chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient described a red swelling around the injection site and pain at the injection site. Patient stated that the pain got better, but the swelling was increasing in size.
Information has been received concerning a pt who was vaccinated with one dose of varicella vaccine. It was reported to the pharmacist from a RN that the vaccine bubbled around the needle at injection site and 10 percent of the vaccine was lost. This does not comply with the recommended dosage schedule. The pt sought unspecified medical attention. the pt has since been lost to follow up.
PRODUCT TEMPERATURE EXCURSION ISSUE; This spontaneous report received from a health care professional 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 not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.. No concomitant medications were reported. On an unspecified date, the subject experienced product temperature excursion issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of product temperature excursion issue was not reported. This report was non-serious.
chills; no appetite; feeling very weak; I had covid last year, I am feeling the same way; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient). A female patient (Age: 41, Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on 20Mar2021 as 1st dose single for COVID-19 immunization. Medical history included covid-19 from 2020 to an unknown date. The patient's concomitant medications were not reported. It was reported that, on 20Mar2021, she had side effects, after receiving the first dose of the Pfizer vaccine. Caller stated, "Last night she got chills and had covid last year, felt the same way, no appetite and feeling very weak". She was afraid that she got the covid again, and also scared, caller asked if she should be tested, or go to urgent care. Caller No longer had chills now, just loss of appetite and weakness. Caller had no shortness of breath. The outcome of the events chills was resolved on an unknown date in 2021 and for events just loss of appetite and weakness it was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Homebound nurse reports inadvertently administering duplicate/extra influenza dose to individual as group home manager requested client be vaccinated for flu and COVID-19 on 12/9/21. After this date, it was noted that client already rcvd seasonal flu vaccine on 9/28/21.
Blood clot  in a blood vessel to the spleen; This spontaneous case was reported by a consumer and describes the occurrence of SPLENIC THROMBOSIS (Blood clot  in a blood vessel to the spleen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced SPLENIC THROMBOSIS (Blood clot  in a blood vessel to the spleen) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 17-Mar-2021 to 03-Apr-2021 due to SPLENIC THROMBOSIS. The patient was treated with Surgery (Had the organ removed) for Splenic thrombosis. At the time of the report, SPLENIC THROMBOSIS (Blood clot  in a blood vessel to the spleen) outcome was unknown.            No concomitant medication provided.  No treatment information mentioned.  Company Comment:  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.
Woke up the next morning and both right arm and right upper leg were extremely achy and felt weak. Extremely fatigued all day. General feeling of "just don't feel well" Had to take a nap and then still went to bed early. This morning (2 days after flu shot), had a hard time waking up with alarm. Already extremely fatigued. Achiness in right leg is less. Achniess in right arm is the same. Both still feel weak. Woke up with a cold sore. I'm not prone to frequent cold sores and haven't had a cold sore in over 2 years.
following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore; following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient stated feeling like it was difficult to swallow and redness at injection site. Sent to ER from observation area at COVID clinic.
Night of vaccine, had moderate headache and still have on day 3 (4/12/21) Fever (102), and nausea when eating started Sunday night, 4/11/21. and continues at time of this report on 4/12/21, 7:00pm.   Low grade fever continues as of this report on 4/12/21 at 7:00pm  Rash and itchiness from waistline to breastline. Lots of red bumpy rash in entire waist area up to the breastline. Rash/itchiness started on 4/12/21 at 7:00am
Enlarged heart; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL (ongoing). Vaccination history included: Bnt162b2 (1st dose), administration date: 13Mar2021, for COVID-19 immunization. The following information was reported: CARDIOMEGALY (non-serious) with onset 14Oct2021, outcome "unknown", described as "Enlarged heart".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness onset 1/2 hour after Hepatitis A #1 continued for 12 plus hours. Seen at ER. No definite diagnosis.
Received vaccine 5/25/06 and on day 11, 6/5/06, developed fever 100.4 and broke out in rash. On 6/7/06, seen in our clinic and did have lesions in various stages, 1 clear vesicle on chest, some crusted on face and trunk. (Not numerous)
fever, chills, muscle aches, headache, fatigue - took tylenol and slept a lot - feeling better after 48 hours
Heat - hands first then shoulder then toe and feet. Face very flushed and neck. Each day continued to get worse. Doc prescribed steroid pack and BENADRYL then again had to see him steroid shot almost 4 wk still happening. I am still taking BENADRYL 3 x day.
Swelling; Red area; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swelling) and INJECTION SITE ERYTHEMA (Red area) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (beta blockers and other drugs). Concomitant products included DILTIAZEM, APIXABAN (ELIQUIS), FLECAINIDE, ALENDRONATE SODIUM (FOSAMAX), PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) and TELMISARTAN (MICARDIS) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE SWELLING (Swelling) and INJECTION SITE ERYTHEMA (Red area). At the time of the report, INJECTION SITE SWELLING (Swelling) and INJECTION SITE ERYTHEMA (Red area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.
Woke up next morning (9 am) to a very, very sore left arm. My whole body ached, felt feverish, and a headache. I took 3 tablets of 200 mg Ibuprofen in the morning. Then, I went to work where I felt nauseous and a headache and took 400 mg of Ibuprofen. I went to bed feeling better and took 400 mg of Ibuprofen before bed. I now feel a lot better, just a sore arm!
Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021; No adverse event; patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021).    Concomitant drugs were not reported. It was reported that the monovalent vial of size 5.5 ml was initially stored in refrigerator on 12-Nov-2021  The vial did not underwent any temperature excursion. Treatment medications were not provided.
Baseball size bump in the arm for 2 weeks after the vaccine; Arm starting to turn red but/arm got red from the shoulder to the elbow; it was hot; Swollen; Felt like a bad burn; it was painful; Itched; Covid arm; Not feel good; little bit of an achy arm/Aches; Lowgrade fever; Chills/had chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Baseball size bump in the arm for 2 weeks after the vaccine), MYALGIA (little bit of an achy arm/Aches), VACCINATION COMPLICATION (Not feel good), VACCINATION SITE ERYTHEMA (Arm starting to turn red but/arm got red from the shoulder to the elbow) and FEELING HOT (it was hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 028A21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu shot in October 2021. Past adverse reactions to the above products included No adverse event with Flu shot.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced MYALGIA (little bit of an achy arm/Aches), PYREXIA (Lowgrade fever) and CHILLS (Chills/had chills). On 25-Oct-2021, the patient experienced VACCINATION COMPLICATION (Not feel good). On 26-Oct-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm starting to turn red but/arm got red from the shoulder to the elbow), FEELING HOT (it was hot), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PAIN (Felt like a bad burn), VACCINATION SITE PAIN (it was painful), VACCINATION SITE PRURITUS (Itched) and VACCINATION COMPLICATION (Covid arm). On an unknown date, the patient experienced VACCINATION SITE MASS (Baseball size bump in the arm for 2 weeks after the vaccine). At the time of the report, VACCINATION SITE MASS (Baseball size bump in the arm for 2 weeks after the vaccine), VACCINATION COMPLICATION (Not feel good), FEELING HOT (it was hot), VACCINATION SITE PAIN (Felt like a bad burn), VACCINATION SITE PRURITUS (Itched), VACCINATION COMPLICATION (Covid arm), PYREXIA (Lowgrade fever) and CHILLS (Chills/had chills) outcome was unknown, MYALGIA (little bit of an achy arm/Aches) had not resolved and VACCINATION SITE ERYTHEMA (Arm starting to turn red but/arm got red from the shoulder to the elbow), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (it was painful) was resolving.            Patient stated that she was immunosuppressed.  Concomitant medications included several medications.  No treatment information was provided.
Pt had a diffuse pox-like rash on abdomen, arms, and legs. Pt presented to office 2 days after second vaccine, symptoms present several hours.
Fever 102 - 103. Recommended to take Tylenol 1.2mls and if not better in 24 hours to be seen.
erythema at site, nausea/ vomiting, diarrhea, general malaise, diffuse joint pain, chills, head ache
pt recv vax 22JUL96 & 2wk post vax pt exp h/a;pt recv 2nd dose of engerix-b on 22AUG96 uneventfully;
Initial report received on 10 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 13-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3842AA received on 30 June 2011, lot number C3926AC received on 26 August 2011 and lot number C3977AA received on 26 October 2011 (routes and sites of administration not reported). The subject developed a cough on 24 June 2012, approximately eight months after the last dose. The subject also developed a paroxysmal cough (date of onset unknown). Laboratory testing included negative PCR on 26 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of an unknown antibiotic starting on 24 June 2012 (duration unknown). The subject was not hospitalized. At the time of final contact on 10 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
On 1/8/02, the client reported that on 1/5/02, he noted swelling and redness under his left arm. Advised client to see doctor and he declined.
I was advised to contact you about an issue with Pneumovax 23 syringes administered in our clinic: Lot # UO18309, SN # 101528455965, exp date 1/8/2023. History: On X/XX/22, our XXXXXXXX medical assistant was administering a Pneumovax 23 to the patient. He pressed down on the plunger and the barrel flange shattered, cutting through the glove and removing a small chunk of skin form his left index finger near the cuticle. He unfortunately disposed of the syringe in the sharps container. There was no blood exposure to the patient. Injury was reported to practice manager.
Fever, Chills, Body pain/ache, Muscle weakness/pain, Nausea, Loss of appetite, Dizziness, Sweating, Joint weakness/pain, High blood pressure
Approximately 15 hours after shot chills, aching body/joints, weak legs, headache.  This lasted one day.
Was contacted by pt's mother afternoon of injection who informed office that pt had called her during her lunch hour and reported a rash on her thigh and some nausea. Pt was contacted. Denied use of new soap, detergent, fragrances, contact with chemicals, etc. On 3/26 pt was contacted again she stated rash went away on 3/25 but reappeared on 3/26/08, arms were itching but no rash presented. Pt stated she did not use the Benadryl 25 mg or 1% Hydrocortisone cream. Was told to contact office if no improvement.
3/25/21 6:00 pm  chills, shivering, muscle aches, numbness in left arm hand and left leg. 8:00 pm migraine headache, nausea &  vertigo.
5/2/21: Petechiae on arms, legs and inside mouth. Platelets at 1,000. Hospitalized through 5/27/21. 1st line of treatment was platelet infusion. 2nd line of treatment was IVIG. 3rd line of treatment was rixutan infusions weekly for 3 weeks. 4th line of treatment was Doptelet in increased doses for 10 days.  Discharged with platelets at 20,000 and return for blood work on June 1st; follow-up with surgeon in 2 weeks to check spleen.
11.17.15  1:30pm  CST  --  Hello, I am writing to report patient is experiencing reactions to the Vaccine administered yesterday, 11.16.15 at her 4yr Check-Up.  She was fine last night, playing, singing, happy, active, etc...   Before bed she began complaining of her leg being sore and hurting.  I know tenderness is a side effect of the vaccines being injected into the muscle.  Patient awoke earlier than usual this morning with a fever and the injection site redness, tenderness and a headache (she said).  She refused eating, but did take her fluids, and was uncomfortable and had a fever of 100.6 degrees.  Her entire body was very warm to the touch.  I gave her the recommended dosage of Tylenol (as discussed in her visit with you).  This did not seem to help.  When I checked her temperature again 2 hours later, she was down only to 99.8.  She's been laying covered up, on the couch all day so far - absolutely not like herself (usually she's going and going and going all day).  Finally, it seems the Tylenol is helping SOMEWHAT and I got her to eat some broth n noodles soup.  She is finally sitting up on the couch and wanting to play a little.  I will continue to monitor her as always.
Initial report received from health care professional on 24 October 2013. A 24-year-old female patient received FLUZONE ID (lot number UT4722BA and expiration date unknown) intradermal in left deltoid (dose number not reported) on 19 October 2013 and BOOSTRIX on 19 October 2013. The patient's medical history was not reported. The concomitant medication was not reported. On 19 October 2013, the patient felt week and heart racing. The patient also experienced hives and itchy at the injection site. Patient felt like the heart racing and anxiety related. Laboratory investigation includes ran tests and nothing found. Corrective treatment were not reported. As of this report, the patient had recovered from the events. Documents held by sender: none
This spontaneous report as received from a physician refers to an 18 year old adult patient (no patient information provided). The physician inadvertently administered to the patient with PNEUMOVAX 23 (lot#, dose, route, frequency and indication were unknown) instead of MENACTRA. No adverse effect was reported. Additional information is not expected.
joint pain in arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (joint pain in arm) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PROPRANOLOL, LISINOPRIL, VITAMIN D3, CALCIUM and THYROID T3 for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (joint pain in arm) and HEADACHE (headache). On 09-Apr-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN IN EXTREMITY (joint pain in arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication provided.
began having very bad diarrhea; feels pressure in her stomach; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (began having very bad diarrhea), ABDOMINAL DISCOMFORT (feels pressure in her stomach) and NAUSEA (nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included LISINOPRIL, IBUPROFEN and HYDROCHLOROTHIAZIDE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DIARRHOEA (began having very bad diarrhea), ABDOMINAL DISCOMFORT (feels pressure in her stomach) and NAUSEA (nausea). At the time of the report, DIARRHOEA (began having very bad diarrhea), ABDOMINAL DISCOMFORT (feels pressure in her stomach) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
got the first dose of the covid vaccine/tested positive with covid; tested positive with covid; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on an unknown date, at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications was not reported. She was positive with covid and is asking when she could get the second shot of the vaccine. The outcome of event was unknown.  Information about Lot/Batch has been requested.