chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Feb2021 as dose 2, single (Lot number: EN6201) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 065F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "assorted fruits" (unspecified if ongoing), notes: Allergy to assorted fruits.; "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Negative; (18May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Anti-viral details: Product: COVID 19 Treatment (PAXLOVID) on start date:10May2022 and stop date:13May2022. Indication is used for treatment of COVID-19. Other medication in 2weeks product: Allegra180 mg, Levothyroxine 25 mcg. Other medical history: None. The patient experienced adverse event, Side effect: dyspepsia within hours of taking Paxlovid. Resolution of symptoms on 13May and negative test: stopped taking Paxlovid (day 4 - did not finish course) rebound symptoms of coughing and congestion on 17May. Retested and came back positive 18May.  Adverse event experienced on: 17May2022. If patient is recovered. the patient did not receive treatment.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the events drug ineffective and covid19 cannot be totally excluded.
patient stated when getting her second shot. She got a red itchy blistered rash on the bottom of her arm  a couple day later. She took a Benadryl and it got better.
no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 5-year-old female patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes. On 11-NOV-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage).There was no previous temperature excursion. The call was due to digital data logger.   No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
After vaccine patient had abrupt onset of fever to 103 with chills, vomiting and achiness.
This initial spontaneous case, was received on 06-Oct-2017, concerning a 72-year-old elderly female patient. The patient's medical history included diabetes (since an unspecified date). On 28-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 01044621A and expiry date: 30-Jun-2018). The patient received the vaccine, which had floating particulate matter in the vial after refrigeration (explicitly coded as poor quality vaccine administered). It was reported that, the product had very fine white particles, which looked foggy and did not suspended in the solution (explicitly coded as particle present in liquid product). The patient did not experienced any adverse event after the vaccination. The reporter stated that, product was always stored in the refrigerator within the recommended storage conditions. As per the PTC (product technical complaint) (PTC reference number: PR 436457) investigation performed, it was concluded that, the particulate matter in the returned complaint sample was confirmed to be consistent with the appearance of Influenza Virus Vaccine; it contained protein typical to that of influenza virus with no atypical structures. As there was no safety issue associated with the batch (01044621A), the final severity for the PTC was re-assessed as low. Retention sample description testing was also performed and confirmed the AFLURIA vials were satisfactory. Manufacturing and Filling investigation were not able to determine a causal link to the reported particulate matter observed by the customer. This investigation confirmed all manufacturing processes were performed as per registered procedures and test requirements. The Quality attribute review had demonstrated that, the filled lot and associated Bulk and Monovalent Pooled Harvest lots were within statistically derived process control limits and specification. Trending of the PTC event was performed and determined that, the complaint report was not part of an emerging trend for the lot or complaint type. A Safety Assessment completed by the clinical safety physician determined no safety issue has been identified for lot 01044621A. This complaint was not considered indicative of a quality issue for the batch and lot 01044621A was considered suitable for continued use in the market. The reporter assessed the events as no-serious. Non-significant follow-up received on 14-Nov-2017: Updated PTC Reference Number: PR436457. The narrative was amended accordingly. Follow up received on 06-Dec-2017: The PTC investigations result were updated. The narrative was amended accordingly.
MULTIPLE PULMONARY EMBOLI, CARDIOMEGALY - CURRENTLY BEING EVALUATED
Extreme menstrual pain and cramps. First day of cycle causes horrible cramping, enough to make me physically sick.
Rash from elbow to shoulder on vaccinated arm -- occasionally itchy --"scabbed up" according to mom -- not swollen or warm to touch.  Diarrhea x 2 days no fever or other symptoms.  ADLs WNL. We have a photo if you tell us how to send it to you.
pt recv vax 1996 & 20MAR97 pt exp erythematous lesions, papules & vesicles approx 40-50;
I had fever that night of 10/2/22.  But I do not consider that an adverse reaction.  I started breaking out in hives on the face on 10/4/22 but it was minor.  However, on the next day, Oct. 5, I woke up with a swollen face, including eyes and eyelids.  I looked horrible.  I took benadryl and by Thurs., the swelling was less but nevertheless still noticeable especially on the eyes.  By Fri. 10/7 the swelling was less noticeable.  Finally, by Sat ., 10/7, I was back to normal.  I did not see any doctor, just contacted Pharmacy for info on who to contact for adverse side effects.
Blood Pressure immediately increased during first shot . 161/121 then they transported me to ER to run some tests. Heart rate stayed around 143/101 for the next three days. 7 days after short, a red burn rash appeared on both arms, sensitive to sweat and air blowing over skin. Rash affected way of life.  Second Vaccine I took two Tylenol an hour  prior to the vaccine  immediate raised my heart rate from 139/97 to 136/102 but it came back down after laying/sitting in a bed for 1.5 hours (143/94) BP stayed high for three days then lowered to 128/78. Red Burning Rash has continued and isn't going away.
I had the Data logger off of the refrigerator to down load temps to Iris and it was off the refrigerated longer than I anticipated it to be so the X came on. There was NO involvement with the vaccines only the Data logger its self.
Started my menstrual cycle off cycle within hours of receiving the vaccination.  This was extremely out of cycle as I had completed my cycle a week prior.  I am 44 years old and never experienced bleeding so heavy that I bleed through hygiene products and onto my clothes within a matter of an hour or two and this has been a frequent issue since I got vaccinated.  Additionally the time between my cycles has been reduced to 14-18 days between.  There are times I start off cycle and menstruate for just one day and it is so heavy I am bleeding through products in an hour or two, it stops, and then my period starts two weeks later. I have a schedule APPT with a physician coming up in October due to the significant changes and issues with my period.
PURPURA, ALL OVER ERYTHEMAPOUA, MACULOPAPULAR,  STERIOD INJECTION DEXAMNTHASONE AND DEPOMEDROL, RX FAMOTIDINE 20 MG BID PRN FOR ITCHING
Erythema migrans; face is itching a lot and it is starting to tingle; face is itching a lot and it is starting to tingle; experiencing lot of erythema where some basically from shoulder to half way my neck is swollen; erythema is actually, limb erythema is swelling of my limbs throughout of my shoulder and neck; erythema is actually, limb erythema is swelling of my limbs throughout of my shoulder and neck; Tiredness; all over body pain and swelling; all over body pain and swelling; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EW0180 and expiry date was not provided) via an unspecified route of administration on unspecified date at 11:00 as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient had previously received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided) on unspecified date as a single dose for COVID-19 immunisation. On an unspecified date, patient had erythema migrans, face was itching a lot and started to tingle, lot of erythema where some basically from shoulder to halfway neck was swollen, erythema was actually, limb erythema was swelling of limbs throughout shoulder and neck, tiredness, all over body pain and swelling. For 4 days patient had normal side effects basically erythema migrans, extreme tiredness and lots of all over body pain then after those side effect went away patient started experiencing lot of erythema where some basically from shoulder to halfway neck was swollen this was the new side effect after those other side effect wore way and today was having lot of, face was itching a lot and started to tingle. Patient wants to know was this something that needs to concern about because this was listed on the normal like this was the week and if getting the new symptoms week after was normal. Reporter seriousness for erythema migrans, face was itching a lot and started to tingle, lot of erythema where some basically from shoulder to halfway neck was swollen, erythema was actually, limb erythema was swelling of limbs throughout shoulder and neck, tiredness, all over body pain and swelling was unspecified. The outcome of events erythema migrans, extreme tiredness and lots of all over body pain was resolved on unspecified date and for other events was unknown.
Wrong dose for Moderna COVID Bivalent was given on 10/14/2022 (As146B) at 0.25mL dose instead of the 0.5mL. The other 0.25mL (061F22A) was  given on 10/28/2022
brachial plexus neuritis, severe burning sensation in hand, numbness, lack of full motor movement, neuritis/neuropathy, dec in muscle
Chills, fever, joint pain, fatigue, pain at injection site, facial pimples. HAD SAME REACTION TO DOSE ONE, UNSURE EXACT DATE, PHARMACY.
chills, fever 100.2, body aches, sore arm, red at injection site approx 3 " around, nauceous, weakness, severe headache, difficulty breathing, face swelled and was red like a rash.  Called primary care doctor the said take benedryl and if not better go to urgent care.  Took benedryl.  Got worse with breathing so went to urgent care.  They would give me steroids but I am allergic.  Sent me to emergency room.  Went to emergency room by the time I was seen at 10:30pm on 9/4 my breathing had eased and swelling in face had gone down.  Doctor decided not to give epi  pen or steroids and told me to return if I got worse.
3 days after receiving the first shot I started to have pain in the hip joints on both sides. At first I thought it was just sore muscles from golfing but it is still present over a month later. Then on April 14 I woke up and both of my ankles felt extremely sore despite the fact that I haven't been doing any physical activity due to the hip pain. By April 15 at the end of the day my ankles were both extremely swollen and I was having a hard time getting around. I finally went in on Monday April 19 to Urgent Care as my PCP couldn't get me in so soon. The doctor there thought it might be cellulitis and prescribed me antibiotics. After taking those for over a week now there has been no improvement. I finally got into my PCP today April 26 and he is scheduling a entire series of lab work to be done. He thinks I have somehow developed vasculitis. He stated that he did not know if that could happen from the vaccine but I had no problems whatsoever and was very active until 3 days after the vaccine shot, so I find it hard to believe that the two things aren't related somehow.
Patient being monitored after vaccine developed swollen uvula and heavy lip 20 minutes after administration. Patient given benadryl with relief and evaluated by nurse practioner.
This case was reported by a pharmacist via call center representative and described the occurrence of unilateral blindness in a 64-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 22nd February 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced unilateral blindness (serious criteria GSK medically significant), inflammation and drug dose administration interval too long. The patient was treated with prednisone. On an unknown date, the outcome of the unilateral blindness, inflammation and drug dose administration interval too long were unknown. It was unknown if the reporter considered the unilateral blindness and inflammation to be related to SHINGRIX. Additional details were reported as follows: After receiving 1st dose of SHINGRIX, the patient developed inflammatory condition that had caused blindness in one eye. The patient did not receive 2nd dose within the six month time frame, which led to lengthening of vaccination schedule. No further details were provided.
there was leakage due to the needle not being attached securely; there was leakage due to the needle not being attached securely; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number XX33P, expiry date 31-JAN-2026) for prophylaxis.   On 08-SEP-2023, the patient received Bexsero. On 08-SEP-2023, an unknown time after receiving Bexsero, the patient experienced accidental underdose (Verbatim: there was leakage due to the needle not being attached securely) and needle leak (Verbatim: there was leakage due to the needle not being attached securely). The outcome of the accidental underdose and needle leak were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-OCT-2023 The reporter reported that patient received the Bexsero and there was leakage due to the needle not being attached securely which led to accidental underdose and needle leak. No reactions reported.
Case number PHEH2014US003962 is an initial spontaneous report from the pharmacist received on 24 FEB 2014 with a follow-up received on 01 APR 2014. This report refers to a 16-year-old male patient. His medical history included unspecified immunodeficiency and IgG disorder. His vaccination  history included administration of seasonal influenza vaccines, (manufacturer and batch number unknown) on undetermined dates, which were well tolerated. He was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: 006011A , expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly in to the right deltoid on 29 DEC 2013 at 9:00 PM. This was the first application of FLUCELVAX. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).   Follow up received from the pharmacist on 01 APR 2014. Updated medical history, vaccination history, batch number of FLUCELVAX and site of application.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 01 APR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
pt rec'd a booster dose of moderna, he should not have, pt is under 18years old.
Became limp p/sz, temp 105.4; Seen at Med Ctr negative lab cultures; Rechecked when became febrile again (24 hrs p/sz) Given Antibiotic for beginning of otitis @ that time; No more Pertussis vax;
Vaccine experienced a low temperature excursion.  Patient revaccinated on 10/26/22 per recommendations of Sanofi_Pasteur
Approximately 48 hours after the rota virus vaccine, my daughter, an exclusive breastfed baby, had a bloody stool followed by green mucus stool. She has continued to have these types of diapers off and on for the past two months. We have tried eliminating dairy, soy, eggs, and nuts from my (the mother) diet. We tried to give her the Similac Alimentum formula, but she would not take it. Her diapers continue to have bloody and green mucus every couple days.
COVID-19  I  received my 2nd booster shot on 04/02/2022 and my COVID-19 symptoms started on 06/27/2022 at 12:00PM  I started  experiencing fatigue I thought it was from the traveling I had.  Tested positive for COVID-19 on 06/29/2022.  I had fatigue, body ache, fever 100 degrees, sore throat,  nasal congestions, headache. I called my doctor he prescribed  PAXOVID  for 5 days. I started taking medication on 06/30/2022.  07/04/2022 and 07/05/2022 I tested negative;
She got her vaccine, patient complained of difficulty breathing, throat closing in and feeling weak.  Vital signs monitored, oxygen administered.    Parent administered EPI Pen dose x2.   She was then sent to the ER.  They did blood work, monitored her and when she was stable she was sent home.
Patient was sent to ED on 11/10/2022 from a residential facility because of lethargy and altered mental status. Patient was last seen at his baseline around 6:30 PM. Patient has right-sided hemiparesis from his prior CVA and has had weakness in his right upper extremity chronically. He also has mild slurring of the speech. The noted stated patient's wife stated facility informed her that patient reported increased weakness on the right side and a facial droop and hence sent the patient to the ED for further evaluation. Per note low suspicion for an acute large vessel occlusion. Patient's EKG showed no concerning ischemic changes. His troponin was normal. His labs are otherwise largely unremarkable. Urine showed no evidence of infection. His chest x-ray does showed concern for possible pneumonia. He is at risk for aspiration. He did not endorse cough or shortness of breath, given presenting tachycardia, elevated temperatures, borderline hypotension, It was prudent to cover patient with antibiotics, Updated wife. Will admit to the hospitalist for further management. no further information is known about the outcome of this patient. Please follow up with the provider for any additional information.
pt recvd vax & 24hrs post vax began to exp itching rash on calves which spread all over legs & foreamrs;ER or MD visit was required to treat these adverse events;rash & itching are being controlled w/DPH, solu-Medrol, dexamethasone, Pred
Pt states that she was diagnosed with COVID several months ago, but facility has not record.   Pt admitted for acute PE, and tested positive for COVID on 1/1/2022.
Client called into Health Center and stated that he got the Moderna vaccine at the clinic this am, 11:00 am. He states that by 3:30 pm he noticed that his eyeball was very red (red Crayola color red but not itchy). He took 25 mg of Benadryl at 4 pm and stated that it was already improving with the Benadryl.
This was my second Pfizer COVID vaccine (first received on 03/29/2021 with no reactions at all). After this second dose I had fever and flu like symptoms the same night (overnight for only about 10-12 hrs, better the next morning). About 6 days after the injection I started breaking out in intense hives all over torso and arms and legs, every evening they appear and subside in the morning. Self treated with Benedryl for about a week, then switched to daily Zyrtec, but still 8 months later they still come every day without antihistamine use. Have been diagnosed with CHRONIC SPONTANEOUS URTICARIA.  Also have episodes of bad ANGIOEDEMA with swelling appearing randomly in face, lips, feet, and hands.