chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (swollen arm) and pain in extremity (sore arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced peripheral swelling (swollen arm) and pain in extremity (sore arm). At the time of the report, peripheral swelling (swollen arm) and pain in extremity (sore arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported. This case linked to MOD-2021-302671 (patient link).
Fever over 100.4, cold feet hands, excessive tachycardia over 125 beats (normal is 60 for me), chest pain, abdominal pain/ abdominal cramping , global headache 8/10
COVID Breakthrough. The patient presented to the hospital on 9/30/21 with fatigue and possible COVID concern "for a few days". Tested positive on 9/30/21 at the hospital. He is on 12L of Oxygen as of 10/1/21
Dizziness and palpitations approximately 27 hours after receiving the vaccine. Resolved after approximately one hour.
I received my first shot of Moderna vaccine on February 12 and my second on March 12, 2001. I experienced very slight reactions to both injections composed of mild aching, and tingling sensation of shoulders and back and very slight soreness at the injection sight and lasting only 24 hours after the injections.  On evening of May 24, 2021, I experienced a very upset stomach followed by multiple bowel movements during the night and intense aching of the joints, fatigue, tingling sensation of my back and shoulders, chills and loss of appetite lasting through the following day and night.  I awoke on May 25, 2021 feeling better but still experiencing slight fatigue and a mild head ache.  During these days both my wife and I consumed the same foods and carried out identical schedules.  My question is: could this have been a delayed reaction to the Moderna vaccine?
who finished taking Paxlovid; who finished taking Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 80-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, on 06May2022 as dose number unknown (booster), single, as dose 2, single and as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "who finished taking Paxlovid". Clinical course: The patient finished taking Paxlovid and wants to know how long he has to wait to get the bivalent gray cap formulation of the Pfizer BioNTech Covid 19 vaccine as a booster. He received his last Covid booster (did not clarify manufacturer) on 06May2022. How long after stopping Paxlovid can he get the bivalent Covid Booster? The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Result Unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19.
30-40 min after vaccine administered pt felt achiness to arms. Pt reports that at 0130 am she had a temp 102.8 and anxiety/jittery. Pt c/o swollen hands headache, and stiff neck. Pt took Motrin and Tylenol for symptoms. Was given Benadryl 25 mg at 1145 on 3/22/07
Information has been received from a consumer concerning her 7 year old son who on 10/24/00 was vaccinated with the 2nd dose of pneumococcal vaccine 23 polyvalent. Within 6 hours, post vax, the child's injection site arm swelled from his elbow to his shoulder to 3 times it's normal size. He also developed a fever of 103F. The fever "went down" as of 20:00 on 10/25/00. The child was seen by a physician who put him on a steroid and an antihistamine. It was noted as of 10/26/00, the child still has pain and swelling in his arm. Upon medical review, the pt's experiences were considered to be "Other Medical Events". No further information is available.
Seizures noted night of immunization day. ER. No showed EEG appt.
[t recv vax 7AUG96 & 6SEP96 pt devel Henoch-Schonlein purpura;
Major PE detected on CT Scan at an ER; This is a spontaneous report from a contactable consumer (patient).   A 74-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9810 ) on 09Feb2021 at 11:00 (at 74 years) at single dose in left arm for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Patient took the first dose of the vaccine (lot EL3247) in Jan2021 at 11:00 am  (at 74 years) in left arm for covid-19 immunisation. No COVID prior vaccination. On 31Mar2021 at 12:00 the patient experienced major pulmonary embolism (PE) detected on computerised tomogram (CT) Scan at an emergency room (ER). The event required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Event was serious duet to hospitalization and life threatening illness.Patient was hospitalized in 2021 for 4 days. Patient was treated with Heparin and Eliquis. Patient was tested post vaccination: Nasal Swab was done on 31Mar2021 and was negative. The outcome of the event was recovering.
Vaccine card improperly marked and did not indicate a bivalent covid vaccine was given.  Patient received 2 doses of Pfizer bivalent covid vaccine.
Allergic reaction started on 5/30/21 (4 days after receiving the vaccine) - rash on left arm and abdomen, shallow breathing/wheezing a few hours after the rash developed. Patient went to the ED and the rash resolved by 6/1/21.
pt recv vax 16FEB98 & 20MAR98 pt devel a rash;6MAR98 lab eval revealed a negative titer;
Vaccine given at approximately 10:45am. Symptoms of tingling accompanied by brief sharp pain (1-2 seconds duration) occurred intermittently within twenty minutes of injection. This has repeated 6 - 7 times until now (3pm). Pain and tingling occurs left lower pelvic region and starts to radiate to left upper thigh.
Very bad toothache; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Very bad toothache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 042B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TOOTHACHE (Very bad toothache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Toothache, at an unspecified dose and frequency. At the time of the report, TOOTHACHE (Very bad toothache) outcome was unknown.            No concomitant medications were reported by the reporter. Patient stated that it was her 1st Booster dose which was administered on 09-Nov-2021.
Information has been received from a 71 year old female patient with a history of shingles, MRSA, hives from taking CELEBREX and "rashes to other medications," who on 20-MAR-2008 was vaccinated with a 0.65 mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included NORVASC, PREMARIN, and ibuprofen. On 15-MAY-2008 the patient experienced hives in about four spots on her body after receiving zoster vaccine live (Oka/Merck). The hives were "very itchy." The patient stated that she had undergone "routine labs." At the time of this report, the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No further information is available. This is in follow-up to report (s) previously submitted on 6/24/2008.  Follow-up information received on 24-MAR-2009 indicated that the patient was a retired nurse.  The patient called back and mentioned that about 58 days after receiving ZOSTAVAX (Merck), she developed a rash on the entire right arm.  The right arm was very itchy.  The ZOSTAVAX (Merck) was given in the right arm.  The caller reported that it took about 1 week to clear up.  The reporter also mentioned that she had a shingles lesion on her temple back in 2002.  The retired nurse reported that on 17-MAR-2009, she experienced a horrible itch on the left rib cage.  She also added that she noticed one large 50 cents piece size very red lesion, not rough but she could feel it.  On the moring of 18-MAR-2009, there was another lesion that was the size of a 50 cent piece that was on the top of the initial lesion so "it looked like a snowman".  The lesions were very red.  The retired nurse went to the physician on the morning of 18-MAR-2009 and the physician prescribed VALTREX.  The nurse did not take the VALTREX because of the cost.  There was not itching in the morning but the retired nurse experienced it later in the day on 18-MAR-2009.  On the morning of 19-MAR-2009, there was no itching but the lesions were black and blue (lost the redness).  By 20-MAR-2009, the lesions are a slight black and blue and very faded.  The lesions are gradually disappearing.  No further information is available.
pt recv vax & devel swelling & redness in arm, achiness, a fever of 102 & h/a which hurt so bad that pt could not get out of bed;also became extremely irritable & had a couple of outbursts that was never done before;
Hives to bilateral arms 25 min after receiving vaccine. 1105 BENADRYL 50mg/CLARITIN taken per self. 1150 hives spreading to legs, high, buttocks seen by Nurse Practitioner - prescribed Prednisone 10/21/13 hives continue, spread to back and below bilateral breasts.
sore throat, congestion, fever. 01/02/2021: COVID positive. Given Balmlinivimab and Decadron. Admitted to hospital through ER on !/5/2021 with chest tightness and shortness of breath. Throughout stay given Cardizem, Amiodarone without conversion. 1/5/2021 1800 transported by ambulance to medical center. Cardioverted at medical center.
swelling of her lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 08Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling of her lymph nodes on 22Jan2021, 2 weeks after getting the vaccine. The outcome of the event was unknown. The patient wanted to know if this was a normal side effect of the vaccine. The patient also wanted to know the risks of the Pfizer-Biontech covid-19 vaccine and what should she do about the side effects.  Information about the lot/batch number has been requested.
epigastric burning, BP 202/104. pt took omeprazole and drank 16 oz water 20min later 226/93 code med called and transferred to ED
2nd Meningococcal given.  1st Meningococcal given 10/22/07.
Soreness on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on the Injection Site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness on the Injection Site). At the time of the report, VACCINATION SITE PAIN (Soreness on the Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
A physician reported that a 40 year old female sustained an injury with a foreign body. As part of wound management, the physician administered a SC injection of Tetanus Toxoid Adsorbed, Ultrafined at 10:00 on 5/2/00. Later that day, the pt became concerned that the injury site appeared infected; she went to the ER. The infected injury was treated with cephalexin. A second dose of Tetanus Toxoid Adsorbed (manufacturer unknown) was administered by the ER staff at 15:00 on 5/2/00. On 5/4/00, the pt developed a fever of 100.4F and she also developed redness, inflammation, warmth and pain at each TD administration site.
Hospice Resident received first Covid 19 vaccine dose on 1/6/21.  1/7/21 resident had decreased appetite noted in am but ate 100% of meal at dinner.  1/9/21 resident had decreased appetite with emesis x 2, loose BM x 2.  Call placed to hospice.  1/10/21 5:44 am resident able to take HS meds, ingest 2 cups of shake.  No emesis or loose stool noted.  12PM nurse noted resident not eating meals but ingesting milkshake and medications without any problems.  Hospice contacted for change in condition.  1:00 pm hospice ordered Phenergan 12.5 mg Q 6 hrs PRN.  Labs to be drawn 1/11/21. Hospice notified POA.  1/11/21 12:24am Resident had blood in stool. Resident denies any pain, on 2L of O2 for comfort.
Two weeks after 1 shot started experiencing nausea and diarrhea for 5 days.  The morning of my 2nd dose started having dizziness.  The next day after the 2nd shot started having dizziness, headache, blurred vision and chills. The dizziness continued until I visited the clinic on 6/4/2021.  Was prescribed Meclizine for the dizziness.  Dizziness and nausea continued until visited an ENT on July 6, 2021.  Because of the severe headaches and dizziness he referred me to get a VNG.  The results showed something on the back, left side of my brain.  Received a MRI on 8/25/2021. The results was negative, believed it was inflammation.  Left arm (both shots were administered) started having sharp, throbbing pain.  Referred to receive vestibular therapy for the dizziness and physical therapy for my arm.  That started 8/24/2021 - 9/27/2021 (3 days/week).
Information has been received from a physician concerning a 23 year old female patient with no pertinent medical history who on 27-JUL-2010 was vaccinated with the first dose of GARDASIL (lot number not provided). There were no other vaccinations given at the same time. The physician reported that 2 or three days after vaccination (on approximately 29-JUL-2010) the patient experienced generalized rash and urticaria. The patient had been treated with steroids, prednisone and BENADRYL. At the time of the report the patient had not recovered. The patient sought medical attention by an office visit. Follow up information has been received from the physician who reported that the patient experienced delayed hives reaction that started 5 days after the first dose of GARDASIL (on 01-AUG-2010) and progressively worsened despite BENADRYL around the clock. The physician reported that the patient would not be continuing with the series with GARDASIL. At the time of the report the patient's out come was unknown. Additional information has been requested.
This spontaneous report as received from a pharmacist student regarding a 66 year of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-DEC-2016 the patient was vaccinated with an expired dose of PNEUMOVAX23 from lot # L021367 with expiry: 05-NOV-2016 (route and dose not reported), for prophylaxis. No adverse effects reported. No product quality complaint (PQC) involved. Additional information has been requested.
6 to 7 hours after receiving the flu vaccine he complained of heaviness in his arms and legs.  "They feel like they weigh too much".  Became very upset.  Mom had to calm him calm lasted about 20-30 minutes.
The patient stated "hurting a bit" after the injection which she deemed as normal after a shot. The pain was very evident the following day, progressing and increasing. She stated that the pain spread to her whole upper shoulder. It is ongoing. She has seen an MD.
Muscle pain & stiffness,  loss of sleep, weight loss, muscle weakness , extremely swollen hands ( could barely get out of bed, could pick up a glass with 1 hand, needed help dressing myself)
explosive diarrhea; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (explosive diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sjogren's syndrome and Rheumatoid arthritis.   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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (explosive diarrhea). At the time of the report, DIARRHOEA (explosive diarrhea) had not resolved.            concomitant medication was not reported treatment information was  not provided.   This case was linked to MOD-2021-099514 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
Patient developed 10 x 10 cm area of redness, edema and warmth 24 hours after receiving Dtap (INFANRIX) at site of injection. Patient seen 12/22/06 at 5:30 p.m. by MD and was given prescription for Keflex.
Patient given Moderna 0.5mg Covid Vaccine when should have been given Pfizer covid vaccine due to age (16years old). No adverse effects ere noted by mom when contacted. Per CDC guidelines, patient will receive 2nd Moderna vaccine.
Acute pericarditis - cough and chest pain for 2 days prior to ED visit with diagnosis. Improved over time with treatment via colchicine.
Patient had 3 days of fevers, body aches, chills after 2nd injection.  Then developed intermittent shooting pains in both arms and legs.  Also has numbness in her hands and feet.   It has now been over a month since vaccine - symptoms are dissipating, but still present
Patient never received the second primary dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient never received the second primary dose) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient never received the second primary dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient never received the second primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient never received the second primary dose).    HCP was unaware if patient was taking other medication.  Pharmacist stated the patient had received her first Moderna dose about 2 years ago. Now patient wanted to get the second dose. Patient's HCP  was aware that patient did not receive the second dose.  No treatment medications were reported.   Reporter did not allow further contact
temperature excursion due to Adacel vaccine was exposed to 27F for more than 3 hrs/No AE; Initial information was received on 01-Jul-2020 regarding an unsolicited valid non-serious case from a other health care professional.  This case is linked to cases 2020SA172973, 2020SA172697, 2020SA174880, 2020SA174885, 2020SA174942, 2020SA174911, 2020SA174941, 2020SA174910, 2020SA174910, 2020SA174932, 2020SA174940 and 2020SA173110. (Same reporter)  This case involves a 11-year-old male patient who was received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], that was exposed to 27 Fahrenheit for more than 3 hours and the excursion occurred due to temperature of the refrigerator was manually changed it (product storage error).   Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication were not reported.  On 13-May-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot U6621BA, expiry date: 22-Mar-2021] via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to Product storage error temperature too low.  At the time of report, 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.
4 patients received a vaccine from a syringe that had been at room temperature for approximately; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients received a vaccine from a syringe that had been at room temperature for approximately) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No specified medical history has been reported .     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients received a vaccine from a syringe that had been at room temperature for approximately). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients received a vaccine from a syringe that had been at room temperature for approximately) outcome was unknown. Not Provided      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.   Concomitant medications was not provided. Treatment information was not provided.
D1 to D2: Nausea, Fever (High: 102.9F), Stomach Pain, Diarrhea, Headache D3 to D7: Stomach Pain, Nausea
Thirty minutes after receiving vaccine, associate became nauseous and had a headache. She progressed to vomiting and fever of 102. This continued for several days.
Three days after receiving the vaccine I began having pelvic pain. The pain originated on the right side, near my right ovary. Ovary felt enlarged to palpation. Pain increased with bending over or crouching. Pain worsened when lying on the side of the opposite ovary, due to feeling of "heaviness." Pain improved with resting.  Two days later the pain migrated to my left side, and left ovary also felt enlarged. Pain was a 6/10. Intermittent nausea. No vomiting, bleeding, discharge, shortness of breath, chest pain, fevers, chills, diarrhea, or changes in urine or bowel habits. No concerns for STD exposure. After three full days (thursday evening through sunday evening, 6/17-6/20), the pain subsided with ovulation.
pt recv vax 20FEB97 & onset vesicular rash 25FEB97;first seen 4MAR97 given claritin for itching;
Pt recvd 2nd dose of Hep B vax on 27FEB92 & on 28FEB92 exp a h/a, neck & arm stiffness & shoulder pain; tx APAP-pt recovered;
Fever, sore arm, swelling on injection site, headache, chills, body aches