chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse event; received bivalent booster instead of primary dose one; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received bivalent booster instead of primary dose one) and NO ADVERSE EVENT (No Adverse event) in a 22-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received bivalent booster instead of primary dose one). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received bivalent booster instead of primary dose one) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received bivalent booster instead of primary dose one).    No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2022: Live Significant information received- Narrative updated, Reporter Additional mail id added.
Arm was hurting really bad where the injection was.  The injection spot was red and looks like it had fever in it.  I couldn't pick up my 7 week old son because it hurt so bad.  I also had a mild headache.  On Friday morning, my arm around the injection had a large knot on it.  I finally went to the doctor on Nov. 15th because the knot was not going away.  The knot was about 3 inches in diameter from the injection.  I kept taking medicine for the pain.
No additional AE; Patient was administered expired GARD ASIL 9 vaccine; This spontaneous report was received from a pharmacist and refers to 30-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-APR-2021, the patient was vaccinated with expired HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # R017624, expiration date 17-MAR-2021 (exact dose, route of administration and anatomical location were not reported), for prophylaxis. No additional adverse event was reported.
CLIENT STATES THAT SHE AWOKE THE DAY AFTER IMMUNIZATIONS WITH SEVERE ITCHING ALL OVER BODY & THEN NOTICED THAT SHE WAS "COVERED FROM HEAD TO TOE WITH HIVES". SHE STATES THAT THE ITCHING and HIVES LASTED ABOUT TWO DAYS and THAT SHE REQUIRED REPEAT DOSES OF BENADRYL TO HELP WITH SYMPTOMS. SHE DENIES ANY WHEEZING OR TROUBLE BREATHING, FEVER, OR OTHER SYMPTOMS/REACTIONS. SHE DID NOT SEEK MEDICAL TREATMENT OR ADVICE.  SHE STATES THAT SHE WILL NOT BE COMPLETING THE SERIES.
At 11:30AM patient had Tdap in left deltoid, and both meningococcal and pneumococcal vaccines in the right deltoid. By 7:00 PM, patient developed severe pain, dizziness, fatigue, chills, myalgias, arthralgias, headache, and increasing redness in the right deltoid area at the site of pneumococcal and meningococcal vaccine administration. She was seen by PCP then sent to the ED one day later, was admitted. White blood cell count elevated at 27,000. Fever noted. She was admitted to hospital. Started on broad spectrum antibiotics. Redness in right deltoid was severe and associated with severe tenderness. Patient not septic. Felt to be a reactive phenomenon rather than infectious. General symptoms of malaise, chills etc. regressed. On 5/9/13 discharged to home in stable condition with plan to see PCP the next day (today).
Felt feverish, throat felt swollen and difficulty breathing and headache a few hours after flu shot was administered. Called my primary doctor?s office who recommended going to Urgent Care facility.  Doctor prescribed throat medication and recommended I take the rest of the day off.  I have been having headaches, body aches and throat hoarseness and have been home for the pass two days.
developed and retained diplopia, with increase intensity after the 2nd shot...its been going on for 14 almost 15 weeks.; developed and retained diplopia, with increase intensity after the 2nd shot...its been going on for 14 almost 15 weeks.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 28Feb2021 (Batch/Lot Number: EN6205) as dose 2, single for covid-19 immunisation at the age of 42-year-old. The patient medical history and concomitant medications were not reported. The patient previously the first dose of bnt162b2 (lot number EN6201) in the right arm on 07Feb2021 (at 42-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to Bactrim. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. The patient took unspecified concomitant medications within 2 weeks of the COVID-19 vaccine. On 08Feb2021, the patient developed and retained diplopia, with increase intensity after the 2nd shot and it's been going on for 14 almost 15 weeks. The event resulted in Doctor or other healthcare professional office/clinic visit and was treated. Outcome of the events was not recovered. Lab tests included a computerised tomogram (CAT scan); ear, nose, and throat (ENT) scope, and A1C blood tests, all of which were completed on unknown dates with unknown results. Since vaccination the patient was tested for COVID-19 on 05May2021 via nasal swab which was negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021550228 Same patient, same drug with different dose, similar AE.
Immediately after vaccination was administered the patient fainted but stayed in the chair. After she came to in about 10 seconds I offered her a cold compress for her head. After a couple of minutes the patient felt good enough to move to observation area. I started getting a vaccine ready for another patient and this patient saw the needle and fainted again. I rushed over to her chair and kept her from falling. After she came to in about 10 seconds I offered to call 911 but the patient refused. Her brother came over from shopping and after a couple more minutes they decided to leave together.
Pt received 2nd dose of Energix and developed rash & petechiae over both lower limbs.  Had been on lower arms but this resolved in a couple of days.  Had soem itching of areas.
Indigestion (heartburn) - started the evening of day vaccine received (12/29/20) around 5:00 p.m. Began again on 12/30/20 around 10:00 a.m. Extremely abnormal for this to occur with me.
pt recvd vax & at 10pm had episode of staring w/ limping & unresponsiveness; had sz; to er;
I have Covid. Cough, runny nose, fever, fatigue. I don't know how to answer how severe the symptoms are. They are still ongoing for 3 days now. I'm still sick. I'm taking vitamin C, D and zinc as recommended by my doctor. I didn't qualify for any of the medical treatments.
This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored program.  A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 25Jan2021 at 13:00 (at 78 years) at single dose for COVID-19 immunization. The patient medical history included anxiety, headache, dry eye and low potassium, each from an unknown date and unknown if ongoing. The patient's concomitant medication included potassium oral at 10 meq daily for low potassium, cholecalciferol (D3) oral at 2000 iU once a day to help with bones, fish oil oral at 1200 mg once a day, alprazolam at 0.5 mg as needed (take one three times a day) for anxiety, clonazepam oral at 0.5 mg once a day for anxiety, nortriptyline HCl oral at 10 mg once a day, paracetamol (TYLENOL) at 500 mg as needed for headache, estradiol (SYSTEN) ophthalmic one drop as needed, all from an unknown date and ongoing.  The patient experienced one or two hours after the vaccine (on 25Jan2021), she went to talk, she couldn't get her sentence straight. She knew what she wanted to say but she couldn't say it. Her first thought was that she was having a stroke and it really scared her. She became very tired and went to sleep, when she woke up, she was talking straight but she was still really tired. The next morning (on 26Jan2021) she had diarrhea three time and after that she felt better. The patient outcome of speech disorder and diarrhea was recovered on 26Jan2021 and the outcome of tiredness was recovering.  The information on the batch number has been requested.
Patient had seizure and was unresponsive for several minutes. Blood pressure monitored and EPI PEN given, then became responsive. EMTS arrived & transported to hospital.
Rash started sometime overnight 03/08-09/2021. Call physicial and was prescribed 6 day declining dosage steroid regimen. Also developed elevated temperature, general fatigue and aching muscles/joints. Fever tx'd with antibiotics with no reolution. Antibiotics were continue with increased dosage with no results after several weeks. It was determined thru blood work and urine samples that the infection was system wide with pronounced effect in both kidneys. Dr in Urology unsuccessfully attempted to place stents in both ureters. I was admitted to hospital by Dr on May 13, 2021 where the stents along with nephrostomy tubes were successfully placed in the Radiology Department. I remained in the hospital on IV antibiotics until May 17th when I was dc'd home with visiting nurses from hospital to check the tubes and flush them prn. The tubes were removed on May 27 during an outpatioent procedure at hospital. It is planned that the stents will possibly removed on October 20, 2021 during a cystoscopy procedur by Dr. An appointment with Dr. is scheduled for October 13, 2021 for a followup exam and consideration of options, if any for a third covid-19 booster shot.
Pt recv vax on 10/28/98; on 10/29/98 pt exp pain/swelling/ hot/red LA; dx=cellulitis; tx=Keflex
fever for 12 hours after second Moderna Covid-19 vaccine; sore body aches for 24 hours after second vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever for 12 hours after second Moderna Covid-19 vaccine) and MYALGIA (sore body aches for 24 hours after second vaccination) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 039K20-2A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (fever for 12 hours after second Moderna Covid-19 vaccine) and MYALGIA (sore body aches for 24 hours after second vaccination). In March 2021, PYREXIA (fever for 12 hours after second Moderna Covid-19 vaccine) and MYALGIA (sore body aches for 24 hours after second vaccination) had resolved.            It was reported that patient took Acetaminophen.   This case was linked to MOD-2021-386431, MOD-2021-386479 (Patient Link).
About 3 minutes after vaccine given, pt. felt headache, dizziness, tinnitus, and syncope. Resolved after about 10 minutes.
Psoriasis, Autoimmune Disease; psoriasis scales appeared first on elbow then on center of forehead, within 6 months it had spread to cover over 90% of entire skin surface.
Initially, there was muscle pain and soreness at the injection site. 6 hours after injection, began feeling strong fatigue and with intense body pain, especially in the legs. A bad headache developed and chills and fever progressively worsened over the following 2-3 hours. Walking became difficult due to leg pain, dizziness, and extreme body weakness. By 8 hours post-injection, nausea and stomach pain developed. By 8-9 hours post injection, a large amount of vomiting occurred for approximately 30 minutes. Fever, sweating, chills, and rapid heart rate continued throughout the night. Highest recorded temperature was 102 degrees F. Zofran and Tylenol were used to treat symptoms. By next morning, achiness, weakness, headache, and exhaustion continued, but with less intensity. Low grade fever recorded at 11am the following morning, which subsided throughout the day. Fatigue and achiness slowly subsided after 3-4 more days.
I noticed a dark pink area about 1 1/2 inches below injection site on my arm the morning after my flu vaccination. It is still there as of 2:55 PM today, Friday. It's about 4 inches long and an inch or so high. Itches slightly, and feels warm to the touch. Doesn't bother me too much and I have no idea if it has anything to do with my flu shot but I have never had any reaction to the vaccine before.
Lab confirmed herpes zoster diagnosis in an individual previously vaccinated with zoster vaccine. Painful, unilateral rash in multiple dermatomes. Seen by her PCP. Treated with valacyclovir and acyclovir. Not hospitalized, lasted less than 4 weeks.
Approx 22 hours after receiving the shot, started feeling lethargic, cold, shaking uncontrollably, patient left work. At home the temperature was 103.5 F. Stayed in bed that day, used ice, tylenol 500mg to decrease temperature. Stayed in bed for 3 days. Able  to get up 3 days later on April 4th.  Maintained fluids with care from husband.
Information has been received from a woman at a physician's office concerning a 67 year old female with a sulfa allergy and a history of uterine dilation and curettage x 6, fracture right leg, tubal ligation, increased lipids, high density lipoprotein increased, oestrogen replacement therapy, gastrooesophageal reflux disease, sciatica, spinal stenosis, carpal tunnel syndrome, PPD skin test positive, benign paroxysmal positional vertigo, knee pain, colonic tubular adenoma, hand osteoarthritis, oesophagogastroduodenoscopy (February 2007) and arthroscopy left knee (November 2003) who on 09-MAY-2007 was vaccinated SC on the left with a first dose of Zostavax (Oka/Merck) (lot # 656859/0357U).  On 09-MAY-2007, the night of having the vaccine, the patient experienced throbbing pain in her knees, shoulders, wrists, back of legs and heels all at once.  Then in the AM on 10-MAY-2007 the pain was gone, but then the patient had a horrible wave of nausea and fatigue.  No additional information was provided.  Additional information has been requested.
mom states sz like state-starry eyes w/t101, throat sounds-to hosp 440PM;t103 & APAP given @ that time;pt started to shiver then limp for 30min-never stopped breathing;APAP given;pt cranky @ home to sleep 9-930PM;130AM t104;fussy
pt recv vax 1997 & several months later exp alopecia w/great big patches of hair loss;tx w/medit was reported that the hair loss started in the summer which was worsened;
Symptoms. Redness, swelling. Muscle pain, fever, tiredness. Symptoms occurred within 3 days after vaccination.
Patient experienced two episodes of debilitating inflammatory arthritis after the second and third rounds of Hepatitis B vaccination. The interval of onset of joint symptoms following the second and third vaccination was nearly identical. Patient received the RECOMBIVAX HB vaccine. Patient was not receiving relief from CELEBREX. So, it was suggested that patient discontinue CELEBREX and switch to a short course of oral steroids, prednisone 15mg daily for one week, 10mg daily for one week, and then 5mg daily for one week. Symptoms resolved with use of the oral steroid regimen.  7/3/09 Rheumatology consult received    with DX:  Recurrent inflammatory polyarthritis.  Most likely culprit is hepatitis B vaccine. Pt developed joint aching of the hands, wrists and shoulders as well as swelling of fingers following 2nd and 3rd Hep B shots.  Pain noted on abduction, bursal tenderness and synovial thickening.  Tx: steroids and anti-inflammatories.
Mild case of shingles?, itchy blisters on Right side of back, not painful.
Went to ER 8/24 - several weeks after last Moderna shot.  Intense stomach and back pain.
After vaccine, I had severe headaches for several weeks.  By December 6, I had weird facial disfigurement. I went to hospital on December 8 thinking I had stroke.  The emergency room diagnosed Bells Palsy with damage to the seven facial nerve.  Follow-up appointments with my practitioner, neurologist, and hospital neurology department confirmed I had permanent nerve damage which lead to disfigurement, loss of facial movement on left side of face including, chin, cheek, taste, nose, eye, and forehead.  I have regained maybe 30% but symmetry of my face is still not improved.
pt recv vax;exp swelling of lips p/ typhoid vax;tx w/ antihistamine w/ good results & was not hosp;
I had my 2nd does of the Pfizer COVID vaccine on Jan 7th.  Ovulated and became pregnant on Jan 18th. Started bleeding on Feb 1. I had a positive pregnancy test Friday Feb 5th. Serial blood draws at the doctor the next week confirmed I was pregnant with low chance for a viable pregnancy. Later blood work confirmed I had a miscarriage.
This case was considered medically important (OMIC). Information regarding Prevnar was received from a consumer regarding her son who developed autism. The patient received a dose on an unspecified date in 2002. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered in 2002. Dose regimen was 1 dose. Concomitant medications were not reported. It was reported that the patient was diagnosed with autism in 2003. The outcome is unknown. No additional information was available at the time of this report.
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On an unknown date in 2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Within hours, I had the following: low fever, sore throat, cough, runny nose, frequent sneezing, labored breathing, weakness and fatigue. Redness, swelling and soreness in area of arm where I received vaccine. These symptoms lasted a full week. Only today on day 9, do I feel close to normal again.
PATIENT HAD PFIZER VACCINE ON  Dose 1 date: 12/24/2020,  Dose 2 date: 01/14/2021, AND TESTED POSITIVE TO COVID.
The day of my vaccine, during my 30 minute window, I felt a surge of what felt like an adrenaline and like I was going to pass out. That went away and the rest of the day was fine.   Day 2: Elevated resting heart rate around 10-20 bmp higher than usual, also had tingling in arms, hands, and feet. Went to urgent care they ran labs, liver levels were elevated as well as blood pressure.   Have had 2 severe panic attacks that have wakened me up from my sleep, thought I was having a heart attack. Called 911, they checked vitals and did ECG, everything came back normal.   I?ve also have had a looming feeling of impending doom and dread that comes and goes out of nowhere; I?ve never had this before and it?s the most terrifying thing ever.   My appetite has been significantly lower to non-existent.  The first 48 hours after receiving the shot I was insatiably hungry, which is also unusual, but as the weeks have gone one I have had little to no appetite.   At times I feel as though I?m in a fog; brain fog, and slightly spacey. This is intermittent. I?ve also had some chest pressure, not really pains, and some heart palpitations. Haven?t had shortness of breath or fatigue thank god!    Lastly, and the most strange adverse reaction is I haven?t been able to get an erection. I used to have regular morning erections, but that?s been non-existent since I got the shot.
Client came into the clinic for various vaccines including FluMist, Hep B, IPV, DTap, and MMRV. Her brother also needed 5 vaccines. The combo vaccine of HepB - DTap - IPV (Pediarix) was mistaken for DTap. Pediarix was given along with extra doses of Hep B and IPV. No signs or symptoms seen. The language line was called (family's primary language was foreign but spoke well) and explained to the father that extra doses of Hep B and IPV were given because of mistaking the combo vaccine for the singular vaccine of DTap. Explained to him that the child should  not experience any negative side effects from this mistake. Asked him if he had any further questions and to follow up for the child's next vaccines.