chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 01-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 with expiry date: unspecified for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012631 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
JJ was administered 05/18/21 and 1 dose of Moderna was administered on 07/05/21.
Possibly a demyelinating neuropathy; I still have intermittent lumbar discomfort; started experiencing tingling sensation (paresthesia) in both legs without loss of sensitivity or strength/mild tingling sensation in my feet and sometimes legs depending on posture; I started having lumbar pain similar to a mild muscle cramp.; back and joint pain/I started having lumbar pain similar to a mild muscle cramp.; back and joint pain; shivers; headaches; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received second dose of bnt162b2 (lot number: el1283), via an unspecified route of administration, administered in Arm Left, on 09Jan2021 11:30 as single dose for COVID-19 immunisation. Medical history included mild asthma, allergies to fur, mites and olive tree pollen from an unknown date and unknown if ongoing. Concomitant medication(s) in two weeks included finasteride taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of bnt162b2 (Lot number: ek5730) at 30-year-old on 19Dec2020 08:00 PM at left arm for COVID-19 immunisation. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. A few hours after the second dose, the patient experienced back and joint pain, shivers and headaches for two days. On 19Jan2021 (reported as 10 days after the second dose), the patient started experiencing tingling sensation (paresthesia) in both legs without loss of sensitivity or strength. Also, the patient started having lumbar pain similar to a mild muscle cramp. The paresthesia was somewhat strong for a week and started to very slowly fade away, but the patient still has intermittent lumbar discomfort and mild tingling sensation in his feet and sometimes legs depending on posture. Possibly a demyelinating neuropathy. No treatment AE. The outcome of the events was recovering.
OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: Graves disease (under control). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse event following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. which was off label use (off label dosing frequency, dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. Reporter stated that, "I have Graves under control had 2 j j vac and 1 booster now blood clots on thinners but hurt all over mostly my lower back". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20221242050 (dose number in series 3).
Patient stated that 3 days after second dose of Moderna, she developed a rash on her thigh and went to the hospital. Patient did not mention this prior to the 3rd dose (first booster) after the fact. Informed the patient to watch out for signs and symptoms of anaphylactic reactions such shortness of breath, and/or difficulty breathing to seek immediate help. Also told patient to keep me informed if there is an allergic reaction.
Pediarix & IPV immunizations given at same time, resulting in 2 doses of IPV being administered.
patient fainted about 1-2 minutes after receiving immunization. He got up out of the chair and said he was okay and stood with his mother in the same room while his father received the shot. After his father got up, they all moved to the door to exit and while pharmacists back was turned, the child fainted and fell to the ground. 911 was called and arrived, and the child and parents refused medical attention and signed off to refuse medical attention with the paramedics.
Within 7 minutes of vaccination, patient became dizzy, flushed, put head between legs. Layed him down on cool floor. Felt faint - cool floor felt good. Admin. 50 mg BENADRYL (PO w/food). W/in 15 minutes, feeling better. Called family to p/u and take home.
Pt came to office with complaints of lightheadness and different feeling.  No rash, no shortness of breath.  BP 110/70, R 20, HR 80.
Trouble swollowing, itching and weeping eyes, vomiting, aching body, fever, difficult breathing. I considered going to Emergency, if breathing worsened I would have.
Lingering pain at site of injection in left arm.  Following initial pain lasting 3-4 days the pain  returned on 23rd day following shot.  Continuous pain ranging from dull to sharp, treated at home with ibuprofen/acetaminophen, and heat wraps.  Today is day 32 since the shot and the pain is still present
Pt received Shingrix 4/22/20, the next day she called and said she was having a reaction. Injection site was swelling w/ pain, headache, body aches, reduced movement of arm with heat radating. She came in 4/23/20 4/23/20, she came in and we gave her a methylprednisolone sodium succinate 125mg intramuscular, which seemed to help with the reaction, she reaction with Both Shingrix, she got flu with first Shingrix and only reaction with the Shingrix on 1/7/20
patient experienced rapid drop in BP resulting in loss of consciousness at 10min post injection.    recovered quickly, bp was monitored and after consultation with EMS patient was allowed to leave imz siteunder her own power
Information has been received from a pharmacist referring to 2 newborns (numbered 146 and 147). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours)) that temperature was 32F, the lowest being 29/7F. On 04-JUL-2015, there was a low temperature of 30/2F. On 29-AUG-2015 the patient were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
HCP advised that her office administered a vaccine to a patient that is being identified as a pediatric dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP advised that her office administered a vaccine to a patient that is being identified as a pediatric dose) and NO ADVERSE EVENT (No adverse event) in an elderly 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. 053D22A) 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 WRONG PRODUCT ADMINISTERED (HCP advised that her office administered a vaccine to a patient that is being identified as a pediatric dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP advised that her office administered a vaccine to a patient that is being identified as a pediatric dose) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (HCP advised that her office administered a vaccine to a patient that is being identified as a pediatric dose).    No concomitant medications were provided. No treatment medication was provided.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On unspecified dates on or after 05-AUG-2015, the patients was vaccinated with improperly stored doses of ROTATEQ (dose and route of administration not provided). No concomitant therapy was reported. No adverse effect was reported for any patient. The outcome of the event was unknown. No product quality issue was reported. This is one of the several reports from the same reporter link. Additional information has been requested.
Ear pain (Acute Recurrent otitis media); Facial Trauma; Head trauma; Numbness; Segmental and somatic dysfunction of cervical region; Segmental and somatic dysfunction of cervical region; Bell's Palsy; This case was reported by a lawyer and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  The initial information received on 08 July 2020 via medical records (The case is medically confirmed). As per the records he had underwent Throat surgery. As per the pharmacy records the male patient was receiving Shingrix during 27 September 2019 and on 10 January 2020. As per the records, he had ear pain Onset: 2 week(s) Acute recurrent otitis media; duration: 2 Week(s). On 17 February 2020, his discharge Instructions included Bell's Palsy and he had left side drooping, he also had Facial ,Head Trauma and Numbness. As per the assessment dated 26 May 2020, he was present with bells palsy since February 2020. He had segmental and somatic dysfunction of cervical region and segmental and somatic dysfunction of upper extremity.
mouth and crotch blisters; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of blister in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (the patient stated chicken pox nearly killed him/her).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced blister (Verbatim: mouth and crotch blisters). The outcome of the blister was not reported.   It was not reported if the reporter considered the blister to be related to Shingles vaccine.     It was not reported if the company considered the blister to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAR-2023 This case was reported by the patient via interactive digital media. The patient got one Shingles shot and had mouth and crotch blisters. Follow-up would not possible as no contact details were available.
Right arm sharp pains began within 1 week of receipt of the vaccine. Pain present with laying on the arm. Right arm pain persisted with swelling presenting on 4-26-21.
Itching and it increased from the site of the injection to just below the elbow. The site was red and swollen. Dr. informed patient that she is allergic to thimerosal. Dr. perscribed smoothing cream to help with the itching.
Moderate pain in arm interfering with activity day 2 to 5. Pain radiated up neck and ear/jaw area. I have old left shoulder rotater cuff injury, long healed. Had surgical manipulation and long term PT.  Reminded me of that experience. Vertigo and nausea intermittent incidents during days 2 to 5 severe enough, for example, I had to abort a grocery shopping trip in the middle and was unable to drive another time. Nearly continous headache, earache and jaw/teeth pain on left side (trigemic nerve irritation). Day 2 to 7. Severity fluxuated but at times made it impossivle to eat (jaw pain) or sleep. Frequency of severe pain level episodes tapered after day 5.
Severe abdominal pain, acid reflux, vomiting stomach acids, fever, chills, whole body muscle and joint pain, pain and swelling at injection site.
Information has been received from a female consumer reporting n herself, who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported) (dose and route not reported). The patient stated that subsequently from the time she received the ZOSTAVAX (Merck), she had several outbreak of shingles (18 times). It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. No further information is available.
Fatigue, headache, and fever at 3:30 pm; rapid heart rate at 8:30 pm;  Received IV fluids and MOTRIN at emergency room.
Almost immediate mild swelling an pain in area of injection. This got somewhat worse by 2 - 3 hours after the vaccination and continued for over 6 days.
exposed to few degree cooler; This case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's Comment: The case was reported by the patient. The patient who received her first Shingrix dose back in August 2022.  The patient stated that, pharmacy called her to let her know that the vaccine dose she received was exposed for half an hour to temperatures few degree cooler than the recommended storage temperatures and advised her to contact her Healthcare provider for further guidance on whether she needs to repeat the first dose in the Shingrix series given the circumstances.  The patient received her Shingrix dose at pharmacy. The patient did not know the specifics of the temperature excursions (exact temperature at which the vaccine was stored) and whether the temperature excursions happened before or after vaccine reconstitution.  The patient stated that, she contacted her healthcare professional and they referred her to the Shingrix manufacturer for further guidance.  Advised for healthcare professional and pharmacy to call and obtain thermostability data. The patient could not provide Shingrix vaccine information including Shingrix dose, volume injected, lot or expiration date when asked and suggested we contact pharmacy for this information.  The reporter was the patient, she consented for safety follow-up with both her healthcare professional and the administering pharmacy.  Additional Supportive Information: The patient received Shingrix which was exposed for half an hour to temperatures few degree cooler than the recommended storage temperatures, which led to incorrect storage of drug.
Fatigue; Flat welt size of quarter, became raised size of a baseball; Fever/low grade temperature; Body aches; chills; During the 1st week of 1st vaccine I had welt on my left arm that lasted for almost 10 days; Large rash on both arms; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Flat welt size of quarter, became raised size of a baseball), URTICARIA (During the 1st week of 1st vaccine I had welt on my left arm that lasted for almost 10 days), RASH (Large rash on both arms), PYREXIA (Fever/low grade temperature) and MYALGIA (Body aches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anaphylaxis, Hypersensitivity, Hives (Due to allergy patient had Hives/urticaria) and Allergic reaction to antibiotics (Sulfa Antibiotics caused Rash over whole body, swelling, itchy and throat closing) since 2018. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Nasal congestion.    On 08-Mar-2021 at 11:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PYREXIA (Fever/low grade temperature) and MYALGIA (Body aches). On 08-Mar-2021 at 5:40 PM, the patient experienced HYPERSENSITIVITY (Flat welt size of quarter, became raised size of a baseball). On an unknown date, the patient experienced URTICARIA (During the 1st week of 1st vaccine I had welt on my left arm that lasted for almost 10 days), RASH (Large rash on both arms), CHILLS (chills) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 18-Mar-2021, HYPERSENSITIVITY (Flat welt size of quarter, became raised size of a baseball) had resolved. At the time of the report, URTICARIA (During the 1st week of 1st vaccine I had welt on my left arm that lasted for almost 10 days), RASH (Large rash on both arms) and CHILLS (chills) had resolved and PYREXIA (Fever/low grade temperature), MYALGIA (Body aches) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Body temperature: 99 (High) Body temperature - 99 degree Fahrenheit. On 09-Mar-2021, Body temperature: 101 (High) Body temperature - 101 degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-154482 (E2B Linked Report). This case was linked to MOD-2021-153717 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow up received on 24 July 2021 contains new information where Patient details, Adverse event information pertaining to Hypersensitivity reaction were provided.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-154482:Crosslinked case of reporter first dose
Patient stated that she experienced fever and vomiting an hour after the vaccines were given. It lasted 5-6 days. Her whole body was numb and in pain. Her arm was swollen.
Pfizer 8/27/21 and 9/22/21. Positive on 1/23/22
Developed shingles 3 weeks post second vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 08:00 hours (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies (unknown) and drug allergy to (NSAIDs). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Feb2021 at 08:00 hours (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient developed shingles 3 weeks post second vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of shingles and included treatment with pain management.  The clinical outcome of the event shingles was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I called patient to inform that overdue for 2nd dose in series. I was informed that family believes that the Shingrix shot caused patient to have a Stroke on 11-28-19 (21 days after vaccination). Patient had been in previous good health (no blood pressure issues or high cholesterol).