chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female patient who was vaccinated IM with her first dose of GARDASIL. The patient experienced lower back pain after receiving the vaccination of GARDASIL. The physician did report that the patient was a gymnast. The physician recommended that the patient see a specialist regarding the lower back pain. The outcome of the patient's lower back pain was not reported. Additional information has been requested.
This spontaneous report was received from a 60 year old female patient (reported as currently 70 year old). No medical history and concurrent conditions were reported. The patient's drug reactions/allergy included topical dermatitis to few unspecified cosmetics and epinephrine. Approximately in August 2006 (reported as fall 2006), the patient was vaccinated with PNEUMOVAX 23, 1 normal shot, in the left arm as it was precautionary at 60 years age and an unspecified flu shot in her right arm. The patient did not experience injection site reaction in the right arm but a half hour after receiving PNEUMOVAX 23, the patient developed injection site pain and flu like symptoms, approximately in August 2006 (reported as fall 2006). The next morning the patient went to see her physician and received treatment with three rounds of prednisone (unspecified dose) orally to make her feel better. The patient was also instructed to start physical therapy to help with her frozen shoulder. No lab diagnostic tests were performed. The outcome of the events was reported as recovered/resolved. Causality assessment was not provided. No product quality issue was involved. Additional information has been requested.
This spontaneous report was received from a Registered Nurse (R.N.) referring to an identified patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unspecified date, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # N035173 expiring on 09-JUN-2019, for prophylaxis) (dosage schedule and route of administration were not reported). Concomitant therapies included Merck sterile diluent properly stored. The administered dose of the vaccine experienced a temperature excursion of 6 degrees to 14 degrees F for 3 hours and of 15 degrees F to 46 degrees F (21 degrees F) for another 2 hours, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports from the same source. Sender's Comments: US-009507513-1806USA004922; US-009507513-1806USA004923.
Soreness, fever, pain in right arm started about three days after vaccination. Applied cold compress and took Ibuprofen  or Aleve  as recommended . Nagging pain still persists with great intensity at times,  especially when I try to lift my arm. Disrupts my sleep at night. The  arm muscle where injection was made is still sore two weeks after the second injection.
Started running a fever (99-102, varying) 5 days after vaccine.  The fever left and then came back daily for 3 days intermittently.  She was lethargic but still eating and drinking fine. No rash is present. Vomiting on morning of day 3, nearly back to normal on day 4 with a slight fever and will continue to monitor.
Sick from the side effects; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick from the side effects".  Additional information: This report is not related to a study or programme. Patient mentioned he took the vaccine for Covid, the Pfizer COVID vaccine and initially stated he wanted to report an event. He then went on to state he is sick from the side effects and wanted to speak to someone on about it. He confirmed he has not reported these events to our safety department previously.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm where injection was administered was very painful for about a full week from the time of the injection, but excruciating shoulder pain followed at that same time. Doctor that I saw for the pain in early January says it is probably bursitis.  I have used ice as well as heat. Doctor recommended 600 to 800 mg of Ibuprofen three times daily, but these don't seem to help. I still have agonizing pain daily.
Patient was given Menactra instead of Prevnar by Medical Assistant. Patient's mother was contacted and asked to observe child closely particularly for fever.  Patient was taken to the ER.
I had a running nose, fatigue, and cough. I tested positive for COVID-19. I talked to my doctor, and she prescribed me Paxlovid.
Patient called the pharmacy to complain of a black and blue arm and sore muscle that had been happening since the shot was given. Patient had not been to see the doctor and the swelling and pain was going down in the left arm that the vaccine was given in
This spontaneous report as received from a licensed nurse practitioner and a healthcare worker and a nurse practitioner refers to an unspecified amount of patients. Concomitant medication and pertinent medical history were not provided.The healthcare worker reported that on unknown dates, unspecified amount of patients were vaccinated with PEDVAXHIB (lot number, dose, route and frequency were not provided) which were improperly stored. The PEDVAXHIB was exposed to a lowest temperature of 32F for a total of 136 hours over 17 days occurring since 01-JAN-2014. The nurse practitioner reported that she was unsure if the PEDVAXHIB had undergone excursions since 01-JAN-2014. She reported that "some" might have undergone multiple excursions and "others" might have undergone no excursions but she was not exactly sure of which ones. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
had a reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (had a reaction) 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. On an unknown date, the patient experienced ADVERSE EVENT (had a reaction) (seriousness criterion hospitalization). At the time of the report, ADVERSE EVENT (had a reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided. Treatment medication was not reported.; Sender's Comments: Very limited information regarding the events has been provided at this time.
4-17-21: Starting by 10:00am I felt mild aches and a sore arm (at injection site).  I took two Tylenol and was able to complete household chores.  By 6:00 pm, I was very tired and had developed Covid arm (red, swollen, mild pain with touch).  I took two Tylenol and rested on the couch for the evening.  I woke up on 4-18-21 with a mildly painful right armpit lymph node.  Body aches, injection site pain and fatigue were gone.  By 5:00pm I had developed a rash on the right side of my neck and across my chest (at my bra line).  (The rash on my chest is how my body normally reacts after I've had a virus.). The rash and Covid arm started to diminish by 4-19-21 and was completely gone by 4-20-21.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Concomitant medications, past drug and medical history information were unknown. Approximately on an unspecified date in 2013 (reported as "a year or two ago") the patient was vaccinated with a dose of ZOSTAVAX (lot #, strength, dosage, frequency and route unspecified). On an unknown date after receiving ZOSTAVAX, the patient experienced a big rash and was treated with an unknown anti-viral. It was unknown if there was any relevant lab work. As of 30-AUG-2015, it was unknown if the patient continued on ZOSTAVAX and the outcome of the big rash was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Tired after vaccine; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient that:  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: unknown), via an unspecified route of administration on an un-specified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient experienced tired after vaccine on an unspecified date. The outcome of event was unknown.  Information about lot/batch number has been requested.
NUMBNESS IN RIGHT HAND; CHILLS; NAUSEA; LOW-GRADE FEVER (100.2); SORE INJECTION SITE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included disabled. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021, and dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced nausea. On 15-MAR-2021, the subject experienced low-grade fever (100.2). On 15-MAR-2021, the subject experienced sore injection site. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 16-MAR-2021, the subject experienced numbness in right hand. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, nausea, and low-grade fever (100.2) on 16-MAR-2021, was recovering from sore injection site, and had not recovered from numbness in right hand. This report was non-serious.
Severe headache medicine couldn?t get rid of Pain in the same arm shot was given Fever Chills Aches and pains Could barely lift my arm cause it was so sore
Patient received shot in left arm. Patient waited to see if adverse event would occur. First patient had dizziness and weakness, followed by impaired vision and hearing, then followed by numbness in both arms. Episode lasted about 15 minutes.
1ST dose - armpits got swollen; 2nd dose - the next day, I couldn't get out of the couch. Slept longer. Extreme fatigue till Sunday. Don't know when my GI problems happened. Like making noise in the tummy and not sure if its after certain foods. I get gassy. I mentioned to my doctor but he didn't say anything about this and I view this as an inconvenience and not life altering.
Janssen 4/1/21 and 12/3/21. Positive on 12/30/21
Left lateral upper arm - 2 well circumscribed circular areas of erythema -2 cm x 2.5 cm, slightly warm, no induration, non tender, no swelling.
I have it now and yes I've been vaccinated / suspected vaccination failure; I have it now; the pain is horrible,; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with calamine and antivirals nos. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient was vaccinated and had shingles now. The pain was horrible. The patient was on an antiviral medication for pain and calamine. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Information has been received from a doctor of pharmacy concerning a white male pt with no known allergies and no known medical history who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647654/0865N). There was no illness at the time of vaccination. Subsequently, in November 2003, the pt developed local reactions including arm swelling and soreness, heat and redness.  The pt also developed an erythematous rash. Unspecified medical attention was sought. Subsequently, the pt recovered from the local reactions. A product quality complaint was not involved. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned three other pt's who each had an experience post vaccination with pneumococcal 23v polysaccharide vaccine (Lot #647654/0865N)(WAES #0310USA03184).  Additional information is not expected.
She had a brain aneurysm. We question if this was related to the covid 19  vaccine
swollen palm; Red palm; rash around neck, behind ears and in the chest; tiredness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen palm), PALMAR ERYTHEMA (Red palm), RASH (rash around neck, behind ears and in the chest), FATIGUE (tiredness) and CHILLS (Chills) in a 62-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced FATIGUE (tiredness) and CHILLS (Chills). On 01-Feb-2021, the patient experienced RASH (rash around neck, behind ears and in the chest). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen palm) and PALMAR ERYTHEMA (Red palm). On 03-Feb-2021, RASH (rash around neck, behind ears and in the chest), FATIGUE (tiredness) and CHILLS (Chills) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen palm) and PALMAR ERYTHEMA (Red palm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Live follow up received on 10-May-2021: No new information was received.
On 3/24/17 at approximately 7-8 p.m. client reported onset of generalized pruritus which was continuous until 3/29/17 and intensified each evening. 9/25/17 a.m. onset of severe lower leg pain which persisted until 3/29/17 with tolerable generalized body pain. Pressure in mid chest on inspirations only. No shortness of breath, cough, or rash with above complaints. Return to normal 3/30/17. Client reported that her paternal grandmother was severely allergic to Td. Client had Td - 12 yrs ago and did okay. Dr. advised against future Td.
pt recv vax on 28FEB97, ran low grade temp (99) soon p/vax & cont x 1wk, had sz on 7MAR97;sent to ER via amb hosp x 2.5d;
Patient received two doses in one syringe.  Should have received 0.5cc, 1.0cc was administered.
The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022; The patient received vaccine past its 30 days of an expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2022 at 12:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Mar-2022 at 12:07 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had received the vaccine dose number as booster.  No Concomitant medication reported.  The patient had any race.  It was reported that a series of approximately 540 patients had received lot 066H21A past its 30 days of an expiry date. The vaccine was administered up until its manufactured expiry date of 04-Apr-2022 and this lot number was no longer possessed.  No Treatment medication was reported.
At 2:17 pm on 4-12-16, the above named child received PREVNAR 2. At 1:38 AM on 4-13-16, patient presented to ER due to vomiting, seizing with apneic episode. Fever as high at 104 axillary, at home. Was cyanotic and lethargic for 5 minutes.
HEART RACING; FELT LIKE ADRENALINE RUSH; SKIN TINGLING; GOOSEBUMPS; TROUBLE SLEEPING; LOW ENERGY; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021, vaccinated to left arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021 (Saturday), the patient experienced low energy. On 28-MAR-2021, the subject experienced heart racing and adrenaline was rush. On 28-MAR-2021, the patient also experienced tingling in her skin, goosebumps, trouble sleeping and heart racing. The patient still having these symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low energy on MAR-2021, and had not recovered from felt like adrenaline rush, skin tingling, goosebumps, trouble sleeping, and heart racing. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Initial misuse report received from a healthcare profsesional on 09 September 2013. An expired dose of MENACTRA was given to a patient. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Patient with redness, golf ball size swelling, warm to touch at injection site.  Temperature to 101, 24 hours.  Cool compresses, Benadryl every 6 hours. Call if temperature over 48 hours and no decrease in swelling or high in symptoms.
Fever that night. Persisting congestion, coughing, sore throat and mild headache.
Flu shot admin. Pt denied any allergies. 1hr 45 mins pt came back to health dept. arm swollen, warm to touch and painful. Inst. to use ice compresses x 24hr then heat. Call MD or call 911 if resp. symptoms. 10/23 pt states has rash. 10/23 MD notified. Pt inst. to call MD and make an appt.
This spontaneous report as received from a pharmacist refers to a 83 year old male patient. The patient had no medical history or concurrent conditions. On 05-MAY-2015, the patient was vaccinated with the dose of ZOSTAVAX injection (doses not reported), subcutaneous, lot # K008883, expiration date 20-SEP-2015. The patient had no concomitant medication. On 05-MAY-2015, 5-10 minutes after administration of ZOSTAVAX the patient experienced varicella-like rash, which manifested as blisters, appeared at the injection site while the patient was still at the pharmacy. No lab diagnostics studies were performed and no treatment was given for the event. The outcome of varicella-like rash, which manifested as blisters, appeared at the injection site, and the causality between adverse event and ZOSTAVAX were not reported. The patient sought medical attention as the reaction occurred at the pharmacy. Additional information has been requested.
Had a fever of 102, a rash on his face, and vomiting. Tylenol was given, fever went away and vomiting stopped. Rash started to disappear on Monday.
3/4/11 fell in B/R PPV given (L) deltoid 3/7/11 at 1930 - no ASE doc until 1400 on 3/9/11 when hes spiked temp 102 - SOB - O2 sats 88% R/A - course crackles (R) upper lobes - sent to ER for eval of S/S and arm swelling - to hosp at 1600 = admitted - returnes 3/12/11 with diagnosis (L) upper arm cellulitis "(R) rotator cuff improvement - provider documents suspected local reaction to PNEUMOVAX injection".
MASSIVELY HUNG OVER; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced massively hung over, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and massively hung over was not reported. This report was non-serious.
Approximately 24 hrs after vaccination. Noted left arm swelling and c/o numbness from shoulder to wrist. After 48 hrs remains swollen but no erythema numbness improving from elbow to wrist. Normal ROM,no weakness. Will try ibuprofen for inflammation.
Fever 100.5F, orally on 8/7/06. Rash, flat, blanching, well circumscribed lesions, on trunk and arms developed 8/28/06.
Pt states she developed hives and "a rash with pimples," about 3 1/2 hrs after flu shot. Went ot PMD 10/22 and received "steroid shot" without effect. Saw dermatologist 10/23 and given Clarinex and Medrol (unable to td. po. steroid). Saw allergist 10/24, given Allegra, Zantac, and steroid injection with relief.
body aches, headaches and nausea started around midnight with fever and chills starting the next morning     took Tylenol every 4 hours for symptoms       symptoms continued through to around 1pm on 02/04/2021
Information has been received from a health department nurse concerning a 39 year old female who in 1973 and in 1978 was vaccinated with the first and second dose of MMR II (LOT# not reported), respectively. In July 2010, the patient was vaccinated with the third dose of MMR II (albumin status unknown) (LOT# not reported). Titer was drawn on unspecified date, and the patient failed to seroconvert. Unspecified medical attention was sought. The patient's outcome was unknown at the time of this report. No further information is available.