chrisvoncsefalvay/vaers-outcomes huggingface dataset:
either 6 or 8 doses were administered from 2 vials of same lot number that were past expiration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (either 6 or 8 doses were administered from 2 vials of same lot number that were past expiration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (either 6 or 8 doses were administered from 2 vials of same lot number that were past expiration). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (either 6 or 8 doses were administered from 2 vials of same lot number that were past expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. The reporter stated that 6 or 8 doses were administered over 2 different days 29Sep2021 and 30Sep2021 from vials that were past expiration.
fever for several days low grade, severe pain in arm for two weeks, swelling/inflammation of lt arm, neck, shoulder & back to point that sitting up straight in chair was too painful;bad cold;some soreness;
On this date I had 2 immunizations, one in each arm: SHINGRIX 50mcg (Zoster vaccine recombinant A) and FLUZONE HD PR 17-18 (influenza virus vac split H). 24 hrs of chills, vomiting, body aches, and headaches. On 1/27/2018 I went to pharmacy to have a flu vaccination. On the form I was asked to check the vaccine I was going to received and I asked about the new (I was told improved shingles vaccine) and whether I could have that at the same time as the flu shot. The pharmacist said that I could. A few hours later, I started to get chills, achiness, nausea and vomiting. 24 hours later I started to feel a little better. I'm hesitant to have the second shingles shot for fear that it will produce similar symptoms.
I received my comprehensive physical exam around the time of my second Moderna shot on May 26, 2021.  I received my first Moderna shot on April 30, 2021.  My blood was drawn the day before my second shot, on May 25, and I had a TSH reading of 8.06, higher than it had ever been before (my TSH was tested 5 times since September 2016).  My blood was drawn again 6 weeks later, on July 16, and the TSH reading was 15.03!  T3 and T4 levels were normal: T3 uptake 32, free T4 index 2.1, T4 total 6.5.  I seem to feel decreased energy and possibly a change in mood associated with hypothyroidism.
I experienced the typical reactions of headache, achy joints , and sore arm on 01/25/2021 which continue today, however my anaphylactic event occurred yesterday 01/26/2021.. after my shower I was feeling odd my hands and feet were tingly and I could feel my b/p go up . I made a phone call trying relax but mid call  I could not speak due to throat and tongue swelling and then development of a cough trying to clear my throat.  I grabbed my sons epi pen but I was able to still get air so I didn?t use it. My husband transported me to the ER. They took my straight back took my vitals and administered Benadryl, Pepcid and Dexamethasone  IM  and worked well, they observed me for few hours and I was released. I have follow-up appt tomorrow with primary care,
Patient experienced an anaphylactic reaction 2 days after the injection.  Pt experienced a swollen tongue, and face.  It is unsure if the patient had these symptoms from the injection or from other circumstances.
Received vaccine 3/16, arm and neck sore that afternoon. 3/18 developed muscle aches in back. 3/19-20 - experienced chills, fatigue, myalgias, headache. recovered by 3/21. 3/25-26 had another wave of dizziness, nausea, chills, HA, vomiting. 4/1 - nausea; 4/3 migraine with aura (hadn't experience migraines for several years prior). 4/5 - migraine with aura. PCP advised that she could elect to receive second dose, pt is delaying second dose for the time being.
Information has been received from a medical assistant referring to a 9 weeks old female patient. No relevant medical history or concurrent conditions were reported. On 11-JUN-2015, the patient was inadvertently vaccinated with improperly stored oral, ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
SWOLLEN LIPS; RED SPOTS ON BODY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included lactose allergy, and bees allergy. The patient experienced drug allergy when treated with lithium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982,expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 16:45 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced swollen lips. On 08-APR-2021, the subject experienced red spots on body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen lips, and red spots on body. This report was non-serious.
PATIENT WAS GIVEN MONOVALENT MODERNA VACCINE AS BOOSTER. NO BIVALENT WAS ONHAND.
Initial report received on 19 May 2008 from another manufacturer, report number A0723483A. The original reporter to the other manufacturer was a sales representative who received the report from a physician. A four-year-old male patient had received a fourth dose injection of IPOL, lot number A0342 (route/site not reported) and a fifth dose injection of Infanrix (Manufacturer GlaxoSmithKline), lot number AC14B069AA (route/site not reported) on 18 March 2008, and approximately two days later, experienced severe swelling in his left upper arm through his elbow. The physician indicated that the subject had received an unspecified treatment and the event resolved. According to the physician, the extensive swelling of the patient's left arm was not considered to be possibly related to the use of IPOL. The reporter for this case is the same as for case number 2008-01358.
12/06/2021 The patient presents with COVID-19 symptoms x1 week. Pt states his symptoms began on 11/27 and was tested positive on 11/29. Pt and wife both were found to have COVID-19 and received the Regeneron Infusion on 11/29. Pt reports he has been increasingly weak with associated diarrhea. Pt's wife is concerned for dehydration. Pt has been fully vaccinated against COVID-19. Denies any other symptoms or complaints.  The onset was 1  weeks ago.  The character of symptoms is COVID-19 symptoms.
Covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Covid-19) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) contracted COVID.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The reporter stated his wife received every vaccine that she was eligible to receive. She was blood type O. She contracted COVID. She did receive Moderna COVID19 vaccines. He knows other people who got COVID because they lost their sense of smell and taste. He stated the flu did not do that, but COVID was attack that part in the body. He believed that his wife would have been worse had she not been vaccinated with Moderna's vaccines.  No treatment information was reported.
Raised rash (5 mm diameter), severe ongoing headache, slight muscle aches, lethargy. Still chronic at this time -09/19/2011.  Will seek treatment tomorrow.
Patient reports starting two weeks after she received the moderna booster she started having visual changes(halo vision), worsening headaches, worsening pain in her back, and required Emergency Room Visit with new high blood pressure readings 200's/90's
Arm pain that kept me awake at night; Body aches; massive exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533) via an unspecified route of administration in the right arm on 01Apr2021 at 15:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hemochromatosis, rhinitis and migraine. The patient did not have any allergies to medications, food, or other products. Concomitant medications included paracetamol (manufacturer-TYLENOL), ibuprofen (MANUFACTURER UNKNOWN), ondansetron (manufacturer-ZOFRAN), cyclobenzaprine hydrochloride (manufacturer-FLEXERIL), vitamin D nos (MANUFACTURER UNKNOWN) and cod-liver oil(manufacturer-FISH OIL) all started from an unknown date for unknown indication. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 18:00, the patient experienced arm pain that kept the patient awake at night, body aches and massive exhaustion but no fever for 2 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events arm pain that kept the patient awake at night, body aches and massive exhaustion were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected
Unauthorized age group vaccinated/after the administration was given it was found that the patient who received it was 16 years old.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age group vaccinated/after the administration was given it was found that the patient who received it was 16 years old.) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age group vaccinated/after the administration was given it was found that the patient who received it was 16 years old.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age group vaccinated/after the administration was given it was found that the patient who received it was 16 years old.) outcome was unknown.        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 medication was received by the patient  No Treatment information was received by the patient.  No other side effects have been reported from the administration of the vaccine.
My son had eaten peanut butter and almonds several times with no reaction and also had healthy skin. Not even one month after receiving his vaccines he developed severe allergies and went into anaphylactic shock and was allergy tested after that showing allergies to many different things.
12 hours later flu like symptoms; Chills; Bodyache; Fever up to 102 degrees for next 24 hours; Followed by severe headache and nausea that lasted next 48 hours straight. Day 4 and 5 on and off headaches; Nausea that lasted next 48 hours straight; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03May2021 at 18:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer in 2014, smoker, anxiety and chronic inflammatory lung disease (COPD). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included alprazolam (XANAX), ascorbic acid (VITAMIN C) and zinc (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient previously took hydrocodone bitartrate; paracetamol (VICODIN) and experienced adverse effects. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Apr2021 at 17:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 04May2021 at 05:00, 12 hours later the patient experienced flu like symptoms, bodyache, chills, fever up to 102 degrees (units unspecified) for next 24 hours. Followed by severe headache and nausea that lasted next 48 hours straight. Day 4 and 5 she had on and off headaches. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events flu like symptoms, bodyache, chills, fever up to 102 degrees (units unspecified) for next 24 hours was resolved with sequelae on 05May2021. The clinical outcome of the events severe headache and nausea that lasted next 48 hours straight; day 4 and 5 had on and off headaches was resolved with sequelae on an unknown date in May2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
left shoulder started hurting; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (left shoulder started hurting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shoulder pain (left shoulder pain) since an unknown date.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced ARTHRALGIA (left shoulder started hurting). At the time of the report, ARTHRALGIA (left shoulder started hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Jan-2021 and was forwarded to Moderna on 27-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (left shoulder started hurting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shoulder pain (left shoulder pain) since an unknown date.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced ARTHRALGIA (left shoulder started hurting). At the time of the report, ARTHRALGIA (left shoulder started hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Redness, swelling, tenderness began 2 days after receiving "the most painful shot I've ever had". Continues with minimal redness, itchiness at day 7. Using cold compression.
Racing heart. Chest pain.  squeezing. Palpitations. Unbearable back pain
possibly not receiving both components of Shingrix; possibly not receiving both components of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number Z4J77, expiry date unknown) for prophylaxis.   On 11th March 2022, the patient received the 1st dose of Shingrix. On 11th March 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-JUN-2022  Reporter's comments: The pharmacist reported that, the patient received dose of Shingrix and they were researching a patient's vaccine history due to them possibly not receiving both components of Shingrix.   The reported lot number was Z4J77 (confirmed twice). However, this was not bringing up any matches. The reporter consented to follow up by email but the reporter declined to provide date of birth. Additional Supportive Information: The pharmacist reported that, the patient received dose of Shingrix and they were researching a patient's vaccine history due to them possibly not receiving both components of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Within 30 minutes of the injection, mild facial numbness. It went away within a couple of hours. However the next morning after suffering through about 12 hours of fever and shakes I woke up with spinal inflammation which caused me to suffer from cervical vertigo for about 2 weeks.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 28th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. SHINGRIX was discontinued. 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 patient experienced unbearable arm pain for a few days after receiving SHINGRIX, and that they did not want the second dose, the onset of symptoms was unknown. The reporter was not certain if the pharmacist declined to provide patient information.
arm ache/Couldnt lift arm because it hurt; dead arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Aug2021 11:00 (Lot number: EW0182) at the age of 15 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (ongoing), notes: 3 years ago. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Aug2021, outcome "recovered" (Aug2021), described as "arm ache/Couldnt lift arm because it hurt"; LIMB DISCOMFORT (non-serious) with onset 03Aug2021, outcome "recovered" (Aug2021), described as "dead arm". The patient underwent the following laboratory tests and procedures: influenza a virus test: negative; influenza b virus test: negative; sars-cov-2 test: negative.  Additional information: Her 15 year old son had an arm ache for 2-4 days after the first COVID-19 Vaccine. First dose, experienced a dead arm in the injection arm, which was the right arm. Couldnt lift arm because it hurt. Felt like was punched in the arm.   No follow-up attempts are possible. No further information is expected.
6/3/05 7 hours post vaccine - nausea, achyness, fatigue, lasted 2 hours resolved without treatment 6/9/05 severe headache, paleness, while at dentist office lasted less than 10 minutes resolved with ereedine, history of similar headaches.  Later that evening abdominal cramps, with vomiting, mild headache, low grade fever, continued into time with provider
Patient reports that 3-4 days after receiving the vaccine that he had a few "spells" when he became lightheaded and felt as though he would pass out.  He has seen cardiologist who will be doing some additional tests as it could be related to cardiac issues. He is no longer having this problem.
Developed  stuffiness, sinus congestion, non-productive cough, fatigue, chills, loss of taste/smell on 10/11/2021 and was tested for Covid 19 at the Hospital on 10/14/2021 and result came back positive.
Low grade fever 100 degrees, general ill feeling, swollen foot, missed work.  symptoms started the next day following the vaccine and was still present at the time he called the pharmacy late Tuesday 06/29/21
Patient called pharmacy Monday morning to report side effects of swollen lymph node under arm and fever of 101 degrees. Suggested patient call his primary care physician and told him I would report side effects.
Pt started to have bronchospasm/cough approximately 15 min after receiving COVID-19 vaccine. She has asthma and states that this happens often. Ventolin inhaler was administered in clinic and bronchospasm/coughing resolved shortly after.
sinus congestion, post nasal drip headache fatigued and winded at times, congested and sinus pressure