chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 1:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 1:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 78.31.  Concomitant products were not reported.  On 11-Jan-2021 Excursion time was reported at 2pm with temperature as 35 degrees Fahrenheit respectively , total doses given for the day was unknown, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 09 vials were sent to clinic. Vaccine BUD date was 07-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Pt received his first Pfizer vaccine and completed all screening questions and passed them.  Pt was given the vaccine and approx. 1-2 minutes after he stated he was nauseated and then had a syncopal episode where he fell on his knees and side but was caught before hitting his head.  Pt came to in 5-10 seconds and was treated by ER team and taken to the ER for evaluation d/t being hypotensive.  Pt was doing well when transferred.
Warmth, swelling, pain at injection site (6x8 cm), headache; treatment: hot compresses, Advil.
Significant thigh (R) swelling and pain persisting 5 days post vaccination. Painful to touch and to walk as well. Tx - MOTRIN recommended.
2 weeks after, feeling like I will pass out, ongoing symptoms off and on for over a week.
Administered, reconstituted with non approved diluent; Administered, reconstituted with non approved diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comment: The reporter stated that, the patient was administered Shingrix reconstituted with a non approved diluent .  They were trying to figure out which patients received an incomplete dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: The reporter stated that, the patient was administered Shingrix reconstituted with a non approved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070806:Same reporter US-GLAXOSMITHKLINE-US2022070808:Same reporter US-GLAXOSMITHKLINE-US2022072616:Same reporter
8:30 PM started having muscle aches, redness, pain , and swelling around injection site. 10:30PM fever, chills, muscle aches, joint pain, skin sensitivity, headache, dizziness, fatigue, and pain, redness, and swelling at injection site.
Within 48hours patients left arm developed redness down to elbow, hot skin, temperature, nausea.
Patient reports today, she had local swelling at injection site.  Swelling of lip, shortness of breath, fever and vomiting approximately 30 hours.  After vaccine 4 hours later, went to emergency room was told signs and symptoms were not a reaction to the shot, doesn't know why and was told to take BENADRYL and TYLENOL.  Left arm swollen, warm to the touch involving about a 6.5 to 7 centimeter area today.
He is experiencing pain in his bones, in his muscles and a little fever; He is experiencing pain in his bones, in his muscles and a little fever; He is experiencing pain in his bones, in his muscles and a little fever; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Apr2021, patient experienced pain in his bones, in his muscles and a little fever. Reporter want to know if he can take ibuprofen after having taken the covid vaccine and what pills he can take for his side effects from the covid vaccine. Outcome of the events was Unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
starting that evening, developed swollen lymph nodes only on the left underarm, persisted for about five days, discomfort but no significant pain associated with swelling
Possible adhesive capsulitis s/p COVID vaccination.  Had her second COVID vaccine on 5/13.  She had more pain with the second dose than the first injection.  C/o persistent pain in her left arm since. Started as pain at the area of injection--no redness or swelling. Immediately after her vaccine, she had a lot of body aches in her knees. That improved after about 1 week, but arm continued to feel sore. She felt like the shot went very deep on the second vaccine.  For a while, her tricep was painful. ROM is impaired.  She has been able to go about her normal activity. Over the last 1 month, the pain has migrated into her deltoid muscle -- worse with sudden movements or reaching for something or catching herself.  Hard to even run due to pain with running motions so it is now interfering with her daily life.  Mostly bothered by aching pain. She has a sensation of numbness into her left wrist.  No neck pain, back pain. She does have some left shoulder pain if she sleeps on her left side. She started using heat and ice over the last week. Using arnica and performing exercise.   Is moving arm differently. Dorsal wrist is numb and tingly, sleeping differently. Fingers feel cooler.  Is right handed, but also using left arm less due to discomfort.
Died; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were provided.  It was reported that a person died after receiving a COVID-19 vaccine. No further details were provided.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
My breasts also appear more full as if they have grown; My Period has been noticeably late since the vaccine; The swelling and pain in my breasts is noticeable and not normal for my cycle; The swelling and pain in my breasts is noticeable and not normal for my cycle; Specifically, very sore within the areolas all the way to my armpits which is completely abnormal for me; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old non-pregnant female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171, Expiry date: unknown, at the age of 37 years), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 as dose 2, single for covid-19 immunisation. The medical history was not reported. There were no concomitant medications. No known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737, Expiry date: unknown, at the age of 37 years), dose 1 via an unspecified route of administration, administered in Arm Left on Apr2021 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced her period has been noticeably late since the vaccine, the swelling and pain in her breasts is noticeable and not normal for her cycle, specifically, very sore within the areolas all the way to her armpits which is completely abnormal for her. Her breasts also appeared more full as if they had grown. Her period had always been regular prior to this shot. No other changes in her health, eating, exercise, stress, medication to explain the odd changes on 08May2021. The patient did not receive any treatment for the event. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
The pt ran fever & acted strange started jerking; Mom gave APAP bathed in cool water; took to ER temp there was 103.6R blood work & urine obtained & was WNL; Returned to MD on following day had infected throat & ears, started on ATB;
Adverse reaction until 40hrs after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction until 40hrs after the second shot) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction until 40hrs after the second shot). At the time of the report, ADVERSE REACTION (Adverse reaction until 40hrs after the second shot) had resolved.            The action taken for mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was NOT APPLICABLE.   No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-054243 (Patient Link).
had a weird side effect after he got the 2nd and the 1st booster dose of the Moderna Covid-19 vaccine; His left eye is now droopy; face pain under his left eye which eas very intense; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (face pain under his left eye which eas very intense), IMMUNISATION REACTION (had a weird side effect after he got the 2nd and the 1st booster dose of the Moderna Covid-19 vaccine) and OCULAR DISCOMFORT (His left eye is now droopy) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20 and 047C21A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Hypertension Ashtma Cholesterol allergies to sulfa (possibly).  Previously administered products included for an unreported indication: MODERNA COVID-19 VACCINE on 09-Feb-2021 and FLU VACCINE VII. Concurrent medical conditions included Hypertension, Asthma, Cholesterol and Sulfonamide allergy.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2022, the patient experienced FACIAL PAIN (face pain under his left eye which eas very intense). On an unknown date, the patient experienced IMMUNISATION REACTION (had a weird side effect after he got the 2nd and the 1st booster dose of the Moderna Covid-19 vaccine) and OCULAR DISCOMFORT (His left eye is now droopy). At the time of the report, FACIAL PAIN (face pain under his left eye which eas very intense) was resolving and IMMUNISATION REACTION (had a weird side effect after he got the 2nd and the 1st booster dose of the Moderna Covid-19 vaccine) and OCULAR DISCOMFORT (His left eye is now droopy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
recieved first dose and was diagnosed with covid; recieved first dose and was diagnosed with covid/Started showing symptoms; I had COVID/; experienced swelling; on 25Jan I exposed to someone who had COVID; This is a spontaneous report from a contactable consumer a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL0142) via an unspecified route of administration on 28Jan2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was diagnosed with COVID-19 infection on an unspecified date, started showing symptoms; had COVID-19 infection, on 25jan i exposed to someone who had covid ( COVID-19 infection  on 25Jan2021 with outcome of recovered, experienced swelling (swelling) (non-serious) on an unspecified date with outcome of recovered. Description of Product Complaint: The consumer stated that he was calling to see if he can get some guidance on whether he should get his second dose or not. Here is the reason why, on 25Jan he was exposed to someone who had COVID. He didn't know that at the time. On 28Jan he got first dose of the vaccine. On 29Jan he started showing symptoms. On 30Jan he was in emergency room and had the antibody infusion treatment. He was recovered and due for his second dose on 18th but given the facts that he had COVID and had antibody treatment makes him want to know if he should still be getting the second dose. Pharmacy says one thing and his doctor says another so he was wondering what Pfizer says. Therapeutic measures were taken. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of injection site soreness in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline).  Concurrent medical conditions included eczema.  Previous and/or concurrent vaccination included PENTACEL (non-gsk); Sanofi Pasteur; unknown; unknown given on 18 February 2011.  Concurrent medications included Hydrocortisone.  On 18 February 2011 at 16:30 the subject received 1st dose of ROTARIX (1 ml, intramuscular, right thigh).  On 18 February 2011, less than one day after vaccination with ROTARIX, the subject experienced injection site soreness and intramuscular formulation administered by other route.  The 5-month old subject received oral vaccine ROTARIX via intramuscular injection in the right hip.  Immunization series was discontinued.  The subject experienced soreness at injection site with previous vaccination, suspect vaccine and additional details were not provided.  At the time of reporting the injection site soreness was improved.  The vaccination course with ROTARIX was discontinued.
I was pregnant. I became immediately very sick feeling & tired. My blood pressure went way up and stayed, I had 6 grams of protein in my urine by 4 days later. I was hospitalized. My son was born 13 days after the vaccine by C-section and was 30 days premature.
Started after falling asleep. Was woken up by profuse sweating and then sleeplessness. Went to work and felt muscle aches and weakness all over. Then major exhaustion with a bad headache.
Food does not digest properly, stomach does not work properly, gets full off of one cup of water, nauseous,
Patient was given 0.2ml of the 30mg formula instead of 0.2ml of the 10mcg formula.
5/24/13 received Tdap, MENACTRA and HPV vaccines. Developed headache 5/26/13 worsening ea day until this am, when headache is less. However also developed (R) posterior neck pain on palpation and w/ROM of head.
Positive COVID test 17Apr2022; Positive COVID test 17Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6203), in right arm, on 23Mar2021 as dose 2, single (Lot number: EN6203), in left arm and on 19Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: NSAIDs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Apr2022, outcome "recovering" and all described as "Positive COVID test 17Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) Positive, notes: Nasal swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical information: No other vaccine in four weeks. No covid prior vaccination. Covid tested post vaccination and was positive.  Follow up attempts are completed. No further information is expected.
I had gotten sick with covid and developed hyponatremia and hypokalemia  and had to be hospitalized.
Tinnitus, this getting louder and louder; This is a spontaneous report from a Pfizer-sponsored program  from a contactable female consumer (patient). A 74-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EN6201, Expiry date: Unknown, NDC and UPC number: Unknown) dose 2 intramuscular, administered in the left arm on 15Feb2021 (at the age of 74 years old) as dose 2, single for COVID-19 immunisation. PQC was not present. Investigation assessment was done. Medical history included Hashimoto's, High cholesterol, hypertension, bone density abnormal. Historical vaccine included bnt162b2 (BNT162B2, solution for injection, Lot Number: EL3247) dose 1 administered in the right arm on 20Jan2021 as dose 1, single for COVID-19 immunisation. Prior to vaccination, no other vaccines were given within 4 weeks. Concomitant medication(s) included denosumab (PROLIA) taken for bone density abnormal (shot every six months). On 17Feb2021 the patient experienced tinnitus, this getting louder and louder. No treatment was given. The patient underwent lab tests and procedures which included blood test resulted unknown results on an unknown date. The clinical outcome of the events was reported as not recovered.  Lot number requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101242529 same reporter/drug/AE, different patients
Per reports from patient's mom after returning home, patient had swelling at injection site, and swelling to left eye. She took him to emergency room and was given benadryl and steroid shots.
developed a knot that was getting larger and harder in the shot area; started turning red and started swelling and developed a knot that was getting larger and harder in the shot area; started turning red and started swelling and developed a knot that was getting larger and harder in the shot area; Took the shot in the back of my arm; This case was reported by a consumer via interactive digital media and described the occurrence of injection site induration in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had 3 outbreaks of shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site induration, erythema, swelling arm and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site induration, erythema, swelling arm and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site induration, erythema and swelling arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had 3 outbreaks of shingles. The patient thought that taking the vaccine would help and took the shot in the back of his/her arm which led to vaccine administered at inappropriate site. On an unknown date after receiving the shot, the patient started turning red and started swelling and developed a knot that was getting larger and harder in the shot area. The patient stated that he/she had to take a shot to count- react the vaccine and was told never to take another one. The follow-up could not be possible as no contact details were available.
11SEP96 pt recv vax & w/in 12 hrs dec bronchospasm;no URI sx;
Patient has Subacromial/Subdeltoid bursitis confirmed by ultrasound that is not responding to treatment.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient complained of nausea/dizziness followed by blurry vision. He felt like he was going to black out. I took his vitals at 11:43 am and his BP measured 78/53 with a pulse of 45. He was also sweating profusely. The paramedics came within a 5 min time frame and patient was stabilized within 10-15 minutes later.
Synopal episode after patient received vaccinations (in first 3-5 min after vaccination). Patient fall on floor and suffered CHI (concussion). Patient was taken via EMS to ED for further evaluation and observation.
I tested positive for Covid 19 on March 13, 2023, I experienced coughing, headaches, body aches, and diarrhea, fever of 100.8. I was prescribed Paxlovid for my symptoms.