chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports she felt normal for the remainder of the day on 1/21/2020 after receiving the vaccine at about 2:30pm. The following morning on 1/22/2020 the patient reports she woke up in the morning and her arm was red with some swelling. Patient reports that her arm felt tender from the elbow to the shoulder and more on the inner side of her arm (under armpit to inner elbow).  The patient denied broken skin or blistering. The patient also denied shortness of breath. Patient contacted  us on 1/23/2020 to report the reaction, she noted that the redness and swelling were improving, and she denied any itching.
Is it normal to have a ball where you got the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (Is it normal to have a ball where you got the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Is it normal to have a ball where you got the vaccine). At the time of the report, VACCINATION SITE MASS (Is it normal to have a ball where you got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.
Was at daycare - had taken nap/aroused fussy - consoled/but then noted not breathing 911 - to ER/dx with cardiac arrest ELLD.
I had flu like symptoms, and I had a fever of 102. I was fatigued and achy. That lasted for about a week. That was with the 1st vaccine. After I took 2nd vaccine, I got really achy and had severe pain in my back and hips it was very painful it would travel down my whole body. It would go from my left side to my right side. So, I went to the doctor and was given an injection of anti-inflammatory meds to calm the anti-inflammatory reaction. It lasted for about 5 months.
Got Td on 8/11/03 pm had fever at night RA at deltoid ?, red swollen 30mm. Took Tylenol, ice. Feel knot R under arm and R groin.
This spontaneous report as received from a health care worker refers to a 4 month old patient. Patient medical history and current condition was not reported. On 09-MAR-2015 the 4 month old patient was vaccinated with M-M-R II vaccine of dose 0.5 ml via subcutaneous route outside the prescribing information. No adverse effect was reported. The outcome of the event was unknown. Additional informatino has been requested.
RED BLOCHY RASH APPEARED THAT WERE BURNING AND ICHYON  STOMACH, CHEST,  ARM PITS,  BACK BOTH UPPER LEGS, NECK, UNDER CHIN KEEP SPREADING TO ALL ARE BODY LOWER LEG RED BLISTERS
Sore; Red; the injection site became hot; area involved increased in size; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number T9KE4, expiry date 25th September 2021) for prophylaxis.   Concomitant products included sulphamethoxazole, trimethoprim (Bactrim).   On 20th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 21st July 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The reporter has a consumer that received Shingrix in the left deltoid and the injection site became red, and hot and the area involved increased in size over several days. The red area was at the time of reporting and the size of her hand and it was still hot and sore. The consumer indicated that she was taking Bactrim at the time of the injection and wondered if that might had caused the reaction. The reporter was unable to provide any additional information because the consumer was not in the pharmacy at the time of the call.
This spontaneous report was received from a pharmacist and refers to a 59 years old patient of unknown gender. On 29-MAY-2015, the patient was vaccinated with improperly stored PNEUMOVAX23 (route of administration, dose, lot number, expiry date). The vaccine was exposed to -10.4 C for 2 hours on 26-MAY-2015. No adverse effect was reported. This is one of several reports form the same reporter. Additional information has been requested.
headache, body aches, fever, nausea, fatigue from 7am July 7, to 10am July 8
Swelling at shot site, tenderness at shot site, joint pain i.e. knees and elbows, back pain, low grade fever, migraine headaches, flu like symptoms, tightness in chest.
Pt received 2nd dose J&J vaccine 11/19/21 in right arm, stood to walk towards entrance, got dizzy, and fainted. No witness was able to see if pt hit her head. Pt was disoriented for less than 30 seconds, EMS called. BP was 142/98 laying down at 1615. Pt was A&Ox4, reported nausea, pupils equal and reactive bilaterally. Blood sugar 93 at 1618. EMS arrived at 1623 and assumed care, advised pt and mother I recommend she be evaluated at ER d/t unknown if pt hit her head. Pt refused ER evaluation. Mother and pt educated on warning signs of concussions as well as declining neurological symptoms that warrant immediate medical attention.
Took the Moderma vaccine, dose 1.  Soreness in arm, achy all over, 103 fever for six hours, nausea, headache
1) lump in left armpit (golf ball size) day 3 2) swelling, redness, itching (post card size around injection site) day 5  Not/not worrying now that I researched and found that these are common after effects of the Moderna vaccine. Just reporting to help scientific research.
Pt waited here 20 min after injection. Approx 45 min - 1 hr after her arm started itching and was red. She took Benadryl. 1 1/2 hrs later she had diff breathing, dizzy, nausea. She called 911. They gave her epi and an IV took to medical center. Was told to cont BENADRYL every 6-8 hrs for next few days.  11/16/09 Medical records received for DOS 10/28/09. Final DX: Allergic reaction.  S/P 1 hr vaccine c/o  dyspnea, feelig faint, itching. Diff breathing. Swelling, dizziness.  Small area red/blanching at injection site. D/C to home. Stable.
Dull pain in left shoulder got worse with every day activity. Had physical therapy had cortisone injection on 8/11/2015. Nothing helped.
Increased pain, swelling redness and heat in left deltoid > 3days local symptoms only, no systemic symptoms.  Took Tylenol and Benadryl prn.
12 year old male light headed and feel like he was going to pass out. Patient taken to EMS room to lay down. Patient felt better after 5 minutes of rest on cot. @1415, Patient sat on edge of bed and tolerated without any problem. @1425, patient walked out without any trouble.  P: 64, BP: 128/80,  SAT 98%.
kinda got sick over the first one; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (kinda got sick over the first one) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-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 ILLNESS (kinda got sick over the first one). At the time of the report, ILLNESS (kinda got sick over the first one) outcome was unknown. Not Provided          No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD21-084330, US-MODERNATX, INC.-MOD-2021-098427 (E2B Linked Report). This case was linked to MOD-2021-098023 (Patient Link).; Sender's Comments:  MOD21-084330: US-MODERNATX, INC.-MOD-2021-098427:fiancee ( C-F) 1st dosage case
12 hrs after vaccination (upon waking in morning) temp was 101°; throughout the day it was accompanied by severe fatigue, and continued to rise to 103° at it's highest that night. Treated with acetaminophen, fluids and bed rest. By morning, the temp was close to normal, and stayed relatively low from then forward, with no further treatment required.  Fatigue continued, but improved steadily through the 6th & 7th.
patient received vaccination and after 15 minutes self reported tingling and numbness in her left arm. she felt hot to the touch and experienced mild anxiety. patient waited an additional hour and 45 minutes before being picked up.  she was stable when she left and stated she would go to urgent care.
Left arm swelled up and turned red patient complained of pain on 10/9/2010. Pt. returned to pharmacy on 10/11/2010 and arm was still red. Advised to see a physician. Swelling was gone.
Patient came to pharmacy 2/8/22.  Said she still has some soreness in upper arm and shoulder since receiving Janssen Covid-19 vaccine.  She agreed to call her doctor and let us know  the outcome. Patient returned to pharmacy on February 10th.  She said the doctor's office told her the soreness she described was within normal limits.  She discussed with the office person reporting this to CDC. Patient told me the office said there was no need for them to report a normal reaction but advised her than she can file on her own if she wants.  She indicated to me that she might do so, since very little is known about the Covid vaccines and how they affect people.  I called patient later in the day to request additional information so  I can file this report.  She did not answer the phone and did not respond to the voice message I left for her.
Pruritis onset 2 days later lasted for 4-5 days. All over body. No rash. Day 9 onset of red raised mark at injection site. Eyes burned, red- reaction to contacts and could now wear. Lasted into day 10.
Administration of an expired Twinrix dose to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number P9LT9, expiry date 01-JAN-2023) for prophylaxis.   On 09-AUG-2023, the patient received Twinrix. On 09-AUG-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Administration of an expired Twinrix dose to a patient). The outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt Date: 09-AUG-2023 The reporter wanted to know the guidance on this situation. The reporter did not provided patient information. The patient received a Twinrix which was already expired, which led to expired vaccine used. The reporter did consent to follow up.
patients were vaccinated with expired vaccine doses; vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were vaccinated with expired vaccine doses) and PRODUCT STORAGE ERROR (vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were vaccinated with expired vaccine doses) and PRODUCT STORAGE ERROR (vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were vaccinated with expired vaccine doses) and PRODUCT STORAGE ERROR (vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that the pharmacist thought that the expiry date of the vaccine was JUNE 2022, However the vaccine expired on 01-Apr-2022.  It was confirmed that the vial didn't undergo temperature excursion issue.  Vaccine was placed in refrigerator on 4-Apr-2022.  No treatment medication were reported.
Distributive shock requiring fluid resuscitation, epinephrine, methylprednisolone,  hydrocortisone
Headache; chills; fatigue; fever (100F); This is a spontaneous report from a Non-contactable consumer. This male consumer (patient) reported for himself.  An adult male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 15:00 (Lot number: FF2590) 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 Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 01Apr2021, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 11Mar2021, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 16Oct2021 04:00, outcome "recovered" (Oct2021), described as "Headache"; CHILLS (non-serious) with onset 16Oct2021 04:00, outcome "recovered" (Oct2021), described as "chills"; FATIGUE (non-serious) with onset 16Oct2021 04:00, outcome "recovered" (Oct2021), described as "fatigue"; PYREXIA (non-serious) with onset 16Oct2021 04:00, outcome "recovered" (Oct2021), described as "fever (100F)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, chills, fatigue, pyrexia.  Additional information: Patient did not have other vaccine in four weeks. Patient did not have covid prior vaccination. Patient was tested for covid post vaccination.   No follow-up attempts are Possible. No further information is expected.
Rash developed on inner arm from elbow down 120 hrs post injection. Administered to upper left arm.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 15th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's husband. The patient received SHINGRIX on left arm. The patient experienced sore arm and a half-dollar sized red spot for 2 days and then they resolved. The reporter did not give consent to follow-up.
A report has been received from a Health Professional concerning a 2 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 19-Dec-2012. The reporter reported that patient was administered expired FLUMIST on 19-Dec-2012. The outcome of the event of ADMINISTERED SIX DOSES OF EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
pt recv vax; to er,would not stop crying; site of injection red, swollen & painful;
Arm in pain, Dr says Infection occurred [warm arm and swollen, and fever] [Also given flu shot on left arm during same visit]. Occurred same day of getting vaccinated. Really painful, cannot move arm due to it.
Pain and erythema at injection site started 2.5 hours after injection. Erythema continued 24 hours post injection. Pain was severe (10/10) 18-24 hours after injection. Pain mild still 48 hours post injection. Systemic reactions included chills and fever 18-36 hours post injection, myalgia and fatigue 24-36 hours post injection, and nausea and dry heaving 48 hours post injection. Treatment included acetaminophen and ibuprofen until 48 hours post injection, diphenhydramine 48 hours after injection.
Potential Adverse Event because of a infection that occurred after receiving the first dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Potential Adverse Event because of a infection that occurred after receiving the first dose of Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTION (Potential Adverse Event because of a infection that occurred after receiving the first dose of Moderna COVID-19 vaccine). At the time of the report, INFECTION (Potential Adverse Event because of a infection that occurred after receiving the first dose of Moderna COVID-19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was provided. No relevant Concomitant medications were reported.
Pt reports she developed a red, itchy and burning rash, the size of a golf ball approximately 14 hours after receiving her 2nd dose of Moderna COVID-19 vaccine. The rash is not raised. She also reports that her lymph node on the rite side of her arm has increased in size.  The rash is from her shoulder down to her mid arm.
had a little pain on the arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had a little pain on the arm injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: J&J COVID-19 vaccine (received one J&J COVID-19 vaccine ). Past adverse reactions to the above products included No adverse event with J&J COVID-19 vaccine.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (had a little pain on the arm injection site). At the time of the report, VACCINATION SITE PAIN (had a little pain on the arm injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704245, US-MODERNATX, INC.-MOD-2023-704428 (Linked Report). This case was linked to MOD-2023-704428 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704245:Child case US-MODERNATX, INC.-MOD-2023-704428:Wife case
Anaphylactic reaction occuring 15 min after administration. Benadryl and Epi administered and EMS called.  Sent to ED, currently being treated
Patient reported SOB and headache 15 minutes post injection. BP 156/110, pulse 106, SP02 100. Patient was transported to emergency room via ambulance after EMT evaluation.
Uncontrollable itching all over my body that began 10 days after 2nd dose. It has been 6 days since the itching started and it still hasn?t subsided. No visible rashes on my skin.  Currently taking prednisone as prescribed by my doctor. I will finish the prescription friday. The itching in unbearable. It  is on my scalp, back,  hands, feet, chest, vagina and legs. At nighttime it effects my hands the most.
Patient broke out in a rash that covered her whole body and face. Mom said only place that did not have rash was back of knees and forehead. Rash described as itchy - very bumpy individual spots. May have been fluid filled. Rash lasted until Monday. No fever.
This spontaneous report as received from a Registered Pharmacist concerning a 65 years old male patient who had a little subcutaneous fat and very taught skin was vaccinated with ZOSTAVAX (Dose, route and lot # not reported) on 17-JUL-2012, the pharmacist stated that when he was trying to administer ZOSTAVAX subcutaneously an unknown amount of vaccine went "into and under the skin". No other co-suspects were reported. No concomitant medications were reported. The pharmacist described that on 17-JUL-2012 the patient developed a raised area the size of nickel at the injection site. No treatment information was reported. The outcome of patient developed a raised area the size of nickel at the injection site was reported as not recovered/not resolved. The patient sought medical attention "Happened in pharmacy". The relatedness for patient developed a raised area the size of nickel at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
2 month old child was given an expired dose of PENTACEL with no reported adverse event; Initial information received on 15-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old female patient who experienced 2 month old child was given an expired dose of pentacel with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13V (CRM197) (prevnar 13) and rotavirus vaccine (rotavirus vaccine) for Immunisation.  On 14-Jul-2022, the patient received a  0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (0.5 ML 1X (Once) and Drug Treatment Duration: NA) (lot number: UJ542AA; expiration date: 10-Jul-2022)  via intramuscular route in the left thigh for Immunization   .  On 14-JUL-2022 the patient developed a non-serious event 2 month old child was given an expired dose of pentacel with no reported adverse event (expired product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event expired product administered.   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 the 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.