chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Moderna COVID vaccine given to patient on 2/16/23 that expired on 2/12/23; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine given to patient on 2/16/23 that expired on 2/12/23) 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)) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Feb-2023, 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 16-Feb-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 (Moderna COVID vaccine given to patient on 2/16/23 that expired on 2/12/23). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine given to patient on 2/16/23 that expired on 2/12/23) 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 (Moderna COVID vaccine given to patient on 2/16/23 that expired on 2/12/23).    No concomitant product reported by reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Moderna COVID vaccine was given to patient on 16-Feb-2023 that expired on 12-Feb-2023 with Lot number 015B22A.  No treatment medication reported by reporter.
Moderna Dry Heaves, just 1 session. temperature, body ached all over, tired, headache.  Side effect only lasted from 3am 3-5 -21 until 3 am 3-6-21.
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (it was worst).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for himself/herself. The age at vaccination was not reported. Before receiving Shingles vaccine, the patient got worst case of shingles. The patient received Shingles vaccine every year. After receiving Shingles vaccine, the patient got very mild shingles 2 times. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided. This case had been linked with case US2021AMR187022, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR187022:same patient same reporter
pt recvd vax;48 hrs later,devel local rxn described as "cellulitis" manifested by redness & warmth at the inject site; tx w/ Keflex; rxn resolved w/in several days;
8MAR93 mom reports febrile seizure approx 1 hr p/vax; t103.7; c/o listless behavior x 2 days treated w/APAP & Ibuprophen;
Tested positive for COVID 19; Tested positive for COVID 19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 33-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks. Patient had no COVID prior vaccination. Patient was tested for COVID post vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Dec2022, outcome "not recovered" and all described as "Tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Dec2022) Positive, notes: Nasal Swab, Tested positive for COVID 19. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Arthralgia, Fever, site discomfort, chills, fatigue
nausea; headache; tired; felt like she has to throw up; I was feeling a little light headed; she cant shake this feeling it wont leave her; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0164), via an unspecified route of administration on an unspecified date 2021 (age at the time of vaccination 50-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date 2021, the patient experienced nausea, headache, tired, felt like she has to throw up, I was feeling a little light headed, and she cant shake this feeling it wont leave her. Consumer was informed about the role of Pfizer Drug Safety. Consumer was suggested to contact Medical Information Department for the concern. As the consumer was unwilling to complete the report, further probing could not be done. Hence, limited information available over the call. The outcome for all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Vaccination site lump; Vaccination site redness; Vaccination site warmth; Vaccination site swelling; mild soreness at the injection site; mild soreness at the injection site; mild soreness at the injection site; This spontaneous report was received from a registered nurse, concerning a 36-year-old female patient. The patient's pertinent medical history included skin cancer diagnosed in 2012. The patient did not have any concomitant medications and drug reactions or allergies.  On 10-DEC-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, in the left deltoid, at a dose of 0.5 milliliter (ml) by intramuscular route (lot number U008315, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 15-AUG-2023), indication reported as "human papillomavirus (HPV) vaccine". Subsequently, she experienced mild soreness at the injection site that lasted a few days and then went away (vaccination site pain).   On 25-FEB-2022 and 16-JUN-2022, she was vaccinated with the second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, in the left deltoid, at a dose of 0.5 milliliter (ml) by intramuscular route (lot numbers U032636 and U029623, which were verified to be valid lot numbers, expiration dates not reported but upon internal validation established as 26-OCT-2023). The reporter further stated, the patient developed new onset of mild soreness at the injection site that lasted a few days and then went away (vaccination site pain) on unspecified dates in 2022 reported as "after the second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)".  On 03-JUL-2022 reported as "approximately 2 weeks after the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)", the patient experienced redness, warmth and swelling with a lump at the injection site (vaccination site erythema, vaccination site warmth, vaccination site swelling and vaccination site mass). The patient was advised to use cold compress. However, she contacted physician on 05-JUL-2022, as there was no improvement, she was still experiencing redness and swelling.  At the time of the report, the outcome of the events vaccination site erythema, vaccination site warmth, vaccination site swelling and vaccination site mass was reported as not resolved.  Causality assessment was not provided by the reporter.
Severe headache, chills, flu-like symptoms, nausea, vomiting, loss of appetite, extreme fatigue, metallic taste in mouth, pain and swelling in right arm. Symptoms began the night of the vaccine and are still ongoing the following day.
Mild episodes of Migraine; Arm pain where I received the shot; Nauseous; Throwing up several times; This cost me some hours with my work because of this pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 14Apr2021 (Lot number: EW0169) at the age of 24 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: MIGRAINE (non-serious), outcome "unknown", described as "Mild episodes of Migraine"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Arm pain where I received the shot"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; VOMITING (non-serious), outcome "unknown", described as "Throwing up several times"; PAIN (non-serious), outcome "unknown", described as "This cost me some hours with my work because of this pain".  Additional information: Other Products and Investigation Assessment are reported as NO  No follow-up attempts are possible. No further information is expected.
I woke up the morning after my second Pfizer vaccine with severe body aches, chills, mild headache, low-grade fever, puffy injection site that felt warm to the touch and hurt.  The worst of it was the whole body aches and chills, which made me feel like I have felt in the past when I have had the seasonal flu.  The symptoms lasted all day, with the chills finally leaving by around 10 pm. By the following morning, so about 48 hours after the shot, I felt pretty much normal. I was told I could get these side effects, and don't think they are unusual per se, but thought it was my duty to report them for longitudinal studies.
Lip swelling beginning 48 hours following 1st dose of vaccine. Lips swollen, tight, dry and mildly itchy. Little bumps around the edges of both upper and lower lips.
Within 10-15 minutes of receiving the shot my left arm had a burning sensation into my finger tips. The muscle was sore for the following 2 days and I had trouble lifting my arm higher than shoulder height. A large red raised patch has been at the injection site since 4/6 and has not gotten better on day 8. The skin is itchy and hot to the touch and it feels like a golf ball size lump is under the surface.
Information has been received form a physician concerning a 6-year-old male who on was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live.  Subsequently, on approximately 16-DEC-2005, the child developed a severe case of chickenpox.  The child had lesions all over his body, including his mouth and scalp.  Unspecified medical attention was sought.  The outcome was recovering.  It was noted that there was an outbreak of chickenpox at the child's elementary school.  There was no product quality complaint involved.  Additional information has been requested.
1.  Someone needs to upgrade those needles, they are too thick.  Felt a rush when the "medication" was going into my body. 2.  Sore arm... extreme sore arm, hard to lift. Immediately after receiving the shot.  No other symptoms the rest of the day (except sore arm) I felt I got lucky but then...  3.  Next day around 11am I felt extremely tired, arm was still sore.  4.  Rashes (hives) started appearing on my left lower leg, minutes later, rashes on right leg. rashes started disapearing 5.  Hours later (next day), rashes on lower back, hours later rashes on side of stomach (below armpits). Rashes disappeared. Hours later rashes on upper back. 6.  Next day rashes on stomach. Rashes would disappear after half hour or so and would start appearing again on different part of my body, but they started on lower legs and little by little started going up my body. 7.  Tired for a whole week. 8.  It's been a while and last time I got rashes was about 3 days ago. Not sure if I won't get them anymore.
At left arm: Cellulitis-redness, hot to touch, started on Keflex. Admitted to Hospital 5/23/04.   Nurse follow up on 06/18/04 states: "Remove: Rhinitis, Pharyngitis."
This spontaneous report as received from an executive refers to unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were provided. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB Pediatric (unknown route, strength and dose) lot # K018180 and expiry date of 17-SEP-2016. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt reports right arm pain/numbness since receiving Tdap vaccine at outside facility. Previously diagnosed with tendonitis.
I have to wait nine months for my second dose . (referring to vaccine). Later on, she stated: " I caught it twice; I have to wait nine months for my second dose . (referring to vaccine). Later on, she stated: " I caught it twice; This is a spontaneous report from a contactable consumer.   A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose, for COVID-19 immunisation.  The patient medical history included "I caught it back in October of last year (COVID-19; Oct2020)". Concomitant medications were not reported.  The patient stated, "I have to wait nine months for my second dose (referring to vaccine). Later on, she stated: I caught it twice (covid-19)". The outcome of the events was unknown.   Information about lot/batch number has been requested.
due for their 2 nd dose of Shingrix in March 2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th November 2020, batch number ce4de, expiry date 25th September 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that, patient was due for their 2nd dose of Shingrix in March 2021 but was coming in now. The reporter stated that, 2nd dose had not yet been administered. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Covid Vaccination Monitoring Documentation: PT admit 11/12/21 ? 11/23/21. POC SARS COV2 ANTIGEN POS 11/12/21. Pfizer 1/22/21 Lot# EL9261, Pfizer 2/12/21 Lot# EN9581.
Little pain when she raises her left arm. Redness just above the elbow to just below the shoulder approximately 60% of circumference of arm. Warm to touch and swollen.  Patient had a similar reaction more than 5 years ago to Pneumovax 23.
Moderate to severe shortness of breath.  Was seen by PCP, ER, and cardiologist.  Also several days of bradycardia/tachycardia.  Heart rate fluctuated from 36-202.
broke out in hives;pt reported this to staff upon returning to have PPD read, 48hrs later;hx reported allergic to eggs but eats them;hives
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient 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 11-Jan-2023, 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 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case contains information for the 60th out of 100 adult male patients described by the reporter. Concomitant Medication use information was not provided by reporter. Nurse reported that an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again. The 100 adult male patients were involved. Moderna COVID19 vaccine bivalent, dosage given in ml unknown to the HCP.  Treatment Medication use information was not provided by reporter   This case was linked to MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-697752:Master case
Moderna vaccine was given after published expiration date. No adverse reaction. Vaccine was given on 05/02/2022. expiration 04/29/2022. No signs or symptoms noted at the time of vaccination, Patient was monitor for 15mins after administration and tolerated well.
Parent called office at 12:00pm. stating that patient had a headache, vomiting, and felt like her throat was closing.  Mom brought her immediately to Emergency room. Was given epipen, solumedrol, Pepcid, Benadryl, Zofran and Tylenol.  Given IV fluids (normal saline)Monitored. Discharged home at 4:37PM. Was given prednisone and epipen prescription on discharge.
Point of injection began swelling, became every hot, extremely sore/tender to touch. Called Dr., iced area, took BENADRYL, ibuprofen. Swelling increased for few hours, remained steady following day. By 11-3-13 arm was good.
5/18 arm slightly sore, 5/19 right arm deltoid red, hot, hard lump size of base ball. Treated with ice advil. Arm less swollen, still red and warm.
Immediate metal taste after first dose.  Two days later intense panic attacks that I haven't experienced in 20 years.  Thought I was going to have to call an ambulance  Second dose had another panic attack the day after but not as intense.  Did have burning in my mouth for 3-4 weeks
Patient present with a fever and concern for COVID due to exposure. Patient ended up testing positive for COVID and is fully vaccinated.
This spontaneous report as received from a Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 04-SEP-2018, the patient was vaccinated with improperly stored VARIVAX lot # N022981, expiration date: 23-AUG-2019, dose 1 for prophylaxis. Concomitant therapies included sterile diluent. The vaccine had temperature excursion of -14 degree C to -10 degree C for 10 hours 15 minutes. Previous temperature excursion of -14 degree C to -10 degree C for 135 Hours and 45 Minutes. The call was due to the digital data logger. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001739.
Dizziness, lost of balance, lightheaded, vomiting , sweats onset around 11:30 am went to ER diagnosis was Vertigo,
Within 2 hours of receiving the first  Covid19 Moderna vaccine injection I suddenly became very tired and with strong chills throughout rest of day and throughout the night. No fever that I am aware of.  I slept on and off for many hours.  It actually continued for 4 days in varying degrees and on Day 5 I woke up that morning feeling like my old self, energized and ready to have a normal day...which I did!!
The pt experienced a local erythematous reaction with pruritis on the right shoulder area. No generalized reaction.
Swollen arm Itchy arm Chills Uncontrollable shivering Fever Sweating Extreme fatigue Bad dreams  Remained at hospital for 30 minutes after injection  for observation due to history of asthma and ibuprofen allergy.  No reactions that that time.   Symptoms started approximately 12 hours after injection.  Gradually went away and almost gone after 72 hours.
Patient reported a hard spot, itch and redness on her left arm at site of injection on the first day, possibly on the second day after injection. Patient states that The site was warm to the touch , she had mild pain that was tolerable. No fever was reported. The site went from bright red to dark red . It was reported by the patient that it bothered her for the first 5 days; but she thinks its getting better. I told the patient that I would inform her physician of the reaction and for her to monitor it and contact myself or the doctor immediately should her condition changes.