chrisvoncsefalvay/vaers-outcomes huggingface dataset:
they were not suitable for use due to extended shipment/no AE; they were not suitable for use due to extended shipment/no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2019SA271944, 2019SA278134, 2019SA278136, 2019SA278138, 2019SA278139, 2019SA278140, 2019SA278141, 2019SA278135 and 2019SA271944 (same reporter).  This case involves a patient of unknown demographics who received Deteriorated dose of vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED from an extended shipment.  Patients past history and concomitant therapy was not reported.  On Oct-2019, patient received a multi-dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot: UJ254AC) (no dosing details were reported.  It was of actual medication error case due to Deteriorated drug administered (Poor quality product administered) and Product shipment delay (Product distribution issue).  It was unknown whether adverse event was noticed or not.  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.
pneumonia; Flu; Initial information received on 06-Jan-2022 regarding an unsolicited valid Social Media serious case received from a patient.  This case involves an unknown age and unknown gender patient who experienced pneumonia and flu while receiving Influenza vaccine.  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 vaccine produced by unknown manufacturer (form, strength, dose, frequency, route, lot number, expiry date unknown) in unknown administration site as prophylactic vaccination.  On an unknown date the patient had pneumonia (unknown latency). This event was assessed as medically significant. The patient was hospitalized for this event.  On an unknown date the patient had flu (influenza) (unknown latency).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome: Unknown for both the events; Sender's Comments: Sanofi Company Comment dated 13-Jan-2022. This case involves an unknown age and unknown gender patient who experienced pneumonia and flu while receiving Influenza vaccine. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed
5" p/vax pt reported mild itching w/o urticaria, SOB, chest tightness, + central facial redness w/o swelling;12:00 still c/o mild itching over arms;(no redness @ site) but no objective itching, urticaria, SOB or other distress;
3 other members of my family had COVID-19 beginning Dec 18, 2021. I was tired and run-down but did not test positive while they were sick. I had my booster vaccination on Jan 5, 2022. I then tested positive for COVID-19 on January 27, 2022. I was very fatigued, congested, and had a cough. No high fever. My symptoms were not as serious as my family members. My son's turned into COVID-19 pneumonia. My husband was down for about 2 weeks with a horrible cough, fever and fatigue. My daughter ran fever and had a lingering cough.
no immunity shown on the serologic labs; she needed to receive MMRII vaccination for work. Her other concern was that she is told she only needs to receive one; bleeding gums; Painful patchy white dots on gums; Painful patchy white dots on gums; stomach ache; nausea; muscle fatigue; This spontaneous report was received from a consumer referring to herself (34-year-old female patient). Her historical condition included thyroidectomy. Concomitant medications included levothyroxine sodium (SYNTHROID). She denied providing information about drug reaction/allergies.  On unknown day when she was a child, the patient was potentially (she did not have records nor documented proof) vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection (exact dose, dose number, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On 02-JUN-2023, the patient was vaccinated with one dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection (0.5 mL, lot #415124 which was verified as non-valid upon internal review, expiration date was reported as 13-FEB-2024 but could not be confirmed due to non-valid lot #, route of administration and anatomical location were not provided) for prophylaxis (Extra dose administered).  On unknown day, there was no immunity shown on serological laboratory which is why she needed to receive the extra dose for work. On 03-JUN-2023, the patient developed painful patchy white dots on gums, stomach ache, nausea and muscle fatigue. On 06-JUN-2023, the patient experienced bleeding gums. At the time of reporting, the patient was recovering from the events. The action taken with the suspect vaccine regarding the events was not applicable.  The relatedness between the events and measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection was not provided.
No adverse reactions. Pt given Dtap instead of Tdap. Box of Dtap placed with Tdap.
Follow-up with PCP 1 wk after Pneumococcal 23 given Lt arm. Area redness, swelling, tenderness, pt felt warm, no documented fever, generalized body aches. Pt treated with warm compresses and few Ibuprofen. Provider prescribed methylprednisolone and AUGMENTIN. Advised pt to use cold compresses and Ibuprofen. Follow up 2-3 days.
Patient reports symptoms appearing on 12/12/16. Redness at the injection site and spreading up arm approximately 3 inches in diameter. Patient states the arm is hot to touch and itches. A knot has formed at site of injection. Patient had no fever to previously administered PNEUMOVAX 23. No fever or anaphylactic response reported by patient.
Myalgia, Arthralgia, Fever, NauseaVomiting, chills
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of insomnia in an adult male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 6 June 2011 the subject received 1st dose of BOOSTRIX (details unknown). On 6 June 2011, less than one day after vaccination with BOOSTRIX, the subject experienced insomnia. The healthcare professional reported that the subject was a physician at the office and had received BOOSTRIX on 06 June 2011. He complained of insomnia when he came back into work on 07 June 2011. At the time of reporting the outcome of the event was unspecified.
Pt recvd 3 doses of Engerix-B & titers were checked 6 months p/last dose; Titer result was 8.2 inidicating a low pos response;
Card says Pfizer 1-29-2021  ELA264 Pfizer EN6200 2-19-2021  please note the six might be the letter G. I cannot differentiate the handwriting  Approximately one week after the second Covid 19 vaccine, patient was seen by a doctor,  sent home and returned to doctor a few days later when he was referred to the E.R . for a stroke work up.  He was diagnosed Mar 1, 2021 with a stroke and has partial permanent vision loss.
PT WAS ADMINISTERED VACCINE AT 11:27 AM AND WAS ASKED TO WAIT OUTSIDE FOR 15 MINUTES. AROUND 11:35 PATIENT STARTED FEELING LIGHT HEADED AND DIZZY. PHARMACY ASSOCIATE ON THE FLOOR  ALERTED PHARMACIST. I WALKED OUTSIDE AND HELPED THE PATIENT LAY DOWN ON THE FLOOR , ELEVATED LEGS, ADMINISTERED COLD COMPRESSION. AROUND 11:45 PATIENT STARTED FEELING NORMAL. ASKED THE PATIENT TO STAY UNTIL 12:00 PM. PT WAS FEELING BETTER AND HE LEFT PHARMACY AT 12:05PM
Noticed golf ball size red, swollen area of left leg on 7/22/03 in AM. Brought in HD at 4:45 PM. Red swollen 6-7 cm area on left leg, warm to touch. To use Benadryl, Tylenol and warm washcloth to area. RTC 7/24 if no improvement. 7/24/03 child taken to HD area 7-8 cm still red, swollen and warm to touch. 7/25/03 PC to home. Mom states she took child to ER last night.
Diagnosed with Fibromyalgia; Arm was achy; Shoulder was achy; A spontaneous report was received from a consumer concerning a 84-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shoulder ache/arthralgia, arm ache/pain in extremity and fibromyalgia..   The patient's medical history, was not provided by the reporter. No concomitant medications reported.   On 19 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced shoulder and arm ache. The patient states that he was diagnosed with fibromyalgia.  Treatment for the events were not reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, shoulder and arm ache  and fibromyalgia were unknown.
The pain from shingles has come back. It worse then before. The doctor has increase Lyrica medication. I have to take it 3 times a day. I'm still in pain.
Info has been received from a health professional concerning an adolescent male who in 1995 was vaccinated with a dose of varicella virus vaccine live. On 5/25/05, the pt presented with chickenpox with more than 50 vesicular lesions. He was treated with OTC calamine lotion. No product quality complaint was involved. No other information was provided. The pt's sister experienced chickenpox following vaccination with varicella virus vaccine live. Additional info has been requested.
Complained of fatigue. Monitored for an additional 45 minutes while waiting for his girlfriend to arrive to drive him home. B/P 128/72, P-88, R-20, SaO2- 98%.
Patients left upper arm became inflamed and itchy on 7/31/19. Applied ice with good relief.
In 1997 I was inoculated with an unknown substance without my consent, I believe, in continuance of a research program conducted by a certain agency which began in 2000. My whole body was itchy for 7 years and still is my BBB was penetrated & psychosis ensued.
Patient experienced a rash/hives on the back of her neck roughly an hour or so after receiving the vaccination. She took diphenhydramine 25mg  to help with the itching, which helped to decrease the rash and itching.
This is a spontaneous report from a contactable consumer via Pfizer sales representative. An elderly female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (MANUFACTURER UNKNOWN), via an unspecified route of administration in the arm on an unspecified date at a single dose for immunization. The patient's medical history was not reported. Concomitant medications included the influenza vaccine (FLU VACCINE II). On an unknown date, the patient experienced pain and swelling in arm. Patient approached the company representative in the waiting room, and mentioned she received the flu shot and pneumonia shot on same day in separate arms. She experienced pain and swelling in arm that received pneumonia shot. She did not specify which pneumonia vaccine. The action taken in response to the events for the vaccine was not applicable. Therapeutic measures were taken as a result of pain and swelling in arm and included treatment with unspecified antibiotics which she received after going to the urgent care. The clinical outcome for the events of pain and swelling in arm was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.
2 hrs p/vax pt was noted to be very lethargic, temp has risen to about t104  & pt was shaking all over pale also; 911 was called & taken to ER;
Information has been received from a female consumer who on 11/23/2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647635/0864N).  On 11/23/2004 the patient reported that she had received the vaccine in her physicians office and that afternoon her arm started to hurt and it was very painful to raise my arm.  The consumer reported it felt like there was a lead weight in my arm.  The consumer reported that this continued over the next 2 days and finally subsided the third day.  She also reported that the site was slightly swollen, but not really hot to touch or red.  She reported that this was the third pneumonia vaccine she has received and never had this severe of a reaction.  Further information has been received.  The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory.  The lot complies with industry standards.  Follow up information from the doctor's office reported that this patient is not one of their patients and they do not have any information to provide.  No further information is available.
Pain in the left arm, severe chills, severe hot flashes, burning eyes, runny noise, headache, sneezing.
PATIENT ORIGINALLY RECEIVED HER 1ST DOSE OF PFIZER ON 3/18/21, WHEN SHE CAME IN FOR HER 2ND DOSE ON 6/8/21 SHE WAS TOLD IT'S BEEN TOO LONG OF A GAP BETWEEN DOSES AND RECOMMENDED TO RECEIVE JANSSEN VACCINE INSTEAD TO COMPLETE HER VACCINE SERIES. PATIENT REPORTED NO ADVERSE REACTIONS TO PFIZER. ON 11/29/21, SHE CAME TO CLINIC TO RECEIVE HER BOOSTER DOSE AND THAT'S WHEN THE ERROR WAS DISCOVERED. PROTOCOL SAYS TO KEEP THE SAME MANUFACTURER FOR THE PRIMARY SERIES OF COVID VACCINATIONS, NOT SURE WHY PHARMACIST ON 6/8/21 CHANGED HER TO JANSSEN VACCINE.
COVID; COVID; This is report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4489583-00.  A 38-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 37 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for psoriatic arthropathy; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID". The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event(s) Drug: HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB) and the event COVID-19 Causality as per reporter (Drug/Vaccine) was Not Reported Causality as per reporter between PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN) and the event COVID-19 was Possible Causality as per reporter between MODERNA COVID-19 VACCINE(ELASOMERAN)(Injection) (ELASOMERAN (TOZINAMERAN) and the event COVID-19 was Possible The reporter considered "covid" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Saw Dr. on 6/11 for a sinus infection.  Started antibiotic.  On 6/21, started burning with urination, flank pain, and blood in the urine.  continued for 4 days.  Urine culture negative but treated with antibiotics as a precaution.  On 7/9, burning with urination again, blood in urine, and flank pain on 7/11 again for several days.  Negative urine culture.  Kidney/bladder CT scan done on 7/15.  I will have a cystoscopy on 7/20.
My hands and feet would swell up. My doctor sent me to get blood work. My inflammation levels were 3 times what they should be. Nothing has resolved this issues. Then I had my second dose 3/18/2021, lot number 002B21A. My inflammation continued. I have been been to my doctor multiple times over this issue. This causes my hands and feet to swell so bad that I can not walk. This has affected my mobility.
After vaccine was administered, approximately 10 minutes went by, patient complained of a bad headache and nausea
headache; feeling tired; This is a spontaneous report from a contactable consumer based on information received by Pfizer. A 53-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included psoriatic arthropathy. Concomitant medication included etanercept (ENBREL) taken 50mg weekly for psoriatic arthritis. The patient experienced headache, feeling tired on 18Mar2021. The outcome was unknown.   Pfizer is a marketing authorization holder of BNT162B2 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 BNT162B2 has submitted the same report to the regulatory authorities.   No follow-up attempts are possible, information about batch number cannot be obtained.
PAIN, TENDERNESS AND SWELLING OF LYMPH NODES IN SAME ARM AS INJECTION- LASTED 4 DAYS., FATIGUE,HEADACHE, AND NAUSEA FOR 24 HOURS.
At 9:10 c/o feeling lightheaded, dizzy, finger of left hand tingling, radiation to elbow. Mild soreness at injections site. Vitals 97.2, 140/90, P 75. Student reports nerve damage to hand-does not receive shots in arm. Did not report this to nurse at time of injection. Redness and swelling at injections site. Student reclined to floor. Lungs clear, bilaterally to site (+) breakfast. Reports taking Flexeril for pulled stomach muscles. 9:30 B/P 140/75 P 72. Student reports Sx's. Mother called-notified of Sx's-reaction to vaccine. Mother to pick up for home. 9:50 B/P 130/80 P 80.
pt's arm where recvd vax feeling heavy;9OCT95 it started to itch on 11OCT95 it started go get red & hot & hard
Sensitive skin ~ 30 minutes, very achy joints throughout whole body ~ 30 minutes, uncontrollable chills/shivers ~ 1 1/2 hours, fever ~ 1 hour, severe headache ~ 8 hours, exhaustion ~ 20 hours.
Vaccine administered 10/24 and patient's arm is still sore 11/1. Has a hard time moving arm. Patient contacted pharmacy 11/1 via phone.
Developed redness, pain, itching L upper arm day after vaccine. Worsening area. Had tactile fever.
Back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1 (unknown manufacturer)), for COVID-19 Immunization. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "Back pain". Therapeutic measures were taken as a result of back pain.  Additional information: The reporter's lady friend had back pain after the second Pfizer shot. she received her second dose a week apart from the reporter. The patient is on pain killers.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tested positive for strep throat; shocked she has strep throat; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:ELO142), via an unspecified route of administration on the left arm at the age of 62 years on 12Jan2021 10:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and asthma from an unknown date and unknown if ongoing. Concomitant medication included budesonide, formoterol fumarate (SYMBICORT) and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) both for asthma. The patient had the first part of the Pfizer vaccine. Overall, she had no side effects, but in between getting the vaccine her asthma was bothering her. She went to an Urgent Care and was getting her asthma medicines changed and got tested for Covid and for Flu and both were negative. She was also tested for strep throat and that was positive. She didn't really have any symptoms of a sore throat or anything, she maybe felt some sinus drainage prior to it, but no symptoms. She was shocked she has strep throat and they gave her medication for it and she was almost done with that and wanted to make sure she is able to get the second part. It was clarified her asthma was bothering her prior to getting the vaccine and she was in the midst of getting her asthma medications changed because her asthma wasn't controlled and she was having something with the medications. She had the Covid, flu, and strep testing at her visit on 20Jan2021. She was being seen at the Urgent Care because of her asthma already, not about the vaccine and was given something for the strep. No other vaccines given that day or 4 weeks prior. No problems with vaccines in past. Asthma medication, Symbicort was changed because she felt like she was having side effects. Not sure when she stopped it, but started taking it she started taking it again right before she had testing and got the vaccine. May have stopped taking it about end of November, but tried it again around testing time. She mentioned taking regular medications and medication for high blood pressure and asthma medication. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Jan2021 and streptococcus test: positive on 20Jan2021. The outcome of the event was recovering.
piercing crying 30 mins upon awaking from nap convuls like tremors @ same time; t99 (had recvd APAP) episode lasted several minutes according to mom of pt; no treatment recvd;
Information has been received from a health professional concerning a patient (4 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Patient states sometime after second dose, developed "occasional red, itchy patches, like eczema." Transient, on left extremities only, same side as vaccine.