chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Called to provide patient information (Administered improperly stored vaccine); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Called to provide patient information (Administered improperly stored vaccine)) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Called to provide patient information (Administered improperly stored vaccine)). On 09-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Called to provide patient information (Administered improperly stored vaccine)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.   This case was linked to MOD-2021-128210, MOD-2021-128181 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up document received contains No New Information. On 09-Aug-2021: Followup received  contains No New Information.
A report was received from a health care professional on 6 November 2003 concerning a 77 year old male vaccinee who received expired Fluvirin on 5 November 2003. On 5 November 2003 the vaccinee received expired vaccine. No adverse event had occurred at the time of this report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301007, PJP200301008,PJP200301011.
Muscle twitching in right upper back. Every 29 Minutes or so. Won't go away.
No additional AE; administered after a temperature excursion; This spontaneous report was received from a Licensed Practical Nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 19-JUL-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) by oral route, lot # 1837116, expiration date: 24-MAR-2023, administered for prophylaxis (formulation, and strength were not provided), after the vaccine was exposed to a temperature excursion of 4 hours 12 minutes and at a temperature of 10.8 Celsius degree (product storage error). No additional adverse event was reported (no adverse event).
Employee documented, "Reaction of the CoVID vaccine and (supervisor) send me to the Emergency.
24 hours, post vax, injection site became inflamed, swollen and hot into joint area and to knee (left VL). Child did not run a fever. Local reaction only. Seems to be itching. 48 hours, post vax, much improved.
She reported having a red blotch  about 2.5 inches in diameter on her arm below injection site. It was tender, swollen and warm to the touch. It only lasted a bout two days
Redness and swelling at injection site (L arm), swelling is hard and size of silver dollar. Aching down to mid forearm.
Patient had severe local reaction and pain that persisted. Patient was seen during virtual visit, refused to come in for F2F appt. Appt was 10/30/2020
on 10/26/23 patient called pharmacy and asked if he complete his series of 2  shingrix doses because his doctor office alerted him that they have no record of his vaccination the pharmacist check pt's file also the wed site but found only 1 dose completed.  The pharmacist gave pt the shingrix vaccine on that same morning as his second dose on 10/29/23 the pharmacist thought about his case and looked all over the paper signed by pt when he received his vaccines and found that he already received 2 dose in 2021 1st: 05/22/2021 2nd: 07/24/2021 The pharmacist immediately informed the pt about the error that the pharmacist gave him an extra dose (3rd) on 10/26/2023 pharmascist appologized pt for the mistake and follow up with him about side affect that he might expericened. The pt stated that he had a severe headache the night of 10/26/23 but he felft better and better every day after, however on 10/30/23  pt stated that sometimes he still feel headache. pharmacist advised him to take tylenol, take orange juice and water to help him with the symptom. 10/30/23 pharmacist contacted the dr (pt's pcp) and spoke to staff about the administration error. Dr message to the pharmacist that was OK and she is aware of the event Will follow up with pt regarding his headache
Within a couple of days, my vision was blurry and I felt like there was something in my eyes. They were irritated and didn?t respond to allergy drops or artificial tears. Around 5/6/2021, I noticed a bump/swelling on my left eyebrow. It was tender, and continued to swell for days. Approx. 5/10 I noticed some other bumps on my face and forehead.  I began to feel shooting pain into my scalp, and i would be awakened by the throbbing in my eye and brow.
One week and one day later a rash appeared at the vaccine injection site that was not there prior.   The rash is circular, red, warm, it is about 1 inch around the center in size (2x2 inches).  It is not painful at this time.
I received my second dose at 1:30pm and began having symptoms almost exactly 12 hours later at 1AM the next morning. Symptoms consisted of: fatigue, body aches, chills, fever 101f, headache, and left arm soreness. Symptoms resolved by 8pm that same evening. I did take 1,000 mg tylenol the morning of 1/12 because I had to work, this did help some, but only aided in resolving the headache.   1/11/21: received dose 2 of vaccine at 1:30pm 1/12/21: symptoms began 1AM 1/12/21 symptoms resolved around 8PM
Moderna COVID-19 Vaccine EUA  Eczema flared-up unexpectedly in anterior left forearm and on radial side of wrist. Both flare-ups happen occasionally but neither had happened for over 12 months before vaccination.w
mom reported poss rxn to vax;pt seen by MD 9APR97 w/6-8 red, warm, scattered indurated blotchy areas on rt deltoid;febrile 103, h/a bilat temples;abduction lt arm to 30-limited secondary to pain;cellulitis w/systemic feature, myalgia;
Headache vertigo Narrative:  pt in vaccine clinic observation area with complaints of headaches and vertigo. Symptoms resolved without treatment.
No adverse effects reported; the patient was vaccinated with an improperly stored M-M-R II; This spontaneous report was received from a medical assistant, regarding a 16 year old male patient. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included hepatitis b virus vaccine (unspecified), meningococcal acyw conj vaccine (carrier unspecified), poliovirus vaccine inactivated (unspecified) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid.   On 24-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # R027997, expiration date 01-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  No information regarding the temperature excursion was provided. A digital data logger was involved. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA012355: US-009507513-1910USA012356: US-009507513-1910USA012357: US-009507513-1910USA012360: US-009507513-1910USA012981: US-009507513-1910USA012352: US-009507513-1910USA012351: US-009507513-1910USA012240: US-009507513-1910USA007637: US-009507513-1910USA012359: US-009507513-1910USA012349: US-009507513-1910USA012350: US-009507513-1910USA012353: US-009507513-1910USA012354:
Large red area around injection site reported 2 hrs after administration. Followed up with patient 6 hours post administration and reaction had not worsened. Patient reported no tightness of chest or breathing difficulties.
Child received Tdap vaccine at approximately 9:20 AM, left immunization area. Brought back to immunization area at 9:33am. Color pale, he stated he was sick to his stomach. Child laid down on floor. BP 80/40. O2 sat at 9:40am-99% Pulse 88. Vomited small amt clear fluid. Scool notified parent. BP at 9:44am 84/60, Pulse-78, O2 sat - 98%. Emergency Crew arrived at 9:47 am, child's color improving, child oriented to person and place. Child left with Emer. Crew at 9:52am. Child back in school on 6/8/18, he was not taken to ER. Parent took child home on 6/7/18.
pt recvd vac & found dead at home; found in crib face-down with head resting on a large pillow;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 61-year-old male patient who received SHINGRIX. Concomitant products included Diltiazem, LIPITOR, Losartan and hydrochlorothiazide. On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 30th May 2018, 19 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site pustule, ingrown hair, injection site pain and injection site hyperpigmentation. On an unknown date, the outcome of the injection site swelling, injection site pustule, ingrown hair, injection site pain and injection site hyperpigmentation were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site pustule, ingrown hair, injection site pain and injection site hyperpigmentation to be related to SHINGRIX. Additional details were provided as follows: The reported caller pharmacist was the patient. The patient received SHINGRIX vaccine on left deltoid.
at time of injection pt felt a cold tingling  sensation down right arm, sensation went away shortly after vaccine. the next day pt had arm pain, HA, fatigue, and nausea. then slowly the tingling to the right arm returned along with redness and warmth of injection sight and pain to right axiallary region
Full body rash, skin sloughing off, mucous membrane lesions, vision changes, trouble breathing, heart pounding/palpitations, shaking, chills/sweats, headaches, difficult focusing, dehydration. Treated with Prednisone, topical steroids, antibiotics, Xyzal, Benadryl, continues with fatigue.
Very painful stiff neck; Very painful stiff neck; rapid heartbeat; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 11Jan2021 13:15 at single dose (left arm) for COVID-19 immunization. The patient had no medical history. The patient had no known allergies and patient was not pregnant. Concomitant medication included gabapentin, diltiazem hydrochloride (DILT-XR), losartan and ezetimibe (ZETIA). On 14Jan2021 at 22:00, the patient experienced very painful stiff neck and rapid heartbeat. The patient had no therapy for the events. The patient had no other vaccine in 4 weeks, and did not have Covid prior vaccination. The patient was no Covid tested post vaccination. Outcome of events was not recovered.  Information on Lot/Batch has been requested.
Child moved during 2nd spray of FLUMIST and much of dose went into his eye. (R) eye washed out with 3 vials of Saline.
Pt received Tdap in left arm and then Flu shot in right arm. A few seconds after receiving Flu shot pt fainted and within a minute started to wake up. After 15 minutes pt was fully recovered. Called pt a little over one hour later and spoke to pt & he felt fine.
8 hours and 10 minutes  after vaccine was administered, I started to have a terrible pain in my stomach, dizziness, nausea, and went and sat on toilet.  The room was spinning and all of a sudden I woke up on the floor of the bathroom with no recollection of how I got there. (I must surely have fainted.)  I was covered in sweat soaking the back of my bathrobe.  There was no one at home and I tried to stand up, but my legs wouldn't hold me and I was having trouble breathing.  I crawled to my bedroom across the hall and heaved myself into the bed.....then the terrible pains started in my kneecaps, ankles, and I got a horrible headache in the forehead area and in the back of the head where it meats the neck.  I almost called Emergency, but after about a half hour, the breathing slowed down, but the other symptoms remained.  It was a horrible night and luckily, I fell asleep for about an hour, only to wake up with the same severity of symptoms.  I literally could not get out of  bed I was so weak.    My 94 year old mother and I live together, and I am usually the one taking care of her.  This has lasted I am writing this 2 days later, still in bed, but I am able to make it to the bathroom.  It has been absolute terrible.  I seriously felt like I was dying, which is ironic since my first two Covid shots were fine and have never had a reaction to any shots or vaccinations in my life.
Extremely dry skin; Near cracking; Eyes burning; itchy eyes; dry eyes; headache; muscle ache; chills; tired; Sever pain at injection site.; skin warmed; This is a spontaneous report from a non-contactable consumer. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 08:15 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included LASIK(Laser-assisted in situ keratomileusis) eye surgery on Nov2020. Concomitant medications included lifitegrast (XIIDRA) for lasting headaches from dryness on third and last month of treatment. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 08:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 13:00, the patient experienced extremely dry skin, near cracking(chapped skin), eyes burning, itchy, dry (similar feel like seasonal allergies) and other typical symptoms like headache, muscle ache, chills, tired, skin warmed and severe pain at injection site(vaccination site). The patient took advil liquid gel 300 mg as treatment for the reported events. It was reported that all symptoms were muted after receiving Advil. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The clinical outcome of the events extremely dry skin, near cracking, eyes burning, eye itchy, headache, muscle ache, chills, tired, skin warmed and severe pain at injection site were recovered on 06Apr2021, while that of the event dry eyes was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Overall my symptoms were very mild after the shot. Mainly just a sore arm for a few days.  After a few days I noticed my eyes were acting super sensitive to light. A couple times a day it feels like they are being strained and it sometimes makes me nauseous. I also have experienced  headaches near my eyes. I rarely have experienced headaches in the past.
Pt got MMR on 11/16/04. Returned to clinic today with rash to arms, abdomen, neck, legs. Rash worse in folds of neck, elbows, abdomen. Patient reports rash and itching began this morning after eating eggs and that she has never had a problem with eggs before. Patient left clinic to see her private doctor. Patient left clinic to see PCP.
High fever that resulted in loss of pregnancy; High fever; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6206), via an unspecified route of administration on 08Apr2021 12:00 (at the age of 35-year-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On an unspecified date, the patient experienced high fever that resulted in loss of pregnancy. Events caused doctor or other healthcare professional office/clinic visit. Patient received treatment for events. The mother reported she became pregnant while taking BNT162B2. The mother was 3 weeks pregnant at the onset of the event. The mother was due to deliver on 17Dec2021, and last menstrual period date was on 12Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequel.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Pregnancy loss and fever cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
pt recv vax 12MAY95 & 27MAy95 or 28MAY95 pt exp 30 lesions of a varicella-like rash; MD expressed a concern w/particular lot# of vax; No further details were provided;
pt reports pain in rt knee, elbow & wrist w/swelling in nee starting 22JN98;states joints still painful & knee still swollen @ this time;
loss of both vision and hearing; herpes simplex; erythema multiforme; pneumonitis; loss of both vision and hearing; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On 25-JAN-2016 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date in 2016 (reported as shortly after the vaccination), the patient was diagnosed with both forms of herpes simplex, erythema multiforme and pneumonitis, and suffered the loss of both vision and hearing. The patient's symptoms had resulted in physical limitations not present prior to using the vaccination. Patient also experiences mental and emotional distress due to physical limitations and seriousness of his condition. As the result of vaccine live(ZOSTAVAX), the patient suffered severe, serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. He also suffered medical expenses, the loss of accumulations and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, loss of both vision and hearing, and erythema multiforme were determined to be medically significant. All the events were considered to be disabled by the reporter.
After the vaccine was administered I waited the 15 minutes with no symptoms. I started at 1:00 in the morning with chills and uncontrollable shaking and the feeling of never being able to get warm. I woke up with a 101 degree fever and a severe headache, muscle aches and the inability to get out of bed. I spent the whole day in bed and unable to eat that day. The next day I still had a fever of 100, muscle aches, severe headache and listlessness, but able to eat a little. I wasn't able to finally get out of bed that day until around 5:00 p.m. From then on all of the symptoms had pretty much subsided and I was able to get back to daily activities.
Was seen in office 3/3/22  for sudden onset left leg pain with standing up from seated position. Around 2:49 pm received covid booster shot (3rd dose Pfizer vaccine). Returned to clinic on 3/4/22 due to perceived side effects from vaccine. Around 8:30 pm on 3/3 started to cough. Woke up in the morning late, slept in, felt fatigued. Dizziness started in the AM at school, no LOC. Rested head and felt better. Was walking at lunch and saw "a black figure" in right eye and started to "hear little talking noises." The noises lasted for about 15 minutes, the black blob in the vision for about 10 minutes. Rapid antigen test at home negative. Cough started around 8:30 pm. Had stuffy nose at lunch time. Also reported ear pain and ringing resolved by time of the visit on 3/4.
Patient had seizure and was rushed to hospital. He stayed in the hospital over night for high blood pressure after seizure.
Information has been received concerning a 29 year old pregnant female with an aspirin allergy and "no medical history" who on 03/21/2001 was vaccinated with varicella vaccine. There was no concomitant medications reported at the time of vaccination. on 03/21/2001, the pt received varicella vaccine. After the vaccination, the pt experienced swelling at the injection site without any other symptoms. Subsequently, the swelling at the injection site resolved. It was reported the pt is on prenatal vitamins. The pt sought unspecified medical attention. Additional info has been requested.
HYPOTENSION 11/22/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Vial of vaccine was  reconstituted with 1.5ml of diluent instead of 1.8 ml.  Called patient 6/12 to explain what happened and patient noted she had no side effects from the vaccine.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with the dose of ZOSTAVAX (dose, lot number and route of administration were not reported). In 2012 (reported as "last year") the patient was seen in the office for an active case of shingles. The patient sought medical attention via office visit. The patient stated that she never had received ZOSTAVAX. The patient told the nurse that the day it was documented that she had received the ZOSTAVAX, she was seen in the office for treatment of shingles, not the shingles vaccination. The outcome of shingles was reported as recovered/resolved on an unknown date. The relatedness between the shingles and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
I have developed mild tinnitus in my right ear this winter. I have seen that scientists are investigating a possible link between the COVID vaccines and tinnitus, so I thought I should report it. It is sometimes annoying but not major. I did not have any adverse reactions after the first two shots; only after the booster. I'm not sure when it actually began. I thought it was some sort of strange electrical humming in my house, but when I couldn't locate the source, I realized it was my ear.