chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021 at 10:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021 at 10:47 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.55.  Concomitant products were not provided.  On 27-Feb-2021, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
After the shot I had nausea and fatigue for 2 days. Months after I had a sore throat, fatigue, and sniffles. I saw the doctor on a cruise, and he tested me COVID-19 and it came back positive.
This spontaneous report received from a registered nurse referred to a 4 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 22-SEP-2016, the patient was vaccinated with M-M-R II (lot number: M004305), dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830: same reporter US-009507513-1609USA013814: same reporter US-009507513-1610USA004339: same reporter.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 26-NOV-2014 the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # H017027, expiration date 14-SEP-2014) subcutaneously (dose not reported). No adverse effects were reported. Additional information has been requested.
3/12/21 - 6:00pm Behind the knee cramp started. The pain progressed all the way from my knee all the way down to my foot.  My right arm is sore around where I got the shot.  I am having some chills. No fever.  By 7:00 pm it is very hard to walk and took 3 Advil.  By 10:00 pm my left is still hurting but I think the pain is less.  3/13/21 - 5:43 am got up and I am able to walk with minimal pain.  7:00am ? I am noticing that the top of inside my mouth (the palate) feels sore.  I am going to try some gly-oxide.  8:15am ? pain in my right leg is getting worse. Taking 3 Advil.  8:30am ? rinsed mouth with Peroxil and then with Gly-oxide.  My leg pain is back this evening but not as bad as it had been before.  3/14/21 ? During the night my mouth was very sore, so I got up to do a rinse with Gly-oxide.  Woke up with a headache.  Took 2 Advil.  My upper arm is sore and I have a redness with knotting.  My leg paid is almost all gone. I think I am going to be okay!
Started aching right away.  Went to doctor and they did not think there was anything wrong.  By 2nd doctor visit could hardly walk and diagnosed with Fibromyalgia Rheumatica.  Patient sent to therapy and it did not help. Patient had a lot of pain in joints and couldn't comb hair.   In August, patient prescribed steroids (Prednisone) and decreasing dose over time as condition inproves--from 4 to 2 a day.  Patient told that had to be weaned off steroids slowly to avoid headaches.     Doctor specified patient should not receive 2nd dose because of problems that resulted.  Patient is at 75% recovery.
pt was inadvertently administered a dose of DTP; devel tenderness @ inject site & low grade fever; treated w/APAP; pt recovered;
About 24 hours after vaccine began experiencing lethargy, tiredness, and injection site soreness. 24-48 hours later began experiencing muscular and skeleton pain in right arm. Pain lasted approximately 6 weeks and was so severe at times I couldn't perform simple everyday tasks. Saw dermatologist for sebaceous cyst on scalp and rash on back of neck.
diagnosed with Covid 19/tested positive for Covid-19; diagnosed with Covid 19/tested positive for Covid-19; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age (Age: 62 Unit: Unspecified) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1st via an unspecified route of administration on 26Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested positive for covid-19 (drug ineffective) on an unspecified date. It was reported that the patient called in to ask if he can still get his second dose of the vaccine. He got his first dose last 26Mar2021. Second dose is scheduled on 17Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
COVID-19 test / PCR nasal swab test was positive; COVID-19; Headache; Fever of 99.0; Ill; This is a spontaneous report from a contactable consumer (patient) and nurse. A 48-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) at age 48-years old, the first dose via intramuscular route of administration in the left arm on Jan2021 08:00 (Batch/Lot Number: EL3248) as a single dose, then at age 48-years old the second dose via intramuscular route of administration in the left arm on 02Feb2021 16:45 (Batch/Lot Number: EL3248) as a single dose for COVID-19 immunization at a workplace clinic. Medical history was not reported. The patient did not have COVID-19 prior to receiving the BNT162B2 vaccination. Concomitant medications were not reported. On 08Apr2021, the patient reported he was ill. On 09Apr2021, the patient began to experience headache and a fever of 99.0. On 12Apr2021, COVID-19 test (PCR nasal swab test) was positive. The events resulted in a doctor or other healthcare professional office/clinic visit. Treatment was reported as unknown. The outcome of events vaccine failure, COVID-19 test positive, illness, headache and fever was recovering
Severe Rt. Arm pain waking up early AM, 12 hours after the shot, with total body weakness, dizziness, flu-like feelings, lasting a full day, had to stay in bed.   Then after 24 hours, Rt Underarm Lymph Nodes swelled up with much pain, although Rt Shoulder muscle was better, and I could get out of bed and move around a little the 2nd day.  The Rt. Underarm Lymph Nodes are still swollen and painful, after 48 hours.
arm sore; chills; she felt tired and weak; she felt tired and weak; headache; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Mar2021 as SINGLE DOSE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient received her 1st dose on 28Mar2021. She also mentioned that she felt arm sore, headache and chills for a few days now. Also, she felt tired and weak. The outcome was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt in need of Pneumovax vaccine, LN inadvertently administered Expired Immunization. LN informed PCP of inadvertent vaccine administration and clinical/medical director, LN called Merck& Co in and spoke with medial staff in regards to inadvertent vaccine administration staff stated they would call this LN in 1 business day with more information on inadvertent vaccine administration.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 23rd November 2018, the patient received the 1st dose of SHINGRIX. In February 2019, 1 hr after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The pain in arm resolved within 2-3 days. The reporter did not consent to follow-up. This case linked with US2019026015, reported by same reporter for the same patient.
Sore joints; temp 100; chills; swollen lymph nodes in right armpit; mild headache; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Right arm on 04Mar2021 14:30 (at the age of 50-years-old) as a SINGLE DOSE for COVID-19 immunisation. The patient's medical history was not reported and patient had no known allergies. Concomitant medication included atorvastatin, taken for an unspecified indication on an unspecified date received within two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EC-3249), via an unspecified route of administration, administered in Left arm on 11Feb2021 at 14:30 (at the age of 50-years-old) as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 05Mar2021 at 09:00, the patient experienced Sore joints, temp 100, chills, swollen lymph nodes in right armpit, mild headache. The patient underwent lab tests and procedures which included body temperature: 100 degrees on 05Mar2021. No treatment was received for adverse events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The 3rd day my stomach is very bloated with lots of bubbling.; The 3rd day my stomach is very bloated with lots of bubbling; 2 days later had headache, stomach cramps, threw up and diarrhea; 2 days later had headache, stomach cramps, threw up and diarrhea; 2 days later had headache, stomach cramps, threw up and diarrhea; 2 days later had headache, stomach cramps, threw up and diarrhea; Got light headed the day of the vaccine; Thumb locked up.; The my left hand started hurting and my thumb locked up.  It hurts even to pick; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the right arm on 03Mar2021 at 14:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the 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 vaccination. Concomitant medications included levothyroxine sodium (MANUFACTURER UNKNOWN), chlortalidone (MANUFACTURER UNKNOWN) and bupropion hydrochloride (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received clindamycin (MANUFACTURER UNKNOWN), amoxicillin (MANUFACTURER UNKNOWN) and sulfa (MANUFACTURER UNKNOWN) taken for an unknown indication. On 03Mar2021 at 14:00, the patient experienced light headed the day of the vaccine. On 05Mar2021, 2 days later the patient experienced headache, stomach cramps, threw up and diarrhea. On 06Mar2021, the 3rd day, the patient stomach was very bloated with lots of bubbling. On an unknown date in Mar2021 the patient's left hand started hurting and thumb locked up.  It was mentioned that it  hurted even to pick up a sheet of paper. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events light headed, headache, stomach cramps, threw up and diarrhea, stomach was very bloated with lots of bubbling and left hand started hurting and thumb locked up were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Within minutes of administration of vaccine in left arm, patient had deep aching pain in Left shoulder. Within hours patient developed frozen shoulder and was unable to move shoulder for 3 days. Also unable to sleep due to pain. Patient then started gentle range of motion exercises and had improved mobility but still significant pain and weakness. Patient started PT 12 days after vaccine and is still undergoing twice weekly PT. Patient is now 5+ weeks after vaccine, still with pain and weakness in shoulder, is having some improvements after PT but is not back to baseline.
arm really hurt; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date and the patient arm did not hurt with it). Concomitant products included thyroxine sodium (Levothyroxine) and estradiol (Estrace).   In October 2018, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after starting Levothyroxine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient had no underlying disease and historical condition. The patient received Shingrix and experienced pain in arm. The patient stated she understands that arm hurt was a common side effect.
Information has been received from a registered nurse within the physician's office concerning an 8 year old patient was vaccinated with the second SC dose of varicella virus vaccine live (Oka/Merck) (no lot number was given). Subsequently, the patient developed an injection site reaction of redness and injection site swelling on the arm where the vaccine was administered. Unspecified medical attention was sought. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
No adverse event; Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, 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 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of 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 ACCIDENTAL UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent).    No concomitant medications were reported. No treatment medications were reported. 7 patients received 0.25 mL doses instead of 0.50 mL of Moderna COVID-19 Vaccine Bivalent on 21Oct2022.   This case was linked to US-MODERNATX, INC.-MOD-2022-663507, US-MODERNATX, INC.-MOD-2022-663578 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-663578: US-MODERNATX, INC.-MOD-2022-663507:
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Psoriatic rash all over the body-Severe
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient started to feel dizziness after 15 minutes of the waiting period. He was told to lay down and lift his feet up. He mentioned that it was  BP after 15 mins was 135/73. Water  and orange juice were given. Patient laid on the floor with legs up for 15 mins. After that the BP down to 117/73. He was able to walk okay and he said he felt okay 100% before he left.
Cellulitis of left upper extremity, necessitating doctor's visit and course of antibiotic which was started today
Patient received the Pfizer original strain vaccine and should of received the Pfizer bivalent omicron coverage.
shingles; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age BNT162B2 (Pfizer Covid-19 Vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient mentioned that she was due for the second dose the next Tuesday at the time of reporting. She currently has shingles (onset date not specified) and would like to know if that would interfere with her second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Complained of rash x 3 days (started 4/2/04). Seen in office with numerous lesions on trunk and extremities, mouth, eyelids, hair--various stages. Imp: chicken pox
Changes in menstrual cycle.  Brown spotting, cramping  and no period for 2 months  after 2nd vaccine.   I am usually very regular.
This spontaneous report as received from a licensed practical nurse, refers to a 12 month old patient (gender was not reported). On 22-OCT-2014, the patient was vaccinated with the dose of MMR II (dose, lot number and albumin status were not reported), subsequently a little to right of the vastus lateralis (almost on the backside). No adverse effects were reported. Additional information has been requested.
This case was reported by a physician via a sales representative and described the occurrence of stinging at the injection site in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of Twinrix. At an unspecified time after vaccination with Twinrix, the subject experienced stinging and burning at the injection site. This was also reported to be a product complaint as the reporter felt the events were related to a quality issue with the Twinrix injection. The outcome of the events are unspecified. It was reported that 10 subjects (including this one) experienced burning and stinging at the injection site following administration of Twinrix form the same lot. Linked cases include: A0752060A, A0752087A, A0752088A, A0752090A, A0752091A, A0752092A, A0752093A, A0752094A and A0752095A. Follow-up information was received on 04 November 2008, by a physician and described the occurrence of injection site stinging in a 28-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 29 September 2008, at an unspecified time after vaccination with Twinrix, the subject experienced injection site stinging, injection site burning and product complaint. On 29 September 2008, the events were resolved. The physician considered the events were related to vaccination with Twinrix. The physician associated the events to possible irritating substance in lot AHABB128AB. The lot was removed from vaccination circulation.
started 2 days after second Moderna vaccine dose  with HA and body pain, arthralgia.  patient reports fingernail splinter-like erythematous lesions  also  seen  on physical exam. elevated ESR and CRP ( at the time patient had worsening  hidradenitis suppurativa lesions)
Rash on legs, left foot swollen, noticed rash the same night of Flu shot given. No redness at site of injection.
My diverticulitis in May was a flare up and I was in the hospital for 3 days.  When I was in the hospital the nurse advised that had a lot of the diagnosis of diverticulitis.  In June I was talking to the staff at the dentist, and they had people in the office that had the same issue with the Moderna vaccine.  I wanted to report due to what I was hearing and that maybe it was not just because. I have had two battles of diverticulitis since the vaccine.  I am still trying to deal with one currently.  I am having difficulty taking antibodies due my long list of allergies. I have to so many.
pt recvd vax 13NOV90 & 5 to 7 days following vax devel hives specified as a rash of large welts over entire body, seen by MD treated w/Hydroxyzine & pred; MD felt exp contact dermatitis;
swelling and redness started hours after and continued. Whole arm swelled up and went to ER on 10/12/19 since it was getting worse. ER (Dr.) prescribed Zofran, Prednisone, and Norco (patient didn't pick up Norco though).