chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy; Swollen; Red; Sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchy), INJECTION SITE SWELLING (Swollen), INJECTION SITE PAIN (Sore) and INJECTION SITE ERYTHEMA (Red) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included WARFARIN, PRAVASTATIN and METOPROLOL for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced INJECTION SITE PAIN (Sore). On 20-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itchy), INJECTION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (Red). On 13-Jan-2021, INJECTION SITE PAIN (Sore) had resolved. On 21-Jan-2021, INJECTION SITE PRURITUS (Itchy) had resolved. At the time of the report, INJECTION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (Red) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No new information.
muscle aches; joint aches / pain in that knee; weakness; Prior to Shingrix vaccine she had arthritis in her left shoulder / Didn't have anything in her right shoulder and now she does; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis and knee replacement (had a knee replacement on her left knee prior to Shingrix).   On 25th February 2020, the patient received the 1st dose of Shingrix. In March 2020, 1 week after receiving Shingrix, the patient experienced muscle pain, joint pain, weakness and shoulder arthritis. On an unknown date, the outcome of the muscle pain, joint pain, weakness and shoulder arthritis were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, joint pain, weakness and shoulder arthritis to be related to Shingrix.  Additional details were provided as follows: The reporter did not have the lot number or expiry date. Prior to Shingrix vaccine she had arthritis in her left shoulder and did not have anything in her right shoulder and now she does. The patient received Shingrix and a week later developed muscle aches, joint aches, and weakness. She did not have any problems with the knee prior to Shingrix and now had pain in that knee. The muscle aches, joint aches, and weakness are ongoing at the time of this report. Consented to follow up.
Patient reports headache, nausea, and body aches starting the day of vaccine administration and continuing to day of report (9/12/13).
Pt fainted with-in one minute after receiving Gardasil. Her eyes had dilated pupils and her color was pale. She was quickly placed supine. Mother stated she woke her up and brought her in. She had not eaten or had fluids that morning. She was talking after being placed supine and had completely recovered 3 min later.
pain in the right arm, inflammation, a type of abscess formed in the arm and I waited for it to go away after the vaccine and it has not disappeared
Initial minor soreness at vaccination site. At 2:00 am, I experienced intense shivering, perspiration, body aches and the repeated need to urinate (about 10 or 12 times over the following two and a half hours). The symptoms were very similar to malaria (which I've had four times), although these symptoms, especially the shivering, seemed more intense (perhaps because of my advancing age). It got to the point where I was intent upon calling 911 if the symptoms didn't subside by 5:00 pm. But they subsided before then, and I went back to sleep.
This case was reported by a physician and described the occurrence of swelling injection site in a 4-month-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). On the morning of 27 August 2012, the subject received a dose of KINRIX (.5 ml, unknown route, left thigh) as the 2nd dose in series and experienced wrong vaccine administered and vaccine administered at inappropriate site. The subject was younger than the indicated age for KINRIX. KINRIX is indicated to be used as the fifth dose in the DTaP series and the fourth dose in the IPV series. The preferred site for injection is the deltoid. On 29 August 2012, 2 days after vaccination with KINRIX, the subject experienced swelling injection site. The swelling was less than a centimeter 3 days post vaccination. The subject was "mistakenly given KINRIX on 27 August 2012 for the second dose in the primary series. The subject went to an alternate physician (reporter) 3 days later with swelling less than or approximately a centimeter at injection site. The subject had no fever or other discomfort. The physician refused to provide contact information for follow-up. At the time of reporting the outcome of the events was unspecified. The physician considered the events were probably related to vaccination with KINRIX.
Patient received Flu and PNEUMOVAX on 11/21/2013. That evening she didn't sleep well, was dizzy, (L) arm became red, swollen and very tender under arm, shoulder and down to elbow.
Since having her 1st vaccination, her INR levels have gone to critical levels requiring Vitamin K; This is a spontaneous report from a contactable nurse. This nurse reported for a female patient of an unspecified age received bnt162b2 (BNT162B2, BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took warfarin. On an unspecified date patient experienced since having her 1st vaccination, her inr levels have gone to critical levels requiring vitamin k (international normalised ratio increased). The patient underwent lab tests which included international normalised ratio: had consistent inr levels within therapeutic range on had consistent INR levels within therapeutic range per her physicians preference , international normalised ratio: her inr levels have gone to critical levels on Since having her 1st vaccination, her INR levels have gone to critical levels requiring Vitamin K on 2 separate dates. Therapeutic measures were taken as a result of event. I am inquiring about the possibility of the Pfizer COVID-19 vaccine affecting a patients INR levels. I currently work in an Assisted Living and have a resident who is on warfarin and previous to getting her COVID vaccination, had consistent INR levels within therapeutic range per her physicians preference. Since having her 1st vaccination, her INR levels have gone to critical levels requiring Vitamin K on 2 separate dates. We have investigated all other possibilities for this unusual INR increase and have came up with no other explanation being found. I would greatly appreciate any information/insight you may be able to give me. The outcome of event was unknown.  Information on lot number/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
flu shots ended up with cancer and gone from cancer; Initial information received on 03-Dec-2020 regarding an unsolicited valid serious social media case received from a consumer.  This case involves two patients with unknown demographics who experienced cancer (neoplasm malignant), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, patients ended up with cancer (neoplasm malignant) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment prior to death.  It is unknown if an autopsy was done. The cause of death was reported as Neoplasm malignant.  There will be no information available on the batch number for this case.; Sender's Comments: This was a poorly documented social media case received from social media involves two patients with unknown demographics who had cancer (neoplasm malignant) and died after vaccination with an INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. Also, patient's medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: cancer
"CC: Sore throat Symptoms:  Cough:no Shortness of breath: no Difficulty breathing: no Loss of taste: no Loss of smell: no ------------------------  Fever > 100.4: no Subjective fever: Chills: no Rigors: no Myalgias: no Headache: yes Sore throat:yes Diarrhea: no Nausea/Vomiting: no Nasal congestion/rhinorrhea:yes  Additional symptoms:PND"
1 hr after immunization with flu, arms broke out in hives, itchy, had diarrhea. Didn't take anything for it. By the end of the day all went away.
Gave vaccination without complication in L thigh. Mother called approximately 45 minutes later to say that her daughter was in the backseat of the car and that her cheeks were very red and she was slumped over. She said she had "to speak very loudly for her to respond". She was told to stop and call 911 if daughter was unresponsive or otherwise drive to ER. She was seen at ER and given the diagnosis of "allergic reaction to vaccine". She was given Benadryl; redness resolved and responded well.
Flu injection hurt left arm badly while being administered.  Have since suffered with intermittent pain at the injection site, all down the arm, and wake up some mornings with pins and needles in arm.  Have had some left shoulder and back of neck pain.  Left leg/foot feels strange at times.  Have visited doctors and talked with a couple of nurses.  In all, I've been prescribed Naproxen 500 mg, told to take B-12 and Magnesium, and prescribed Neurontin.  In addition, I have used ice and heat.  It is my opinion that the health care professionals do not really know what to do about it.  One suggested I may have to get a nerve study done.
This spontaneous report as received from a register nurse refers to a 2 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 06-FEB-2014, the patient was vaccinated with dose 1 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Patient received 1    2     3. Blacked out after the 3rd vaccine, fell over onto assistants shoulder. Couldn't remember what happened. Diaphoretic. No significant change in vitals. BP before 95/63 after 103/52 pulse before 51 after 53.
Presented with Hives, diminish with Benadryl, worsen with Heat, Upset Emotions, etc.
About 4am after the vaccination I woke up with a terrible headache took tylenol and was in bed the remainder of the day d/t extreme fatigue.  About 6pm I was able to get up and move around and felt a little better and all symptoms begin to subside within about 24 hrs.  7/29/2021-Expected delivery date
First effect was large red blotch around the site of injection. Second effect was 16 days after injection with large raised blotch area on upper left leg and a small blotch on the upper right leg. The blotch was swollen,warm to touch and itched. Took Benedral gelcaps and put a prescribed cream for relief.
Initial unsolicited report received from a consumer on 21-MAR-2017. This case involves a 10-year-old male patient who was vaccinated with a sixth dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) (batch number, expiry date, dose, dose in series, route and site of administration were not reported), on an unspecified date and also received other five doses of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified dates. Patient's medical history and concomitant medications were not reported. Patient's Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as Milk allergy. On an unspecified date, following the vaccination, the patient experienced pertussis. It was reported that the patient required emergency room/doctor visit. Lab data (reported as Unknown) and corrective treatment were not reported. On an unspecified date, the patient recovered from the event. Upon medical review, the case was considered as serious due to important medical event: Pertussis. List of documents held by sender: none.; Sender's Comments: This case concerns a 10 years old male patient who experienced pertusis after the vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (Manufacturer unknown). Time to onset is unknown. Further information on medical history including birth history, time to onset, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Redness and 'swelling' from shoulder to elbow on Rt arm where client received vaccine.  States child uses arm with no voiced pain, though is tender to touch. Mother used cold compresses on 8/15/12.  Recommended intermittent warm compresses today with Tylenol or Ibuprofen for discomfort. Mother to contact physician if no improvement by 8/18/12.
Pfizer 12/28/20, 1/18/21, 9/23/21. Positive on 1/24/22
Pt states night of the 2nd vaccinations fever, chills lasted several  days. Violent loose stool, vomiting, night sweats . Dr. visit 05/26/2021 - 06/16/2021. Gastro 06/22/2021, still waiting for results. Symptoms still continuing
A 20 year old male presents for take check of smallpox vaccination. Pt initially vaccinated on 3/31. F/u for take check 4/10. Revaccination was needed. Pt was revaccinated 4/28, 15 jabs. Pt came in today with disseminated lesions on left ant arm. No fever or other systemic illness. Pt does have erythema 1 inch at site. Streaking down for period of 2 weeks or only lesions ///. Instructions to go to ER. Temperature 101.
Swelling and bleeding in gums; lower left portion of mouth; no pain. Took two 220 mg Naproxen Sodium tablets to help with arm pain at injection site; unsure if helped with gum issue. Swelling receded within 12 hours
Large circular/oval rash (approximately 4 in x 3 in) appeared 1 week after administration. Rash slightly itches but causes no pain. Patient felt flushed and slightly light headed then noticed rash while taking a shower. Checked for signs of bursitis when patient came into the pharmacy but none present. Patient has no shoulder pain or stiffness. Patient also noted that she noticed her cheeks were red as well and was concerned that the rash may be spreading but also was not sure if the flushing on her cheek was rosacea. Advised patient to take oral BENADRYL at night and use BENADRYL spray or cream if itching increases or becomes uncomfortable. Patient will follow up with pharmacy if symptoms change. UPDATE: Followed up with patient approximately 10 hours from when reaction started/when they came into the pharmacy and rash has not grown in size or spread. Patient reports she believes the redness is going down and her itching as not increased. Patient has not taken BENADRYL or another medication at this time therefore improvement was not due to treatment. Patient will still follow up with pharmacy if symptoms change and then be advised to follow-up with PCP if necessary.
Pt recvd 3 doses of Recomb last dose recvd JUL90 & following each vax pt devel urticaria & mild elevation of bilirubin to 1.5mg & direct bilirubin 0.3 mg; also exp pruritus & dermatographism; tx meds;
DEATH (5 PEOPLE KILLED); This spontaneous report received from a consumer via a social media via a company representative concerned multiple patients (5 people) of unspecified age, race and ethnicity. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered 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 patients experienced death (5 people killed). On an unspecified date, the patients died from unknown cause of death. It was unknown whether an autopsy performed. It was reported that "I know 5. Should be pulled immediately J&J Stop killing people". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).  Version created to amend previously reported information on 05-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1- Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event.  20220216228 -COVID-19 VACCINE AD26.COV2.S-Death(5 people killed). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Narrative:  92yo male died at Hospital, no information on cause of death. Pt had received covid vaccines on 1/20/21 & 2/26/2021. Likely pt's death is not related to covid vaccines given advanced age and long distance of time btwn date of vaccines administered and date of death.
Patient developed Acute Interstitial Nephritis confirmed with renal biopsy, with associated AKI from baseline normal renal function to eGFR < 15
Local pain, swelling, redness; fever, chills, sweats, fatigue, arthralgias x 3 days - starting to improve now.
MMR given on 09/02/03. Pt returned on 09/04/03 with a 2.5" x 4" welt (redness) on right arm. Pt states itching. No Tx received. Pt to observe injection site and return if not better.
This spontaneous case, initially received on 24-Jan-2018, was reported by a nurse and concerns a 04-year-old male child. The patient's medical history and concomitant medications were not reported. On an unspecified date in Dec-2017, the vaccine underwent first temperature excursion. It was reported that, FLUCELVAX QUADRIVALENT PFS had been out of range for 80 hours, and reached at the highest temperature of 9.1 Celsius. On 04-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left/right deltoid, batch number: 195228, expiry date: 31-May-2018). The patient had no adverse event following the vaccination. The reporter assessed the events as non-serious.
Redness, swelling, pain. Patient seen by FNP. Was prescribed cephalexin 500mg and prednisone 20mg.
After consent signed by mother and vaccine dose #1 administered, patient returned on 5/14/21 for second dose when it was noted that the patient was under age as per  the manufacturers recommendations
Pulmonary fibrosis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4450845-00.  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 69 years intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1159488), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: PULMONARY FIBROSIS (medically significant), outcome "recovering". The action taken for upadacitinib was unknown. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of pulmonary fibrosis with Rinvoq (Upadacitinb) was no reasonable possibility.  The reporter causality for event "pulmonary fibrosis" is possible to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported event and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Almost immediately after the first shot, my smell and taste became altered with a chemical and metallic taste/odor.  This continued and immediately after the second shot, it became more intense for a few days.  It has now been two months since the 2nd shot, and everything tastes and smells this way - some things worse than others. I also have very thick/white post nasal drip (congestion) constantly since the first shot.  The taste/smell feels like it comes from that area - deep back of the throat.  I also have a somewhat numb and thick-feeling tongue, but there is no visual indication of abnormality.