chrisvoncsefalvay/vaers-outcomes huggingface dataset:
probably should have recieved a full 'additional' dose Moderna; patient who recived one J&J and one Moderna booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (probably should have recieved a full 'additional' dose Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who recived one J&J and one Moderna booster) 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.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (probably should have recieved a full 'additional' dose Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who recived one J&J and one Moderna booster). At the time of the report, ACCIDENTAL UNDERDOSE (probably should have recieved a full 'additional' dose Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who recived one J&J and one Moderna booster) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided.
Symptoms started 3 hours after vaccine. Severe chills, fever, vomiting, body aches and weakness. PT fell in bedroom.
Not feeling good; Tossed and turned all night; Tiredness and mild aching; Really achy all over/felt achy; Little sick to stomach; Low-grade temperature; Feeling pretty bad; Little touch of headache; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 29Jan2021 11:45 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included fluticasone, cetirizine hydrochloride (ZYRTEC), azelastine, and colecalciferol (D3). The patient received the first dose of the COVID vaccine on Friday, 29Jan2021, at 11:45 in the morning. She had a little touch of headache on an unspecified date in 2021. On 30Jan2021, she reported feeling really achy all over, felt a little sick to stomach, a low-grade temperature, and feeling pretty bad, which she took Tylenol for. At 10:30 AM she took two more Tylenol and after that she still felt achy. Tylenol didn't touch it. She talked to a pharmacist who advised her to try and not take anything. She stated that the pharmacist was wondering if it will water down the effects of the COVID vaccine. Got through morning of Sunday, 31Jan2021, she reported she tossed and turned all night. She didn't feel like she had a fever, could have had a low-grade temperature. On 31Jan2021, morning at 09:30AM felt ok for two hours. Tiredness and mild aching were creeping back up on her. The other symptoms have since gone away, but the general feeling of tiredness has been going on for up to 4 days. On 01Feb2021, Monday, she felt tiredness like she didn't know if she could stay awake or not. She has tiredness and was not feeling good all over. It was day four at 12:00 PM. She was worried as to how long it would go on. She was looking for information on how long symptoms may last after vaccination and if any neurological symptoms were recorded during trials. She also wanted to know if side effects are more severe during the second dose of the vaccine compared to the first dose. She was so scared to get second COVID Vaccine on 19Feb2021. She heard some people do really well, and some people have been pretty sick for 48 hours. She was concerned about herself and this dragging on past four day. She wants to know if this has been heard of. The outcome of the event "Little touch of headache", "Little sick to stomach", "Low-grade temperature", and "Feeling pretty bad" was unknown, and for other events was not recovered.
pt states began to have pain across shoulder blades on 29SEP98 @ approx 5PM;on 30SEP98 exp lt sided neck pain like a crick & also lt arm pain;1OCT98 pt states shoulder blade pain better;taking muscle relaxers;
t104.0 13MAy started relieved w/APAP & then inc again;red, warm swollen lt arm;c/o being sleepy-napped 13MAY to bed early-napped 14MAY very unusual for child;to the change of character;c/o arm hurting,would not move it;to ER;dx rxn;
I got a CT scan, it showed that I had a lung.  My spot on my lungs increased in size a lot in a few months.  They are unsure that the vaccine had increase the speed for the spot.  I also development cancer in my thyroid as well.
Wheals globally all over started about 2 hours after vaccines. They disappear with BENADRYL but come back when BENADRYL wears off. Treated with Prednisone 20mg BID x 5 days and Triamcinolone cream q8 hr.
My thinking was foggy, pain in my back, muscle pain, fatigue. Blurry vision, achiness in my body. Resting heart rate was over 100. I have been diagnosed with Thyroid Eye Disease and Graves' Disease in July 2021.
By mistake an expired vaccine was given (exp 5/23 on 8/24/23). The vaccine was given again the following day 8\25\23. To date no adverse reaction reported by patient.
The patient also complained of headache, sinus congestion and left ear pain/left ear infection; The patient also complained of headache, sinus congestion and left ear pain; Injection site erythema; Injection site swelling; The patient also complained of headache, sinus congestion and left ear pain; This spontaneous report was received from a registered nurse refers to a 31 year old (also reported as 33 year old) non-pregnant female patient. The patient's pertinent medical history included smoker and hashimoto thyroiditis. The patient's drug reactions/allergies was reported as none. Concomitant therapies included levothyroxine sodium(SYNTHROID).     On 27-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R034248 with expiry date of 07-AUG-2020) (strength and dose were not reported) intramuscularly in the left arm for smoking history(prophylaxis). On 27-AUG 2019, the patient experienced erythema and swelling at the injection site especially noted after working at her salon, which progressed over a 48 hour period. On the same day, the patient also experienced headache, sinus congestion and left ear pain. She was seen by her doctor on 29-AUG-2019 and diagnosed with injection-site erythema and a left ear infection. The patient was treated with meloxicam as needed for pain and amoxicillin 875 mg twice a day for 7 days for the ear infection and told to rest, ice the injection site and call if the erythema and swelling increased further at the injection site or within the next two weeks if not better. Laboratory diagnostics performed was reported as none. The outcome of ear infection, headache, injection site swelling, injection site erythema and sinus congestion was reported as recovered on an unknown date in 2019(recovery date also reported as no phone call from the patient as of 09-SEP-2019). The causality assessment was not provided by the reporter. No product quality complaint was filed.
HIVES - started 10:30 PM, 3/31/21 and got worse, so went to emergency room at 3:30 AM  4/1/21. Received three medical injections and four prescriptions to fill.  All hives disappeared, but started again (much worse with intense itching this time)  at 12:15 AM, 4/2/21, So went to the emergency room again and got same three injections again.
pt recvd vax 11MAY93 & returned to the office on 13MAY w/ 7.3cm area of localized pain, redness & induration (non-fluctuant @ the inject site; the next day the area had enlarged to 8cm;
Vaccine provided to patient. A few minutes later, store staff said patient had passed out in store. Found patient in aisle, coming to. Mom came out of rest room. Told us that she has a history of pass out, in general. Mom not concerned. Patient and mom refused 911 call. Gave patient cold compress for back of neck and water. Left under her own power.
Information has been received from a certified medical assistant concerning a 61 year old male patient with coronary artery disease, hypertension, depression and hyperlipidaemia, with no known drug reactions/allergies, who on 07-OCT-2008 was vaccinated with PNEUMOVAX 23 (Lot No #660718/0551X), 0.5 ml, intramuscularly. Concomitant therapy included bupropion HCl, losartan potassium, KLONOPIN, CRESTOR, nefazodone HCl and aspirin. On 08-OCT-2008 the patient developed pain, swelling, and redness at injection site. The patient had fever and chills. On 10-OCT-2008, the patient had a persistent fever of 103.6 F, erythema and pain at the right shoulder. The patient was prescribed KEFLEX. On 11-OCT-2008, the patient went to the ER and was admitted for further treatment. The patient was given ROCEPHIN GR and BACTRIM DS. The certified medical assistant reported that the redness got progressively worse. According to the patient's office chart, the patient didn't have fever but the ER notes documented a temperature of 101 F with chills. The patient was released on 13-OCT-2008. On 17-OCT-2008, the certified medical assistant reported that it was noted in the office chart that the patient was treated for right arm cellulitis. The patient was given vancomycin. The certified medical assistant reported that further notes on that day said "skin: right arm, lateral, mildly red, minimally swollen, no temp. The diagnosis was "cellulitis". Additional information has been requested.
swelling in the thigh area; Fluzone Quadrivalent being administered to newborn child; Fluzone Quadrivalent being administered to newborn child, Supposed to give Hep B when this occurred; Initial information received on 10-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Fetus male patient (DOB 09-Jan-2020) who developed swelling in the thigh area (swelling) and fluzone quadrivalent being administered to newborn child, (product administered to patient of inappropriate age), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of HEPATITIS B VACCINE[HEPATITIS B VACCINE] .  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Jan-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiration date not reported) via intramuscular route in the left thigh.   On an unknown date, the patient developed a non-serious swelling in the thigh area (swelling) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was also an actual medication error case due product administered to patient of inappropriate age and Wrong product administered. It was reported as Fluzone Quadrivalent was administered to newborn child. Supposed to give Hep B when this occurred.  No laboratory data reported.  Final diagnosis was swelling.  No corrective treatment was received.  The outcome was unknown for the event swelling.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on batch number was requested.
pt recv vax & approx 9mo later pt devel 40 plus lesions;
Received 1st dose of Pfizer-BioNTech COVID-19 Vaccine EUA on March 09, 2021, and the second (Pfizer) on March 30, 2021. Had to go to the ER on April 07, 2021 for swelling in my left calf. Blood work indicated blood clotting.
Approximately 4 hours after GARDASIL injection (#2) developed severe joint pain, fever (100.5), vertigo, (small) bruise at injection site. Pos tr. hematuria.
Information has been received from a licensed practical nurse concerning a female patient "in her 40's" who in the "past two weeks" was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot#651329/1047P).  In the "past two weeks" the patient experienced vomiting and local swelling at the injection site.  Unspecified medical attention was sought.  Additional information has been requested.
pt recv vax 12AUG96 & mom called 14AUG96 states t103 ax temp since then;advised bring to clinic for check up;lt ear red -sent to MD treated ear 14AUG96;16AUG96 doing well;
WEAKNESS, FEVER, VOMITING Narrative: 69 yo male with PMH of CAD, OSA, hx of VTE, OA, obesity, HTN, HLP, lumbar radiculopathy, GERD called triage line on 3/18/2021 to report that he had to go to the local ED (non-Facility) on 3/17/2021 because he had wheezing, extreme weakness, fever, projectile vomiting. Pt said he was given fluids and SL zofran and symptoms improved. This occurred after his second dose of COVID19 vaccine on 3/16/2021. Pt received the first dose on 2/17/2021 with no complications. At the time that this was reported, we have no outside records to review.
Pt recv vax on 10/31/98; in 1/99 pt exp tender lump on left thigh; dx=second sterile subcutaneous abscess
still get terrible pain/getting worse; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. He/She had got the Shingrix vaccines, but still get terrible pain and it's getting worse. The patient was asking that could you be prescribed pain medication if you had pain but no blisters or sores.  Additional supportive information: Follow-up would not possible, as no contact, details were available.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old male patient who received SHINGRIX (batch number G45LN, expiry date 13th March 2021) for prophylaxis. Co-suspect products included SHINGRIX (batch number E3Z7E, expiry date unknown) for prophylaxis. The patient's past medical history included shingles (20 years before date of reporting). On 27th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th January 2019, the patient received the 2nd dose of SHINGRIX. On 30th November 2018, 3 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced cold sores lip and tingling lips. On an unknown date, the patient experienced shingles, cold sores lip, tingling lips and condition aggravated. The patient was treated with VALTREX and VASELINE. On an unknown date, the outcome of the shingles, tingling lips, cold sores lip, tingling lips and condition aggravated were unknown and the outcome of the cold sores lip was not recovered/not resolved. It was unknown if the reporter considered the shingles, cold sores lip and tingling lips to be related to SHINGRIX. It was unknown if the reporter considered the shingles, cold sores lip, tingling lips and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient experienced cold sore lips and tingling of lips after 1st dose of SHINGRIX. The cold sore lips and tingling of lips got worsened after 2nd dose of SHINGRIX. The patient was seen by a physician who diagnosed shingles. The patient was prescribed VALTREX and VASELINE to place on sores. The tingling and the sores are improved.
This spontaneous report has been received from an office manager referring to a 18 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 12-APR-2018, the patient was vaccinated with the first dose of GARDASIL 9 by intramuscular route (strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. On 26-APR-2018, the patient was received the second dose of with GARDASIL 9 (lot # N022584 with expiration date of 15-JUN-2020), by intramuscular route (strength, dose and anatomical location were not provided) for prophylaxis. No adverse effects were reported.
I woke up extremely nauseous, whole body ached, severe head ache, vomiting, later progressed into fever at 1200. I had chills and muscle pain. Friend who received flu shot with me also experienced the same symptoms. I called the health clinic and talked to the NP, she told me that there was nothing she could do and I just had to wait it out.
3:00 am, I woke up because I started having a migraine style headache - some fever and chills and achiness; but the headache was the worst and it kept me down for 36 hours. I took ibuprofen 800 mg every six hours - it helped the headache be less severe.
Approx 2 days after immunization developed swelling by (L) medial supra clavicular area & some discomfort (L) neck with swelling     Treatment with either tylenol / ibuprofen apply cold pack to area, follow up with PCP
Gradual onset of hives starting morning after vaccines. Pt complained also of mild respiratory discomfort relieved with Benadryl. Pt presents to clinic with complaint of urticaria with pruritus. No history of previous reaction. No known other allergies. No current medications.
Breakthrough Case  Patient also received Moderna Booster Lot #003F21A on 11/26/2021 at Pharmacy
Seen 9/2/14 s/p vaccine given. Pt prescribed ibuprofen, BENADRYL, Increased BACTRIM. DX: vaccine reaction.
Localized swelling, hives (arms and torso), redness and warmth. Pt. has received yearly for 10 years without problems.
The injection was warm to touch; The injection site swell up; Hurt for 3 to 4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (The injection was warm to touch), VACCINATION SITE SWELLING (The injection site swell up) and VACCINATION SITE PAIN (Hurt for 3 to 4 days) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 930904, 030L20A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced VACCINATION SITE WARMTH (The injection was warm to touch), VACCINATION SITE SWELLING (The injection site swell up) and VACCINATION SITE PAIN (Hurt for 3 to 4 days). At the time of the report, VACCINATION SITE WARMTH (The injection was warm to touch), VACCINATION SITE SWELLING (The injection site swell up) and VACCINATION SITE PAIN (Hurt for 3 to 4 days) had resolved.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter. After receiving the booster at the injection, it swell up and was warm to the touch and hurt for about 3 or 4 days  Patient was taking other medication. HCP  was aware side of the effects.   This case was linked to MOD-2021-376348 (Patient Link).
fever 101 for two days heart racing shortness of breath heart irregularity  also happened 12/15/21 with booster 067HZIA
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unspecified date the patient was vaccinated subcutaneously with a 0.65 ml single dose of ZOSTAVAX (lot# not reported). In 2012 a few weeks ago the patient who had been vaccinated with ZOSTAVAX had a shingles outbreak on his torso. Unspecified treatment was given for the event. At the time of report, the outcome of event was recovering. Additional information has been requested.
I issues with my eyes, then I found I had to get cataracts.  I also got a rash on my neck and used medication till now.  I underwent a vision test. I also have long haul of COVID symptoms. I also have depression, anxiety, keratosis and have problems with pain in my wrist.
I did not have an adverse reaction to the vaccine. I was exposed to COVID-19 either on the plane or train out of country. I tested positive for COVID-19 in 12/2022. I felt like my face melted. I had a slight fever, mild headache, congestion and horrible cough. I contacted my provider and got the prescription for PAXLOVID. I tolerated the medication without any complications. As of today, I have a slight cough, congestion and fatigue.
Early MAR92 recvd 1st dose of Engerix-B; day p/vax devel local reaction: swelling, hot, tender lasted for several days & went away;
Pfizer-BioNTech COVID-19 Vaccine EUA Bell's Palsy  Face paralysis
Approximately 3 days after the 2nd dose - Slight symptoms of hemorrhoids; however, this one was not as severe as after the first dose. This only included slight discomfort/itching. I only had to use 1 or 2 treatments of Tucks before the symptoms disappeared (last about a day or two). No medical treatment was sought for either the first or second occasion.   Ongoing - Starting perhaps a month after my 2nd dose, I've begun having mucus build up in my sinuses. In addition, I frequently experiencing a "tickle" in my throat that triggers coughing.   The sinus build up happens throughout the day and is usually resolved by "snorting" and either spitting out (or swallowing) the mucus. I haven't kept track of the color, though. This is something very abnormal for me, as I've never had sinus build up (except for sometimes during allergies or colds). I have not had an allergy issue or cold leading up to or during these issues.   Also, the "tickle" in my throat that triggers coughing, happens intermittent, maybe once or twice a day. It can trigger coughing fits of varying lengths. Both the sinus build up and throat tickle are ongoing. I have not yet sought medical treatment as they don't really impact my day to day; they are just things that I've noticed happening now (that did not occur prior to the vaccination).   I'd like to mention that I did not experience any of the typical "flu-like" symptoms immediately after receiving either COVID vaccine dose. I was prepared for and expected to get sick. However, I had no typical flu-like adverse reaction at all within 48 hours of receiving either dose.
This spontaneous report was received from a registered nurse and refers to 5 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 improperly stored VARIVAX (lot number: M000756, expiry date: 06-JAN-2016, route of administration was not reported). Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.