be related to prevnar 13,Linked Report(s) : US-PFIZER INC-2017143842 Same reporter/drug/AE, different patient.
pt was dressed to leave waiting area & became cyanotic & not responsive to shaking by mom pt examined by pediatrician & became more awake w/color;
leukocytoclastic vasculitis-confined to legs-started 3-4 days p/multiple vaccinations;
Bell's Palsy of Left lower face/jaw started upon waking 4/22/21, pt's 2nd dose was 4/20/21
Two days after vaccination, I started having major fatigue, body aches, diarrhea, nausea, "run down", no appetite and wanted to sleep a lot. The fatigue lasted 1 1/2 weeks and had to have help around the home. Around the 7th day, I began having tremors. I started feeling better about 2-3 weeks after vaccination. I feel fully recovered.
she just woke up screaming; She couldn't move either; she had pain all over; This spontaneous case was reported by a consumer and describes the occurrence of SCREAMING (she just woke up screaming), HYPOKINESIA (She couldn't move either) and MYALGIA (she had pain all over) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced SCREAMING (she just woke up screaming), HYPOKINESIA (She couldn't move either) and MYALGIA (she had pain all over). At the time of the report, SCREAMING (she just woke up screaming), HYPOKINESIA (She couldn't move either) and MYALGIA (she had pain all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Fever, chills, body aches muscle and joints, headache, ringing ears, eye pain
C/O stiffness, sharp shooting paints that started minutes to hours after injection, pain has continued since. There is no swelling or redness. Area just posterior to deltoid is painful to touch.
Patient received the pfizer pediatric booster vaccine, but it was undiluted. When I called the parent to inform them, they stated the kids are already feeling agitated and out of it.
First symptom to arise was chest tightness "band around my chest", and around 1330 - chills; through the night developed a sore throat and cough. At 0600 felt lousy, developed body aches and left early to go home. Left at 0600, came home and went to bed. Woke up at 1530 - states fever returned and raging "102.5," rigors, felt miserable and exhausted. Continues to endorse chest tightness but states that this has significantly improved . States she reached out to her PCP and they advised likely allergic. Symptoms spontaneously resolved by 10/12/22 without treatment.
Feeling unwell, General body aches; he does every once in a while get an asthma episode; Fever; Feel a bit achy; Mild headache; vision is hard to focus; Not feeling right on and off; This is a spontaneous report from a contactable consumer or other non hcp (Patient himself). A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0150, expiry date: unknown), via an unspecified route of administration, administered in right arm on 02Apr2021 as 1st dose, single for covid-19 immunization. The patient's medical history included Type 2 Diabetes mellitus, patient reported that it was diagnosed at least 10 years ago, and his sugar levels had been in very good control, Covid-19 from unknown date in Nov2020 to unknown date in Dec2020. The patient's concomitant medications were not reported. On 03 Apr 2021maybe started Saturday after the vaccination the patient experienced with mild Headache and not feeling right on and off for 6 days. Patient reported that his head feels worse since he got the slight fever, he took Tylenol to deal with the fever in morning, like 11:00 AM then he did not feel quite right, probably feels worse to next day, sometimes his vision was Hard to focus he was to struggle a bit to focus or just worse because of the fever. since he got the vaccine, in the first couple days, he might have just felt like things were a little blurry and again it was very mild, but it seems worse than it had. on 08Apr2021 the patient feels little achy, and he took the Tylenol and only felt worse because of the fever and later felt better and had general body aches the patient did have COVID back in the end of November, then he recovered in the beginning of December, he got an asthma episode still that he believes was triggered by the COVID. The patient reported that he had a blood work on 03 MAR 2021, he saw his doctor on 10 MAR 2021 and his blood work was pretty normal. His blood sugar was very good, and he also has been very active, he walks every day. The patient enquired second dose was scheduled for 23 APR 2021, was it fine to have a second dose. The patient did not visit Emergency Room or No Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient took TYLENOL 500 mg for the treatment to the events (LOT: SJA014, scan code:30044439; NDC: 50580-449-36EXP: 06/2024). The outcome of the events headache, vision is hard to focus was not recovered, fever was recovering, feeling unwell, general body aches, feel a bit achy asthma episode and was unknown.  No follow-up attempts are needed. No further information is expected.
Administration error. 1st dose 11/24/21, 2nd dose inadvertently administered at 14 days on 12/8/21. No adverse reactions observed.  Per CDC guidelines rescheduled another dose 3 weeks from today on 12/29/21.
Pt vaccinated with DTP and developed a fever 103.5 X 48 hrs.
area of cellulitis lt hip site of inj measles 10cm red, hot indurated;
headache; nausea; body aches; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN (body aches), CHILLS (chills) and FATIGUE (fatigue). On 19-Mar-2021, the patient experienced HEADACHE (headache) and NAUSEA (nausea). At the time of the report, PAIN (body aches), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products also include STATIN  No treatment medications were reported