chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was given 2nd dose on Day 22 as opposed to the recommended day 28 after 1st dose.  Earliest patient can receive vaccine would have been 4 days early which would have been 4/18/2021, but was given the shot on 4/16/2021.  no adverse events reports , left message for patient to call us back
The wrong pfizer vial was grabbed from the refrigerator and an undiluted pediatric pfizer dose was administered to an adult. When the wrong vial was drawn up, the regular pfizer vaccine label was attached to the syringe. Pt received less than the recommended 30mcg per dose of the adult vaccine. Based on CDC Interim Clinical Considerations, we told the patient that she can return for a repeat dose today. Pt said she will come back tonight.
Patient reported sudden fatigue. ?I feel very sleepy all of a sudden.? No LOC or other complaints. Vital signs were within expected parameters. She left the site before additional info on her history could be gathered.
This spontaneous report was received from a 65 year old female patient reporting on herself. The patients concurrent condition included fibromyalgia that she described as pain up and down her hamstrings. The patient's concomitant therapies included ARMOUR THYROID TABLETS, aripiprazole, sertraline hydrochloride, trazodone hydrochloride, omeprazole and valacyclovir hydrochloride. The patient had no drug reactions or allergies. On 13-MAR-2018, the patient was vaccinated with PREVENAR 13. On 23-MAY-2018, the patient was vaccinated with PNEUMOVAX 23, intramuscular for prophylaxis (dose, lot number and expiration date were not reported). Later that day, the patient developed severe pain in the vaccinated arm and shoulder (Pain in extremity)(unspecified side). Patient reported the pain was so severe that it limited her ability to move and use her arm. On an unknown date, the patient called her physician, who prescribed SALONPAS, TIGER BALM, but patient reported none of these treatments helped the arm and shoulder pain at all. Patient reported that the arm and shoulder pain had decreased in severity but was still constantly present. Patient reported that, on an unknown date, she developed "the exact same kind of pain all over" her right leg, since "about a month or two ago", in 2018, described as "getting worse when she bends her knee or lifts her leg," and that the pain was so severe, that it was limiting her ability to move and use her leg. Patient reported that this leg pain was different than pre-existing leg pain related to fibromyalgia. No lab diagnostics or studies were performed. The outcome of pain in extremity was reported as not resolved. The causal relationship between the aforementioned event and vaccination with PNEUMOVAX 23 was not reported.
Around 5pm: fatigue, ongoing for 28 hours Around 9pm: mild fever, increasing to 100.6, continuing off and on throughout next day Around 11pm: headache, continuing through 4pm next day Next day: muscle soreness, joint aches, mild nausea
On 01/12/05 (two days after vaccination) patient noted her left arm was red, sore and warm to touch.  Area of redness was approximately 4" x 7".  On 01/14/05 she returned to clinic and was advised to see her PMD.  She saw her PMD on this date and was told her arm was "infected".  She was prescribed Amoxicillin/clavulanate 875/125 mg. which she has been taking.  At time of interview, 01/18/05, patient states her arm is improving.
Information has been received from a 34 year old female who on approximately 05SEP2003 was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. The patient reported that on approximately 12SEP2003, about a week after the vaccination, she experienced joint pain in her arms and legs. Medical attention was sought and the joint pain was treated as arthritis. The patient was taking naproxen sodium and cortisone for the joint pain which provided only moderate relief. At the time of this report, the patient's joint pain persisted. No further information is available.
Ever since the completion of both COVID-19 vaccine doses, my menstrual cycle has been overly painful, long, and extremely (to an almost uncontrollable state). This has never been the case since I was 13 years old. My 2nd COVID-19 vaccine was the beginning of February, any by the end of February when my cycle started my period was out of control. It is now May, and has not resolved at all. Every month my cycle is worse and worse. It went from 4-5 days pre-COVID vaccine, to 7-8 days post- COVID vaccine. The menstrual cramps are so awful, which I have never had before. The flow/heaviness is so extreme and uncontrollable, I can't even leave the house for the first 2-3 days. This needs to be looked into. The ONLY thing with me that has changed, in the past couple of months is getting the vaccine. Nothing else would cause this. I have read some articles that are saying post-menopausal women are getting periods again and younger women are experiencing unusually abnormal periods. Please look into this and research it, as this is definitely not right
No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     It was Unknown if Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 28-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) 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 (Dose administered after manufacturer date of expiry).    No concomitant medications were reported. It was reported that the expired dose of vaccine was given on 28-Feb-2023, they had been receiving monovalent that had been expiring early, like a week and a half. Dose was administered after manufacturer date of expiry. Product was Monovalent vaccine. The vial did not undergo any temperature excursions  No treatment details were reported.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Patients' medical history, concurrent conditions and drug reaction/allergies were not reported. On 24-AUG-2016 or 25-AUG-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M020103, expiration date: 15-FEB-2018, (dose and route of administration were not reported). The administered doses of Gardasil 9 underwent temperature excursion at 55 Fahrenheit degrees, for 28 hours and 20 minutes. No previous temperature excursions were reported. Patients' concomitant medication was not reported. No adverse effects reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Pain in finger joints and hip on right side (opposite of injection site). Patient believes the flu shot to be the only change in medication/treatment since experiencing the new pains. She dose get some sort of injections in her spine or neck from a different provider. She recalls "feeling liquid going in" at the time of immunization, which was peculiar to her.
Two miscarriages since administered. First on May 17. Second on August 30.   No prior history of miscarriage or pregnancy issues. Previously had 2 healthy, normal pregnancies
knocked out for 3 to 4 days after 2nd dose; headache; being very tired 2nd dose; left arm hurt after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (knocked out for 3 to 4 days after 2nd dose), HEADACHE (headache), FATIGUE (being very tired 2nd dose) and VACCINATION SITE PAIN (left arm hurt after 2nd dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 20-Mar-2021, the patient experienced HEADACHE (headache), FATIGUE (being very tired 2nd dose) and VACCINATION SITE PAIN (left arm hurt after 2nd dose). On an unknown date, the patient experienced FATIGUE (knocked out for 3 to 4 days after 2nd dose). At the time of the report, FATIGUE (knocked out for 3 to 4 days after 2nd dose) had resolved and HEADACHE (headache), FATIGUE (being very tired 2nd dose) and VACCINATION SITE PAIN (left arm hurt after 2nd dose) outcome was unknown.            No concomitant medication information was provided.  It was reported that in the immunization card and other documents from Pharmacy shows that 1ml of Moderna Covid-19 Vaccine for each of primary doses and for booster dose received on 28-Mar-2022 was 0.5ml. Patient said that inappropriate doses of primary and booster doses were given for primary series of the Moderna Covid-19 vaccine. The patient also reported that the records now showed as 0.5ml for primary series and received 0.25ml for booster dose. Patient was not sure which dose she received for her primary series.  No treatment medication information was given.   This case was linked to MOD-2022-526395, MOD-2022-526424 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Mar-2022: Follow up received contains no new information
Information has been received from a registered nurse concerning a 25 year old female with no medical history or drug allergy who on 13-MAR-2009 was vaccinated with the first dose of VARIVAX (Merck) (lot # 660076/1850U, SQ, 0.5ml) and initially experienced no adverse event. On 24-MAR-2009 the patient was vaccinated with MMR II in the opposite arm. On the same day, the injection site area of the arm which VARIVAX (Merck) was administered to developed swelling. The patient was told to treat the area with antihistamines, ice packs, and hydrocortisone cream. The patient had no lab diagnostics studies performed. At the time of the report the patient was not recovered. The patient sought medical attention- office visit. Additional information has been received on 24-APR-2009 from a registered nurse who reported that the patient received second dose of VARIVAX (Merck) (Lot # not reported) 0.5 ml, subcutaneously on 22-APR-2009. On 23-APR-2009 the patient was experiencing difficulty breathing and was brought to the emergency room. While at the emergency room the patient experienced a systemic reaction and "coded". Upon internal review, systemic reaction and "coded" was considered to be an other important medical event. Additional information has been requested.
Day 1-2: injection Site Pain. Day 3-current: Low grade fever, cold like symptoms. Day 10-current: swelling at injection site, pain at injection site. Injection site is hot to the touch.
I woke up the following morning feeling extremely drowsy. Swelling of lymph node under my arm and fingers and every so often my arm will swell showing my veins. Redness.  extreme cramping. Cramping  on the 2nd and 3rd day in the lower extremities.  2nd, 3rd and 4th day had headache. I still still get the drowsiness every once in a while as well as other symptoms.
This spontaneous report as received from a licensed practitioner nurse reporting on a 61 years old female patient with no pertinent medical history and no drug reactions/allergies who on 17-AUG-2012, was vaccinated with a dose of ZOSTAVAX (lot# H009779, exp March 2013, dose and route not reported). It was reported that on 18-AUG-2012, the patient developed an injection site reaction following vaccination with ZOSTAVAX. The patient developed an injection site reaction described as a 2x2 inch red, swollen area at the injection site that was warm to the touch without rash, but a little bit itchy during an office visit on 20-AUG-2012. The patient was treated with ice packs, BENADRYL and OTC cortisone cream (unspecified). At the time of the report, the patient was recovering from adverse events. The patient sought medical attention-office visit. The relatedness for 2x2 inch red, little bit itchy, out rash, warm to touch and swollen area at injection site were unknown for ZOSTAVAX. Additional information has been requested.
Patient received both doses of Pfizer COVID vaccine (on 1/12/21 and 2/3/21). Despite this, patient tested positive for COVID in the ED on 9/10/21.  On the morning of his ED visit, patient was noted to be lethargic and had an episode of rigors and shaking. Patient did receive his flu shot on 9/9/21 (specific vaccine unknown). In the ED, patient was found to be febrile, hypotensive, tachycardic, and hypoxic (SpO2 92%). A chest X-ray was done and showed infiltrates in both lungs, and a urinalysis showed possible UTI.  Patient was admitted to the hospital on 9/10/21 for COVID treatment (remdesivir and dexamethasone) and antibiotics for UTI vs. PNA. Patient is currently on day 3 of hospitalization and is requiring 2L of oxygen.
Woke up feeling sick, experiencing Stuffy head, a bit of a cough, body aches, sinus and nasal congestion.  Symptoms got much worse over the next 2 days to the point where I could not breath.  Sought medical care on 01/18 at an Urgent Care.  There I tested positive for Flu, Strep Throat and COVID-19.  COVID-19 rapid test, positive.  Doctor proscribed Paxlovid, Methylprednisolone, cough syrup. Felt better in about 3 days, symptoms diminished through about the 10th day later.  Fulling fully recovered took about a month.  Still do not have sense of taste at time of reporting.
Rash at injection site. Developed to an infection after 3 days. Took Rifampin & BACTRIM. Pt. has history of MRSA.
Fainted on 2/11/2021, bowel incontinence, and vomiting
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-JUN-2016 the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II single 0.5ml dose (rHA, lot # L007577, expiration date 05-MAR-2017, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 24 hours with the highest recorded temperature of 47 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received form the same source. Additional information has been requested.
Fever of 101.7 orally, chills, body aches, lack of appetite, no energy on Oct 10th. Rash at injection site for a 8 cm area on Oct 12
3-5 minutes after receiving vaccines, pt fainted, fell to floor, hitting right cheek and head. Was "shaking". No LOC, no seizure. He appeared pale and sweaty. He was given water, placed supine on exam table. Monitored for approximately 90 min. Had transient nausea and tingling.
I had a shingles injection this afternoon. I experienced chest tightness / pain that went to the back.
Heart palpitations  for both the first and second shots right after the shot was given and felt up to 8 hours after the shot " Covid Arm"  large red area at injection site started 8 hours after injection was hard knot and the knot lessened but the red blotchy area also became itchy and continues. Have had it now 3 days
Rash started 2 days after vaccination; Typical sore arm but couldn't use arm for 2 days; Fatigue; Nerve pain from elbow to pinky; Macules on arm, Bier spots; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Nerve pain from elbow to pinky), MACULE (Macules on arm, Bier spots), RASH (Rash started 2 days after vaccination), VACCINATION SITE PAIN (Typical sore arm but couldn't use arm for 2 days) and FATIGUE (Fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027D21A) for COVID-19 vaccination.     The patient's past medical history included Insomnia. Concurrent medical conditions included Fatigue and Penicillin allergy.    On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced NEURALGIA (Nerve pain from elbow to pinky), MACULE (Macules on arm, Bier spots), VACCINATION SITE PAIN (Typical sore arm but couldn't use arm for 2 days) and FATIGUE (Fatigue). On 20-Jul-2021, the patient experienced RASH (Rash started 2 days after vaccination). The patient was treated with PROPRANOLOL for Postural orthostatic tachycardia syndrome and Tachycardia, at a dose of 1 dosage form. In August 2021, RASH (Rash started 2 days after vaccination) had resolved. At the time of the report, NEURALGIA (Nerve pain from elbow to pinky), MACULE (Macules on arm, Bier spots), VACCINATION SITE PAIN (Typical sore arm but couldn't use arm for 2 days) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Polymerase chain reaction: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had rash started about 2 days after the 1st dose and went away 3 weeks later, typical sore arm  but couldn't use the arm for 2 days, Fatigue, Nerve pain from the elbow to the pinky, macules on arm not raised, bier spots.   Patient has seen a great number of specialists but the lab work is normal. Patient also got a T cell test, nucleocapsid test done.   This case was linked to MOD-2022-494528 (Patient Link).
This spontaneous report was received from nurse practitioner referring to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. on 22-JUL-2014 patient received improperly stored MMR II [lot # J009382/ exp. date 08/08/2015] exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with the cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
Family member reported that after receving first injection patient went home and a few hours later became lethargic to the point where she did not know she had an injection, could not answer questions and could not feed herself.  Patient had extreme lethargy and did fall once.  This lasted 24 hours.
Expired vaccine administered to 5 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 5 patients) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 5 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 5 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on Modernatx.com the expiration date was 14 Aug 2021. The nurse said that she had a screenshot of the above lot number 010A21A entered the lot number expiration date check program that shows the expiration date as 14 Oct 2022.  Date the vial was initially stored in the refrigerator was not provided and the vial did not undergo any temperature excursions.  No treatment drugs were reported.
Patient presented to second dose mass Moderna vaccination drive through clinic. Patient did not have an appointment but reports they were supposed to return for second dose. Paperwork given to complete which was checked off that patient had received Moderna previously. Patient did not mark through this or make any comment to the nurse administering that they had not received Moderna originally. The nurse gave immunization appropriately based on paperwork that patient filled out and per patient request. Upon coming back to the department and entering in the shot in vaccination facility it would not let us enter as it reports that the first dose was Janssen vaccination. Upon going back through paper records we found that patient was given Janssen vaccination on 3/12/2021. Verified with nurses working the clinic on 3/12/2021 where Janssen and Moderna were both being administered and they reported that they were sure that paperwork was correct in the fact that they ask everyone a second time which vaccine they wanted and confirmed before administering. Unfortunately some who received Janssen overheard the instructions that were being given to those who received Moderna in the same building and chose to come back to the second dose clinic.
Dizziness, Nausea, Injection Site pain. Lasted a few hours after returning home.
PT RECEIEVED SECOND DOSE OF VACCINE 3 DAYS TOO EARLY. 1ST DOSE GIVEN WAS ON 8/9/22. PT DID NOT HAVE ANY ADVERSE REACTIONS BUT DID RECEIVE THE VACCINE TOO EARLY.
Achy pain at injection site started "a couple hours" after vaccination. Approximately 3 days later she noticed increased pain - described as sharp pain with movement, and decreased range of motion. No redness/swelling/warmth/drainage noted at injection site. Went to family physician, he recommended ibuprofen which was not effective. Returned to physician and had xray of shoulder done - xray was normal with no abscess or joint problems noted. Started on naproxen 550 after xray which "seems to dull it" - referring to pain. She was advised by physician to see him again if no improvement, states it has been "getting worse again" in last 2-3 days. Reports difficulty sleeping at night due to pain with movement of R arm. She states she also tried wrapping her arm and using a sling but this did not help, and had her sister who is a massage therapist "work on it" but this did not help.
Approximately 5 minutes after receiving Pfizer Covid vaccine (FK9729); patient asked for water and became unresponsive.   Patient diaphoretic, had clenched teeth and uncontrolled spasms to arms.  Patient placed patient in a lying position on chairs.O2-94-97%;  BP: 142/90, Patient at this time was more responsive; spasms were less frequent.  Patient reports feeling better; but continued to have weakness to left leg.  EMS arrived at approximately 10:15am; BP: 140/92;  O2-97-98%.  Patient agreed to be transferred to Hospital for further evaluation. Pt was admitted 2/17 - 2/19/22.