chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; Customer called in to report that they gave 2 children the 6mo-2yr vaccine dose 2 months past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Customer called in to report that they gave 2 children the 6mo-2yr vaccine dose 2 months past expiration) and NO ADVERSE EVENT (no adverse event) in a 2-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-May-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Customer called in to report that they gave 2 children the 6mo-2yr vaccine dose 2 months past expiration). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Customer called in to report that they gave 2 children the 6mo-2yr vaccine dose 2 months past expiration) 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 EXPIRED PRODUCT ADMINISTERED (Customer called in to report that they gave 2 children the 6mo-2yr vaccine dose 2 months past expiration).    No concomitant medication was reported. No treatment medication was reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-734254 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734254:Patient 02
At 11:15 am of 3/26/21, after taking a shower, I was applying cream on my neck and I noticed a huge lump on the left side of my neck. Being an MD ( anesthesiologist), I examined the lump and felt like a size of a walnut in a shell. I immediately called my Primary and I went to his office. We discussed about my Covid vaccine. And he requested Chest X-ray. In the future, head and neck CT.
I noticed that I started to experience leg vein swelling gradually after receiving my vaccination for Dose 1 and Dose 2, but it became more noticeable after Dose 2 Pfizer-BioNTech April 10, 2021 lot EL3302. My veins are more visible in the legs with swelling, with pain that is throbbing and numbing pain. I can not determine if the pain is in the leg or the back, not sure where it is coming from. When I go to stand the leg will give out and cause a balance issue or fall issue. Upcoming visit with surgery on 04/18/2022 and will communication this issue with the physicians and neurologist to check for blood clots and to determined the cause of the leg vein swelling.
Headache, Myalgia, Arthralgia & Fever Narrative:  woke in middle on night the day after shot feverish, and with other s/s as noted above.
Itchy rash on arms, neck, chest, and face. Also, elevated resting heart rate, 90+ resting. Took Benadryl and I am fine now.
fevers 102.5 to 103; 28AUG to 31AUG; fine red rash;
swelling in her lymph nodes on the right side/ neck; soreness on the side of my face; Discomfort; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received one dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via unspecified route single dose for protection from COVID-19 2 o' clock or 3 yesterday (09Jan2020), at 43-year-old. Medical history included: multiple sclerosis. Concomitant medication included: sertraline 50 mg once daily at night; antidepressant (unspecified). The patient previously took glatiramer acetate (COPAXONE) once for multiple sclerosis and amantadine, was allergic to both. The patient didn't notice soreness on the side of her face, was probably from the vaccine started yesterday (09Jan2020). The patient was doing fine but then noticing was getting swelling in her lymph nodes on the right side. The patient did not notice the swelling, but she noticed the discomfort first last night (09Jan2020), '9th, 10 pm' (not clarified further). The patient thought that it was a 'pimple' (not further clarified) there. And then later today (10Jan2020), or just maybe an hour ago, when she felt that on her neck, she found lymph nodes swollen. So far, no treatment was taken. No lab work done. Action taken for BNT162B2 was not applicable. Outcome of the events was resolved.
Patient felt dizzy/lightheaded about 15 minutes after the vaccine - as she was getting up she fell and hit her chin - had to lay down and felt better after some rest and intaking water/food. No need
This person received the 1st dose COVID-19 vaccine  Pfizer @ 08:13am.   Then @0930 am, c/o "feeling something on top of her chest, heaviness of chest", sweaty hands, clammy, chest pain.   Rapid Response Team called at 09:35 am.  Transferred to Emergency Room.  In ED: Diagnosis included but not limited to STEMI, NSTEMI, unstable angina, anxiety.  At 10:04am- based on EKG, code STEMI was called. Consultation with cardiologist.  Then the patient was sent emergently to Cath Lab.  The patient was admitted to ICU,  intensive care, following Cath Lab
Breakthrough case admission after three vaccines Pfizer 1/19/21 Lot# EL3249;  Pfizer 2/9/21 Lot# EM9810;  Pfizer 9/29/21 Lot# FE3592
About 5 minutes after receiving the Covid vaccine patient fainted, she was pale and reported feeling very tired and had tingling in her hands.  After drinking water. Patient was feeling better but still felt tired. After 10 minutes paramedics arrived and took her vitals. Her blood pressure and pulse were normal.
FEVER, DIARRHEA, HEADACHE, WEAKENESS, MILS ABDOMINAL DISCONFORT
Shingles; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on 16Apr2021 with outcome of unknown.  Information on the lot/batch number has been requested.
Approximately 2 hours of severe tremors, along with nausea, and body aches. Followed by several days of fatigue and headache, missing several hours of work. Ibuprofen and rest for several days. Symptoms mostly resolved after approximately 1 week.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 07-JAN-2019, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date: 07-NOV-2020, thimerosal free, strength, dose, frequency and route unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
Pt experienced a rash and was treated with prednisone.  Approximately 3 weeks following onset the pt recovered.
CERVARIX was given to client instead of GARDASIL. Client had no problems, 1-800-CDC called for guidance - no answer yet.
PATIENT CALLED 12/19 STATING HE HAS RXN FROM FLU SHOT. HE STATED THAT SHOT WAS GIVEN BIT HIGH WITH LIMITED RANGE OF MOTION. HE MENTIONED THAT HE HAD BRUISING THIS MORNING THAT IS ABOUT 6 YO 8 CM DIAMETER. ADVISED HIM TO USE SOME ICE PACKS AND CALLED PCP TO FOLLOW UP. HE DID MENTIONED THAT IT'S GETTING BETTER AFTER FEW DAYS. PHARMACVIST ADVISED TO FOLLOW UP WITH PCP TO GET IT CHECKED OUT. PHARMACIST WILL DO A FOLLOW UP PHONE CALL 2 DAYS LATER.
Swelling of the lymph nodes on the right-side (supraclavicular, armpit and side of breast). Chills, night sweats, arm pain, stiff neck, fatigue and body aches.
at 2pm I got freezing chills, then I would get hot, then cold again. by 7pm I had a fever and I could not get warm, with aches and pains, I was up all night shaking and my overall body hurt. The next morning I felt like a truck hit me I couldn't eat I was nauseous, a pressure headache, that evening I felt a little better I ate toast, the next day the same, the third day I felt better but it took a while for the pressure  headache to go away
nonmigrating, localized rash on both hands, red flushing face, no chestpain , pressure, or shortness of breath, starting to resolve at 12:33 p,m  12:28 pm oxygen saturation95% blood pressure 170/89 heartrate 68  12:45 pm  blood pressure 159/87 heartrate 64
The tingling became almost numb in my feet at 72 hours; After the second vaccine both my feet and hand became very cold and tingling; After the second vaccine both my feet and hand became very cold and tingling; This is a spontaneous report from a contactable consumer (patient). A 49-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: En6203), via an unspecified route, administered in Left arm on 03Mar2021 10:00 AM (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19 (prior to vaccination). Patient had no known allergies. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: El3248), via an unspecified route, administered in Left arm on 09Feb2021 at 04:45 PM (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient had no other vaccination 4 weeks prior to Covid-19 vaccine. On 03Mar2021 at 06:00 PM (8 hours after the second vaccine), the patient experienced both her feet and hand became very cold and tingling. It has continued for four days - seemed to be worse at 72 hours and was hopefully improving on day 4. The tingling became almost numb in her feet at 72 hours (on 06Mar2021 at 10:00). She never had a feeling like this before. The patient had not tested for Covid-19 post vaccination. The patient had not received any treatment for the resulted events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information was expected.
mild rash; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EL1284), first dose via an unspecified route of administration at the right upper arm on 18Jan2021 at single dose for covid-19 immunization. The patient had no medical history, no concomitant medications and no investigation assessment. The patient got her first COVID vaccine on 18Jan2021, and has broken out in a mild rash, and it was, she has had this when she had the shingles vaccine, she broke out with that too, so this was consistent with her with vaccines and other medications, and she has been on diphenhydramine hydrochloride (BENADRYL). She almost felt a little rash coming on the evening of 18Jan2021, and by the 19Jan2021, she clearly had a rash on the back. She started diphenhydramine hydrochloride, and it was almost gone. Her primary care doctor just retired, she was in limbo, she did not have a new one yet. This was her first dose. The patient stated that she didn't want to get COVID and to get back to normalcy. NDC, expiry, dose were not listed on vaccination card. On the back, says she was supposed to get the second on 08Feb2021, she didn't know if this information was needed, but there were no openings period to get it on the 08Feb2021, so she was scheduled to get the second one on 11Feb2021. The outcome of the event was recovering.
Ibuprofen the night of vaccination, due to mild body aches and arm soreness. All resolved 24H later. Depo-Provera injection on 12/22/20, next day developed mild body aches, and progressed over the next few days to upper body stiffness on side of Depo-Provera injection, with muscle spasma; never experienced with Depo shot previously
Hives/rash starting in left upper arm, spread to both upper and forearms and both thighs.
This case was reported in a literature article and described the occurrence of hepatitis B infection in a unk patient who received Hepatitis B vaccine. Concurrent medical conditions included renal failure (Requiring hemodialysis) and hepatitis B exposure (via another patient at the hemodialysis station). On an unknown date, the patient received Hepatitis B vaccine (unknown). On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced hepatitis B infection (serious criteria GSK medically significant), not responding to therapy and possible vaccination failure (serious criteria GSK medically significant). On an unknown date, the outcome of the hepatitis B infection, not responding to therapy and vaccination failure were unknown. It was unknown if the reporter considered the hepatitis B infection to be related to Hepatitis B vaccine. Additional information: This case was reported in a literature article and it described a case of lack of efficacy in a subject of unknown gender and age who had received hepatitis B vaccinations (manufacturers unknown). The subject's concomitant medical conditions included renal failure that required haemodialysis. No further information on the subject's medical history, concurrent medical conditions or concomitant medication was provided although the authors mentioned that the haemodialysis was the only risk factor that this subject had for hepatitis B. On an unspecified date, the subject received an unknown number of unspecified hepatitis B vaccinations (number of doses, dosage, administration routes and sites unknown; batch numbers not provided). On an unknown date, an unknown period after the administration of the vaccines, the subject failed to respond to the vaccinations according to the authors. Later the subject tested positive for hepatitis B surface antigen in March 2013 and had a hepatitis viral load >1.1 x 108IU/mL in July 2013. This case was assessed as medically serious by GSK. This case was considered as a possible vaccination failure. A serology result was positive for hepatitis B surface antigen in March 2013 and the subject's hepatitis B viral load was more 1.1 x 10E8 IU/mL in July 2013. The subject's hepatitis B virus genome sequence and the sequence of a hepatitis B positive subject who attended the same haemodialysis unit matched 99.9%. Based on this result and the observation of substandard infection control measures in the haemodialysis unit, the authors believed that the transmission of the hepatitis B virus was related to the haemodialysis procedure. Treatment was unknown. At the time of reporting the outcome of the events was unspecified. The authors did not comment on any possible causal relationship between the vaccination and the events. The authors concluded that "This was the first reported haemodialysis-related hepatitis B virus transmission from a subject with reactivation. This case underscored the challenges in identifying haemodialysis subjects who reactivate; it also might have policy implications for expanded hepatitis B virus testing among haemodialysis subjects with resolved infection, particularly those with severe immunosuppression".
Cannot stop coughing; worsened; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Oct2021 13:00 (Lot number: FF8841) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LANTUS; LOSARTAN. Vaccination history included: Bnt162b2 (Dose no: 1, Lot no: ER6206, The caller didn't have an side effects with the first two doses), administration date: 05Mar2021, when the patient was 52 years old, for COVID-19 immunization, reaction(s): "No reaction on previous exposure to vaccine"; Bnt162b2 (Dose no: 2, Lot no: ER8133, The caller didn't have an side effects with the first two doses), administration date: 26Mar2021, when the patient was 52 years old, for COVID-19 immunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: COUGH (non-serious) with onset 08Oct2021, outcome "not recovered", described as "Cannot stop coughing"; CONDITION AGGRAVATED (non-serious) with onset Oct2021, outcome "not recovered", described as "worsened". Therapeutic measures were taken as a result of cough. No follow-up attempts are possible. No further information is expected.
Injection site became swollen, red, sore, itchy and hot.  Area was approximately 4" X 5".  Day 4, swelling and itching is still present.  Day 5 five day,a quarter sized lump remains which is slightly itchy.  Self treated with cold compress, ibuprofen and anti-histamine (Clarinex).
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 15-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
TINY 1 MM SLIVER/GRAY SPOT PRESENT WHERE VACCINE WAS GIVEN, NO REDNESS, NO TENDERNESS, NO LUMP PRESENT.
Information was received 30-JUN-2017 via a phone call from a licensed practical nurse who reported that a patient (age and gender not specified) was administered an improperly stored dose of PNEUMOVAX 23 on an unspecified date. Lot number and expiration date were not provided. No adverse effects were reported. No additional information was provided. This is one of several cases from the same reporter. Additional information was requested. Sender's Comments: US-009507513-1707USA009866: US-009507513-1707USA009865: US-009507513-1707USA005581: US-009507513-1707USA009868: US-009507513-1707USA009869.
Several month later I experienced a more severe insect bite allergic reaction to what I think was a mosquito.  I was already allergic to mosquito bites prior to the vaccine so I'm not certain this is related. But reported it just in case.
Swelling, redness, warmth @ site of injection. Edema approx 8 cm diameter.
Roughly 16-18 hours after second dose, felt extreme vertigo with alternating fever/chills for 3 days. While fever and chills finally subsided, vertigo did not and an onset of tinnitus on 3-4th day. After suffering baseline disorientation/"brain fog" and vertigo sought out ENT and had audiology report, while hearing was in normal limits there was evidence of some dysfunction of the cells in the inner ears - started Prednisone steroids
COVID-19 Breakthrough. The first symptom would have been a stuffy nose and then a slight occasional cough about a day or so later. By Monday or Tuesday I developed a fever that went up to 102 degrees. Then it felt very much like when I had it before. I became very weak, achy, and fatigue. The cough became more persistent. The fever came back, weakness and tiredness lasted or about two days. The cough became progressively worse and the other symptoms have gone but the cough still remains. I called the doctor on Tuesday and he prescribed me Paxlovid and I finished that course as of yesterday. I also upped my zinc, vitamin D and vitamin C, Pepcid in combination with the Paxlovid. It seems that at least half the people that got off the cruise tested positive.
Patient had received his vaccine at least 30 minutes prior to incident. Patient found by another person outside. Patient had reportedly fallen on sidewalk. When found, patient was unresponsive but was breathing and did have a pulse. Patient had laceration on forehead which was bleeding profusely. Patient became responsive after a few minutes. Patient could not remember how or why he fell, but did know his name and DOB. 911 was called and reported to scene about 15 minutes after fire department and two sheriffs showed up. Patient was transported to ER.
BAD DREAMS; NO APPETITE; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol consumption, and non smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 16/AUG/2070) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced bad dreams. On 08-APR-2021, the subject experienced no appetite. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad dreams, no appetite, fever, and nausea on 10-APR-2021, and had not recovered from headache. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.