chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022).    No concomitant medication was reported.   It was reported that 4 doses of the Moderna Covid-19 vaccine were administered on 18-JUN-2022. 3 doses of Moderna Covid-19 vaccine were administered on 22-June-2023. Expiry date was reported as 27-Mar-2022.  No treatment information was reported.     This case was linked to US-MODERNATX, INC.-MOD-2023-731892 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731892:Master case
approx 24 hrs p/vax pt broke out in  hives w/ c/o itching; no resp sx pt was taken to PMD & was given DPH & rx for DPH to use as needed @ home;
Body aches, really bad back ache and legs aching. Left arm were vaccine was given really sore and armpit and whole left side of body hurt. Burning in throat.
Patient called in to triage stating that the night after she received the second dose of the Pfizer COVID19 vaccine. She reports feeling  nauseated.  Friday 4/9/21 and Saturday 4/10/21 She reports brain fog.  At times she feels unbalanced and does not feel well enough to drive.  She felt very weak "lack of muscle control manifested as muscle weakness. She stated "the weakness is in the middle of the night". "Lose control of my muscles in the legs".   Fell asleep on the floor as she is too tired to walk to bed this has happened 6 times in the past 4 months. Last 2 times were after the COVID19 vaccine  Alert and aware of her surroundings but feeling weak. She reports this happens the night before she "gets covid19".  She reported she is a "COVID19 Long Hauler" She stated she is still "lethargic and weak" since getting the shot. Since getting COVID 19 Vaccine no shivering and no fever.
Broke out with chicken pox 9/23/04. Received Varivax 10/11/1996
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 20-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Concomitant medications details were not reported by the reporter.    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reportedly, In this report the patient was not Eligible. Breakdown of doses were reported as 51 doses from batch number AS7140C and 60 doses from Batch number AS7148B.  Treatment details were not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689946 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689946:Master case
lost appetite; sore throat; muscle pain; lot of headache; nausea; fever goes up and down; tiredness; could not get up, could not walk because of muscle pain; just arm pain / pain in her arm; This spontaneous case was reported by a physician and describes the occurrence of GAIT DISTURBANCE (could not get up, could not walk because of muscle pain), DECREASED APPETITE (lost appetite), OROPHARYNGEAL PAIN (sore throat), MYALGIA (muscle pain) and HEADACHE (lot of headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (just arm pain / pain in her arm). On 04-Feb-2021, the patient experienced GAIT DISTURBANCE (could not get up, could not walk because of muscle pain). On an unknown date, the patient experienced DECREASED APPETITE (lost appetite), OROPHARYNGEAL PAIN (sore throat), MYALGIA (muscle pain), HEADACHE (lot of headache), NAUSEA (nausea), PYREXIA (fever goes up and down) and FATIGUE (tiredness). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (could not get up, could not walk because of muscle pain), DECREASED APPETITE (lost appetite), OROPHARYNGEAL PAIN (sore throat), MYALGIA (muscle pain), HEADACHE (lot of headache), NAUSEA (nausea), PYREXIA (fever goes up and down), FATIGUE (tiredness) and VACCINATION SITE PAIN (just arm pain / pain in her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
On May 14, 1999 the pt experienced varicella with fever. The pt was 34-36 weeks pregnant the time of onset.
On 10/12/2004 developed hives. Given Benadryl 0.5tsp. q6-8 hours
Patient received 2nd dose of Pfizer COVID-19 vaccine earlier than the recommended timeframe. First dose was given on 02/17/2021, 2nd dose was given on 03/05/2021.
-Dizziness began on 08/12/2022 and subsided on 08/14/2022 -Headache began on 08/12/2022 and subsided on 08/14/2022 -Soreness at the injection site began on 08/12/2022 and subsided on 08/14/2022 -Mild body aches began on 08/12/2022 and subsided on 08/14/2022
Symptom progression: Sudden onset of left trapezius tightening w/ radiation to left posterior neck. Progressed to sinus swelling, right eye pain w/ pressure & right anterior headache & nausea. Tachycardia, tachypnea, chest pressure & tightness, air hunger & angioedema.  Treatment 03/30/2021: Epinephrine (Adrenalin) @ 0215 Famotidine (Pepcid) @ 0255 Loratadine (Claritin) @ 0255 Lorazepam (Ativan) @ 0220 Magnesium Oxide (Mag-Ox) @ 0540 Methylprednisolone sodium succinate (Solu-Medrol) @ 0210 Ondansetron (Zofran) @ 0210 Potassium Chloride (KLOR-Con) @ 0356
Patient was ambulating, felt light-headed, then lossed consciousness.  He was caught, so there was no head trauma.  About 5 minutes later, while the patient was seated, he felt light headed, lossed consiousness, and then had a full body seizure with tensed upper and lower body muscles and eyes rolled backward.  It lasted 5-10 seconds, patient regained consciousness, and then was completely alert and oriented within one minute. His mother later reported that about 5 hours after the initial event, he got very light headed but then recovered.  He has been completely normal since then.
Approx 24 hrs after admin,  Aches, chills. Headache. Fatigue.  Difficulty sleeping. Nausea. Jacky cough.   Temporary relief with Tylenol 500 mg tid.
15-20 cm area of erythema, warm to the touch around the DTaP injection site. Pt given KEFLEX 250mg/5mL QID x 10 days.
Information has been received from a health professional concerning a 62-year-old male who on 26-JUL-2006 was vaccinated with a dose of Varivax. However, it was noted that Zostavax was ordered. The reporter indicated "med sound alike error". Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 17-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M033906, expiration date 07-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius (C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082.
Pt reports "I was extremely weak, fatigued, high fever, swollen lymph nodes in my left arm pit and elbow.  my right arm (injection site) is red, swollen, tender and warm to touch"
Moderate erythema at injection site, measures 4.5 inches in width, warm to touch with itching present.
After 4th does (Moderna Bivalent) pounding heart, high blood pressure. No issues with this before. BP at end of July was 110/78.
Brain fog, fatigue, loss of coordination, mood swings.  Symptoms have persisted for 16 days. It continues to affect my ability to perform daily work/home activities. I have not sought treatment yet
On 4/26/21 patient developed symptoms of cough, fatigue, and congestion. Tested positive for COVID-19 on 5/1/21. Meets criteria for vaccine breakthrough case.
Pt states arm is red, swollen 50% bigger than usual and hot to the touch.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of VAQTA (lot # K009954 with expiration date 13-NOV-2015 and lot # L014068 with expiration date 02-NOV-2017; dose and route of administration were not reported). No adverse effects were reported. It was also provided that during the previous call on 23-OCT-2015 (no adverse event were reported at that time), the medical assistant reported a vaccine temperature excursion and inquired about the stability of M-M-R II, PROQUAD (Merck), VARIVAX (Merck) and ZOSTAVAX, but none of these vaccines have been administered to the patients. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received FLUZONE 2011-2012 multidose vaccine at 3PM on 11/7/11. At 6 PM on 11/8/11 Pt experienced constant, severe, pain, numbness and tingling in joints and the whole arm down to wrist and fingers for 6-8 hours. After this symptoms improved but still sore (couldn't lay on arm) for 3 days.
Most pain located in head, fever briefly of 101, Nasal congestion, and chills.  Coughing developed about midway through disease.  Pain in sinuses at back of head.  This lasted 3.5 to 4 weeks.  I went to urgent care and got Prednisone and Doxycycline finally cleared up the symptoms.  Pain remained in rear sinuses and began to travel down neck.  On left side it hurt most and remains.  Right side of neck is stiff and not painful.  Pain goes down neck and into left shoulder.  Physical Therapy is helping, but pain can be debilitating.  X-Ray did not show any issues with neck.
Information has been received from a physician concerning a 58 year old male patient with drug hypersensitivity to "horse serum" and a history of cholecystectomy who on 16-MAY-2007 was vaccinated with a dose of Pneumovax 23. Concomitant therapy included Lipitor and Synthroid . On 16-MAY-2007, three hours after receiving the Pneumovax 23 the patient experienced severe pain in his left arm in the area of injection site. He also had a fever and flu-like symptoms. On 17-MAY-2007 patient still had a fever and flu like symptoms but the pain in his left arm had diminished somewhat. Additional information has been requested.
Pt obtained TDAP on 6/25/08, developed 5x8 rash on LD. Pt c/o slight pain, warm to touch.
Fatigue - the next day. I was really, really tired and had a headache. The next day, I woke up totally fine. I was fine for two or three days. Then I noticed under my arm pit - it was hurting real bad - that took four days to clear up; pain and nothing visual to see. And I had a red spot on vaccination area and it was growing and it went all the down to my elbow. My doctor had me mark it with a circle. It took three weeks for it to clear up. The doctor put me on antibiotics for it.
Covid 19 vaccine was given after beyond use date/expiration date..  Vaccine was maintained at proper storage/handling temperatures.  Parent has been contacted, and states patient did not have any adverse reaction.   Pfizer and CDC have been contacted for stability information and revaccination recommended.
I developed chills, fever, a headache and nausea shortly after the vaccination and I developed a small rash but nothing like after the 1st dose.
Pt. was given Moderna for first vaccine.  The vaccination card was written improperly and said Pfizer, when it should have said Moderna. When pt. came to the clinic for his 2nd vaccine and presented his vaccination card, we verified his card and gave him Pfizer for his second dose. Pt. has hearing disability and was not able to communicate and verify.
Patient was very nervous at time of immunization but was fine. When we notified her that her 15 minute wait time was up she reported being nauseous. I asked patient to wait a little longer. Soon after that she got up to go to the bathroom. She then came back to pharmacy and said she tried to make herself throw up because she was nauseous but she couldn't. She said that her stomach felt bloated and her right arm felt cold. She asked if she could take something for her stomach. I suggested simethicone and she did take that. I asked her to wait longer and she did. 15 minutes later I checked on her and she said she was ok but that she felt as if she had just gotten off of a roller coaster being anxious/nervous and stomach upset.  She said she felt ok but would probably have her daughter drive her home.
A nurse reported that a 76 year old female received her second dose of Pnu-Imune 23 on 10/16/01. On 10/18/01,  she developed an injection site reaction  characterized by a 4 inch by 4 inch area of redness and tenderness. The patient's physician recommended treating it with warm compresses. She recovered.
Redness; Swelling; Pain; Its hot and itchy and swollen at the injection site and it has started to go purple in the middle; Its hot and itchy and swollen at the injection site and it has started to go purple in the middle; Its hot and itchy and swollen at the injection site and it has started to go purple in the middle; This is a spontaneous report from a non-contactable consumer. This consumer (patient) of unknown age and gender reported that he/she received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 19Mar2021 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced erythema, swelling, pain, it was hot and itchy and swollen at the injection site and it has started to go purple in the middle. The event outcome was unknown.  Limited information was available over the call as the consumer was not willing to proceed with the questions.  No follow-up attempts were possible; information about lot/batch could not be obtained.
Today after imms. L arm swelled up at injection site and was very warm to touch. 12 days after imms were given arm is still discolored and warm to the touch.
laboratory positive for chicken pox 3/19/2021. had one dose varivax. Parents had refused 2nd dose.  Saw MD for confirmation. Was exposed to his father with shingles.
pt recvd vax; devel urticaria on face & abdo w/ itching and burning at site; no resp sxs; tx in er w/ DPH & resolved;
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. In February 2019, the patient received SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site itching and skin breakdown. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site itching and skin breakdown were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site itching and skin breakdown to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. About a week ago from the date of reporting, the patient received SHINGRIX on the left side of her body (did not indicated that it was given on arm). The patient experienced itchiness, redness and swelling at the site of the injection. The patient also experienced bursts or bumps on the right side of her neck. The patient would call her doctor if events did not resolve in a few days.
Patient visited primary doctor two weeks after receiving vaccine complaining of flu like symptoms, was diagnosed with viral infection, a week or so later he had trouble closing his eyelid, he went to urgent care where they diagnosed him with Bell's palsy.
Had typical sore arm, tired, and shivers. However between the first and second vaccine and after the second vaccine I have on and off rapid heartbeat/palpitations
Patient noticed on Saturday, 3/19/22, while in the shower that she had a red area on her left arm. It was slightly swollen and warm to the touch. It was located approximately 2-3" below where the Shingrix injection was given. She phoned her PCP who said she should go to Urgent Care. At Urgent Care, she was diagnosed with cellulitis. She was placed on Cephalexin 500mg 3 times daily for 5 days. Patient indicates that the cellulitis is resolving as of Monday 3/21/22.
This case was reported by a consumer via call center representative and described the occurrence of pain burning in a 69-year-old patient who received Herpes zoster (shingrix) for prophylaxis. In December 2021, the patient received the 1st dose of shingrix. On an unknown date, less than a month after receiving shingrix, the patient experienced pain burning. On an unknown date, the outcome of the pain burning was not recovered/not resolved. It was unknown if the reporter considered the pain burning to be related to shingrix. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had had the dose of shingrix 1 month ago. The patient also had Pfizer booster recently. The patient reported that he/she had burning pain (no hives) under the skin of his/her upper back. The patient was due to get 2nd dose by 28th January 2022. The reporter wanted to know should he/she consult PCP (primary care physician).
This spontaneous case reported by a consumer, describes the occurrence of pain (whole body hurting) and arthralgia (both shoulders hurting) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 036A21A) for COVID-19 vaccination. Concomitant products included simvastatin and levothyroxine for an unknown indication. On Mar 3, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 3, 2021, patient experienced pain (whole body hurting) and arthralgia (both shoulders hurting). At the time of the report, pain (whole body hurting) and arthralgia (both shoulders hurting) outcome: unknown. Treatment include (1) naproxen (unknown strength) x1 dose; (2) acetaminophen (unknown strength) x2 doses; (3) ice packs applied topically (as needed). Reporter did not allow further contact.
Muscle pain at injection site CONTINUES with same severity as day of injection and subsequent days. Persists 10/20/10 (almost two weeks) - difficult to lift arm etc. Scar left at injection site.
Rash and bump on arm where shot was given and around the neck. Flu symptoms and fever the day after the shot
Patient arrived at the pharmacy 2 days after vaccine administration with swollen lymph nodes in the clavicular area.  She described feeling general ache on the night of vaccine administration.  The day after, vaccination, she described seeing the enlarged lymph node in the clavicle area.  Patient was followed up the day later and also described having tenderness and pain in her axillary area as well.
Covid-19 I tested positive for Covid-19 on March 14, 2023 at I experienced congestion; headaches; coughing; and a low grade fever. I was prescribed Lagevrio for my symptoms.
papular rash 20mm lt upper arm @ inj site;pt denies pain or itching;no redness or heat @ site;lesion very similar to herpes zoster w/no pain involved;