chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stomach pain that feels like someone punched me in the stomach; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain that feels like someone punched me in the stomach) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 006B21A and 022M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Osteopenia (Severe) and Arthritis (arthritis in thumb).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In December 2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain that feels like someone punched me in the stomach). The patient was treated with ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) for Stomach pain, at an unspecified dose and frequency; ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (MAALOX [ALUMINIUM HYDROXIDE;MAGNESIUM HYDROXIDE;SIMETICONE]) for Stomach pain, at an unspecified dose and frequency and SUCRALFATE (CARAFATE) for Stomach pain, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain that feels like someone punched me in the stomach) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had been giving self an injection with a pen concomitantly for arthritis.  The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had stomach pain that feels like someone punched patient in the stomach since December 2021. Patient couldn't do sit ups and was on pepcid, maalox, and carafate and the medications had been improving symptoms. The pharmacist told to patient stomach pain will not go away.   This case was linked to MODERNATX, INC.-MOD-2023-700856 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-700856:Case for Bivalent dose
Dad of patient was in room while injection was given. Later in same day dad noticed reaction on same. Plan of treatment per doctor cold compresses and Benadryl. Referral to allergy clinic.
Within an hour or two the Patient reported severe pain and swelling and inability to move her arm. We advised her to call or see her Doctor which she did the next day.
Narrative:  COVID infection following COVID vaccine series 01/27, Pfizer, dose #1 02/16, Pfizer, dose #2 08/20 COVID swab, result: detected 08/22 pt cc: No symptoms exposure: unknown
received a dose of the Moderna COVID19 vaccine bivalent after its beyond use date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID19 vaccine bivalent after its beyond use date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender 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 an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID19 vaccine bivalent after its beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID19 vaccine bivalent after its beyond use date) 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 (received a dose of the Moderna COVID19 vaccine bivalent after its beyond use date).    No Concomitant medications were provided. It was reported that 1 Patient received a dose of the Moderna COVID19 vaccine bivalent after its beyond use date   Reporter does not had more information of the event at that time. No treatment medications were provided.
I am concerned because they inadvertently gave my 16 year old son the Moderna vaccine instead of Pfizer. We are worried because Moderna has only been approved for 18 and older. He doesn't have adverse events, just fatigue.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, and concomitant medication. On or about 16-FEB-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a physician's office, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-Aug-2016, the patient was treated at the physician's office for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The patient was prescribed prednisone for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
A physician reported the occurrence of limb swelling in a male subject of unspecified age who was vaccinated with Infanrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not provided. On an unspecified date, the subject received his fourth injection of Infanrix. Twelve days post-immunization, he developed limb swelling. The physician stated that he had not examined the subject.
Sore arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to sulfur), Allergy to antibiotic (Allergic to Erythromycin), Hypothyroidism and Anxiety. Concomitant products included SERTRALINE for Anxiety, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) outcome was unknown.            The patient called to report some side effects which the patient experienced after receiving second dose. The patient experienced Sore arm and Chills. It was also reported that the patient had never tested positive for Covid-19 and did not receive any other vaccine within 1 month prior to Moderna Covid-19 vaccine.  Reportedly, the patient did not seek for medical care attention.  No treatment information was provided.   This case was linked to MOD-2022-541551, MOD-2022-541806, MOD-2022-541807 (Patient Link).
Swelling; Pain at the injection site; Redness; Arm is warm to touch; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling, injection site pain, injection site erythema and skin warm. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site erythema and skin warm were recovering/resolving.   It was unknown if the reporter considered the injection site swelling, injection site pain, injection site erythema and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced  swelling,  pain at the injection site, redness and the arm was warm to touch,  No other information was provided. Patient was in a hurry so did not provide other information. Consent to follow up was provided.
Swollen to the size of a baseball, red, sore,itchy, and hot to the touch.
Parents note left hip inflamed @ vaccine site.  Received both Kinrix and MMR in that upper leg.  NO c/o pain.  Ambulation and all movement without a problem. Cold compress at home, ibuprofen if needed.
Recipient presented with pallor and diaphoresis. Recipient reported seeing "black spots" and feeling "dizzy". Apple juice and pretzels were provided. Symptoms persisted for approximately 15 minutes and then abated.
Herpes type outbrake on penis three weeks after vacination.One month later again the same outbrake.Five weeks later a rash on left side of stomach and now post-herpetic neuralgia.
Very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Very bad headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Food allergy.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Very bad headache). At the time of the report, HEADACHE (Very bad headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.   This case was linked to MOD-2021-116457 (Patient Link).
Patient called on 9/28/07 at 2:45 to let us know that she had hives on both arms and c/o eye lids being very itchy this was at approximately 3:00 pm on day of injection patient took 50mg of Benadryl with relief noted. Also took another 25mg at bedtime due to itching arms and eyelids. Patient ? MSG allergy. Told patient to come in and be seen - noted healing hives on both arms.
Fever of 103F during the night with vomiting, pain and weakness of right leg. Also had inconsolable crying.
Urticarial rash developed 4 days after vaccination.  Resolved with Benadryl.
This spontaneous report as received from a physician refers to a 1 year old patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On 22-APR-2016, the patient was vaccinated with VARIVAX (lot # L049536 expiry date 08-DEC-2017, dosage information not provided). Concomitant medication was not provided. On an unknown date in 2016, the patient experienced local cellulitis. On 06-MAY-2016 and 07-MAY-2016, the patient was seen by the physician and the patient was treated with KEFLEX for local cellulitis. Since then patient's symptoms were resolved, on an unknown date. Causality assessment was not provided. Upon internal review "cellulitis" was determined to be medically significant. This is one of several cases received from the same source. Additional information has been requested.
Rash began on back, then spread to buttocks and chest. Lesions are itchy. To do Benadryl and gave script for Acyclovir by mouth.
COUGH; SORE THROAT; RUNNY NOSE; MUSCLE PAIN; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced cough. On 19-JUN-2021, the subject experienced sore throat. On 19-JUN-2021, the subject experienced runny nose. On 19-JUN-2021, the subject experienced muscle pain. On 19-JUN-2021, the subject experienced severe headache. On 20-JUN-2021, treatment medications included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, fexofenadine, ibuprofen, naproxen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, cough, sore throat, runny nose, and muscle pain. This report was non-serious.
injection site pain; bruising at injection site; injection site redness; severe chills; headaches with the vaccine; high fever of 104.3; This spontaneous report was received from a consumer, regarding herself, a female patient of unknown age. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were reported as unknown.  On 10-NOV-2020, the patient was vaccinated with a single dose shot of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# unknown; dose, frequency, route and expiration date were not reported) to prevent pneumonia from her pharmacy.  On the same date, the patient had some adverse experiences such as injection site pain, bruising at injection site, injection site redness, severe chills, high fever of 104.3 (unit not reported), and headaches with the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). She stated as of 16-NOV-2020 (reported as today), she still had these symptoms. No treatment was given for the events. The patient stated that she was going to contact her physician for follow-up. It was unknown if lab diagnostics or studies were performed. The patient did not sought medical attention. The outcomes of the events were reported as not recovered. The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
p/walking to car p/vax in lt arm pt became dizzy;lt arm was painful & when move it became nauseated;exp tinnitus saw rings in field of visions & was nauseated;pt guardian called 445PM & informed that pt recovered & was feeling much better;
ABOUT 50 MINUTES AFTER RECEIVING VACCINE PATIENT DEVELOPED SWEATINESS, DIZZINESS, GENERALIZED WEAKNESS. HAD SIMILAR REACTION TO FIRST DOSE IN DECEMBER BUT DID NOT SEEK MEDICAL ATTENTION OR REPORT REACTION.
administered with an expired vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Oct-2021 and was forwarded to Moderna on 26-Oct-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided. They moved the vial from the freezer to the refrigerator on 18-Oct-2021 and administered it to 12 patients today. It was not know if these were the patients' 1st or 2nd doses.
Pt is working at vaccine site.  1 hour 1 15 post vaccine pt states she felt hot in her face and hands.  Came to Triage 1 where evaluated by EMT & MD.  BP 118/55, HR 52, Resp 20, 02 100% RA.  Pt stayed for 10 mins and then said she was fine and went back to work.
Patient received vaccine 7/16/2021 and was admitted to the hospital with a Corneal Abrasion. At the time of admit he tested positive for COVID-19.  Homeless
Tachycardia a consistent heart rate of 90 to 120 bpm with a resting heart rate of 79 bpm. Flushing/red check. High blood pressure, chest pain, back pain.   Follow up with Cardiologist December 20th 2021
First dose- Local symptoms: Pain-discomfort, swelling. General symptoms: nausea. 1/25/21,Second dose- Local symptoms: Pain-discomfort, swelling. General symptoms: nausea, chills, muscle pains, fatigue. Narrative:
Onset of symptoms began at 5:30 PM the day of my vaccination and started with severe aches in my lower back,  a headache  developed within an hour,  by 9:00 PM I was running a low grade fever (100.1) and was feeling nauseous likely because of the developed headache/light sensitivity.   By 9:00 AM on the 4th, I was just feeling lethargic with a bad headache.   All symptoms were gone by 10:30PM on the 4th, the day after I received the vaccination.   There was also injection site pain, but was mostly gone by 4/5.  I began taking Tylenol at 6:30 on the 3rd and was taking it every 4 hours until the evening of the 4th. I also used a heating pad and took an epsom salt bath to help alleviate aches and pains.
There was a temperature excursion of Temp 82.3F for 4 hours.  The drug should not have been used.  Patient has had no adverse symptoms.
Very sore arm, fever (101.4), fatigue, aches, chills -- resolved after 1-2 days. Red itchy shoulder at vaccine site starting after 7 days
Shingles  On Tuesday 4/20 had bad headache on left side of head only in two spots. Then had a electrical like sensation down my neck to the top of my left shoulder. Later in evening my back hurt and I checked the spot and I had red swollen spot on left side under my armpit. Called Dr. office Wednesday 4/21 to get an appointment. Doctor away sa w  np. He prescribed valcylovir and gababentin. On Sunday 4/18/2021 I had a severe reaction to the second dose. Could not drink or get out of bed.
Patient began to feel lightheaded and proceeded to lie on the ground immediately after I gave her the vaccination. Her mother was present and stated that her daughter has vasovagal syncope and that this always occurs whenever her daughter gets nervous about something (even at the eye doctor when receiving eye drops). The patient's eyes rolled into the back of her and began to shake uncontrollably and lost control of her bladder. The patient came to about a minute or so later and drank some orange juice. She was monitored for an additional 30 minutes. The mother told me not to call 911 since this has happened to her daughter before.
A 55-year-old female consumer reported that she received influenza virus vaccine, trivalent, types A & B (2002-2003 formula) (manufacturer unknown) on 24-OCT-2002.  Concomitant therapy included levothyroxine sodium (Synthroid), estradiol (Estrace) and medroxyprogesterone acetate (Provera).  Medical history included allergies to sulfa drugs and sulfites, and hypothyroidism.  Within 2 days of receiving the flu vaccine, the patient experienced "intense itching all over body", such that she "scratched her skin raw".  Treatment included "oral and topical steroids", but the patient stated "the steroids made it worse".  She discontinued treatment after one week.   The patient stated the itching resolved spontaneously in mid-December 2002.
Redness and swelling for 2 days at the place of injection.  Fatigue and dizzyness
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).    Concomitant product use was not provided by the reporter.  Dosage text was reported as Additional Booster.  Nurse reported an adverse event 100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again 100 adult male patients were involved.  Treatment information was not provided.  This case contains information for 24th of 100 adult patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-697752:MASTER  CASE
This case was reported by a nurse and described the occurrence of an injection site reaction in a 32 year old male who received hep B vaccine recombinant (Engerix B) for prophylaxis. On 9/29/03, the pt received the second dose of Engerix B (5444A4). Later that day, at an unspecified time post-immunization, the pt developed an injection site reaction characterized by swelling, warmth, redness, and induration that was approximately 1.5 inches from the injection site. The pt was seen by the physician. The outcome of events is unknown. Per follow up report events resolved on Sept 29 2003.