chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Bexsero administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXA94AA, expiry date February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   In July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comments: The nurse reported that a patient administered Bexsero which was expired onFebruary 2022. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Chills fever sore throat myalgia. Seen at school clinic sent home. Temp 99.6 WBC 20.2  L10 GR 85 Throat culture  and urine culture negative Flustar negative. Child placed on Cefzil 500 mg po BID. Dad demanded Tamiflu 75 mg po BID
WBC "little elevated; Received first dose 08MAR2021, 21MAR2021 has symptoms of SARs-COV-2 and COVID-19 Virus tested positive; Received first dose 08MAR2021, 21MAR2021 has symptoms of SARs-COV-2 and COVID-19 Virus tested positive/ she got sick; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 08Mar2021 (lot number: EV6205) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first dose on 08Mar2021, on 21Mar2021 had symptoms of SARs-COV-2 and COVID-19 Virus tested positive on an unknown date in Mar2021. The patient also reported greater than 3 weeks since getting the first dose of the vaccine. The patient had a blood test last week in May2021 (based on 17May2021) white blood cell count (WBC) "little elevated". The patient stated she was calling about the COVID vaccination. She stated she got the first vaccine on 08Mar2021 and then two weeks later on Sunday 21Mar2021 she got sick and she started getting symptoms which turned out to be COVID symptoms which had started 2 weeks after the vaccine and symptoms ended around 06Apr2021 or 07Apr2021. The events outcome for "Received first dose 08Mar2021, 21Mar2021 has symptoms of SARs-COV-2 and COVID-19 Virus tested positive" was recovered in Arp2021, for WBC "little elevated" was unknown.
Developed diffuse macular rash and chest pain.  Positive cardiac enzymes along with normal ECG thought developed myocarditis. Treatment was pain control with Ibuprofen. OP notes, he was placed on BACTRIM on the same day of immunization.
Her second dose taken this Tuesday and her platelet dropped to 111 thousand, they dropped 111 thousand since the first shot; 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 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18May2021 (Lot number: EW0186) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: Verbatim: Depression; "Anxiety" (unspecified if ongoing), notes: Verbatim: Anxiety; "COPD" (unspecified if ongoing), notes: Verbatim: COPD. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, EW0176, Left Arm), administration date: 27Apr2021, when the patient was 63 years old, for Covid-19 immunization. The following information was reported: PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "Her second dose taken this Tuesday and her platelet dropped to 111 thousand, they dropped 111 thousand since the first shot". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: her platelet dropped after the first shot and they continue to drop until she got the next shot then they dropped more. She was being treated for low platelets. When she got her first shot her platelets were around 50 and went to 305 up. She got her second shot this and now her platelets drop to 111,000.  No follow-up attempts are possible. No further information is expected.
still red; still / swollen; soreness is finally getting better / a week still sore; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included WHOOPING COUGH VACCINE for prophylaxis.   On 13th November 2020, the patient received Shingles vaccine and WHOOPING COUGH VACCINE. In November 2020, less than a week after receiving Shingles vaccine, the patient experienced erythema of extremities, swelling arm and pain in arm. On an unknown date, the outcome of the erythema of extremities, swelling arm and pain in arm were recovering/resolving.   It was unknown if the reporter considered the erythema of extremities, swelling arm and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient received whooping cough and shingles and they both were still red swollen and the soreness was finally getting better. boo boos on both arms. The patient same here but it's been a week still sore at the time of report.
Information was received on 16-JAN-2018 from a lawyer regarding a case in litigation concerning a male patient, age not reported. The patient was inoculated with ZOSTAVAX on an unknown date, at an outpatient clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. The male patient was subsequently treated by a physician (on an unknown date) at the outpatient clinic and another physician (on an unknown date) at the outpatient clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further and proximate result the patient suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Outcome of herpes zoster/shingles, vaccine did not prevent shingles, and weakened immune symptoms was unknown. Additional information has been requested.
Soreness at injection sites (each arm). Headache. Lethargy, weakness, dizziness. Felt warm, but temperature tested normal. Pain in neck, shoulders, elbows, wrists, hips, thighs, knees and ankles. Took Advil and Tylenol during day. Rested.  Seem to have recovered in about 24 to 36 hours.
Two days post vaccination patient began having itching, redness, swelling and hot to the touch at injection site. has traced the redness with pen and states redness is expanding.  states about 3 in in diameter,  states some redness after injection with a small lump but the last 3 days redness has grown and expanded. Encouraged to apply ice pack, may take Tylenol/Anti Itch medication for sxs.  Continued to expand. Went to Urgent Care 1/17/21. Rx Cephalexin.
SWELLING ARM; CHEST PAIN; SWELLING OF CHEST; PAIN IN ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included swelling in chest, and chest pain, and other pre-existing medical conditions included the veins in chest wall are involved and could take up to 6 weeks to resolve. this person was still in pain and swelling continues and was now being asked to see a cardiologist. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced swelling arm, chest pain, swelling of chest, and pain in arm. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pain in arm, swelling arm, chest pain, and swelling of chest. This report was non-serious.
Patient received a dose of Pentacel on 06OCT2021 that expired on 01OCT2021 with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician, other health care professional and consumer/non-health care professional via Medical Information (Reference number- 00801434) and transmitted to Sanofi on 06-Oct-2021.  This case involves a 2-month-old male patient received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] on 06oct2021 that expired on 01oct2021 (expired product administered).  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 06-Oct-2021, the patient received first 0.5ml (total) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot: UJ382AA and expiry date: 01-Oct-2021) (Frequency = once) (Strength = standard) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered).  It was reported "Caller wished to report this event and receive information on how to proceed".  This case was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse 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.
Vomiting the day after vaccination. Pregnant 16w4d at time of vaccination, due sept 19 2021. No history of pregnancy-related vomiting in prior 4 weeks.
severe headache and pressure - lasting 5 days and counting SOB and chest pain - lasting 5 days and counting Joint pain and inflamation - inflamation for 3 days - pain 5 days and counting Dry eyes and throat - sore throat - 5 days and counting
Swelling of R jaw, unable to open mouth completely, difficulty eating, some discomfort. I took Motrin for pain.
Diarrhea; Stomach pain; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach pain) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B218) for COVID-19 vaccination.    Co-suspect product included non-company product depo for an unknown indication.    Concomitant products included CHLORPROMAZINE, DULOXETINE HYDROCHLORIDE (CYMBALTA), BUSPIRONE HYDROCHLORIDE (BUSPAR), ARIPIPRAZOLE (ABILIFY) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient started depo (unknown route) at an unspecified dose. On 10-Apr-2021, the patient experienced DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach pain). At the time of the report, DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach pain) had resolved. gas medicine      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was taking depo shot concomitantly. Treatment included gas medicine for diarrhea and stomach pain.
Site of DTaP on L deltoid very red, swollen, hot to touch, site of flu shot on R deltoid also very red, swollen and hot to touch.
No adverse event; Patient was vaccinated after the expiration date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 26-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated after the expiration date). Concomitant medications details were not reported by the reporter. Reportedly, at the time of unannounced visit by an representative on 28-Sep-2022, 50 doses of Moderna vaccines were left in the health department which were looked well but later on the day stated that were uncompliant due to the same lot of Moderna vaccines had expired on 07-Jul-2022. Additionally it was mentioned that the expiration code on the packaging slip was not the expiration code, had to scan the code to determine the actual expiration code, thus failed to did by not reading carefully the packing slip. Treatment details were not reported by the reporter.
fever; chills; sweating; warmth at injection site; lymph nodes swollen and painful; lymph nodes swollen and painful; Body aches; headache; tired; nauseous; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Lot number was not reported) as single dose (at age of 26-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. First dose of bnt162b2 (BNT162B2) was administered on 27Jan2021 (at age of 25-year-old) for covid-19 immunisation. On 18Feb2021 08:00 patient experienced fever, chills, sweating, warmth at injection site, lymph nodes swollen and painful, headache, body aches, tired, nauseous. No treatment was administered for the events. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.
Candidate had came in for MMR vaccine, he complained of pain to  right arm where the TDAP vaccine was injected. RN ,was asked to assess the injection site. There was no redness noted on the right arm, slightly warm on the injection site compared to the right lower arm,  the injection site was still visible correct site which  was in the deltoid area, denies any tingling or numbness , with full range of motion of the right arm, complained of localized pain to right arm, denies any shooting pain to the right arm, fingers. He was adviced to keep taking Ibuprofen, apply alternate warm and cold compress. Follow up again Monday 10/26/2020 .
received the vac on 4/6, starting aprox 8th -9th I start to not feel good... just thought is was a mild reaction to the shot... by the 12th I felt terrible, very short of breath and unable to walk with out thinking I was going to die...... waiting as long as I could then I went to urgent care on the 14th and was told I probably have asthma and was given a few medications... on the 18th things were not any better and I no longer could take the pain and not being able to breathe... so I went to the hospital and was admitted to the PPC floor of the hospital after being in the ER.  the next morning I had to have a procedure to break up BLOOD CLOTS in my lungs... I spent 4 days in the PPC ward and now home trying to recover from this... I was told my condition was very serious and was lucky I came in... Of course the doctors will not say this was a direct link to the shot ... i never had any problems before and never any blood clots.  The doctor who did the procedure told me to make sure I REPORTED IT.... I was released from the hospital on the afternoon of the 21st.. 4 days!
Chills the night of injection. Very tired the next day.Hives in both arms. Still getting them after over a week of injection. Itching like crazy. Keeping me awake. Benadryl and hydrocortisone. Still not helping. Now taking 25mg Hydroxyzine.
Delayed hypersensitive reaction of itchy hives all over my body; Delayed hypersensitive reaction of itchy hives all over my body; Delayed hypersensitive reaction of itchy hives all over my body; This spontaneous case was received on 19-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-03840), processed together with additional information received on 20-Oct-2020 and concerned a female patient of unreported age.   The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included a flu vaccine in 2016 with delayed hypersensitive reaction of itchy hives all over the patient's body on it (reported as the exact same reaction which the patient experienced in 2020).  On an unspecified date 2020, the patient was vaccinated with Flucelvax QIV 2020-2021 (influenza vaccine, subunit influenza virus vaccine polyvalent, dose, route of administration, anatomical location and indication: not reported). The batch number reported was 279844.  On an unspecified date in 2020, an unknown amount of time after receiving Flucelvax QIV, the patient experienced delayed hypersensitive reaction of itchy hives all over the body. The patient was advised and treated by a doctor.   The outcome of events was not reported.  The reporter assessed events as related to influenza virus vaccine polyvalent. The patient had the exact same reaction to the 2016 flu vaccine.  This case is linked to the case 202005291 (the same patient).  Company comment: A female patient of unreported age, was vaccinated with Flucelvax QIV vaccine. An unknown amount of time after receiving Flucelvax QIV, the patient experienced type IV hypersensitivity reaction, pruritus and urticaria. Reportedly, the patient had the exact same reaction to the 2016 flu vaccine. With information available, causality is assessed as possibly related for all events.; Reporter's Comments: The reporter stated: I had the exact same reaction to the 2016 flu vaccine.; Sender's Comments: A female patient of unreported age, was vaccinated with Flucelvax QIV vaccine. An unknown amount of time after receiving Flucelvax QIV, the patient experienced type IV hypersensitivity reaction, pruritus and urticaria. Reportedly, the patient had the exact same reaction to the 2016 flu vaccine. With information available, causality is assessed as possibly related for all events.
3 days after vaccination I had this itching sensation on my right wrist, as I looked at it and started to scratch and rub I notices small bumps appear and when scratched had a clear fluid release with a small puncture opening, Since the Pharmacist said  a side effect could include a Ugly, Red Rash and clear with in 3 days I was not concerned.  But now 2 Months Later I still have the bumps and it has spread to my Torso, Left Arm and Chest.  it is not a constant itching sensation, but when it is itchy, a clear liquid still appears and the bumps never go away.
It started about 3 AM with a sore throat and I thought I had a sinus infection. I also had body ached, chills, fever, and then back to a sore throat for a few days. I was given PAXLOVID which helped me so much along with TYLENOL for the fever.
Painful Injection; Diarrhea; This case was reported by a consumer and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th October 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and diarrhea. The patient was treated with loperamide hydrochloride (Imodium). On an unknown date, the outcome of the pain in arm and diarrhea were recovered/resolved.   It was unknown if the reporter considered the pain in arm and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and in her left upper arm and complains of painful injection that lasted for approximately 3 days. Approximately 12 hours following vaccination caller reports starting to have diarrhea that lasted another 12 hours while taking Immodium AD for relief. The reporter consented to follow up. The caller was a GlaxoSmithKline employee. GlaxoSmithKline employee was not a field representative.
On Sunday around 8pm patient got extremely tired before bed. This was unusual for him. He was falling asleep on the couch. He complained of a headache which he maybe only ever had once in his life. He wasn't running a fever. He woke up at 5:30am throwing up. It was almost all yellow bile. He slept on the couch the entire day waking up briefly and threw up probably 7 or 8 times throughout the day. He couldn't even watch TV he felt so exhausted and sick. He never ran a fever the whole time. He was able to urinate and take a couple ounces of fluid around 6pm Sunday. So Sunday at 5pm was the last time he threw up. He threw up when we tried to give him Motrin.  We did have a call with a Dr and we're told to go to emergency room if he gets better or can't keep fluids down.  The next day (today that I'm writing this) he still spent most of the on the couch but was drinking and able to keep small food down. We have 2 adults and 2 other kids in the house and no one has been sick but him.
Vax on 12 May 15, 14 May redness on (R) arm and neck, 17 May stiff in neck. Notes itching on redness. Back of neck scaly/flaky. Husband applied alcohol w/o relief.
Large local reaction with papulo-macular erythematous area with 8cm X 8cm on R upper thigh with STS and R thigh diameter (31 cm) L thigh diameter (30cm), increased STS noted after 12 hrs s/p shot. Fever to 104 after 12 hrs s/p shot.
The vaccine was given at 16 days after the initial dose. Not 21. Therefore he is not considered fully vaccinated and will have to repeat his second dose.
Patient states her arm was in extreme pain, which kept her from sleeping. She states the pain in her arm was so bad she couldn't use her arm and stayed home from school the next day.
Reported dizziness b/p 112/72  pulse 72,   PSO2 100% brought to lay down felt better shortly. Drank water and ate a snack.  Stated she was fine and ready to leave.  Informed to seek medical attention with any further problems.