chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received TWINRIX (batch number unknown, expiry date 30th September 2018) for prophylaxis. On 14th February 2019, the patient received TWINRIX. On 14th February 2019, unknown after receiving TWINRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follows: The age at vaccination was not reported. On 14th February 2019, the patient received TWINRIX which was already expired on 30th September 2018. The pharmacist did not have additional information available at the time of this call, as he was not in-office. The vaccine administration facility was the same as primary reporter.
Flu like symptoms next day; Sore; 102 fever; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms next day"; PAIN (non-serious), outcome "unknown", described as "Sore"; PYREXIA (non-serious), outcome "unknown", described as "102 fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Description of Event: Flu like symptoms next day, Sore, 102 fever. Name of Product: Pfizer BioNTech Covid bivalent. Awareness Date: 14Sep2022. Country of Occurrence: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd 3 doses of Engerix-B & it was determined that pt did not seroconvert; 4th & 5th doses of Engerix-B were administered;
pt recvd vax 11MAY92 & in SEP92 pt tested pos for ANA & rheumatoid factor; prev rheumatoid factor in 1986 had been neg; joint were swollen p/vax sx w/optic neuritis & rheumatoid arthritis;
Note - It was determined after I phoned you that dizziness  was caused by low blood pressure, not the flue vaccine.
Sore left arm two hours after the vaccine was administered. on 6/21. Soreness subsided the next day.  On 6/27 hives were noticed on both arms with mild itchy symptoms. 6/28 hives appeared on both legs with mild itchy symptom.  Hives are still noticeable the morning of 6/30 on both legs and arms, Benadryl was given at 9:00 am.
weak short of breath; terrible headache; heart palpitations; flu symptoms; I still feel terrible. I now need to see a immunologist.; This is a spontaneous report from a contactable consumer (patient herself). A 52-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW1077; Expiration date: unknown) via an unspecified route of administration, administered in Arm Right on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: penicillin. Prior to vaccination the patient was diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW1077; Expiration date: unknown) via an unspecified route of administration, administered in Arm left on 24May2021 14:00 as single dose for COVID-19 immunization with reaction fever, flu symptoms, congestion, severe headache, pcn(Drug hypersensitivity). On an unspecified date in 2021 after the second dose the patient experienced weak short of breath, terrible headache, heart palpitations, flu symptoms, i still feel terrible. i now need to see a immunologist. The adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.  The patient underwent lab tests and procedures which included Covid-19 which was positive on unspecified date prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of all events was not recovered.  Follow-Up (07Jul2021): Follow-up attempts are completed. No further information is expected.
1 week 1 day after vaccine. My arm started a small red spot and sore at injection site. Day 2 yesterday pain more noticeable, area larger, red, warm to the touch and noticed joint pain. Last night started body chills. This morning area very red, larger and more sore. Called pcp and was started on antibiotics
Stiff neck, lightheaded, weakness and joint pain. Started 7/14/2018.
After coming into the observation post vaccination, the patient told the nurse that she was itchy. The nurse assessed her and did not note any hives but did see scratch marks. Soon after, the patient stated she felt hot and had a headache. She quickly noted that her throat  had begun to also hurt at that time. EMT's came over to assess her, per the nurses request  the EMT's at that time suggested to the patient that she be further evaluated at the hospital.  She accepted the transport to the ER.
This case was reported by a consumer via call center representative and described the occurrence of pruritus in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included automobile accident (about 2 weeks prior to getting SHINGRIX). On 10th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 7 days after receiving SHINGRIX, the patient experienced pruritus, burning sensation, skin rough and skin irritation. The patient was treated with topical steroid nos (Steroid Cream). On an unknown date, the outcome of the pruritus, burning sensation and skin rough were recovering/resolving and the outcome of the skin irritation was unknown. It was unknown if the reporter considered the pruritus, burning sensation, skin rough and skin irritation to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received the dose of SHINGRIX and about 1 to 2 weeks later she noticed an irritating itch on her bottom. She developed an area on her skin on her right buttock that was rough, itchy and irritated, about 2x2 inches. It was really bad for 2 to 3 weeks and was improved at the reporting time, but every time she thought it was going away it started itching again. She had used an ointment on it and steroid cream. Only the steroid cream seemed to help. She saw her doctor, who thought it was not shingles, but was unable to tell her what it was.
Inconsolable crying x 4 hrs within 8 hrs of receiving DTAP.
Post vax pt developed generalized itching as well as an injection site reaction characterized by warmth, redness, and swelling. The reporter indicated that the pt is a healthcare professional and self-treated her symptoms (treatment was unspecified). The itching, warmth, redness and swelling resolved. As of 4/12/01 a "small" lump at the site Pnu-Imune-23 administration persisted. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Pnu-Imune-23 lot 474-936.
arm soreness at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness at vaccination site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm soreness at vaccination site). On 27-Jan-2021, VACCINATION SITE PAIN (arm soreness at vaccination site) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, SARS-CoV-2 test: Positive.         The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable. Concomitant medication and treatment drug were not reported.   This case was linked to MOD-2021-021557 (Patient Link).
101 fever lasting 24 hours, not alleviated with meds, total body aches and chills, significant weakness and fatigue. Fever broke after 24 hours with continued weakness, body sweats the next day. Day 3 started with headache and ended with severe GI disturbances.
devel wheals on face & extremities 10 min sp/vax; tx w/DPH w/relief; remained on DPh x 24 hrs no other adverse effects-found to have OM when examined;
This spontaneous report as received from a healthcare worker refers to a current 73 years old patient. The patient was vaccinated with ZOSTAVAX (lot number not provided) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The patient developed a huge water blister the size of a lemon, at the injection site. The outcome of adverse event was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested. This is one of several reports received from the same source.
05/01/2008 10:30 AM student c/o "high fever", took temp 101 degrees. Called mother and she came to get him.
Sweating mainly from the waist up.; chills; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweating mainly from the waist up.), CHILLS (chills) and PYREXIA (fever) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating mainly from the waist up.), CHILLS (chills) and PYREXIA (fever). At the time of the report, HYPERHIDROSIS (Sweating mainly from the waist up.), CHILLS (chills) and PYREXIA (fever) 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.   Concomitant medication history not provided. Treatment included Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: initial additional On 04-May-2021: initial additional On 10-May-2021: initial additional
About 36 hours after receiving a Moderna Covid 19 booster injection on 10/29/21, I noticed a red rash starting to form at and near the injection site. In the following 24 hours, the rash grew to about 4 inches long and 2-3 inches wide and was well beyond the injection site. I am using an over-the-counter hydrocortisone cream on the area.
17 year old male patient received a full dose of Moderna COVID vaccine on 12/9/21 at a Church. Mistake was not disclosed to the patient and the patient returned today to receive the 2nd full dose. Patient received the 2nd dose and was only informed of the mistake afterwards.
onset of sx was about 5-7min p/vax;ringing in ears x 2-3min, gave  pt a h/a for some length of time + blurred vision (same time frame);no tx necessary;
pt recvd vax; devel gen welts/hives the am of 5apr95; 6 days later DTH elixir prescribed;condition more widespread 6apr95;MD prescribed prelone syrup;infant started on amoxicillin 28mar95 for OM
This case was reported by a pharmacist and described the occurrence of leg pain in a 72-year-old male subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  The subject's medical history included arthritis, diabetes, high cholesterol and hypertension.  Concurrent medications included Caduet.  The subject received no other vaccinations on the date of receipt of Flulaval.  Information regarding receipt of previous immunization with Flulaval was not provided.  The subject had no adverse events following receipt of prior immunizations.  On 16 November 2007 at 2:21 p.m., the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm).  On an unspecified date on or after 16 November 2007 and on or before 20 November 2007, less than one week after vaccination with Flulaval, the subject experienced left leg pain.  At the time of reporting the event was unresolved.  Follow-up information was received on 18 December 2007 via a pharmacist, who reported that the outcome of the event was unknown.
PATIENT RECEIVED DOSE AND ABOUT 30 MINUTES POST VACCINATION, PATIENT COMPLAINED OF THROAT SWELLING AND TROUBLE SWALLOWING. 911 WAS CALLED, PAIENT REFUSED EPI-PEN, WAS GIVEN 20 ML OF LIQUID BENADRYL AND PICKED UP BY AMBULANCE
Several days after the shot I developed very intense hives from my ankles all the way up to my waist and also along my arms. there was no other possible cause for the hives (e.g. no changes to diet, allergens, pets, detergent).  have been taking Benadryl to calm down the hives but they continue to flare back up after 48 hours. This was also my first time ever receiving a flu shot.
mom stated 4-5 hrs p/vax pt woke up & was cranky, started throwing up; got feverish (103-105); given APAP; would start choking during noc off & on for about 2 wk; also tired, weak, inactive, coughing, anorexia, difficulty swallowing, flu;
Dose at 12:25 12:32: Employee reported warmth, flushed, diaphoretic, dizzy, nauseous 12:34: Lied to floor with feet elevated. BP: 112/52 Reported Tingling lips- administered diphenhydramine 50mg at 12:36 1239: 122/78 1245: Feeling better, sat up in chair 12:56: Another wave of heat, nausea, dizziness- lied to floor. drank water. Denies breathing or troubles swallowing . Lip tingling has resolved
simply wanted to receive his second dose of the Moderna Covid-19 primary series; Body aches; fever; chills; all (flu-ish); got really sick; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (all (flu-ish)), ILLNESS (got really sick), PRODUCT ADMINISTRATION INTERRUPTED (simply wanted to receive his second dose of the Moderna Covid-19 primary series), MYALGIA (Body aches) and PYREXIA (fever) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In March 2023, the patient experienced INFLUENZA (all (flu-ish)), ILLNESS (got really sick), MYALGIA (Body aches), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (simply wanted to receive his second dose of the Moderna Covid-19 primary series). In March 2023, INFLUENZA (all (flu-ish)), ILLNESS (got really sick), MYALGIA (Body aches), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (simply wanted to receive his second dose of the Moderna Covid-19 primary series) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  It was reported that not able to find a second dose and says that patient just gonna get a Pfizer. patient did not want to speak with anyone about it, didn't even want to give more information.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2023: Follow-up  Live Significant  information accepted, Myalgia, Fever, Chills, Flu, Sickness Event added.
A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. The reporter stated that the patient was inadvertently administered with expired FLUMIST quadrivalent. The outcome of the event of inadvertently administered expired FLUMIST quadrivalent is unknown. The report was considered to be non-serious.
Rash all over body but mostly on face 12 hours after administration; not itchy; chills right before onset of rash; no shortness of breath; antihistamines are not helping reduce rash
03-06-07 fever, bumps next day head, neck and hands persisted for one week. Seen by DR 3-12-07 diagnosed cradle cap. Cream prescribed by physician then 1 week later bumps gone (Ketoconazole cream RX).
Pfizer-BioNTech COVID-19 Vaccine:  About 10 minutes of sitting post her vaccine, she?not well.? Within 3 minutes of that statement she became nauseous and feeling hot. Code 10 (Employee/Visitor Event) was called.  was given ice water and a cool cloth for her neck. is on chemo treatment and took one of her own Zofran pills.  had no rash, itching or signs of angioedema. We encouraged to go with the ER personnel to the ER to be observed and treated if needed. She agreed.
pt had 1 seizure, was limp & listless p/ER & child had a 38 temp adm;
After I got the injection I waited the thirty minutes due to previous hives I had only soreness at the injection site but then I had a dull throbbing from my shoulder to my elbow it feels internal like but not muscle related but it is not sore to the touch this has persisted for five weeks. My doctor said he did not think it was related to the injection and put me on anti-inflammatory medicine which has not seemed to help and I have taken four doses so far.
Within 12 hours my lower back became in so much pain that I couldn't even turn over to get out of bed. I had to take off work indefinitely to try and recover, but I still hurt to do simple things such as getting dressed or showering.
Patient called to report that she had been in pain since her flu shot on 9/26/21. She stated that when she was given the shot, she felt like it was injected a little high up and that it was painful as it was being administered. The next day she began to feel pain about 3 inches away from the injection site. She feels some joint and arm pain when the arm is in movement as well as when it's not in movement. There is no redness and the pain is not severe but she was concerned since this had never happened and since it has taken her long to heal.
Pt given flu vaccination 0.5ml 3 yes and older. Should have been given 0.25 6-35 months.
the patients who recv vax & devel pneumococcal septicemia or pneumonia;it was unk whether the exp was r/t the vax;
Itch; I can't sleep that night; can't wear a lot of stuff; Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), PRURITUS (Itch), INSOMNIA (I can't sleep that night) and PRURITUS (can't wear a lot of stuff) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L28) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced RASH (Rash), PRURITUS (Itch), INSOMNIA (I can't sleep that night) and PRURITUS (can't wear a lot of stuff). At the time of the report, RASH (Rash), PRURITUS (Itch), INSOMNIA (I can't sleep that night) and PRURITUS (can't wear a lot of stuff) 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.
Patient reported a large fluid filled sac with a marble size lump.  Patient reported she worsened for approximated 4 days then slowly started getting better.  She massaged regularly to help lessen the size.  At 3 week follow up, we were able to confirm she had a swollen lymph node surrounded by fluid filled sac.  Patient was confident it was getting better.  I advised to run this past  a physician but felt it would be ok.
Patient was given a PENTACEL and an ACTHIB. No adverse reaction occurred. Parents were notified per physician and child was brought back and RECOMBIVAX was given.
Pt developed soreness at injection site. Next day developed redness and pain/swelling at elbow below injection site. Primary doctor treated pt for possible cellulitis.
Day 1 - Nausea then fatigue and sleepiness for about 24 hour. Day 2 - Headache and generalized myalgia Day 3 - Felt great - thought it was over Day 4 - Recurrence of tinnitus I'd experienced over a year ago, as well as dizziness looking up or to my extreme right.
Itching all over resolved with Benadryl. Left upper arm redness, swelling, increased warmth increased over several days. Treated with Keflex/Triamcinolone Cream
pt recv vax; felt dizzy shortly p/ vax;was clammy to touch;had pt sit down for a while;BP 152/92 @ 9:25am & 156/100 @ 9:35am & 166/90 @9:45am;advised to see PMD asap about elev BP;
Has UTI; This is a spontaneous report from a contactable consumer. This 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number unknown at unspecified route on unspecified date in Feb2021 as single dose (at the age of 66 years) or COVID-19 immunisation.  On Feb2021 the patient experienced UTI (urinary tract infection) and was started on Cefuroxime Axetilas treatment.  Outcome of UTI is unknown.  Information on the lot/batch number has been requested.
Continue with pain in left arm since April 20, I am taking 2 Advil Avery day to control the pain waiting to the pain let go, but not happening, and I and starting to worry
c/o tingling in both hands, light headed, profuse sweating and color pale. 120/68, 83, 28, 98%O2 sat. T 97.7 Narrative:  c/o tingling to both hands, light headedness, profuse sweating, and color pale. 120/68, 83, 28, 98%O2 sat.; 122/62, 84, 24, 98% O2sat.; 119/60, 82, 20, 97% O2sat. ; at discharge 125/88, 78, 18, 98% O2 sat.. 09500: Recovered and "feeling better."
I have a past medical history, about 2 years ago, I had an auto accident and had whiplash in my neck. With treatment, the pain went away and had completed resolved. My neck pain started with the 1st dose of the Pfizer (lot # EK5730 IM LA). This pain continued and I went and got my 2nd dose. The pain continued to bother me. I did take meloxicam and tramadol, which helped to relieve the pain but the pain will still return. I went to a chiropractor in 2/2021, but the pain never went away. I tried getting a massage, taking other medications like my Celebrex which really did not help. I finally decided to take my Meloxicam 1 pill daily for 1 week and rested my neck by refraining from putting any strain or stretching on my neck. This definitely improved my pain and symptoms. I finally got to see my PCP, the pain had significantly improved and I was given a prescription for Meloxicam and Tramadol. I still have intermittent pain in the back of my head. I haven't fully recovered.