chrisvoncsefalvay/vaers-outcomes huggingface dataset:
low grade fever broke off after 24 hrs of having the second shot; severe pain at injection site; chills; muscle pain; joint pain; tiredness; Severe pain at injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Severe pain at injection site), VACCINATION SITE PAIN (severe pain at injection site), CHILLS (chills), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Severe pain at injection site). On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (severe pain at injection site), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (tiredness). On 03-Feb-2021, the patient experienced PYREXIA (low grade fever broke off after 24 hrs of having the second shot). On 02-Feb-2021, CHILLS (chills) outcome was unknown. At the time of the report, VACCINATION SITE PAIN (Severe pain at injection site) had resolved and VACCINATION SITE PAIN (severe pain at injection site), MYALGIA (muscle pain), ARTHRALGIA (joint pain), FATIGUE (tiredness) and PYREXIA (low grade fever broke off after 24 hrs of having the second shot) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
10 days post injection, developed sore lymph nodes under vaccinated arm. 12 days post injection, developed a hot, red, raised, ring-shaped rash/lesion centered over the vaccination site, which had a "burning" sensation.
Assuming SIRVA - immediate arm/shoulder soreness which then developed into pain & reduced range of motion which still continues today.  There was also nerve pain that existed for some of this past year.  Also reduced muscle strength (sometimes very difficult to reach & hold dinner plate from cabinet & even hold a hair dryer, put on a car seat belt, etc.).  Medicine (acetaminophen, ibuprofen & aspirin) doesn't relieve pain.  Symptoms continued to worsen; therefore, Dr. appt on 10/19/21 - physical exam was done which then led to 6 weeks of physical therapy.  Continued with pain & range of motion wasn't restored.  Therefore, another Dr. appt - Xray to confirm no tears and an ultrasound was done.  Received a steroid shot on 12/13/21 & again on 2/23/22 but continue with pain & reduced range of arm/shoulder motion.
patient was really not feeling a 100%; still felt low energy; he is tired; feeling sluggish; mind was in a fog. He had brain fog.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 72-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EW0153), via an unspecified route of administration on 03May2021 at 14:30 (at the age of 72-year-old) as single dose for COVID-19 immunization. Medical history included diabetic, cancer and thyroid (Levothyroxine or Synthroid 100 mg further not clarified). Concomitant medication included pantoprazole taken for acid reflux, losartan taken for blood pressure, simvastatin taken for blood cholesterol, metformin, ascorbic acid (VITAMIN C ACID), mecobalamin (VITAMIN B12), VITAMIN B COMPLEX, VITAMIN D NOS, antioxidants NOS, adalimumab (HUMIRA), tocopheryl acetate, ubidecarenone (COQ10), fish oil, chondroitin sulfate, glucosamine sulfate (GLUCOSAMINE CHONDROITIN SULFATE) taken for arthritis. Prior Vaccinations (within 4 weeks) was none and the patient did not have any adverse event prior to vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EW0158), via an unspecified route of administration in right arm on 12Apr2021 at (at the age of 72-year-old) for COVID-19 immunization (his appointment was at 2:53 pm and the vaccine was given within 5 minutes of the appointment). On an unspecified date in May2021, after receiving second dose of BNT162B2, the patient was really not feeling a 100%, still felt low energy, he was tired, feeling sluggish and mind was in a fog (he had brain fog). It was reported that the patient got his second vaccine on 03May2021 and it took him a whole 7 days before he could finally say, he thought he came back to normal but since then and today was Wednesday and today was fifth, he was really not feeling a 100%, he thought he was a 100%, he told he was a 100% Monday, which would had been at 4:00 the day of his second shot. He was still feeling low even with his vitamins (Unspecified Medications), he took his vitamins, and he was just okay for a few hours. The patient stated that he wanted to feel 100 percent, and he tried to go in the open air and sunshine to feel better. He stated that he felt alright in the morning, and he described various vitamins that he was taking. Reclarified, the patient described that he felt like he was dragging on and on. The patient stated that he went back and forth in how he feels. He stated for the past two days, even with his vitamins, he was alright in the morning, but then felt like he was dragging, later in the day. The patient did not take any treatment for events. The patient stated that he was improving, but so slowly. No emergency/physician room visit due to events. No relevant tests. The outcome of the events was resolving.  No follow-up attempts are needed. No further information is expected.
Daughter stated that she had to take her mother to the ER 4 hours after receiving the injection. She was admitted to the hospital for sepsis. According to the daughter the doctor said that the vaccine contributed to the onset of sepsis.
Parents in office today for PE - states child had redness & swelling over the entire upper arm the day after vaccine. Area approximately 2 x 3in redness, irregular shape around injection site - no induration at this time.
Vaccine got expired on 01-Apr-2022, was refrigerated on 04-Apr-2022 and administered on 19-Apr-2022; Vaccine was expired on 01-Apr-2022 administered on 19-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 19-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine got expired on 01-Apr-2022, was refrigerated on 04-Apr-2022 and administered on 19-Apr-2022) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 19-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine got expired on 01-Apr-2022, was refrigerated on 04-Apr-2022 and administered on 19-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 19-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine got expired on 01-Apr-2022, was refrigerated on 04-Apr-2022 and administered on 19-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vial was initially put in the refrigerator on 04-Apr-2022.The vial did not undergo any temperature excursions.The pharmacist thought that vaccine will expired on Jun-2022, however vaccine was expired on 01-Apr-2022.  No Treatment medication was reported.
Severe pain in left arm. Inability to lift arm. Pain with any movement.  36 hours.
Patient reports she woke up on 6/28 with left arm pain. States it felt "internal" and throughout the entire "muscle system". Felt like she needed a sling. Couldn't move arm for the first three days, then gradually increased range of motion. No numbness/tingling, no problems grasping items. Currently unable to use the arm as she preciously could, can't put hair up or lift things. She called the clinic on 6/29/18, she was advised to have it evaluated. She called again 7/10/18 stating that it was still sore and was advised to be evaluated. Writer spoke with her today, 7/13/18, and advised that she have it evaluated in the next few days as she is still having symptoms and it has been three weeks since her vaccination.
as per mom , the evening of 4/25/22 after receiving the vaccines , baby seemed quiet and not crying. had 100.3 F temp, she gave 1 dose of tylenol. all night baby did not wake up or cry to feed which he would normally do . when mom tried to breast feed, he would feed . next morning , he was not moving or crying. did feed when mom fed .  was brought 4/27/22 morning to clinic with the same complaints. when examined was looking around when in mom s lap. cried when put on examining table and also started moving . rest of physical exam was normal. Cbc was ordered and mom was advised to go home and I will follow. when called back after a couple of hours , mom was concerned as was not improving . baby was sent to ER . after evaluation, spinal tap was advised which parents were reluctant and then was evaluated by a hospitalist who advised outpatient neurology consult and didnot think spinal tap was warranted. on 4/28/22 , I had a follow up appointment and baby was still the same . I advised baby get admitted which parents were reluctant but agreed after I did a phone consult with neurologist and examined the baby that afternoon again. was admitted to hospital that evening and had a work up done to rule out infection/ brain space occupying lesion. neuro consult also done . baby started improving a little clinically so was discharged . seen in clinic next week when was improving. had better eye contact and more active. as per mom, was 70% better . has follow up appt with neurology 5/23/22
Patient came in to obtain two vaccines from a previous visit that werent given. Went to clarify with pediatric dept what was needed and was told she needed meningitis vaccines BEXSERO and MENVEO. Those were the immunizations that were given. Patient actually needed Tdap and MENVEO. Patient didnt have any reactions or  side effects.
Left leg swollen 35cm, right leg swollen 30cm, whole top part of thigh is red, hot and hard to touch.
Five days following  administration of the vaccine, axillary lymphadenopathy occurred, on the same side of the body in which the vaccine was administered. Lymphadenopathy persisted for 48 hours. Seven days following vaccine administration, an erythematous rash developed on the left wrist. The following day (eight days following vaccine administration), the rash spready to encompass the upper left arm and shoulder. Generalized severe pruritis was noted, not localized to the area of the rash. Pruritic involvement included but was not limited to scalp, face and, lips. The rash and pruritis did not resolve following oral antihistamine administration.
On 3/7/2021 pt states she developed a rash and hives on her face, back and stomach.  Pt treated it w/ Benadryl, Zyrtec and Pepcid AC.  These symptoms lasted about 7 days. On 3/5/2021 pt developed serious dizziness and balance issues.  pt says she is very unsteady and cannot balance herself and is still having these issues.  she states she lost at least 50% of her balance after taking the vax.  pt contacted her PCP and was told to go to physical therapy 2 times per week.  pt says this is helping but seems to be working very slowly.  pt will continue therapy for about 6 weeks and then will FU w/ PCP.
No additional AE reported; Customer reported expired GARDASIL 9 was a administered to a patient today (12/08/2022). She said the vaccine had expired in Sep2022 (exact date was unknown to the caller). She was calling to check if the vaccine was still viable? She said she would; This spontaneous report was received from a nurse and refers to a female patient of unknown. The patient's pertinent medical history, drug allergies or reactions, and concomitant medications were unknown by the reporter.  On 08-DEC-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL (route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number 1687291, with an expiration date of 11-SEP-2022) administered for prophylaxis (expired vaccine used). No additional adverse event (AE) or product quality complaint (PQC) were reported.
COUGH, HIVES, VOMITING 15 MINUTES AFTER VACCINE ADMINISTRATION. EPIPEN JR AND 7.5ML OF BENADRYL ADMINISTERED. PATIENT RESPONDED WELL TO TREATMENT. PATIENT SENT TO ER BY AMBULANCE.
1. Close exposure to COVID: Requesting COVID test. No respiratory symptoms. Afebrile, stable, nontoxic. COVID PCR obtained.  Chief Complaint(s):  Chief Complaint Patient presents with ? Dizziness     TEAM NOTES: Pt is here today for dizziness.     ASSESSMENT and PLAN: 1. COVID-19  2. Acute suppurative otitis media of both ears without spontaneous rupture of tympanic membranes, recurrence not specified  3. Acute pansinusitis, recurrence not specified  4. Dizziness        Patient Instructions In addition to COVID you have a bilateral ear infection and sinus infection. Start taking amoxicillin as directed, continue to completion. I would recommend a probiotic pill or yogurt (like "Activia" or "live active cultures") 2 hours after antibiotic.  If not any better in the next 3-5 days or starts to get worse please return the office for evaluation. Start taking plain mucinex/Robitussin (not DM) every 12 hours.  Take with plenty of water. Continue flonase. Please call with questions.
Initial unsolicited report received from a nurse on 28-Sep-2015. This case involves a 61 years old female patient (age reported as 60 years) who was vaccinated with a first dose of FLUZONE ID (batch number: UT5354BA and expiry date was not provided) via intramuscular route in the left deltoid on 25-Sep-2015. There was no illness at the time of vaccination. Patient did not have any known allergies. Concomitant medications were not reported. On 26-Sep-2015, 1 day post vaccination; in the morning, the patient developed injection site "golf ball sized lump" which was red, warm to touch and there was induration at the site. The vaccine was given intramuscularly instead of intradermal route. Thus it was a wrong route of administration. Laboratory data and corrective treatment were not provided. The patient was recovering from the above mentioned events. List of documents held by sender: none. Addendum: 25 April 2016 Upon second medical examination of the case at the time of internal review the following has been change in the case; Amend the suspect product code 476 instead of 390, corresponds to the LOT number UT5354B.
L arm swollen and painful still at 6 days, but this seems to be "plateau" day. Shoulder joint pain and pain up into her neck. Started 24 hr after injection & still hurts her today. No s/sx overt infection.
Identical twins in for office visit.  Both children have speech delays and answer to each other's names.  Worker from group home did not know the days either.  Pt received #3 flu .5cc shot one week apart fro #2 flu on 12/03/2003.  LPN, no incident to report.
Pt complained of a rash 2 days after receiving ZOSTAVAX. Pt came in and the rash was similar to a shingles rash - wrapping around the middle. I referred her to her PCP. He prescribed valacyclovir 1 gm TID after her phone call. The rash was blistering & burning.
This spontaneous report as received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 22-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J009689 with expiration date of 29-JAN-2015 (route of administration were unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for a total of 144 hours and then at 33 Fahrenheit (F) Degrees (0.555555556 Celsius) for a total of 40 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported and nor product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
I have received a flu shot for a few years..this was the first time it was painful when the vaccine was being administered. On 10/05/11 arm felt sore like a tetanus shot for 24 hours then was fine until 10/13. Severe shoulder pain..any movement above shoulder height or when reaching across body extremely painful waking me up all through the night..
11/22/04 am mother first notices beginning of rash over body and swelling around both eyes. Child complains that it itches. 11/23/04: She brings him in to clinic. Periorbital swelling with slight redness is noted, eyes bilat. His body, arms and legs are covered in urticarial, irregular shaped wheals of varying sizes. Child appears to be in no distress. Denies trouble breathing now or earlier. No fever. And is not complaining of itch at this time. Mom is instructed to give OTC Benadryl as directed and have him take baking soda baths for itch. 11/24/04: FU by phone. Mom reports; rash almost completely resolved by afternoon of 11/24/04 and was completely gone by the next day.
Started having nausea, fever, chills, headache and achiness with a bad cough. Took a home COVID-19 test and was positive. Symptoms kept becoming extremely worse over the next couple of days. I was extremely tired and weak and could barely get out of bed before feeling exhausted again. Contacted doctor and was prescribed PAXLOVID. After full course of PAXLOVID, started feeling a little better but kept the metallic taste in my mouth. After about 10 days, I would go through periods where I would be awake for 24 hours and couldn't sleep. Then the next day I was back to feeling exhausted and had a hard time getting out of bed. This happened sporadically several times. I was able to function somewhat back to normal about 2 weeks later. Has still remained more fatigued and have a lingering cough.
Mom states has rash on both legs at inj site, Dr thinks it is related to Bandaid.
Patient called to schedule second dose Moderna, but the wrong vaccine type (Pfizer dose 2) was scheduled instead. Nurse failed to verify with the patient the type of vaccine. Nurse failed to verify CDC card. Nurse failed to communicate with scribe prior to administration. Patient received Pfizer vaccine lot #EW0175, Exp. 8/31/21 at 12:33 pm in left arm. Patient had language barrier. Her husband accompanied her and translated on her behalf. Scribe translated medication error in her language. Patient was concerned with efficacy. No adverse effects at this time.
Drug dose administration interval too long; shingles; This case was reported by a physician via sales rep and described the occurrence of shingles in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 14th May 2018, the patient received the 1st dose of Shingrix. In March 2019, the patient received the 2nd dose of Shingrix. On 22nd August 2018, 100 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. In March 2019, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were provided as follows: The patient had out break of shingles post 1st vaccination. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient did not have out break of shingles post 2nd dose. The reporter agreed for follow up contact.
Pain at shot site for over a week - unable to raise arm above head for over a week, could not resume exercises. Have not felt good since getting shot. No energy - was very active before shot. Moving slower now - not active as before shot.
Per pt , Heart Palpitations, BP 210/137 EKG- A fib
Patient reported to me (about 2 months later) that she developed swelling around the area of the injection. Patient states this area was swollen for about 4 days before going away. No long term harm from this injection site reaction.
she is nervous after second dose of Pfizer vaccine; after the second shot PT stated her arm is red and hurting badly; after the second shot PT stated her arm is red and hurting badly; my arm is so swollen; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received crizotinib (XALKORI), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 250 mg for an unspecified indication; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was nervous after second dose of Pfizer vaccine. After the second shot, patient stated her arm was red and hurting badly. Her arm was so swollen. The action taken in response to the eventsfor crizotinib was unknown. Outcome of the events was unknown.   Information on the batch/lot number cannot be obtained. No further information is expected.
pt recv vax 2AUG96 & became pregnant;pregnancy confirmed by blood tests;estimated date of delivery 9MAY97;@ approx 7 to 9 wk pt exp miscarriage;
LEGS ARE VERY TIRED; WEAKNESS IN BOTH LEG; PAIN IN BOTH LEG, BUT WORSE IN LEFT; HARDLY WALK; CHEST PAIN DURING NIGHT; HEADACHE; SOMETIMES DIFFICULTY BREATHING; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced sometimes difficulty breathing. On 08-APR-2021, the subject experienced chest pain during night. On 08-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced hardly walk. On 12-APR-2021, the subject experienced legs are very tired. On 12-APR-2021, the subject experienced weakness in both leg. On 12-APR-2021, the subject experienced pain in both leg, but worse in left. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sometimes difficulty breathing on 09-APR-2021, and chest pain during night on 08-APR-2021, and had not recovered from headache, hardly walk, pain in both leg, but worse in left, legs are very tired, and weakness in both leg. This report was non-serious.
Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium