chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness after the first day with my arm; This is a spontaneous report from Pfizer sponsored program Sup-port via contactable consumer (patient, self-reported). A 76-year-old female received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VAC-CINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date (age at vaccination: 76 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient reported that she received the second dose of the Pfizer BioNTech COVID-19 vaccine 9 days ago and would like to know if she was okay to take Prolia. The patient stated she has not started taking this medication yet as she was supposed to meet with her endocrinologist tomorrow about starting the injections every 6 months and would just like to know if there is any information available before she sees him/her. The patient also mentioned that after her first dose of the vaccine she "had no reaction whatsoever" but then goes on to state that she had "just a little soreness after the first day with her arm" on an unspecified date. The patient stated that she placed ice on the injection site and "after 2 days it didn't bother her." The patient also stated that "with the second shot it only bothered her one day." The patient underwent lab tests and procedure included antibody test and nasal swab test with negative results on an unspecified date. The patient would like to know if she has bloodwork taken after receiving the Pfizer BioNTech COVID-19 vaccine and asked what she should expect. Outcome of the event was un-known.  Follow-up attempts are completed. No further information is expected.
Severe pain in shoulder/arm, motor deficit.  Treated with Tylenol and Advil and ice, pain persisted approx. 48 hours.  Motor deficit improved, but still present
T-102.6,rapid breathing-2nd SIP immun.Pt taken to MD.Had DPT/OPV # 3 this am @ hlth dept-T not taken, now fever,"rapid breathing". No problems /w previous DPT, teething.T-102.6,ears clear-throat clear,neck w/o nodes,lymps clear.
approx 24hr p/vax a wheal approx 40mm in diameter devel w/redness & pain @ a sl rash;there was severe itching;
No additional AE/; one of her very experienced was administering the vaccine into the deltoid of a 17 year old patient when she was sprayed with the dose.; it seems like the hub wasn't on like it normally is, the hub looks crooked; This spontaneous report was received from a nurse, concerning a 17-year-old female patient. The patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were unknown by the reporter.  On 01-AUG-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe injection, product quantity: 1, lot #1775808, expiration date: 20-AUG-2023, administered intramuscularly for prophylaxis (dose was not provided). The reporter stated that while her "very experienced" was administering the vaccine into the deltoid of the patient, she was sprayed with the dose (occupational exposure to product, captured in MARRS#2308USA004789). She stated that "it seemed like the hub wasn't on like it normally was, the hub looked crooked" (syringe issue) (accidental underdose).  The gauge and size needle and syringe used were 25 gauge, 1 inch. The reporter stated that it did not spray from the insertion site where the needle was within patient arm, it came from the defective prefilled syringe.  No injuries and no adverse event were reported. ; Sender's Comments:  US-009507513-2308USA004789:
one of two pts exp a local reaction (reporter felt was cellulitis or allergic reaction) w/in 24 hrs p/DTP/OPV; pt also had swollen lymph nodes & a fever; no treatment initiated;
Patient presents to clinic on 10/07/2021 and states that he would like to make a report about his symptoms after the second dose of Pfizer COVID-19 vaccine on 09/30/2021. States that he has had fatigue and abdominal pain two days after the second dose and has not had any relief, but has not followed up with a PCP. States that he has not been able to go to work since the second dose. States that his supervisor told him to make a report at the place where he received his COVID 19 vaccines.
Received Tdap on 10/23/13 to Lt deltoid area. Presented on 10/25/13 with pain and swelling to that area. Exam showed 9 cm diameter area with swelling, warm erythematous tender with many blisters at the center. Tx: compress (warm), analgesic, triple abx oint. daily.
Rash, started 2 wks ago, burning, painful left lower side and rash broke out 2 days ago. Dx - Shingles. VALTREX, 1g tablet TID x 7 days.
For 3 days whole body ache including fingers and have had a constant headache don't want to do the second shot
Moderna Covid-19 Vaccine EUA: SWOLLEN, PAINFUL LYMPH NODE near collarbone. This has been present for two-weeks. There has not been enough publicity or information provided about this side effect, which can be worrisome, especially to women. I had to do my own research to learn that this might continue for another two weeks and that I shouldn't get a mammogram until a few weeks after my second dose. This swollen lymph node might even be present when I get my second dose March 13, so I'm left wondering how that second dose might further impact lymph nodes that are already swollen. Please, please, add more information about this side effects to all your brochures, patient information, etc. Thank you.
MOC reports pt began gasping for breath w/in 1 hrs of inject, 1/2 of face became swollen; pt taken to hosp ER was given DPh; rxn ceased w/in 1 hr p/visit to ER;
5 hours of high pitched crying inconsolably after vaccines (DTaP, IPV, Prevnar, Comvax).
On evening, post vax, pt had inconsolable crying. Next morning episode of hypotonia, 2 days total. High pitched cry and prolonged irritability.
Puffing, swelling and redness of left sub-clavical area. DVT detected via ultrasound Started IV heparin, then transitioned to oral Eliquis. Stayed in hospital 2 days.  Venous embolism and thrombosis of subclavian vein, left (CMS/HCC)   Internal jugular (IJ) vein thromboembolism, acute (CMS/HCC)   AKI (acute kidney injury) (CMS/HCC)   Pericardial effusion
Facial edema and sorethroat lasted about 24 hours; given Benadryl x 2 which helped transiently; symptoms resolved by 10/28/2009
Irregular periods each month, experiencing a 3 day period 6 days before my regular 5 day cycle
Patient's daughter stated that patient received the 2 shot Moderna series in June 2021 - could not provide exact dates. Patient has not received the booster.   Covid PCR Positive 2/11/22
Severe flu symptoms. Particularly muscle weakness, pain. Ongoing, better but still a little weak. Expected something, but this was tough, and I'm pretty fit.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 57-year-old male patient received BNT162b2 (BNT162B2), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "felt very tired". Additional information: Patient received second Pfizer Booster (COVID-19 Vaccine) so number 4th shot on an unknown date in 2022 (reported as almost 2 weeks ago now) and just little bit felt tired couple of days 2-3 days with it. Then felt better and but now (at the time of this report) patient felt very tired again. The reporter understood that side effects could be off and on. 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) : PFIZER INC-202201058024 Same reporter/event/dose, different patient;
I received the vaccine on 1/29 at 5 pm and was feeling fine afterwards with only a slightly sore arm at the injection site.   Then yesterday, 1/30 around 6 pm, I started to have a very fast heart rate, despite not exerting myself and only sitting down at the time. Between 6-6:45 pm, I had a heart rate between 125-140 bpm, according to my fit bit device that tracks my heart rate on my wrist. Anyways, after that I was going to the bathroom and started to feel nauseous, light headed, felt hot and chills like a fever, abdominal pain and vision issues (blackening in some spots and blurry on and off) so I went to lay down. I didn't vomit and the chills/hot fever feeling went away in 15 minutes. I also took my temperature and it was normal. My abdominal pain continued but the light headedness and nausea and vision issues subsided. I was unable to get up and do other stuff, so I just slept it off. I'm feeling better this morning. I  had also drank about a half glass of wine (maybe 2 oz), so i'm not sure if that contributed to it, but i've never felt that way after drinking wine, especially that small of an amount. I had also drank this wine around 4 pm and that was 2.5 hours before I started feeling this way and did not drink anything on the day I received the injection.
Hives - anterior chest/neck - 3 hrs after rcving INFLUENZA vaccine nausea & vomiting; Elevated HR slightly swollen eyes. Rash resolved within 2 hrs. No treatment.
Heart palpitations, nausea, reflux, insomnia (ongoing)  High fever, chills, itchiness in whole body, body aches, skin sensitivity
Pediatric 5-11year Pfizer lot FL2757 given 10/7/22
In less than 60 seconds, I became Diaphoretic, had substernal chest pain radiating to back, nausea and eventual vomiting. This lasted for a long period of time, I asked to go to ER because I was so alarmed. I felt great all day prior to injection. I had been at work as a nurse with Mobile County Public School System, until I came to get vaccination .
Patient requested the Pfizer COVID-19 booster, 3rd dose. Patient was administered the MONOVALENT Pfizer-BioNTech as a booster dose instead of the BIVALENT Pfizer BioNTech booster dose that is currently approved.  Patient tolerated vaccine and showed no signs of adverse reactions as was noted during the 15 minute wait after receiving the vaccine.
just a few minutes after receiving the second dose of the covid pfizer vaccine, PT began to feel faint. I asked what he had eaten through the day and he reported nothing really. I got him some chips and water but he still wasn't feeling well and talked about feeling bag like this one time a the dentist office. I called for an assistant and moments later, mc fainted. He did not response for about 30-60 seconds even though I was yelling his name and firmly rubbing the center of his chest. The assistant and myself lowered him to the ground where he came to. I checked his blood pressure and it read 76/45. I asked him to continue to talk and placed a cold pack on his head b/c he reported feeling very hot. After 5 minutes on laying on the ground, his blood pressure came up to 107/74. He stated he was very hungry and his grandmother went to get him pizza. I had him sit up on the ground for another 5 minutes before letting him stand up and sit in a chair to eat the pizza. After which he reported feeling much better. I did call after the pharmacy closed to check with him and his mother reported he was feeling much better.
My arm is swollen, my throat hurts, I have a painful lump under my arm, nose stopped up, body aches, feeling fatigued on going headache
This spontaneous report as received from a pharmacy technician refers to a 4 years old female patient. The patient was vaccinated with lot # (666029/1456Y) RECOMBIVAX HB (dose and route not reported) on 16-AUG-2012, that expired 06-AUG-2012. No adverse event effect had been reported or observed. Additional information has been requested.
at night the pain began to settle on the lower back where hips meet back; Feels like it was swollen to the point where she couldn't bend, move, or lift; back aching; diarrhea; washed out; high fever for an adult that peaked at 102.5 with increasing headache; groin lymph nodes are really sore and aching; high fever for an adult that peaked at 102.5 with increasing headache; pulling pain near her groin and had some trouble urinating; pulling pain near her groin and had some trouble urinating; This spontaneous case was reported by a consumer and describes the occurrence of GROIN PAIN (pulling pain near her groin and had some trouble urinating), DYSURIA (pulling pain near her groin and had some trouble urinating), BACK PAIN (back aching), DIARRHOEA (diarrhea) and BACK PAIN (at night the pain began to settle on the lower back where hips meet back) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced GROIN PAIN (pulling pain near her groin and had some trouble urinating) and DYSURIA (pulling pain near her groin and had some trouble urinating). On 25-Mar-2021, the patient experienced HEADACHE (high fever for an adult that peaked at 102.5 with increasing headache), LYMPH NODE PAIN (groin lymph nodes are really sore and aching) and PYREXIA (high fever for an adult that peaked at 102.5 with increasing headache). On 26-Mar-2021, the patient experienced BACK PAIN (back aching), DIARRHOEA (diarrhea) and FATIGUE (washed out). On 27-Mar-2021, the patient experienced BACK PAIN (at night the pain began to settle on the lower back where hips meet back) and SWELLING (Feels like it was swollen to the point where she couldn't bend, move, or lift). At the time of the report, GROIN PAIN (pulling pain near her groin and had some trouble urinating), DYSURIA (pulling pain near her groin and had some trouble urinating), BACK PAIN (back aching), DIARRHOEA (diarrhea), BACK PAIN (at night the pain began to settle on the lower back where hips meet back), SWELLING (Feels like it was swollen to the point where she couldn't bend, move, or lift), HEADACHE (high fever for an adult that peaked at 102.5 with increasing headache), LYMPH NODE PAIN (groin lymph nodes are really sore and aching), PYREXIA (high fever for an adult that peaked at 102.5 with increasing headache) and FATIGUE (washed out) outcome was unknown.            No Concomitant medications were provided. Treatment information included Advil.   This case was linked to MOD-2021-064849 (Patient Link).
104 constant fever 3 days with first vaccine; 4 days with second vaccine; Severe back pain and stiffness unresolved and ongoing (now on day 7); arm swelling at injection site with second vaccine - hard knot the size of a small egg, hot to the touch, bright red coloration - unresolved and ongoing (day 7); numbness of the left arm, left side, and left leg - second vaccine- ongoing and unresolved (day 7); pain, tingling varying with numbness of the left hand and finger and left foot and toes- second vaccine - ongoing and unresolved (day 7); extreme fatigue - both vaccines - ongoing and unresolved (day 7); vomiting and nausea - unable to keep down solid food, can keep down cold liquids but nothing warmer than room temperature -  ongoing and unresolved (day 7) recommendation to see PCP for referral to neurologist, immunologist as soon as possible.
Patient is fully vaccinated as on 03/09/2021 with Pfizer and contracted COVID, tested positive on 9/03/2021
606 doses were given after expiration date; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient didn't reported any adverse events. The vials didn't undergo any temperature excursion. The vaccine was kept in the refrigerator on 0411/2021.  No treatment information were provided.
Sore throat; Stuffiness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Stuffiness) and HEADACHE (Headache) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Stuffiness) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Stuffiness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.
Information has been received through the Merck pregnancy registry from a nurse who reported that on approximately 19-SEP-2008, a 2 week old old infant was born with an unspecified weakness to a mother who received the first dose of GARDASIL vaccine (yeast) about a year ago, approximately in September 2007. There was no concomitant medication. The patient is now receiving physical therapy. The patient sought medical attention with an office visit. At time of reporting, the patient had not recovered. Additional information has been requested.
Developed watery diarrhea and vomiting. Hospitalized for dehydration 12/14/14-12/16/14. Per mother's history, child was confirmed to have Rotavirus.
After the first shot her joints and muscles hurt; After the first shot her joints and muscles hurt; This is a spontaneous report from a non-contactable consumer reported for a female patient (daughter). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date as Dose 1, single for COVID-19 immunization. The patient medical history was not reported. There is no Concomitant list reported. It was reported that patient received Pfizer vaccine. The dates of vaccination and lot numbers are unavailable. On an unspecified date after the first shot her joints and muscles hurt. The same doctor as his put her on steroid pills, and within the next day, all her symptoms went away. The doctor tried to refer her a rheumatologist, but they have to wait a year to get an appointment. The patient states that he received another referral, but it is very hard to get a hold of the doctor. Therapeutic measures were taken as a result of events and treatment included prescribed steroid pills which made her symptoms go away. The outcome of the events was recovered on an unspecified date.  Product Complaint: There is no product complaint associated with this case.  No follow-up attempts are possible, information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100929337 Same patient, drug, reporter and different dose and event.
Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced PYREXIA. At the time of the report, PYREXIA had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  It was reported that the patient experienced fever post receiving the booster shot.  The patient received the booster shot on 08-Oct-2021 and was having a temperature on the day of reporting (09-Oct-2021).
I received my second dose of the Covid vaccine on the morning of April 8. Starting in the afternoon I began experiencing extreme arm pain, which improved after 2 days, but did not subside.  8 days later (over a weekend) I reported to my Dr that I was experiencing worsening arm / shoulder pain - it subsided slightly with ibuprofen, but has not gone away. As of today (5/20/21) I am still experiencing some real moderate pain in / around my shoulder joint that is affecting range of motion, and does not seem to be improving over time - ibuprofen helps but doesn't eliminate it.
This spontaneous report was received from a Physician referring to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL lot # reported as: K010215 expiration date: 05-MAY-2017 (dose and administration route were not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of several reports from the same reporter. Additional information has been requested.
he got this motion in his face; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FACIAL DISCOMFORT (he got this motion in his face) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FACIAL DISCOMFORT (he got this motion in his face). At the time of the report, FACIAL DISCOMFORT (he got this motion in his face) outcome was unknown.            No concomitant medications were reported.   It was reported that the patient got the Moderna COVID shot, and was refusing to receive it at first. As soon as the patient got the Moderna vaccine, he got the motion in his face. It stretched out or something.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730200 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730200:Case for mother (same reporter)