chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergy; patient received her first dose of Pfizer Covid-19 Vaccine and mentioned that she was breastfeeding; patient received her first dose of Pfizer Covid-19 Vaccine and mentioned that she was breastfeeding; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and baby. This is the maternal report. A 44-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 31Dec2020 at a single dose just to protect myself (covid-19 immunization). Medical history included blood pressure high and lost weight because she was breastfeeding. Concomitant medications included labetalol for blood pressure high. The patient reported that she had an allergy like maybe after a day (01Jan2021). The patient received her first dose of Pfizer Covid-19 Vaccine and mentioned that she was breastfeeding. The patient mentioned that she did not taking any treatment for the adverse events. The outcome of the events was unknown.  The following information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092765 same reporter/drug, different event/patient (baby)
Redness, swelling, warmth of injection site (R) arm - unmeasured fever, shivering - now with headaches (frontal) and feeling dizzy. No respiratory symptoms - no hives.
Intussusception - diagnosed 10/28/10 symptoms were: vomiting x 3 d., crying
Got Covid after getting the 1st dose of the vaccine; Got Covid after getting the 1st dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 12Jan2021 (reported as 20 days ago from the time of the report) at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was supposed to go in tomorrow (02Feb2021) and get her 2nd dose, but she got COVID after getting the 1st dose of the vaccine on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
102 F fever; Vomiting; Itchiness all over the body; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness all over the body), PYREXIA (102 F fever) and VOMITING (Vomiting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced PRURITUS (Itchiness all over the body). On 21-May-2021, the patient experienced PYREXIA (102 F fever) and VOMITING (Vomiting). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchiness all over the body), PYREXIA (102 F fever) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Body temperature: 102 (High) Unknown.         Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant drug was not reported.
A 26 year old patient experienced injection site warmth and a bump after being administered  Trumenba; Inappropriate age at vaccine administration; A 26 year old patient experienced injection site warmth and a bump after being administered  Trumenba; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 26-year-old patient received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE WARMTH (non-serious), outcome "unknown", VACCINATION SITE NODULE (non-serious), outcome "recovered" and all described as "A 26 year old patient experienced injection site warmth and a bump after being administered  Trumenba"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "Inappropriate age at vaccine administration". Follow-up attempts are completed. No further information is expected.
I administered 3 immunizations HPV, TDAP and Menveo. After I administered all three injections, I was wiping away a little bit of blood when the patient started to lean forward and pass out. I caught the patient and then I helped lower her to the ground with another nurse. When patient came to we had her stay seated on the floor for a couple of minutes. I stayed with the patient while the other nurse went and got the patient some crackers and juice. We stayed with the patient 15-20 minutes after shots (they are required to stay that amount of time). Then the other nurse took patient's vital signs all within normal limits. BP 110/74, P 80, SPO2 98%. Patient verbalized that she was feeling normal again after the 20 minutes. After which we waked patient and her father to check out and told them if there is any more problems to call the clinic and let us know. The physician's assistant that saw patient was notified of the event.
pt recv vax;3-4 days later,devel irritability;hosp;L/P performed;CSF cultures neg;dx of aseptic meningitis;9 wk later,CSF + for poliovirus I & II;2nd dose recv w/ no adverse rxn;3rd dose withheld,pt recv inactivated polio vax instead
Unusually started menstral bleeding.  My period had just ended 7 days ago.  Have suspected PcOS, amenorrhea .hadn't had period in 1 year.  Got my period a few days after 1st moderna shot, too.  Came on and off for 4 weeks.  Then today it came back.
This spontaneous report was received from a healthcare worker concerning multiple unspecified patients (demographics unknown). On unknown dates the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (Lot # L015049; expiration date: 29-APR-2017). No adverse effects were reported. Additional information has been requested.
Patient experienced perspiration, dizziness, and fainting with no loss  of consciousness. Patient was talking and  answering questions appropriately.  B/P 120/80, FSBS 131 @ 1:52PM.  EMS was notified and Patient was transported to local hospital.  I spoke with the patient today and he states he was discharged from hospital and everything was fine. He states he is doing good today.
Patient started having leg cramping on 4/13/2021, presented to the emergency department on 4/18/2021 with increasing shortness of breath and chest pain.
Confirmed Breakthrough Case  COVID-19 (Pfizer) 1  09/28/2021  Pharmacy Pfizer 30135BA   COVID-19 (Pfizer) 2 10/26/2021 Pharmacy  Pfizer FF2593
As soon as I received the second dose of the vaccine my left arm started to hurt a lot. The pain was increasing to a point where  I was not able to hold anything with my left arm.  It felt like someone was punching me in the arm, or a had a needle in there, throbbing in the left shoulder. The pain and tenderness in the front of my arms continue.  This pain continues,. I went to see an specialist on 03/22/2021, and he said a have Impingement syndrome of left shoulder from the covid vaccine.  On 03/23/2021 Md prescribed me DEPO-MEDROL INJ 40 mg and Physical Therapy
low grade temperature(99.2) sore arm with a hard knot at sight of shot ,severe headache, chills, body aches, joint pains, and very fatigue    treatment: tylenol  for pain, exercise arm,  About ten hours later all symptoms  were clear except the headache last  four days.
Vaccine error - Vaccine was administered past its beyond use date.  The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.
pt vax in 1995 & in 1999 pt exp fluid filled vesicles. pt seen by MD 16jan99 who confirmed chickenpox
Patient received all 3 vaccines at one time. This was her Covid booster but received Pfizer as her primary series. A few minutes after vaccination, while at the pharmacy counter in her wheelchair, she stated she didn't feel good. She started to look a little red. She kept saying that she couldn't breathe. Since she was complaining about having trouble breathing, an EpiPen was administered and EMS was called. She then began dry heaving and complaining of back and rear end pain. EMS arrived and took her to the ambulance and convinced her to go to the hospital for assessment. She called me about 2 hours later and said that she was home and feeling much better.
Chills, aching, progressed to pin-pricks, slurred speech unsteady gait. Further, progressed S.O.B, lips swelling.  No Benadryl at home. Called 911, waited 7:30 am then went by POV to ER. Patient unable to walk  or talk upon arrival to ER.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concurrent condition, historical condition and concomitant therapy was not provided. On 28-JUL-2016 (reported as today), the patient was vaccinated with a dose of expired ROTATEQ (lot # K022995, expired date 22-JUL-2016, oral; dose was unknown). No adverse effect was reported. Additional information has been requested.
> Post-injection, whilst at the vaccine location, my left arm (site of the injection) felt slightly sore. The pharmacist requested a 15 minute time frame to check for any severe adverse reactions. The soreness was not deemed a severe adverse reaction. > In the evening, around approximately 6:30/6:45 pm, I noticed a slight headache. > Around 2:20/2:30 am, I awoke feeling nauseated and the headache had worsened. I was also experiencing a constant fluctuation of hot flashes / cold chills for several hours. This persisted into the morning, until approximately 8 am. > After lots of hydration, rest, and heachache medicine (Acetaminophen), I felt better; this was around approximately 11:45 am/12:00 pm.
First 48 hours extreme/severe pain in right shoulder (person who administered dose put shot too high - almost in tendon - so that could have contributed), severe headache, diarrhea.  Next two plus weeks, I felt like someone took a dump inside my body; like my body was a cesspool.  I felt gross, ill,  uncomfortable, out of sorts, with joint pains which migrated around my body.   When that finally seemed to be resolving, I woke on April 14th (3 weeks post vaccine) with LOUD ringing in my right ear (ringing both ears, but right side worse).  2 weeks later I was diagnosed with acute neurological-sensorial hearing loss and was put on prednisone.  A week later, my hearing test was back to baseline, but I am still dealing with tinnitus which seems unstable and changing (I guess thankfully, since I hope this will go away).   Prior to the second vaccine I'd been feeling better than I had in years due to a new exercise program begun in late January 2021.  Was feeling younger, healthier, stronger than I had in years and was pain free.  My diet is super healthy (not the typical diet of a typical American) - consisting of  whole, unprocessed vegetables, protein and healthy fats.
Head fog, dizzy, joint pain, chills, 24 hours after shot. Went away after nights sleep.
Chronic Left Deltoid Pain with NEW SENIOR HIGH STRENGTH VACCINE, Pain is still present with Exacerbations. This did not happen with previous years on the Regular Flu vaccine.
Patient had 2 month old check-up w/ routine vaccines on Nov 16 2006. Patient received vaccines about 10:30am. Mom called to speak w/ nurse at 4:30pm same day stating patient was crying and unconsolable for 1/2 hour. Tylenol was given at 10:30 am and 2:30pm. Temp 98.2. Taken by mom at 4:30pm. Drinking and voiding within normal limits. Dr. consulted with mom and advised ice pak, given Tylenol and call if not improving. 11/18/06 seen in office for rash. Low grade temp and vomiting.
Moderna COVID-19 Vaccine EUA On day 8 after receiving the first dose, skin around injection site appeared to be slightly raised, red, warm to the touch, slightly sensitive/itchy/burning. (on upper left arm)
Sever chest pain following morning which was Jan 23rd 2021.  Went to hospital and was told it was just a strong response to the vaccine since I had covid-19 on Dec 10th.
patient start wheezing after 10 minutes of the injections,  and stated that he feels his throat is closing up
Patient received an expired dose of IPV (polio vaccine). No adverse reactions. Vaccine must be reported (advised by agency to complete this form).
No other issues or adverse effects reported; Expired vaccine being administered; This spontaneous report was received from a licensed practical nurse and refers to a 65-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date in 2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S030588, expiration date 20-OCT-2020 (dose, frequency, route of administration were not reported). No other issues or adverse effects were reported.
10/30/21 presents to EC ED for shortness of breath, worsening dyspnea on exertion and leg swelling, hypoxic in mid 70s. PMH of T2DM.
12/10/09 - Blotchy, red, flat rash on R upper chest, shoulders and R arm. No wheezing, lungs CTA. BENADRYL 25mg po given @ 10:38 - 11:00 am. Blotches clear on skin. Denies itching. Home with father @ 11:46 am.
Patient experiencing left sided weakness, inability to talk and minimal ability to communicate.  Patient had a massive ischemic stroke, and elevated troponin levels debilitating patient completely.  Treatment is to remain mostly comfort measures
Patient's husband came in today stating that the patient developed pneumonia symptoms two days after receiving vaccine (9/18/2018). He said they had to visit the hospital (he didn't have the name of the hospital) and was discharged over the past couple of days. Patient was prescribed augmentin for their pneumonia on 10/4/2018 for 2 days (previous therapy was administered in hospital). Patient's husband states they are taking her into urgent care today because she's still not feeling well.
No additional AE or PQC reported; PROQUAD was administered after the expiry date; This spontaneous report has been received from a registered nurse concerning to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On 18-MAY-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) 0.5 mL, lot # T037955, expiration date 09-MAY-2022 (route of administration and anatomical location were not provided) for prophylaxis (expired product administered). There was no temperature excursions to report. No additional events were reported.
This spontaneous report was received from a 60 year old female licensed practical nurse (patient) regarding herself via a company representative. On 21-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as J000429 and 10-APR-2014 respectively, dose unspecified), subcutaneously in the left arm. There were no concomitant medications. On 22-JUN-2013, the patient experienced sensitivity to the touch and intermittent skin discoloration around the injection site after receiving ZOSTAVAX. The patient did not seek any medical attention. No treatment was given. It was unspecified if any lab tests were performed. The patient was not recovered from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Approximately 14 days after receiving my 3rd Moderna dose, I began developing symptoms very similar to dermatographia. Light itching anywhere on my body would turn red very quickly, while prolonged or heavier itching would also result in raised bumps at the site of itching. It would take 30-45 minutes for this redness and swelling to disappear. Around the same time that these symptoms developed, I also began having GERD or heartburn-like sensations, where an uncomfortable pressure would gradually build-up between the chest and esophagus. This pain would last for no more than 5 minutes typically, but occur about 3 times a day throughout the day and night. Currently taking Zyrtec to control some of the itching.
Patient presented with complaints of watery and itchy eyes, redness present in bilateral eyes - artificial lashes in place, pain in left arm approximately 20-22 minutes post administration of Fluzone Vaccine 0.5 ml. No complaints of shortness of breath or difficulty breathing, states feels sleepy.  Patient reports history of Asthma and allergies; did not take medications this morning, uses nebulizer at night, also did not use last night. Vitals checked at 11:40 am BP 104/69, Pulse 87, Pulse Oxemitry 100%, Resp 18.
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 2:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:43 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 76.24 and 76.32 during initial and later dose respectively.  No concomitant medication was reported by reporter.  Vials were in cooler storage and were not in frozen storage during high-pace COVID-19 vaccination at around 2021.   Vials were moved to fridge on 23-Mar-2021 (Lot: 019B21A), 24-Feb-2021 (Lot: 014M20A) and moved to clinic on 27-Mar-2021 (Lot: 019B21A), 27-Feb-2021 (Lot: 014M20A). Vials were punctured right before administration. Vials best before use date were 22-Apr-2021 (Lot: 019B21A) and 26-Mar-2021 (Lot: 014M20A). Vials were undergone temperature excursion on 10:00 AM with 35 degree Fahrenheit (Lot: 019B21A) and 09:00 AM & 13:00 PM with 27 and 26 degree Fahrenheit (Lot: 014M20A).  No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Raised, red, swollen rash around injection site. About 1.5 inches wide and 3/4 inch tall.
Left deltoid area very warm with area of induration just below that a large erythematous area. Pt states day following immunization he had chills and fever. Pt c/o soreness and stiffness in left neck and shoulder today.  11/18/2002 spoke with pt regarding his c/o neck stiffness and left deltoid tenderness after receiving immunizations on 10/24/2002. He states that the areas are much better now and he states was seen by MD. Called MD' office and it was confirmed that pt was seen on 10/28/2002. The nurse at the office stated that a diagnosis of cellulitis was written in his chart on this visit. If further information is needed please contact. Sincerely RN
Accidentally took her second Vivotif which was stored out of the refrigerator for about 48 hours; A spontaneous report was received from a pharmacist on 16SEP2022. It described a female patient (unknown age) who "accidentally took her second Vivotif which was stored out of the refrigerator for about 48 hours" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took the first dose of Vivotif which was stored correctly following which she left the product out of the refrigerator for about 48 hours and accidentally took her second Vivotif pill. Reportedly, the old pack of Vivotif was replaced with a new pack and she took her third dose which was stored at the correct temperature. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer accidentally took her second Vivotif which was stored out of the refrigerator for about 48 hours (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer accidentally took her second Vivotif which was stored out of the refrigerator for about 48 hours (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non-serious as per medical assessment.
tested positive for covid-19; tested positive for covid-19; suspected bronchitis; Become sick with respiratory symptoms; This is a spontaneous report received from contactable reporter (patients daughter). This patient daughter reported that non-pregnant female of 75-year-old received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266) assumed it was given on the right arm on 12Feb2021 as SINGLE DOSE for COVID-19 immunization. The patient was not pregnant. The patients medical history was reported as COPD, congestion heart disease, cardiomyopathy and diabetic. Patient was allergic to Levaquin. There were no concomitant medications. The patient historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, Expiration date: 31May2021) received on the right arm as patient is lefty on 22Jan2021 at SINGLE DOSE for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. On 24Mar2021, the patient had fever and became sick with respiratory symptoms. On 30Mar2021, was suspected to have bronchitis and was tested positive to Covid-19. As of 30Mar2021, at 02:30 the patient was transported to the hospital with a fever of 102.7 and difficulty breathing. The patient was prescribed azithromycin for suspected bronchitis. The events resulted in a visit to emergency room/department or urgent care. The clinical outcome of events was not recovered. The patient underwent lab tests and procedures which included Covid test which was positive on 30Mar2021.  More information has been requested.
Patient presented with headaches, nausea, vomiting, fever 3 days after vaccination.
Chills pretty quickly, headaches; sore at injection site. Poor sleeping and feeling "flu-ish" the next day, nausea during the night (no vomiting) and after lunch the second day.