chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Maternal exposure during breast feeding; Moderna Bivalent given as second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (No adverse event), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and WRONG PRODUCT ADMINISTERED (Moderna Bivalent given as second dose) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.  On 28-Dec-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Dec-2022, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and WRONG PRODUCT ADMINISTERED (Moderna Bivalent given as second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 28-Dec-2022, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) and WRONG PRODUCT ADMINISTERED (Moderna Bivalent given as second dose) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and WRONG PRODUCT ADMINISTERED (Moderna Bivalent given as second dose).    No concomitant and treatment medications were reported.   Reporter did not allow further contact
Pt describes great pain in shoulder after receiving PNEUMOVAX. Pain has decreased in severity since immunisation.
an induration in the patient's skin where the vaccine had been given; the patient felt febrile; This spontaneous report was received from a physician via a company representative referring to a middle 50 years old male patient.  The patient had diabetes. Information about concomitant medication and drug reactions/allergies was unknown.    On an unknown date in 2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dosage detail, strength, lot # and expiration date were not reported) intramuscularly for prophylaxis. On an unknown date in 2018 (reported as the day after the patient was administered the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)), the patient experienced an induration in the skin where the vaccine had been given and the patient felt febrile. The patient called the physician office and the physician had sent the patient to the hospital (demographics unknown) the same day as the office visit. If the patient had stayed in the hospital or if it was just an emergency room visit was unknown. The outcome of the events was reported as recovered. Causality assessment was not provided.
Fever ranging from 101.4-102.6 lasting over one day. Currently still have fever (although reduced) of 100.2.
ARM red, swollen, painful to touch and with movement, red streaking to arm pit, very tender, achy and tired, swelling lasted 3 days, still tender as of 8/5.
Sore arm; This is a spontaneous report received from a non-contactable consumer, Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Miralax, reaction(s): "Reaction". Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "Sore arm"; Bnt162b2 (DOSE 2), for COVID-19 immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional Information: The patient and her husband took the initial Pfizer COVID-19 vaccine and the bivalent COVID-19 vaccine last Oct2022 and had a sore arm. The patient started taking MIRALAX (reported as propylene glycol) and possibly had a reaction to it. The patient's husband wants to know if vaccines have the same product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300080183 Same patient, product, and event; different dose;US-PFIZER INC-PV202300080184 Same patient, product, and event; different dose;
arm was sore; Not feeling 100%, not feeling well; feverish/Feeling a little feverish; tired; increase urination; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient (Age: 66, unit: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Feb2021 at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient experienced arm was sore, not feeling 100%, not feeling well, feverish/feeling a little feverish, tired, increase urination. Reporter got 1st dose on Tuesday. Reporter says her arm was sore for 2 days. May be the 3rd day I started noticing I didn't feel well. Reporter says on Sunday, she felt Feverish, thermometer showed normal range. On Monday, she felt like the same off and on. Reporter says today, She is feeling tired and possibly increase urination. Reporter says, I know people complained about arm soreness. Reporter says she heard symptoms increase after the 2nd dose. Reporter is asking if it is normal to feel unwell or uncomfortable a week later. Reporter asking if she should I get the 2nd dose after this experience with the 1st dose. Reporter asking for recommendation to do before next dose to Lessen effects of 2nd dose. Reporter gives examples: like drinking more fluids. Reporter says, I saw you shouldn't take Tylenol before. Reporter stated she is calling regarding the Pfizer Covid Vaccine that she had last Tuesday 23Feb2021 and she is feeling a little feverish and not feeling 100%, not feeling well. She states that her doctor appointment is not until after second shot is scheduled. She is wanting to know if this is a normal side effect. Reporter refused to answer any further questions and just wants to be transferred to someone that can answer her question. She states that she has been on hold for an hour already and is already behind. Outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
VIRAL PINK EYE Monday 3/15 AM I received the  vaccine. That night I had some mild achiness and headache which continued the next day. Nothing exceptional. The next morning, Wednesday, when I woke up I was surprised that my right eye was a bit crusty. It was rather red but not painful. I thought it would go away ignored it but that night I realized it was still red.  I did some research about pink eye and realized I fit the description for viral pink eye.  But when I saw that 90% of all viral pink eye is caused by the Adenovirus - the same that is used in the vaccine I realized I should report the coincidence. I made an appointment with my doctor to confirm before submitting this report.
raised lesions on her lower back; This case was reported by a consumer via call center representative and described the occurrence of skin lesion in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin lesion. On an unknown date, the outcome of the skin lesion was not recovered/not resolved.   It was unknown if the reporter considered the skin lesion to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient reported that she took her first dose  of Shingrix vaccine series. The patient stated that after vaccination she developed some raised lesions on her lower back. The patient's health care professional ruled out shingles and bed bugs. The patient reported that she would see her dermatologist. The patient declined to provide any other information. The patient did not consented to follow-up.
Metal taste in mouth; dizzy; headache; nausea; hot / cold; brain fog; exhausted feeling; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the first dose of BNT162B2 (Lot number was not reported), via an unspecified route of administration, administered in left arm on 10Mar2021 09:45 (at the age of 38-year-old) as single dose for COVID-19 immunization. The patient is not pregnant. Medical history included ADHD, psoriasis, multiple joint arthritis and allergies. The patient's concomitant medications were not reported. On 10Mar2021 at 11:15 AM, the patient experienced metal taste in mouth, dizzy, headache, nausea, hot / cold, brain fog, and exhausted feeling. It was unknown if there are treatment received for the events. No Covid prior vaccination. Covid not tested post vaccination. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I started having symptoms like slight fever (101.0) brain fog, couldn't read the newspaper even if it was about sports which I love.  I contacted the doctor via telehealth the next day and I was prescribed Paxlovid, and I saw a change right away. After the 28th of August I no longer had a fever.  I was so fogged that simple task like getting aspirin at the pharmacy was a major task because I kept having brain fog. I started recovering within 6 days but was told that its normal for me to test positive.
VERTIGO; ARM WAS A BIT SORE; METAL TASTE IN MOUTH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered in MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.   In MAY-2021, few minutes after receiving the shot, the patient experienced metal taste in mouth and arm was a bit sore. In AUG-2021, the patient suddenly began having vertigo (dose series 1). The patient had been coping with it and it was finally getting a lot better.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient was recovering from metal taste in mouth and arm was a bit sore. The outcome for vertigo was unknown.  This report was non-serious.  This case, involving the same patient is linked to 20211125013 (dose series 2).
Headache in back of head, swelling and pain in armpit area lasting for 1 week. Swelling in throat and having problem swallowing.
By the second day after the vaccine, she lost all ability to speak.  Instead of communicating verbally as she had been, she would screech if excited and cry if upset.    It would show that she knew what she wanted to say but couldn't get the words out.  She would them become frustrated and just screech if excited or again, cry if upset.  This lasted for six months.  I watched her be unable to speak a single word for six months...  She now only repeats what she is told but rarely ever initiates conversations or speaks words of her own choosing.
Patient was given vaccine. He did not state he was scared of needles. i asked him to have seat outside pharmacy for 15 minutes to observe him. His friend with him said he passed out in the chair sitting down.We called 911 and I went to assess him and spoke to him and touched him with no response. He proceeded to slide out of chair and I brought him to the floor and laid his to the side. He twitched and eyes fluttered. I then injected him with epi-pen thinking he may have been having an allergic response. His skin was white. After injection his coloring came back and slowly started to speak.He was able to form sentences. Police and EMS came and assessed him within 10 minutes and took his blood pressure. He was coherent and coloring resumed on patients face. Patient stated he had a little of tingling and mentioned he passes out occasionally after giving blood. Patient was released and aunt came to store and did not seek any further medical attention even though ems wanted him to get checked out. Blood pressure continued to rise and EMS believes patient  had vasophagal syncope.
Dizziness; my mouth was dry; I felt like I was having Arrhythmias I went to Hospital on June 29th - tested and I had PACs and PVCs as well; Little runs of atrial Tachycardia -Super Ventricle Tachycardia; D-Dimer was slightly elevated. CTA of the chest - CT with contrast of chest. IV fluids - liter of fluids - was dehydrated. They referred me to a cardiologist. I had to wear a heart monitor for two weeks and it showed the same thing as I was seeing in the ER - occasional PVCs and a lot of PACs and Super Ventricle Tachycardia. No treatment. I am feeling some Arrhythmias now in fact. But I don't have the dehydration anymore.
Chest pains, fatigue, passing out for long periods at a time. Passing out after intense physical activity.
This case was reported by a physician via a sales representative and described the occurrence of stinging at the injection site in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX. At an unspecified time after vaccination with TWINRIX, the subject experienced stinging and burning at the injection site. This was also reported to be a product complaint as the reporter felt the events were related to a quality issue with the TWINRIX injection. The outcome of the events was unspecified. It was reported that 10 subjects (including this one) experienced burning and stinging at the injection site following administration of TWINRIX from the same lot. Linked cases include: A0752060A, A0752087A, A0752088A, A0752089A, A0752090A, A0752091A, A0752093A, A0752094A and A0752095A. Follow-up information was received on 04 November 2008, by a physician and described described the occurrence of injection site stinging in a male subject of 35 unspecified age unit who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown). On 29 September 2008, at an unspecified time after vaccination with TWINRIX, the subject experienced injection site stinging, injection site burning and product complaint. On 29 September 2008, the events were resolved. The physician considered the events were related to vaccination with TWINRIX. The physician associated the events to possible irritation substance in lot AHABB128AB. The lot was removed from vaccination circulation.
she experienced a slight reaction with slight fever the next day; she experienced a slight reaction with slight fever the next day; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (she experienced a slight reaction with slight fever the next day) and PYREXIA (she experienced a slight reaction with slight fever the next day) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Patient had no allergies.  Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE and FOLIC ACID for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION COMPLICATION (she experienced a slight reaction with slight fever the next day) and PYREXIA (she experienced a slight reaction with slight fever the next day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In January 2021, VACCINATION COMPLICATION (she experienced a slight reaction with slight fever the next day) and PYREXIA (she experienced a slight reaction with slight fever the next day) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient took Tylenol and felt fine after an hour.   This case was linked to MOD-2022-638295, MOD-2022-638298 (Patient Link).
3 1/2-4hr p/vax pt vomited had 2 min of staring, clenched teeth, unresponsive to those around;pt was seen in ER;CBC showed WBC 16,000;no fever several blood test nl;had a similar episode the next day;CAT scan, EEG & more blood test-all nl;
Delayed adverse effets; Feeling fatigue/very tired all the time; Just a bad feeling/Don't feel right; Feels hungover all the time; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Just a bad feeling/Don't feel right), HANGOVER (Feels hungover all the time), VACCINATION COMPLICATION (Delayed adverse effets), FATIGUE (Feeling fatigue/very tired all the time) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dry mouth. Concomitant products included CEVIMELINE for Dry mouth, BUPROPION HYDROCHLORIDE (WELLBUTRIN), TOPIRAMATE (TOPAMAX), LAMOTRIGINE (LAMICTAL), ASA, ROSUVASTATIN CALCIUM (CRESTOR), LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN, HCTZ, MULTIVITAMIN [VITAMINS NOS], GABAPENTIN, VITAMIN D [VITAMIN D NOS], ALENDRONATE SODIUM (FOSAMAX) and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 28-Feb-2021, the patient experienced FEELING ABNORMAL (Just a bad feeling/Don't feel right), HANGOVER (Feels hungover all the time) and FATIGUE (Feeling fatigue/very tired all the time). On an unknown date, the patient experienced VACCINATION COMPLICATION (Delayed adverse effets). At the time of the report, FEELING ABNORMAL (Just a bad feeling/Don't feel right), HANGOVER (Feels hungover all the time), VACCINATION COMPLICATION (Delayed adverse effets), FATIGUE (Feeling fatigue/very tired all the time), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Tylenol for fever and chills   This case was linked to MOD-2021-036845 (E2B Linked Report).; Sender's Comments:  MOD-2021-036845:Same reporter, different patient and event
Per patient that night he got home from getting the vaccine he was very tired and felt "run down". That continued for a total of 48 hours. Also had severe pain (still has moderate pain today 5/7/18), redness, swelling, and stated that the day after he got the shot he had post nasal drip/cough start (however, patient also stated that he has seasonal allergies and had some mild sinus symptoms the day before getting the vaccine).
HEADACHE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown, vaccination site not reported) dose was not reported, administered on 25-MAR-2021 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 MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and fever was not reported. This report was non-serious.
PATIENT RECEIVED VACCINE ON 4/5/21.  LATER IN DAY, ARM BECAME RED, SWOLLEN AND SORE.  PATIENT STATES ARM WILL RED, SORE AND SWOLLEN SOME.  PHYSICIAN RECOMMENDED PATIENT PUT HYDROCORTISONE ON SITE.
RED PATCHES/HIVES ON BACK, DESCRIBED AS "PRICKLY". GAVE BENADRYL 25 MG (10 ML), PO, PER PROVIDER VERBAL ORDER.
VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8° (10 mins); This non-serious spontaneous report with reference numbers 02197725 / 02197588 was received by partner on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 01-AUG-2022 and forwarded on 03-AUG-2022, from a HCP. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins)" and Vaxelis remained not applicable.  For reference purposes this case is linked to MCM-003725, MCM-003726, MCM-003724, MCM-003724, MCM-003735, MCM-003737, MCM-003738, MCM-003739, MCM-003740, MCM-003741, MCM-003742, MCM-003743, MCM-003744, MCM-003747, MCM-003749, MCM-003751, MCM-003752, MCM-003753, MCM-003757, MCM-003759, MCM-003760, MCM-003761, MCM-003763, MCM-003766, MCM-003767, MCM-003769, MCM-003770, and MCM-003772, due to same reporter.  No further information is expected.
Pt came in on 1/8/03. States about 3 days after Flu shot, his left arm started hurting down to the elbow. Hurts to move it and can't sleep on the left side. Says arm was slightly swollen for 2 days after shot. He recalls no fevers. States it's difficult to lift his arm up over his head. He has soaked it in warm water and Epsom salt with no improvement. T/C, who suggested vitamin B6, 50 mg 1 q d. Pt to get some. Also, suggested to keep moving arm as much as possible. He called HD on 1/21/03 to say his arm is still the same, even with vitamin B6 used. States has no money to go see a MD.