chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Post Dose #1 on 8/25/22, my menstrual cycle came 2 weeks early. I am regular at 28 days usually. I was in the midst of fertility treatment IUI cycle. I had taken clomid to induce follicle growth in my ovaries. On monitoring visit prior I had 2-3 follicles growing. After the second vaccine my follicles ceased and there was no growth and my fertility cycle was canceled. My menstrual cycles were off for the months of September, October and November with extremely heavy bleeding day 1-3, bleeding through feminine products despite changing them every 1-2 hours, bleeding through products at night with accidents, then moderate on day 4 then suddenly stopped. Normally my cycle is 6 days. Day 1 is moderate, day 2-3 is heavy but not bleeding through feminine products, and I haven?t had an ?accident? in over 30 years, then light for day 4, day 5 is moderate again then tapers off during day 6, and can have sone slow taper/spitting into day 7.  In addition, all my joints felt stiff. I couldn?t even bend my leg to wash the bottom of my feet for over 2 weeks. I still feel very stiff but can bend my legs more now
Fatigue, arm pain,  contractions (baby due date 7/30/2021)
PATIENT INDICATED THAT HE WAS NOT "GOOD " WITH INJECTIONS BUT SEEMED FINE UPON RECEIVING IMMUNIZATION. PATIENT FAINTED WITHIN MINUTE OR TWO OF RECEIVING IMMUNIZATION AND MAY HAVE HIT HEAD WHEN FALLING TO THE FLOOR. PATIENT BECAME COHERENT WITHIN SECONDS OF FAINTING. PATIENT SAT IN CHAIR AND DRANK SOME PROVIDED WATER.  REPORT WAS FILED ON THE FALL WITH MANAGER IN CHARGE OF GROCERY.  PATIENT LEFT THE STORE AFTER APPROXIMATELY 30 MINUTES. LATER THAT AFTERNOON RECEIVED CALL FROM GRANDMOTHER THAT PATIENT LEFT STORE AND GOT SOMETHING TO EAT, CAME HOME AND WAS SITTING IN CHAIR  AND BECAME NAUSEOUS AND VOMITED. SHE CALLED AS TO WHAT TO DO AND I ADVISED TO GO TO HOSPITAL TO GET CHECKED OUT.
Pt received vaccine, and 15 minutes lately complained of cramps  in her torso area.  Shortly after reported a bit light headed. We had her lie down with legs elevated.  This did not appear to help. Shortly after still complaining of cramping was given 1 tablet of 500 mg acetaminophen.  Breathing appeared normal. Shortly after complained of tingling all over.  911 was called .  Then she complained of stiffening of her jaws.  An epipen was administered at this time and pt appeared to be doing better   even though shaking at this time, posssibly from epipen.  Shortly after emergency personnel arrived and tool over. She was transported to the hospital. On a follow up phone call a couple of hours later she stated she was stable but the dr's hadn't  given resolution of what happened.
101 fever for 3 days Chills Severe Headache Severe Body aches Sweating Tired Fatigue Couldn't function for 2 days
Pt got the ADACEL vaccine on 12/27/14 the next day pt said the area was sore but not red advised pt to put cold compressor on later on the 31 of Dec pt noticed redness on the sight and on the 3rd of Jan went to emergency room. Dr said it is cellulitis gave Rx for pt said it is better no tender and the redness stopped spreading.
I experienced swelling in my lips, my tongue felt funny, and I had to take Benadryl to prevent the swelling from getting worse. I had a high fever of 102, fatigue, missed 2 days of work. I have lingering swelling in my lymph nodes including under my left arm that flare up at random intervals. Doctor stated that she's having reactive lymph nodes that are over sensitive post vaccine.
AFTER vaccination and patient attempted to stand and fell backwards in seat.  Patient was incoherent, hot, sweaty, loss color to face and lips and unresponsive. Blood pressure was check 100/46 65 heart rate and temp less the 85degrees. Patient was unresponsive for about 10 minutes. EMS was summoned and the patient was given water and juice to drink. Patient slowly returned to a normal state after about 30 minutes but was still slow to respond.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.  The Pharmacist reported administration of an expired  Moderna vaccine to patients of around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.  Reporter has provided lot Number of vaccine as follows: 006C21A (10-10-2021), 026B21A (09-17-2021), and 031B21A (9-22-2021).  Reporter stated that vaccines were stored in freezer and used one to two vials which were placed in fridge each day as needed.
Acute hypoxemic respiratory failure due to COVID-19; Shortness of breath; History of COPD;
low temperature (96.5); Chills; slight tremors; soreness at injection site; This is a spontaneous report from a non-contactable consumer (patient). A 77-years-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration on 10Feb2021 08:15 at age of 77-years-old at arm left at single dose for COVID-19 immunisation. Medical history included bladder cancer, high blood pressure and no known allergies. Concomitant medication included allopurinol, amlodipine, valsartan, indapamide, atorvastatin (LIPITOR), pregabalin (LYRICA), metformin hydrochloride (MEDFORMIN), metoprolol succinate (TOPROL) and vitamin supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the 1st dose of BNT162B2 on 18Jan2021 at age of 77-years-old for COVID-19 immunisation. The patient experienced chills, low temperature (96.5) and slight tremors, soreness at injection site on 10Feb2021 06:00 (as reported). No treatment was received for the adverse events. The events outcome was recovered on an unspecified date in Feb2021. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
Pt received both FLUZONE HD and PNEUMOVAX 23 in left arm, PNEUMOVAX lower and second of two shots. Reported significant poke pain compared to flu shot. Waited in pharmacy for 15 min, left feeling fine. Called in to pharmacy Monday reported case of Cellulitis that started on Sat (9/29). Went to local Urgent Care on 9/30 received KEFLEX 500 (TID x 7 day). Followed up Wed (10/3) and pt reported improved symptoms and beginning of resolution of fever/erythema.
developed 101.9 fever, chills, neck and shoulder pain (still ongoing), clenching, whole body ached, a lot of joint and back pain; fever returned Saturday at 3:00 then Sunday resolved.
To preface, after each shot, for a full day and a half(perhaps around 31 hours), I had some intense pain that would hurt if I moved my arm in most ways but was pretty fine if I didn't move it at all. It's my understanding that a lot of people have had this symptom following the shots. However, a few times since the second shot, I've gotten that same pain in the same area, although not quite as painful. I never experienced this sort of thing before the shots.
received 1st Shingrix in 2020; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The reporter asked if a patient received 1st Shingrix in 2020, whether he need to restart series. It was unknown if the patient received 2nd dose, which led to incomplete course of vaccination. Follow up would not be possible since contact details were not provided.
Tingle and numb left hand, leg, head, back side of the neck. Pain in the neck. ?Heavy? chest
after SEEN my Dr  for yearly   up  blood test and EKG routine checkup  MAY 10th that's when I notice MY NECK BEATING UP AND DOWN  small area right side of neck  thinking I'm having SIDE EFFECTS  from PFIZER VACCINATIONS and my HIGH BLOOD PRESSURE MEDS  maybe having side effects   comes and goes daily since  MAY 12th   after I got my 2 DOSES OF PFIZER SHOTS  APRIL 12TH AND MAY 1ST 2021.  MY  IN GENERAL IS GOOD NEVER HAD HEART ISSUES OR  IRREGULAR HEART BEATS EVER IN MY LIFE I AM 68 YRS OLD  BORN  9/11/52
G3P2 EDC 4/17/20 Arm became extremely sore even to very light touch, hard nodule one spot where vaccine was injected and nodule became larger over 2 days from pea sized to golf ball sized. Red area began dime sized and now baseball sized. Restrictive arm movement.
shaky; numbish; heart was kind of racing; my arm is like super numb and kind of hurting; voice is kind of breaking; dizzy; fatigued; shaking; tingling sensation; head throbbing; my back is not pain but feels like pressure; had a little slight headache; This is a spontaneous report from a contactable consumer or other non hcp. A 30-year-old female patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL9266; Expiration date was not reported) via an unspecified route of administration on 10Feb2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 10Feb2021 the patient experienced had a little slight headache, on 11Feb2021 experienced shaky, numbish, heart was kind of racing, my arm is like super numb and kind of hurting, voice is kind of breaking, dizzy, fatigued, shaking, tingling sensation, head throbbing, my back is not pain but feels like pressure. Caller (female,30 years old) got first dose of PFIZERBIONTECH COVID-19 VACCINE , caller said: it says Pfizer EL9266, yesterday, (10Feb2021), stated that she was fine yesterday, just had a little slight headache but today, caller stated I started feeling very shaky, kind of like numbish, my body kind of numbish and like my heart was kind of racing and my arm is like super numb and kind of hurting and I don't know if you can tell but even my voice is kind of breaking and I don't know if that's normal or do I need to go to the doctor, hospital. Caller wanted to know that to do. Explained that I will be happy to check if what she is reporting was reported in clinical studies, explained to the caller that she needed to reach out to her HCP regarding her symptoms. Call got disconnected, I called back spoke to the caller. Upon a callback caller provided additional side effects, caller stated: I felt dizzy , fatigued, my body was shaking, heart racing, my arm started getting numb, I got this tingling sensation all over my body, head throbbing, my back is not pain but feels like pressure which is weird" Did not speak to the doctor yet. Do I need to go to the ER or this is just normal. Refer caller to HCP/if allergic reaction ER/hospital. DSU: Caller was not transferred to safety as she needed to get in touch with HCP regarding her symptoms. The outcome of events were unknown.  Follow-up attempts are completed. No further information is expected.
Child had seizure like activity in parking lot. EMS was called. Child recovered on own without any intervention. Left facility in private vehicle with mother.
Patient reported headache and lightheadedness within 15 minutes of vaccination. Patient did not improve and was transported to ER by EMS.
She developed genital aphthous ulcers. They gave her pain medication in a form of Toradol and Gabapentin - helped with the pain. She soaked in a bathtub. They didn't give her steroids as they didn't want it to affect the vaccine.
CHILLS; FEVER; HEADACHE; This spontaneous report received from a parent concerned a patient of unspecified age and sex. 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 not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 14:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021 04:00, the subject experienced chills. On 20-MAR-2021 04:00, the subject experienced fever. On 20-MAR-2021 04:00, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and headache was not reported. This report was non-serious.
102.9 degree fever for about 8 hours and pretty bad body aches for 12 hours. both starting at 6am.
9-16-07 Headache, vomiting all day. 9-17-07 Headache, upset stomach.
pt adopted child recv vax & exp no s/sx of varicella & has no known significant post med history;mom w/hx of varicella exp shingles;
Approximately 4 hours after administration, my arm from my elbow up through my clavicle was extremely sore and painful to the touch. It hurt to even touch the skin in that region (extending from elbow to neck). The intense pain lasted for 3 days, and I was unable to lift my arm laterally for two of those three days, and other range of motion was very limited. My arm was hot and tender, and pain in my clavicle lasted well beyond a week. Even after icing it and using ibuprofen, the pain and sensitive skin issue remained.
large areas of very tiny red bumps on stomach, mildly irritating, which appeared a few weeks after my first shot (and a few days before my second shot)
Pt developed varicose vein in left leg. Developed some minor systemic symptoms such as fatigue and arthralgias with exercise. In 2007 varicosity became extremely painful and swollen, 3 DVTs found and diagnosed with antiphospholipid antibody syndrome. Comprehensive evaluation for vaccine causality conducted by the clinic with rheumatology input. RESULTS: After extensive investigation by the clinic and Rheumatology consultants, it is our expert opinion that patient's antiphospholipid antibody syndrome should be considered a LINE OF DUTY YES based on recommendation 1 above and the following variables: a. He was symptom and disease-free at entry level of job with indeterminate/negative autoantibodies. b. He developed the 1st symptoms of thrombosis while at work in 2004-5 one month after experiencing hand trauma. c. He received multiple vaccinations during service and antibody levels continued to rise sequentially. These vaccinations include the vaccine (tetanus) which has a biologically plausible mechanism described for triggering autoimmunity via a molecular mimicry mechanism.
I had a sore are for3 days, then the morning of the 21st woke up with a red, raised lump at the injection site, and it is itching.
Fever; body aches; pain that goes up her neck and behind her head; pain that goes up her neck and behind her head; This is a spontaneous report received from a contactable consumer (patient herself). A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0151; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 06Apr2021 15:00 (at age of 64-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included ongoing hypertension; high blood pressure and blood cholesterol increased; high cholesterol, she was diagnosed last year. She has been taking pills for it since last year and ongoing thyroiditis. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as no. Patient's medical history (including any illness at time of vaccination) was reported as no. Family medical history relevant to AE(s) was reported as no. Other products was reported as unknown. It was reported that on 07Apr2021 caller stated she had a fever; the next day after the vaccine, at 2 o'clock, she started feeling body aches, and thought she had a fever, too. She still felt a little pain in her neck- it was not much, but she can still feel it. She clarified the pain went up her neck and behind her head, and it was still there a little bit but she was taking Ibuprofen. Caller confirmed she did not have the Ibuprofen with her at the time of the call to provide product information, but stated it was 600 mg. She clarified the fever and body aches stopped after she took Ibuprofen and she also took a Tylenol then, too. The adverse event did not require visit to emergency room or physician office visit. Caller was calling about the COVID-19 Vaccine. Caller stated that she was supposed to have her second vaccine on 27Apr2021 but she thought it was yesterday, 28Apr2021. She stated that she missed her appointment and she needed to make another second appointment. Caller stated that she got the vaccine. She stated she called her doctor and they said that they have no vaccines at clinic to give out. The outcome of fever and body aches was resolved on 07Apr2021 while not recovered for other events.  No further details were provided or obtained.  No follow-up attempts are needed. No further information is expected.
Approximately 30-45 minutes after vaccination, patient c/o allergic reaction, flushing, hoarseness and throat closing. Pt in clinic had her own diphenhydramine and took 25mg x 2 PO and injected her own Epi-pen. NP observed flushed face and neck and red blotches on her body. RN called EMS and started PIV. EMS injected diphenhydramine 50mg IV and transported to ED. Vital signs at 3:58 PM: BP 169/110, HR 100 02 sats 99%. In ED, patient received diphenhydramine 50mg IV at 1622, methylprednisolone 125mg IV at 1623, normal saline 500ml IV at 1644, KCL 40mEq PO at 1956 and 2049 (for low K+), ipratropium-albuterol nebulizer at 2050, lorazepam 1mg PO at 2218 and KCl 10mEq in 100ml NS at 2228.  Patient was observed and monitored in ED overnight and discharged in early AM on 4/2/15 with no additional reactions.
The next day 24 hours later experienced Rt. hand numb and tingling for and disruption of sleep cycle with extreme nightmares lasted for 2 days.  Her short term memory has been effected for the past 9 days for example she can not remember if she has taken her medication or having the conversation with her home health aide.
Initial information has been received from a registered pharmacist concerning 38 unspecified patients of unknown age. The patient's pertinent medical history and drug reactions or allergies were unspecified. On an unspecified date, the patient's were vaccinated subcutaneously instead of intramuscularly with a 0.5 ml dose of RECOMBIVAX HB, (lot # 1740AA, Expiration date: 07-JUN-2014) (lot number is an invalid lot number for hepatitis b vaccine), that was stored at -5 degrees to 10 degrees C from 11-JUN-2012 to 13-JUN-2012. It was reported that the patients did  not had any adverse effects. This is one of several reports from the same source. Additional information has been requested.
Patient came in for the COVID-19 vaccine booster. When in the clinic the patient received a vaccine dose at 0.3mL undiluted. The correct dose was provided, the wrong concentration given.
severe chills followed by high fever, muscle aches, cold sore, and hot flashed for days after
Moderna COVID-19 Vaccine EUA. Eight days after receiving the vaccine noted swelling, redness, mottled skin, and itchy at the injection site. On day nine increase in redness and swelling.
On June 12 I woke up with a headache and a sore throat. I did a home test and it came back positive. I called an urgent care and they tested me again for Covid. In the days following I got tired, developed a fever, and a strong cough. I was prescribed PAXLOVID and about 5 days after I was feeling fine. I went out, ran some errands, etc. Then about 3 days after all my symptoms came back, the headache, the fever, the fatigue. All in all, it lasted about 12 days.
Patient states on 1/17/2021 @ 2:00 PM a rash appeared on right arm around vaccine injection site that was an inch in diameter.  1/19/2021 area is now a red, hot, raised area that itches 3.5 Inches by 4.5 inches.
On November 7th patient noticed gait had changed and was shuffling when he walked.  Weakness progressed to hands and arms.  Admitted to Medical Center. Patient intubated on a ventilator with diagnosis of possible GBS.
This infant had a 9 x 10 cm erythematous, warm macular area with central clearing to the feet and upper thigh. Recommended treatment of Aveeno bath and Benadryl for 2 days, then as needed.
A report has been received from a Pharmacist concerning a 38 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The patient experienced administration of only a half dose of FLUMIST in one nostril, which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious by the reporter.
Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe
temp 101 @ 2200 6JUL92 seen in urgent care screaming rt leg swollen & red rx APAP;
per patient he was vaccinated in a drive through clinic and the vaccinator had him outstretch his arm outside the car. He said that he felt his deltoid muscle contract during the immunization...with discomfort. A week after the vaccination his arm is still very tender at the injection site, with redness and a bruise.
For 2 days following administration of ROTATEQ vaccine, baby had blood in his stool (total of 2 times). Following the first incident at 2 months, child was seen in the office. Issue self-resolved within 2 days.
Patient had slow progression of kidney disease but since vaccine had unexpected  acute kidney failure. He had to have dialysis and may need biopsy of kidney to confirm if he needs lifelong dialysis. He is still being hospitalized.
Redness of left arm and swelling from shoulder to elbow. Edema in upper arm. Severe pain resulting in limited range of motion of (L) arm. Pt ran fever as high as 102.4 x 3 days.