chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported.; VARIVAX underwent a temperature excursion and was administered.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 milliliter (ml) once (lot number S020159 which has been verified to be valid, expiration date reported as 31-JUN-2021, but upon internal validation established as 30-JUN-2021) (vaccination scheme, route of administration and anatomical site of injection were not reported), as prophylaxis (product storage error). The administered dose of the vaccine was stored at a temperature of -12.8 degrees Celsius, during a time frame of 1 hour, as recorded by a digital data logger. There was no previous temperature excursion. No additional adverse events were reported in the patient.
This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 64-year-old male patient who received SHINGRIX (batch number 539A2, expiry date unknown) for prophylaxis. On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th June 2018, 27 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with antivirals for systemic use (Antiviral). On 22nd June 2018, the outcome of the shingles was recovered/resolved. The reporter considered the shingles to be probably related to SHINGRIX. Additional details were received as follows: This case was reported by a pharmacy technician. The patient received a dose of SHINGRIX in left arm. On 22nd June 2018, the patient was prescribed an antiviral medication. There was no seriousness criteria reported for the patient (hospital overnight or prolong an existing hospitalization, life threatening, persistent or significant disability/incapacity, death, require surgical or medical intervention and congenital anomaly).
Patient called pharmacy on 10/9/15 and said she experienced severe swelling on the right side from arm to fingers and toes. She also experienced skin tightness on swollen areas, fever, severe pain. She took 4 ADVILS the night of 10/8/15 and that relieved the pain and warmness. She said swelling decreased but some pain and swelling still there.
In the waiting time period, patient indicates to paramedic that she feels dizzy. Paramedic proceeds to inform me of the situation. We proceed to take her to the private area to take her vital signs. Dr. is called indicating the situation. He refers to adding 30 minutes of observation.
Fever body aches, chills, pain at injection site Narrative:  fever lasted 12 hours
05/15 Breakthrough case of COVID. Due to pre-existing conditions PCP recommended I go to ER. Was in ER for 7 hours. I was given MAB therapy. I have noticed no improvement since receiving MAB therapy.
Injection site reaction- red swelling in a thick circular pattern about 3 in long and 2 in wide, with small bumps surrounding.  Pain in arm.  Chills, body temp changing from hot to cold, flu-like symptoms, fatigue, etc (stated she has all the general symptoms except fever). Reported roughly 48 hours after immunization
He got his vaccine, the first day was fine other than arm soreness.  That evening he started feeling almost like flu-type symptoms with light chills, felt like he had a fever, discomfort.  He wasn't nauseated.  Probably Sunday he took a shower and he noticed that he had a rash under his arms on both sides, going down his chest on both sides.  It was a fine rash.  Then the next stage he had big hives around his back, belt line/kidney area.  Then his hands started having rashes, palms of his hands and the wrists.  Then he dealt with this with over the counter medicines Allegra for hives and rash which helped a little bit.  He was taking it as directed, and then took it every 12 hours and it cooled it off a little bit. Last sunday he went to the Clinic, and he was given Prednisone, tapering dose starting with 4.  When he took the big dose the 4 tablets and it calmed it down a bit, and then with the tapering it would not go away it stayed with him, and actually got worse.  So he then had an APT with his PCP this past Thursday, 7/27/23 for his regular check up, and the first thing he did was took his shirt off and showed him that he had a reaction from the vaccine.  His opinion was that he got into some chemicals and he told him that was not it.  He gave him another pack of Medrol dose pack and Saturday night he slept about 2 hours as he was red rashy.  His top lip started swelling on Friday.  He had hives on the back of his neck, down  his legs to his ankles, his torso, around his private parts and was itching like crazy and was more red than white.  On Sunday he would wet himself down and had a rash with Epsom salts which did calm the itch down, but it is receeding.  He is still blotchy, still itching, but not as red as he was on Saturday or Sunday.  He was told to go back to his doctor in 10 days.  He has an appointment with his dermatologist on 8/8/23.    He has never had a reaction to any type of vaccine, COVID or flu vaccines.  He had had COVID before the vaccines were out and was in the hospital for about 3 days of that, and had gone through that and was given stuff to bring him back as he was tired, but then got the vaccines 3 of them, and had no reactions to those.
Day 1 - Pt no reaction to vaccines (received FLUZONE (R)/PNEUMOVAX (L)). Day 2 - Evening - Fever, swelling, redness on left of arm. Day 3/4 - Pt went to MD - MD admitted Pt due to swelling on arm. Day 5 - Came to pharmacy with KEFLEX prescription.
Migraine attack; Twitching of the left eye; Felt fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine attack), BLEPHAROSPASM (Twitching of the left eye) and FATIGUE (Felt fatigue) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 26-Mar-2021, the patient experienced MIGRAINE (Migraine attack), BLEPHAROSPASM (Twitching of the left eye) and FATIGUE (Felt fatigue). At the time of the report, MIGRAINE (Migraine attack), BLEPHAROSPASM (Twitching of the left eye) and FATIGUE (Felt fatigue) had resolved. Not Provided          Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-026168 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Contact information updated, event outcome and dose details  were updated. On 07-Jul-2021: Follow-up received on 07-JUL-2021 and contains No Significant Information; 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.
Received #2 dose of Pfizer Covid19 Vaccine on 1/08/21 at 10 AM. Approximately 12 hours later she woke up with right eye pruritus with sensitivity, maculopapular erythematous rash and itching over left cheek to temple. She was rubbing at her eyes and did develop local swelling around the right eye. She treated herself with benadryl and advil. Her swelling and eye sensitivity decreased later that day but she developed a fixed itchy maculopapular rash on btl forearms (pictures in chart). She works in the ED as a technician and was seen during her shift 36 hours post shot. Diagnosed with a possible delayed reaction to the vaccine and discharged with prednisone, allegra, hydroxyzine. Symptoms have resolved except for residual hyperpigmentation over areas on forearms where the rash was and still feels itchy, though this increased after stopping antihistamines for her visit.  She reports no episodes of lightheadedness/syncope, increased nasal congestion, difficulty breathing post vaccine. She has no history of anaphylaxis or allergic reaction to prior vaccines.
Treatment of COVID-19; Treatment of COVID-19; disease recurrence; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 01Mar2021 as dose 2, single (Lot number: EN6205), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 06May2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "artery disease" (unspecified if ongoing), notes: other medical history: artery disease; "hypertension" (unspecified if ongoing); "sulpha based meds" (unspecified if ongoing), notes: known allergies: sulpha based meds. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2015, stop date: 21Aug2022; CLOPIDOGREL, start date: 01Jan2021; GABAPENTIN, start date: 01Jan2018; METOPROLOL TARTRATE, start date: 05Aug2015.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (03Sep2022) Positive, notes: I have tested positive on 03Sep2022. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence.  Additional information: Patient appear to be had a relapse of covid 19 after taking Paxlovid. Patient had tested positive on 03Sep2022 with symptoms of headache and nasal congestion. Patient started Paxlovid on 22Aug and took all 5 days of the prescribed medication.
Day of shot, sore arm, which was expected.  However, next morning, I was out of control (they didn't work) of my legs and hips.  Extreme pain, like burning nails in my feet and legs.  Had to have someone with me at all times.  I can't find the words to describe the agony I went through.  Thought I was dying, and wished I would.  Son called priest for last rites.
I had fever, body ache, chills , congestion and sinus pressure for over a week. I tested positive for COVID after and negative before my shot
Started on the 8th day.  Within the first 12 hours I had a fever, chills, aches, cough,  and head congestion.  As of today 3/31, tire and lack of energy.  I do hav a history of sinus infections and spring allergies.
The vial was initially stored in refrigerator on 20-6-2022 and administered on 22-jul-2022; receiving doses after its beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 20-6-2022 and administered on 22-jul-2022) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 20-6-2022 and administered on 22-jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 20-6-2022 and administered on 22-jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that 4 does were given from 1 vial. The vial did not undergo any temperature excursions. No treatment drug details was reported.
Tinnitus after Moderna booster on 12/04/21.  Constant and has not stopped or gotten better.  I has been going on for 2 weeks now.
While calling to follow up on patients who had received the Janssen vaccine, the patient reported to RN Case Manager that he has been experiencing abdominal pain x 1 week.  Pt denied any other signs or symptoms at this time.  Reported that he had received a Janssen vaccine on 03/31/2021.  Pt was advised to go to ER for further evaluation, but declined to go.  Pt stated he was going to "wait it out".
Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; Allergic reaction resulting in full body hives, swollen hands, eyelids and lips; This is a spontaneous report from a contactable other health professional (patient). A 27-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) at the age of 26 years old, via intramuscular route in the left arm, on 10Jan2021 at 13:00, at a single dose, for COVID-19 immunization. Medical history included high blood pressure. The patient's concomitant medications were not reported. The patient has no known allergies. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 12Jan2021, at 07:30 A.M., the patient experienced allergic reaction resulting in full body hives, swollen hands, eyelids and lips. The patient did not receive treatment for the events. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination.  Information on the lot/batch number has been requested.
Chills, weakness, loss of appetite, headache, lymph node ache in armpit of vaccinated arm, cold sweat and nearly passed out at one point. Symptoms started at 11PM Friday (day of vaccination) and continued throughout the next full day (Saturday). Tapered off that evening with minor headache, achiness the next day (Sunday). Took advise & tylenol intermittently; did not really help.
received first dose in 2019, back to get 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received first dose of Shingrix on 16th October 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-June-2022 Reporter's Comments: Pharmacist stated that the patient was back to get the 2nd dose. Consented to follow up via postal Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
PT w LOC and 2 episodes of tonic clonic movement immediately following injection of HPV. LOC x 45 sec. Immediately following gaining consciousness patient was appropriate w questions. Patient Noted Prior to syncope room began spinning. Minutes later as per patient Felling fine.
limit the number of vaccines he received (MMRII and ROTATEQ); Information has been received from the patient's mother who was also a speech pathologist, referring to a male patient of unknown age. The patient's concomitant medications and drug reactions/allergies were not reported. The patient had down syndrome and due to that was immune compromised and the patient had stomach issues.   The reporter wanted to limit the number of vaccines the patient received. The patient had to get measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (frequency, route of administration, lot number and expiration date were unknown) for prophylaxis at his six-month visit and she was considering holding the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (frequency, route of administration, lot number and expiration date were unknown) for prophylaxis to limit the number of vaccines he received (inappropriate schedule of product administration). No product quality complaint (PQC) was involved.
Pain, redness, hot, throbbing, high size (now dollar coin size), irregular shape, core at injection site is hard and itching at this time.
Fatigue, Shortness of Breath, Heart Palpitations, chest Pain, Rapid heart rate
Patient received vaccine and walked over to the observation area when she started to stagger and had to be held up by her father. Brother was with family as well. Nurse noticed immediately the status of the patient and assisted. Patient was placed in chair in observation next to father, at which point patient went limp and was placed on the floor on mat. Once on the mat nurses state patients eyes rolled back and she started to convulse on the floor. Patient placed on side, 911 called. Patient vitals BP 103/65, HR 90, SaO2 98%, Temp: 97.4 F. Patient able to sit up on her bottom without feeling dizzy or nausea. Paramedics arrived at 1318. Vitals and EKG within normal limits. BG 91. Paramedics recommended patient be taken to the emergency room since patient did not have a previous history of seizures. Father agreed. Patient left site at 1325 without further incident.
Felt tired as heck; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired as heck) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pain in jaw. Concomitant products included IBUPROFEN (ADVIL 12 HOUR) for Pain in jaw.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, 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 experienced FATIGUE (Felt tired as heck). At the time of the report, FATIGUE (Felt tired as heck) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-044328 (E2B Linked Report).; Sender's Comments:  MOD21-044328:Crosslinked
Muscle spasm in my right eyebrow that has been ticking every 10 minutes for over 24 hours; Muscle spasm in my right eyebrow that has been ticking every 10 minutes for over 24 hours; Left arm in pain; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 00161) via an unspecified route of administration in the left arm on 24Apr2021 at 13:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, autoimmune pancreatitis, allergy and asthma; all from unknown date and unknown if ongoing at the time of this report. Concomitant medications included cetirizine hydrochloride (ZYRTEC), fluticasone propionate/salmeterol xinafoate (ADVAIR) and salbutamol (ALBUTEROL); all on an unknown date for unknown indication. The patient previously received amitriptyline (MANUFACTURER UNKNOWN) and morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 at 18:00, the patient experienced, left arm in pain (the patient was told about this) and muscle spasm in the right eyebrow that has been 'ticking' every 10 minutes for over 24 hours and this was concerning for the patient. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm in pain and muscle spasm in the right eyebrow that has been 'ticking' was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing; the vaccine may have been refrozen; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing) and PRODUCT STORAGE ERROR (the vaccine may have been refrozen).    This case included information of patient 1st out of 4 specified patients. None of the patient were pregnant.  Concomitant products were not reported.  The vial was initially stored in the refrigerator on 29-Mar-2022, and the vial was administered to patients on 13-Apr-2022, 15-Apr-2022, 22-Apr-2022. The vial did not undergo temperature excursion. The patient received expired original booster Moderna COVID-19 beyond 30 days after thawing and the vaccine may have been refrozen. Patient had no adverse event.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-695198, US-MODERNATX, INC.-MOD-2023-695263, US-MODERNATX, INC.-MOD-2023-695333 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695263:3 of 4 patient US-MODERNATX, INC.-MOD-2023-695333:4 of 4 patient US-MODERNATX, INC.-MOD-2023-695198:2 of 4 patient
pt recv vax & 19NOV97 pt devel a hematoma on lt upper arm, petechiae, thrombocytopenia, & spleen tip was palpable;p/being seen in ER pt was hosp & given battery of blood tests & dx w/ITP;tx w/steroids p/blood cult results were obtained;