chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got shingles shot and got bad case of shingles/Suspected Vaccination failure; Got shingles shot and got bad case of shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and got bad case of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
changes in menstruation; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose:1, Manufacturer Unknown , but mentioned her and her family got two doses of the vaccine last Dec.), administration date: Dec2021, for COVID-19 Immunization; Covid-19 vaccine (dose:2, Manufacturer Unknown , but mentioned her and her family got two doses of the vaccine last Dec.), administration date: Dec2021, for COVID-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "changes in menstruation".  Additional information: Reporter's real concern though was asking if changes to menstruation with the girls could be like a reaction, for her two daughters. Reporter wanted to know if there were any reactions or any effects to any girls menstruation for a side effect.  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-202200398438 same reporter/drug/event, different patient
Injection was apparently given in the bicep area as opposed to the deltoid.  Patient complained of soreness and swelling thereafter (which is improving by the time she comes in for her second vaccination,) but she still has some limitations in range of motion which inhibits her work as a sign language interpreter.  She has had no distal paresthesias or weakness, just soreness surrounding the site which she indicates to be the left inferolateral bicep area where there is a minute reddish  (presumed) puncture site and underlying induration.
Extreme fatigue set in about 8-10 days after the second dose of Moderna.  A very healthy (exercise 6 days a week and carefully watch diet) man who is known for his endless energy suddenly struggled to get out of bed.  Fatigue continually got worse from June 8th until July 1st.  On July 1st my heart went into arrythmia with bpm reaching 140 at rest.  Normal rest is 66 bpm.  The arrythmia continued to persist sporadically until I went to the Emergency Room on July 5th.  It had progressed to the point that my heart would not stop racing and I thought I was in big trouble.  At the ER I learned that my blood pressure had ballooned to 185/125 and my glucose was 152.  No previous tests had ever shown any blood work problems in any area.  And I have never felt like this in my life.  Now my blood pressure is back to normal and eating very low carb to bring the glucose down.  But still having an episode of depression and lack of desire to do anything.  Totally unlike me at any point in my entire life.  Possible delusional thoughts now as well.
I had severe knee pains and overall joint pain. I had blood and urine work ordered by doctor.
body pain; feels awful; swelling; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a physician concerning a 16 year old male who on 14-OCT-1994 and on 16-DEC-1997 was vaccinated with the first and second doses of MMR II (lot # not provided) respectively.  On 10-NOV-2009 the patient experienced mumps.  On 13-NOV-2009, the first blood work revealed serum IgM negative, serum IgG 4 and serum amylase 567.  On 13-NOV-2009, the patient was diagnosed with mumps.  The patient was afebrile.  Parotitis count was 161.  It was unspecified if the patient sought medical attention.  In follow-up, the physician indicated that on 13-JAN-2010 the patient was diagnosed with mumps.  Parotitis was on the left.  On 13-JAN-2010 the first blood work revealed serum IgM 0.12, serum IgG 4.62 and serum amylase 326.  Additional information has been requested.
SEVERE PAIN IN RT ARM  BODY ACHES CHILLS FEVER NAUSEA
23JAN97 one lump @ back of neck;28JAN97 papular rash hands, arms, trunk;
within 15 minutes of immunization, patient experienced a feeling of fainting, lightheadedness, and ringing of the ears. Patient laid on the floor for an additional 30 minutes and was then released after feeling better.
Patient states a week after the shot she developed a painful lump near her shoulder under her neck. The pain worsened over time and moved to the under side of her armpit. Patient states she is unable to lift her arm due to severe pain even now 6 months after the shot. She has seen multiple doctors and has not received a proper diagnosis but all doctors are stating this is due to the moderna shot (per patient report)
Swollen right side of lip and cheek, resolved with Benadryl, 7/31/21 woke up at 2 am itching all over, large red, itchy, welts all over body, continued to spread all morning . Received oral prednisone script and started to improve that afternoon.
This initial spontaneous report was received from a registered nurse via company representative, concerning a 2 month old male patient. The patient did not have pertinent medical history or drug reactions or allergies. The patient's concomitant therapies included PEDIARIX, hib conj vaccine (unspecified), PREVNAR 13 and unspecified "2 month shots". On 25-OCT-2018, the patient was vaccinated with ROTATEQ, orally for "vaccination" (dose, strength and lot number were not reported). On 28-OCT-2018, the patient threw up blood (haematemesis), therefore, he was taken to an unspecified hospital and died on the same date. No laboratory test or studies were taken, moreover, it was unknown if an autopsy was performed. No product quality complaint (PQC) was reported. At the reporting time, the action taken was assessed as not applicable. The reporter did not provide a causality assessment for the event haematemesis. Upon internal review, the event haematemesis leading to death was determined to be medically significant. Reported Cause(s) of Death: The patient threw up blood.
Pt adm 1st dose of vax w/no noted problems; 04DEC90 vaccinated w/2nd dose exp elevated eczematous rash of arms & legs; tx oral DPH & hydrocortisone cream;
Most painful shots; This case was reported by a consumer via media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   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 injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient stated that the shingles vaccine was the most painful shots the patient ever had. The contact details were not reported hence follow up not possible. For tolerance to the 2nd dose refer linked case US2021AMR195555, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR195555:same report, different dose
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the expired dose of PNEUMOVAX23 (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Left thigh: about 4.5x4.5cm swelling, red area at site of injection - given on 9/29/06. Examined in office 10/2/06 - improving.
pediatric patient was given Pentacel with only diluent with no adverse event; Initial information regarding an unsolicited valid non-serious case received from the other healthcare professional via phone at a call center as a Medication Inquiry on 11-Jan-2021.  This case involved a 9-month old female patient who was given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (PENTACEL) with only diluent with no adverse event (Product preparation issue).  It was an actual medication error due to inappropriate reconstitution technique.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine for prophylactic vaccination.  On 28-Dec-2020, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE 0.5 mL (lot number: U6842DA, expiry date: 05-Jul-2021) via intramuscular route in the right thigh for prophylactic vaccination.  On 28-Dec-2020, it was reported that pediatric patient was given Pentacel with only diluent with no adverse event (Product preparation issue).  At the time of reporting, the patient did not experience any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
2.5 inch hive on inner aspect of left thigh.  Lungs clear. No respiratory distress.  Apical pulse 124 and regular.  Transferred to personal physician who described this as a severe local allergic reaction to the DTaP.
COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.    There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and diluted per Instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Pt states "had flu vaccine a couple of weeks ago and I think I am having a reaction. I have paresthesia. Pt had similar symptoms 5 years ago and was treated by a neurologist who couldn't find anything. Symptoms started morning of 12/28 around 07:00 AM when pt woke up. "I am having numbness that starts in my toes and fingers and progresses up my extremities, also having facial numbness. I think it is from the flu vaccine."
Case number PHEH2013US003889 is an initial spontaneous report received from a nurse on 11 Feb 2013 with a follow-up received on 08 Mar 2013: This report refers to a 12-years-old male patient. His concomitant vaccination included administration of BOOSTRIX (other manufacturer, batch number: ACSB102BA) intramuscularly at 0.5 ml on 08 Feb 2013. It was reported that he received only MenCYW-135 liquid component of MENVEO (batch number: 11081) intramuscularly on 11 Feb 2013 and did not receive MenA lyophilized conjugate. No adverse events were reported following the inadvertent administration. Follow-up received from the nurse on 08 Feb 2013: Updated concomitant vaccination and date of vaccination.
First dose of Moderna was on January 8th, arm was sore, then 1 week later January 15th I noticed  swelling of my arm & a huge red circle hot to touch around the injection. I called my workforce & filed an incident report, on Tuesday I went to my work place & showed my arm to nurse, they reassured me that I would be okay for second dose which is Feb. 5th.  I saw on the news that a healthcare worker had the same thing 1 week later(video shows her arm). I have been icing it which helps a little but redness is still there,do you have any suggestions as to what to do? I would appreciate it.
NERVE PAIN from ear to top of head; Harp pain on top of head; Intramuscular formulation administered by other route; SORENESS AT INJECTION SITE; FEVER; HEADACHE; TIRED; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2022, the patient received Shingrix (subcutaneous). On 9th December 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, fever, headache, tiredness and intramuscular formulation administered by other route. On 14th December 2022, the patient experienced nerve pain and pain. On 10th December 2022, the outcome of the injection site pain, fever, headache and tiredness were recovered/resolved. On an unknown date, the outcome of the nerve pain, pain and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site pain, fever, headache, tiredness, nerve pain and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-DEC-2022 Reporter's Comment: The consumer was the reporter and the patient.  The reporter reported that patient received the Shingrix vaccine and experienced fever , headache, soreness at injection site and was feeling tired. The reporter reported that there side effects started in the evening the day she got her injection and went away the following morning.  The consumer reported that yesterday on 14th December 2022 patient experienced nerve pain from her ear to the top of her head and had harp pain when she touched the top of her head.  The call got disconnected and agent called patient back but the call went straight to voicemail.  The reporter was unable to collect patients date of birth and HCP contact information. Additional Supportive Information: The patient received Shingrix vaccine via Subcutaneous route, which led to intramuscular formulation administered by other route.
Acute appendicitis, laparoscopic appendectomy on Wed April 21, 2021
Woke up from high fever (103.9). Began staring off in space. Started seizing. Called ambulance immediately. Taken to emergency room. Give phenobarbital and tube placed down airway. Flown to hospital. Seizures lasted 40 min. Admitted to Pediatric Intensive Care Unit. Weaned off phenobarbital after 24 hrs. Nurse follow up on 05/13/04 states no new information. Nurse follow up on 06/07/04 states: ADD: febrile seizure ADD: status epilepticus.
She got 2 vaccines. Left pharmacy and came back 1/2 hour later - was shaking. Ambulance came and said she had panic attack. Her son came and took her home.
Chemical taste within the first five minutes. Feeling of tongue and throat swelling. Tightness in sinuses.   Pharmacy have me benadryl and offered an epi pen.   The epi pen was refused. The pharmacy insisted I have someone pick me up at the store and drive me to the closest hospital.   I sat in the ER for 45 minutes with no treatment before leaving.   Later that night I called the ER and was advised to take benadryl for 72hrs at any point I did not feel good or the reaction got worse I was to call 911.
My right shoulder was extremely painful. Unable to move or use my arm for 24 hrs. Was in so much pain that I took Oxycodone at 12:00 am, another at 3:00 am. TYLENOL with codeine at 5:00 am and another at 7 :00 am. Was not expecting so much pain. If I did not have the RXs, I would have to go to the emergency room. I still have pain and it goes down by arm. I have been told that the injection was given to high.
two years ago she was at the doctor's office to receive a dose of flublok, but was administered a different influenza vaccine instead with no reported adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from a Patient.  This case is linked to case 2023SA311693(CLUSTER).  This case involves a 58 years old female patient where reporter reported two years ago she was at the doctor's office to receive a dose of influenza quadrivalent recombinant vaccine [Flublok QIV], but was administered a different Influenza vaccine instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza quadrivalent recombinant vaccine and influenza vaccine lot number not reported via unknown route in unknown administration site (dose, frequency, route, formulation, strength and expiration date: not provided) for Immunisation (wrong product administered). Information on the batch number was requested.  Patient states that two years ago she was at the doctor's office to receive a dose of Flublok, but was administered a different influenza vaccine instead. She states after running some titers her doctor did administer a dose of the Flublok about two months afterwards  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
22MAY91 recvd DTP/OPV/HIB started running fever of 102 given APAP; temp went up next day 23MAY91; Excessive crying, mom states feet turn blue; Rash appear all over poss virus;
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient reported no adverse reactions after the administration of vaccine.  No treatment medications were reported.  Vaccine number 1 NDC code was reported as 80777-0273-99.
Facility from 12/30-1/13; Discharged to another healthcare facility; Prior onset, reported papular diffuse rash (non-pruritic).  IVIG 5x days start on 12/31, Intubated 1/2-1/10.  Per MR - "ER for mild R weakness on 1/28...Now bedridden per son, weaker, arms feel weaker, able to swallow, no dyspnea, no pain. Denies recent illness.  s/p IVIG clinically improving. Discharge to skilled nursing facility for physical therapy."
no symptoms of adverse event,  patient stated that he was unvaccinated at start of series at pharmacy, he was given a dose of Pfizer-BioNTech on 09/02/2021 and a second dose on 09/23/2021.  Later we found out that patient was concealing the fact that he completed a series of MODERNA at another (doses given 03/12 and 04/09). Patient received 4 mRNA COVID vaccines instead of 3.
The doctor ignored the second page of shots that we gave her showing all of the shots that my son had. She then procceeded to give duplicate shots of DTAP,MMR,VARIX (?) AND MTX along with TB shot. Once we realized she did not give him his 18 months shots, that we went in there for, she denied we gave her both sheets of paper (that she had in her hands) and said we needed to bring him back in 3 days later to get the 18 month shots. He still has not had the 18 months hots because he got really sick a week later and we are too afraid of what resulted from those duplicate shots.
Erythema multiforme on same arm vaccine flu shot given opposite side. no temp, no other rash or symptoms.
This spontaneous report was received from a consumer (the patient's wife) and refers to a male patient of unknown age. No information about the patient's medical history, drug reactions, allergies and concurrent conditions was provided. On 26-NOV-2016, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and site of injection were not reported). On 28-NOV-2016 (also reported as 18-NOV-2016), 2 days after receiving the ZOSTAVAX, the patient had started vomiting. Information about the concomitant therapies was not provided. The outcome of the event and causality between ZOSTAVAX and the event of vomiting were unknown. Product quality complaint was not involved. Additional information is not expected as there were no contact details provided.
extreme nausea, severe vertigo lasting 3 days, persistent vertigo since vaccination-unpredictable in terms of when, and how severe
Fever, chills, sweats, nausea, muscle ache all over. Pain near injections site. Felt very like flu without the respiratory issues. Slowly abated and as of today (day 3) I'm mostly back to normal. Tylenol helped.
pt recvd vax; w/in 48 hrs was found to be HBSAG positive;