chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her approximately 20 year old daughter with no pertinent medical history, who in November or December 2008 was vaccinated with the second dose of GARDASIL (no lot # provided) and broke out in hives on her face with swelling on her face. There was no concomitant medication. Patient sought medical attention by going to the allergist and was allergy tested which determined she is allergic to GARDASIL which will not be reintroduced. At the time of this report, the patient had not yet recovered. Additional information has been requested.
Expired Havrix administered; This non-serious case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix 1440) (batch number 2BA99, expiry date 16-DEC-2022) for prophylaxis.   On an unknown date, the patient received Havrix 1440. On an unknown date, an unknown time after receiving Havrix 1440, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 24-Mar-2023 The patient received 1440 el u/mL of Havrix that was expired.  Also the reporter wanted to understand if it was allowable dose.  The representative would put on task as well as reporter would like interaction. The reporter agree to follow up from GSK. The patient was administered an expired dose of Havrix 1440, which led to expired vaccine used. This case has been linked to the case US2023046061 reported by the same reporter.; Sender's Comments:  US-GSK-US2023046061:Same reporter/different patient
Pt came into the pharmacy 8/21/18 stating that her right arm where she got the PNEUMOVAX vaccine on 7/13/18 is still sore to touch and painful upon moving her arm above her head.
I had an itchy scratchy throat and unusual, severe pain around my ribs. I had a cough and stuffy nose. The symptoms lasted about 4 days. I called my doctor on December 1, 2022. I then had a chest X-Ray. The rib pain had not disappeared, and I visited my doctor again on December 15 and she told me I had costochondritis, inflammation of the rib cartilage. I still continue to be very fatigued.
56 yoF presented with dizziness, headache, and nausea after receiving 2nd dose of Moderna Covid-19 vaccination. Pt displayed an elevated BP of 143/88. Pt transported to local ER.
sore arm after she got the 1st vaccine; This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional) for a Pfizer sponsored program (159558). The reporter is the parent.  An 85-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm after she got the 1st vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shingles occurred on approximately 10/20/21, Bells Palsy occurred on 10/26/21.
Information has been received from a pharmacist concerning a female patient, who on 22-OCT-2012 was inadvertently vaccinated with an expired dose of ZOSTAVAX, subcutaneously, lot # 669639/0613AA (expiry date 30-JUN-2012). No adverse effects reported. This is one of two reports from the same source. The other linked report is 1210USA013212. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 26-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose, frequency and route were not reported) lot # L004014, expiration date 04-MAR-2017. No adverse effect has been has been reported. Additional information has been requested.
Full body stabbing  pain. Excessive cold chills nausea low grade fever then high grade fever swollen arm at injection and hot to touch. Horrible headache light sensitivity  2days now
Patient reported blacking out while waiting her allotted 15 minutes post vaccination and urinated on herself. The pharmacist on-duty was alerted to the incident per the patient. Once the patient came out of her black out stage the pharmacist sat with the patient for 15 additional minutes and the patient reported feeling fine and her uncle picked her up the the pharmacy.
diff breathing, wheezing, poor appetite, choking started 28OCT;On 31OCT went to ER, nebulizer treatment;dx w/acute bronchitis & asthma (chronic also) Pred, Cephalexin;BP 100/80
Information has been received from a 64 year old female who on 29-MAR-2007 was vaccinated with a dose of Zostavax. No pertinent medical history. There was no concomitant medication. On 31-MAR-2007 the patient experienced redness at the injection site and swelling at the injection site, size of a lemon. No labs or diagnostic tests performed. Subsequently, the patient recovered. No product quality complaint. Unspecified medical attention was sought. No further information is available.
After vaccines were given infant became very pale and lethargic. Vomited after vaccines. Infant was monitored for O2 and heart rate. Provider checked lungs and refluxes. Infant ok after 1 hour 15 min observation. Went home.
High pitched crying >3hrs; Baby limp & difficult to arouse w/in 24hrs;
severe h/a & rash on face morning p/receiving dose; rash on hands 5 days post vax
10/15/15 pt. reports doctor visit for nerve damage and possible shoulder impingement secondary to FLUVIRIN injection being given too low on the arm (left).
Very swollen node on right-side of neck; This is a spontaneous report from a non-contactable consumer, the parent. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 20Apr2021 (at the age of 16-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 11May2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 20Apr2021, the patient developed a very swollen node on right-side of neck after the first shot. This lasted for several weeks and did not start to slowly diminish until several weeks after the second shot. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event very swollen node on right-side of neck was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Tinnitus began abruptly during the night of December 10. At the onset, the sound was loud ringing with buzzing in both ears.  Visit with ENT December 17 showed no hearing loss, no pressure in the ear. ENT supposed the ringing due to stress and would go away. Sought help from GP January 3, who supposed sinus pressure. Began a week of treatment with Flovent decongestant. No change in tinnitus symptoms.
I developed  Atrial Flutter. I have never had any cardiac issues my whole life. I have had EKG?s and have always been Sinus Rhythm.  I am an RN. I put myself on a cardiac monitor at work and  captured several tracings of Atrial Flutter.
pain on the side; This is a spontaneous report from a contactable nurse (reported for herself). A 73-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein, lot/batch number and expiration date not reported) (reported as pneumonia vaccination) via an unspecified route of administration on an unspecified date at single dose for Pneumonia; influenza vaccine via an unspecified route of administration on an unspecified date at an unspecified dose for Flu. The patient's medical history and concomitant medications were not reported. Got the vaccine for Pneumonia and Flu. The patient did not get adverse reactions, but stated she only had pain on the side. The outcome of the event was unknown.  Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Patient previously got COVID vaccine 017B21A on 3/26/21. Patient was inadvertently given P ER8733 on 4/14/21.  He thought he was receiving the second dose of M.  Mistake was realized after looking at patient's vaccination card.  Patient continues to be asymptomatic as of today's date.
Woke up with a jerking feeling that went all the way down her body. She had that 2 to 3 mins for a couple of hours. After having it for one day it subsided.
Patient here for evaluation of shortness of breath on 11/24/2021, progressively worsening over the past few days.  He endorses wheezing, and cough.
Patient verbalized history of dizziness with fainting/falling to floor after receiving flu vaccine. At 1056, Pt complained of dizziness. Placed into wheeled chair, and brought to private holding room. transferred to gurnee.  At 1057, B/P 146/71,  heart rate 68bpm, Pulse ox 98%. Pt stated Dizziness 8 out of 10, with mild pain to forehead. Seated with head of bed up at 30 degrees. Offered both juice and water to drink  At 11: 02, BP 148/76. Heart rate 71 bpm, 95% pulse ox. Pt states dizziness now 6 out of 10.  At 11:18, B/P 135/74, Heart rate 65 bpm, 96% pulse ox. Dizziness 4 out of 10  At 11:29 BP 129/76. Heart rate 64 bpm, 95% Pulse ox. Dizziness one out of 10. Patient states minimal pain to forehead. Sat to edge of bed, without incident.  Patient brought to standing position, shifted weight from side to side multiple times, and ambulated around holding room without incident. Stated feeling able to return home, and dizziness gone.  Left to home with husband at 11:31
tiredness; headache; nausea; feeling unwell; muscle pain; joint pain; This is a spontaneous report from a contactable consumer (self-reported) via medical information team. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9261, expiry date unknown), via an unspecified route of administration, in arm left, on 30Jan2021 as single dose for COVID-19 immunization. The patient medical history included Obesity and difficult time metabolizing medications. Family history included her daughter and grand daughter have EDS. She would probably be the genetic carrier. The patient concomitant medication included ongoing esomeprazole sodium (NEXIUM) and she has been on it about 2years, ongoing valsartan and she has been on it about 2 years. It was reported that the patient had experienced Tiredness, headache, muscle pain, joint pain, nausea and feeling unwell; all events on 07Feb2021, and everything is ongoing. The outcome of the events was not recovered.
Patient feels that her throat is closing started today after receiving 2nd dose of covid vaccine She was given Benadryl 50 mg po before coming to urgent care She received first dose of Pfizer vaccine and 12/22/2020 and had same side effects Denies chest pain, shortness of breath, rash  States she was given steroid injection and Ativan last time which helped
No adverse event; Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported. 27 adult patients received pediatric dose of Bivalent  COVID-19 vaccine 0.25 ml instead of 0.5ml.                                 No treatment information was provided by the reporter. This case contains information for the 20 of 27 adult patients described by the reporter.
some mild side effects; itching  all over their body; this is interfering with his sleep; it said that getting hives; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (some mild side effects), PRURITUS (itching  all over their body), SLEEP DISORDER (this is interfering with his sleep) and URTICARIA (it said that getting hives) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (some mild side effects), PRURITUS (itching  all over their body), SLEEP DISORDER (this is interfering with his sleep) and URTICARIA (it said that getting hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (some mild side effects), PRURITUS (itching  all over their body), SLEEP DISORDER (this is interfering with his sleep) and URTICARIA (it said that getting hives) outcome was unknown.            No concomitant medication was provided by reporter.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot number, expiration date were not reported). On an unknown date, the patient experienced vesicular rash at the injection site. The outcome of vesicular rash at the injection site was unknown. Relatedness between vesicular rash at the injection site and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Pt diopheric. C/O difficulty breathing, pt cool to touch. 3 cc Epinephrine. MD seem to think it was not a true reaction it might of been a physcialogical reaction. Pt doing fine.
Information has been received from a physician concerning a 7 month old (reported as a 31.5 week old infant) patient who on 17-APR-2012, was vaccinated with the first dose of ROTATEQ, oral (lot number 672244/1847AA, expiration date 17-AUG-2013) (dose not reported). No adverse effects reported. Follow-up information has been received from the registry nurse concerning the 7 month old male patient and whose birth weight was 7lbs. The patient was vaccinated with ROTATEQ (lot number 672244/1847AA, expiration date: 17-AUG-2013) on 17-APR-2012. The patient did not seek medical attention. Additional information is not expected.
Information has been received from a physician concerning an 88 year old female patient with hyperthyroidism, coronary artery disease, hypertension, chronic obstructive pulmonary disease and atrial fibrillation who "about 2 years ago", in approximately 2008 was vaccinated with "a single dose" of 0.65 ml of ZOSTAVAX (Merck) subcutaneously. According to the physician, the patient was hospitalized on 04-JAN-2010 for chronic obstructive pulmonary disease exacerbation and was put on high doses of steroids. Then, on an unspecified date, prior to developing shingles, the patient was discharged from hospital. About 3 days later of hospitalization, on 07-JAN-2010 the patient presented with zoster outbreak on her left upper thigh. The physician also mentioned that she saw the patient last week (on approximately 14-JAN-2010) and started her on famciclovir. At time of reporting the patient was recovering. The physician considered exacerbation of chronic obstructive pulmonary disease and zoster outbreak to be disabling. additional information has been requested.
Approx. 9 AM, notice slightly raised rash on legs, applied hydrocortisone cream.  Approx. 10 AM noticed swelling of lips and along jaw line, went to pharmacy, told to take Benadryl.  Felt achy and "blah" for rest of day and next 2 days. Rash and face kept at bay only if I kept taking Benadryl and applying cream.
Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced sore arms after receiving the Shingrix vaccine. The reporter was unable to obtain additional information. The reporter did not consent to follow up. This case has been linked with US2019125912, reported by the same reporter.
pt recv vax 1AUG95 & w/in days of vax devel a gradual onset of multiple annular, sl scaly, predominantly dermal plaque;AUG95 pt was seen in MD office in late AUG95;biopsy showed lymphocytic dermatitis & poss gyrate erythema;
11/9/02 1/2" below injection site red area 1.5" by 2" with itching. Patient rubbed area with alcohol; took Benadryl. Area faded and disappeared within 2 days. 11/15/02 Same area became red with some itching. Benadryl (PO) rubbed area with cortisone ointment 11/18/02. No other problems.
Hours later I experience a crushing migraine, chills, fever, body aches, and soreness through the night for the next 14+ hours
Became lethargic and began vomiting on 10/22/10; continued with diarrhea on 10/24/10 and vomiting on 10/25/10.  Suffered a possible febrile seizure on 10/25/10 around 4:30 pm.
chest pain; headache; fever; 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 61-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FJ8762) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tromethamine, reaction(s): "GI bleeding", notes: She and her mom have a reaction to tromethamine. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "For me, I had chest pain"; HEADACHE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section.
545PM woke up, gagging, lips turned blue, shaking; did not feel warm;
Unusual (reason for submission):  Blood 02 dropped to 94-96 the day after 2nd COVID vaccination.  I take O2 reading daily (generally).  Always been rock solid at 98 with maybe a 97 every two months.  This is really an outlier event.  Reading taken on six different fingers with one monitor reset.  Returned to 98 following day.  Other expected symptoms:   Temp 99.8  (generally 97.6 - 98.0).  Injection shoulder sore, felt puffy (but no visual difference).  Medium "Brain Fog" (senses seemed disconnected, lack of concentration).  Lethargic legs (not sore or weak, just slow to respond).  Left neck and ear aches.  Slept about 14 hours day after shot.  No symptoms other than sore arm the day of shot.  BP and blood sugars up, but at higher end of my normal ranges.  BP 175/93  (16th).  (at 149/93 on 17th). Blood stick reading 198 (16th).  (at 158 on 17th)
Vaccine was received from our Pharmacy on 6/9/22, vaccine expired in 10 weeks due to refrigeration storage which would have been 8/18. Patient received vaccine after expiration date. Spoke to regulatory authority, they advise patient to be revaccinated for their booster.
Pt drove up post vaccine to observation lot. Pt stated " I feel short of breath and heart racing".  EMT(on site) was called, Hr-88, o2-97% RA. Respiratory rate WNL. Pt kept for observation for 30 minutes. Pt discharged at 3:50 pm. EMT follow up with patient before discharge.
Pt had severe nausea and vomiting 15 min after inj. noted to be SOB after emesis - VS stable, kept 10 min extra - no further emesis, VS stable. let go home
Shingles; This case was reported by a consumer and described the occurrence of shingles in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2020, the patient received Shingrix. In September 2020, 8 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. The age at vaccination was not reporter but patient could be 70 or 71 years old at time of vaccination. The patient received the Shingrix vaccine and 8 days later patient was diagnosed by physician with Shingles.  The patient's pharmacist suggested to her to  contact the manufacturer of vaccine.
Within 1.5 hours of vaccine #1:  Eye pain (both), itching without visible rash (left buttock only), thumb pain, brief leg "heaviness" (both) and fatigue, brief RLQ pain, increased tinnitus.    The next evening:  low back and neck (bone?) pain while attempting to sleep, out of character to usual back pain.  By day 3 post injection, left nose tingling similar to onset of cold sore, which included left side of mouth the  next day.  By 7 days post injection, entire mouth area felt tingly similar to Novocaine wearing off.  This lasted 3 days.  Now improved. (took B-12 p.o.)  Other brief episodes of chest discomfort, gum irritation, and anxiety.    Vaccine #2 scheduled for 2/19/2021