chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain; Rash both legs; Rectal bleeding; Rectal pain; Feeling abnormal; Skin disorder; Skin discoloration; Pain localised; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program. A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), intramuscularly on 20Aug2021 (at the age of 14-years-old) as dose 2, single for COVID-19 immunization; and adalimumab (HUMIRA), subcutaneously from 26May2021 (lot number was not reported) to an unspecified date at 80 mg (day 1, loading dose), and subcutaneously from 23Jun2021 (lot number was not reported) and ongoing at 40 mg (40 mg, 1 in 14) for pediatric Crohn's disease. Medical history included eczema. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was not reported) intramuscularly on an unspecified date as dose 1, single for COVID-19 immunization, and experienced bloody stool, Crohn's, dizziness, oral intake reduced, difficulty sleeping, fear, activities of daily living impaired, feeling sad, wound secretion, and cyst. In Aug2021, the patient experienced rectal bleeding, injection site pain, rash both legs, and rectal pain. On an unspecified date in 2021, the patient experienced feeling abnormal, skin disorder, skin discoloration, and pain localized. The action taken in response to the events for adalimumab was dose not changed. The outcome of events rectal bleeding, Rectal pain was recovered in Aug2021 while the event pain localised was recovered on an unspecified date in 2021. The outcome of the remaining events was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of the report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information, the causal association between the events rectal hemorrhage, feeling abnormal, vaccination site pain, rash, skin disorder, skin discolouration, pain and proctalgia and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  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.
ADMINISTRATION ERROR:   "Patient reported that the RN  attempted to give him his first dose. When RN pushed the vaccine syringe she did not feel resistance and patient did not feel vaccine go in. Both were surprised that apparently the syringe was empty.  When the RN asked a supervisor she was informed another does could not be given to the patient."  Vaccine was prepared in a separate preparation area - not by nurse administering.   Patient is being rescheduled to receive 1st dose ASAP.
Day after vaccination 1 felt like a full on case of the flu with joint pain and muscle pain throughout my body.  Hip and shoulder muscles were especially painful (i.e. difficult to get down to a seated position).  The flu like feeling was gone after about 10 hours of sleep and the third day I just have the muscle and joint pain.  Am working through it and trying tai chi.  Tylenol.
Slight discomfort in arm area of vaccine towards evening of first dose. Wore off by the next day. On 2nd dose, swelling in vaccine area by about 7:30 the evening. weakness in body and headache on Saturday . Started feeling chill  Saturday about 8:00 PM onwards. Late in night I took 1 Tylenol. By Sunday morning, the chill had subsided . The weakness got less as the day went by. On Monday feeling got better until now. I am now feeling more like my normal self. I took Tylenol on Sunday and Monday. I haven't taken anymore since.
Initial report received on 02 June 2010 from an investigator participating in a study under the reference number M5A11. A 6-month-old male subject experienced a febrile seizure 1 day after receiving the following vaccines: a third dose of PENTACEL (lot number C3481AA); a first dose of MONOVALENT FLU A/H1N1 NO PRESERV.-U (lot number UT030EA); a first dose of FLUZONE (lot number U3262FA); a third dose of ENGERIX-B (GSK, lot number AHBVB769AA); a third dose of PREVNAR (Wyeth, lot number D78697); and a third dose of ROTATEQ (Merck, lot number 1056Y). On 30 December 2009, the subject experienced a seizure episode at daycare. That evening he experienced a generalized tonic-clonic seizure, witnessed by his mother. The episodes were characterized by generalized shaking, lasting an average of 1 minute. The subject had no recent history of head injury. He was taken to the emergency department, where he was noted to have a fever of 102.5 degrees per rectum, and a history of cough prior to the seizure episodes. Physical exam was otherwise normal. The subject was treated with TYLENOL and fever resolved. Subject was discharged to home in stable condition with impression of acute febrile illness and febrile seizure. He was seen the following day by his physician and physical exam noted nasal congestion and throat pink. He was diagnosed with viral syndrome. The subject was considered to be recovered from febrile seizure on the 30 December 2009. The investigator considered the event medically significant because technically, any patient experiencing complex febrile seizure should have been admitted to the hospital. Since the event, the subject experienced additional episodes of seizure with fever (dates unspecified) and seizure without fever (21 February and 05 March 2010); these seizures were not considered to be part of the episode reported after vaccination. According to the investigator, the event was related to the study vaccine. Documents held by sender: Discharge summary, physician notes.
I received the Moderna booster and had the usual side-effects of aches, chills, just not feeling well. Those symptoms started around 11:30 PM same day as shot. The following day, around 2 PM, I started having dizzy spells, and from 5 PM through 7:30 AM (7:30 AM on Friday, 1/14), I had an attack of really bad vertigo. This left me completely incapacitated. I vomited throughout the entire evening into the early morning hours. Vertigo is a component of Meniere's. The last time I experienced an episode of vertigo was about 6 years ago, Now, as I write this, the tinnitus in my left ear is slightly worse "than usual". In the past, these vertigo attacks come in waves. So I would not be surprised if I have another vertigo episode.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of VARIVAX (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. It was reported that there was no lot numbers, expiration dates and patient data readily available. Nurse reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. The nurse stated that 9 doses of VARIVAX (Merck) with lot number K006137 were administered since fridge incident (since 09-DEC-2014). Follow up information has been received from a licensed practical nurse on 18-MAR-2015. On 05-SEP-2013, the patient of unknown age and gender was vaccinated with a dose of VARIVAX (Merck) that underwent a temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected, all available information has been received.
Severe headache and limb numbness ~ 30 minutes after vaccination Sent to emergency department - no treatment needed
I woke up this morning  (9/13/21) and could not feel my both feet, became lightheaded and weak, had no strengths. it lasted about 30 minutes and feeling came back but I still have some tingling and numbness although better, still very weak overall. I contacted my PCP and pharmacy and was told not to get second vaccine and to go to ER if symptoms come back or get worse
Vaccine was given in patients left deltoid. Patient was ok and got up and was talking to his siblings and stated he wanted to watch his little brother get his shots.  I was administering his brother's shot into the left vastus lateralis and the brother who had been standing there collapsed onto my shoulder as I was still administering his brother's vaccine.  After finishing the shot in his brothers leg I took the patients shoulders and guided him to the nearest chair.  I ensured the boy was conscious and talking and his eldest brother came to pick him up. He was nauseous so he took him out of the room as I finished his youngest brother's shots.  The brother brought him back in the room and we laid him on the exam table.  He was a bit nauseous so he was given crackers and orange juice.  He recovered very quickly and left the exam room walking on his own.
Low fever 1* to 2* degrees, neausea, vomiting. Lasting for a few hours. Felt fine the next morning.
Right arm did not hurt immediately after shot. By 12:30 am arm hurt extensively and I started with chills that were so bad my teeth were chattering.  By approx 2am I had a fever of 103.2 and every single part of my body felt like I had been beaten with a baseball bat. I hurt so badly that I was unable to sleep at all that night. I took two 500mg Tylenol at approx 2:15 am but it was vomited right back up. Nausea continued through the night. Started vomiting every time I had to get up for something.  Was not able to take my morning meds or more tylenol until approx 11:00am. even with tylenol, fever hovered between 101.6 - 102.5. Unable to do anything all day. Now, at 5:54pm on day 2 I still hurt all over, though not as badly. My fever is 100.9.
1) Moderate (6/10) Headache starting 18 hours post injection, did not persist beyond 12 hours, treated with 400mg motrin (treated concurrently with #2) 2) Upper body Muscle Aches, starting 18 hours post injection; did not persist beyond 12 hours,  treated with 400mg motrin (treated concurrently with #1) 3) Pain at injection site within an hour, persisted for 2 days, did not treat.  *total medication taken: 400mg Motrin
Entire upper arm indurated, area where Varivax given blistering, skin taut, warm to touch, swollen. Pt states less swelling today than yesterday. More swelling near Varivax site than TD area.
On day 10 day post the injection, two red blotches, square or rectangular shaped, each about 1 cube inch, noted near the injection site , maybe just below as I could not see the actual injection site.  It was hot and tender. Size extended by Day 11 slightly with the  two squares becoming a more rounded single site. I took some Benedryl at that time about 4pm and then took Acetominophen and Famotidine at bedtime.
Had reaction; Rash; Body aches; Fever; A spontaneous report was received from a consumer concerning a female patient (Unspecified age) who experienced had reaction/vaccination adverse reaction, body aches/myalgia, fever/pyrexia and rash.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number not provided) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date the patient experienced had reaction, body aches, fever and rash.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events had reaction, body aches, fever and rash were unknown.
PEDIARIX, ACTHIB and PREVNAR administered and child developed hives on both feet diminished within 5 minutes.
chills; tired for a few days; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and FATIGUE (tired for a few days) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included White coat hypertension (Have high blood pressure).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced CHILLS (chills) and FATIGUE (tired for a few days). At the time of the report, CHILLS (chills) and FATIGUE (tired for a few days) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal normal.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No concomitant medication reported   An electrocardiogram was performed  Treatment using steroid tablet, Pepcid for stomach, a children's dose of diphenhydramine, and diphenhydramine12.5mg every 4-6 hours was reported  Application of cold cloth on arm was reported
Rash all over body -no blisters- c/o of it itching. Day after vaccine - felt loopy, relaxed, and crying. Next day felt "gross", nauseous and rash onset.
Started feeling covid symptoms about 5 days after the booster.  I tested positive on the 9th day.  I was extremely sick for about 2 weeks.  Severe covid fog and confusion, high anxiety, severe tinnitus, no fever, night sweats, no real cough/congestion, bad body/back aches, and heart palpitations ever 30-40mins and continued for about 3.5 weeks after I started to feel better.  I got Omicron around Christmas.  Delta symptoms started to go away.  Sick w/ Omicron just for 2-3 days w/ normal symptoms.  Did experience chest tightness/shortness of breath.  On 4/20/22 I tested positive for covid again.  Just had a low grade fever.
This spontaneous report as received from a pharmacist refers to a 53 year old female patient. Patient's concurrent conditions and relevant medical history was unknown. History of drug reactions/allergies was none. On 27-AUG-2014 the patient was vaccinated with ZOSTAVAX (dose and frequency unspecified) (lot number: K003601 with expiry date of 19-MAR-2015). Concomitant therapies included thyroid medication. Pharmacist reported that after administration of ZOSTAVAX on 27-AUG-2014, the patient developed pain, itching and redness at the injection site on an unspecified date following the administration. Pharmacist reports that no rash was present. Pharmacist reported that on 29-AUG-2014, the patient reported that the red area appears to be expanding. Pharmacist states that she advised the patient to apply cool compresses to the site. The patient sought medical attention by calling the pharmacist. The outcome of the events was reported as not recovered/not resolved. The causality of the events with ZOSTAVAX was not reported. Product quality issue was not involved. This case is linked to #1409USA002986 via same reporter link. Additional information has been requested.
Patient given Pfizer bivalent in place of Pfizer monovalent. Patient needed to received 2nd dose of primary series.
Dizzy, headache, unable to walk straight, pain throughout body. Two Cases of shingles after vaccine. Also note, my children who received the Pfizer vaccine and had their varicella titers checked no longer had immunity.
This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID symptoms improved then got worse) in a 61-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 treatment. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication. Concurrent medical conditions included Psoriasis and Allergy. On 29-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Jul-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 01-Aug-2022, after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (COVID symptoms improved then got worse). At the time of the report, COVID-19 (COVID symptoms improved then got worse) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. It was reported that, the patient was taking any other medications or products within 2 weeks of staring COVID-19 treatment. The patient informed that, COVID symptoms improved then got worsened on August 1. Device date was: 03-Aug-2022. No Concomitant drug details was reported. No treatment drug details was reported. Company comment: This Spontaneous case reported by patient concerns a 61 years old female patient, with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19 (COVID symptoms improved then got worse) about 33 days after receiving the 1 dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient was started with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-Jul-2022 to 19-Jul-2022 for an unknown indication. On 01-Aug-2022, COVID symptoms improved then got worse. Concurrent medical conditions included Psoriasis and Allergy. No other information regarding labs, diagnostic procedures, and treatment was available in the report. Ongoing Covid 19 pandemia and use of Paxlovid are confounders. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This Spontaneous case reported by patient concerns a 61 years old female patient, with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19 (COVID symptoms improved then got worse) about 33 days after receiving the 1 dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient was started with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-Jul-2022 to 19-Jul-2022 for an unknown indication. On 01-Aug-2022, COVID symptoms improved then got worse. Concurrent medical conditions included Psoriasis and Allergy. No other information regarding labs, diagnostic procedures, and treatment was available in the report. Ongoing Covid 19 pandemia and use of Paxlovid are confounders. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pt received influenza vaccine in RUE at Pharmacy on 10/5/21. Presented to medical facility on 10/14 with persistent pain and bruising of the RUE starting within hours of receiving the vaccine.
no adverse event; ROTATEQ adminstered after temperature excursion; This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 22-MAR-2022, the patient was vaccinated with a 2 mL dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # 1742431 exp date 31-JAN-2023) orally after temperature excursion. The temperature if excursion was 9.2 C for a time frame of 36 minutes. There was no previous temperature excursion.
Pt received second dose of GARDASIL (HPV) & c/o swollen lips, sore throat x 12-15 hours.  No shortness of breath.
An adult dose (0.3ml) of Pfizer's adult formula was inadvertently administered to a six your old child for her second dose. At this time (2 1/2 hours after vaccination), no adverse reaction has been noted. Mother was notified of the error and encouraged to watch for any adverse reactions. She was encouraged to call her pediatrician which she did. He advised she bring the child to his office to be seen.  Her pediatrician spoke with the department's administrator and stated he plans to advise mom of possible signs and symptoms to watch for.
2 days after vaccination, left leg, red, warm, swollen; fever started 3 ays after vaccination @ 101F on  4th day, Also right leg red and warm. Treated with Augmentin 400/5 , 3ml PO BID x 10D
Patient began to feel light-headed 15 minutes after receiving the vaccine.  He attempted to go to the bathroom because he felt nauseous.  He started to feel faint and laid down on the floor.  He attempted to get up twice, but kept passing out.  He remained laying on the floor for roughly 30 minutes afterward until he felt better to sit up.
on 13-AUG-2020 a patient was administered improperly stored PEDVAXHIB; This spontaneous report was received from a licensed practical nurse, referring to a 6-month-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 13-AUG-2020, the patient was vaccinated with an improperly stored haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) injection, by intramuscular route (lot number S036823 which has been verified to be valid, expiration date reported and validated as 31-MAR-2022) (dosage, vaccination scheme, frequency and anatomical site of injection were not reported), as prophylaxis. The administered dose of the vaccine was stored at a temperature of above 47 degrees Fahrenheit / 9 degrees Celsius (C) (8.9 C), during a time frame of 33 minutes, as recorded by a digital data logger. There was no previous temperature excursion.