chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired doses given to 53 patients; 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 (Expired doses given to 53 patients) 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 EXPIRED PRODUCT ADMINISTERED (Expired doses given to 53 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses given to 53 patients) outcome was unknown.        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.   No concomitant medications were provided. Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15 JUL 2021: No new information.
SLEEP APNEA 4/11/2023 LEFT KNEE ARTHROPLASTY FAILURE, SUBSEQ
Red, swollen lesion, about 2" in diameter body aches for 2 days.
awful bitter bitterness in my mouth; It makes me nervous also; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: DYSGEUSIA (non-serious), outcome "unknown", described as "awful bitter bitterness in my mouth"; NERVOUSNESS (non-serious), outcome "unknown", described as "It makes me nervous also". Additional information: Patient wanted to know why it's bitter, leaves an awful bitter bitterness in the mouth and it's making the patient very nervous.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 07-DEC-2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles. The pt was prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
About February I noticed my heart would be racing for little or no reason.  I also would hear myself breathing like I was out of breath just climbing stairs.  I started having these symptoms more and more often.   Even waking up gasping for air at night.  My husband asked me to see a doctor.
I have COVID; I have COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Aug2022 as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have COVID". Clinical course: Patient wanted to know if she could still have another booster of covid-19. She already had 2 boosters. Caller mentioned that she started to take Pfizer vaccines because she was up in years and she was healthy. She had no lasting effects at all from Pfizer vaccines. They were wonderful and happy to take them. She also had 2 boosters in November and Aug2022. She was wondering if she needed to go for a new 4th booster. She has not had any booster since 2022. She had one in February. She mentioned that she is worried because half of 2023 was gone, and she needs to know if boosters were ready.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300124294 same patient, different vaccine dose/event;
Pt dx with (chicken pox) varicella on 7-9-13. Rash face, neck, chest, abdomen, back. Temp: 98.7 degrees.
Received flu and pneumovax vaccines 10/15/13 in PCP office. Seen in urgent care on 10/18 and 10/19/13 for R upper arm swelling, redness, warmth, and pain. RX Augmentin 875 mg/125 2x day, Benadryl 50 mg 2xday; Loratadine 10 mg daily.
Fainted; Didn't know if it was a convulsion or a seizure; Shaking; was very anxious; This is a spontaneous report from two contactable pharmacists. A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0167, expiry date: Aug2021), via an unspecified route of administration, administered in the left deltoid, on 30Apr2021 15:30, as 1st dose, single, for COVID-19 immunisation, at a pharmacy/drug store. There were no medical history and concomitant medications. On 30Apr2021 15:30, the patient received the first dose of the COVID-19 vaccine and was very anxious. She wanted her mom to be present. On the same day, 30Apr2021 15:35, five minutes later, the patient was shaking, and she fainted. The reporter did not know if she was having a convulsion or a seizure. A few minutes later, the patient was sitting and becoming more alert. The patient was given water and one dose of Benadryl. The patient's vital signs were checked (unknown result). The reporter talked to the patient's mother and contacted the patient's pediatrician. The events resulted to emergency room and physician's office visits. Later in the evening, the reporter followed up with the mother and she confirmed that the patient was doing well and better. The mother asked the reporter if the patient should get the second dose of the COVID-19 vaccine. The outcome of the events fainted, shaking,  "didn't know if it was a convulsion or a seizure" and "was very anxious" was recovering. The reporter assessed the events fainted, shaking,  "didn't know if it was a convulsion or a seizure" as serious (medically significant). The reporter considered that BNT162B2 has a causal effect to the adverse events.  Follow-up (18May2021: New information received from a contactable pharmacist includes: reporter information, lab data, suspect drug details (vaccination site and vaccination time), event details (onset time provided, outcome updated to recovering, causality and seriousness assessment provided).  Follow up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, and on a reportedly closed temporal association, the company assessed that a reasonable possibility could not be excluded that the reported events (fainted;  didn't know if it was a convulsion or a seizure) were related to the suspect product BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt received Dtap in RD and IPV in right arm SQ. Upper arm swelled up and got red, hot, and sore. Began in the afternoon of 2/24/06. As of today per mom arm not as swollen or red. Condition improving.
No additional AE information provided.; Nurse reported the patient was administered an improperly stored dose of ROTATEQ on 21-MAY-2020.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies, reactions, or concomitant medications were not provided.  On 21-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (lot number 1660704 which has been verified to be valid, expiration date reported and validated as 20-MAR-2021; route, dose and vaccination scheme frequency were not reported) (improper storage of product in use). No additional adverse event (AE) information provided.  The administered dose of the vaccine was exposed to temperature excursion of 12.1 degrees Celsius for 16 hours and 11 minutes. Data logger was involved. There was no previous temperature excursion. The outcome of the event improper storage of product in use was unknown.
The event "rectal temperature of 103 deg. F" was considered medically important. Follow-up information received from the patient's physician on 22-Sep-2003 provided a family history, vaccines given within four weeks (none), and verified that the information contained in this report is correct. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a consumer regarding a 4-month-old male patient who patient received the second dose on 19-Aug-2003 along with Tripedia, IPOL, Act-HIB, Recombivax vaccines. Medical History: The patient's concurrent illness includes "reflux." The physician indicated that tehre is a strong family history of "unusual allergic reactions" to medications and vaccines. Product Details: Indication for Prevnar was immunization. Product was administered on 19-Aug-2003. Concomitant Therapy: Concomitant therapy included Zantac (ranitidine hydrochloride and Tylenol (parecetamol). Dose regimen was one dose (intramuscular). Event Details: On the morning of 19-Aug-2003, the infant received a dropperful of Tylenol (paracetamol) prior to receiving the vaccines. This was repeated at 2:30 pm that afternoon. He then started fussing and screaming. He was taken back to the physician an hour later; his temperature at that time was 98.9 deg. F. The infant fell asleep at 4:00 pm until 8:00 pm, when he woke up sweating with a rectal temperature of 103 deg. F. He was seen in an emergency room. He "looked grey/white," and was vomiting, fussy, and crying. The reporter stated that laboratory tests revealed his "urine, blood, and liver were normal." He was treated with Feverall (paracetamol) suppositories and released at 2:00 am on 20-Aug-2003. As of 25-Aug-2003, all events have resolved except "some soreness at the thigh injection sites." Related case(s): See related case(s): HQWYE363526AUG03 (The infant didn't feel well, had a gurgling stomach, didn't sleep, eat or drink, looked grey white, was vomiting, and had abnormal urine and abnormal liver enzymes following receipt of his first dose of Prevnar, Tripedia, IPOL, ActHIB, and Recombivax HB vaccines on 16-June-2003 at 2 months of age).  Manufacturer Comment: Information regarding these events has been forwarded to the manufacturers of the concomitantly administered vaccines. (OMIC)
I saw the hives; Curvy streak beyond where the muscle ends; Very red in that area; a reaction under the site where the shot was given. Probably like 2 inches wide; rash (like hive) on the area where the vaccine was administered; It was itching; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (a reaction under the site where the shot was given. Probably like 2 inches wide), VACCINATION SITE URTICARIA (I saw the hives), VACCINATION SITE ERYTHEMA (Curvy streak beyond where the muscle ends), VACCINATION SITE PRURITUS (It was itching) and VACCINATION SITE ERYTHEMA (Very red in that area) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (It was itching) and VACCINATION SITE RASH (rash (like hive) on the area where the vaccine was administered). On 11-Jan-2021, the patient experienced VACCINATION SITE REACTION (a reaction under the site where the shot was given. Probably like 2 inches wide). On 12-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Very red in that area). On an unknown date, the patient experienced VACCINATION SITE URTICARIA (I saw the hives) and VACCINATION SITE ERYTHEMA (Curvy streak beyond where the muscle ends). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of UNK dosage form. On 12-Jan-2021, VACCINATION SITE URTICARIA (I saw the hives) had resolved. At the time of the report, VACCINATION SITE REACTION (a reaction under the site where the shot was given. Probably like 2 inches wide), VACCINATION SITE ERYTHEMA (Curvy streak beyond where the muscle ends), VACCINATION SITE PRURITUS (It was itching), VACCINATION SITE ERYTHEMA (Very red in that area) and VACCINATION SITE RASH (rash (like hive) on the area where the vaccine was administered) outcome was unknown.        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.; 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.
Very sore left arm and fever approximately 6 hours after vaccination. Treated with Naprosyn. Symptoms not present next morning.
chest tightness shortness of breath throat closing 30-45 minutes after injection. Left work, drove home and used rescue inhaler and took a prednisone. states she was fine after that.
This spontaneous report as received from a pharmacist refers to a 2 year old patient. Medical history and drug reactions or allergies were not reported. On 04-FEB-2015 the patient was vaccinated an expired dose of PNEUMOVAX 23 (lot # J013345 expiration date 11-JAN-2015). Concomitant therapy was not reported. No adverse experience reported. Additional information has been requested.
This non-serious initial spontaneous case, was received from other-health professional (nurse), concerns a 4-year-old child of unspecified gender. On 31-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 00144621A and expiry date: 31-May-2018). On 31-Oct-2017, 4-year-old child was vaccinated with AFLURIA QUADRIVALENT which was explicitly coded as inappropriate age at vaccine administration. It was reported that the patient did not experience any adverse reactions. The reporter did not provide the seriousness assessment.
Patient reports a swelling in armpit that began approximately 21 hours after injection. At this time it is about 3 inches in diameter, and is very painful. Patient will follow up with MD.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, FATIGUE, CHILLS Narrative:
No additional AE; Patient who is over 15 weeks old received the first dose of ROTATEQ; This spontaneous report was received from a physician referring to a 4-month-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 04-FEB-2022, the patient who was over 15 weeks old was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE).
Within a few hours I did not feel well. By morning I was experiencing flu like symptoms: fever of 102-103, chills, body aches, headache. This lasted for several days.
Patient's arm was red at injection site and had a fever, we applied warm compresses and gave him ibuprofen. Monday morning his arm was really swollen and red and with the school nurse looking at his arm too once he was at school and the redness was spreading and his arm really was achy we went to the pediatrician.  The pediatrician sent us to hospital for IV antibiotics.  During these three days patient's blood sugars were high and very irregular, he felt terrible.  His arm was hot and very achy.
Pt developed immediate swelling and induration after Tdap injection which lessened but was still painful and erythematous 1 week after injection. Treated Kw/clindamycin for possible cellulitis - pt reported improvement in swelling and pain 1-2 days after treatment. Clindamycin 300 mg TID, oxycodone 5 mg BID.
Symptoms in this area: red, dotted, close together, itchy rash. Across shoulders that spread down arms and trunk. Nausea and vomiting. Painful joints. Fever 101-102. Went to urgent care. Given course of prednisone. Took BENADRYL and TYLENOL.
FEVER; OFF LABEL USE; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; This spontaneous report received from a consumer via a company representative concerned a 5 year old female. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced fever, off label use, and inappropriate age at vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of off label use and inappropriate age at vaccine administration was not reported. This report was non-serious.
PATIENT DEVELOPED PAIN IN HER RIGHT CALF ON 07/22 THAT DID NOT SUBSIDE. NOTE: PATIENT HAD A PROCEDURE DONE ON HER CALF TO TREAT HER VERICOSE VEIN.
rash, little red bumps, under breast around waist to breast, neck, back, face, ears, scalp itches, went to pcp on 3/11, given prednisone. Derm appt on May 18th
Numbness; Tingling / Tingling down his legs; Painful calves; Second shot two weeks later; This case was reported by a consumer via call center representative and described the occurrence of numbness in a 27-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Previously administered products included RabAvert (For 1st dose refer case US2020AMR153824).   On an unknown date, the patient received the 2nd dose of RabAvert. On an unknown date, less than 2 weeks after receiving RabAvert, the patient experienced numbness, tingling, pain in calf and drug dose administration interval too long. On an unknown date, the outcome of the numbness, tingling, pain in calf and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the numbness, tingling and pain in calf to be related to RabAvert.  Additional details were reported as follows: The patient received Rabavert for post-exposure prophylaxis. The reporter was patient's the mother. The patient received 2nd dose two weeks later after 1st dose in left arm and he experienced tingling and numbness, tingling down his legs and painful calves. The patient received 3rd dose refer case US2020AMR153823.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR153824:same patient
Normal arm pain at injection site to begin with. Two days later, severe right shoulder pain, feet and both ankle pain. On my right hand, my first finger is swollen. The 2nd finger first knuckle has a nodule. The finger swelling and nodule have never went away - since January. I did not contribute any of this to the vaccine until later. Pain now moves and effects different joints. I have bilateral shoulder, hand, knee, ankle and feet pain. Hands and feet swell off and on. Bloodwork was done in March. I was told I "could" have RA. Pain and stiffness worsens to the point I have difficulty walking at times. Had another MD look at same bloodwork, IF I do have RA, it is seronegative RA. So I don't have the same antibodies a person with RA has. This is when I started to suspect the vaccine was the cause for all my problems. I was working out 3 times a week to the vaccine. No joint pain or swelling at all.
Was given shots at 10am, gave 0.4ml Tylenol and 4 hours later started crying for 12 hours before settled down-would not settle down to even take a bottle.
The patient received the vaccine and sat for about 5 minutes to wait for another in her party to get vaccinate. At about 5 minutes after receiving the vaccination, the patient stood up to leave the pharmacy and stated she was feeling tired and wanted to go straight home. She left the pharmacy and was looking a little pale to her mother. Her mother asked if she wanted to go back into the pharmacy and sit back down. The patient turned back to the pharmacy door and passed out hitting her head on the window as she collapsed. The shock of hitting her head revived her and the pharmacist that administered the vaccine came out to help, get Emergency Services called, and to check her vitals such as pulse, gum color, ask her name and such. The patient responded coherently and agreed to get up to sit inside the pharmacy while Emergency Services was called. She drank some water and felt tired, but otherwise alright. Emergency Services was busy, so the patient's father picked her up to take her home and she spoke to a doctor on a tele-medicine call and then the patient ate lunch.
Patient received vaccine and while waiting the recommended 15 minutes, patient's father stated patient started to experience dizziness, light headedness, and was "seeing stars". Father also noted the patient was feeling weak while having patient grip his hand. EMS was called and arrived at roughly 6:00 pm
Fever around102F for 3 hours, petered out slowly over the next 8 hours Headache Nausea/vomiting Chills Slight shortness of breath All symptoms resolved within 24 hours of onset
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 08-JUN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported) (incorrect product storage). No adverse effects were reported. No product quality complaint was involved. This is one of several reports reported by the same reporter. Additional information has been requested.
RASH RAISED ALL OVER BODY SOME WITH CENTRAL CLEARING, ERYTHEMA MULTIFORME.