chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a medical assistant referring to a patient of unknown age and gender. On 30-APR-2015, the patient was vaccinated for prophylaxis with a dose of ROTATEQ oral, lot # K011663, (expiration date, dose and site of administrations were not reported) that was exposed to temperatures outside of the recommended range during 40 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information is not expected as all the follow ups requested to complete the case were received.
Due to a pharmacy substitution client received Infanrix Dtap vaccination rather than Adacel Tdap vaccination, University Drug Information Center indicated that the pediatric Infanrix version contains the same amounts of tetanus and pertussis and an increased amount of the diphtheria component. The patient should be adequately immunized. They may, however, be at an increased risk of adverse reactions due to the elevated diphtheria component. The agency was contacted per doctor name reported and they concurred with this information. The patient was contacted per the University and did not experience any serious adverse reactions. Follow-up corrective actions are being taken at the University.
Immediate - unexpected, extreme wave of pain starting from injection site traveling to the elbow, almost felt like I could feel the liquid of the shot moving down my arm to my elbow  - persistent muscle pain in arm thereafter (this muscle pain was similar to pain experienced after flu shot, but worse; not as bad as the initial wave of pain)  7pm - Elevated resting heart rate of 108, palpitations, slight dizziness, chest tightness. Lasted for 1 hr.   No symptoms were experienced with second dose of vaccine.
Woke up at 3am on 3/7/21 with Chills and Cold Sweet, Fever 98.8, Body Ache, Muscle aches, could not move because everything ached Had to stay in bed all day and sleep on and off as the fever occurred. Took Tylenol every 4 hours. Was not hungry at all. Woke up the next day at 6:30am with a fever of 99.4 took Tylenol and went back to sleep until noon and woke up feeling much better for the first time. Then kept feeling better as the day went on. Continued to take Tylenol. Friday morning woke up feel great and was able to work since Tuesday that I took the vaccine
Nearly 1 week after injection, I began experiencing pain starting midpoint of both my maxillary and mandibular right jaw extending to my ear and on occasion near by right eye.  The pain started gradually but increased in intensity that on June 8,  I visited both my dentist and primary doctor's office.  A panaramic xray was taken by my dentist - revealing no dental cause.  My doctor determined  I was experiencing Trigeminal nerve resulting from the Zostavax vaccine.  I initially was prescribed 100mg (2xdaily) Gabapentin (Neurotin)   The amount was increased to 400mg (3xdaily) on June 12.  The pain intensified as the days went on .  Carbatrol was prescribed but the pharmacy was unable to fill due to supplies.  But June 23 when it was filled, the intensity of the pain began to decrease so it was decided to continue with the Gabapentin.  The pain finally resolved by the beginning of July.
Itch w/hot feeling in rt arm;little swollen on rt arm, but redness & little pain;warm compress to rt arm area & take APAP tablets for pain;
2 hr p/vax pt became limp perioral cyanosis, trembling of jaw; lasted 5 mins; came to clinic; irritable; took bottle; t102.3; given APAP;
erythematous maculopapular eruption on bilateral cheeks, extensor arms and legs and lower back
5mins p/inj pt felt funny;lost consciousness became rigid & had tonic clonic jerking of extremities;episode lasted less than 1min;no incontinence;pt was oriented afterwards & had no neuro deficits;h/a x 4 days;marked swelling of inj site
Beginning 2 hours after vaccine:  Headache/migraine,  vice grip feeling in front and side of head and down nose Extreme nausea, overheating, dizziness  Overheating gets worse, no fever but inability to cool down even after putting ice on body Nausea worsens, shaking begins with whole body shaking  The following day:  Diarrhea, fatigue Other symptoms resolved
about a week after the 1st injection, pain, swelling, tenderness and itchy patch(?) appeared 2-3 inches down from injection site for about 3 days
Swelling, redness and induration (8cm X 8cm) on left upper arm at DPT injection site. Occurred 24 hours after shot.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 23Feb2021 (Lot number: EN6200) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 IMMUNISATION. The following information was reported: DISORIENTATION (non-serious), outcome "unknown", described as "Disorientation"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "Confused"; MALAISE (non-serious), outcome "unknown", described as "I don't feel very good with my head/giving something in my head". No follow-up attempts are possible. No further information is expected.
Parental report of hives.  (Not seen by the provider)  Responded to Bendaryl.  No report of respiratory distress/wheezing.
Migraine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 Immunization. The following information was reported: MIGRAINE (non-serious), outcome "recovered".  Additional information: A male patient called and stated, "Our COVID booster almost took out his legs, and he don't appreciate that". Caller also stated, "(incomprehensible words) product was a good one and (incomprehensible words) was a piece of crap and if he had the money, he'd do us for". Caller also added, he got the same effect for the COVID booster, weakness and pain on both legs". "he don't need that". Caller verified that the product was the Pfizer COVID-19 vaccine booster dose and mentioned that "the first two of the vaccine, the second one gave him a 5-day migraine which is understandable because it's (incomprehensible words) family".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I drew up 0.2 ml of the Pfizer vaccine without diluent by mistake and my co-worker, , administered this to the stated patient. I attempted to contact the patient's mother after I realized my error and have left several voicemails with no returned call. I was advised that the 2nd dose of the vaccine should be administered on time as long as no adverse side effects occurred and no readministration was needed.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 19-OCT-2015, the patient was vaccinate with ZOSTAVAX (0.5 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 35 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
40yo G7P3215 pregnant with EDD 7/28/21.   Patient had h/o preterm delivery x2 and was receiving Makena (hydroxyprogesterone caproate) weekly IM injections, last dose 5/13/21.  Pregnancy was complicated by AMA, had low risk NIPT, 2nd tri state screen, and normal level 2 anatomy ultrasound.  She was diagnosed with GDM A1 5/14/21.  Patient seen 4/29/21 at 27w with normal pregnancy.  Next visit 5/20/21 was diagnosed with IUFD as no heart tones noted.  She was not clear on last time fetal movement felt, but thought that demise occurred in the week prior to visit.   Received Pfizer COVID vaccinations 4/8/21 and 5/6/21.   She had induction of labor and delivered stillborn infant on 5/21/21 with birth weight 1305g.  Gross examination was unremarkable as was work up - will include below in item 19.
This spontaneous report as received from an other health professional refers to a patient of unknown age. On 21-JUL-2017, the patient was vaccinated with GARDASIL 9 lot # M042853 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA004691: US-009507513-1708USA004693: US-009507513-1708USA004694: US-009507513-1708USA004695: US-009507513-1708USA002122.
I woke up in the middle of the night very uncomfortable. I had a slight stabbing pain on one side of my ribs like a rub on my lung. I felt crappy the next day. It resolved the next day I mentioned it to my doctor on my next visit.
6 days after vaccination she became fussy.  This progressed and by 8 days after vaccination she had projectile vomiting and bloody/mucosy diarrhea.  She was seen in our office and subsequently admitted where intussception was confirmed and treated.
I WAS AWAKEN ON SUNDAY, OCTOBER 23, 2022 AT 2:30 AM, WITH A SENSATION OF BURNING FLUID VIBRATING IN MY LARGE TOE ON MY RIGHT FOOT; THIS SENSATION CONTINUED IN THE INTIRE RIGHT FOOT.  THE DISCOMFORT WAS SO INTENTS, THAT I REMOVED MYSELF FROM THE BED, AND APPLIED ALCOHOL THAT OFFERED SOME RELIEF.   I NOTED WHERE THE VACCINE WAS GIVEN IN THE ARM, THE AREA FELT VERY WARM.  I ASSOCIATED THE TWO HAD SOME CONNECTION; THEREFORE I WANTED TO REPORT THE ADVERSE EVENT.
She got dizzy & didn't do well; DIdn't do well; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (She got dizzy & didn't do well) and MALAISE (DIdn't do well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced DIZZINESS (She got dizzy & didn't do well) and MALAISE (DIdn't do well). At the time of the report, DIZZINESS (She got dizzy & didn't do well) and MALAISE (DIdn't do well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided. Patient friend was not sure regarding the vaccine but thought it was Pfizer.
I went in to get my booster and felt the liquid go up into my shoulder and up neck, into my skull. On Monday, 12/6, after my shower in the morning, my lymph nodes were swollen and I was very tired; with a sore throat. I noticed there was redness on my lymph nodes, which died down in the same day. Today, on 12/8, my throat is sore and my lymph nodes are still swollen.
Day 8 after vaccine developed a reddened area with itching.  Slight swelling.
Foot pain; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Foot pain) 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.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Foot pain). At the time of the report, PAIN IN EXTREMITY (Foot pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The nurse asked whether she should take a Medrol dose pack first for her foot pain or take her booster dose of the Moderna COVID-19 vaccination before she goes on vacation in a few weeks. No treatment  medications were reported.
Information has been received from a licensed practical nurse concerning a 6 year old male who on 03/28/2001 was vaccinated with one dose of varicella vaccine. On 04/11/2001 the pt developed a rash and "other lesion." The LPN reported that the pt's sibling also was vaccinated with one dose of varicella vaccine, that same day, and developed side effects. The pt sought unspecified medical attention. Upon follow-up, the physician reported that the initial adverse event pertained to the injection site and that the condition resolved. Additional info has been requested.
Hives noted on ankles, wrists, buttocks, no wheezing heard but did develop cough - noted more hives near site of HIB and Prevnar.  Hives came and went for less than 28 hours.
I missed the 2 to 6 month window; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st shot on 11th November 2022).   On 21-AUG-2023, the patient received the 2nd dose of Shingrix. On 21-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: I missed the 2 to 6 month window).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 11-Oct-2023 The patient stated that since she missed the 2 to 6 month window, she should get a follow-up shot between 21st October 2023 and 21st March 2024. The patient stated that the phone was a landline in the home, no texting, you may leave a message. The reporter did not want GlaxoSmithKline to contact her physician.  The patient received 2nd shot of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Felt like funny bone was hit although the needed hit no bone; tingling and numbness in arm; now cannot raise arm.
1/2 hour after receiving Hep B vaccine #2, had onset of headache over Right eye with body chills. Next day, complained of soreness at injection site. On 7/15/02 still complained of not feeling well with body aches.
This spontaneous case was initially received on 28-SEP-2015. The case report was received from a(n) Health Professional and concerns a(n) 65 year old female patient. The patient has no pertinent medical history and no drug reactions/allergies. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug9s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 09-SEP-2015 - unknown stop date, Batch  no: U57407, Route of administration: Unknown, Dose: 0.5 ml, Site: Opposite arm to ZOSTAVAX administration. Additional suspect drug(s): PREVNAR13 and ZOSTAVAX, Site: Opposite arm to AFLURIA administration.  Reaction(s)/event(s) and outcome: On 17-SEP-2015, 1 week 4 days after starting / treatment with AFLURIA the patient experienced Injection site was painful/pain at the injection site (non serious, outcome: Recovering / Resolving), Injection site reaction (non serious, outcome: Recovered / Resolved). On an unknown date but by 21-SEP-2015 when the pharmacist spoke to the patient, after starting / treatment with AFLURIA the patient experienced the redness encompassed the patient's whole tricep and down onto the elbow of the patient (non serious, outcome: Recovering / Resolving), Injection site was red (non serious, outcome: Recovering / Resolving), Injection site was warm to touch (non serious, outcome: Recovering / Resolving). The pharmacist stated there was no visible rash outside of the redness on the arm of the patient that was administered ZOSTAVAX. The patient began to experience pain at the injection site of the ZOSTAVAX on 17-SEP-2015. The patient said she could "feel" the injection site reaction coming in the arm that got AFLURIA on 17-SEP-2015, however, the reaction did not appear until 18-SEP-2015. The injection site reaction resolved by itself. She is feeling fine. It is unknown whether the patient has received AFLURIA before. Event treatment: The patient has not treated her reaction. Reporter's assessment; Not reported.
An 88-year-old female patient fully vaccinated and boosted (11/19/2021), found COVID-19 positive 1/18/2022 on admission to hospital. This patient admitted through the emergency room because of severe nausea and vomiting with abdominal pain, which was not easily identified. The patient was very dehydrated due to prerenal azotemia with metabolic acidosis. She was given fluid boluses, and maintained on IV fluids (ongoing). Ultrasound of the abdomen came back positive with severe cholelithiasis. Consultation was made for general surgery. She was taken to the OR for exploration. Patient found to have a large stone in her colon. Enterotomy made and the stone removed. Apparently, patient fell due to a dizzy spell. The patient denied any history of seizure. Positive for cough with difficulty breathing. D-dimer >10,000. Lovenox given for DVT prophylaxis.  IV antibiotics. The patient has acute renal failure. Cr 2.61. She is already on IV saline infusion. Patient discharged.
gout resolved after COVID 19 vaccine; This is a spontaneous report received from a contactable reporter(Pharmacist) reported that a male patient received the first dose of BNT162B2at single dose in 2021 for COVID-19 immunisation. Relevant history included gout. Relevant concomitant drugs were unknown.  The patient could not open and close his hand due to severe gout. The patient was concerned about getting the shot because the gout had been going on for months.  The pharmacist told the patient he needed to get this shot because it was going to protect the patient from COVID and that was more important than any potential issues. He got the patient's confidence, gave the Pfizer COVID vaccine and the patient came in the next day and spoke with the pharmacy manager. The patient reported that after months of having issues, he could open and close his hands, the gout was gone. The patient thanked him and wanted to hug him. The pharmacist stated that it may have all happened to happen to same time or maybe it was serendipity. The situation was interesting and had made him a legend at the pharmacy. The patient came in for his second shot and he was reportedly still symptom free.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Patient vaccinated x3 (Moderna): 2/26/21, 3/26/21, 8/25/21  Patient admitted to hospital 1/24/22 after testing positive for COVID19
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for the 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes, on 25-SEP-2013 for 45 minutes, on 26-SEP-2013 for 2 hours and 30 minutes and on 01-OCT-2013 for 4 hours. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked).
Got a really bad headache starting around 5:00 pm on 12/29/20 , Headache remained for about 3 days. 12/30/20 around 11:00 am starting to get severe low back pain radiating to the upper back , breathing taking pain this lasted into the night of 12/31/20.  extreme fatigue still currently 1/4/2021 , Agitation and mental offset ( Angry) and emotional for 5 days.
she had the Spikevax on 07Nov2023 and in the afternoon had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines.; she had the Spikevax on 07Nov2023 and in the afternoon had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines.; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (she had the Spikevax on 07Nov2023 and in the afternoon had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines.) and CHILLS (she had the Spikevax on 07Nov2023 and in the afternoon had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 032M20A and 045A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Left ventricular dysfunction (on medication) and Left bundle branch block (on medication).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (she had the Spikevax on 07Nov2023 and in the afternoon had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines.) and CHILLS (she had the Spikevax on 07Nov2023 and in the afternoon had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines.). At the time of the report, MALAISE (she had the Spikevax on 07Nov2023 and in the afternoon had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines.) and CHILLS (she had the Spikevax on 07Nov2023 and in the afternoon had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment medication reported.   This case was linked to MOD-2023-748940, MOD-2023-748947 (Patient Link).
Local skin/soft tissue reaction on mid outer Rt thigh approx 8 cm in diameter. No fever or SOB.
Dizziness, Headache, chills, sweats Narrative: Received 2nd vaccine for covid on 2/6/21 early in the morning. On 2/7/21 around 01:30 am started experiencing dizziness, nausea, body aches, chills, sweaty. Employee reports that feels better today has taken aleve to help with some body aches. Employee was advised that these are normal side effects of the vaccine. Advised to follow up with PCP if anything worsens.
THERE WERE NO ADVERSE AFFECTS REPORTED. PATIENT STATED SHE WAS FINE. VACCINE WAS GIVEN THREE WEEKS TOO EARLY.
pt recv vax & devel a bad cold;w/in 2 days post vax pt had diff breathing was hosp & regular mechanical ventilation;pt was d/c from hosp p/2wk;
Right upper arm 3 cm circumference arm at injection site with positive swelling and redness, no temperature, no pain to touch and no distress. Localized reaction not cellulitis.
pt recv vax & devel cough & c/o backache, eyes looked puffy,  color getting pink;MD called epi given w/02 via mask & mins p/pt feeling well;