chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm itching; arm has a red spot of the size of a quarter  like a lump; arm is tender; arm has a red spot of the size of a quarter  like a lump; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm itching), ERYTHEMA (arm has a red spot of the size of a quarter  like a lump), TENDERNESS (arm is tender) and PERIPHERAL SWELLING (arm has a red spot of the size of a quarter  like a lump) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Nickel sensitivity (usually gets rashes for her nickel allergy).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PRURITUS (arm itching), ERYTHEMA (arm has a red spot of the size of a quarter  like a lump), TENDERNESS (arm is tender) and PERIPHERAL SWELLING (arm has a red spot of the size of a quarter  like a lump). The patient was treated with CORTISONE for Pruritus, Erythema and Tenderness, at an unspecified dose and frequency. At the time of the report, PRURITUS (arm itching), ERYTHEMA (arm has a red spot of the size of a quarter  like a lump), TENDERNESS (arm is tender) and PERIPHERAL SWELLING (arm has a red spot of the size of a quarter  like a lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Severe arm stiffness, nausea, headache, skin pain, joint pain beginning morning after vaccine requiring patient to rest for 2 days. Has seen gradual improvement in symptoms since, and is still recovering.
Redness, itching on injection site. Treatment (BENADRYL, TYLENOL).
RN noted that after administration of the vaccine, while the needle was being removed from the client's arm, the client moved her body. RN noted the needle grazed the client's skin over the client's left deltoid area after removal from the client's arm.
Feels like lump in back of throat, given Epi at clinic without resolution.  No shortness of breath or pain
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. Per guidance from the Department of Health, Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.
This spontaneous case reported by an other healthcare professional, describes the occurrence of illness and inappropriate schedule of product administration in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. In May 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced illness and inappropriate schedule of product administration. At the time of the report, illness outcome: unknown and inappropriate schedule of product administration: resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information.
had shot had shingles/Suspected vaccination failure; Shingles twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shot had shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles twice). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and experienced Shingles twice. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
I became very fatigue and had lots of body aches. I experienced lots of sweating in my palms. This lasted for about 30 hours and went away.
pt found unresponsive & gurgling in the morning of 27JUN97;pt taken to hosp & had a tonic clonic sz & tx w/valium;pt intubated;pt loaded w/phenobarb w/resolution of sz activity prior to transport to hosp adm to PICU on ventilator;
Headache that started the day after injection still have a headache on and off for two weeks.
She told nurse she was feeling like her lymph nodes were swelling and didn't feel quite right. She is down in the ED. she elected to walk there, escorted by the nurses.
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent condition, concurrent medications and drug reactions/allergies were not reported. On 20-NOV-2018, the patient was vaccinated with an expired dose of M-M-R II (strength and dose were not reported) (lot # M045395 and expiry date: 14-NOV-2018) subcutaneously for prophylaxis. The administered dose of M-M-R II was reconstituted with sterile diluent (manufacturer unknown) (lot# M044950 and expiry date: 30-MAY-2019). No adverse effects were reported. There was no product quality complaint (PQC) reported.
13yo girl presents for second dose of Pfizer with mother. Immediately after injection of Pfizer vaccine, patient lost consciousness for approximately 15 seconds while RN nearby and holding her upright in a chair. Patient did not fall or injure herself. Upon resumption of consciousness, patient laid down on cot for 5 minutes, vital signs stable. Patient alert and oriented x4. States she did not eat or drink today prior to coming to receive her vaccine. Mother states patient has a history of low iron. Patient does not take medications, has no allergies, and has no medical history. Patient able to ambulate steadily and independently out of vaccine site with mother. Captain on scene to assess the patient and deem her appropriate for leaving.
Patient called stating a red area around site, a bump under the skin, & itching. Md was called told pt to monitor.
This case was reported by a other health professional via call center representative and described the occurrence of frozen shoulder in a 54-year-old female patient who received Influenza vaccine Quadrivalent unspecified season. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced frozen shoulder. The patient was treated with non-drug therapy (Physical therapy). On an unknown date, the outcome of the frozen shoulder was recovered/resolved. It was unknown if the reporter considered the frozen shoulder to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The reporting office manager or clinical supervisor was not aware of any concomitant medications or vaccines, or any other medical history. The patient did not know brand (s) of flu vaccine (s) used in the past, and did not have lot numbers or expiration dates. The patient experienced frozen shoulder at least twice after the administration of an unknown brand of flu vaccine. The reporter stated that the patient believed that this happened on both sides, and that symptoms lasted for 4 months.
NEUROLOGICAL PROBLEM AFTER YOUR COVID VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced neurological problem after your covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of neurological problem after your covid vaccine was not reported. This report was non-serious.
At 12:00am after receiving vaccine - felt fluid running down back of throat - went to bathroom - swollen face with left eye conjunctival hemorrhage. Better as of 11/14/05.
Numbness of tongue; Numbness of fingers and toes; Sweaty palms; Tingling of fingers and toes; Severe rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA ORAL (Numbness of tongue), HYPOAESTHESIA (Numbness of fingers and toes), HYPERHIDROSIS (Sweaty palms), PARAESTHESIA (Tingling of fingers and toes) and RASH (Severe rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included ESOMEPRAZOLE for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (Numbness of tongue), HYPOAESTHESIA (Numbness of fingers and toes), HYPERHIDROSIS (Sweaty palms), PARAESTHESIA (Tingling of fingers and toes) and RASH (Severe rash). At the time of the report, HYPOAESTHESIA ORAL (Numbness of tongue), HYPOAESTHESIA (Numbness of fingers and toes), HYPERHIDROSIS (Sweaty palms), PARAESTHESIA (Tingling of fingers and toes) and RASH (Severe rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up received on 26-MAY-2021 and contact information was updated.
Gave prophylactic Td vaccine to a factory worker who receives frequent cuts and scratches. 2 days later sought medical attention for a local, hot, swell, tender to touch at injection site.
Information has been received from a lawyer regarding a case in litigation a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 28-NOV-2012, the patient was vaccinated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot#, expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On 21-AUG-2016, the patient was treated by the physician for a vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as shingles and was prescribed LYRICA for management of his painful symptoms and chronic pain (onset date was not reported). As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
Vaccine given: 7/21/09 - Fever day (1) 101.7 - MOTRIN q 6-8 hrs given - Child c/o soreness to arm - Headache, nausea, stomach aches and pain, diarrhea, decreased appetite - dizziness, lower back pain.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On unknown dates since July 2015, the patients were inadvertently vaccinated with improperly stored doses of (Merck) VARIVAX (dose, route and lot number were not provided). No adverse reactions were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient noticed a rash around injection site starting on 9/27/23. Noted that it was itchy, redness. Reported that the redness diminished by following day but still itchy and some soreness. Diarrhea reported on morning of 09/28/23 as well.
SYMPTOMPS : NAUSEA -  PATIENT DENIED TO TAKE ANY TREATMENT AS IT WAS NOT MUCH COUGH - SUGGESTED  TUSSIN DM., DRINK LOT OF WATER, REST WAS SUGGESTED' IF WORSENS THE SX, TO CONTACT DR OFFICE .
Initial information received on 27-Jun-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a 11 years old male patient who received 0.5 ml dose of DAPTACEL (Lot number: C5117AA, expiry date: 31-Jan-2019) instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 27-Jun-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was unknown if any adverse event was occurred or not following the vaccination. 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. Documents held by sender: none.
Case vaccinated with J&J on 5/11/2021. tested positive for covid 19 on 12/30/2021. Admitted to Hospital on 12/30/2021 and expired on 01/07/2022 while still hospitalized.
The shot was given Wednesday around 1 PM and on Thursday around 4 PM I started having chills and nausea. Saturday morning I noticed a blister on my back Saturday night more blisters on my legs but very few and not in a row like a nerve track. Sunday morning a few more blisters appear. Basting an itch a little bit nothing severe at this time.
I called her at 7:45 pm after being notified by another store that she had called and said she had developed a fever. She developed body aches and a "burning forehead". Her temperature was reported normal when her neighbor took it. I told her to go to the ER which she agreed.
Pt vaccinated w/MMR 19MAR90; On 30MAR90 developed a generalized macular rash on his face, arms, legs, chest & back; Asymptomatic x/rash which was non-pruritic;
This spontaneous report as received from a healthcare professional refers to 2 patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD lot # reported as N009774, expiration date 20-SEP-2018. The sterile diluent used to reconstitute the PROQUAD was properly stored. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of -9 degrees Celsius for 7 hours. Data logger was involved. There were no previous excursions reported.
Fever 104 F, injection site pain, tiredness, muscle pain, chills, joint pain, feeling unwell
This case was reported by a physician and described the occurrence of injection site reaction in a 4 year old female pt who had received Infanrix injection for prophylaxis.  The pt had no known drug allergies. On 05/21/03 the pt received the 5th dose of Infanrix in the left leg. On the same date, she received an injection of MMRII in the left leg. On 05/22/03, one day post-immunization, the pt experienced an injection site reaction characterized by swelling, itching, warmth, redness and soreness. The affected area was "baseball size". The subject was seen by the physician; no medical treatment was provided. The events were worse on 05/23/03.  The reporting physician considered the events were probably related to vaccination with Infanrix.
Persistent hypoxemia as well as intermittent cough and sputum production along with shortness of breath , required hospitalization.
patient female age 44 requested to have Fluzone and Pneumococcal (pneumovax23)  and Boostrix administered.  Consent form reviewed - patient noted latex allergy.  Fluzone administered 1st in left deltoid. I chatted with patient for a couple of minutes before moving on to administer the Pneumococcal vaccine.   She rotated her chair to prepare for the last IMZ at which time she thought she was having a hot flash.  Her head tilted to the right and fell forward.  I supported her head and directed pharmacy technician to call emergency services  (time: 10:48a) and a code white.  I directed pharmacy technician to had me the adult Epi pen.  Patient  said again she was having a hot flash, I advised that I believed she was having a reaction to the 2nd IMZ and wanted to administer epi. Patient was experiencing difficulty breathing her mother appeared (she was shopping). I stated that her daughter was having a reaction and I advised that I needed to administer EPI.  Mother and daughter agreed.  EPI was administered.  with in 3 to 4 minutes she was breathing without laboring.  I provided the first responders with the information regarding IMZ and EPI administered.  her vital signs were checked  - EMTs recommended that she be evaluated at the hospital - Both mother and daughter asked my opinion.  I stated that it would be prudent to go and be checked. The mother returned to the pharmacy (4:34p) to pick up medrol dose pack for her daughter.  She informed us that Her daughter received 2 bags of NS, medrol pak and was released home.  She thanked the team and myself for reacting professionally and with great care for her daughter
This case was reported by a other health professional via sales rep and described the occurrence of low back pain in a 16-year-old male patient who received BEXSERO (batch number 165401A, expiry date 30th March 2018). Co-suspect products included MENVEO (batch number M16010, expiry date 30th October 2017). Concomitant products included FLUZONE. On 29th September 2016, the patient received BEXSERO .5 ml and MENVEO .5 ml. In October 2016, 15 days after receiving BEXSERO and MENVEO, the patient experienced low back pain (serious criteria hospitalization), numbness of extremities (serious criteria hospitalization) and walking difficulty (serious criteria hospitalization). On an unknown date, the outcome of the low back pain, numbness of extremities and walking difficulty were unknown. It was unknown if the reporter considered the low back pain, numbness of extremities and walking difficulty to be related to BEXSERO and MENVEO. Additional details were reported as follows: This case was reported by a medical assistant (MA). On 29th September 2016, the patient concomitantly received FLUZONE vaccine as well. The patient experienced numbness of arms and legs. The patient required an emergency room visit. The healthcare professional did not know the outcome or how long the patient was in the hospital.
Near immediate (likely vasovagal) syncopal event with short (less than 20 sec) seizure. Lip laceration and cheek contusion as result of falling forward from exam table and striking face on adjacent cabinet. Return to normal (aside from laceration and contusion) over 15-20 minutes.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The reporter stated that the patient received the GARDASIL (0.5 ml, intramuscular, anatomical location, lot number were not reported) series as followed: first dose was administered too early. No adverse effect reported. Additional information has been requested.
I was shot January 6th, arm sore the next day, achy the next day and Jan 9 woke up with 101 fever and felt extremely achy my whole body.  I took Ibuprofen the 9th and 10th worked the 11th 12th and the 13th at 5 pm I lost my sense of taste and smell.  I was tested the 14th and tested positive at the clinic.  My husband and daughter tested positive the following week.  We all quarantined.  I refused the second shot after getting so sick with the first one.
One day following Pfizer Covid vaccine (dose 1) - 10 hours after vaccine - patient had a syncopal event.
COVID-19 Positive on 12/13/2021, death due to COVID-19 on 12/25/2021
On the 26th, I noticed a few small red bumps on my left arm in the afternoon. On the 27th, the bumps became one large red patch which became itchy and burned and was hot to the touch. I put hydrocortisone on it, iced it, and took a Zyrtec - it is still here. Will be taking Benadryl tonight to see if that will get rid of it.
Arm Soreness; Lethargy; Rash; Small blotchy area towards her left back; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2020, the patient received the 1st dose of Shingrix. On 29th August 2020, 48 days after receiving Shingrix, the patient experienced erythema. On an unknown date, the patient experienced pain in arm, lethargy and rash. On an unknown date, the outcome of the pain in arm, lethargy and rash were recovered/resolved and the outcome of the erythema was recovering/resolving.   It was unknown if the reporter considered the pain in arm, lethargy, rash and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient had left arm soreness, lethargy, and a rash on her left side.   The patient also noticed a small blotchy area towards her left back but that it was disappearing.   The patient wanted to know if getting the 2nd dose of Shingrix would be contraindicated because of the rashes.  The reporter did not consent to follow-up. No information was given.
Patient had redness on 4/1/22 that initially went away, but came back on an unknown date. On 4/11 patient's mother calls providers office to report symptoms. 4/12 patient's mother brings her in and Dr. diagnosed patient with Cellulitis. Treated with Cephalexin 250mg TID x 7 days starting on 4/12.