chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe Vomiting the morning after the vaccine. Since early morning that he woke up he was not able to drink or eat anything because he would vomit.  Took him to the ER and they gave him fluids and Zofran.
Patient received the Pfizer vaccine on 12/21/20 and 1/13/21 so was fully vaccinated when they tested positive for COVID-19 on 9/16/21.
I was on my menstrual cycle day 2 and my cycle suddenly stopped.  Normal cycle is 7 days.  Swelling of my arm with bruising.
8 days later after vaccine on 1/7/2021 on the vaccine site it was very itchy, it was red, &  really hot to the touch. The next day on Friday I went to urgent care & the doctor wanted me to take Benadryl. It lasted about 3 days.  The redness is what stayed for a week.
Pt received FLUARIX QD preservated free 10/31/18 pt calls office 11/2/18 stating patient rt arm was red and pain yesterday 11/1/18 but this morning when pt woke up pt had Rt red swollen and had drainage around injection site.
Patient came for her booster and mentioned that with her second dose she experienced a sore jaw 2 days after her shot. She received the shot on a Wednesday, the symptoms started on Friday through Saturday, and resolved by Monday. She did not consult with her physician at the time. She mentioned that she had severe lock jaw about 15 years ago after receiving a tetanus shot.
Patients daugter-in- law called and she said her mother in law had 2 hours nosebleed. She called around 11:00 am I asked any headache, confusion and dizzness. Daughter-in-law said none of that and she orinted to place and time she said yes. The nosebleed compltely stopped. I check back with  daughter-in-law at 14:00 P.M she said she  is doing fine. If she does not feel ok to go to ER.
Pt was seen with redness-macula 4 mm base of penis. No other sx. No fever, felt well. Discussed STD and given GARDASIL #1. Later -STD next morning developed with fever -> 102, ST HA, SV, V came in - mod ill at rash, neck - CBC - WBL - 18, 000. Hospitalized - spinal tap normal all cultures.Treated with ROCEPHIN. Gradually got better. I do not known if related to vaccine. I know my pt would have a hard time getting #2/3.
received a shot of the Pfizer-BioNTech Covid 19 Vaccine (gray cap) more than 12 hours after the first puncture of the vial; Off label use; Initially stated that the date was Aug2023. Later clarified that the date is fuzzy and looks like Aug2021.; Dose 4 Booster; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Mar2022 10:41 (Lot number: FJ9943, Expiration Date: Aug2021) at the age of 55 years as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, DOSE 1), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, DOSE 2), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, DOSE 3), for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (medically significant) with onset 29Mar2022, described as "received a shot of the Pfizer-BioNTech Covid 19 Vaccine (gray cap) more than 12 hours after the first puncture of the vial"; OFF LABEL USE (medically significant) with onset 29Mar2022, described as "Off label use"; EXPIRED PRODUCT ADMINISTERED (medically significant) with onset 29Mar2022, described as "Initially stated that the date was Aug2023. Later clarified that the date is fuzzy and looks like Aug2021."; IMMUNISATION (medically significant) with onset 29Mar2022, described as "Dose 4 Booster". Therapeutic measures were not taken as a result of poor quality product administered, off label use, expired product administered, immunisation. Clinical Course: Caller stated that a patient received a shot of the Pfizer-BioNTech Covid 19 Vaccine (gray cap) more than 12 hours after the first puncture of the vial. First puncture was yesterday March 28th 2022 at 12:58 pm and the patient received the shot today 29Mar2022 at 10:41 am. Regulatory authority Support CEP 159558 has a pharmacist has a Covid 19 vaccine (gray cap) that expired that they already administered to one of their patients. Stated that they will do a report with VAERS. Is her fourth dose since she is immunocompromised. Stated that she was immunocompromised prior to getting the vaccine. Patient details: Height, weight and ethnicity unknown. Stated that the vaccine was pharmacy prescribed. Product details: Stated that she cannot read the expiration date. Stated that she has the bottle. Initially stated that the date was Aug2023. Later clarified that the date is fuzzy and looks like Aug2021  No follow-up attempts are possible. No further information is expected; Sender's Comments:  Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
My first covid vaccine was 3/12/2021.  I was extremely fatigued 3 days after the vaccine which prevented me from working.  The second vaccine was 04/09/2021.  I had a severe reaction starting the that evening which continued for 48 hours with fever, chills, headache and nausea.  At the end of 48 hours - I felt back to normal.  Exactly 2 weeks following the second shot, I was dizzy, feverish and had severe chills.  These symptoms only lasted for a couple of hours.   But exactly 2 months after the second shot, I experienced a dullness of sensation in both arms and hands.  This condition has persisted for 6 months and continues now in Dec 2021.  In addition to the dullness and stiff feeling, I experience throbbing internally in my hands at night.  My hands often have a bloated feeling in the morning.  I am also having issues with tinnitus.    I do not know if these symptoms are due to the vaccine but it is the only thing different in my life that preceded these symptoms.  I have had many tests done with no conclusions regarding the cause of these symptoms.  I went to the ER on June 9 due to the onset of the dullness in my hands and arms- the urgent care believed that I was having a stroke and the ER doctor suggested MS which was ruled out with the brain MRI.  I subsequently met with my primary care physician 2 times followed by a neurologist for 2 visits and a full evaluation of nerves in my arms/hands and legs.  No one has any conclusion for my symptoms.  I am not anti vaccine but can only guesstimate that this may be the source of my symptoms.  Thank You for your time.
1 week following vaccine rash from  1 inch below shoulder to below the elbow with burning, itching and slight edema.
Left arm pain starting the day after receiving vaccine - worsening pain, with light touch, decreased function as I have had trouble lifting things with affected arm. Interrupts sleep when I accidently roll over on the the left arm. Woke up this morning with an area of redness, firmness, and warmth to left arm just below where injection was given. Deep pain now radiating in to my axilla. Increased pain with arm movement today. Treatment: I have been taking ibuprofen 800mg every 8 hours since Tuesday morning 2/9/21.
Right arm in area of vaccination has hurt since it was done but no visible marks or masses or bruising on arm and arm is fully functional, arm can hurt resting and with movement.
ADMINISTRATION OF VACCINE OUTSIDE OF PRODUCT LABELLING; USE OF VIAL WITH EXACT TIME FRAME UNSURE, AT LEAST 24 HOURS PUNCTURED IN REFRIGERATION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: 043A21A expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced administration of vaccine outside of product labelling, and use of vial with exact time frame unsure, at least 24 hours punctured in refrigeration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine outside of product labelling and use of vial with exact time frame unsure, at least 24 hours punctured in refrigeration was not reported. This report was non-serious.
cannot even speak for herself; vomiting, throwing up; This is a spontaneous report received from a non-contactable consumer.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: APHASIA (hospitalization), outcome "unknown", described as "cannot even speak for herself"; VOMITING (hospitalization), outcome "unknown", described as "vomiting, throwing up". The consumer reported that they were healthy, eating right. The patient (wife) is in the hospital. She cannot even speak for herself, vomiting, throwing up.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt was having shortness of breath and becoming hypoxic. came through ED on 5/20/21.
Presented to Prison Urgent Care/TTA on 2/26/21 with L facial droop and L arm and leg tingling. Presumptive Dx of Bells Palsy but sent to ED given extremity involvement. Neg ED CT Head w/o contrast with Dx: Bells Palsy.
FEELING OF A LIGHTENING BOLT(ZAP) THROUGH BODY; CHILLS; LOW FEVER; HEADACHE; SWOLLEN GLANDS; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, Laboratory data included: Computerized tomogram head (NR: not provided) Normal. On 09-APR-2021, the subject experienced swollen glands. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced low fever. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced feeling of a lightening bolt (zap) through body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, headache, low fever, swollen glands, and feeling of a lightening bolt(zap) through body. This report was non-serious.
Chills, body ache, pain in my joints and spine, nausea, fatigue.
No adverse event; patient was given adult due to size (weight 221lb, height 5'11.5") given outside ACIP recommendations.
Information has been received from a pharmacist concerning a 46 year old female who on approximately 19-JUL-2008, "about 3 weeks ago" was vaccinated 0.5mL, IM with MMR II (lot# not reported). It was reported that shortly after the patient's vaccination the patient developed a sore throat. The symptom has continued to the present. The patient has been treated with Amoxicillin. The patient sought unspecified medical attention in her doctor's office. Additional information has been requested.
14JUL97 PM pt vomiting & mild fever reported to MD;15JUL97 had strep throat;16JUL97 called nurse taken to ER;t103 poss sz;
This spontaneous report was received from an unspecified reporter concerning a patient of unknown age and gender. It was reported that on an unknown date, unspecified patient might have been vaccinated with an expired dose of Hepatitis B Vaccine (manufacturer unknown) (lot number, expiry date, dose and route unspecified). It was unspecified if Hepatitis B Vaccine (manufacturer unknown) was administered or not. It was inquired if Hepatitis B Vaccine (manufacturer unknown that expired 3 days ago can be used. No concomitant therapy was reported. Additional information has been requested.
Rash; would call it hives; very itchy; Rash; would call it hives; very itchy; Rash; would call it hives; very itchy; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 02 patients (wife and Husband). This is 1st of 02 reports. A 76-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included type 2 diabetes was diagnosed A lot of years ago, she thinks in 1995, heart problem. Concomitant medication(s) included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported. Insulin was administered via pen, once a night. The patient stated that for diabetes, she takes a lot of medications and there are several of them. Consumer further stated that she has preventives for heart problem. She has been using and is on them permanently. Consumer stated, "They are all taken orally." She thinks her weight, it's like 180 pounds somewhere around there and she was not sure. The patient experienced rash; would call it hives; very itchy in Feb2021. Consumer stated, she had a side effect but she don't know if it's a side effect that you have. It's not listed on the sheet that she got when she got her shot of our vaccination. The patient had a rash. She would call it hives. They itch like double. There were a couple of on her right shoulder, she had two on the back of her left calf, on her leg and she had on her whole left arm where the vaccination shot was put in, completely covered in hives and they were very itchy. Consumer further stated that she wants to know what to do about it. The itch was like double, and this had been day 4 and she had the last, the second vaccination on 4th Feb on left upper arm. She wanted to get rid of these hives. They were driving her nuts. Consumer stated, 4 days ago, 19Feb 2021, somewhere around that she started having the events. Consumer further stated that she wants somebody to tell her what she was supposed to do. She don't want to go through all this stuff. She enquired what to do about these hives. The patient had got Calamine lotion, it's calamine topical suppressant and she had got Wal-dryl, it's a generic for Benadryl as treatment. The patient was still experiencing the adverse events and stated otherwise she wouldn't be calling. They were still there, it's still driving her nuts. The patient has not done lab test. She has got to do it another month. Outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021219067 same drug/same event, different patient.
I had my 1st does of the Pfizer COVID shot 01/12/21 with only a sore and some fatigue, lasting 24hrs. I then had my 2nd does 02/03/2021 with a severe sore arm, flu like symptoms (fever, chills, sweats, body aches) lasting 48hrs. These were not adverse events and were expected. The "adverse event" came first on 04/13/2021 almost 2 weeks after my last period, I had untimely minimal spotting, which went away by 04/14/2021. However, on 05/08/2021 through 05/15/2021, 8 days after my period (04/29/2021) I had another "period" with more heavy spotting, which turned into another full period. On 07/08/2021 & 08/08/2021, minimal 1 day spotting returned post period like in April. From March through June I was experiencing periods with more heavy bleeding, lasting a full 7 days, rather than my usual 5-6 days, and my cycles were off, several days and/or weeks from their usual 1-3 days early or late. I was experiencing much more heavy cramping in this time frame, in addition to increased bloating. As of July 2021, and Aug of 2021, periods had returned to a more timely frame, periods are now lasting only 5-6 days again, and bleeding flow is more normal like pre-vaccination times. The only side effect remaining is minimal spotting for less than 24 hours, almost a week after my period. Usually occurs now at the start of the ovulation cycle, and may just be residual blood/uterine lining shedding during ovulation, but pre-vaccination this did not happen at the start of ovulation or at all post period, until my next cycle.
Patient had dizziness and was looking pale few minutes after getting the vaccine. Her lips turned blue for few seconds. We gave her glass of water  and wiped her face and neck with wet napkin and within few seconds she was fine. She sat for 10 minutes and left.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 09-JAN-2014, 21-MAR-2014, 09-MAY-2014, 11-JUL-2014 and 03-SEP-2014 the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # H020250 exp date 06-NOV-2014 also reported as 08-NOV-2014) (dose and route not reported) that were improperly exposed to 7 degree C from 15-MAY-2013 to dates of vaccination to each patient. No known adverse effects were reported. This is one several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
Pt has t105, severe tremors, rash on back, stuffy nose, hacking cough, very lethargic will drink water & juice; Refuses food & milk; has only 1/2 dose of APAP; referred to ER STAT; pt has ear infect given ATB;
6/20/2017 12:00:00 AM - RN; Pt called stating vomiting and dry heaving 12 hours after 2nd oral typhoid. I recommend she see her PMD, stop the oral typhoid; 7/5/2017 12:00:00 AM - RN; Pt. called today to update on status. She has difficulty eating, lost 13 pounds, has had many lab tests including blood, urine and stool with her PMD.. She will be seeing an ID MD in 2 days. Dr. aware 7/10/2017 2:04:25 PM - RN; spoke to pt today. She saw ID MD on Friday. Is on antispasmotic.to help her eat. She has gained 2 pounds since Friday. No other treatment, is feeling better.
i also got gout; i had terrible fatigue; nausea; was sick for 6 days to the point where i could not get out of bed; was sick for 6 days to the point where i could not get out of bed; i ached all over; Initial information received on 03-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 91 years old female patient (63.5 kg) who experienced terrible fatigue, nausea, sick for 6 days to the point where she could not get out of bed, ached all over and got gout after receiving Influenza Vaccine.  The patient's past medical history included Gout with i also got gout on the sixth day, and that lasted 3 days. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Atrial fibrillation, Blood pressure high and Drug allergy with Allergies: Lamisil, Oxycodone, Tetracycline.  Concomitant medications included Lasix, Levothyroxine Sodium; Apixaban (Eliquis); Prednisone And Ascorbic Acid, Copper Gluconate, Fish Oil, Tocopherol, Xantofyl, Zeaxanthin, Zinc Oxide (Ocuvite Adult 50+ [Ascorbic Acid; Copper Gluconate; Fish Oil; Tocopherol ; Xantofyl; Zeaxanthin; Zinc Oxide]).  On 12-Sep-2023, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Prophylactic vaccination (immunization). Information on the batch number was requested.  On 12-Sep-2023 the patient developed aterrible fatigue (fatigue), nausea, sick for 6 days to the point where i could not get out of bed (illness) (hypokinesia), ached all over (pain) (latency: same day).  On 18-Sep-2023 the patient developed gout (latency: 6 days)  Action taken: not applicable.  It was not reported if the patient received a corrective treatment or the events.  At time of reporting, the outcome was Recovered / Resolved on 19-Sep-2023 for the event (fatigue), nausea, (illness) (hypokinesia), (pain) (duration: 7 days) and was Recovered / Resolved on 21-Sep-2023 for the event gout (duration: 3 days).
Fever 101 x 2 days treated with acetaminophen p.o. Headache x 6 days not responding to acetaminophen.  Body aches/ weakness x 5 days. Treated with rest and extra p.o. water  Calf stiffness x 3 days. Treated with extra p.o. water and rest.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2014, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Day after first dose, weak, chills, body aches, muscle ache, sleeper all day and night . The 3rd day back to normal
I received my first dose of the Moderna vaccine on 1/21/21. I had a sore arm the day after the injection and very some slight feeling of flu like symptoms for 24 hours. I was fine after that.  Yesterday, 11 days after the initial vaccine, I woke up with a very large red, itchy rash at the injection site. Again, I felt some slight flu-like symptoms. By this morning, the flu symptoms are gone and the redness has subsided dramatically. A large but light pink rash remains.  I googled it and understand it?s a common reaction to Moderna but thought it should be reported. This was a little unusual in that it appeared 11 days after the vaccine.
Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an adult female patient who was subjected to receive a 0.5 ml dose of vaccine IMOVAX RABIES (Lot number: N1B051M (IMOVAX) and Lot M0308 (diluent); expiry date: 26-Feb-2019) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of syringe issue since some pressure built up in the syringe and the vial exploded. Glass was in her hand. The syringe blew off of the needle which occurred during preparation. It was reported that the patient couldn't able to get administered with the dose. List of documents held by sender: none.
12/23  report feeling lightheaded, anxious, body aches, fatigue, headaches, chills without fever, dry cough and nasal congestion
Shingrix vaccine 12/21/21 @ 0930am. Woke up following morning with shingles rashes on left lower quadrant abdomen., coughing non productively for 7days.
I gave him Tylenol at time of vaccination 4 hours later he was crying unconsolably for approximately one hour.  I gave more ibuprofen and it helped.
Information has been received from a physician concerning a patient with milk allergy who was vaccinated with ROTATEQ vaccine. Upon return for an office visit, the infant presented with bloody stool. Upon internal review, Bloody stool was determined to be an other important medical event. Additional information has been requested.