chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The shingles shot hurt me like heck; My arm throbbed for days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: The shingles shot hurt me like heck.) and pain in arm (Verbatim: My arm throbbed for days). The outcome of the pain was not reported and the outcome of the pain in arm was recovered/resolved.   It was not reported if the reporter considered the pain and pain in arm to be related to Shingles vaccine.   It was not reported if the company considered the pain and pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 28-FEB-2023 The case was received from the patient via interactive digital media. The reporter stated that the shingles shot hurt him/her like heck.  The patient's arm throbbed for days but he/she would take the shot, over the disease,anytime. The follow-up could not be possible as no contact details were available.
Pt recvd vax on 29MAR91 & approx 2 days later devel a sore & stiff neck;
Up and down persistant fever with very bad chills for 2 days straight on Sunday and Monday 3/14- 3/15/2021.  Also accompanied by very bad body aches and pain in my left arm. Left arm pain radiated to left axilla.  Strong headache for three days 3/14-3/16/2021.  Left arm still hurts on 3/17/2021
Patient fainted shortly after vaccine administration.  She was sitting on the exam table and began to lay back and closed her eyes, and became pale in color.  For approx. 10 sec. she was unresponsive and then gained consciousness, but was confused at this time.  Patient regained good color in skin tone. Two staff remained with her as she sat up; she drank some water and then sat in a chair next to her mother. The patient c/o nausea for approx. 20 min post vaccination.  She was frequently monitored for an hour until she stated she felt better and was no longer nauseated.  Patients mother was comfortable taking her home at this time.
Shoulder Got Sore; Felt Blah; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 3 patients. This report is for 3rd of 3 patient.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient's shoulder got sore and felt blah. The outcome of the events was unknown.  The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up. ; Sender's Comments: Linked Report(s) : -PFIZER INC-202101090541 same reporter/drug, different patient.
First shot was on 03/29.21, I didn't know but I was already pregnant about 7 weeks.  Second shot was taken on 04/21/21.  On 05/11/21 and 05/12/21, I checked in on Emergency Care with craps and light bleeding. A ultrasound and blood tests were done and I was informed I had had a miscarriage. We don't know if it was just a coincidence or if there is any link to the Covid19 vaccine but I was oriented  by CDC to report the finding if I would like to.
He had a sore arm/my arm was sore; This is a spontaneous report from a contactable consumer or other non hcp.   A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 17Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced he had a sore arm/my arm was sore on an unspecified date. The event outcome was reported as unknown.  No follow up attempts are possible; Information about Lot and batch number could not be obtained.
Patient presented to the emergency room approximately 45 min after receiving her 2nd dose of Moderna COVID-19 vaccine (2/12/21 at 1652).  About 15 min after receiving the vaccine, she began having a rash to her upper chest, she stated that she felt very shaky and had heart palpitations.  Nurses in the vaccine clinic gave her a dose of 25mg of Benadryl, 975mg of Tylenol and 20mg of Pepcid.  Patient was shaky, but breathing easily and able to speak in complete sentences without difficulty, denied any difficulty in swallowing and her O2 saturation was within normal limits as well as her heart rate is normal sinus rhythm.  She states that her only allergy is to  minocycline and she currently treats for depression, bipolar disorder and has a platelet storage pool disorder.  She is currently on Symbicort, zinc, Vit C, and Vit D because she had COVID-19 several months ago.  She still gets residual shortness of breath from it. She denies any chest pain, nausea or vomiting
Pt had fever and jerking episodes that required hospital admission. Work up was negative including LP and EEG. Episodes occurred the evening of her 2 mo shots. They have recurred since without fever.
Redness, swelling, fever, chills, dizziness, unable to use right arm.  Patient went to urgent care on 10/13/2010 was diagnosed with cellulitis at injection site and prescribed Dicloxacillin.
This case was reported by a physician via call center representative and described the occurrence of adverse reaction in a adult male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced adverse reaction and product supply issue. On an unknown date, the outcome of the adverse reaction was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient mentioned in passing that he received his 1st dose of SHINGRIX vaccine and he experienced a significant reaction with the intramuscular injection as he would expect with an intramuscular injection. The patient was upset about SHINGRIXhingrix availability and it was a difficult call. This was all the information collected regarding the adverse event.
prescription for MENVEO, two dose series; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a adult female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received a 1st dose of Menveo approximately 2 months ago while she was in the hospital). Concurrent medical conditions included cancer.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 24-MAY-2022 Reporter's Comments:  The pharmacist reported that she had received a prescription for Menveo for an adult, cancer patient.  The patient had received a dose of Menveo approximately 2 months ago while she was in the hospital.  The prescription of the pharmacist was for Menveo to be administered after 17th May 2022.  The pharmacist reported that the physician wanted the patient to receive a two-dose series.  Till the time of reporting this second dose had not been administered. The reporter provided limited information. The pharmacist was not at the pharmacy at the time of reporting. Additional supportive information: The patient received the prescription for Menveo and physician wanted the patient to receive a two dose series but till the time of reporting this second dose had not been administered, which led to intercepted drug prescribing error.
Patient reported it to the pharmacy on 3/24/22 . States that after getting the vaccine on 11/8/21 it started to hurt.
Product supply issue; fairly sick; joint pain; felt tired / run down; achy; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness, joint pain, tiredness, pain and product supply issue. On an unknown date, the outcome of the sickness, joint pain, tiredness and pain were recovered/resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the sickness, joint pain, tiredness and pain to be related to Shingrix.  Additional information received were as follows: In mid December 2018, the patient received 1st dose of Shingrix. The patient was fairly sick (joint pain and just felt tired, achy) for about 2 days. The patient also experienced joint soreness and felt run down for about 2 days. The patient asked if it would be better or worse after the 2nd dose of Shingrix. The patient got the call to come for the 2nd dosage and they were out of stock when the patient showed up. The patient did not received 2nd dose of Shingrix at the time of reporting , which led to product supply issue. The patient was supposed to get 2nd dose of Shingrix in the afternoon and the clinic the patient used to get the vaccine has been out everytime. The patient was hoping that extra month did not have too big inpact on the effectiveness.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medications were reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient received additional booster dose. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live significant follow up: Added age group and updated in narrative.
11/9/10 FLUZONE Lot UH223AC exp 6/11. CLL stage 0 osteosclerosis. CIDP x 20 y increased 1999 - H1N1 SC and 11/9/10 - H1N1 SC.
Site: Swelling at Injection Site-Medium, Systemic: Diarrhea-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Vomiting-Medium, Additional Details: patient reported diarrhea & vomiting which made her feel weak and dehydrated that she went to ER. Pt also observed swelling under her arm, numb and tingling in the arm.
Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2021 (Lot number: 33025BD) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 30Dec2021, outcome "not recovered", described as "Headache". Therapeutic measures were taken as a result of headache.  Additional information: Reporter stated she was a healthy 67-year-old with no problems, no diabetes and no cancer and no high blood pressure and had nothing of that nature and stated she had bronchitis which was diagnosed twenty years ago prior to her getting the Pfizer Covid vaccine and the spelling of bronchistis was captured as stated by the reporter as she was unsure of the spelling of that. Reporter stated she was not a sick person and was very well and had been on the job for 35 years. Stated she can't get an appointment with the people at the hospital where she took the Pfizer Covid vaccine and stated her headache began when she took the vaccine on 30Dec2021, and it was ongoing and the same and she had never had headaches. Stated she began no new medication and was taking the same medications she always took and her headache was strange and she had the headache all last week until now and takes Tylenol enough and the dosage of that was 600mg and she took it when she came home on 30Dec2021 and had the headache and took the Tylenol and the only thing was that when she took the Pfizer Covid vaccine she had not eaten all day long and never gets headaches if she did not eat; stated she had no lot, expiry date to provide for the Tylenol. No other products and investigation assessment reported.  Follow-up attempts are completed. No further information is expected.
Diagnosed with/tested positive for COVID19; Diagnosed with/tested positive for COVID19; This is a spontaneous report from a contactable consumer or other non health care professional. A 36-years-old male patient received first dose bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL3248, expiry date: 30Apr2021) via intramuscular route of administration in Arm Left on 28Jan2021 10:00 (age at vaccination 35 years) as DOSE 1, SINGLE for covid-19 immunization and second dose bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL3248; expiry date: 30Apr2021) via intramuscular route of administration in Arm Left on 19Feb2021 10:00 (age at vaccination 35 years) as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination. Patient received other medications Novolog, Tresiba, Levothyroxin, Lisinopril within 2 weeks to vaccination. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. Concomitant medications included insulin aspart (NOVOLOG) taken for an unspecified indication, start and stop date were not reported; insulin degludec (TRESIBA) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19 prior to vaccination and patient was tested to COVID-19 since the vaccination. On 26Jul2021 at 11:30, the patient experienced diagnosed with/tested positive for covid19. No treatment was received for the covid-19 event. Patient had physician office visit for covid-19 event. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Jul2021 Nasal Swab. The outcome of the events vaccination failure was unknown, and covid-19 was recovered. A product quality complaint group providing investigation results concluded that the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3248 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3248, fill lot EL3231, and the formulated drug product lot EL3224. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up attempts are completed. No further information is expected.
Received vaccine on 31 day of refrigerator storage; 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 PRODUCT STORAGE ERROR (Received vaccine on 31 day of refrigerator storage) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A.) 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 PRODUCT STORAGE ERROR (Received vaccine on 31 day of refrigerator storage). At the time of the report, PRODUCT STORAGE ERROR (Received vaccine on 31 day of refrigerator storage) 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 reported.  The reporter stated that seventeen patients were administered with vaccine on 31 day of being stored in the refrigerator. It was mentioned that there was no temperature excursion and the temperature was strictly maintained. The expiration date was till October 2021. No further information was provided.  Treatment information was not reported.
HAD ALLERGIC REACTION TO VACCINE. ADMINISTERED VACCINE AT 8:05P. AT 8:20 PT REPORTED FEELING FUNNY, TIGHTNESS IN ABDOMEN AND CHEST. CALLED 911 AT 8:20P. TOOK BP - 179/108 PULSE 82. STARTED HAVING DIFFICULTY BREATHING. ADMINISTERED EPIPEN AT 8:25P. EMS ARRIVED, ADMINISTERED IV BENADRYL AND TOOK PT TO EMERGENCY DEPARTMENT. PRIOR TO VACCINE ADMINISTRATION REVIEWED ALLERGY FILE. DECIDED TO GO WITH ONE DOSE JANSSEN DUE TO HISTORY OF ALLERGIC REACTIONS, NO REACTIONS TO POLYETHYLENE GLYCOL OR POLYSORBATE NOTED. REVIEWED RISK AND BENEFIT WITH PATIENT PRIOR TO ADMINISTRATION
Muscle pain-arms, legs, back-cannot stand to have anyone touch her skin -pain-deep congested cough.  Poor appetite, lethargy to 99-100 degrees F.  By arne on 03/28/2003-Non prescription amoxicillin treatment.  Seen by MD 04/04/2003-ordered amoxicillin stopped.
Nausea the next morning, arm pain for 48 hours, fever the following evening and muscle aches the entire following day
This spontaneous report as received from a physician refers to a 75-year-old male patient with no drug reactions/allergies. Current conditions included diabetes and high cholesterol. On 22-OCT-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot #0423AE in verification process, expiration date 02-APR-2013) dose and route not reported. Concomitant medications included unspecified medication for diabetes and high cholesterol. The physician reported that the patient developed shingles following vaccination with ZOSTAVAX on 31-OCT-2012. Treatment was not given for the event. No laboratory diagnostic studies were performed. The patient sought medical attention by contacting the office. The event did not resolve at the time of this report. Additional information has been requested.
Does your vaccine cause tinnitus?; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Does your vaccine cause tinnitus?) 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 TINNITUS (Does your vaccine cause tinnitus?). At the time of the report, TINNITUS (Does your vaccine cause tinnitus?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided by the reporter.  No treatment information was provided by the reporter.
48 hours post vax, the pt complained of swelling and pain at the site. Diagnosed with a sterile abscess to the left arm.
Panic attack. Seen by EMS on site. Discharged home at 12:40 p.m.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time). This case contains information for the 5th of 8 adult patients described by the reporter. No concomitant medication was reported by reporter. Patient received booster dose. Total 2 vials and 8 doses were affected. Vial did not undergo any temperature excursion and were in refrigerator the entire time. 4 patients were administered on 22-Jul-2022 and 4 patients on 02-Aug-2022. No treatment medication was reported by reporter.