chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per client, approximately forty-five minutes post first vaccine- she stated her throat felt like it was closing and she become short of breath. She stated she did not require any medical assistance. She stated it slowly resolved itself. Client presented to get her second Moderna vaccine on 3/05/2021 and informed staff at that time of reaction post first vaccine. Client stated she had informed her PCP. Who felt it was alright for her to get her second shot.  Client was informed at the time of her second shot, that she would  not be receiving it that day.  The clinic that day was as a POD site. Client was informed that the health department would get in touch with her at a later time to determine if she was eligible to get second dose.  Client verbalized understanding. It was determined that due to client having an immediate reaction after the first vaccine, that she would not be eligible to receive the second vaccine at the health department. Client was called to inform her of this the following week and the client did not answer the phone.
Small swelling under the right arm pit after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Small swelling under the right arm pit after booster shot) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 025B21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Small swelling under the right arm pit after booster shot). At the time of the report, PERIPHERAL SWELLING (Small swelling under the right arm pit after booster shot) outcome was unknown.            Patient is having an appointment to see the doctor on 07-Dec-2021.  No concomitant drugs were reported by reporter.  No treatment drugs were reported   This case was linked to MOD-2021-405715 (Patient Link).
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; 42 Dose administered after 30-day use by date; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (42 Dose administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (42 Dose administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (42 Dose administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (42 Dose administered after 30-day use by date).    Concomitant medication details not reported by the reporter. Vial size was reported as 0.4 ml per vial. Vial was initially stored in refrigerator on 23-DEC-2022. Vial did not undergo any temperature excursion. Treatment details was not reported by the reporter. This case contains information about patient 38th out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:(Patient 1)
haven't gotten the second dose; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (got the first dose before Covid).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: haven't gotten the second dose).The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-SEP-2023 The reporter wanted to know if she could complete the Shingrix series 3 years apart.  She was seeing patients who got the first dose before Covid and are now coming back in to see her and still have not gotten the second dose.  She wanted to know if she should restart the series or if she could give them the second dose.  She referred out to the pharmacy only, she did not vaccinate in office. No additional information was available. Till the time of reporting, the patients did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Pt received 1st dose of Havrix on 1/14/22 Lot 2JD3Y
This spontaneous report was received from a pharmacist referring to a 2 unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX 19400PFU (dose, route of administration, lot # and expiration date were not provided). There were no concomitant medications reported. On an unknown date (reported as "6 months post vaccination"), the patients were diagnosed with shingles. At the reporting time, the outcome of shingles was unknown. There was no product quality complaint (PQC) involved. Additional information has been requested.
Headaches; terrible pain in his stomach; he has been up all night with the stomach/stomach ache; Nausea; wants to throw up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78-year-old male patient received BNT162b2 (BNT162B2 NOS), on 13Jan2023 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: HEADACHE (non-serious) with onset Jan2023, outcome "not recovered", described as "Headaches"; NAUSEA (non-serious) with onset Jan2023, outcome "not recovered"; ABDOMINAL PAIN UPPER (non-serious) with onset Jan2023, outcome "not recovered", described as "terrible pain in his stomach; he has been up all night with the stomach/stomach ache"; VOMITING (non-serious) with onset Jan2023, outcome "not recovered", described as "wants to throw up".  Additional information: It was reported that, reporter stated, "they got Pfizer shot yesterday and her husband and she have headaches which was ok, but her husband was 78 and he had a terrible, terrible pain in his stomach and nausea. She wanted to ask if it is accepted for one of the side effects, she have been reading, but she could not find the stomachache. When paraphrased the concern: Reporter stated, that the patient still had headaches and he has been up all night with the stomach and wants to throw up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. received vaccine on Fri. at 2:45 PM by Sat. pt. came back to pharmacy complaining of pain and soreness. RPh advised pt. to take some TYLENOL and place ice on it. Pt. came back on Mon. with a bruise the size of a golf ball with a bump (knot) under the skin and still complaining of soreness. RPh took a look and advised the pt. that it looked like an adverse reaction to the shot. While not uncommon, it was still possible it could happen. The pt. was upset about the pain and swelling. RPh called her primary doctor and they agreed with the RPh that it sounds like a localized ADR and also advise pt. to use some ice and TYLENOL. RPh relayed the info to the patient. Chief complaints: swelling, bruise, knot under skin, soreness.
Patient was anxious before coming in for vaccine. After vaccine, patient started to feel a tight chest and her lip started to become inflamed. After this was noticed, I gave the patient Benadryl 25mg to take and then had the EpiPen on hand just in case. After a few minutes, she said that she was starting to feel better. After 30 the patient felt more comfortable and her lip swelling had gone down. I informed the patient that she needed to go to urgent care or the ER if she was having any trouble breathing and that her next vaccination of the series (if she chose to get it) would need to be at a clinic.
LYMES-LIKE SYMPTOMS, INCLUDING JOINT PAIN IN R-SHOULDER-FINGERS-NECK-LUMBAR;NUMBNESS IN BOTH HANDS-FEET-TONGUE;EXTREME MUSCLE FATIGUE; SWOLLEN LYMPH GLANDS; BONE SPUR GROWTH IN CERVICAL VERTIBRE; DEGENERATIVE CHANGES IN CERVICAL-LUMBAR VERTIBRE.  ALL THE ABOVE ARE OCCURING AT PRESENT TIME.  TREATMENT HAS BEEN NERVE-BLOCKING INJECTIONS AND MEDICATIONS.
Information has been received from a healthcare worker referring to an unspecified number of unspecified patients of unknown age and gender. The unspecified patients received improperly stored VARIVAX (Merck), (lot# K009757, expiration date 09-JUL-2016; lot# report as K026387, expiration date 15-DEC-2016 and lot# L007226, expiration date 03-MAR-2017), (dose, frequency and route not reported) on unspecified dates. No adverse effects were reported. Additional information has been requested.
achy; fever of 99.9 degrees; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st December 2020, less than a day after receiving Shingrix, the patient experienced pain and fever. On an unknown date, the outcome of the pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the pain and fever to be related to Shingrix.  Additional details were reported as follows: The patient had a fever of 99.9 degree F and was achy and these events began after receiving the vaccine. Consented to follow up.
Dizziness,  fatigue that lasted  12/18-12/22 - Pt sought medical attention and started to take  meclizine for the prolonged dizziness Pt says  dizziness continues
Information has been received from a physician concerning a 15 month old female pt with no past medical history who on 10/16/02 was vaccinated with a first dose of MMR II (641882/0531M), in the right leg. There was no illness at the time of vaccination. On 11/5/02 the pt developed unilateral mumps and swollen right and left face. Unspecified medical attention was sought. Follow-up noted that there was no redness or tenderness. It was also reported that the pt recovered. No further info is expected.
Body ache, body chills, fatigue, headache, injection site pain - all symptoms lasted 24 hours.   Took acetaminophen every 6 hours till symptoms subsided.
Received Moderna  Booster for Covid November 30. 2021  December1, 2021:  I awoke at 7 AM with significant aching and soreness throughout my body. In addition,  there was headache concentrated at temples and behind eye orbits. By afternoon of this day, developed a fever of 99.6 degrees. December 2, 2021:  All aforementioned symptoms of discomfort were resolved.  Fever resolved.  Later on this day, reddened skin around injection site and another reddened area below injection site appeared on the injected arm.  These discolorations were slightly swollen and indurated. December 3-5, 2021:  Reddened areas on injected arm persisted and expanded. December 6-10, 2021  Reddened areas  faded day by day, until presently almost invisible.
Edema, erythema & cellulitis of arm. Treated with BACTRIM DS 1 tab po BID x7 days. Patient went to ER for further treatment.
Metallic taste in her mouth. No treatment given except to continue to monitor. No SOB or difficulty breathing at present.
Patient gave us a date that did not match the information in the database and MD's office. He gave a date of 11/15/2016. We called him to confirm. He stated the date he gave us was correct. But when we called MD's office to compare, they had 12/15/2016, similar what is reported to the immunization database.
CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 37 year old male. 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 06:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 38. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, and fever. This report was non-serious.
This spontaneous report has been  eceived from a physician assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 08-MAY-2018, the patient was vaccinated with an expired dose of VAQTA (dose and route unknown, lot # N002921 with expiration date 08-APR-2018) for prophylaxis. No adverse effects reported. No product quality complaint (PQC) was involved. Therapy was also reported as not discontinued.
DOSE ONE OF THE COVID 19 PFIZER VACCINE ADMINISTERED WAS 6 DAYS EXPIRED
No adverse effects were reported.; Patient was administered improperly stored VARIVAX; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 14-JUN-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number R035222 with expiration date in 04-DEC-2020 (strength, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot number, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008695: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662: US-009507513-1906USA008722: US-009507513-1906USA008723: US-009507513-1906USA008724: US-009507513-1906USA008725:
No adverse event; Patient received 1st dose of Moderna vaccine on 3-Feb-2021 and second dose of Moderna on 7-Nov-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose of Moderna vaccine on 3-Feb-2021 and second dose of Moderna on 7-Nov-2021) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose of Moderna vaccine on 3-Feb-2021 and second dose of Moderna on 7-Nov-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose of Moderna vaccine on 3-Feb-2021 and second dose of Moderna on 7-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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose of Moderna vaccine on 3-Feb-2021 and second dose of Moderna on 7-Nov-2021).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728660 (E2B Linked Report). This case was linked to MOD-2023-728660 (Patient Link).
4:10 pm local reaction after vaccine: swelling - redness. Ice applied right away and supervisor notified. Vital signs checked - monitored -BENADRYL given st flared in @ arm area. Swelling disappeared after 1 hr.
Felt ill the day after the injection. On the 3rd day I woke up with chest pain and heart palpitations. I went to the emergency room. Once there I worsened with severe pain, nausea, vomiting, and more heart palpitations, elevated blood Troponin. I was admitted, treated with IVs and medicine, rest and discharged with instructions to continue medication, follow-up in 2-3 weeks with the cardiologist, avoid exertion and take it easy.
Pt recv vax on 11/23/98; on 11/25/98 pt exp varicella-like rash on arms & trunk
skin cellulitis; feeing warm; hard; a big red blotch on arm; arm got really itchy; This spontaneous case was reported by a non-health professional and describes the occurrence of CELLULITIS (skin cellulitis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PRURITUS (arm got really itchy). On 09-Apr-2021, the patient experienced CELLULITIS (skin cellulitis) (seriousness criterion medically significant), FEELING HOT (feeing warm), INDURATION (hard) and RASH (a big red blotch on arm). At the time of the report, CELLULITIS (skin cellulitis), FEELING HOT (feeing warm), INDURATION (hard), RASH (a big red blotch on arm) and PRURITUS (arm got really itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. 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.; 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.
pruritus, erythema multiforme, w/in 5-10 minutes of administration
10-20-10 received PNEUMOVAX and flu vaccine. Called office 10-21-10 to report fever, swelling in arm, redness in arm and nodule. Sore to touch. Coming to office 10-22-10 for visit.
Symptoms of pityriasis started showing 7 days after the administation on the left upper torso and hip along with mild flu symptoms.
Information has been received from a Doctor of Pharmacy concerning a 70 year old female patient with egg allergy who on 16-MAY-2011, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot #670384/0253AA; expiration date 18-MAY-2012). The pharmacist reported that the patient developed a hard, red, warm lump at the injection site at some unspecified time. The pharmacist reported that the patient returned to the pharmacy on 18-MAY-2011, to show the lump to a different pharmacist. It was reported there was no rash, urticaria or other symptoms noted by the pharmacist. At the time of the report the patient's outcome was not reported. Additional information has been requested.
Next day I woke up with Oral shingles; headache; aches along jawbone to lower ear, gums and teeth hurt.  Shingles eventually erupted on face, nose lips, heading toward eye. All on the right side of body/mouth
Little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Swallowing difficult, Breathing difficult, Heart rate increased, Hives, Itching, Tightness in chest (Couldn't sleep or breathe due to tightness in chest), Weakness and Walking difficulty. Concomitant products included TAFAMIDIS MEGLUMINE (VYNDAQEL) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Little tired). At the time of the report, FATIGUE (Little tired) outcome was unknown.            The patient had been pre-approved for Vyndamax and had been using Vyndaqel for the past month and a half and the side effects were deadly. The patient was told there were no side effects with Vyndaqel. The patient experienced difficulty in swallowing and those 4 pills of Vyndaqel were very large and hard to swallow. The patient doesn't have any difficulty in swallowing, but those pills got stuck.  The patient also reported that they tried using applesauce and banana to help get them down, but this might have been part of why the patient felt hard to breathe. The patient also had a fast heart rate and experienced hives, and itching.  The patient stated that they had tightness in their chest, had weakness and could not work. The patient was not able to sleep or breathe due to the tightness in their chest and was so wiped out that they couldn't even walk.   Reportedly, the patient took both the doses of the Moderna COVID vaccine and felt a little tired afterward and was still a little tired. The patient also reported that they had stopped taking Vyndaqel and have been able to sleep and breathe for the past 2 nights.  The patient has scheduled an appointment with their doctor to discuss about this.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.