chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of seizure in a 5-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 24 June 2009 at 13:30 the subject received 1st dose of HAVRIX (.5 unknown, unknown, right thigh). On 24 June 2009, 30 minutes after vaccination with HAVRIX, the subject experienced seizure. This case was assessed as medically serious by GSK. The subject was treated with antihistamine. On 24 June 2009, the event was resolved. The nurse reported a subject experienced a seizure about 30 minutes after receiving HAVRIX. The subject was at home when this occurred. The office requested the subject come back into the office and be checked. He was treated with anti-histamine and they are not going to continue the vaccine series for this subject.
Exposed to some people with COVID I think last night; took a Rapid COVID test this evening and she tested positive; Exposed to some people with COVID I think last night; took a Rapid COVID test this evening and she tested positive; Not feeling well; This is a spontaneous report from a contactable consumer (patient). A female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL9263, Expiry Date: unknown) via an unspecified route of administration on 28Jan2021 as dose 1, single and received second dose of  bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL9269) via unspecified route of administration on 18Feb2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, patient was exposed to some people with COVID last night and took a rapid COVID test this evening and she was tested positive. Patient was also not feeling well. It was reported that patient received both dosages. It was reported that "She said she went to a friend's party all day on Saturday. She says, I went to my friends party all day Saturday and both she and her husband have it In another word, I think what she was trying to say is she went to a party Saturday and I think whoever has the party, that person and her husband had the COVID (Further clarification was unknown, hence split case was not made), then she said she just took a Rapid COVID test this evening and she tested positive and she is not feeling well. I don't know exactly what but she tell me that she had to rest. I don't know what exactly the other symptoms she is having as far as the COVID 'goes' but she definitely took a rapid test and tested positive. It was reported that there was product complaint. Lab test included rapid covid test on an unspecified date and result was positive (she has a COVID). The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected
no additional AE details; patient was inadvertently administered an expired vaccine; This spontaneous report was received from a physician assistance and refers to a patient of unknown age and gender. The patient's concomitant therapies included: Merck sterile diluent. The patient's concurrent conditions, medical history, allergies and drug reaction were not provided.  On 12-JUL-2022, the patient was inadvertently vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), injection, expiration date: 02-JUN-2022, (strength, dose, dose number, lot#, route and site of administration were not provided) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Patient reported to our clinic on 3/24/21 when he received his second dose, that he had diffuse hives all over his chest/upper body after receiving his first dose of the covid-19 vaccine. He also reported redness and swelling at the site. He reported that the symptoms went away after a few hours and he did not do anything to treat the hives.
Pt had cold sx day of vax; pt was given 2 doses of Tempra @ appropriate time post vax; mom states that pt became limp, & would not eat the evening of vax; fever went from 102.4-103; pt had no fever day of vax;
Patient developed signs and symptoms consistent with Bell's Palsy starting 3 days post vaccination.  Symptoms of eye, ear and neck/throat pain persisted and worsened over the next week.  Patient was evaluated by her PCP on day 6 post vaccination and was prescribed amoxicillin for potential bacterial sinusitis.  Two days later symptoms had worsened and she presented to the local ED where an EKG and CT scan were normal and the diagnosis of Bell's Palsy were determined.  Patient completed a 10 day course of high dose prednisone plus acyclovir and has been continued on 400mg Ibuprofen q6h for the past two weeks due to persistent pain/inflammation.  As of today symptoms are improving but are not yet fully resolved.
ear pain, congestion, cough, sinus drainage, sneezing. Mild rash on her face, wonders if it could be a strep rash although she really doesn't have a sore throat. starting 12/20/21
I woke up and I couldn't take a deep breathe as the day went on It was harder and harder to breath. It felt like a stabbing pain in my back by my kidney. I hadn't done activity that day. I toughed it out till Monday and went to the walk in clinic.  I was given anti-inflammatory and muscle relaxers.  Symptoms went away in  24 hours.
30 mins after event arm was itchy. The following day arm continued to be itchy and a hive developed.  No history of adverse reactions to vaccines or medications.
The pt was given Pneumovax and developed right arm (?) with a fever of 99.3. WBC elevated. The MD states "I suspect this is related to administrated techniques not to serum."
VIOLENTLY ILL FROM THE SECOND SHOT; This spontaneous report received from a patient via media through a company representative concerned a patient of an unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received covid-19 vaccine ad26. cov2. s (Unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following covid-19 vaccine ad26. cov2. s (Unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced violent illness (Dose number in series 2) after second shot of vaccine. It was reported as "Well, we know. I also ot violently I'll from the second shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of violently ill from the second shot was not reported. This report was non-serious. This case, from the same reporter is linked to 20221211945.
within 24 hours of her second Pfizer vaccine, she developed a right pneumothorax and was hospitalized.
shingles after the first dose of the vaccine; This is a spontaneous report from a contactable consumer or other non-health care professional. A patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on Feb2021 (reported as last week of February) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Mar2021, the patient was diagnosed with shingles after the first dose of the vaccine. The patient's second dose was scheduled on 18Mar2021. Patient was concerned about the second dose because of the shingles or are there any recommendations on how long she should wait. The clinical outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. Follow-up attempts have been completed and no further information is expected.
Eye on right side of face swollen; Slight bruise; Tender to touch; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration on 19Apr2021 at 16:15 in left arm (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. 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 other medications within 2 weeks of vaccination. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration on 22Mar2021 at 16:00 in left arm as a single dose for COVID-19 immunisation. On 21Apr2021, at 04:30, 36 hours after second dose the patient woke up to eye on right side of face swollen, slight bruise and tender to touch. She had never heard of this as being a side effect. Plus, her injection was in left arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events of eye on right side of face swollen, slight bruise and tender to touch were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a pharmacist concerning a female patient  who was vaccinated with a 2nd dose of  Hepatitis B vaccine. Subsequently, the patient experienced flu-like symptoms. No further information is available.
Felt cold, chills, pain @ site of injection (could not lift arm), fever spiked, uncontrollable shaking, drop of blood pressure.  Husband called 911.
tinnitis and had ringing and buzzing in both of her ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 68-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EN6208) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tinnitus" (unspecified if ongoing), notes: Verbatim: Tinnitus; "citrus and nuts" (unspecified if ongoing); "citrus and nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 12Mar2021, outcome "not recovered", described as "tinnitus and had ringing and buzzing in both of her ears".  Additional information: Patient stated she has not had treatment for the tinnitis and states if it is helpful to include that she has had tinnitis intermittently in the past and has not had this particular symptom of tinnitis with ringing and buzzing in both of her ears for a couple of years until this morning# states she retired about 4 years ago so if she had to estimate she would say the tinnitis she had prior to the vaccine as not something that was continuous but more intermittent and began about 6 years ago. patient stated she experienced tinnitis and had ringing and buzzing in both of her ears that began she estimates about 9:00 this morning on 12Mar2021 and the tinnitis is ongoing and it is continuous, but she would say it is moderate as opposed to horrible and remains the same as when the tinnitis began this morning. Patient stated the facility is a hospital about a mile from her home# states the wait was about 30 minutes because they asked her about sensitivity to medication or food sensitivities and she mentioned with citrus and nuts she has had instances of gasping for air and so she stayed for 30 minutes instead of 15 minutes at the facility and had no problems. additional vaccines administered on same date of the pfizer suspect reported as none. Event does not require to visit emergency room and physician office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Day after vaccination, patient noticed high heart rate on her iWatch at 133 while sitting. Later that night, patient noticed her shoulder was hot and painful. She woke up around 3am with high HR and fever 100.9. Husband brought her to emergency department. Patient also c/o headache.
All of these adverse events are mild and I am not seeking medical attention as yet.  Very sore shoulder at needle injection.  Intermittent Headache. Increase in encephalopathy. Nausea. Lightheadedness. Off balance. Weakness.
received 1st dose of Pfizer COVID vaccine on 12/22/20 and 2nd dose on 1/12/21, lost taste and smell on 5/24/21, tested positive from community on 5/26/21
Shingrix shots on 6/23/22 and 3/10/21; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10th March 2021).   On 23rd June 2022, the patient received the 2nd dose of Shingrix. On 23rd June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient had a both Shingrix shots. The interval between shots was over a year. The reporter wanted to know do he/she need another injection. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule. The follow-up could not be possible as no contact details were available.
Rash on R ear lobe down cervical neck on R side per school nurse. Nurse talked to doctor and was diagnosed with shingles.  Rash had been wet, is now dry & child returned to school per RN.
My ear plugged within hours of receiving my first vaccine shot and a blackish substance was found in my ear - never figured out what it was.  I was not previously dealing with any health or ear issues.  Within 2 days my ear was in a lot of pain and I went into urgent care on 09/04 where they gave me antibiotics to try and reduce the inflammation.   My pain went down but continued to remain plugged, so I went back in 09/07 to urgent care and they irrigated my ear and advised my ear drum was ruptured and put me on an ear drop.  My ear has continued to be plugged and I have since been to my primary care doctors clinic (09/21) where they re-irrigated my ear, but did not think my ear drum was ruptured.  This temporarily unplugged my ear, but my ear has since replugged and has a brownish/blood substance in it.  I contacted my primary doctor's office today again (09/23) and was again put on antibiotics.
Headache, brain fog, tiredness, achy, sore arm started approximately 23 hours after administration of vaccine
After vaccine started with dyspnea \Tx: Pepcid 20mg Benadryl 50mg Atrovent 0.5mg
Symptoms - red, swollen, warm to site, slight pain (1:10 scale) at inj site at 24 hrs. Placed on KEFLEX Q 6 hrs x 7 days by ED Dr.
4/20. Painful lumps in temples, Head swollen.  Temperature 101 to 102.   04/30. started a week of Clindamycin. 150mg/3 times a day By 5/5 developed dry hacking cough, bad headaches, night sweats, aches in lower joints. 05/06. Started a week of Sulfamethoxazole-Trimethoprim  800,  160mg, 2 times a day By 5/12. head has gone down, sweats, temperature late in the day, cough continued.  Some vision changes.  Food tastes OK but no liquids taste right By 5/24. cough, temperature some days, night sweats aches in lower joints continue.  Taste of liquids still not right.
Information has been received from a physician concerning a male, with eczema and a history of milk colitis (no bloody diarrhea involved), which resolved when the pts formula was changed to alimentum, and a cold, who on 8/1/06, was vaccinated with a first oral 2 ml dose of Rotavirus (lot 653754/0139F). Concomitant therapy included a dose of Prevnar. On 8/2/06 the pt developed loose water stools, x 4. On 8/3/06 the pt was seen in the office. At that time, the pt had green watery stools with bright red specks of blood. The pt was also noted to be spitting up. No internal fissure was noted on examination. The pt was not hospitalized. As of 8/24/06, the pts stool became firmer and he was noted to be recovering. No product quality complaint was involved. No other information was provided. Upon internal review stools with bright red specks of blood was determined to be an other important medical event (OMIC). Additional information has been requested.
pt recv vax 22AUG96 & 19DEC97 hosp w/pneumococcal pneumonia & sepsis;
pt recvd vax 10NOV92 & 1230PM & 3AM next day had petit mal sz lasting 2 minutes; mom gave APAP; no fever, no fussiness or sore leg; had grand mal sz;
Patient expired on 11/18/03 due to ruptured Aorta.  Presented at ER 11/14/03 after "not feeling well", for a few days, complaining of tiredness and loss of appetite. Discharge Summary received on 12/01/2003 states change in mental status.
One and a half weeks post vax, the pt experienced shoulder joint achiness and extreme fatigue. No treatment was given, and he is currently being tested for Lyme disease and rheumatoid arthritis.
pt devel erythematous, blotchy rash 7cm x 5cm on the anterior aspect of lt thigh 1 day p/vax;? hypersensitivity reaction;pt seen 8JAN88 & adm to hosp for inc erythema & induration dx cellulitis vs hypersensitivity rxn;
The issue was identified in2020, the year prior to the Pfizer vaccination.  Follow-up occurred following both of the vaccinations.  As the patient, I do not see a connection between the breast cancer and vaccination even though it is an "adverse event" .  Nipple Inversion had been identified during 2020 and the situation was followed up during 2021.  A diagnostic mammogram was completed on 2/8/2021.  Surgical Exploration completed 6/29/2021 identified Stage Zero breast cancer cells.  A second exploration on 8/3/2021 increased the distance between cells and margin.  Radiation is being recommended.
Arm was hurting; Face was swollen; Felt very tired/ not gotten out of the bed; Has a fever of 100 F; Has achiness in his muscles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting), SWELLING FACE (Face was swollen), FATIGUE (Felt very tired/ not gotten out of the bed), PYREXIA (Has a fever of 100 F) and MYALGIA (Has achiness in his muscles) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting), SWELLING FACE (Face was swollen), FATIGUE (Felt very tired/ not gotten out of the bed), PYREXIA (Has a fever of 100 F) and MYALGIA (Has achiness in his muscles). At the time of the report, PAIN IN EXTREMITY (Arm was hurting), SWELLING FACE (Face was swollen), FATIGUE (Felt very tired/ not gotten out of the bed), PYREXIA (Has a fever of 100 F) and MYALGIA (Has achiness in his muscles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 100 f (High) 100 F.         No concomitant medications reported.  No treatment information provided..
On 1/21 developed severe abdominal pain and intractable vomiting- went to a local Hospital and admitted with pancreatitis and leukocytosis . Developed into idiopathic acute necrotizing pancreatitis and developed bilateral pleural effusions and an ileus, required tertiary care center and was transferred to a local clinic on 1/26  for tachycardia with pulse reaching 170, respiratory distress requiring O2 at 6Liters. Was discharged 1/30/23 and on 2/5/2023 developed shortness of breath and severe abdominal pain and went to local ER and was found to have a large fluid collection around the pancreas requiring tertiary care center and he was transferred to another health care facility.  He required a NJ for nutrition. Had increased pain while there. Now has a second fluid collection. Has been in pain continuously. He also is now having left shoulder pain and is unable to lift/ move his arm. He is currently still inpatient
pt recvd vax 10FEB94 & 10 mins later pt LLT was sl swollen, red, & rashy around inject site; DPH given & ice was applied to inject site;
expired dose of Ipol was administered to patient, No AE; Initial information received on 07-Jul-2020 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff).  This case involves a 60 year old male patient who received a 0.5 ml second dose of vaccine IPV (VERO) [IPOL] (lot number: P1A461M) via subcutaneous route in the left arm for prophylactic vaccination on 07-Jul-2020, that was expired on 03-May-2020 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included TETANUS VACCINE and HIB VACCINE (HIB) for prophylactic vaccination on 07-Jul-2020.  It was an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
On 2-27-2006 12:00 am approx high 103F fever, body disconform. 6:00am-vomit of last dinner food, high fever 103 F and vomit, small dark red dots over abdominal area and inflammation. Fever. Children Motrin and Tylenol phedanoz supp 12.5mg. Symptoms until 2/28/06. Child doesn't want to eat.
Patient came to health department 11/8/2023 two days after receiving shingrex and covid vaccinations both in the left deltoid. Patient showed nurse blisters on arms and hands similar to chickenpox blisters and 7 inches below left deltoid, a 9cm area swollen and painful on anterior aspect of left upper arm. patient has history of lymphedema. No difficulty breathing or area of generalized hives. Told patient to seek MD opinion.