chrisvoncsefalvay/vaers-outcomes huggingface dataset:
achy body; feeling exhausted; headache; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (achy body), FATIGUE (feeling exhausted) and HEADACHE (headache) in a 25-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Previously administered products included for Product used for unknown indication: Influenza vaccine on 18-Nov-2022. Past adverse reactions to the above products included No adverse event with Influenza vaccine.   On 18-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form, second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 19-Nov-2022, the patient experienced PAIN (achy body), FATIGUE (feeling exhausted) and HEADACHE (headache). At the time of the report, PAIN (achy body), FATIGUE (feeling exhausted) and HEADACHE (headache) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that patient was feeling exhausted, with an achy body and a terrible headache. It was unknown if the patient experienced any additional symptoms or events. No treatment medication were provided.   Reporter did not allow further contact
First experienced arm pain at site of injection, chills and body aches within 13 hours of the 2nd COVID-19 Pfizer vaccine. 27 hours following administration of the vaccine in addition to body aches and chills, I then experienced headaches, fever of 101.8, and fatigue.
Gouty edema lower legs & feet. By the 25th was unable to walk. Hospitalized from Dec 30th to Jan 3rd. Blood tests revealed a dramatic increase in uric acid level.
Moderna vaccine was administered outside of Facility - reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------- I21.09 ACUTE ST ELEVATION MI, ANTERIOR WALL 9/14/2022 RHABDOMYOLYSIS I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 9/14/2022 RHABDOMYOLYSIS I21.4 ACUTE NON ST ELEVATION MI 10/4/2022 RHABDOMYOLYSIS I95.9 HYPOTENSION 9/14/2022 RHABDOMYOLYSIS
Medical asistant called in a temperature excursion on Varivax; No additional AE/PQC reported at this time; This spontaneous report was received from a medical assistant regarding a patient of unknown gender, who at the time of the report was 12-months-old. The, the patient's concurrent medications, pertinent medical history, drug reactions or allergies were not reported.  On an unspecified date, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) administered subcutaneously,  lot # T021826, expiration date was provided and also validated as 25-JUN-2022 (dose, strength, vaccination scheme frequency and anatomical location were not reported) for prophylaxis (improper storage of product in use). The vaccines were exposed to a temperature excursion of, the temperature frame was from -58 degrees Fahrenheit (F) to +5 F and the vaccine was at 6.3 F for 6 hours 0 minutes and 30 seconds, another temperature excursion at 10.9 F for 0 hours 7 minutes and 30 seconds, which were detected by the Digital Data Logger. It was reported there was a previous temperature excursion. No additional adverse event (AE) was reported.  This is one of the five linked reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA008255: US-009507513-2104USA008185: US-009507513-2104USA008081: US-009507513-2104USA008342:
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 12-JAN-2018, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX 19400 PFU, subcutaneous for prophylaxis, lot # M041511 and expiration date on 08-JAN-2018. The sterile diluent used for reconstitution of ZOSTAVAX was properly stored and not expired (lot # M047667, expiration date 25-JUL-2019). The medical assistant reported that ZOSTAVAX had not had any temperature excursions and there were no adverse effects reported for the patient.
Rash, (papulo-vesicular) on trunk, noticed on 1/28/01 and a fever. Exam on 1/29/01.
Initial misuse report received from a healthcare professional on 09 MAY 2013. It was reported that 1 year ago, a patient was given first pre-exposure dose of IMOVAX 1 day after expiration date (expiration date: 13 MAY 2013). No information was provided regarding the patient. No adverse event was reported. Documents held by sender: None
gave a Menactra instead of an MMR yesterday with no AE; Initial information regarding this unsolicited valid non-serious case from Regulatory Authority (Reference number- 00421820) was received from Pharmacist and transmitted to Sanofi on 08-Jan-2021.  This case involved a 7 months old male patient who received a 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] instead of MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE [MMR] (lot: U6575AA, expiration date: 08-May-2021),  gave a Menactra instead of an MMR yesterday with no AE (Wrong vaccine administered). The dose was given in the left deltoid via intramuscular route.  Past vaccination included meningococcal vaccine(unknown brand) 2 years ago. The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was a actual medication error due to wrong vaccine administered (Wrong product administered).  At the time of reporting, no adverse event was reported.  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.
Patient called this reporter today 11/13/19  with complaints of swelling, pain, and vertical rash trending down the patients arm from the injection site. (Pt received flu and pneumovax 11/11/19 n left deltoid.) Pt states that Monday night 11/11/19 they could not sleep due to cold sweats, hot flashes, and pain at injection site. Pt did not take temp on Monday to confirm fevers. Today 11/13/19 patient states left arm is warm to touch and vertical rash is still present. This reporter paged ordering MD. Dr. suggested patient be seen today. Due to patient living far from this medical center. Patient is going to be seen today by PCP.
Information has been received from a licensed visiting nurse that a registered nurse observed 2 patients who experienced a mood change after vaccination with GARDASIL vaccine (yeast) (Lot number not reported). The registered nurse reported that the patients had also received other vaccinations at the time of vaccination, but the specific other vaccines are unspecified. Attempts are being made to obtain additional information on a multi-patient report. Additional information has been requested.
I received the first Moderna vaccine on March 15, left arm hurt to touch, couldn't lift it overhead, had sound halucinations and fatigue.  On the eleventh day things got ugly. Sharp chest pain and  jaw pain, blood pressure 130/104 (my normal is 125/60), for four days couldn't eliminate but a small amount of urine, dizzy spell-almost passed out, vitreous detachment in eye, lost taste and smell 24 hrs (test for covid-19 was negative), blood pressure jumped to 180/112, temp 94.4, TMJ/node pain and swelling three weeks, teeth didn't occlude four days and couldn't get floss between any teeth for a day (so weird), severe shooting wrist pain, couldn't hold a pen or type for 24 hrs, hand tremors, sound halucinations of metal scrapping, hammering, thumping when laid down, super itchy rash under armpit one week, occipital node swollen, top of head painful to touch, ankle swollen, pounding heart beat, dry cough, oxygen readings of 88, sub- normal temperature 94.8 to 95.8 for several days and a month of very high blood pressure readings with tinnitus, fatigue, cloudy thinking and speech. Most reactions lasted a day up four days, all were on the right side of my body, most resolved before the next started. The longest ongoing issue is high blood pressure. Finally went down to 124/66  but not consistently. Spent three weeks around 138/104 and when walking uphill, heart would start pounding, felt faint, nauseated, head ached and had difficulty breathing. Alcohol and salt triggered a reaction or made blood pressure jump to 180/104. Leaning forward to do yard work or and strenuous activity like walking made heart pound violently, head ache, and blood pressure go up. Laying down makes heart flutter. Most of the symptoms listed are for myocarditis. Once the CDC reported that kids were having these issues I reduced activity and and more bed rest and am feeling slightly better.
injection site soreness, red rash, itching; injection site soreness, red rash, itching; Injection site soreness; This is a spontaneous report from a contactable Healthcare professional (Patient herself). A 62-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9263, Expiration date: Not reported), via an unspecified route of administration on 16Feb2021 03:15 PM at a single dose at her left arm for COVID-19 immunisation. Medical history included high blood pressure. No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included losartan, tocopherol (VITAMIN E), ascorbic acid (VITAMIN C), cyanocobalamin (VITAMIN B12), estradiol (YUVAFEM) and replens iron, all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced injection site soreness, red rash, itching on 18Feb2021. No treatment received for the adverse event. The patient had not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.  Information about batch number has been requested.
This spontaneous report as received from a certified medical assistant (C.M.A) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-AUG-2015, the patient received a dose of M-M-R II (lot#, expiration date, dose and route of administration were not reported) that was inadvertently reconstituted with improperly stored sterile diluent (dose one, lot# reported as L016272, expiration date 24-FEB-2018, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe muscle aches, fatigue, headache, sore throat and chills, all lasting 24 hours beginning about 9 hours post vaccine.
FEVER; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Eye was quivering and trembling for a short while; This spontaneous case was reported by a consumer and describes the occurrence of EYE MOVEMENT DISORDER (Eye was quivering and trembling for a short while) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 040A01A) for COVID-19 vaccination.     Concomitant products included VITAMIN B COMPLEX (B-COMPLEX [VITAMIN B COMPLEX]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 20-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) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced EYE MOVEMENT DISORDER (Eye was quivering and trembling for a short while). At the time of the report, EYE MOVEMENT DISORDER (Eye was quivering and trembling for a short while) had resolved.            Concomitant product included Hair ,Skin, Nails vitamins. The patient treatment data was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-060473 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: updated the event outcome from unknown to recovered/ resolved On 27-May-2021: Reporter said she did not have an email ID or fax number and said she felt better.; Sender's Comments:  -MODERNATX, INC.-MOD-2021-060473:2nd dose
About 10 minutes after the shot I had heart palpitations, racing heart, and felt dizzy. That lasted about 10 minutes. About 2 hours later, I noticed my lymph nodes on my neck were getting larger. About 5 hours later, I felt really exhausted and irritable and my arm was sore. About 8 hours later is when my husband noticed I looked unwell. My eyes were dark and glassy and I felt nauseous. 11 hours after the shot was when the very intense body aches kicked in, joints, muscles, and everything felt very inflamed and my fever started. Throughout the night, all of that worsened until about when I woke up the next morning around 11AM. Everything felt better. I was mildly sore and everything improved throughout the day. The tendonitis and nerve issues in my arm started a few months after the shot. I saw Dr. (Privacy) first. He prescribed me with tizanidine and meloxicam. He was hopeful that it would improve in about a month, but asked me to come back or give him a call if it did not. He thought it was tendonitis or ulnar nerve entrapment. I waited about a month and half and it had slightly improved but started to get worse again. I am an (privacy) so I thought that might have something to do with it but I had never had problems with it before. I cut my hours in half and that still wasn't helping. I took a couple of weeks off of work and that didn't help either. That's when I decide to call him again. He referred me to an arm specialist.
Large red raise thing that looks like a rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Large red raise thing that looks like a rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE RASH (Large red raise thing that looks like a rash). At the time of the report, VACCINATION SITE RASH (Large red raise thing that looks like a rash) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Jan. 4: felt dizzy and sluggish rest of day Jan. 5: injection site swollen, very painful where she was having difficulty raising the right arm, chills, headache, fever Jan. 6: fever and right arm soreness She?s taking over the counter meds
Knees are swollen after booster shot; Can not walk after booster shot; Knees hurt after booster shot/Both shoulders hurting after booster shot; Injection site hurts after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Knees are swollen after booster shot), GAIT INABILITY (Can not walk after booster shot), ARTHRALGIA (Knees hurt after booster shot/Both shoulders hurting after booster shot) and VACCINATION SITE PAIN (Injection site hurts after booster shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 045A21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced JOINT SWELLING (Knees are swollen after booster shot), GAIT INABILITY (Can not walk after booster shot), ARTHRALGIA (Knees hurt after booster shot/Both shoulders hurting after booster shot) and VACCINATION SITE PAIN (Injection site hurts after booster shot). At the time of the report, JOINT SWELLING (Knees are swollen after booster shot), GAIT INABILITY (Can not walk after booster shot), ARTHRALGIA (Knees hurt after booster shot/Both shoulders hurting after booster shot) and VACCINATION SITE PAIN (Injection site hurts after booster shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Within approximately 15 min of recieving the vaccination the patient displayed hives, swollen tongue and was immediately taken to the emergency department for evaluation.  She was given Decadron, Benadryl and a prednisone taper pack.
Immediate fever & chills, subsided in two days. One day later severe vertigo/dizziness/nausea. Vomiting every 30 minutes for 24 hours until prescription suppository received. Continued dizziness, now one month later, persists every day. Walking like I'm drunk, not steady or in a straight line. Woozy, feeling like I could fall. Mild nausea (one severe bout a week ago; used prescription). Incapable of engaging in daily activities like normal.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 45 year old male. 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 not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958534, 20210958564, 20210958570 and 20210958784.
pt slept for 3hr-nap p/vax pt lt upper arm red in color & hot to touch area sl edematous;pt afeb, pt sl irritable for approx 3-4 days;
dizziness; heart palpitations; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient) reported for herself that a 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9269), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 10:30 (Age at vaccination 57 years) as dose 2, single for covid-19 immunisation. Medical history included rheumatoid arthritis from 2009 and ongoing, blood pressure high from 2000 and ongoing and stress from an unknown date and unknown if ongoing (She said her high blood pressure was brought on by stress). There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number : EL3249, Expiration date: Unknown), via an intramuscular route of administration on 20Jan2021 (Age at vaccination 57 years) as dose 1, single for covid-19 immunisation. On 13Feb2021, the patient experienced heart palpitations; On 28Feb2021, dizziness. The patient was not received treatment for events. Patient did not performed lab test. It was reported that caller stated she received both doses of Pfizer COVID 19 vaccines. The first dose was on 20Jan2021 which she had no side effects. The second dose on 9Feb2021. That weekend on 13Feb2021 and for 2 weeks on she experienced heart palpitations and dizziness started on 28Feb2021. She stated it's been the same. She went back and looked at the information and knows they are side effects but she wants to know how long should they last. She stated the hospital is the last place I want to go. The dizziness, it ok. It's the heart palpitations are more bothersome. Consumer stated, "I was wondering, because I got my first Pfizer dose on 20Jan (not clarified) and then I got my second dose on 09Feb (not clarified) and from about two weeks, I have been having heart palpitation and yesterday, I started getting little dizzy. So, I looked at the publish sheet that they gave me and those two were the side effects. She said both the heart palpitations and dizziness have persisted. Additional Information for Other Conditions: Reported she was diagnosed with high blood pressure in approximately 2000. She said her high blood pressure was brought on by stress. She said she was able to get off her medication at one point, but then her husband got sick and the stress from that caused her to start taking medication again. She said she did not want to go to the hospital because of the COVID-19 Virus. Vaccination facility type was hospital. No additional vaccine administered on Same Date of the Pfizer Suspect. Patient did not visited to emergency room and physician office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical outcome of both events were not recovered.   Investigation Assessment: No  No follow-up attempts are possible. No further information is expected.