chrisvoncsefalvay/vaers-outcomes huggingface dataset:
area of the injection site "itched and itched and itched"; extremely tired; felt just a little queezy; "was nervous"; slept like a day and a half; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS ("was nervous"), HYPERSOMNIA (slept like a day and a half), VACCINATION SITE PRURITUS (area of the injection site "itched and itched and itched"), FATIGUE (extremely tired) and NAUSEA (felt just a little queezy) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced NERVOUSNESS ("was nervous"), HYPERSOMNIA (slept like a day and a half), FATIGUE (extremely tired) and NAUSEA (felt just a little queezy). On 09-May-2021, the patient experienced VACCINATION SITE PRURITUS (area of the injection site "itched and itched and itched"). The patient was treated with HYDROCORTISONE (CORTIZONE 10) (topical) from 09-May-2021 to 11-May-2021 for Injection site itching, at a dose of UNK dosage form. On 11-May-2021, VACCINATION SITE PRURITUS (area of the injection site "itched and itched and itched") had resolved. At the time of the report, NERVOUSNESS ("was nervous"), HYPERSOMNIA (slept like a day and a half), FATIGUE (extremely tired) and NAUSEA (felt just a little queezy) had resolved.        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.   Concomitant medication included Tylenol and reported As needed for arthritis. Treatment included  Aloe. Patient reported the events lasted for 3 to 5 days then completely resolved and she did not seek medical treatment.   This case was linked to MOD-2021-118017 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-Up received on 09-JUL-2021 included events information.
Complete left biceps tendon rupture at elbow occurred while playing basketball on 3/12 (2 days after vaccine given). Ipsilateral arm to vaccine.  Symptoms were popping sensation and immediate pain.  Complete rupture confirmed on MRI. Undergoing surgical evaluation for repair.
Extreme bloating and debilitating gas pains, extra bowel movements, lasting for hours, headache, fatigue.  Gas-X used for relief and finally helped at around 2:30am. Felt better throughout 2/19, and finally almost back to 100% on 2/20.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with a dose of MMR II (HSA, lot # J005846, expiration date 13-APR-2015, dose and route not reported), which was improperly stored. No concomitant therapy was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Tachycardia; I am unable to do marathons and be active as before; Hungry all the time; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID: 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 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 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: TACHYCARDIA (non-serious), outcome "unknown"; DECREASED ACTIVITY (non-serious), outcome "unknown", described as "I am unable to do marathons and be active as before"; HUNGER (non-serious), outcome "unknown", described as "Hungry all the time". The event "tachycardia" required emergency room visit.  Additional information: The patient was nurse front of line in the pandemic. The patient took 4 doses of Pfizer, had few health problem end-up at the ER with tachycardia. The patient had a great healthy life as a Vegan, was unable to do marathons and be active as before plus was hungry all the time. The patient was not sure if will took the 5th dose. The patient should not had taken any dose at all. The patient need help now.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021800614 Same patient, product; different event;
Information has been received from a physician assistant concerning a 16 months old female patient. Information about medical history, concurrent conditions and concomitant therapies were unknown. On 06-MAR-2019, the patient was administered GARDASIL 9 (strength, dose, route, lot # and expiration date were not reported) for prophylaxis.(product administered to patient of inappropriate age) The patent also administered along with multiple unspecified vaccination at the pediatrician office. On 07-MAR-2019, the patient was brought to physician assistant's facility and had a low grade fever. No treatment was given to the patient. No lab diagnostics/studies was performed. The outcome of low grade fever was reported as not recovered. The causality between the low grade fever and GARDASIL 9 was not provided.
Information has been received from a LPN concerning a 56 year old Caucasian female with neuropathy, leukopenia, osteoporosis, urinary incontinence, atrial fibrillation and allergies to Evista, Betadine, NSAIDS, Prevacid, Paxil, Celexa, Biaxen and adhesives. On 08/25/03 at 9:45 AM the pt was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 643784/0676M) in the left deltoid. Concomitant therapy included alendronate sodium. On 08/26/03 the pt developed lymph node swelling and tenderness with a low grade fever. The pt also developed injection site warmth and erythema. Subsequently, the pt recovered on 08/28/03.  It was also reported that the pt was seen by a physician in 10/03 and no symptoms were noted. It was noted that the pt did not experience any adverse events following prior vaccinations. There was no product quality complaint involved. No further information is available.
diffused light erthema over 50% of lateral upper arm ,tender to touch ,limited ROM at shoulder.
Chills, pain at injection site, fever 4 degrees above normal, intense headache, jaw ache, muscle ache, especially in arms and legs. Only relief for arms and legs was extending, shaking and kicking - muscle phase lasted 4 hours. Couldn't sleep until next day.
storing their Moderna in the refrigerator and administering it until its expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (storing their Moderna in the refrigerator and administering it until its expiration date) 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 (storing their Moderna in the refrigerator and administering it until its expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (storing their Moderna in the refrigerator and administering it until its expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Patient developed typical zoster rash on 4/21 (4 days after receiving Zostavax). This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a consumer concerning his wife, a 66 year old female with no pertinent medical history, drug reactions or allergies who on 16-Apr-2008 was vaccinated with a "single dose" of ZOSTAVAD (Merck). Concomitant therapy included FOSAMAX and XALATAN, also reported as "not under any medicatin on a continuous basis". On 20-Apr-2008 the patient developed shingles, with progessively severe pain. The patient was prescribed anti retroviral therapy with famcicivoir to be taken over one week. There were no lab diagnostic studies performed. There was no product quality complaint. At the time of reporting the patient had not yet recovered. Follow-up information received 12-May 2009 via medical records: On 16-Apr-2008 the patient was vaccinated intramuscular with a dose of roster vaccine live (Merck). The patient's medical history consisted of oteropenia (12-Mar-2004), eczema (12-Mar-2004) internal haemorrhoids (12-Mar-2004), borderline glaucoma (12-Mar-2004), irritable colon (12-Mar-2004), flat feet (12-Mar-2004), derangement minscus NEC (12-Mar-2004), malignant neoplasm uterus NOS (12-Mar-2004), symtosatic female cilmacteric (24-Feb-2004, and a history of vaginitis atrophic (24-Feb-2004) and a hysterectomy.The patient's concomitant medications were updated to include the following: MSD, XALATAN, MSD, ANUSOL HC and CITRACAL + D. On 16-Apr-2008 the patient contacted her physician with complaints of "pain in the side" and a "rash under breast". On 21-Apr-2008 the paitent was seen by her physician and assessed for diabetes, hypertension, cadiovasular disease, unintentional weight loss/gain, difficulty chewing and/or swollowing (no findings). The patient described the rash as itching and burning on her right side (thoracic at bra line). The physical examination revealed classic lesions of vesicle in linear pattern (general impression herpes zoster post vaccination). The patient identified on increase in pain located in the nerves. On a pain scale her pain was characterized as a 4 out of 10 that occurred constantly. The patient was treated with FAMVIR 500 mg tablet three times a day for one week, DARVOCET 100/650 mg tablet one - two every 6 hours as needed for pain at night and TYLENOL during the day. On 01-May-2008 the patient was seen by her physician for follow-up medical problems related to the "dermatomal rash" she developed post vaccination. It was noted the rash has nearly healed (few erythamatous papules under left breast). The patient was discontinued from FAMVIR 500 mg tablet three times a day for one week and DARVOCET 100/650 mg tablet one - two every 6 hours as need for pain. The physician also reported it was difficult to determine if the vaccine was associated or concidental shingles. Information received on 12-May-2008 contained the following adverse experiences: trochanteric buruitis (12-May-2008), joint pain pelvis - primary encounter diagnosis (12-May-2008) and sleep apnea (12-May-2008). Additional information is expected.
The pt received 4 vaccines on 5/16/00. ON 5/17/00 at the DTaP site, erythema with indurated edema was experienced. Seen in clinic on 5/14/00, no erythema at visit but tissue around site of left leg was slightly hard. No fever or dyspnea. Child is playful.
2/11/21 - Sweats, cough, severe muscle/joint pain - unable to move back and shoulder.
Rash - Near Injection Site; Swelling - Near Injection Site; Swelling - Under Tongue; Arm Pain; A spontaneous report was received from a consumer, concerning a male patient of 82 years old age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Arm Pain, Rash - Near Injection Site,  Swelling - Near Injection Site, Itchy Sensation - Near Injection Site, Swelling - Under Tongue .  The patient medical history was not provided. concomitant product use was not provided by the reporter.  On 22Feb2021 , prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number:031M20A ) via intramuscular route for the prophylaxis of COVID-19 infection.  On 22Feb2021, the patient experienced Arm Pain.  On 25Feb2021, the patient experienced  Rash - Near Injection Site,  Swelling - Near Injection Site, Itchy Sensation - Near Injection Site, Swelling - Under Tongue .The treatment medication was not provided.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events, Arm Pain, Rash - Near Injection Site,  Swelling - Near Injection Site, Itchy Sensation - Near Injection Site, Swelling - Under Tongue . were considered to be unknown at the time of this report.
UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) 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 unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was non-serious.
Patient states she had irritation across her shoulders and had to sit with the paramedics for 30 minutes
the patient received dose of PNEUMOVAX 23 and developed temperature for 1.5 days, "teeth chattering", chills, headache, nausea and tiredness and swelling at injection site; the patient received dose of PNEUMOVAX 23 and developed temperature for 1.5 days, "teeth chattering", chills, headache, nausea and tiredness and swelling at injection site; the patient received dose of PNEUMOVAX 23 and developed temperature for 1.5 days, "teeth chattering", chills, headache, nausea and tiredness and swelling at injection site; the patient received dose of PNEUMOVAX 23 and developed temperature for 1.5 days, "teeth chattering", chills, headache, nausea and tiredness and swelling at injection site; the patient received dose of PNEUMOVAX 23 and developed temperature for 1.5 days, "teeth chattering", chills, headache, nausea and tiredness and swelling at injection site; the patient received dose of PNEUMOVAX 23 and developed temperature for 1.5 days, "teeth chattering", chills, headache, nausea and tiredness and swelling at injection site; This spontaneous report was received from a pharmacist and refers to a female patient of an unknown age. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 05-SEP-2019, the patient was vaccinated with (PNEUMOVAX23) injection, one dose, for prophylaxis, lot number: S005857, expiration date: 03-DEC-2020 (also reported as 30-DEC-2020) (exact dose and route of administration were not provided). It was reported that (PNEUMOVAX 23) was in a syringe, not in a vial.  On the same day, the patient developed temperature for 1.5 days, "teeth chattering" chills, headache, nausea, tiredness and swelling at the injection site.  The outcome of the events was unknown. The causality assessment was not provided.
Max/low temperature reached: Negative 0.2C Duration out of labelled range: 96 Hours with no adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to cases 2023SA322719(CLUSTER) and 2023SA322724(CLUSTER).  This case involves temperature excursion for Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] max/low temperature reached: negative 0.2c duration out of labelled range: 96 hours with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection via unknown route in unknown administration site for Immunization (strength, batch, and expiry date: unknown) max/low temperature reached: negative 0.2c duration out of labelled range: 96 hours  with no adverse event (poor quality product administered) (latency same day). Information on the batch number was requested.  It was reported, Nurse asks for the stability data of unopened FLUZONE QIV, FLUZONE HD QIV and ADACEL following a temperature excursion, she would also like to know the recommendations following administration of the involved vaccines to patients post excursion. Reason: Refrigerator Malfunction Max/low temperature reached: Negative 0.2C Duration out of labelled range: 96 Hours Human error: No Does extended stability data cover the excursion: No, unopened FLUZONE QIV, FLUZONE HD QIV and ADACEL are no longer covered by the extended stability data. If negative advice, was the product administered to a patient: Yes. Batch/lot number requested, not available at the time of call. Follow-up with caller possible. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data; the vaccines were also administered to patients post excursion.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event max/low temperature reached: negative 0.2c duration out of labelled range: 96 hours with no adverse event.  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 the 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.
disc herniations; back pain/ pain; This is a spontaneous report from a contactable consumer (patient's husband) via the medical information team and Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 09Apr2021 (lot number and expiration date were not reported) as single dose for COVID-19 immunization. Medical history included autoimmune diabetes: pancreas no longer produces insulin and is nothing but cysts; immunocompromised person; and precancerous. The patient uses a DEXCOM 6 to monitor her blood sugar. Concomitant medication included three unspecified insulins and the machine (DEXCOM 6) tells her how much to take. On an unspecified date, the patient had disc herniations and lots of pain. She was seen by a doctor yesterday (13Apr2021) for her back pain and was asked if she had a vaccine yet. The doctor gave her a local shot, maybe a corticosteroid injection, in her back. She was also prescribed with prednisone 20 mg, twice daily. The patient's husband was concerned that even without the prednisone she would already have a lower response to the vaccine and wanted to know if that was correct. The outcome of the events was unknown.
There was swelling the next day at the injection site. It grew to about 4 inches x 3 inches a week later (Friday, 22 Jan). It was itchy and it was warm to touch. It grew a 1/2inch larger around the swelling the next day (Saturday, 23 Jan).
Slight edema, redness left upper deltoid, also warm to touch, occurred with in 24 hours of vaccination. Tylenol/Motrin, Ice pack as needed.
Delayed Second dose by 118 Days; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-May-2021 and was forwarded to Moderna on 04-May-2021.    This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed Second dose by 118 Days) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed Second dose by 118 Days). On 04-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed Second dose by 118 Days) had resolved. 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 concomitant details were provided No treatment details were provided
62 yr old consumer received the Fluzone HD, no AE; 62 yr old consumer received the Fluzone HD, no AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 62 years old patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number not reported via unknown route in unknown administration site on 02-Oct-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to overdose and Inappropriate age at vaccine administration and overdose.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Myalgia, Arthralgia, Localized pain; chills, fatigue Narrative:
This spontaneous report was received from a healthcare professional, refers to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The healthcare professional informed that on an unknown date, the patients were vaccinated with improperly stored doses of VAQTA, # L022259, expiration date: 06-APR-2017, (dosage and route were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Right arm with 4" X 3" area of erythema, central area of duskiness and increased warmth and tenderness. Full ROM. Treated with Motrin for pain and Benadryl and warm compresses.