chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial information received on 8/17/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 38 year old female patient received 0.1ml of TD ADS ADULT vaccine administered ID in error instead of TUBERSOL. The site of administration was not reported. Approximately three and a half weeks alter, the  patient reported that she had developed an 8mm pustule with a white center at the administration site. At the time of this report, the patient was scheduled to be seen by a dermatologist. It is not known if she recovered from these events. From additional information received on 12/23/04 from a health care professional, it was reported that the patient received the vaccine in the forearm. Reportedly, the patient never went to see a dermatologist, but was seen in the emergency department instead as she could not get a clinic or her own primary care physician to treat her. Per the reporter, the patient went to the emergency department inappropriately and was later admitted to the psychiatric unit for behavioral/drug seeking problems. The reporter also stated that the report is unreliable as it was never verified by the vaccine administrator that the event occurred as stated by the patient. It has been presumed that the patient recovered from the event, which never progressed beyond a pustule and was considered to be a minor event. Vaccine administrator and responsible physician information was also provided.
temperature excursion on open IPOL;due to human error; total time out of range is 3 hours and 10 minutes with a minimum temperature of 29.3F with no reported adverse event; Initial information received on 08-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who had temperature excursion on open ipol due to human error; total time out of range is 3 hours and 10 minutes with a minimum temperature of 29.3f with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  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 IPV (VERO) (lot T1D481M,expiry date 25-JUL-2022) via (unknown route,administration site,dose,strength,frequency) for immunization.  On 02-FEB-2022 the patient had temperature excursion on open ipol;due to human error; total time out of range is 3 hours and 10 minutes with a minimum temperature of 29.3f with no reported adverse event (product storage error) (unknown latency) following the administration of IPV (VERO).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (temperature excursion on open IPOL;due to human error; total time out of range is 3 hours and 10 minutes with a minimum temperature of 29.3F with no reported adverse event).  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.
Head ache, fever,  chills, body aches, fever blisters, swelling of the injection site and fatigue
I found out I was pregnant late July. This was my third pregnancy, I had never miscarried before. Relieved the vaccine 8/2. I started bleeding heavily 8/9 and continued thru 8/17. Test confirmed pregnancy was lost.
redness & swelling lt thigh 1 x 0.5cm not hot or glossy;
I had extreme dizziness, facial numbness, tongue tingling and was observed during the observation period. Later that day I had nausea and fatigue that lasted for 12 hours.
Information has been received from a registered nurse concerning a 20 year old female who on 09-OCT-2008 was vaccinated with the first  0.5 ml dose of GARDASIL vaccine (lot#661764?0650X). There was no concomitant medication. One week later after getting GARDASIL vaccine the patient developed alopecia, she would not be taking any more doses of GARDASIL vaccine. At the time of reporting, the outcome was unknown. No additional information was provided. The patient sought unspecified medical attention. Additional information has been requested.
Little blue where the shot was given; Little blue where the shot was given, so it feels like a mosquito bite, it's a little swollen and it hurts; Little blue where the shot was given, so it feels like a mosquito bite, it's a little swollen and it hurts; I had Pfizer Booster shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number: unknown), as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose and Bnt162b2 Second dose), for COVID-19 immunization. The following information was reported: On an unspecified date, the patient had Pfizer Booster shot (unspecified shot) yesterday and had a side effect, it's little blue where the shot was given, so it feels like a mosquito bite and it's a little swollen (and it hurts). The clinical outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Roughly 6 hours after initial vaccination muscle spasms in right eye lid began. These have occurred throughout the day, though not non-stop, every day since the first dose of the moderna covid vaccine
Around 5 minutes after injection patient felt dizzy, warm, sweat, then experienced syncope.  Fell with no injuries.  Regained consciousness immediately.
Patient Parent indicated on information form that patient was 7 years old when in actuality patient was 6 years and 8 months old. Patient received TDap instead of Dtap.
Patient has complaints of chills, dizziness, rash under armpit, moderate left arm swelling, and mild nausea. Reaction is at the site of injection and in the armpit.
30Nov90 TD @ .5cc IM lt deltoid admin. Pt returned to clinic 1Dec90 c/o soreness lt upper arm-shoulder to antecubital area.Area red,hot,tender,induration, 15cm X 15cm
Patient stopped crying, had a blank stare, seizure like reaction. Happened 2 times within a minute.
Patient received the Covid-19 vaccine. She reports symptoms of Anaphylaxis Patient was dizzy, light-headed, and BUE tingling @1111.  At this time denies shortness of breath and difficulty breathing.  Patient was given juice, water, and granola bar.  No difficulty swallowing noted.  1116: Patient noted that she was feeling worse with throat tightness without difficulty breathing.  Vital signs stable with 100% O2 saturation.  1118: Rapid response called.  Patient reports throat feels tighter and difficulty swallowing noted.  Lungs clear, HR regular both radial and apical.  I have observed for 40 minutes. Treatment/intervention:  Patient observed.  Taking given water, juice, and granola bar.  Vital signs taken every 5 minutes per protocol.  1120: rapid response team arrived.    1111 98.9 82 128/73 16-18/100%  1116 93 148/86 16-18/100%  1120 95 164/95 16-18/100% Patient took 2 puffs of her personal albuterol inhaler  1127 Care transferred to rapid response team.  Patient transported to ER via cart.
Severe muscle and bladder spasms for several hours causing several falls and incontinence.  Occurred with each dose of the vaccine. Worse with each subsequent dose.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with expired Moderna vaccine) and PRODUCT STORAGE ERROR (Vaccine Placed in refrigerator on 11-Jan-2022 and administered on 01-Mar-2022) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Pfizer (Batch no: EL9265.) on 28-Jan-2021 and Pfizer (Batch no: EL9265.) on 18-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with expired Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine Placed in refrigerator on 11-Jan-2022 and administered on 01-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with expired Moderna vaccine) and PRODUCT STORAGE ERROR (Vaccine Placed in refrigerator on 11-Jan-2022 and administered on 01-Mar-2022) 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 patient received booster dose on 01-Mar-2022. The vaccine was  placed in the fridge on 11-Jan-2022 and doses were administered more than 30 days after 11-Jan-2022. The vial did not experience any temperature excursions. No patient had reported adverse reaction. The patient did not report adverse reaction to the reporter's knowledge. No treatment medications were reported.
LA-dull, constant pain from elbow to shoulder. loss of range of motion of arm, painful if laying on that arm.
Case number PHEH2013US002487, is an initial spontaneous report received from a healthcare professional on 23 Jan 2013: This case refers to a multiple patients (3- patients). These patients may have received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M11081) intramuscularly without being reconstituted with Men A component on an unspecified date. No adverse reaction reported following this administration error.
Slightly raised 3cm wide red circle at injection site. Approx. 12hrs after vacc. (patient was sleeping so may have been sooner). Tender to touch. Vacc. time Tues about 5:30pm 9/20/11. Noted on waking Wed 9/21/11 7am.
12/28/14 - 24 hrs after FLUZONE administration, pt developed a 10 cm area of erythema around the flu vaccine administration site as described to Dr ER. Pt treated Kw/ KEFLEX but thought to have local reaction to flu vaccine.
Recipient began complaining of feeling "jittery," nauseated, shooting pains from the injection site to the neck and headache. She stated that she was feeling better after approximately 30 minutes and that all symptoms had resolved other than the neck pain and headache.
Seizure 8/25/08-records received for DOS 7/7-7/9/08-DC DX: Seizure disorder secondary to vaccinations. Admitted via ED with history of seizure while in car seat, became stiff, pale and then lethargic. Postictal in ED.
came into peds office 24JUL94 late by ambulance w/febrile sz t104.4 R; had 2 seizures; MD wishes to schedule EEG; pt had sz seen in ER in JUL approx 2 wks prior;
Fevers and  chills, large scarlet red mark/welt around injection site of around 4 inches wide, pain/redness/warmth around injection site. Red welt was settling down on 1/3/19.
In less than 24 hours, headache, fever 103, aches, shakes.    In second 24 hours after shot, fever down to 101, aches, shakes, headache.  In 3rd 24 hour period after shot, fever down to 99, no shakes, no aches, only headache.  by 4th 24 hour period after shot, not adverse symptoms.  All normal.
Initial report received from a healthcare professional on 16 April 2013. A 30-year-old female patient had received intramuscular first dose of ADACEL vaccine (Lot number: U4612AA, anatomical site of administration was not reported) on 16 April 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was on 13 September 2012 and the expected delivery date was 20 June 2013. The patient's medical history, risk factors (e.g.: alcohol, tobacco or recreational drugs) and concomitant medications were not reported. As of 16 April 2013, the patient had no adverse event. List of documents held by the sender: None.
It was found that a box of 10 MENVEO vaccines were not reconstituted correctly so the patient only received half of the dose. Once discovered corporation was contacted, the manufacturer, and the patient was offered re-vaccination of the vaccine to provide complete immunity. The vaccine is Meningococcal conjugate MENVEO MCV40, manufactured by GlaxoSmithKline (GSK).
27 year old female with PMHx as below notable for ulcers and GERD who presents for acute onset of nausea 5 minutes after she received her 2nd covid vaccine.  Pt is A&Ox4, denies shortness of breath, denies chest pain. No angioedema, rash, swelling, stridor noted. Airway intact. VSS. Afebrile. Transported pt to ED for further evaluation.
Within 2 weeks and have not stopped.  Numbness in legs, pain in legs, pins and needles in legs, burning in legs, pain in lower back, pain in spine, severe headaches, headaches behind eyes, pins and needles in face, blurry vision, temporary loss of vision, jaw pain, locking fingers, unable to stand up, unable to walk, unable to run.
sore arm; This is a spontaneous report from a contactable other health care professional (Nurse). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06Aug2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient only had a sore arm, nothing else. The outcome of event was unknown.  The batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
No adverse effects reported; one patient received one dose of PROQUAD that was reconstituted with MENACTRA instead of sterile diluent; one patient received one dose of PROQUAD that was reconstituted with MENACTRA instead of sterile diluent; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 15-MAY-2019, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R018778, expiration date 29-DEC-,2019 subcutaneously (strength and anatomical location were not provided), that was was reconstituted with meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) lot # U5916AA and expiration date of 27-JUN-2019 instead of sterile diluent. No adverse effects were reported.
She started with left leg jerking.  then it was right arm jerking.  Then all legs and arms jerking for about 10 seconds She said her eyes felt like a bright light
about ten minutes after injection was given Patient started to complain of a sore and scratchy throat. Brought back to med obvs at 11:36 and was alert and stable at that point in time. Initial VS were: HR: 48, BP: 117/69, SPO2: 99. Patient remained in med obvs with improvement in throat sensation, was able to tolerate drinking water, denied pain or swelling in throat just complained of it feeling dry. At 12:30 patient was stable and felt well enough to go home.
SORE ARM--EVEN NOW THAT IS IT A MONTH AFTER VACCINE HER ARM IS STILL SORE.
Body aches, fatigue, fever of 101.1, diarrhea (one time), nausea throughout the day, vomiting (one time)
Chronic stabbing pains at the injection site and radiates a couple of inches outward around the site of injection; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 19May2021 at 15:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included post-traumatic stress disorder (PTSD), anxiety, depression and severe anemia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination, for unknown indication on unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received prazosin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 28Apr2021 at 13:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 22May2021, the patient experienced chronic stabbing pains at the injection site that radiated a couple of inches outward around the site of injection. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 26Oct2021, the patient underwent binax test for COVID-19 via nasal swab and the result was negative. The clinical outcome of the event chronic stabbing pains at the injection site that radiated a couple of inches outward around the site of injection was not resolved at the time of this report.
A Pfizer vaccine vial was reconstituted with the incorrect amount of NS (0.3 ml instead of 1.8ml) and a 0.3ml dose was administered to the patient.
pt stated that on the first day after the vax her left arm is red and itching around the injection site.  The redness is worse on the second day.  Pt has not contacted a PCP at this time.
Patient received expired vaccine. Expired 3/26 and received 3/30. No adverse effects.
Information has been received which reported that a 24 month old male who on 02-FEB-2011 was vaccinated with a dose of VARIVAX (Merck) (therapy route and lot # not provided). On 14-FEB-2011 the patient experienced vesicular rash while on therapy with VARIVAX (Merck). Patient sought unspecified medical attention. At the time of reporting, the patient had recovered. Additional information has been requested.
This spontaneous report was received from a nurse refers to a 5 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with an expired dose of M-M-R II lot # K020188, 22-OCT-2016 subcutaneous in the right thigh. The patient was also administered KINRIX and influenza virus vaccine (unspecified) and VARIVAX. Additional information has been requested.
No other AE details available at this time; Temperature excursion; This spontaneous report has been received from a registered nurse concerning a 5 years-old patient. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.       On 11-DEC-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml,  Lot # T021638, expiration date reported as 21-FEB-2021 but upon internal validation established as 21-DEC-2021 for prophylaxis.  The temperature was reported to had been at  -13.3°Celsius(C) for a period of 4 hours and 15 minutes.  No other adverse events details were available at this time.  There was digital data logger involved and  no previous temperature excursion was reported.
it felt like the reaction i generally have had with steroid injections for my spine.  I was wide awake all night.  By the following afternoon I was exhausted and no longer feeling that effect.  Nothing was done since it did not last.  It was suggested that I report it since it is not mentioned as a side effect in the list of information.
Information has been received from an office manager, physician, and medical assistant concerning a female patient over 50 years old who on 06-FEB-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot #658449/0989U) intramuscularly in the deltoid of the right arm. Subsequently the patient developed redness and swelling at the injection site. The patient recovered from the redness and swelling on an unspecified date. The physician stated that these reactions had not occurred at the office before and would like a lot check for pneumococcal 23v polysaccharide vaccine (Lot #658449/0989U). This is one of three reports from the same source. One of the patients also received the flu vaccine in the other arm. A standard lot investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and research and was released. Additional information is not expected.
Administered a Moderna Booster dose on 3/7/22 around 10:24a past the Beyond Use Date of 3/3/2022 and manufactured expiration date of 4/24/2022.  Learned of error today when examining number of doses remaining.
Vesicular lesion on upper upper, lower limbs, thorax very itching for last 48 hours.
I have daily headaches since 04/12/2021. Wednesday evening 04/12 I was working and felt a vice like grip on my head. I had acute leg pains in my sleep that evening but not since then. Every day since then I have a headache. It feels like swelling in my brain (and heat) and I'm very upset and unhappy about it. I am a very healthy with no health problems. I don't go to  doctor or even have a doctor (except a gyn). The headaches have not subsided and are causing me  quite a bit of stress.
Body aches; sleepy; Cannot walk for 3 hrs; incredibly ill; exhausted; Weak; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), GAIT INABILITY (Cannot walk for 3 hrs), VACCINATION COMPLICATION (incredibly ill), FATIGUE (exhausted) and ASTHENIA (Weak) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced SOMNOLENCE (sleepy), GAIT INABILITY (Cannot walk for 3 hrs), VACCINATION COMPLICATION (incredibly ill), FATIGUE (exhausted) and ASTHENIA (Weak). On 16-Apr-2021, the patient experienced MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Apr-2021, GAIT INABILITY (Cannot walk for 3 hrs) had resolved. On 15-Apr-2021, SOMNOLENCE (sleepy) and FATIGUE (exhausted) had resolved. On 16-Apr-2021, VACCINATION COMPLICATION (incredibly ill) and ASTHENIA (Weak) had resolved. At the time of the report, MYALGIA (Body aches) outcome was unknown.            No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up received and contain Non significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I have Rheumatoid Arthritis, and 3 days after my 2nd Shingrix shot I developed a major RA flare. The injection site became hard, red and swollen. It is now 19 days later and the injection site is still hard, red and sore, and the RA flare continues with the fingers of my opposite hand burning, stinging and remaining hot and sensitive.