chrisvoncsefalvay/vaers-outcomes huggingface dataset:
42 year old female patient was in observation are when she reported feeling dizzy. Vital signs were taken at 10:45 BP 130/50, P55, Sat 99. Patient was resting until someone came to pick her up. Patient looked anxious all the time while in observation area and refused to receive any help or transfer to a medical care institution.
This spontaneous report was received from a Licensed Practical Nurse refers to a 14 year old patient of unknown gender. The nurse reported that the patient was administered an expired dose of (Oka/Merck) VARIVAX (lot # H006539, expiry: 09-MAR-2014) on 31-MAR-2014. No adverse effects were reported. No PQC involved. Additional information has been requested.
Experienced light headedness, minimal chest tightness, increased HR and BP lasting 30 min, 4 days post vaccine injection.  I usually have low BP and HR so was unusual to experience these symptoms.
At 7pm on 1/26 (day of vaccine, 7 hours later) I noticed a fever, body aches, chills, headache, and fatigue.  The fever and chills subsided 1/27 at 12pm (although  I was also taking tylenol regularly). The body aches, headache, and fatigue lasted until 1/28  at approximately 3pm.
patient was staring in to space and very despondent; patient was staring in to space and very despondent; lost control of her bowels; lack of muscle tone; could not get up and walk; This spontaneous report was received from a licensed practical nurse via company representative and refers to a 13-year-old female patient. Her concurrent conditions included autism. The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with a second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, administered intramuscularly (anatomical location, lot # and expiration date were not reported) as human papillomavirus prevention. On an unknown date (reported as "within a couple hours of receiving the vaccine"), the patient was staring into the space and was very despondent. She also lost control of her bowels, had lack of muscle tone and count not get up and walk. Due to above event, the patient was hospitalized on an unknown date. The reporter stated that HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was the only vaccine that the patient received on that day. It was reported that the patient received treatment for the events and sought medical attention. The outcome of the events was reported as recovered.  Causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the events was not provided.
Tenderness, redness, and swelling at injection site, lethargy (24 hours)
Information has been received from a registered nurse concerning a 59 year old female with Ceclor allergy, pcn allergy, cephalexin allergy and Ceftin allergy who on 02/20/2001 was vaccinated with varicella vaccine. Concomitant therapy included Lipitor, Zestril, Lopressor and aspirin. On approximately 03/26/2001, the pt developed two lesions, both 0.5 inches in diameter that were slightly red and cracked. The first lesion was on the front of bicep and the second lesion was below the pt's clavicle. The second lesion has totally resolved. Unspecified medical attention was sought. Additional info has been requested.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 24-JUL-2018, the patient received an expired dose of RECOMBIVAX HB, per intramuscular route, lot # M033096 and expiration date on 31-MAY-2018, for prophylaxis. No adverse events were reported for the patient.
12 hrs p/recvd vax pt exp low grade fever, nausea, diarrhea & cramping abd pain; sx lasted 24 hrs;
PATIENT PRESENTED AT THE PHARMACY  AND COMPLAINED OF PAIN IN THE LEFT ARM, NUMBNESS AND TINGLING SINCE HIS FLU SHOT, HE STATED HE HAS NOT BEEN TO THE DOCTORS WANT SOMEONE TO KNOW.
PATIENT HAD AN APPOINTMENT FOR THE FIRST DOSE OF THE MODERNA VACCINE. THE VACCINE WAS ADMINISTERED INTO THE LEFT DELTOID, PATIENT WAS ADVISED TO SIT FOR 15 MINUTES TO MONITOR FOR ADVERSE EVENTS. PATIENT DID WAIT FOR A COUPLE OF MINUTES AND THEN LEFT THE PHARMACY. PATIENT RETURNED TO THE PHARMACY STATING THAT HE DID NOT FEEL GOOD. PATIENT WAS PALE AND SHAKING. PHARMACIST ASKED THE PATIENT IF HE HAD ANY DIFFICULTY BREATHING OR IF HE HAD ANY VISUAL DISTURBANCES, PATIENT SAID NO. PHARMACIST ALSO ASKED THE PATIENT IF HE HAD EATEN SINCE THE MORNING, PATIENT SAID NO. PHARMACIST QUICKLY GOT THE PATIENT A BOTTLE OF WATER AND A CHOCOLATE BAR. PATIENT DRANK THE WATER AND ATE THE CHOCOLATE. PHARMACIST STAYED WITH THE PATIENT TO MONITOR THE PATIENT, SOON THE PATIENT WAS NOT SO PALE ANYMORE. THE PHARMACIST AGAIN ASKED THE PATIENT IF HE WAS FEELING ANY BETTER, PATIENT SAID A LITTLE BIT. PHARMACIST CONTINUED TO MONITOR AND LET THE PATIENT KNOW IF HE FEELS DIZZY OR HAS ANY DIFFICULTY BREATHIING OR ANY VISUAL DISTURBANCES THE PHARMACIST WILL CALL AN AMBULANCE. THE PATIENT REQUESTED THE PHARMACIST CALL THE AMBULANCE. IMMEDIATELY THE PHARMACIST CALLED 911 AND ASKED FOR AN AMBULANCE. THE AMBULANCE ARRIVED AFTER A COUPLE OF MINUTES. THE EMT TOOK THE PATIENT WITH THEM, THE PATIENT WALKED OUT OF THE PHARMACY UNDER THE SUPERVISION OF THE EMT.
Pt received second covid vaccine and stated she felt dizzy while in the observation area.  Pt was taken to back observation room and given ice pack, juice and water.  Vital signs were monitored.  Pt remained stable and stated she felt better after an additional 30 minute observation period.  Pt stated she had taken a Zyrtec this morning on the advice of her PCP so she was not able to receive an additional dose here per pharmacist.  After observation period pt was safely escorted by staff to her husband whom was at the exit.
This spontaneous report as received from a nurse practitioner via field representative refers to a female patient of unknown date. No pertinent history was reported. On 04-DEC-2013 (also reported as 05-DEC-2013) the patient was vaccinated with MMR II 1 single shot for the prevention of MMR II. Concomitant medications was reported as none. On an unknown date, the patient experienced lymph node enlargement in the sub occipital region on the left side of her neck and on the left auxillary, mammary gland enlargement on the left side and the lymph nodes in the post cervical region was enlarged. Patient sought medical attention. No treatment was given. The outcome of events was reported as recovered on an unknown date. Causality assessment was not provided by the reporter. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
The evening of the flu shot, I felt "dead arm" pain when moving my left arm backwards.  When driving my vehicle or vehicles at work, there was again the same pain moving my left arm down/backwards.  I now cannot raise my left arm enough to wash my hair or tie a ponytail with both hands.  I have difficulty dressing and undressing, personal grooming, putting on deodorant, cleaning around the house, ironing and doing laundry, lifting/moving/reaching objects at counter height or above my head, and sleeping.  I feel pain of various levels when just sitting or standing.  The Voltaren helps a bit.  Ice packs and hot showers can reduce the discomfort for a short while. I have gone to physical theray and have had a cortisone shot.
I had a sore arm and I slept a lot for two days. I have boil like symptoms on my skin
Hives, itching, swollen tongue, swollen eyes, weakness, wheezing, swollen throat, tiredness
got really sick after the second dose; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got really sick after the second dose on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021215875 Same reporter/drug diffrent patient
Pain at injection; muscle aches; chills; fatigue; joint pain; low fever; nausea; loss of appetite; second dose of the Pfizer Covid-19 Vaccine on 15Jan2021, but the first dose was received on18Dec2020; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old patient of an unspecified gender received the second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), intramuscular left arm on 15Jan2021 09:00 at a single dose for covid-19 immunization. Medical history included depression, anxiety and known allergies to IVP dye. The patient was not diagnosed with Covid prior to vaccination. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), sertraline hydrochloride (ZOLOFT) and vitamins NOS (MULTIVITAMINS reported as MULTI VITAMIN). The patient did not receive other vaccines in the last 4 weeks. The patient previously took cefalexin monohydrate (KEFLEX) but had allergies. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), intramuscular left arm on 18Dec2020 16:00 at a single dose for covid-19 immunization but had pain at injection, chills, fatigue, nausea, joint pain, headache, brain fog and diarrhea. The patient received the second dose of the Pfizer Covid-19 Vaccine in a pharmacy or drug store on 15Jan2021, but the first dose was received on18Dec2020. The patient experienced pain at injection, chills, fatigue, muscle aches, joint pain, low fever, nausea and loss of appetite on 15Jan2021 19:00 which did not received treatment. The patient has not been covid tested post vaccination. The outcome of the event pain at injection, chills, fatigue, muscle aches, joint pain, low fever, nausea, loss of appetite were recovering while the outcome of the other event was unknown.  The following information on the batch/lot number has been requested.
Singular itchy bumps/ these shoes up on stomach area and left leg; This is a spontaneous report from a contactable other health care professional (HCP) (patient).  A 54-year-old female patient (no-pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/batch number was unknown), via an unspecified route of administration at arm right on unspecified date at single dose for COVID-19 immunisation. Medical history included were none. The patient's concomitant medications were not reported. There was no other vaccine in four weeks and no other medications in two weeks. The patient experienced Singular itchy bumps within 5-7 days after the initial injection, these shoes up on stomach area and left leg on 20Jan2021 12: 00 AM.  They started to dry up, however, after the second dose (as prescribed) and after 5-7 days another outbreak. There was no covid prior vaccination. The patient underwent lab tests included covid test post vaccination, Nasal Swab: negative on 12Jan2021; Nasal Swab: negative on 26Jan2021; Nasal Swab: negative on 10Feb2021; Nasal Swab: negative on 16Feb2021; There was no treatment for event. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Seizure like activity with eye movement, stiffening of body with lethargy afterwards lasting 30 seconds, 4 episodes. Admitted to hospital. Placed on Phenobarbital.
chills, trembling, escalated to violent convuls onset @ 12:00 noon;pt appendages stiff;lips were blue;pt was alert throughout ordeal;rushed to MD office & then ER room upon onset of convuls;pt was administered oxygen & blood test negative;
rash all over body onset 16DEC96 evening;DPH given for itching;photos were taken;
A nurse reported that an adult male subject was negative for antibodies to "Hep B antigen" after receiving 3 injections of Hep B vaccine recombinant (Engerix-B). The subject's medical history, concurrent medical conditions, and concurrent medications were not provided. The subject received injections of Engerix-B in Sept. 01 (lot # ENG5208A2), Oct. 01 (Lot # ENG5235A4), and May 02 (lot # ENG5299A4). Approximately 1 to 2 months following completion of the series, a "titer test" (NOS) was performed and the results were negative for antibodies. The reporting nurse considered the event probably related to Engerix-B administration.
Pt experienced fever to 102 with chills within 12 hours of vaccine. Mild headache. Duration of symptoms 24 hours.
approx. 30-60 minutes after receiving influenza vaccine, pt. c/o feeling anxious and "not right".  Had a reaction to Cipro in past and felt the same way.  Taken to ED, IV meds given.
tinnitus in both ears: high pitched, constant hissing in both ears developed about 1 week after vaccine. Tinnitus preventing sleep
15 months old patient / received / Boostrix (T-dap); This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number KN5ZR, expiry date 16th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th July 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 20th July 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported a 15-months-old patient received Boostrix (Tdap) instead of receiving D-tap, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Severe headache; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): NVSC2022US051829_NS (NOVARTIS).  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: HEADACHE (non-serious), outcome "unknown", described as "Severe headache".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient states that 10 days after injection (3/12/18), she had decreased appetite, headache, painful lymph nodes, body aches, fatigue, fever up to 101.0. No prior history of MMR as a child. Took Ibuprofen 400 mg BID. On 3/17/18 patient developed a macular rash on neck, torso, back, upper arms, proximal thighs with slight itching and low-grade temp 99.5, but otherwise feels improved. Was evaluated by nurse on 3/14, physician on 3/16, 3/17 (home visit), and 4/10. Unknown duration of rash, but was advised to self-quarantine for 5 days. Verified husband was vaccinated as a child.
Information has been received from a physician concerning a 15 year old female patient who in August 2006, was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine. Prior to administration, the patient received the following concomitant therapy: hepatitis A vaccine and meningococcal ACYW conjugate vaccine. The patient had a mild seizure after receiving HPV rL1 6 11 16 18 VLP vaccine injection. She also complained of a great deal of pain at injection site. Medical attention was sought. It was reported that the patient recovered 1 day after the event. Her mother called the physician at home 1 day after the injections to state that the patient was fine. Upon internal review, mild seizure was considered to be an other important medical event (OMIC). Additional information has been requested.
Pt received ADACEL on 9/12/12. On 9/22/12 pt had seizure - where he fell to floor & had diffuse body shaking/twitching. Pt "out" x 4 minutes. Transported to ER, labs & EEG done. Pt given IV fluids, placed on Abx & antiseizure med.
Area around injection site feels hot; Area around injection site is swollen/Swelling seems more pronounced at night; Swelling seems more pronounced at night; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Area around injection site feels hot), VACCINATION SITE SWELLING (Area around injection site is swollen/Swelling seems more pronounced at night) and VACCINATION SITE SWELLING (Swelling seems more pronounced at night) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PHENYTOIN (DILANTIN [PHENYTOIN]), TOPIRAMATE, VITAMIN D3 and FOLIC ACID for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced VACCINATION SITE WARMTH (Area around injection site feels hot), VACCINATION SITE SWELLING (Area around injection site is swollen/Swelling seems more pronounced at night) and VACCINATION SITE SWELLING (Swelling seems more pronounced at night). At the time of the report, VACCINATION SITE WARMTH (Area around injection site feels hot), VACCINATION SITE SWELLING (Area around injection site is swollen/Swelling seems more pronounced at night) and VACCINATION SITE SWELLING (Swelling seems more pronounced at night) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment includes ice pack to painful site.
Weird patchy hair loss began all over head. I know this is not a "severe" symptom but it is becoming increasingly common and this NEEDS to be known. Seems like it kind of stabilized, and then this issue then WORSENED about 2 weeks after receiving my booster.
Information has been received from a physician concerning the 90 year old father of her best friend who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 and may also received the influenza virus vaccine (unspecified) (manufacturer unknown) at the same time. The physician reported that on an unspecified date, the patient developed "flu like" symptoms. It was unspecified if the patient sought medical attention and if lab tests were performed. At the time of the report, the patient outcome was unknown. No further information is available.
This spontaneous report as received from medical assistant refers multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and concomitant therapy were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally (lot # M038728,expiration date 25-APR-2018 or lot # M044724, expiration date 13-JUN-2018) (dose not reported) for prophylaxis. The vaccine was exposed to 1.9 degrees Celsius (°C) for 30 minutes. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA011513:
Mom called 1 day after vaccination to notify of a raised,itchy, rash on BLE. No other complications. Taken Benadryl 25mg and Rx for Medrol dose pak called to pharmacy.
On October 7, I came down with/tested positive for covid. Symptoms included fever, chills, body aches, fatigue. I had approximately 24 hrs of congestion. Urgent care prescribed paxlovid which I took to completion (5 days, 2x  day). Within a ten days of diagnosis, I had two negative covid tests. The only symptom that continued was the fatigue. That resolved approximately two weeks after testing positive.
Information has been received from a certified medical assistant (C.M.A), referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with PROQUAD (lot # M011663, expiration date 08-SEP-2017; dose and route were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Seizure activity; seeing pediatrician. CT scan negative. LP negative; CXR normal
Headache, nausea, chills, muscle ache, joint ache - very much like flu
First day of my shot I got sorriness at the injection site. Then felt tired some first day coming home. Around 12:03 on October 25th Then the 26th I felt low fever with chills and fatigue. Wanted to sleep. On October 27th, 2021 Still feel some fatigue. In the morning
I had my shot at about 1:30pm and took it easy the rest of the afternoon. I drank a lot of fluids throughout the day. At 3:30am I tried to go to the bathroom and I fell back into bed. I was very nauseated and dizzy, and I couldn't get up. I finally got up and tried to deep breathe to steady the room, and eventually I got up and held on to the wall and went to the bathroom. I had to hold on to the wall and furniture to get back into bed, but every time I woke up the room would just be spinning. I wasn't able to go in and work on Wednesday, and I just had to stay in bed all day. I was just constantly having this Vertigo of dizziness and nauseousness. I couldn't eat for probably 24 hours. Eventually I forced myself to eat because I was so dizzy and weak from the shot. I was worried not eating would worsen it. Every time I would try to get up, (I drank a lot of water and Pedialyte), I ended up getting a lot of dizziness. I consulted my friend after two days and asked her about this as a side effect, and she said that it could be a side effect. She suggested a motion sickness medication and I tried to take that on Thursday and it helped a little bit, but on Friday it didn't help. I took two and nothing was happening. I spent all those days in bed. It's just been a lot of dizziness. It's finally starting to subside. I'm finally able to get up and go work at my office. I kept having this sensation like I was going to fall. It's like almost trying to catch yourself. Sometimes I won't even be doing anything or walking, and I can just be sitting and reading, and I get that sensation of the dizziness and vertigo. I would just start closing my eyes and deep breathing until it passes. I've been sleeping sitting down in bed, if I lay out flat I get dizzy. At some point during the night, I get rid of the pillows and sleep flat. In the morning, I have to take my time and sit there for a minute until the dizziness goes away.
Received the booster on October 30. on left upper arm.  To this day, the area where the shot was given still shows the jab as a red dot.  There is no soreness or pain.  Since the date of the booster, an area on my left arm about 2-3 inches  in diameter has turned purple.  To this date the discoloration still exists, but is now starting to turn brown.  I spoke to the pharmacy today where I received the injection and she suggested I report on this site.
severe h/a, nausea, vomiting, weakness, dazed, chills, passing out, cold like sx; lt arm pain & numbness up to lt side neck;
Patient hospitalized with diagnosis on Legionellosis on 12/21/2004. Onset of symptoms 12/16/2004 - patient and family attributed illness to vaccination.