chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna stimulated a menstrual cycle in Menopause with Humira; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Moderna stimulated a menstrual cycle in Menopause with Humira) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, in pre-filled pen. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Moderna stimulated a menstrual cycle in Menopause with Humira) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Moderna stimulated a menstrual cycle in Menopause with Humira) had resolved and ARTHRALGIA (Joint pain) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  Company Comment: This is a spontaneous case concerning  an adult female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Postmenopausal haemorrhage and expected non-serious event of Arthralgia. The events occurred on an uknown date, after the unspecified dose of mRNA-1273 COVID 19 Vaccine. Patient received Adalimumab on an unknown date. The event Postmenopausal haemorrhage had resolved, while Arthralgia was reported as resolving. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.  No treatment medication was reported.; Sender's Comments: This is a spontaneous case concerning  an adult female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Postmenopausal haemorrhage and expected non-serious event of Arthralgia. The events occurred on an uknown date, after the unspecified dose of mRNA-1273 COVID 19 Vaccine. Patient received Adalimumab on an unknown date. The event Postmenopausal haemorrhage had resolved, while Arthralgia was reported as resolving. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
She had a fever for about 5 days, loss of appetite, congestion, fatigue, and a cough that has been going on for about 9 days. She is still dealing with the cough at this time. All of the other symptoms are gone. No medications were prescribed. She was taking MUCINEX, and chewable ibuprofen.
Presents to ED 4/21 with complaints of L side CP starting at approx 2100. Pt reports shooting pain to L side of chest and armpit with palpating area. Pt reports recently diagnosed with LLE blood clot on 4/13, put on eliquis and has been taking for the past 11 days. Pt reports resting makes pain better, palpating makes pain worse and standing makes pain worse in LLE. Pt denies SOB, DOB or cough. Pt denies history of PE, reports multiple bilat lower extrem DVT's. Patient CBC is normal, metabolic panel is normal, troponin is normal. CTA of the chest was obtained and shows no signs of pulmonary embolism. There is some prominence of his pulmonary arteries bilaterally. BNP is also negative. The patient's pain is mostly reproducible on that left chest, doubt ACS in this patient. Patient will be discharged home have him follow-up with his doctor as an outpatient. Patient is stable for discharge.
Right arm, evening of injection she had redness and pain. Redness increased in diameter. No fever or other symptoms. No decrease in range of motion.
mom called ofc on 6JUN95 describing red, swollen face & eyes, chest congestion; describes pt as unrecognizable; advised to take pt to ER ASAP; dx as allerg rxn to childhood immun; no tx given;
I received the vaccine on 3/13 and my wife developed COVID symptoms on 3/23 and received a positive COVID result on 3/25.  I felt fine the entire time and the morning of 4/6 I couldn't taste or smell.  I was given a nasal test and it came back positive for COVID.  It's likely that I contracted it from my wife before the full two weeks were up, but I thought it best to report so any information that could be helpful could be used.  My symptoms have not changed and I don't feel near as bad as after the vaccine or as my wife who didn't have the vaccine was!
12MAR97 h/a;13MAR97 devel mod case chicken pox;
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (manufacturer unknown) (Batch/Lot number: unknown) and as dose 2, single (manufacturer unknown) (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Caller mentions that she had covid now and was taking Molnupiravir 800mg twice a day for 5 days and that she had 2 days to go, she stated she had no fever and was starting to feel a little bit better. Patient stated that she was prescribed this medication instead of Paxlovid since her medications interacts with Paxlovid. She also mentions that her husband was actually on Paxlovid right now. She asked when she can get the 2nd booster dose of the Pfizer Covid 19 vaccine after recovering from covid?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Myalgias, high grade fever (tmax 102.0), malaise that has persisted 36 hours post vaccine administration. Symptoms have been more severe and persisted longer than associated with previous doses.
Flu vaccine given 11/4/15 right arm 11/5/15 right neck became swollen and tender to touch. C/O headache.
Swelling, redness, throbbing pain 48 hours after 3rd Anthrax shot.
Chills, low grade fever, muscle aches, flu-like symptoms for 2 days
Pt received 1st dose of Shingrix on 2/18/22 at a public clinic. Pt called on 3/23/22, over 1 month later, to inform that after she received the vaccine, she went out to her car and started to not feel well.   She reported severe chest pain.  She did not seek medical treatment that day.  She did not contact her PCP.  She states that she has read on social medial that other people are having the same reactions ???  Advised patient to contact her PCP regarding 2nd dose of Shingrix .
The first shot I was tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 09:30 (Lot number: ER8727) at the age of 61 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE BESILATE; TOPAMAX. Past drug history included: Depakote, reaction(s): "drug allergy"; Levaquin, reaction(s): "drug allergy"; Percocet, reaction(s): "drug allergy". The following information was reported: FATIGUE (non-serious) with onset 13Apr2021, outcome "unknown", described as "The first shot I was tired". The event "the first shot i was tired" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of fatigue.  Additional Information: No treatment AE reported. No Covid prior vaccination. No Covid tested post vaccination.  No follow-up attempts are needed. No further information is expected.
warmness, felt like i was going to pass out, had a 2nd wave and went to ER Narrative:
Patient presents to flight Surgeon April 19, 8-15 cm area of erythema & warmth over olectanon process. Pt was hospitalized on IV antibiotics for 2 1/2 days, released to home on oral Augmentin for one week. 60 day follow-up dated 10/18/00 provided no additional data.
mild swelling and tenderness of corresponding vaccine site arm in armpit lymph nodes; mild swelling and tenderness of corresponding vaccine site arm in armpit lymph nodes; This is a spontaneous report from a contactable pharmacist. A 44-year-old female patient received bnt162b2 (BNT162B2), the first dose (lot number: EH9899, expiry date: not reported), intramuscularly, on 18Dec2020 04:00 PM, at a single dose, on the left arm; and the second dose (lot number: EL1284, expiry date: not reported), intramuscularly, on 07Jan2021 11: 00 AM, at a single dose, on the right arm, both for COVID-19 immunization. The vaccine was administered in a hospital. The patient was not pregnant. Medical history included COVID. It was reported that patient was diagnosed with COVID prior to vaccination and was not tested for COVID post vaccination. The patient had no known allergies. Concomitant medications included ethinylestradiol, levonorgestrel (JOLESSA), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), ergocalciferol (VIT D); these are the other medications she received in two weeks. The patient did not receive any other vaccine within four weeks. The patient experienced mild swelling and tenderness of corresponding vaccine site arm in armpit lymph nodes the evening following both covid 19 vaccine doses 1 and 2. This lasted 48-72 hours and then resolved. The first dose was received on 18Dec2020 with reaction occurred on 19Dec2020. The second dose was received on 07Jan2021 with reaction occurred on 08Jan2021 06:00 PM (also reported as "09Jan2021"). The patient did not receive any treatment for the reported adverse events. Outcome of the events was recovered on an unspecified date.
10AUG94 t104.4; 23AUG ill; 24AUG t104.6 ax, sz to MD virus; 25AUG swollen glands-given Rocephin; 26AUG Rocephin #2 rash-face, stomach; 27AUG DPH;
Saturday morning 10/2/10 patient woke up with a sore arm, more than expected.  She spent most of the day in bed, waking up with pain and swelling in the left armpit (same side as vaccination), patient reports fever of 103 and sweating.  Patient self treated with ibuprofen and Aleve.  She slept most of Sunday 10/3/10.  Monday 10/4/10 she had some numbness in the left hand that is mostly better today 10/5/10.
patient got flu shot on 09/01 and on 09/02 1:00 in morning woke up with body aches. At about 7 to 8 am patient had to call 911. He describe symptom as having extreme back pain which felt like snap back and hit by a car. He also had a fever of 102 degree.
Major tingling  and numbness in face and left side of body. Second shot has now been taken and numbness has increased significantly.
Patient reported fatigue, fever 99.8 F, and diarrhea. Symptoms developed around 01/17/2021 or 01/18/2021. Patient felt better around 01/20/2021 but not entirely resolved.
Case number PHEH2012US018691 is an initial spontaneous report received from a health care professional on 05 Sep 2012, and a follow up received on 16 Oct 2012: This report refers to an 18-year-old male patient. He was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) intramuscularly into his left arm on 31 Aug 2012. Concomitantly on the same day he also received intranasal FLUMIST (other manufacturer, batch number: A52108). This MENVEO had reached up to 11 degree Celsius for 30 to 60 minutes due to power outage. It was reported that vaccine was stable and was okay to administer. No adverse event was reported following this administration error (incorrect storage of drug). Follow up information received from a healthcare professional on 16 Oct 2012: Updated concomitant vaccine administered and the reporter's comment on administered MENVEO vaccine.
About three days after the J&J shot, I had a pain running up the left side of my neck, plus it felt like I had excess pressure in  my head.  This lasted for at least two months.   The following weekend I went surfing and the exercise  make me it feel as though I hade been hanging upside down all day.  Even to this day when I exercise, I have this feeling of excess pressure in my head.
Prior to vaccination - anxious hyperventilating. Immediately upon actual injection became glassyeyed, exhibited tardive dyskinesia like symptoms, nausea like symptoms, licking lips, tongue chewing like movements etc.
Patient's husband received his smallpox vaccination approximately 2 1/2 weeks ago.  He is now deployed.   8/29/03 Patient noted a bump on the left side of her face that she thought was a pimple.  No other lesions. 8/30-31/03 Lesion on side of face becoming larger.  Describes as slightly itchy and throbbing.  No drainage.  Also noted a tender spot on the top of her head.    9/1/03 Lesion on face enlarging.  Now noted a similar lesion on scalp.  Noticed that the lesions resembled the lesion at the site of her husband's SPV.  She was also now experiencing mild flu-like symptoms.  Reports feeling tired and began to develop a mild intermittent headache.  Noted tender swollen "knots" on neck.Reported to the ER and was diagnosed with SPV contact transmission.  She was prescribed Keflex and told to follow up with the health center. 9/3/03 Presented to health center.  Reports lesions have continued to enlarge and are now draining small amounts of "yellow fluid."  Describes as tender, throbbing, and itchy.  "Knots on neck are tender."  Continues to have slight headache and feels tired.  Denies dizziness or mental status changes.    Patient's husband deployed on 8/26/03.  She is unsure if he received briefing or trifold on smallpox vaccination but plans to ask him when she speaks with him next.  Neither patient nor her husband had any contraindications to SPV.  She reports he did keep the site covered at all times and frequently washed his hands.  They slept in the same bed, but he kept the site covered.  Patient states they did not keep their laundry and linen separated, and she did handle his laundry.  Patient currently resides with her mother and sister.  She reports they have no contraindications to SPV (ie.  No immunodeficiency, no history of atopic dermatitis/eczema, pregnancy, cardiac problems, and are not on steroids).    Meds prescribed:  Ibuprofen 800 mg po tid, Allegra 180 mg po qd
Sore arm overnight then next day red and swollen below injection site and bump in the red area-soreness.
pt recv vax;2 wk later,devel approx 12 vesicular lesions;md reported 3 children who were exposed to pt devel chicken pox;
pt recv vax 19NOV96 & on 16MAR97 pt exp optic neuritis;It resolved w/in 2-3wk;however MRI showed multifocal plaques consistent w/Multiple sclerosis;pt is currently asymptomatic;
Approximately 15 minutes after patient received the vaccine on November 29th, 2007, she c/o severe left arm pain which patient did not report until follow-up in clinic on January 10th, 2008. She reports that the severe pain subsided after two to three days which now is a mild amount of dull, intermittent pain. Denies anaphylactic reactions on November 29th and any of the other following days. Denies any other neurological symptoms, constitutional symptoms, nausea, vomiting, SOB, diarrhea, headaches, paresthesias, and weakness.
after 3 years of not having her period, she suddenly started bleeding heavily and having menstrual cramps. The bleeding was very clotted and seemed somewhat abnormal; after 3 years of not having her period, she suddenly started bleeding heavily and having menstrual cramps. The bleeding was very clotted and seemed somewhat abnormal; after 3 years of not having her period, she suddenly started bleeding heavily and having menstrual cramps. The bleeding was very clotted and seemed somewhat abnormal; This is a spontaneous report from a non-contactable consumer. A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 20 years). The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated that after 3 years of not having her period, she suddenly started bleeding heavily and having menstrual cramps. The bleeding was very clotted and seemed somewhat abnormal. The patient underwent lab tests and procedures which included nasal swab: negative on an unspecified date. The patient did not have COVID prior vaccination. The patient was not pregnant. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt complained of ongoing muscle ache/pain from below injection site radiating down to forearm for 2 weeks.
PAIN FUL IN ARM; A spontaneous report was received from a concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was painful(Injection site pain), felt like a tetnus shot.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events arm was painful . On the second day, she reported that if felt like they had received a tetanus shot in their arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, arm was painful, felt like a tetnus shot was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
p/vax pt devel varicella w/approx 15 lesions;pt was seen in MD office & noted to have cold sx & bilat OM;
Breakthrough case admission after 4 vaccines Moderna 2/20/21 lot# 023M20A;  Moderna 3/20/21 lot# 002B21A;  Moderna 11/11/21 lot# 058F21A;  MOderna 7/12/22 Lot# 017B22A
After 30 minutes of receiving the first doses I felt a decrease in my body and my heart was racing, it was beating very fast and I turned pale. Then 1 or two days later I saw that I had on my legs on my thighs many pinkish lesions in the form of herpes that do not itch, only that I have many on all my thighs and very few on my hands. My heart keeps racing once or twice a day with up to 100 beats per minute.
Received vaccine 3/19  and then woke up 3/20 with fatigue, chills, nausea, diarrhea, congestion. Pt's symptoms were improving as far as congestion, but fatigue was so severe that pt did not feel that she was able to drive herself around and has missed work as a result. Sx ongoing as of 3/23 at 9:30 am.
Persistent fever initially 102 deg. Now 3-4 wk after 100. Rash at injection site within 3 days followed by diffuse papular rash 3 wk later
This case was reported by a consumer and described the occurrence of personal injury in a female subject of unspecified age who was vaccinated with hepatitis B vaccine for prophylaxis. A physician or other health care professional has not verified this report. On 30 August 2005 the subject received unspecified dose of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced personal injury (unspecified). At the time of reporting the outcome of the event was not known. Follow-up information was received for this case on 27 July 2007 in the form of an incomplete deposition and a form from the Vaccine Adverse Event Reporting System. The documents indicated that the hepatitis B vaccine administered to the subject was Engerix B and that the subject also received tetanus diphtheria. The subject was reportedly 44 years of age at the time of Engerix B administration. Events reported and confirmed via a physician were complex regional pain syndrom of the face, right arm and right leg with moderate to severe chronic pain. The events were considered to be disabling and the subject was bedridden 90 to 95 percent of the time. Other events mentioned included nausea, light headedness and headache. The subject had pre-existing facial neuralgia and an allergy to sulfur biproducts and compounds. The subject also may have an allergy to vaccines containing sulfates. Other medical history included tongue deviation from some unspecified dental procedure performed in 2003, a past history of smoking and in 1978, the subject stop breathing after general anesthesia for several minutes. An MRI performed on an unknown date was negative. At the time of reporting, personal injury, complex regional pain syndrome and chronic pain were unresolved. Outcome of the events was not known.
Patient starting developing tenderness and warmth feeling on her left arm where she got the PNEUMOVAX shot followed by swelling and redness around the injection site. Later on she also has hives around her elbow. Treatment advised was ice compress, Ibuprofen 800 mg every 6 hours and BENADRYL at night.
Throbbing & painful  left upper arm- deltoid, to the point, I was unable to move, rotate, or lift the arm in any direction at all. This was accompanied by tingling and mild swelling of the fingers. mild chills  dose #1 mild headache