chrisvoncsefalvay/vaers-outcomes huggingface dataset:
migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced MIGRAINE (migraines). At the time of the report, MIGRAINE (migraines) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were Reported. No Treatments were Reported. Patient did not have migraines after years, experienced some after the first and second vaccination whit the Moderna vaccine in Jan 2021 as well as recently in late Oct 2021 after a flue shot.   This case was linked to MOD-2021-395791 (Patient Link).
Mother reported swelling and pain at injection site with fever of 101F. Started approx. 3 hrs post-injection and ran for approx. 24 hrs.
A physician reported the occurrence of screaming in a 3 month old female who received Infanrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On 11/25/02, the subject received her first injection of Infanrix (565A9). Later that day, the subject began screaming. The screaming lasted eight hours and resolved without treatment. This report has been linked to report A0389494A due to same reporter.
I fit so sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and felt so sick. The patient stated that the doctor wouldn't give him/her the second shot. Additional supportive information: The follow-up would not possible, as no contact details were available.
Patient has reported longstanding pain in the left arm since injection. She was treated with 2 rounds of steroids and methocarbamol with little to no improvement. She was then referred to an orthopedic doctor for further evaluation and treatment.
Patient tested positive for Covid morning after vaccination with symptoms.  Fever of 100.2, headache, eyes burning, head is heavy, chills, very fatigued
Left arm is very sore, red and swollen. Hard and warm to the touch on 4/28/2017. Mom is giving paracetamol (like TYLENOL). Patient was stated on a oral antibiotic for a cellulitis type change (infection) on 4/28/2017 per Dr.
Flu shot 1/20/00. Onset of itching to trunk and fingers and "whelps" under his r/arm on 1/24/00.
On 8/3/98 pt recv vax; on 8/4/98 pt exp numbness, tingling down RA.  Probable brachial neuritis.  No tx available for condition.
About a week after receiving vaccine I am experiencing vertigo, sometimes extreme, when rolling over in bed or standing up.  It's to the point I feel I might be sick to my stomach.  Never have I had these  symptoms in my life.  Also, I am experiencing joint pain in my hips which I've not experienced before.
The pt developed fever over 104 deg. F, vomiting and diarrhea on the following day of vaccination. She was seen in ER that evening and sent home.
Swollen, hot, red, itching, harder 2 x 2 in area.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant therapies were not reported. On 05-OCT-2018, the patient was vaccinated intramuscularly with the second dose of GARDASIL 9 lot # M024261, that expired on 30-JUL-2018, for prophylaxis(strength and dosage schedule were not reported). There were no temperature excursion for this vaccine and no adverse effects were reported.
pt recv vax 10DEC96 & 13JAN97 pt exp rash on the backs of hands & thighs & a fever 102.6;
around 7pm I had had a cup of coffee and a brownie and I suddenly felt tight in the chest and abdomen. tums did not help but didnt resolve. the next day I still had issues and was light headed. It did go away eventually. I have a history of indigestion/gas issues.
Patient came in for a third additional shot of moderna because patient is immunocompromised.  Patient received only the booster half dose.  Patient reported the error to pharmacy and the patient was told to come back in to get the other half dose to make a full dose.  Unsure if patient will come in.
He developed some chest pain that created discomfort,  then went away after a day.  Expressed concern with second dose side effects. Let him know that if any symptoms exist after dose on 7/22/21 to please call us for non-urgent advice and if pressing to go to the emergency department right away.
pt recv vax & devel 30 pruritic varicella like lesions w/T99.5-100.0;
This spontaneous report as received from a other health professional refers to a patient of unknown age. On FEB-2017 the patient was vaccinated with RECOMBIVAX HB for prophylaxis. On FEB-2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered no adverse event to be not related to GARDASIL 9, PNEUMOVAX 23, VAQTA and RECOMBIVAX HB. The reporter considered incorrect product storage to be not related to VAQTA, RECOMBIVAX HB, GARDASIL 9 and PNEUMOVAX 23. Additional information has been requested.; Sender's Comments: US-009507513-1707USA000480: US-009507513-1707USA000481: US-009507513-1706USA005951:
1 st dose on 27MAR2021 and has not received a second dose; Chest tightness; Painful; Dizziness; Headache; Body pains; Glands in throat swollen and painful/glands in under arm swollen and painful/lymph nodes swollen; Tired; Extreme arm pain; Hardly lift arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1 st dose on 27MAR2021 and has not received a second dose), PAIN IN EXTREMITY (Extreme arm pain), LIMB DISCOMFORT (Hardly lift arm), CHEST DISCOMFORT (Chest tightness) and PAIN (Painful) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (erythromycin) and Allergy to antibiotic (azithromycin).    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Extreme arm pain), LIMB DISCOMFORT (Hardly lift arm), PAIN (Painful), DIZZINESS (Dizziness), HEADACHE (Headache), MYALGIA (Body pains), LYMPHADENOPATHY (Glands in throat swollen and painful/glands in under arm swollen and painful/lymph nodes swollen) and FATIGUE (Tired). On 29-Mar-2021, the patient experienced CHEST DISCOMFORT (Chest tightness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1 st dose on 27MAR2021 and has not received a second dose). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 27-Mar-2021, DIZZINESS (Dizziness) had resolved. On 29-Mar-2021, HEADACHE (Headache), MYALGIA (Body pains) and FATIGUE (Tired) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (1 st dose on 27MAR2021 and has not received a second dose), PAIN IN EXTREMITY (Extreme arm pain), LIMB DISCOMFORT (Hardly lift arm), CHEST DISCOMFORT (Chest tightness), PAIN (Painful) and LYMPHADENOPATHY (Glands in throat swollen and painful/glands in under arm swollen and painful/lymph nodes swollen) 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.   Treatment details included three pills of ibuprofen for the pain in glands. Concomitant drugs and Lab data information, if any, not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant follow up On 11-Aug-2021: Non Significant information
Client reports the night of her vaccine date she went to bed with a fever, and wasn't feeling good.  Woke up around 0400 and could not get out of bed or raise her neck up.  Called son and he took her to ER.  They ran a bunch of test started her on anti-inflammatories and after 45 mins. she was able to move her neck.   Reports going home and no further problem.
Pt vaccinated w/MMR in R upper arm and Dip/Tet in L upper arm 12/19/6.  Rxn occurred approximately 9-10 days after injection.  Seen at MD for rxn which was diagnosed as measles; also was cultured positive for Strep & prescribed Z-pak.  Rash began on back of R hand & spread constantly up arm, across trunk, and by 1/4/6 covered legs and feet.  Also has swollen itching lymph node behind R ear.
Fever, headache, neck stiffness. Pt hospitalized 11/20/2001.
Patient was mistakenly scheduled for, and received his second dose of the Moderna vaccine series 22 days following his first dose, outside of the recommended 28 days and 4 day grace period per CDC. Patient notified of error on 9/10/21. Per CDC, patient does not need to repeat doses or series.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 17-year-old female patient who received MENVEO (batch number M15125, expiry date unknown). The patient's past medical history included asthma and reactive airways disease. Concurrent medical conditions included allergy. Concomitant products included DEPO PROVERA. On 7th July 2016, the patient received MENVEO. On 10th July 2016, 3 days after receiving MENVEO, the patient experienced fever and weakness. In July 2016, the patient experienced cold sweat, shortness of breath, vaginal ulceration, lymphocytes raised and elevated liver enzymes. The patient was treated with ibuprofen, acetaminophen, and albuterol. In July 2016, the outcome of the vaginal ulceration was recovered/resolved. On an unknown date, the outcome of the fever, shortness of breath and weakness were unchanged and the outcome of the cold sweat, lymphocytes raised and elevated liver enzymes were unknown. The reporter considered the fever, cold sweat, shortness of breath, vaginal ulceration, weakness, lymphocytes raised and elevated liver enzymes to be related to MENVEO. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the patient's mother. The patient had been diagnosed with either asthma, reactive airway disease or allergies when she was about five or six years old but the reporter could not remember exactly which one. On 10th July 2016, the patient began to feel weak and developed fever of 103.2 degrees F. The fever only resolved when the patient was taking either ibuprofen or acetaminophen but returned as soon as the medication wears off. She continued to feel weak. The patient's mother reported that sometimes the fever broke and her daughter experienced a cold sweat. On 12th July 2016, the patient went to her gynecologist because she had painful vaginal sores. Her physician told her that she had Herpes, however, the test results came back as negative. The reporter also indicated that the patient experienced periods of shortness of breath. During one episode, the patient inhaled some of her dad's albuterol to help improve her breathing. On Thursday, 21st July 2016, the mother took her daughter to the emergency room. The test results showed that the patient had elevated lymphocytes and elevation in her liver function. The reporter was very concerned about what her daughter was experiencing. She did not clarify what she meant by elevation in her liver function.
Started slight redness itching and swelling after 6 days, still has that. Tropically applied te over the counter .01 percent cortisone ointment.
On Day 5 after receiving the second dose of the Pfizer vaccine, I woke up with hot flashes. I have felt flu-like body aches and a fairly intense headache.  6 hours later I am feeling better but still a little nauseated and "pale" feeling.
After 24 hours, developed flu symptoms, headache, fever, chills, cough. Was unable to work.
Failed to dilute Pfizer (PEDS) dose before administration. Mother contacted of error and she will contact public health of any adverse reactions.
Began itching as soon as vaccine received- took 50 mg of Benadryl po and no further c/o
Starting on 10/20/2021, I started getting more frequent headaches throughout the day. I thought they were occurring because of working on the computer, but I've never had them before like this. I would get 5-6 episodes of headaches throughout the day. Shortly after that, my sleep pattern started changing. I am having a hard time falling asleep, and when I do fall asleep it often is for a short time. I have had episodes of being up for 48 hours at a time. I went to my doctor and they have prescribed me medications, which have not helped me, and its starting to affect my mood and my ability to function.
This patient received HIBERIX for her 3rd dose of Hib. No adverse reaction reported.
Pt vaccinated with DTP experience hyporeponsive episode for a few (6-8) hrs. Started 3-4 hrs after DTP.
Pt recv vax on 2/22/99; on 2/23/99 pt exp fever (101), red/ pain/ swollen/ indurated left upper arm, headache, fatigue; dx=acute medication rxn; tx=Toradol
Patient received a Td booster on the morning of 10/15/01. Within 5-10 minutes of injection, patient began sweatting profusely, "beading out of head". Patient felt like passing out/fainting and started seeing lights at the start of the episode. Patient was feeling better within 30 minutes of onset. Vital signs stable. Patient was continuing to be monitored by nurse.
This initial spontaneous case was received on 17-Oct-2017 from a pharmacist, concerning a male patient of unspecified age. The patient's medical history included sinus infection. On 27-Oct-2016, the patient was administered with FLUVIRIN (dose:0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date: not reported). On an unspecified date, after the vaccination, the patient experienced change in taste in mouth and lost his ability to taste things for about 2 weeks and ability to smell. It was reported that, the patient had never the taste of metallic. It was reported that, the patient had sinus infection and went to ENT. The outcome of the event loss of smell was not recovered, and outcome of the events loss of taste and sinus infection reported as recovered, the outcome of the event taste changed was not reported. The reporter assessed the events as non-serious.
p/vax pt exp unsteady gait; double vision & slurred speech; sought MD care
Patient developed flushing, hives and itching. Patient self-administered loratadine 10mg PO x 1. After 20 minutes after loratadine, patient reported reduced incidence of hives.
Extremely dry mouth making it difficult to eat; itchy at the injection site; rash at the injection site; swelling at the injection site; very runny nose; very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm), RHINORRHOEA (very runny nose), DRY MOUTH (Extremely dry mouth making it difficult to eat), VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE RASH (rash at the injection site) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (very sore arm). On 13-Mar-2021, the patient experienced RHINORRHOEA (very runny nose). On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at the injection site), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). On 17-Mar-2021, the patient experienced DRY MOUTH (Extremely dry mouth making it difficult to eat). On 10-Mar-2021, PAIN IN EXTREMITY (very sore arm) had resolved. At the time of the report, RHINORRHOEA (very runny nose), DRY MOUTH (Extremely dry mouth making it difficult to eat), VACCINATION SITE PRURITUS (itchy at the injection site), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment was administered by patient for events.
Left arm Red, swollen arm shoulder to elbow, painful, ROM, started 10/24/06 afternoon. C/o feeling achy all over, chills that evening. Took TYLENOL improvement today 10/26/06.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (experienced after 1st dose, refer case US2018GSK219175). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, fever, shivering, headache and upset stomach. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, fever, shivering, headache and upset stomach were unknown. It was unknown if the reporter considered the injection site pain, fever, shivering, headache and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced all the known side effects, fever, shivering, headache, upset stomach and pain at the injection site. The patient asked if there are any foods that should be avoided when receiving the SHINGRIX vaccine as the side effects intensified after receiving 2nd dose as compared to the 1st dose.
side effects after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after first shot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pain on 06-Feb-2021.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Feb-2021, the patient experienced VACCINATION COMPLICATION (side effects after first shot). At the time of the report, VACCINATION COMPLICATION (side effects after first shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment medications was not provided.
Patient received a half dose of Moderna (0.25mL) instead of a full dose (0.5mL) which was necessary as it was the patient's first dose. The patient was unable to come back in to clinic same day so patient will be coming in 11/8 to receive a full dose and restart series.
sudden hearing loss in right ear; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of hearing loss unilateral in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2019).   In June 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced hearing loss unilateral (serious criteria GSK medically significant) and influenza-like symptoms. On an unknown date, the outcome of the hearing loss unilateral and influenza-like symptoms were unknown.   It was unknown if the reporter considered the hearing loss unilateral and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient made note to himself/herself to get the 2nd dose of Shingrix on 10th March 2019, but could not find it until June 2019. The patient expereinced alot of flu like symptons and had sudden hearing loss in right ear.  The patient had been to a ear-nose-throat (ENT) specialist and done an magnetic resonance imaging (MRI) and there was no reason for the hearing loss. The patient asked if hearing loss was a side effect from Shngrix.
I was sick like when you get the flu for two straight weeks.  I had absolutely no energy or will to do anything.  Couldn't get out of bed and it felt like my skin was crawling all the time. I have never been so sick in my life.  I am NOT getting second shot because NO doctor will help me understand what happened to me.  But, you need to know!
vertigo, feeling off balance, fatigue, lethargy - resolved in 2-3 days, took anti vert once
Bad migraines; fevers; chills; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (bad migraines), PYREXIA (fevers) and CHILLS (chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (bad migraines), PYREXIA (fevers) and CHILLS (chills). At the time of the report, MIGRAINE (bad migraines) outcome was unknown and PYREXIA (fevers) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had bad migraines, fevers, & chills to the point that her & her doctor decided to put the 2nd dose off for a couple of weeks. The fevers & chills lasted for a  week after the 1st dose. No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-349189 (Patient Link).
Redness at site of immunization 2 days 8/27/03 after immunization given. 50 cent (size) 8/27/03, 8/28/03 size of small orange, 8/29/03 increased size and redness. Width 4.5", length 3 5/8" at office. Redness diminishing, slightly warm to touch. No fever, no pain.
This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), RASH (rash on arm), FATIGUE (fatigue) and ARTHRALGIA (feet hurt, ankles hurt, knees and joints hurt) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, 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 ASTHENIA (weakness), RASH (rash on arm), FATIGUE (fatigue) and ARTHRALGIA (feet hurt, ankles hurt, knees and joints hurt). At the time of the report, ASTHENIA (weakness), RASH (rash on arm), FATIGUE (fatigue) and ARTHRALGIA (feet hurt, ankles hurt, knees and joints hurt) outcome was unknown. Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medications were provided. No treatment was reported for the events.