chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine vial potentially stored for longer than recommended period, potentially stored up to 28 days , No illness, no adverse reactions
Due to a faulty needle, clinical is unsure if complete dose was administered. Per clinician administering vaccine needle prematurely retracted.
12 minutes post vaccination, patient began to report mid sternal chest pressure. 6/10 in intensity and also reported shortness of breath.  MD STAT called and team came to evaluate. Dr. assessed patient and approves patient to go home from vaccine clinic with no further observation. Symptoms improved.  VS as follow :  HR 76 BP 146/71 RR16 O2 Sat 100% on RA.
TDaP was ordered for administration, this nurse administered DTaP.  GSK was notified and sent letter stating vaccine does not need repeated. Give TDaP as scheduled between 11-12y as scheduled.
long-lasting headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 31Mar2021 (Batch/Lot number: unknown) 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 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "long-lasting headache".  Additional information: Caller states that she has experienced long-lasting headache ever since she got the second dose of the Pfizer-BioNTech COVID-19 Vaccine. She had the second shot on 31Mar2021. Somewhere around May or June, She started getting these unrelenting headaches. They're always there. The salient difference in every other routine was the vaccine. There was nothing else that changed". She never had issues with headaches. She read somewhere, some abstracts, that the Moderna vaccine can cause something similar. Do you have information on sustained headaches caused by the Pfizer vaccine. Headache has been reported, but there's no info on how long it lasts (e.g. long-lasting headache). She was asking Were booster shots the same formulation as the other vaccines. It's been almost a year since she got the second dose. Do she need to start over or should she just get the booster dose. First, she was curious if there were any reported effects of the Pfizer Covid vaccine regarding headaches starting a substantial amount of time after the vaccine maybe a month or two later. How can she access that information. Caller states this was based on her experience however she was not sure if there was a connection. Caller states her second question, she had both vaccines, the last one was 31Mar2021, caller states she has not been boosted, her question was can she get a booster now or does she need to get the first and second dose again. Caller states she does not have a ton of time, just wants to make clear she does not have any clear connection between the vaccine and her experience, states she did find a report on the Moderna vaccine but it was all medical jumble, states there may have been a connection there. The lot number for bnt162b2 was not provided and will be requested during follow up.
On the 28th, she began complaining of sore right shoulder. By 30th, moving her arm was extremely painful. That morning, her temp was 95, By 8pm, her temp was 101. We took her to the ER.  The ER drained fluid off her shoulder and found extremely high white blood cell count and sepsis had set in. They hospitalized her last night (Jan 30). She is on high dose of antiobiotics. She hasn't been ill and this week, only trip from home was for a curbside pickup.
vial contains 10 doses however she has been using 1 or 2 at most before she has to throw the whole bottle of 10 doses away with no reported adverse event; Initial information received on 17-Mar-2022 regarding an unsolicited valid non-serious case was received from a pharmacist.  This case involves an unknown age and unknown gender patient who had been using 1 or 2 at most (vial contained 10 doses), before the pharmacist had to throw the whole bottle of 10 doses away 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 an unknown dose of suspect IPV (VERO) (lot number and expiry date not reported) via unknown route in unknown administration site as prophylactic vaccination.  It was reported that the vial contained 10 doses however she had been using 1 or 2 at most before she had to throw the whole bottle of 10 doses away with no reported adverse event (intentional product misuse) (unknown latency) following the administration of IPV (VERO). It was because when the pharmacist looked it up it said to discard the vial 28 days after opening. She stated that she was informed by another pharmacist that it should last longer and she needed to confirm this. She stated that if this is the case she did not know how she could keep ordering one bottle and just dispensing one dose. After the information was provided to her she stated that she wishes she had known this sooner because this was the 4th bottle she had thrown away. She stated that she was torn ordering the vial for a patient over and over and that she did a lot of vaccines.   Action taken with poliomyelitis vaccine (inactivated) (ipol) was not applicable.  It was not reported if the patient received a corrective treatment for the event (vial contains 10 doses however she has been using 1 or 2 at most before she has to throw the whole bottle of 10 doses away with no reported adverse event).  At time of reporting, the outcome was Unknown for the event vial contains 10 doses however she has been using 1 or 2 at most before she has to throw the whole bottle of 10 doses away with no reported adverse event.
Less than two hours after the shot was administered, I started to feel nauseous and overall not well, along with fatigue.  I had chills and remained cold for the next 14 or so hours.  The worst part was the uncontrollable movements of my entire body, which started as almost a feeling of crawling inside then quickly progressed to moving.  This began about 6:30 pm and lasted until almost midnight.  At times, it felt like my muscles were tightening up so much that they were going to spasm.  I have never experienced this and it was quite worrisome.  It was what I imagine people with Parkinson's feel.   I had a reaction to the first shot on 2/14/21 about 26 hours after.  Severe fatigue, body aches and headache.  All were terrible.  Only lasted about 12 hours.
The pt started running a fever exactly one week after MMR and varicella. The next day got very high and went into febrile convulsion went to ER and verified no bacterial infection. Fever medicine did not take it down had to use Tylenol and Motrin. Next day fever still high and slight rash after fever.
It is itching really bad; He hasn't received 2nd dose yet; Rash/ rash on right leg/ spread to knees, feet, arms, and his belly; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (He hasn't received 2nd dose yet), RASH (Rash/ rash on right leg/ spread to knees, feet, arms, and his belly) and PRURITUS (It is itching really bad) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN and AMLODIPINE for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced RASH (Rash/ rash on right leg/ spread to knees, feet, arms, and his belly). On 26-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (He hasn't received 2nd dose yet). On an unknown date, the patient experienced PRURITUS (It is itching really bad). The patient was treated with TRIAMCINOLONE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (He hasn't received 2nd dose yet), RASH (Rash/ rash on right leg/ spread to knees, feet, arms, and his belly) and PRURITUS (It is itching really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included flex pen for diabetes and other BP medications.
lymph nodes in neck, groin and armpits / active not painful but throbbing.; This case was reported by a consumer and described the occurrence of lymphadenopathy in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2020, the patient received the 1st dose of Shingrix. In 2020, less than 3 months after receiving Shingrix, the patient experienced lymphadenopathy. On an unknown date, the outcome of the lymphadenopathy was recovering/resolving.   It was unknown if the reporter considered the lymphadenopathy to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for himself. The patient experienced lymph nodes in neck, groin and armpits which were active not painful but throbbing. This had partially resolved or had started to subside.  The lymph nodes of the groin and armpits were no longer active, but the lymph nodes of the neck were active till the time of reporting (going on a bit) despite the fact that the patient was not sick. The patient did not have a cold and had been tested a couple of times for COVID and was negative. For tolerance to the 2nd dose of Shingrix, refer case US2020AMR252391.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR252391:Same patient
Immediately after injection soreness at the injection site on left arm. A little tired in the evening. Woke up at 12:30 AM chills, headache  and a fever of 100.9.   1:30AM Fever still persistent along with muscle aches. 5:30 AM took two Advil which subsided headache a bit.   Around 10 AM  started feeling nauseous.  Vomiting started 12:30 PM. severe nausea and dry heaves in vomiting persisted throughout the day until 8:00 PM.  Fever was now around 99. Weakness and fatigue. headache subsided nausea subsided a bit. Woke up the next morning feeling weak but better.
After receiving vaccine, Patient was waiting in front of the pharmacy when parent yelled for my attention. I went out immediately to check on patient. She was swaying and eyes were fluttering. Patient was still communicating verbally and said she felt light-headed, was feeling sick, and extremely pale. Got patient a trash can and cold compress to apply to neck and face. She dry heaved, but no vomit was produced. Parents stayed next to patient and I checked on her every 5 minutes. She was okay to leave after sitting for approximately 30 minutes with color returning to her face. No other reaction occurred during this time.
On 4/12 at 6PM felt weak, had fever and chills (felt real hot but did not take temp). On 4/14 5AM neck felt stiff. This went away that day at 3PM. On 4/15/ fine raised rash on inner left arm from wrist to elbow. Soreness in left deltoid but no redness, rash or swelling, rash resolved on 4/16.
Child received immunizations on 07-25-2007 and started with warmth, pain, swelling, and redness to right arm around the site itself on 07-26-2007 around 10:00 a.m. Grandmother called us on 07-26-2007 around 11:00 a.m. saying that it was still red, warm to touch, and swollen but the swelling extended almost down to his elbow now and it was hard to touch and that he had a non-raised rash all the way to his elbow. The child also complained of itching and was very irritable the grandmother said. She was instructed to see the child's MD and she took him around noon on this same day. The doctor ordered Benadryl by mouth for 24 hours and then PRN. This was on Friday and the grandmother said by Sunday the swelling had resolved but the site was still a little hard to touch. This child has had a previous reaction when receiving DTaP but not as extensive. Permission was also received from MD to receive future immunizations.
Pt contracted COVID-19 in Dec/Jan 2022 and died on 1/6/22 due to COVID complications
my hands are swollen; 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 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "my hands are swollen". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shot given 10/2/2020; Second 10/3//2020 the day following injections, I had fever, severe body and head aches.  100.3+ for next 7 days.  Treated with Ibuprofen.  Fever not controlled, each day worsening of symptoms.   On 11-10-2020 I called primary care provider, who recommended I go to the regional hospital emergency hospital.  I had blood tests including COVID-19.  I was treated with IV acetaminophen 1000mg/100ml IV.  Was treated with COVID precautions.   I was released home with instructions.  Test results for COVID was Negative on 11/12/2020.  I had an additional day of fever and body aches, but they resolved.  I talked with the pharmacist regarding this being worst result from flu shot that I have ever had.  They suggested that I file adverse event regarding the shot.
Woke up at 5:30am started feeling faint. Laid down on the floor, then sat up hoping the feeling would pass, started to stand up and collapsed on the floor for 2 minutes, unconsciousness. Woke up after 2 minutes feeling weak, having heart palpitations, had a headache. Went to the emergency room at 7am.
Pt recvd Pneumococcal vax & devel a local reaction which consisted of cellulitis & swelling of the entire arm; pt recvd inject of cortisone and w/in 3 to 4 days the sx subsided; no further details were provided;
This spontaneous report as received from a pharmacist refers to a 81 year old patient. On 22-OCT-2013 the patient was vaccinated with ZOSTAVAX (19400 plague forming unit (PFU), 0.65 ml, subcutaneous, lot # H012521, exp. date: 09-OCT-2013). It was reported that the patient was administered expired dose of ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Information was received on 28-OCT-201 from a 67 year old female patient regarding herself. Medical history/concurrent conditions included high cholesterol, high blood pressure depression and seasonal allergies. Concomitant medications included ZOLOFT, simvastatin and unspecified over the counter nasal spray. On 24-OCT-216 the patient received PNEUMOVAX 23. Later that day, the patient experienced severe pain and swelling at the injection site. The patient recovered. The reporter did not rate the causal relationship. No further AE information reported. Additional information is not expected.
redness & raised area 24hr p/vax no apparent fever; area 2inch in diameter;
Vaccine Administration Error- Patient received a 1st dose of Moderna on 12/27/21. Patient was 17 years old and not the approved 18 years old + for Moderna.
Aches, chills,  generalized soreness, inj. site pain, localized redness and  swelling.  Cough, minimal  yellow phlegm, hoarseness.  Most sx were better after 24 hrs.  The non-productive cough decreased over the next 3 days .   *    I did not check my temp when chilled- the chills lasted about 2 hours only.
Arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was sore at the injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore at the injection site). At the time of the report, VACCINATION SITE PAIN (Arm was sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
The pt received an extra hepatitis dose inadvertently and parent reports no adverse events. Manufacturer was contacted and stated that an extra dose "not found to be harmful".
Shaking- whole body Muscle spasms- arms, leg High fever Severe headache
patient was in the observation area and fainted from her chair to the floor. Observation nurses were able to arouse her immediately and transferred her from the observation area to the EMS room via wheelchair. Patient reported that she has "issues" when she gets her blood drawn bur has never passed out before. She denies chest pain, shortness of breath or nausea at this time. She was given H2O and allowed to rest on the gurney, all vitals were WNL 128/87 pulse 75 pulse ox 100%. Pt was discharged in stable condition to father who was driving her home @ 12:35pm.
Pt received vaccine morning of 10/31/16. She went to work that night and returned to clinic the next morning after her shift. Her arm had become painful, swollen, warm, and red. Pt reported headache as well.
LOSS OF APPETITE; SLIGHT CHILLS; TENDERNESS AT THE SITE; FATIGUE; SEVERE MUSCLE ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On JUL-2021, the patient experienced loss of appetite. On JUL-2021, the patient experienced slight chills. On JUL-2021, the patient experienced tenderness at the site. On JUL-2021, the patient experienced fatigue. On JUL-2021, the patient experienced severe muscle ache. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from loss of appetite, fatigue, slight chills, and severe muscle ache, and had not recovered from tenderness at the site. This report was non-serious.
Client reports temp of 103.5 degrees F, headache, chills, nausea, vomiting 12 hours after receiving TDP. He took TYLENOL and Ibuprofen, applied cold compresses to armpits. Temp came down. No temp after 24 hours. No complaint of redness, swelling, pain at injection site.
Facial paralysis/Bell's palsy/lip and tongue paralyzed; Lip and Tongue Paralyzed; reports neck, ear & head pain that started on 21Mar2021; reports neck, ear & head pain that started on 21Mar2021; reports neck, ear & head pain that started on 21Mar2021; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 13Mar2021 between 15:00-16:00 as SINGLE DOSE for COVID-19 immunization. Medical history included diabetes mellitus from 2016 and ongoing States it started 5 years ago, and it is under control, hypertension from 2016 and ongoing States it started 5 years ago, and it is under control. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks. On 21mar2021, the patient experienced neck, ear & head pain on the left side. On 24Mar2021, the patient experienced facial paralysis, lip and tongue paralyzed the left side of the face, bell's palsy. The patient states that everything started before on sunday then on wednesday he started to get paralyzed on his face. The patient went to the ER on 24Mar2021 and they thought he was having a stroke, so they did a CT and MRI and his brain is fin and Stated that the Neurologist diagnosed him with Bells Palsy. He was admitted to the hospital on 24Mar2021 and discharge 25Mar2021 at 18:00. The patient enquired about getting second shot and he wants to know what is going to happen if he gets the second shot, was it recommended or not recommended. The patient underwent lab tests and procedures which included computerized tomogram: normal on 24Mar2021 brain is fine, magnetic resonance imaging: normal on 24Mar2021 brain is fine. Therapeutic measures were taken. The patient was treated with Acyclovir and Methylprednisolone. The outcome of the events facial paralysis, lip and tongue paralyzed were not recovered and for neck,ear and head pain was recovering  Information on the lot/batch number has been requested.
PT C/O OF DIZZINESS, NAUSEA, AND STATES THAT "ALL SHE READ ON THE INTERNET IS WHAT SHE IS FEELING." VS@ 10:10 AM BP 123/70 HR 67 SpO2 99% VS STABLE. PT WAS OBSERVED FOR 15 MINUTES UNTIL SHE "FELT FINE" AND SENT HOME.
I got very sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's mother had shingles two times).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported.  The patient saw his/her mother had shingles 2 times and hence decided to take the vaccine and got very sick but thought that it was worth it.  The patient stated that having shingles was worse than the effects of the vaccine. The follow-up would not possible as no contact details were available. For tolerance of the second dose, refer US2021AMR205345 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205345:Same patient, same reporter, same suspect, different dose
This spontaneous report was received from a health care professional refers to an unspecified patients of unknown demographics. ON 20-JUL-2015 the patients were vaccinated with M-M-R II (lot #K002285, expiry: 12-NOV-2015; L005291, expiry: 17-FEB-2016; L008684, exp 13-MAR-2017) (dose and route  unspecified) which were exposed to temperatures outside of the recommended range. No adverse effects have been reported. There was no product quality complaint involved. No additional information was provided. The outcome of incorrect product storage was unknown. This is one of several reports received from the same source. Additional information has been requested.
Pt received the first Covid Pfizer vaccine.  20 mins later developed itching and redness on her back and legs.  Pt was monitored by RN,  Pt was seen by Dr.
On the 7/10/2022 had a harsh sore throat. Took a home COVID-19 test and it was negative. Then on 07/11/2022 had brain fog along with sore throat. Home tested again on 07/12/2022 and it was positive. Had a telehealth appointment with physicians at the local medical center and was prescribed PAXLOVID. COVID-19 home test negative. Tested neg on 07/20.