chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse events reported; a pediatric patient received an adult dose of VAQTA; This spontaneous report was received from a registered nurse and refers to a 18-month-old female patient. She had no known drug allergies, pertinent medical history. The patient has not been using any medications nor vaccinations concomitantly.  On 23-FEB-2021, the patient was vaccinated with an adult dose of hepatitis A vaccine, inactivated (VAQTA) 1 ml (instead of 0.5 ml), intramuscularly, in the left thigh, lot # reported as G99R4, expiration date 20-MAY-2022 for prophylaxis. No adverse events were reported.  Lot number G99R4 is an invalid lot number for hepatitis A vaccine, inactivated (VAQTA). Lot number G99R4 does not match any Company product as confirmed by Lot Verification team.
Nausea, flushed face, difficulty swallowing, short of breath. Seen in ED, treated with Solumedrol, Pepcid IV, Discharged home with Prednisone dose pack and Tagamet. Seen in ED again 10/16 then hospitalized 10/17 for continued
patient has had knee pain and swelling which was never present prior to that vax dose and has been struggling with this since, requiring MRI, rheumatology evaluation, and knee aspiration.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Apr2022 as dose 6 (booster), single (Lot number: GL2042) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DVT" (unspecified if ongoing); "PE in 2007", start date: 2007 (unspecified if ongoing); "Factor V Leiden" (unspecified if ongoing); "Prothombrin Mutation (Factor 2)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known alergies: Codeine", notes: possibly. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid started on 24May2023 and stopped on 28May2023.
The Moderna vaccine that was pulled from the refrigerator was over 30 days from the date the vaccine was pulled from the freezer. The vaccine was pulled from the freezer on 9/8/21 (expiring 10/9/21) but given on 10/13/21. The mfg lot # was 014F21A and Exp 01/23/22. Patient has not experienced any side effects as of yet. He was informed almost immediately following receiving the vaccination. He was not upset. Awaiting response from Moderna on how to proceed was told it would take 8-10 days to receive a response,
Very sore arm hurts when moved. Nurse gave both shots in left arm still hurts 7 weeks later.
No adverse symptoms reported; The patient inadvertently received a dose of PROQUAD and a dose of V ARlV AX during the same office visit on 8/24/2020.; This spontaneous report was received from a physician refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   On 24-AUG-2020, during the same office visit, the patient was inadvertently vaccinated with doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) injection, lot # S017265 was confirmed to be valid, expiration date was not reported but upon internal validation was established as 01-DEC-2020 (exact dose, route and site of administration were not provided), and varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot # S019460 was confirmed to be valid, expiration date was not reported but upon internal validation was established as 24-JUN-2021 (exact dose, route and site of administration were not provided), both for prophylaxis, which were reconstituted with sterile diluent (STERILE DILUENT) (multiple drug overdose accidental). No adverse symptoms were reported. The outcome of the multiple drug overdose accidental was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA012457:
Pt did not look at injection site unless it was tender the next day. Noted and marked red area at 2pm. (Noon was when she felt the soreness) Initially red area measured 6x6.5cm Red area enlarged in size, now noted to be 11cm. in length, no induration, no heat.
sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Patient received high dose influenza vaccine at age of 63. No report of side effects since 1.5 hour after administration.
mom called clinic 4DEC95 stating pt cont to have fever, dec appetite, crying >12hrs/day, pulling hair;rash started 3DEC95;was seen by family physician  4DEC95;mom reported that pt had bad ear infect & poss psychological trauma;
Fetal demise sometime between 15-18 weeks based on ultrasound findings. EDC 7/30/2021
Flu like symptoms as after 1st vaccination; Having trouble walking; Fatigue; Stomach symptoms; Diarrhea; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach symptoms), DIARRHOEA (Diarrhea), ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (Flu like symptoms as after 1st vaccination) and GAIT DISTURBANCE (Having trouble walking) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J202A and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ADALIMUMAB (HUMIRA), OXYCODONE, BACLOFEN, LEVOTHYROXINE and IBUPROFEN for an unknown indication.   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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach symptoms), DIARRHOEA (Diarrhea), ASTHENIA (Weakness) and FATIGUE (Fatigue). On 06-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms as after 1st vaccination) and GAIT DISTURBANCE (Having trouble walking). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Stomach symptoms), DIARRHOEA (Diarrhea), ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (Flu like symptoms as after 1st vaccination), GAIT DISTURBANCE (Having trouble walking) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
On 1/27/00, the pt developed shingles on her left leg. The pt sought unspecified medical treatment. The pt was started on therapy with amoxicillin because the physician thought the pt might have impetigo, but wasn't sure as it could have been shingles. The child was complaining of leg pain prior to the rash breaking out. Follow up data states patient recovered by 02-10-2000.
Patient was administered vaccines including the MMR vaccine (the only vaccine she had not received previously) at the office of Dr. on July 20, 2006.  Approximately 9 days later patient developed an all-over rash.  On July 29, 2006 at approximately 9:00 P.M patient developed a fever of 104.5 and became extremely lethargic and non-responsive.  At the advice of her physician, she was taken to the emergency room and admitted to the hospital for observation until 5:00 P.M. on July 30, 2006, at which point she was discharged.
The nurse who vaccinated the patient reported that half of the dose was administered due to the vaccine leaking from the Luer Lock Connection.
her arm went red; her arm hurt, was painful; arm swelling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (her arm went red), PAIN IN EXTREMITY (her arm hurt, was painful) and PERIPHERAL SWELLING (arm swelling) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Redness (a little redness in her other arm after receiving the flu, shingles, and pneumonia vaccine).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced ERYTHEMA (her arm went red), PAIN IN EXTREMITY (her arm hurt, was painful) and PERIPHERAL SWELLING (arm swelling). At the time of the report, ERYTHEMA (her arm went red), PAIN IN EXTREMITY (her arm hurt, was painful) and PERIPHERAL SWELLING (arm swelling) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided
Fever, chills, body pain, headache and mild rash on the chest and back. took Advil every 8 hours. rash disappeared after 24 hours.
mom states loose stool day of vax, but had given milk so thought alergies caused it so felt no illness; 1130 started vomiting & diarrhea-tried pediolite pt refused then went to Jelo water; 24JAN92 to ER hosp; sl fever 99.6; dehydration;
This spontaneous report was received from a registered pharmacist concerning a patient who on 29-AUG-2012 was vaccinated with an expired dose of ZOSTAVAX (dose and route not provided) (lot # 670386/0236AA, expiration date on 17-MAY-2012). No symptoms were reported. Additional information is not expected.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Number of doses/vials: 22. Date the vial was initially stored in the refrigerator: Unknown. Date(s) of administration of vaccine: 2 doses 05Apr2022; 13 doses 06Apr2022; 2 doses 07Apr2022; 4 doses 08Apr2022. The vial did not undergo any temperature excursions. No treatment medications were reported.
Since early to mid-December 2022, I have had sharp pains on the shoulders. I thought that maybe I had slept in the wrong position, because I'm a side sleeper. The left shoulder is more affected, but I also have pain in the right shoulder. The pain sometimes radiates from the shoulder to the elbow on both arms. On the left hand, it sometimes radiates from the wrist to the fingers. I can't lift my arms more than 35 degrees. I can't sleep at night, because the pain is so severe. Since 12/17/2022, I have been constantly taking ibuprofen and acetaminophen every six hours. On 12/19/2022, I went to the chiropractor. He gave me treatment consisting of manual adjustment of shoulder, neck, and back. He also gave me tens stimulation, ultrasound therapy, and spinal decompression therapy. Since then, I have been seeing my chiropractor regularly. I sometimes go twice in a week, and other times I've gone three times a week. In January 2023, the pain became more tolerable, so I stopped going to the chiropractor. However, I continued to take the ibuprofen and acetaminophen. On 1/26/2023, I woke up with severe pain in both shoulders. Instead of going to the chiropractor, I went to my PCP, who gave me a cortisone shot. I got a little bit better, and continued taking the ibuprofen and acetaminophen, though I took it less often than before. On or about 2/16/2023, I started having more severe pain. I couldn't see my PCP that day, because he was on vacation, so I ended up seeing the on-call physician at the clinic on 2/21/2023. He gave me two cortisone shots (one in each arm). It didn't help at all with the pain. On 2/24/2023, I started seeing my chiropractor again. At the time of this writing, I see him three times a week. The pain is still severe and intense (especially at night). I can't sleep well at night because of the pain. On 3/2/2023, I saw my PCP. My PCP did a CRP blood test and an ESR blood test. The results of the tests fell within the normal range. At the time of this writing, I am taking acetaminophen and ibuprofen every four hours. My PCP has referred me to a neurologist to undergo an EMG test, which is scheduled for the near future.
Pt described as when he left office his throat started to feel scratchy, the couple of hours later it progressed to dry cough, red eyes, swollen mouth, tongue & throat - difficulty breathing. Seen MD was given epinephrine then was transported to Hospital where he received IV & maximum dose of Benadryl.
The patient did not have any symptoms or adverse effects of receiving only partial dose; A patient moved while receiving their dose of VAQTA and received only about half the dose; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. Information regarding medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 01-JUL-2022, the patient was vaccinated with the second dose of Hepatitis A vaccine, inactivated (VAQTA) as prophylaxis (exact dose, route of administration, and anatomical site of vaccination were not provided; lot number W007375 has been verified to be valid, expiration date reported and established as 16-JAN-2023). It was reported that the patient moved while receiving the vaccine and received only about half the dose (incorrect dose administered).  The patient did not have any symptoms or adverse effects due to receiving only a partial dose (no adverse event).
Fatigue onset 1/31 around 03:30 PM and progressed to a headache and body aches over the next few hours. Temp was taken at 06:45 and reads 99.6. increased sensitivity to light and sound along with the headache.
Patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported   This case was linked to MOD-2022-531880 (Patient Link).
This spontaneous report as received from registered nurse refers to a 4 year old patient of unknown gender. Pertinent medical history, drug reaction and allergies were not reported. On 17-JUL-2014 the patient was vaccinated with an expired dose of MMR II (lot # H012132, expiration date 25-JUN-2014, 0.5 ml, subcutaneously (dose number and strength were unspecified). No adverse effect was reported. No concomitant therapies were reported. No laboratory diagnostic studies were reported. The outcome of received an expired MMR II was unknown. Additional information has been requested.
Redness, pain and swelling (>4 inches) at injection site, fever > 102 F for more than 48 hours
PATIENT WAS IN WAITING AREA AFTER THE VACCINE. HE HAD REDNESS IN HIS EYES, HAD DIFFICULTY BREATHING, RASH ON BOTH ARMS,  AND WAS SLIGHTLY WARM TO TOUCH. WIFE REPORTED PATIENT HAS HISTORY OF ANXIETY ATTACKS, ASTHMA ATTACKS, AND ALLERGIC REACTIONS TO FOOD.
more than 36 days since the first dose and she did not get the second; arm was red from the vaccination site to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm was red from the vaccination site to the elbow) and PRODUCT DOSE OMISSION ISSUE (more than 36 days since the first dose and she did not get the second) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     Treatment medications was not reported.  The patient's past medical history included COVID-19 in November 2020. Concomitant products included WARFARIN, METOPROLOL, PRAVASTATIN and EZETIMIBE (ZETIA) for an unknown indication.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm was red from the vaccination site to the elbow). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 36 days since the first dose and she did not get the second). At the time of the report, VACCINATION SITE ERYTHEMA (arm was red from the vaccination site to the elbow) and PRODUCT DOSE OMISSION ISSUE (more than 36 days since the first dose and she did not get the second) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications was not reported   Reporter did not allow further contact
Left sided facial numbness; Right sided tongue numbness; Right sided facial pain; Dysfunction of the left eye lid; Started on treatment for bell's palsy / droop of left side of the face; Right ear pain / Bilateral ear pain; This case was reported by a nurse via call center representative and described the occurrence of bell's palsy in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), ear pain, numbness facial, numbness of tongue, facial pain and eyelid function disorder. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the bell's palsy, ear pain, numbness facial, numbness of tongue, facial pain and eyelid function disorder were recovered/resolved.   It was unknown if the reporter considered the bell's palsy, ear pain, numbness facial, numbness of tongue, facial pain and eyelid function disorder to be related to Shingrix.  Additional details were provided as follows: The patient reported that, experienced ear pain 2 to 3 days following vaccination. On 11th February 2020, the patient came in to clinic for right ear pain and on 20th February 2020 for bilateral ear pain, left sided facial numbness, and right sided tongue numbness. On 25th February 2020, the patient came clinic for for right sided facial pain, bilateral ear pain, and continued treatment of bell's palsy. On 3rd March 2020, the nurse did CT scan for facial drooping and dysfunction of the left eye lid and all results came out normal. The patient was started on treatment for bell's palsy. The nurse spoke to the patient on day before reporting and stated that, the patient was better than previously and felt almost normal after long course of steroids. No further details were provided.
I've been in pain on my left side for 4 months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 (Batch/Lot number: unknown) as dose 1, single and administered in arm right (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "rheumatoid arthritis", start date: 2018 (unspecified if ongoing), notes: Before the vaccine I was diagnosed with rheumatoid arthritis and fibromyalgia in 2018,; "fibromyalgia", start date: 2018 (unspecified if ongoing), notes: Before the vaccine I was diagnosed with rheumatoid arthritis and fibromyalgia in 2018,. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "not recovered", described as "I've been in pain on my left side for 4 months". Therapeutic measures were not taken as a result of pain.  Additional information: Patient got the Pfizer Covid 19 vaccine, the first dose in left arm, the second in right arm. In right arm she didn't feel it but have been in pain on left side for 4 months. Before the vaccine patient was diagnosed with rheumatoid arthritis and fibromyalgia in 2018, but before receiving it she did not have such strong pain, now the pain was severe and it happened since she received the vaccine in May2021 (21May2021 approximately). The pain was really strong, and it was really severe. This has been going since she received the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Booster - extended weakness, shakiness, raised painful rash on left shoulder, neck, back and upper chest  - small blister like red dots accompanied by pain in shoulder and neck especially. This has persisted beyond two weeks. I experienced a more widespread rash, less painful after first Moderna shot in January, 2021, but not with second in February.