chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed a rash and it spread to other areas of my body. My Primary Dr. told me to take Benadryl and to keep him abreast if any other symptoms started to appear. I don't do well with needles and became really light-headed (Fire Dept. took me into another room and provided me with water while allowing me to sit there for a while until I was better). Every now and then I randomly breakout randomly with rashes that appear where the rash was before on my arm, chest, and back when I received the 2nd dose of the vaccine.
Patient developed hives on face 2 days after first dose Pfizer lot# EK 5730 on 12/16/2020. Could have been contributing from new N95? However, per patient, she consulted and was approved for the second dose by Dr. and Dr. She received second dose Pfizer lot# EK 9231 on 1/6/2021.
transverse myelitis; paralyzed waist down; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYELITIS TRANSVERSE (transverse myelitis) and PARALYSIS (paralyzed waist down) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DOCUSATE SODIUM (STOOL SOFTENER) for Constipation.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced MYELITIS TRANSVERSE (transverse myelitis) (seriousness criteria hospitalization prolonged, disability and medically significant) and PARALYSIS (paralyzed waist down) (seriousness criteria hospitalization prolonged, disability and medically significant). The patient was hospitalized from sometime in March 2021 to sometime in 2021 due to MYELITIS TRANSVERSE, and then on sometime in March 2021 due to PARALYSIS. At the time of the report, MYELITIS TRANSVERSE (transverse myelitis) outcome was unknown and PARALYSIS (paralyzed waist down) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included a non-specific antidepressant and rosacea medication. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
I have had a headache sinse the evening of when I got the shot 5/28. the headache has been continuous and my eyes burn. I had a similar reaction to shingles shot and to flu shot. I did see an allergist prior to getting the vaccine and tested negative to skin testing for PRG and polysorbate 80 on 5/14
Slight fatigue, headache,  body aches, particularly in legs, similar to influenza.  Very subtle though.  Soreness upon waking as well.  Injection site has no issues, just very light twinge when arm is raised.
Several hours post vax the pt woke up from nap with swollen, red leg and crying loudly. Pt was treated with cold compress and Tylenol. The symptoms persisted for two days. The pt was also restless and fussy. The pt was treated with cold and warmth alternately and subsequently recovered.
Hospitalized with chest pain and hypoxia COVID 19 pneumonia  treated with dexamethasone and remdesivir
Pt was given a dose of ROTATEQ that had expired on the previous day. No signs or symptoms of reaction occured. The dose was repeated with ROTARIX Lot # EY5F7 during the same visit.
headache; fever; sore arm; feeling hot; rash; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING HOT (feeling hot), RASH (rash), HEADACHE (headache) and PYREXIA (fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus and Hypertension. Concomitant products included LOSARTAN and METFORMIN for an unknown indication.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (sore arm), FEELING HOT (feeling hot) and RASH (rash). On an unknown date, the patient experienced HEADACHE (headache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING HOT (feeling hot), RASH (rash), HEADACHE (headache) and PYREXIA (fever) had resolved.            This case was linked to MOD-2020-001419 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Second dose date updated from Jan 2021 to Feb 2021.
Got shingles; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got shingles 1 week after he/she got the vaccine.
15 minutes after vaccination( (9:30 am) patient stated throat fell scratchy and swollen but no problems breathing.  Administered 25mg tablet of diphenhydramine. Patient rested in chair for approximately 30 minutes.  Patient's friend picked patient up left store.
by 4PM pt started getting very sore muscles in lt side of abd, groin, & back;7OCT96 cont to have interior pain saw MD;med given for muscle pain 9OCT96;woke up w/shingles;pain radiating on lt half to lt breast;trouble sleeping;
Ten minutes after receiving his vaccine I went to check on the patient knowing he had had a previous fainting experience with injections. I offered him water and he accepted stated he was ok. 15 minutes after receiving  his vaccine the patient started to feel dizzy and raised his arm to alert me. I went to his side and asked if he was ok and he stated that "it's happening". His head started to fall back and body started to slump to the side. I supported his head and called for the other pharmacist who came over and we were able successfully  get the patient to the floor in the  supine position. I left the patient with the other pharmacist and called 911. By the time I came back he was awake and talking . He remained in the supine position until the medic came and took vitals. We had him sit up and within a few minutes back into his chair where I remained with him until his wife arrived.  I gave him a water and approximately 1 hour after the incident the patient left with his wife.
Fever with chills, headache and severe back pain began approximately 18 hours after shot.  Symptoms persisted for 36 hours.
C/o localized pain w/i 1 hr of inject, was given TYLENOL last NOC at HS had vaccine yesterday; today c/o pain under armpit on side given, brought in to see Dr BENADRYL q 6 hrs and cephalexin x 5days.
Had febrile seizure 11 days p/administration of vax; Petechial rash present when examined the day following the sz;
Pt presented to urgent care on 5/9/17 for 5 days of fevers to 102 at home, chills, malaise, and a perioral rash after receiving a  PNEUMOVAX. Reports that the symptoms began hours after receiving the shot. Fever and perioral rash. Acetaminophen 500 mg prn.
Breakthrough case admission after 5 vaccines Pfizer 2/16/21 Lot# EN6200;  Pfizer 3/9/21 Lot# EN6207;  Pfizer 9/24/21 Lot# FE3592;  Pfizer 3/31/22 Lot# FM0698;  Pfizer 11/29/22 Lot# GJ6738
Fatigue, myalgia. Episode of tachycardia 24 hours after vaccine, lasted 5-6 minutes.
This spontaneous report was received from a 71 year old male consumer, via Pfizer (2015422117), referring to himself. Information about the patient's medical history and concurrent conditions was not reported. The patient reported that, on unspecified date in 2001, 2006, 2014, and in 2015 he received PNEUMOVAX 23, (dose, route of administration, lot #'s and expiration dates were not provided). On an unspecified date in 2015, the patient was given PNEUMOVAX 23 when he was supposed to be given the PNEUMOVAX 23. The patient wanted to know if he should get the pneumococcal 13 (manufacturer unknown) after he has already been given PNEUMOVAX 23. Also the patient wanted to know if the PNEUMOVAX 23 pretty much covered him for pneumonia. Additional information has been requested.
I felt dizzy and nauseous while standing. When I was in the shower, I black out and puked.
Diagnosis: RSV Bronchiolitis, Right upper leg streaking infiltrate with atelectasis. Treatment: Rocephin IV 750mg every 24 hours, Methylprednisolone IV, O2 at 1/2 4 min to maintain saturation >93%, Asthma meds (Albuterol, Atrovent, Pulmicort). Admitted 11/3/05. Discharged 11/9/05.
Patient reported to pharmacy 48 hours after injection to state that he had much pain in injected arm, with swelling and redness and puffiness in the hand.  Patient said he was going to take Benadryl and report to his Doctor if his symptoms did not improve.
This patient received a fourth dose of Covid-19 vaccine (a 2nd Pfizer  dose) 0.3 ml LD IM .  She knew that it was her fourth dose but did not disclose that fact to nursing staff, but did disclose that fact to N P during the visit after being vaccinated.  Patient disclosed that she was afraid of contracting Covid-19 and wanted the fourth dose to protect her from getting it. She had received her booster dose on 11/29/21 Pfizer Covid-19 vaccine. She received the 1st dose Moderna vaccine 12/23/2020, and 2nd dose of Moderna 1/27/2021.
7 days after vaccination large red swollen area at injection site along with numbness tingling on right now arm. Reddened area hot to touch-approximately 2 inches in diameter. Still present 11 days post vaccine now 3-4 inches. Itching and tingling of affected arm.
was given a expired dose of Acthib with no reported adverse event; Initial information was received on 16-Jun-2021 regarding an unsolicited valid non-serious case from a other health professional (GMI Inquiry number: 00644081).  It was reported that a one-month-old female patient was given expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (Suspension For Injection) (lot number: UJ143AA, expiry date: 22-Mar-2021] via an intramuscular route at right thigh for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE, RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and HEPATITIS A VACCINE (HEPATITIS A).  At the time of report, no adverse event reported.  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.
threw up about 4 time; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "recovering", described as "threw up about 4 time". Additional Information: The patient asked if vomiting was 1 of the side effects of having the COVID vaccine. She received her first shot yesterday and reported "I felt fine but when I woke up this morning to get ready for work I threw up about 4 times". She felt better now, she asked if this was from the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. reported facial erythema, injected conjunctiva, pharyngitis, nasal congestion and swelling of the lips approx. 4 hours after the influenza injection.  He took 1 claritin-D, which did not resolve the symtpoms.  He was evaluated by the EMT's 5 1/2 hours post injection.  He refused transport to ER.  He developed a fever lasting from 7 - 14 hours post injection.
This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (concentration, route, dose, frequency and anatomical place of vaccination were not reported) which had a lot # of M021407, an expiration date of 30-APR-2018, for prophylaxis. The doses were exposed to a temperature of 35F, for a time frame of 2 hours and it was reported because a data logger. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009486: US-009507513-1612USA009487: US-009507513-1612USA009485.
Several hours after getting the vaccine, patient reports she had trouble walking. She could "shuffle" but had to be carried up the steps. Patient reports this lasted 4-5 days.
I don't know if this is even from Moderna. For the past several weeks, my eyes have bloody tears in the morning. I have a lot of back pain and it's hard for me to get out of bed. I have noticed watery blood spots on my pillow some mornings. This morning I was crying getting out of bed and I went to the bathroom and my tears were bloody. It frightened me and my doctors don't know why. My  BP is under control. Maybe this means nothing but it has never happened in my life before.
Information has been received from an MD concerning an approximately 40 year old female who was vaccinated IM with the first, second and third dose of Hep B. Subsequently, the pt experienced a rash after the first dose, a "worse" rash after the second dose and was hospitalized overnight after the third dose. Additionally it was noted that the pt had blood work which indicated a negative titer for Hep B.
Vaccine given in right deltoid on 2/13/02. To ER on the night of 2/14/01, secondary to swelling of arm to elbow. In office on 2/15/01, secondary to swelling and redness from shoulder to wrist; tense-red. Admitted to the hospital for observation and IV antibiotics. Discharged in 48 hours. Diagnosis: Cellulitis
ITCHING ON ANKLES/CALVES BOTH SIDES; PINS AND NEEDLES IN LOWER LEGS; WEAKNESS/LACK OF ENERGY; HEADACHE; BODY TEMPERATURE WOULD NOT GO UP (95.2 DEGREES PRESENTLY); This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthmatic, allergic to fragrances, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient had allergy to unspecified cholesterol medications and some diabetic medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced body temperature would not go up (95.2 degrees presently). Laboratory data included: Body temperature (NR: not provided) 95.2 deg. On 26-MAY-2021, the subject experienced itching on ankles/calves both sides. On 26-MAY-2021, the subject experienced pins and needles in lower legs. On 26-MAY-2021, the subject experienced weakness/lack of energy. On 26-MAY-2021, the subject experienced headache. On 28-MAY-2021, treatment medications included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from weakness/lack of energy, itching on ankles/calves both sides, and pins and needles in lower legs, and the outcome of headache and body temperature would not go up (95.2 degrees presently) was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
I would get cold sores around my nose and mouth from one of the herpes viruses. But ever since I took Pfizer dose in February of this year, I never had any more breakouts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 2021 as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 01), administration date: Feb2021, for COVID-19 immunization; Bnt162b2 (Dose 02), administration date: Feb2021, for COVID-19 immunization.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "I would get cold sores around my nose and mouth from one of the herpes viruses. But ever since I took Pfizer dose in February of this year, I never had any more breakouts".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Friday - Nausea started 2 hours after shot - arm soreness about the same time.  Saturday - Nausea continued the entirety of the next day, with the arm soreness increasingly worse.  Experienced bouts of hot sweats, then shivering chills, back and forth all that day and was very fatigued.  Headache started mid-day.  That night I woke up 4 different times covered in sweat.  Sunday - The next morning, still fatigued, headache and nausea were gone, but joint pain/body aches started overnight.  They only lasted a few hours into mid-morning.  Monday / today - All previous symptoms gone, but arm is hot, swollen and red from just below shoulder down to about two inches above the elbow joint.
Immediately after my second dose, I had a really weird nervy feeling down my arm from the injection site, almost like my arm was asleep or very weak.  It lasted about almost 2 weeks actually. The first dose was completely fine. I didn?t have any bad reaction.
Booster shot, same symptoms as 2nd dose, slightly less severe. General nausea and headache lasting approximately 24 hours. Fatigue and extreme tiredness.
Mom states temp 105.3 degrees day after vaccine (HAV) administered & required trip to ER; did not report to HD until months later at an office visit.
Breakthrough COVID-19 case with symptom onset 8/11/2021: cough and headache. Hospitalized 8/11/2021 for unknown duration
Pt recvd 1st dose of Engerix-B approx 3PM 27JAN92 & approx 6PM on same day pt suffered inject site hardness, swelling & pain; swelling lasted for 24 hrs & pain lasted 48 hrs; pain raidiated to wrist & elbow; pt still exp mild ache in arm;
Heart attack Double lung infection  Kidney failure - now have to be in Dialysis 3x a week.
I got the Pfizer booster for Covid 19 and it was administered subcutaneously instead of intramuscularly.  I am a nurse, and noticed immediately when I removed the bandaid that there was a problem. The site was puffy, red, and hard to the touch. I did not develop any muscle soreness or any side effects from the vaccine at all,  which further cemented in my mind that it was administered incorrectly.  Today is 3 days post vaccination. The site continues to be warm, red, hard and swollen. It is starting to turn into a bruise in the center.
Temporary paralysis lasting 4 days. 102.5 fever. Listless.
This spontaneous report as received from a licensed practical nurse, via a sales representative, concerning an unspecified number of patients. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, patients were vaccinated with doses of GARDASIL, (dose, route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that an unspecified number of patients over the last 8 years had reported that each subsequent dose of GARDASIL hurt more than the previous dose. The reporter did not have any patient specific information available. It was unknown if patients sough medical attention. At the time of report, the patient's outcome and the relatedness between the event and suspect therapy were unknown. Additional information has been requested.
This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (Case number: 00809886). A contactable pharmacist reported that a patient of unspecified age, ethnicity and gender, received PREVNAR 13, (lot number not reported), via an unspecified route of administration on an unspecified date as a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had "large localized arm which blew up after receiving PREVNAR 13 (unknown lot and expiry) couple years ago, and was placed on BENADRYL (unspecified manufacturer) (for unspecified time period)." The primary reporter reported the patient had recovered on unspecified date. No additional information provided. No follow-up attempts are possible; information about batch number cannot be obtained.
Systemic: Allergic: Itch (specify: facial area, extremities)-Mild, Additional Details: Patient felt neck and face turn red.
Fluvirin vaccine 10/31/07. Several hours later began to have itch, rash to legs, abd, back. Also noted some wheezing. Began to use Benadryl. Was seen by Employee physician who prescribed Allegra and was off work until 11-6-07.
This spontaneous report as received from a other healthcare worker refers to a patient of unknown age. The patient was vaccinated with dose 2 of GARDASIL (Lot # not reported) in February 2010 and dose 3 of GARDASIL (Lot # not reported) on 30-JUL-2012. NO adverse effect was reported. Additional information has been requested.