chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome 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 ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    Concomitant medications were not reported.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults. No AEs were reported.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  Treatment medications were not reported.
Redness, swelling x 2 of arm size.  Warm to touch.  Blistered with drainage.  Was given antibiotic injection and received an oral antibiotic to start on 06/12/2003.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A 70-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 70, on Oct 7, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of the COVID-19 vaccine (manufacturer unknown), for immunization. The patient developed pruritus/swelling/swollen/itchy, onset Oct 7, 2021, with outcome of unknown; vaccination site pruritus and vaccination site swelling (injection site is slightly swollen and itchy), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
This case was reported by a physician via call center representative and described the occurrence of pruritus in a 64-year-old female patient who received SHINGRIX. Concurrent medical conditions included breast cancer, osteoporosis and clot blood. Concomitant products included Aspirin, Vitamin B12, ARIMIDEX, biotin, finasteride, magnesium, nifedipine, PROLIA, hydrochlorothiazide, calcium + magnesium + zinc + vitamin D, Valacyclovir, Coenzyme Q10, Selenium, Flax Oil, fish oil, Vitamin C and Vitamin D. On 23rd February 2018 03:00, the patient received SHINGRIX (intramuscular). On 23rd February 2018, less than a day after receiving SHINGRIX, the patient experienced pruritus, vesicles, erythema, swelling and pain. On an unknown date, the outcome of the pruritus, vesicles, erythema, swelling and pain were recovered/resolved. The reporter considered the pruritus, vesicles, erythema, swelling and pain to be related to SHINGRIX. Additional details were provided as follows: Concurrent medical conditions included polymorphism. The patient experienced itchy vesicles, redness, swelling, soreness after vaccination with SHINGRIX on right arm and it was 4 inches long. The events were lasted 4 days.
On day 3 post vaccine I started with Vertigo so bad I couldn't get out of bed.  I also ended up with pretty bad headaches, feeling like someone was squeezing my head, ear fullness and pain, brain fog, and the inability to walk straight without falling or bumping into the walls.  Occasional Nausea.  At almost week 3 I've tried Motrin, 1,000 mg a day, Psuedofed, as needed, Miclazine, and Vitamine C
Rash on stomach; itching all over body; This is a spontaneous report from a non-contactable other healthcare professional (HCP). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3302), intramuscular at right arm on 14Jan2021 11:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included granulomatous mastitis and allergy to Shrimp. The patient's concomitant medications was reported as none (no other medications in two weeks). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rash on stomach and itching all over body on 14Jan2021 11:45. Treatment received included Allegra. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Red, swollen, painful upper arm for days. Burning, itchy feeling. Stared 2/8, still mildly painful on 2/16. Started antibiotic 2/15 to alleviate possible infection.
bulging fontanel; started probably 24-36 hrs; brought to medical attention 4 days p/recvd vax; pt not self; 2 days p/vax t102;
Pt screamed uncontrollably for 2-3 hrs p/vax; pt also spiked a fever; temp was 102.3 in the office 40 mins p/APAP;
Shingles presented by distinct skin lesions on the abdomen, back and groin, itch and burning pain, doctor confirmation of shingles Aug 24th, treated with antiviral oral medication starting Aug 25th and symptoms rapidly subsided, skin scaring from lesions
LEFT WRIST DROP, LEFT FINGER ABDUCTOR WEAKNESS, LEFT FINGER EXTENSOR WEAKNESS, LEFT ELBOW EXTENSOR WEAKNESS. NO ASSOCIATED PAIN.
Left sided weakness and heaviness in left  upper and lower extremities. Fever 103.4, nausea, headache, low back pain, chest pain, left lung pain, dizziness, shortness of breath.
I received a GARDASIL 9 shot and I am about 3 weeks pregnant; No adverse effect reported; This spontaneous prospective pregnancy report as received from a 29 years old female patient referring to herself. The patient's concomitant medication included levothyroxine. The patient had no pertinent medical history and no drug reactions or allergies.      On 12-FEB-2020, the patient received 1 shot of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose detail, route, lot # and expiration date were unknown) for prophylaxis. The patient was about 3 weeks pregnant at the time of receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exposure during pregnancy). The patient's last menstrual period (LMP) was on approximately 31-JAN-2020 and estimated due date (EDD) was on approximately 06-NOV-2020. No adverse effect was reported. The pregnancy outcome was outcome pending.
Chest pain, palpitations, troponin leak -- diagnosed with Myocarditis, Admitted to hospital for 2 days. Received supportive therapies with NSAIDS. No intervention or immunomodulors. Echo wnl with normal EF.
Patient was admitted to hospital on 02/20/2022 with complaints of SOB.  He had progressive dyspnea and shortness of breath prior to admission.  Patient was diagnosed with Covid-19 on 02/20/2022.  He was immediately started on high-flow and admitted to the ICU.  He was managed conservatively for several days however he did end up requiring intubation.  He continued to decline on the ventilator and eventually required prone therapy.  At this point, family decided to withdraw care and comfort measures were instituted.  The patient was transferred to the medical -surgical floor.  Patient expired on 03/02/2022.
High Fever (102.7), Chills, Shivering, pain at injection site, headache, red face.
fatigue; body ache; experiencing sore on his arm on the first two days after getting the 1st dose of the Covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm, administration date 04Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04Apr2021, outcome "recovered" (06Apr2021), described as "experiencing sore on his arm on the first two days after getting the 1st dose of the Covid-19 vaccine"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue"; PAIN (non-serious), outcome "not recovered", described as "body ache".  Additional Information:  The patient was scheduled for the second dose on 25Apr2021. He was asking if fatigue and body ache can be experienced a few days after the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient developed redness on chest. patient felt dizzy , hot then felt cold. patients blood pressure was elevated. The patient wanted to be checked out EMS was called and patient taken to the hospital
Only adjuvant administered, no antigen; Only adjuvant administered, no antigen; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comment: The HCP (health care professional) reported that administering adjuvant only (no antigen) to 9 total patients.  Three patients were unidentified, 6 were identified. The AE (adverse event) filed separately for the 3 unidentified patients.  The reporter consented to follow up. This is 1 of the 7 cases reported by the same reporter. Additional Supportive Information: The patient received Shingrix vaccine without antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022193688:Same reporter US-GSK-US2022193687:Same reporter US-GSK-US2022193680:Same reporter US-GSK-US2022193682:Same reporter US-GSK-US2022193685:Same reporter US-GSK-US2022193690:Same reporter
104 degree temperature  Cold chills Breathing labored Sever joint pain Severe headache
covid symptoms include worsening SO, cough, weakness/fatigue x 3 days,  hypoxia w pneumonia, tested positive for covid on 5/23/22
Dizziness,weakness,severe headache, fever, nausea,muscle aches,shivering,stomach pain
In pain; Could barely eat; feeling full; Taste buds are completely shot; muscles ache; can barely move when stand up; muscle weakness; really weak; This is a spontaneous report received from a contactable consumer (patient husband). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Lot number: ER8737, Expiration Date: Jul2021), via an unspecified route of administration on arm right on 02Apr2021 probably about 13:30 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were none. The patient had no family medical history. No additional vaccines administered on same date of the Pfizer Suspect. The patient did not visit to Emergency room or Physician office. The patient had no prior vaccinations (within 4 weeks) and no adverse events following prior vaccinations. It was reported that, the caller is a consumer reporting he and his wife had their first dose Pfizer Covid Vaccine on 02APR2021. Caller reports his wife experienced the same side effects as the caller. Caller's wife was really weak in Apr2021 and was experiencing all the same symptoms as the caller except no chills and no difficulty sleeping. Reports when the wife lays down, she was out cold asleep, and has no difficulty sleeping. The caller states the afternoon after receiving the Pfizer Covid Vaccine when leaving the administering facility, so far nothing bad had occurred. Caller reports he and his wife stopping to get something to eat on the way home from the Vaccination administering site, and in his case he could barely eat on 02Apr2021. This was the same for his wife. It was like it was not digesting on 02Apr2021. She has a feeling of feeling full and not being able to eat on 02Apr2021. Her taste buds are completely shot. Whenever she eats something it taste like cardboard. Mentioned his wife tries to eat because she needs to. She cold, barely finishes her food at the restaurant they went to after getting the first dose. It was like their food was so bland. Caller confirms some of the symptoms he reports are the same for caller's wife. Reports caller's wife is similar to him. She has muscle aches and can barely move when stand up in Apr2021. Caller explained his muscles ache like being beaten with a baseball bat and it's the same for his wife. Muscles ache constantly. Confirmed she was also having muscle weakness in Apr2021. Confirmed his wife was really weak. She can barely stand up. If she sits down on the chair or in a car in the drivers seat, its almost like caller was going to fall asleep. The outcome of the event was reported as unknown.  No follow-up attempts are needed; No further information is expected.
Moderna (1st dose) 7/12/21 Hepatitis B/Tdap (PCP) 7/23/21 PPD (employer) 7/26/21 MMR and Varicella (CMD) 7/26/21  Rash, fever, chills, night sweats, myalgia, fatigue, and malaise started on 8/4/21. Rash started on neck spreading to the remainder of the body. Described as erythematous. Slightly pruritic. Highest temperature 104. Patient attempted to go to the ER, however the wait was too long. Seen in UC on 8/6/21 or 8/7/21. Rapid COVID/Influenza negative. Tylenol/Advil/Benadryl with improvement. No fever since 8/7/21.
Client verbalized feeling nauseated 10 minutes after receiving her vaccination. She was assisted to a private area to be assessed at which point complaint light headedness and passed out. LOC lasted about 30 seconds. 911 was called about 10:AM and on going assessment continued. V/S every 3-5 minutes as follows: BP 160/100, R 20, HR 103, O2 SAT 99%, Rechecked bp 160/100, 85, 18, sat 99% then 142/90, 85, 18, sat 99%. EMS arrived about 10: 36AM. Client was fully awake and conversant with staff. She was transport to the ER about 10:39.AM. She verbalized feeling nauseated at time of transport.
I thought I was getting the flu. The next day I had a fever which went up to 102.7 the next day. I was able to get an appointment the next day. I was given a COVID-19 PCR test on 12/17/2022 and it was positive. I was given the standard medication and I had taken a nighttime cold and flu medication over the counter, so I was beginning to feel better. After 2 or 3 more days, I no longer had any symptoms. I have recovered from all of the symptoms. I have felt very well the last 3 weeks. I recovered very rapidly from it with no lingering effects.
The vaccine patient has experienced headaches, loss of focus and vertigo/ Most troubling is the vertigo; Now after the vaccine patient has experienced headaches; The vaccine patient has experienced headaches, loss of focus; Most troubling is the vertigo and dizziness/ dizziness all the time; Swelling and pain in left armpit area; severe soreness for 5days (14Jul-19).; Swelling and pain in left armpit area; As of today, 26Jul site of injection is still sore to the touch; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA6780), intramuscular, administered in arm left on 14Jul2021 (at the age of 54-years-old) as dose 1, single for COVID-19 immunisation. Medical history included vertigo [Prior to vaccine suffered mild vertigo sometimes (seldom)] and COVID-19 (if_covid_prior_vaccination: yes) from an unknown date. There were no concomitant medications. On 14Jul2021, the patient experienced swelling and pain in left armpit area; severe soreness for 5days (14Jul-19). As of today, 26Jul site of injection is still sore to the touch. Most troubling is the vertigo and dizziness. Prior to vaccine, suffered mild vertigo sometimes (seldom); now after the vaccine patient has experienced headaches, loss of focus and vertigo/dizziness all the time. There was no treatment received for the events. The event 'The vaccine patient has experienced headaches, loss of focus and vertigo/ Most troubling is the vertigo' was assessed as serious and medically significant by the regulatory authority. The outcome of the event Armpit pain was recovered on 19Jul2021, while of the rest was not recovered.   No follow-up attempts are possible. No further information is expected.
patient was administered only the HIB portion of the pentacel vaccine and used sterile water to dilute the HIB portion of the vaccine with no adverse event; Initial information received on 11-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old female patient who was administered only the hib portion of the pentacel vaccine and used sterile water to dilute the hib portion of the vaccine with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE INACT (HAVRIX) for Prophylactic vaccination; INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for Prophylactic vaccination; MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination.  On 04-Jan-2023, the patient received 0.5 ml (once) dose 3 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ666AAA, expiry date: 04-Jan-2023)  via intramuscular route in the left thigh as prophylactic vaccination.   On 04-Jan-2023 (latency: same day) the patient was administered only the hib portion of the pentacel vaccine and used sterile water to dilute the hib portion of the vaccine with no adverse event (product preparation error)  Action taken: not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
My daughter began having explosive diarrhea and severe screaming and crying episodes.  This progressed and the next day she was pulling her knees up and screaming. She had a mild fever of 100.4.  Her stool began to look mucousy and bloody like jelly.  We were seen by her pediatrician, and her stool tested positive for blood and they immediately sent us to Hospital.  They suspected intussuseption from the rotavirus vaccine.  They did an abdominal xray which they did not like what they saw on it so they did an ultrasound.  They determined it must have "resolved itself and popped back out on its own" she was given iv's.  A week or so later she then had an apnea episode that lasted longer than 20 seconds several times and her physician sent us to hospital again. They admitted us to the hospital and did testing such as an echocardiogram, etc.  They dx her with ALTE and said they could not say if it was related to her reaction to the vaccine or not.  Her physician even had her immune levels tested such as IgE etc which were all normal.  Her stool tested postive for rotavirus as well they said.  She was very ill for several weeks and had lost significant amount of weight from the diarhea.  I was breast feeding and from the stress my milk almost dried up. I was lucky that it came back with lots of HARD WORK and power pumping.  Many sleepless nights filled with worry went on for months after her reaction to the vaccine.
About 10 minutes after receiving the 0.5 ml dose of the Jansen vaccine while the patient was waiting in observation, she had a brief (~10 second) LOC followed by a mini seizure. Patient was being observed by 2 EMTs and 3 nurses. Patient recovered quickly, had a strong pulse, steady breathing, and was aware and responsive.
Pt. had soreness and limited range of motion in the arm where vaccine was given. She has treated round the clock with ibuprofen and had noted some improvement by 5 days post vaccine. On further investigation, it appears the vaccine was given too high in the arm.
Vertigo especially with position changes.  Took Meclizine 25 mg twice.  Seems to be resolved after 24 hrs.
Fever began w/in 2 hrs p/immun; t103 w/forehead fever strip & AX; generalized rash later that same day, arm swollen 28JUN day following immun;
Have red, itchy, swelled and, pain 3/4 of the way around my arm. It is very uncomfortable. Should I get the second shot?
1) Within a couple days had a shingles outbreak on my lower back. Blistered sore, scabbed, etc. Pain. 2) After shingles cleared I noticed my ankles and feet were retaining water, swollen looking. Felt heavy, full. Normally have bony, thin ankles and feet. Still a problem but not as exaggerated now. 3) Within a week I began having episodes of a racing heart, moments of discomfort or momentary pain left chest. Very shortlived episodes, but have just stopped having episodes in the past 2-3 weeks. In the same timeframe also would have moments of lightheadedness...I've never fainted but it's what I imagine the moment just before fainting feels like. This has abated as well. 4) Shooting pains in lower limbs and knee inflammation I haven't experienced in many years that are identical to old tick related illness contracted 12 years ago. I've had episodes over the years of it returning, but up until the vaccination it had been at least 4 or more years since I had those symptoms peek back at me. Still suffering from this.
Individual called my office to report symptoms after receiving the Flumist 9/9/2009.  States on 9/11/2009 she developed flu-like symptoms including headache, nausea, muscle aches, temp of 38.7 and a cough.  She was her primary care physician and not given specific treatment.  She states she was not tested for H1N1 at that visit and denies exposure to anyone with the flu.  She said by 9/14/2009 her symptoms had resolved except for residual cough.
3/2/17 - none 3/5/17 - none 3/9/17 - none 3/16/17 - none.