chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Nurse reported PROQUAD was administered after TE; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 26-SEP-2023, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, as prophylaxis (lot number: X009129, which was determined to be valid, with an expiration date on 24-SEP-2024) (strength, dose, scheme, route and anatomical location of administration were not reported).  The administered dose underwent a temperature excursion of 81 degrees Fahrenheit for 3 hours. No previous temperature excursion was reported.   No additional adverse event was provided.
Mom reports pt. had one episode of vomiting after the vaccines. Then pt. had low appetite, refusing to breast feed. Took 2 oz. formula only for 12 hours. Pt was more tired than usual. Mom took pt. to ED for evaluation. Tylenol given at hospital.
Patient received the vaccination in her left arm, then approximately 1.5 minutes later, stated that she felt hot and light-headed.  The patient was already seated, and her husband proceeded to kneel in front of her as she started to faint. Patient regained consciousness within a few seconds. She stated that she was hot and flushed after the event. EMT was called, patient refused treatment. Her O2 sat was taken and was 97%
Atrial fibrillation pulse 150 treated with Rythmol an converted within three hours Weakness in legs with no treatment lasted about 12 hours Obtunded no treatment better the next day
About 4 hours after vaccination with PCV-13 and Pentacel, child remained fussy and then parents observed a purplish skin discoloration along the legs bilaterally. They got concerned and sent photos via the patient portal. They were invited back to the office and upon re-evaluation about 40 minutes after they detected the skin discoloration, all findings had resolved and infant was comfortable and in no distress. Vital signs remained stable.  Her parents were reassured and citation describing the rarity of discolored leg syndrome was reviewed at the bedside. Comfort measures were recommended, family was receptive.
Case number PHEH2012US014992 is an initial spontaneous report received from a pharmacist on 27 Jul 2012. This report refers to a 24-year-old male patient. This patient was vaccinated with VARIVAX (other manufacturer, batch number: unknown) lyophilized vaccine component mixed with MenCYW-135 liquid conjugate component of MENVEO (batch number: X11042) intramuscularly on 26 Jul 2012. No adverse event was reported following this drug administration error.
16:58, Pfizer vaccine booster administered. 17:03, client stood up and reported feeling lightheaded. NP instructed client to lay down on floor with feet on chair. Yoga mat placed under head. Pallor; diaphoretic appearance. Radial pulse regular 2+. A&Ox4. Not a true syncopal episode. 17:05, BP 106/76, A&Ox4. RR 18. Pupils 3 mm equal and reactive. Pulse 2+. 17:08, client reported no longer feeling lightheaded and said he "passed out after shots" when he was a child. Continued to rest in supine position. 17:11, client sat in chair drinking water; skin color returned to normal. RR 16. 17:14 BP 118/70. 17:24, client left site without incident.
On 01/02/2023 I started feeling extreme fatigue, malaise, cold sweats and chills for a few days. On day 5 my cough started progressing and was prescribed PAXLOVID. However my cough still lingered I had a chest x-ray and was negative for Pneumonia and Bronchitis. About a week later I was diagnosed with a UTI. I also had a rash and peeling skin on my feet. This may be due to having RA as this is one of the side effects.
Aches, chills, typical flu type symptoms, Fever to 102 F. Lasted till about midnight. Fever broke and felt fine afterwards. Also had pain in arm on both shots. Worse the first night then less each day for about 3 days.
experienced blood clots; This serious case was reported by a physician via sales rep and described the occurrence of clot blood in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced clot blood (Verbatim: experienced blood clots) (serious criteria GSK medically significant). The outcome of the clot blood was unknown.   It was unknown if the reporter considered the clot blood to be related to Arexvy.     It was unknown if the company considered the clot blood to be related to Arexvy.   Additional Information: GSK receipt date: 17-Oct-2023 The physician reported that his patient got Arexvy (RSV vaccine) and then experienced blood clots. The reporter described blood clots as in the patients legs.  Uncertain if the vaccine was GlaxoSmithKline or Pfizer. The reporter consented to follow-up.
The MOP states she received MMR, hep A and varicella at her 15 month checkup in 2012 and developed a generalized non pruritic papular exanthem approximately 6-8 hours after vaccine receipt. She also had fever of 101-102. The exanthem initially presented to her abdomen and back and lesions continued to evolve and spread to extremities, buttocks, and face. 'It was all over'. She did not believe it was pruretic or painful. There were no pustules or vesicles. Fever also increased to as high as 103 and resolved by the 4th day. She was not fussy, irritable and continue usual activity, eating and drinking. The exanthem started to fade by day 6 and resolved completely at approximately 1 week. She states the child was evaluated by provider who attributed it to the MMR and told her to have further evaluation prior to the second dose. She had no immediate symptoms after vaccine receipt of urticarial lesions, shortness of breath, oral/tongue or facial swelling or agitation or restlessness. The MOP also has a photo demonstrating a large local reaction at the injection site, which resolved without incident. She also denies any recent or concurrent illness symptoms prior to vaccine receipt, stating she would have delayed vaccination if there were any concerns. The MOP has photos of the exanthem which demonstrate popular erythematous lesions with diffuse distribution to her trunk. The MOP also states the younger sibling had a similar dermatoses after receipt of MMR but with a delay of onset of one day.
Mild case of papules, pustules, vesicles on head, neck & trunk, low grade fever 100 degrees F, suspect from VARIVAX 1/21/13.
Patient presented two days after receiving vaccine complaining that she had a fever of 103, pain and arm redness that was sensitive to touch.
Left axilla very swollen, left arm pain x 8 days severe per pt, high fevers subj x 4 days, excess fatigue, sleepiness.
11/21/18 Patient's daughter stated that patient hadn't removed the bandage provided post injection until "the other day". For at least 2 days post-vaccination, patient was fine. Then a delayed reaction occurred consisting of redness, swelling of the arm, pain, itching discomfort.
pt recv vax 1MAY97 & 2MAY97 pt c/o a red blister approx 5-6mm @ the inj site that occurred while training;f/u revealed a wheal devel as the dose was given;p/24hr pt c/o a very sore arm (pain) redness over arm & shoulders from sun exposure;
Insomnia the night immediately following the vaccine. Trouble falling asleep & trouble staying asleep. This also occurred with the second dose of the Moderna COVID vaccine.
Day 1:  shortness of breath, numbness of right hand, fever 102.5 Day 2:  fever 100.6 DAy 3:  fever 100.8
pt became dizzy shortly after administraion (3-5 minutes est.) said she felt like she was going to pass out and then lost consciousness for est. 15-20 seconds.  She regained conciousness and answered general questions correctly then felt faint again a few minutes later and passed out for a shorter time 2-3 seconds est.  Paramedics called and arrived about 1:20pm checked her blood pressure/ HR 3 times over a course of 10 minutes 88/62,93/62, 108/70 respectively. HR was 60bpm (one reading recorded).  EKG -normal ( paramedic ambulance). pt refuse ride to hospital and left facility following paramedic examination- signed waiver a left facility at 1:35pm
Last night all of the sudden the skin on my left leg started to fell like a had a sunburn; it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn; it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn; it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn; she did not get a good night of sleep; exhausted; too I was very aware of my stomach, now feel the tommy again and burning is getting less; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: unknown) via unspecified route of administration on 25May2021 as single dose for COVID-19 immunization. Medical history included drug hypersensitivity. The concomitant medication was not reported. Patient reported that in May2021 after the first dose of the vaccine patient was exhausted for 5 full days, her arm never hurt but she was very aware of her stomach and for 5 days she had to seat still and that finally past. On 10Jun2021 all of the sudden the skin on her left leg started to feel like a had a sunburn, it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn, she tried to put the Aspercreme on it thinking that her take care of this terrible feeling but that did not help it made it worse so she washed it off. This all started off around 9:30 pm last night she finally got in bed around 10 pm. Patient was trying to sleep with her leg outside of the covers because it felt like it needed to be cooled down, she had AC on and fan. "she did not get a good night of sleep because she kept feeling her leg and did not know what else to do for it. "This morning she was very tired of course from last night, very aware of her stomach again which happen along of getting the first shot for those 5 days and she was exhausted and then too she was very aware of her stomach, now feel the tommy again and burning was getting less, but she had no clue was this was something anybody has reported. Patient was highly sensitive to medications. Patient never get any type of immunizations prior to this since she was a child. in a week she will be 78 years old, she was due for her second shot on 15Jun2021.The outcome of the event exhaustion was recovered, stomach burning sensation was recovering and sunburn, burning sensation, tingling sensation, feeling abnormal, sleep disorder was unknown.  Information on Lot/Batch number has been requested.
SYNCOPE AFTER RECEIVING MMRII & FLUARIX QUAD OCCURRED < 5 MINUTES AFTER RECEIVING VACCINES PATIENT FELL & HIT HEAD PATIENT DID NOT WAIT RECOMMENDED 15 MINUTES
Chills and tiredness on 3/14/2021. Injection site pain from 3/14-3/17. Sore breasts from 3/15-3/17.  No treatment. Outcome - resolved.
This spontaneous report was received from a Registered Nurse referring to unspecified number of f patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB (lot # L038502, expiration date on 16-AUG-2018 (dose number, strength and anatomical location were not provided). The vaccines were stored in a temperature of 52F during 30 minutes, 46.9 during 12 minutes, 46.9F during 12 minutes and 47.1F during 16 minutes (cumulative total time out of range was 70 minutes). No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was involved. This is one of several reports  received from the same source. Additional information has been requested.
pt here to received first dose of covid vaccine. pt is 23 months old. Vax received at a Covid Mobile Team Pop-up vax event  Instead of receiving 0.25 ml of Bivalent (6 months+) (Dark Blue Cap / Gray Border), pt received 0.2 ml of Bivalent (6 months - 5 years) (Dark Pink Cap). pt stayed in observation for 15 minutes. per mom, pt was feeling fine.
pt recv vax & 4hr later erythema @ inj site w/swelling which became worse w/times;intervention DPH, ancef, Ibuprophen;
p/vax pt w/fever no temp taken;8/24/99 pt still sick devel rash;mom appeared on belly & back mom recalls 8/25/99;no fever but rash grew to rest of body;rash pin size & no tx;
Pt dx with shingles today by MD- symptoms started about 4-5 days after receiving vaccine
heart attack; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves patient with unknown demographics had heart attack while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient had heart attack (myocardial infarction) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (heart attack).  At time of reporting, the outcome was Unknown for the event heart attack.; Sender's Comments: Sanofi Company Comment dated 03-Jan-2022:This case involves patient with unknown demographics had heart attack while receiving vaccine INFLUENZA VACCINE. Based on limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, any any concurrent conditions precludes comprehensive case assessment.
Patient received first 2 doses of RabAvert at outside facility. Developed itchy rash with "hives" in arms where she received vaccine, along with imbalance and altered mental status. Found to have aseptic meningitis on LP. She received her third dose in the series at our facility (Imovax). She developed itching, headache, and imbalance after this third dose. Felt better with fluids and Benadryl. Pt desires to continue rabies vaccine schedule.
Random heavy period a week before the injection, about 2 after the first dose. Excessive nose bleed approximately 17 hours after the second dose.
About two hours after the receiving the vaccine, I started getting a headache. I was rotating between Tylenol and Ibuprofen every 8 hours. The muscle spasms started Friday neck and shoulder. On Sunday I couldn't even turn my head. Today I noticed I broke out in hives arms, legs, back and stomach.  Today I had a temperature 102 this morning, I just checked it again and it was down to 100. Today I went to my Doctor. She prescribed you Methylprednisolone dose pack and  Cyclobenzaprine hydrochloride for muscle spasms.
Patient received a pfizer vaccine from our site on 4/13/21 and then returned too early for his second dose which was given on 4/27/21.
12 year old present in clinic with mother for shots today. reviewed immunizations. opted to receive vaccines. scanned vaccines into computer prior to administering.  given IM HPV and IM Meningococcal vaccine to left deltoid. IM Tdap given in right deltoid. after administering IM Tdap proceeded to put in lot number and exp dates. the computer would not let me place lot number, RN noticed expiration date 07/01/2022. notified per incident. notified mother of child per incident ( child received vaccine that has expired, informed mother of this and to bring child back in 4 weeks for another Tdap vaccine. mother voiced no complaints, verbalizes understanding
Day after receiving shingles vaccine, pt developed shingles-type pain.  4 days after vaccine pt developed full zoster outbreak.
This spontaneous report as received from a pharmacist reported that he heard from an unspecified nurse that a male patient of unknown age, who was vaccinated with ZOSTAVAX (lot number reported) "a few year ago", was diagnosed with shingles. No other co-suspects or concomitant medications were reported. The patient had sought medical attention via office visit. No treatment information was reported. The outcome of shingles was unknown. Additional information is not expected.
Body aches; Headache; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-May-2021 and was forwarded to Moderna on 06-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PAIN (Body aches), PYREXIA (Fever) and HEADACHE (Headache) had resolved.            The patient doesn't want another follow-up.   This case was linked to MOD-2021-044882 (Patient Link).   Reporter did not allow further contact
I had an instant nose bleed after 1st shot. I was told it was not a side affect. I never had nose bleeds before.  I had been in complete menopause for over 1 year with zero cycles and after injection one I started having abnormal bleedings. This continued until October 2021. My provider did draw labs and I have been through menopause and should have had zero periods. I also developed gastroparesis shortly after second injection.
Urticarial rash starting 2 days after vaccination and persisting for over 1 week. Fever to 102 beginning about 1 week after vaccination.
Approximately 15 min post injection pt began to feel light headed and dizzy accompanised by flushing. Symptoms were reported to have pealed and diminished shortly after. Within 45 minutes symptoms. Seems to be absent.
Pt passed out and appeared to seize. Pt was no aware of person place or time. 911 was called and paramedics took to the ER to evaluate
Patient developed  lower extremity weakness, the weakness progressed and after few days he was not able to walk even with help of crutches. Guillain barre  syndrome was suspected. He was sent to hospital. Lumbar puncture was performed on him showed elevation of CSF protein. He received  IVIG and his weakness improved. He also received Vitamin B12 injection due to Vitamin B12 deficiency
her brain is going blank; back pain that occurs in her left leg past the knee until the top of her foot; back pain that occurs in her left leg past the knee until the top of her foot; She wanted to know if it is like a sciatic nerve pain she is experiencing; she just thought it was swelling in her spine; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EK9231, via an unspecified route of administration in left shoulder on 11Jan2021 at a single dose for covid-19 immunization. Medical history included other problems before taking the COVID-19 vaccine such as joint pain, muscle pain, back pain, spinal stenosis, has a lot of back issues, like sciatic has a lot of problems. There were no concomitant medications. The patient had the COVID-19 vaccine on Monday (11Jan2021). On Tuesday (12Jan2021), she experienced back pain that occurs in her left leg past the knee until the top of her foot. She also mentioned that she had other problems before taking the COVID-19 vaccine such as joint pain, muscle pain, back pain, and spinal stenosis. She wanted to know if the COVID-19 vaccine can cause the adverse event that she experienced. She wanted to know if it is like a sciatic nerve pain she is experiencing. The patient stated it may sound crazy, but she got the COVID 19 vaccine on Monday, she is 72 years old, and has a lot of back issues, like sciatic has a lot of problems, and she got the shot and Tuesday) morning, her back hurt so bad, down into her sciatic, into her butt, leg, her lower leg and as far as her foot, the top of her foot, and she doesn't know if this is something that was going to happen, she read about joint pain, tiredness, that would include joints in the back, she would expect. She wonders if she is out of her head, since it was the very next morning, this was Tuesday, and instantly, she was sitting with ice and trying to get ahold of her healthcare person, she gets pain shots in her back, but she hasn't had them in a couple years, she was going along pretty good, then this was bad enough, it is in her thigh and leg, and is always under her foot, and she just thought it was swelling in her spine. She wonders if it is a side effect or her imagination. When asked for address, the patient stated her brain is going blank. She stated this may be just her. She has bad back problems, and was going along pretty good, it has been a year or two since she has had any kind of anything. But this was a good one, a strong one, the ice hurts so bad. She woke up with it, it is staying the same- after having something like this, she was trying to get ahold of the pain clinic, to get a shot, but that may be 3-4 weeks out. She has had no blood work in a while. Outcome of the events "she just thought it was swelling in her spine" and "her brain is going blank" was unknown; while not recovered for other events.
Immunization administered 2 days ago. Swelling and erythema present at site 1 day after administration. Large local reaction. Advised PRN antihistamines for itchiness.
My hemoglobin dropped to 11.7 g/dl ( 3/16/2021). Previous to the first shot, my hemoglobin was normal at 12.6 g/dl, as of July 2,2020. After the 2nd (second), shot, my hemoglobin dropped to 11.5 g/dl. Finally, after the booster my hemoglobin dropped to 9.5.  Also, after the booster shot on October 15, 2021, my kidney function  EGFR dropped to 20, November 18, 2021. It went up slightly to EFGR 30 on November 29, 2021 (retest).
Pregnant patient received the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the vaccine) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 014M2CA) for COVID-19 vaccination.     Medical history was not provided by the reporter.  Concomitant products included BUPROPION and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 13-Oct-2020 and the estimated date of delivery was 18-Jul-2021. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 08-Apr-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the vaccine) had resolved. Not Provided          Treatment information was not provided.