chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt hot and cold through day; muscle aches; mild headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 24Mar2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 01Mar2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Mar2021, the patient had experienced hot and cold feeling throughout the day, muscle aches, mild headache and fatigue. The clinical outcomes of the events feeling hot and cold, muscle aches, mild headache, and fatigue were recovered on an unknown date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
welts, really itchy, like hives or bumps/behind their knee; shingles; rash was itchy and affected the left side of the stomach, and under the arm; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), RASH PRURITIC (rash was itchy and affected the left side of the stomach, and under the arm) and URTICARIA (welts, really itchy, like hives or bumps/behind their knee) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 028(L or Z?)20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug addiction. Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) for Drug addiction.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HERPES ZOSTER (shingles) and RASH PRURITIC (rash was itchy and affected the left side of the stomach, and under the arm). On an unknown date, the patient experienced URTICARIA (welts, really itchy, like hives or bumps/behind their knee). The patient was treated with GABAPENTIN for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles) outcome was unknown and RASH PRURITIC (rash was itchy and affected the left side of the stomach, and under the arm) and URTICARIA (welts, really itchy, like hives or bumps/behind their knee) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took antiviral medication for the shingles and change body soap and will try antihistamine medications.   This case was linked to MOD-2021-390735 (Patient Link).
Case PHEH2016US026616 is an initial spontaneous report received from a nurse on 11 Oct 2016. This report refers to a 3 year old male patient (of label use). Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUCELVAX Quadrivalent (batch number and expiry date not reported) at a dose of 0.5 ml intramuscular on 09 Oct 2016. No adverse event was reported following this medication error (inappropriate age at vaccine administration). The seriousness of the event was reported as non serious.
Tinnitus in left ear.  Soft high-frequency crickets when my throat gets stressed, including hiccups, burping, stretching, sometimes yawning, muscle tensing, sometimes swallowing, stretching to wake up in the morning.  Last for the duration of the stress, a few seconds.  Left eustachian tube slightly sore, slight earache.  Has gone on for almost a week now.   Best guess is nerve is pressured or damaged?  Will try hydroxide in ear next, in hope it kills whatever's going on.  Whether this will go away or not is unknown at present.
At approximately 1558 pt was given a vaccine a week early. She had been vaccinated with her first dose of Pfizer on 10/23/21 returned on 11/06/21 a week before her next dose was due. The pt did not have her vaccine card and before she was looked up in CIIS the vaccine was given, but instead of Pfizer she had received a booster dose of Moderna. Doctor and supervisors notified of the incident.
PT GIVEN 2ND DOSE OF BIVALENT VACCINE. PT HAD PFIZER BIVALENT ON 09/21/22 THAN GIVEN MODERNA BIVALENT ON 10/18/22.  PT DID NOT HAVE COVID CARD NOR DID HE REMEMBER HE WAS  GIVEN BIVALENT 4 WEEKS EARLIER. ERROR FOUND ON CHARTING VACCINE. NO ADVERSE EVENT
Extremely heavy bleeding on day 2 of my period, soaking through overnight pads every 1-2 hours for a total of 30 hours. Went to the ER on 5/1/2021. Ultrasound showed no masses or fibroids, CBC values were all normal, was given an IV for hydration. Released from ER after about 6 hours as the bleeding had slowed. Bleeding intensity has reduced each day, but still bleeding bright red blood today which is day 8. My periods never last more than 5 days and I?ve never experienced this volume of menstrual blood loss in the past.
RASH; CORTIZON 10 AS TODAY 03/16/2021 RASH STILL ON BUT IS GETTING BETTER IS LIKE A RED 2.5 INCH  LONG BY 1INCH WIDE. I DID NOT SEE MY PRIMARY DOCTOR. SELF TREATMENT.
Itching general thourghout body within 4-6 hours S/P MMR treated with Aterca.
when patient turned in his timer (15 minutes), as he was walking back toward the waiting area, his wife noticed him very pale and lightheaded so she grabbed a chair to have him sit back down, but he fainted and fell back and hit his head and bled. i was just finishing up another vaccine when i was called to the scene at which point he was on the floor. we raised his legs on a chair and a few seconds later he came to and sat up. we called paramedics and placed a cool pack on back of his neck but advised him not to move too much. took his bp (101/71 p 63) and we conversed until paramedics arrived. pt wanted to go on his own to the er but when they stood him up he got dizzy so they took him on a stretcher and advised him to go to an urgent care facility. called wife at eod and she said he received 4 staples and ct scan was normal and they were observing him he was walking around.
Gradual onset of numbness, prickling or tingling in your feet or hands, which can spread upward into legs and arms Sharp, jabbing, throbbing or burning pain Extreme sensitivity to touch Pain during activities that shouldn't cause pain, such as pain in my feet when putting weight on them or when they're under a blanket Lack of coordination and falling Brainfog Problems speaking or communicating Muscle weakness on right side of the face Face and lips swelling Brainzaps Feeling as if you're wearing gloves or socks when you're not
This spontaneous report was received from a physician via a company representative, concerning a female patient of an unknown age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unknown date, the patient was vaccinated intramuscularly with the first dose of GARDASIL 9 (dose, frequency, lot # and expiration date were not reported) for prophylaxis, and experienced swelling on the injection site. On an unspecfied date, the patient recovered of the aforementioned adverse event. No product quality complaint (PQC) was involved. The causality between the mentioned adverse event and the GARDASIL 9 was unknown. Additional information has been requested.
HYPOTENSION 8/19/2022 ANEMIA HYPOTENSION 8/19/2022 MULTIPLE MYELOMA
Pt failed to devel antibody titers following 3 dose series of Heptavax, Recombivax, & Engerix-B.  Engerix-B given MAr, Apr, & Aug90.
Fever, vomiting, diarrhea, severe headache, chills, severe muscle aches, severe muscle stiffness, not able to get up
Information has been received from a licensed practical nurse referring to a 4 year old male patient. No concurrent condition, medical history or concomitant therapy was provided. On 12-JAN-2016 at 15:57, the patient was subcutaneously vaccinated in the left thigh with the first dose of improperly stored VARIVAX (lot # L025207, expiration date on 07-JUL-2017, dose unknown). No adverse effects were reported. All telephone attempts to obtain follow up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.
10 minutes after receiving 2nd dose of vaccine patient "felt weird" then had a syncopal episode. Patient also with tachycardia and diaphoretic. Received monitoring and IV fluids.
A report has been received from a Pharmacist concerning a 58 years 21 weeks 1 day old. Female patient, who had been receiving Nasal FLUMIST (intranasal), 0.1 mL per nostril, with total dose of 0.2mL. FLUMIST (intranasal) started on 28-Oct-2015. The patient was 58 years old and the HCP administering the vaccine did not realize the vaccine is only approved for patients aged 2 to 49 years old. FLUMIST (intranasal) was continued. The outcome of the event of FLUMIST ADMINISTERED TO A 58 YEAR OLD PATIENT was unknown. The report was considered to be non-serious.
1 1/4 IN X 1 IN REDNESS AT THE SITE OF THE INJECTION.  TREATMENT IS BENADRYL AND MOTRIN PRN, ICE PACK.
Report received from a consumer on 14-Dec-2009. A 58 year-old female patient received H1N1 vaccine, lot 00349611A on 03-Dec-2009 by intramuscular injection to the deltoid. The patient reported she was not ill at the time of vaccination, she was not pregnant at the time of vaccination, and she did not have any other vaccinations within the past 4 weeks. On 08-Dec-2009 at 9:00AM, 5 days post-vaccination, the patient developed nausea, diarrhea, stomach ache, chills, and dizziness. Patient described her symptoms as feeling like she had a stomach virus. The patient took ALKA SELTZER. The patient recovered on 12-Dec-2009. Patient did not notify her physician. No further information is expected. The company considered adverse events reported possible to PANVAX. The time to onset was delayed at 5 days and it is unknown if the patient was taking concomitant medication. Information derived from this report does not change the current safety profile of the product. Batch review request received for 00349611A on 29-Dec-2009. On completion of this investigation, it has been determined that all deviations related to the manufacture of this lot were asessed as having no impact on product quality. All QC testing was satisfactory with no out of specification results reported. There are no outstaning issues related to this lot that would potentially affect product quality. In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.
On 02-19-2022  I started to develop severe skin irritation.  Global body Itching, hives, rash, redness and wheels all over my body. Similar to dermatographia symptoms. Specifically on my breasts, stomach, groin, neck, arms, wrists, face, back, ears (everywhere).   Severe skin discomfort and itching, with large visible raised swollen skin where scratched, that appear usually within 2-5 minutes after scratching skin, that worsen and spread in the general area. Wheels/rash significantly worsen on skin when itched or slightly agitated, even through touch. I receive mild symptom relief after taking 50mg of Benadryl every 4-6hrs, but rash/hives/wheels consistently return throughout the day, sometimes from scratching and skin agitation, sometimes without any skin agitation, often becoming worse at night and after bathing.  I have no medical conditions and am in good health prior to my Moderna booster(#3). I take no medications. I have not been exposed to any new foods, environmental factors (cosmetics, chemicals, animals etc.) My symptoms are ongoing and seem to be ramping up in severity as time goes by, not improving as one would hope to see over time. I am in the process on contacting my PCP for further treatment.
Information has been received from a physician concerning a male patient over 60 years of age who in January 2007, was vaccinated with a dose of Zostavax. In January 2007, two days after vaccination, the patient developed a disseminated zoster rash. Unspecified medical attention was sought and the patient recovered a "couple of weeks" after receiving the vaccine. No diagnostic laboratory tests were performed. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
Patient had lightheadedness within minutes of receiving the injections.  She was monitored for fifteen minutes and allowed to go to the waiting room when asymptomatic.  Several minutes later she had syncopal episode after standing up.  She was brought back to the exam room, given water and oxygen via NC.  Vitals were monitored and her mother accompanied her.  After one hour she was symptom free and discharged.
Two days after Johnson & Johnson, my body launched into an involuntary fit of twisting and flailing movement at bedtime that I now think to be dystonia(?). I sweated terribly. It lasted an hour and a half of screaming and crying. Ehlers Danlos makes my joints and muscles very sensitive to being popped and torn, so it was very painful and remains painful, and now I'm noticing unusual pockets of abnormal memory loss and confusion. Today I ran a red light. I have records of phone calls I don't remember making, evidence of chores around the house that I did not do. Very odd.
Rash on chest and back, has not gone away and it has been almost 24 hours. Felt very tired and had headaches and body aches the day after vaccine but those went away.
Patient's mother called with concerns of child developing a rash at the injection site of MMR that was given 9 days previously. She states that the rash spread to her entire body was followed by low grade fever and fussiness. She called the office on 4/16 for an apt and was seen the same day.
At 3pm, five minutes after administration of vaccinations, the patient stated she was feeling warm and slight lightheadedness. I provided her with water and a granola bar. She had no local reaction at site of injections. I paged her primary care physician, but no answer. After 25 more minutes at 3:30pm, she refused any medical treatment by store management and stated she felt completely better.
receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 002C21A and 008B21A) for COVID-19 vaccination.     Patient medical history includes  Attention deficit hyperactivity disorder (ADHD), Anxiety, developmental delay, Hypotension, PTD.  Concurrent medical conditions included Anxiety, Nightmares, Developmental delay, ADHD and Hypotension. Concomitant products included ESCITALOPRAM and TRAZODONE for Anxiety, PRAZOSIN for Nightmares.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Jan-2022 at 12:51 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) to be not related.    No treatment medication was reported.   This case was linked to MOD-2022-473532 (Patient Link).
Pt's mother called 5/29/13 stated that her daughter was having jaw pain and received Td vaccine the wk before. He went to a clinic and was diagnosed with an ear infection and started on amoxicillin on Monday evening 5/27/13. Mother stated the pain is probably caused by ear infection. I instructed on CDC guidelines, side effects, of Td vaccine. She stated she understood. Instructed to follow up with physician if this did not improve.
pt recv ax 14AUG97 & the next day pt exp a site rxn described as warm, swollen & red (half dollar size);
Experience pain in left arm first 3 days, seem like pain was subsiding and on day seven in the morning woke up in excruciating left arm pain. I believe I had slept on it. Day 8 developed itchy rash near the top of left shoulder 9 ?Down forearm, day 13 rash devolped bumps-I have photos of the rash and bumps. Day 14 rash diminishes. Pain in left arm/shoulder continues Day 22 noticed lump (lymph node)base of neck left side-almond sized. From day 15 to 22 lost arm mobility -it was very painful to raise my left arm &especially out to the side.  March 9 I saw my general practitioner. The swollen lymph node at the base of my neck is diminishing in size and flattening out.
This spontaneous report was received from a healthcare worker regarding an unspecified number patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of GARDASIL 9 (dose, lot number, expiration date, route and anatomical location of administration were not reported), which were improperly stored. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
CHILLS; FEVER; MUSCLE ACHES; This spontaneous report received from a consumer concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills, fever, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and muscle aches. This report was non-serious. This case, from the same reporter.
Red rash at administration site. Numbness and tingling in arm. Stomach cramps, joint pain, dizziness.
Left arm deltoid 10 cm bruise. Warm/Induration, Rash.
A 37 year old female patient with acne (being treated with doxycycline) developed symptoms after receiving a first dose of MENACTRA (lot number U2874BA) in the right deltoid and a pneumonia vaccine (manufacturer not reported, lot number 0632Y) in the left deltoid on 22 September 2009 at 8:42 AM. At 6 PM, the patient developed a fever of 102 degrees, body aches, neck pain, and nausea. No other information was provided. The patient recovered. Follow-up information received 28 October 2009 from a health care professional. The pneumonia vaccine was manufactured by Merck, and both MENACTRA and pneumonia vaccines were administered intramuscularly. The event did not require a doctor's visit. When asked if the symptoms required treatment, or if the symptoms resolved on their own, the reporter replied "no". No additional information was provided. Follow-up information received on 16 November 2009 from a health care professional. The symptoms did not require treatment and persisted for two days. List of Documents held by Sender: none.
extreme vomiting; Fever of 99 to 101.1 degrees Farenheight; joint pain in both legs/joint pain in both knees; headache; chills; nausea; sore right injection site arm; swollen lymph node in her right arm; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (extreme vomiting), PYREXIA (Fever of 99 to 101.1 degrees Farenheight), ARTHRALGIA (joint pain in both legs/joint pain in both knees), HEADACHE (headache) and CHILLS (chills) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced VOMITING (extreme vomiting), PYREXIA (Fever of 99 to 101.1 degrees Farenheight), ARTHRALGIA (joint pain in both legs/joint pain in both knees), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea), MYALGIA (sore right injection site arm) and LYMPHADENOPATHY (swollen lymph node in her right arm). At the time of the report, VOMITING (extreme vomiting), PYREXIA (Fever of 99 to 101.1 degrees Farenheight), ARTHRALGIA (joint pain in both legs/joint pain in both knees), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea), MYALGIA (sore right injection site arm) and LYMPHADENOPATHY (swollen lymph node in her right arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2021, Body temperature: 99 to 101.1 (High) 99 to 101.1 degrees Farenheight.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include Birth control pills. Treatment medications were not reported.   This case was linked to MOD-2021-343259 (Patient Link).
I did not have an adverse reaction to the vaccine.  I started felling  symptomatic on 06/26. I had sore throat, runny nose, chills, fever and coughing.  I took Tylenol to help with my symptoms. On 06/30/2022 I went to an urgent care center to be tested for COVID-19 and it was positive.  I was not given a prescription to help me with the symptoms. I was directed to isolate for five days.