chrisvoncsefalvay/vaers-outcomes huggingface dataset:
-1st injection- in first 15 minutes after injection, very minor lightheaded feeling, minor arm soreness for 24 hrs -2nd injection: hurt when injected and pain persisted. Arm pain and muscle soreness persisted for at least 48 hours after injection -Woke up to accidental alarm on phone at 2:30am- felt very nauseous and had headache -In the morning- had bad headache and nausea; no fever detected via infrared forehead thermometer   -Ate a little food and took 200mg x2 ibuprofen -After food, nausea subsided, ~8am but loss of appetite persisted all day -Headache lasted all day, but lessened with ibuprofen. Worsened when walking around house, better when just sitting -Felt better by end of the day, but still felt weak, tired, mild headache, and sore. overall felt unwell. -Overall, felt much better when woke the next morning
Increase in number seiures noted. Previously about 2 / week. Now 2-5 per day.
No adverse event; they gave the wrong concentration of the vaccine to children age group 6 months to 5 years; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (they gave the wrong concentration of the vaccine to children age group 6 months to 5 years) and NO ADVERSE EVENT (No adverse event) in a 1-year-old 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. 201L22A) for COVID-19 prophylaxis.     It was reported that the patient's caregiver did not report any relevant medical history, conditions, allergy, concomitant diseases, or risk factor (including any previous COVID-19 diagnosis).  Previously administered products included for Product used for unknown indication: Kinrix, MMRV and FLU [INFLUENZA VACCINE]. Past adverse reactions to the above products included No adverse event with FLU [INFLUENZA VACCINE], Kinrix and MMRV.    On 01-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 01-Jun-2023, the patient experienced WRONG PRODUCT ADMINISTERED (they gave the wrong concentration of the vaccine to children age group 6 months to 5 years). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (they gave the wrong concentration of the vaccine to children age group 6 months to 5 years) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (they gave the wrong concentration of the vaccine to children age group 6 months to 5 years).    Concomitant drugs were not reported. It was reported that patient received vaccine from a dark pink with yellow box a dosage of 0.2 ml instead of blue cap with gray border since they have not received the vaccine before.  Treatment medications were not provided.  This case was reported for patient 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-728512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728512:patient 01
Rashes on the left arm (COVID arm) started appearing  on Tuesday morning when I woke up and noticed the rashes. (different sizes)
pt recv vax 10AUG98 in afternoon;MOC report 11AUG98 & 12AUG98 pt has been very irritable, crying, fever treated by APAP, loss of appetite, immun site reddened & swollen;
Reported rash on (R) side of face and on arm. Last for 3 days.
After receiving the injection I began to have severe body pain to include extreme headache, muscle aches, and fever which lasted about 24 hours. Since then I have not felt right physically (my equilibrium/balance) and my head has felt I guess the best wat to describe it is foggy it has been hard to think clearly and it seems like even my emotions are off I have been very emotional, which is very abnormal for me. I have not seen a doctor yet as I am hoping it clears up in the near future but just wanted to report it in case it doesn't.  I guess my biggest concern is the brain fog feeling that doesn't seem to be clearing up.
It was reported by phone on 8/20/01 that an 8 y.o. female PT received an Imovax rabies vaccine (lot # not reported) and Rabies Immune Globulin [Imogam] (lot # not reported) on 8/17/01. PT experienced headache, nausea, malaise and low-grade fever, which started 24 hrs, post vaccination and continued for 48 hrs. PT treated symptomatically w/Tylenol. From add'l correspondence received on 9/18/01 it was reported that the PT also experienced dizziness. The symptoms resolved and the PT recovered. Add'l PT, vaccine and responsible physician info. was provided. This case is closed.
Information has been received from a pharmacist concerning a 56 year old female patient with no drug reactions/allergies. The patient's medical history included unspecified cancer. On 06-FEB-2015 the patient was vaccinated with ZOSTAVAX (0.65 ml, once, lot # K020801, expiration date: 31-JAN-2016) subcutaneously at the right arm. On 07-FEB-2015, the patient experienced swelling, redness and warmth at the injection site in her right arm. There was no treatment given for the adverse events. No lab diagnostics studies performed. The patient had sought medical attention by contacting the pharmacy. The outcome of the events was reported as not recovered. This is one of the several reports from the same reporter. Other patients' adverse events were captured in case # 1502USA004169, case #1502USA4635, case# 1502USA004628 and case # 1502USA004646. Additional information has been requested.
Patient reported to me on 9/14/21, that 15 minutes after vaccination while walking to her car, that her tongue felt swollen. Once she made it home she took benadryl. She reported that this helped but her tongue remained sore for the next several days and also had a sore on the top of her mouth.
Patient reports flu like symptoms: chills, fever, shaking, took ADVIL and stayed home from work one day. Felt fine after 1 day.
pt recvd vax & 2 1/2 days p/vax exp hives on body x/for face & 1 leg;hives were treated w/DPH & topicort ointment;sx persist;
Swelling began with in a few hours. It Increased swelling at site injection over the next 2 days. now developing a rash starting the night of the 3rd. Now the rash is spreading over swelling.  Pictures taken. This morning Allegra was taken. Will take Benadryl shortly
Patient experienced immediate L leg swelling, erythema after receiving Vaxelis vaccine in Left leg. Got PCV 15 in Right leg right ager. Face and trunk became very pale, patient very fussy. No mouth swelling or audible wheezing, no respiratory distress. Vitals stable (BP, HR, pulse ox), given IM EpiPen Jr x 1, leg swelling resolved immediately. Vitals remained stable, taken to ED via ambulance. Will need allergist clearance before receiving any future vaccines. Will follow up recommendations from ED.
Swelling left arm around vaccine site 5 x 5cm erythema, non tender.
This spontaneous report was received from a 60 year old male patient, who was reporting on himself. The patient did not have any pertinent medical history, drug reactions or allergies. On 17-AUG-2016 (reported as 2 days ago), the patient was vaccinated with a dose of ZOSTAVAX, one injection, subcutaneously (site of administration, lot number and expiration date were not reported). Concomitant therapies included famciclovir and lisinopril (manufacturer unknown). On 19-AUG-2016, the patient had red, puffy and itchy skin at injection site. He did not seek medical attention. No lab diagnostic studies were performed and no treatment was given for the events. Product quality complaint was not involved. The outcome of the events was considered to be not recovered (reported as "still there"). The relatedness between the events and vaccination with ZOSTAVAX was not reported. No other information was provided. Additional information is not expected as no consent for contact was provided.
Pt received vaccine as below on 2/3/12. On or about 2/14/12 pt developed fine red rash on stomach and back, no fever. He was seen in office on 2/27/12 for right OM.
63 PMH: HTN, multiple sclerosisALL: deniesVS: 96%, HR 54, BP 171/84 (no meds taken today) Symptoms: This is Dose#270yF developed immediate dizziness, heavy feelin in her body and legs. Felt like someone was squeezing her throat but denied difficulty breathing and mouth swelling. She felt slightly disoriented and said she had a recurrence of her speech difficulty which happens with her MS.She refused epinephrine administration for throat tightness but accepted 25mg IM benadryl. Assessment: slightly flushed appearing, complete sentences, coherent, alert and oriented. chest is clear, good air entry bilaterally, no respiratory distress or facial/oropharynegeal edema noted. Heart rate mildly decreased on auscultation. No distress. Treatment: 25mg IM benadryl Patient observed for 30 minutes with symptom resolution and driven home by companion.Repeat vitals O2- 97%, HR- 57, BP - 131/69
Moderna vaccine booster was administered on 11/5/2021 with an expiration date of 10/11/2021. Inquiry has been submitted to Moderna requesting validation of vaccine potency.  A response from Moderna is expected to be received between 8-10 business days.  Expiration date is currently not printed on the vaccine vial or carton and vaccine expiration date listed in is 12/31/2069.  To find the expiration date, ?look up expiration date? tool is to be used from Vial Expiration Date Lookup | Moderna COVID-19 Vaccine . Patient contacted on 12/4/2021 and no adverse effects reported.
Received flu vaccine Nov. 2008 - within weeks of injection, noticed changes in movement of arm (left) - positive stiffness with limited range of motion...  Currently under care of orthopedic surgeon.
Immediately after receiving the shot, I experienced sharp pain in my abdomen/the pain has progressed and keeps getting worse and worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2022 at 13:15 as dose 4 (booster), single (Lot number: FJ4991) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; SPIRONOLACTONE; METFORMIN; PRAVASTATIN. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FC3183, Location of injection: Arm Right, Vaccine Administration Time: 03:15 AM), administration date: 24Sep2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN6198, Location of injection: Arm Right, Vaccine Administration Time: 12:00 AM), administration date: 27Feb2021, when the patient was 56-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL9269, Location of injection: Arm Left, Vaccine Administration Time: 01:00 AM), administration date: 06Feb2021, when the patient was 56-year-old, for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 18Mar2022 at 13:15, outcome "not recovered", described as "Immediately after receiving the shot, I experienced sharp pain in my abdomen/the pain has progressed and keeps getting worse and worse". The events "immediately after receiving the shot, i experienced sharp pain in my abdomen/the pain has progressed and keeps getting worse and worse" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of abdominal pain.  Additional Information: : Immediately after receiving the shot, I experienced sharp pain in my abdomen. I did not tell the pharmacy technician who gave me the shot because I thought this was temporary and it would subside. Unfortunately the pain has progressed and keeps getting worse and worse. Facility type vaccine: Pharmacy or Drug Store. If other vaccine in four weeks: No. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: Unknown. Other medical history: Diabetes, High BP.
pt recvd vax 9FEB93 & exp fever, nausea, vomiting, malaise & a bad taste in mouth; No further details were provided;
Mom called on 3/10 to state that daughter's leg had a red spot and it is growing. Patient is a 5 yo female who had immunizations 2 days ago. The site on the right thigh is where she got her KINRIX vaccine. Mom says she had red and rashey as soon as they were home and it has progressed. Today it is 2 x the size and hurts - has more bruising than rash.
This spontaneous report as received from a consumer reported an outbreak of VARIVAX (Merck). The news stated most of the children, on an unknown dates were vaccinated with a dose of VARIVAX (Merck) (lot# and doses not reported), but still developed the virus. This is one of several reports received from the same source. Additional information has been requested.
Patient fainted within 5-10 minutes after receiving shot but it only lasted about 10 seconds
the 2nd was flu-like symptoms for a day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "No adverse effect". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "the 2nd was flu-like symptoms for a day".  Additional information: Patient received no prior vaccinations. Patient enquired about any insight from company about medical problems after getting the Pfizer booster back in Oct2021. Patient received both other vaccines as Pfizer also. Patient stated that, unlike other two shots (the 1st was no symptoms and the 2nd was flu-like symptoms for a day), the shot instantly felt different being injected. Case was reported as non serious. Patient stated that patient doesn't have the lot number but can email. Expiry date of Covid vaccine was unknown. Patient wanted to report some possible side effects from the vaccine. Patient had been having a lot of problems since patient received the vaccine. Consumer stated that, it's actually from the booster. So the first shot and the second shot were fine. There are normal symptoms (further clarifications unknown hence not captured as an event). There was nothing with the first one, the second was just like feels right. Consumer stated, no, don't have any medical conditions either. Investigations: No, lab test: Consumer stated, no not in last two weeks. They did initially one in the starting. Consumer stated, route of administration and anatomical site as, it was injection on upper left arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported via email that about 2 hours after she received the flu vaccine (FLUZONE HIGH-DOSE Lot# UI642AC) that she had in increase in blood pressure, nausea with vomiting, chills, headache, and muscle aches. She states that the symptoms were present for 3 days and she did not start to feel "completely" better for 5 days. She did take BENADRYL the first night symptoms started and she said it "seemed to help" a little. She did not seek medical care but said she "almost called 9-1-1."
Thur. 6/22/17Received PC23 shot - applied ice that evening as arm was war and red from shoulder to elbow - could feel firmness and tightening - very tender to touch * took ibuprofen.  Fri. 6/23/17 Upper arm very swollen, hot, hard and very red between shoulder and elbow. - so swollen that there was an indentation just before elbow - painful to move left arm across front of body to the right and to left above. Shoulder - again applied ice * took ibuprofen. Sat. 6/24/17 Inner upper arm still slightly swollen and very red from shoulder to elbow. Puffiness and swelling has not moved to the inner elbow area - checked with pharmacist. No issues at injection site (upper left arm) other than normal slight tenderness a time of injection - or in following days. Sun 6/25/17 - very slight redness/puffiness inner upper arm. Mon 6/26/17 - seems to be back to  normal.
arm soreness that prevented her from being able to lift her arm over her head; nausea; fever; loss of appetite; experienced arm soreness; This case was reported by a consumer and described the occurrence of nausea in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2020, refer case US2021AMR004144).   On 28th December 2020, the patient received the 2nd dose of Shingrix. On 28th December 2020, less than a day after receiving Shingrix, the patient experienced nausea, fever, appetite lost and pain in arm. On an unknown date, the patient experienced mobility decreased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, fever, appetite lost, pain in arm and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the nausea, fever, appetite lost, pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The reporter was a Glaxosmithkline employee who reported an event told to him by the patient who was his sister in law.  The patient reported nausea, fever and loss of appetite the evening following the second dose.  The patient experienced arm soreness that prevented her from being able to lift her arm over her head that lasted 4-5 days. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR004144:same reporter
Pt has redness, swelling (large amt), tenderness, and warm to touch at injection site
This spontaneous report as received from a registered nurse refers to an unknown number of patients (age and gender were unknown). On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (lot # 0306AE, exp. date 06-FEB-2014) (dose and route not reported). It was reported the lot of VARIVAX (Merck) underwent multiple temperature excursions that was recently discovered after a review of freezer temperature data over the past two years. This lot of VARIVAX (Merck) exposed to -12C for a period of 160 hours. The excursion date range from2 2-JUN-2012 to 10-AUG-2013. All the stock of the lot number were administered to an unknown number of patients. Last dose administered on 10-AUG-2013. The reporter stated that she believed that some of the VARIVAX (Merck) should have had stability information to support some of the excursions. Upon review, lot # 0306AE exposed to -12C for a period of 160 hours was supported. Temperature excursion did not affect this lot#. No adverse events were reported. This is one of several reports from same source. Additional information has been requested.
During the night I was shivering and left after a few hours for 12 hours. On 7 March 2021 later I woke up and had pain in legs and arms and was worst for 6 weeks. It became extreme painful. Rash across my midriff. Till today the rash is still there not as severe now. 15 March 2021 saw the doctor. No test was done. I started taking a steroid on 8 April 2021. Saw the rheumatologist 16 April 2021. I see her every 6 weeks. I am on steroids now.
This spontaneous report as received from a consumer refers to herself a 52 year old female patient with morphine allergy. The patient's medical history included breast cancer. In July or August 2012 (exact date unspecified) the patient was vaccinated with ZOSTAVAX (dose and not number were not reported) in the right arm for shingles vaccination. The reporter stated the patient was not taken any concomitant medications. On 13-MAY-2013 the patient was diagnosed with shingles, after receiving the ZOSTAVAX. The patient was treated with valcyclovir hydrochloride (1 tablet/3 times a day), and cephalexin (1 tablet/ twice a day). The outcome of shingles was reported as not recovered. The patient sought unspecified medical attention. Additional information has been requested.
dizziness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021 and was forwarded to Moderna on 28-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided Concomitant medication were not provided.
Menstrual cycle time shift to earlier in the month; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date in 2021, the patient's menstrual cycle time shifted to earlier in the month. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle time shift to earlier in the month was unknown at the time of this report.
Information has been received from a registered nurse concerning a 26 year old female patient who was admitted to the hospital on 23-FEB-2011 with a mandibular infection and cellulitis post dental work with valvular heart disease and type 1 diabetes who on 25-FEB-2011 was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported) in the right arm while in the hospital. It was reported that the patient was placed on Clindamycin (length of dose unspecified). On 26-FEB-2011 the patient developed redness in the right axilla and deltoid area. The patient then went on to develop swelling, redness and pain in the entire right upper arm. She also developed chills, fever and nausea. The patient was placed on IV Vancomycin (dose not reported). On 02-MAR-2011 the patient was discharged from the hospital and was fully recovered the same day. Redness in the right axilla and deltoid area, swelling, redness, pain in the entire right upper arm, chills, fever and nausea were considered to be an other important medical event because the patient was treated with IV Vancomycin by the nurse. Additional information has been requested.
Patient experienced dizziness, lightheadedness and brief (30-60 seconds) syncopal episode. Patient was visibly diaphoretic and hypotensive. Patient placed in recumbent position and blood pressure recovered within 5 minutes. Patient observed for 35 minutes total and left in stable condition.
This manifested initially in the afternoon as a pain down the arm, through the arm pit, into back and neck on left side.  This waxed and waned but did not go away for about 6 months.  This cleared up when I had a lymphedema treatment.