chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a three-months old (also reported as four-months old) female patient who received only HIB portion of vaccine PENTACEL without mixing DTap-IPV. The patient's past medical history was not provided. Concomitant medications included ROTATEQ for Immunisation; and PREVNAR for Immunisation on an unknown date. On 09-Oct-2018, the patient received a 0.5 ml second single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5575AA (expiry date: 13-Oct-2019) via unknown route. It was a case of actual medication error due to Inappropriate reconstitution technique. The HIB was mixed with only sterile water diluent. No adverse event reported. 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. List of documents held by sender: none.
Vaccinated: 10:51AM Reaction: 11:14AM 23 minutes after receiving 1st dose Pfizer, pt reported feeling like she was going numb.  Vitals: 143/92, 72, 16, 100% O2 Patient was given crackers, rested, and felt better. Patient was stable and released from vaccination site.
Right deltoid swollen and red. Some bruising noted. Two knots noted under axilla. arm very sore and painful to lift arm for two days. Onset day after injection. Applied heat pads at home.
7 days after receiving the shot I got ?vaccine arm?.  Itching, swelling, redness, warmth on upper arm.  The ?welt? grew over the first several days. All symptoms disappeared 7-8 days later.
1/17/2023 c/o fatigue/tired at HS 1/18/2023 body aches, low grade fever, tender under Rt axillary & swollen. Not warm to touch no drainage.
30 minutes after receiving injection her hands, face and arms began to turn red. Her eyes lids became swollen, she developed swelling at injection sight, and she started itching all over her body. Employee was given 25 mg of BENADRYL.
This case was reported by a nurse via call center representative and described the occurrence of injection site joint pain in a 65-year-old female patient who received SHINGRIX (batch number 524S7, expiry date 28th February 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site joint pain and pain in arm. On an unknown date, the outcome of the injection site joint pain and pain in arm were recovering/resolving. It was unknown if the reporter considered the injection site joint pain and pain in arm to be related to SHINGRIX. Additional details were reported as follows: In 2018, at approximately 9:38 AM, the patient received SHINGRIX on left deltoid. The licensed practical nurse reported that, after vaccination the patient experienced left arm and shoulder pain at the injection site. The reported lot number (52457) for SHINGRIX did not exist and was updated to 524S7, according to sales datasheet.
Cold symptoms at first, but then by next evening, chills, headache, body aches, on and off sweats, skin was sensitive to touch, congestion, stuffy head, sore throat.  Lasted through 11/14/16.
injection site hot and swollen, itching on left arm belly and face, tingling on upper lip, numbness on tong, headache, pain on back of neck, body pain down the back, diarrhea, stomach cramps, very tired, nausea, stomach bloating
Muscle aches and temperature of 100.3 began 1 day post injection, headache additional symptom on day 2 post injection.
Severe redness,and swelling up all the way to the elbow area, severe pain, got worse for the last 12hrs. Tx: tylenol 500mg every 6hrs, started at 8:00pm 12/08/09
administration of rotateq after temperature excursion; This spontaneous report was received from an other reporter (unspecified) and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.  On 15-JAN-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml, po (orally), lot # 1691141 (valid lot #), expiration date reported and also validated as 01-NOV-2021, for prophylaxis. It was detected by the data logger, that the vaccine had temperature excursion (product storage error). It was stored at the temperature of 1.3 degree Celsius (C) for 19 minutes. No previous temperature excursion reported.
Maintained a 103-104° fever for over 12 hours. Also started having paranoid hallucinations.
reported 2 days p/vax 2 hrs post vax exp constant, non-radiating chest pain under lt breast which intensified w/deep inspiration; seen immed by MD; 130/80-82 reg;
Adverse event reported ? Yes; This spontaneous report was received from a female consumer of unknown age reporting on herself.     Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route, frequency, lot # and the expiration date were not reported) for prophylaxis.         On an unknown date, the patient experienced a potential adverse event. Consumer did not confirm weather or not she had any side effects from the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine.   Consumer stated that she was concerned about safety and efficacy of the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine that covered types 6, 11, 18,and 16. Consumer then stated that she had been harassed from outside person that was making outside comments about being fully vaccinated and she wanted to talk to safety division and legal division. Consumer stated "he did not know what he was doing." Consumer refused to elaborate or answer any further questions.   At the time of reporting the outcome of adverse event was unknown.  The relatedness between the adverse event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.
Fever, chills, pain in thigh bone, soreness in joints; took Advil.
I received my first dose of the Moderna Vaccine on 8/12/2021 at Hospital. I have multiple allergies, although none listed on the Moderna Vaccine sheet in the identified ingredients. I experienced some reactions minutes to hours post vaccine after leaving hospital;  Right sided facial numbness, lip tingling on the right side Felt like mild to moderate Sore Throat & sensation of difficulty swallowing Pain between my ears that is similar in my experience to anaphylaxis that was heavy and lingered. I experienced no hives.  Lethargy- slept for over 13 hours on the first day.  The facial numbness subsided within 24 hours.  The below symptoms continued for more than 7 + days.  Sore Throat & difficulty swallowing Pain between my ears similar to anaphylaxis Lethargy and simply just not feeling well.   I experience an episode of a completely occluded Airway on Monday 8/16/2021. Chest tightness at multiple times over the next 7 days post vaccine.   I had to take Benadryl and Motrin twice daily for the pain and swelling during the 7 days. This aided in both sore throat, swallowing and pain between ears discomfort with great effect. I did not go to the doctor. I considered urgent care on the morning of 8/20 if the symptoms did not subside. The symptoms slowly improved.   It took more than 7 days for some of these symptoms to subside and am still left with a hoarse throat and difficulty swallowing. My PCP office has been notified. I have not heard back from them at this time.
fatigued, body aches, chills, upset stomach, sore throat, fever went from 99.6-101.7 for 48 hours
She is drinking juices and sprite to keep from getting dehydrated; she has been feeling horrible; Has been sick; Chills; Can't eat; No appetite; Tired; No energy; Body aches; When she tries to eat her gums are sore; The physician she works for says flu like symptoms; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jun2021, the patient had been sick, chills, can't eat, no appetite, tired, no energy, body aches, when she tried to eat her gums are sore, the physician she worked for said flu like symptoms, she was drinking juices and sprite to keep from getting dehydrated, she had been feeling horrible. Got first dose of vaccine on Thursday and had been sick, chills, can't eat, no appetite, tired and no energy. Patient wanted to know, if this was normal. Patient also reported body aches, when she tried to eat her gums were sore, and no appetite. She was drinking juices and sprite to keep from getting dehydrated. The physician she worked for said flu like symptoms. She asked, should it be going on this long? She stated she will have to ask about the second dose because she may not take it if she was still sick then. The outcome of events was unknown.   Information on batch/lot number has been requested.
heartbeat is fluctuation between 115-130; This is a spontaneous report from a contactable consumer (patient) and from a Pfizer sponsored program (NCSP:159558). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: Unknown) via an unspecified route of administration on 18Apr2021 as Dose 2, Single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an 18Apr2021 the patient experienced heartbeat is fluctuation between 115-130. The patient underwent lab tests and procedures which included heart rate irregular: 115-130  on 18Apr2021 (yesterday) heartbeat is fluctuation between 115-130. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
patient developed tiredness and nausea and a itchy rash extending from the midsection to knees. Rash has mostly resolved after 24 hours and other symptoms have subsided, Patient did not need or seek medical care.
A female reported that her 68-year-old husband received a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 formula) 0n 15-Sep-2003. Medical history: The patient's concurrent illness includes pernicious anaemia. Product details: Indication for Flumist (2003-2004 Formula) was immunisation. Product was administered on 15-Sep-2003. Dose regimen was 0.5 mL (intranasal). Concomitant therapy: Concomitant therapy included Vitamin B12 (Cyanocobalamin and Derivatives). Event details: The caller's husband experienced "sniffles and sore throat" for 2 days following Flumist administration on 15-Sep-2003. The caller also expressed concern regarding the administration of Flumist to people with compromised immune systems and those who are over 50 years of age. No additional information was available at the time of this report.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. The reporter referred to a 18-year-old female patient, who had no known drug allergies or illness at time of vaccination. The reporter informed that this patient was vaccinated with the second dose of GARDASIL (intramuscular injection batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 22-JAN-2014 at 4:20 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Patient was informed to revaccinate and parents were going to consult with physician. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
fever 103.4 noc p/vax 18FEB97 5 days p/vax described rash/welt, cranky w/low grade temp;
Felt lightheaded after immunization, sat in chair with head lowered x about 5 min, recovered without problem. Mom reports this has happened previously post-IZ.
pt recv vax & exp redness, swelling & itchy-type pain; skin was warm to touch & pt exp h/a & diarrhea for the next 2 days; No further details were provided;
the first 12 hrs, nothing abnormal (chills, aches, restlessness in sleep. The morning of day 2 I experienced an overwhelming bitter/metallic taste. This last for 3 days. It was a very strong taste--notably unpleasant. When I ate, I could taste food. I sucked on lozenges to keep the taste at bay. It faded over the 3rd day and was mostly gone on the 4th.
Lost his vision; Breathing almost completely shut down; Severe fever and sweats that night; Ringing in his ears; Cold sweat; Severe fever and sweats that night; Could not get up from the chair or move to 40 minutes; Achy; Arm severely sore; This is a spontaneous report from a contactable consumer (parent of the patient). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration on 09May2021 (Batch/Lot Number: ER8735, at the age of 30 years) as a single dose for COVID-19 immunization at a pharmacy drug store. Medical history included allergies to antibiotics (penicillin and all cross over drugs). The patient has no prior no health issues. The patient was not diagnosed with COVID-19 prior to vaccination. Historical vaccine included the patient received the first dose of the BNT162B2 vaccine (Batch/Lot Number: EW0151) on 09Apr2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication was reported as none. The patient was not taking any other medications within 2 weeks of receiving the vaccination. On 09May2021, the patient received the second dose of the BNT162B2 vaccine. On 09May2021, the patient had a immediate reaction to the vaccination where his breathing almost completely shut down. He experienced ringing in his ears, lost his vision and had cold sweats. He could not get up from the chair or move for 40 minutes. It was reported that the patient meditates, and he kept his breathing going on his own. The pharmacist assisted him. That night he was achy and had severe fever and sweats. He had to rest for many days. His arm was severely sore and took many days to recover. It was reported that the patient has a very high threshold for pain, but this was severe. The patient has not been tested for COVID-19 after receiving the vaccination. The consumer inquired if the patient should avoid all COVID booster shots next year. The consumer inquired if it possibly this was a polyethylene glycol reaction. No treatment was received for the events. The outcome of event arm was severely sore was recovered in May2021. The outcome of the events loss of vision, breathing almost completely shut down, severe fever, ringing in his ears, night sweats, cold sweats, could not get up from the chair or move and achey was reported as recovering.
she was admitted for severe bradycardia with heart rate in the 30s. She had a pacemaker inserted. She was discharged home.
30 minutes after vaccination, started to feel itching on back of head. By the time she got home 30 minutes later, noticed had itchy rash on legs and back. Rash spread to trunk, arms, face throughout the rest of the day, no new lesions 12 hours after vaccination. Seen in clinic 2 days later, rash still present, still very pruritic. No reaction at injection site.
After vaccination, the patient fainted in the administration room.  She was only briefly unconscious, according to the  immunizing, administering technician. She wanted water when she came to.  She was sent to an Urgent Care facility because she said her head hurt.  Both parents were present. Do not know any more.
As patient's mother, held her awake daughter at 3:00pm Tuesday on January 12 2010, the child's eyes started rolling back, her whole body had tremors and she was clenching her mouth. This lasted 4 minutes. Mom said she did not seem to have a fever before this started. At 3:30pm her fever was 103. Her mom call 911 and the paramedics came and took the child to Medical Center and was diagnosed with Febrile Seizure. After DTAP stayed for 5 hours, the child was taken January 13, 2010 to her pediatrician agreed it was Febrile Seizure from the DTAP and should never have it again. Fever spikes of 103-104 have continued from January 13, 2010 to present. Mom is giving MOTRIN 1 tsp every 3-4 hours. Alternating with children's TYLENOL 1tsp prn fever.
HCP report's patient got SHINGRIX two days ago and is now reporting it's very itchy on the area, and pretty red and tender. This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a female patient who received SHINGRIX for prophylaxis.  On 24th July 2018, the patient received SHINGRIX. In July 2018, less than a week after receiving Shingrix, the patient experienced pruritus, tenderness and erythema. On an unknown date, the outcome of the pruritus, tenderness and erythema were unknown. It was unknown if the reporter considered the pruritus, tenderness and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The lot number of SHINGRIX was not provided. The health care professional reported that the patient received SHINGRIX two days ago and experienced very itchy on the area, and pretty red and tender.
Get tire extremely fast when walking daily Shortness of breath daily  Swollen ankles daily  Headaches every morning when I wake up Pressure in left eye often Body was cold the night of the vaccine
Increase in vein system. Veins are visible running along top of fingers . Increase visible veins lower legs and feet. Ringing in my ears! Fatigue increased with periods of heaviness in the chest when laying down.
As epidemiologists thought you might be interested in my experience:  I think I caught COVIC on Jan 26, 2020, before people were aware. I had a high fever and was in bed for 3 days. I marked it on my calendar. Subsequently, I had extremely itchy eczema, in July a big rash on my back. and continuing itchy eczema. Had problems sleeping. My docs did not believe me or think it necessary to test me for antibodies as they felt "the test was not very good." They just said I had dry skin. I had 3 negative COVID tests over the months in prep for surgery.  What is really interesting to me is that last week I received my second Moderna shot and my eczema has DISAPPEARED. What do you think? Am I nuts or observant?
Injection site reaction: warm & pink skin area 3 inch-4 inch diameter. Sent her to clinic - was told to use HC 1% crm/Ibuprofen/ice area.
adverse event after the vaccination; 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 VACCINATION COMPLICATION (adverse event after the vaccination) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse event after the vaccination). At the time of the report, VACCINATION COMPLICATION (adverse event after the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.
sore underarm; swelling; mild aches; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 57-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection and Lot Number: EN6203) via an unspecified route of administration, administered in right arm on 10Mar2021 15:00 (at the age of 57-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO) and Multivitamin taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of BNT162B2 (at the age of 57-years-old) (lot number: EL3247, vaccine location: Left arm) on 19Feb2021 23:45 for covid-19 immunisation. The patient had no known allergies. It was reported that on 11Mar2021 07:00 the patient woke up with a sore underarm the next morning after receiving second dose vaccination. When looking in the mirror, it was noted a swelling. The event went away in 3 days. She also had mild aches but took 3 advil and felt good. The patient did not received treatment for the events. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Patient did not receive any other vaccines within 4 weeks to the COVID vaccine. The outcome of all the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Narrative:  08/25/2021 COVID vaccine dose #1-Patient developed left deltoid pain after vaccination, pain resolved about 8-9 weeks later 09/15/2021 COVID vaccine dose #2-Patient developed right arm pain after vaccination to right arm, pain resolved about 8-9 weeks later 05/05/2022 COVID vaccine dose #3-Patient developed stabbing pain, the pain on his left arm has been slowly increasing. 11/07/2022 At PCP visit, pt reports the pain is 2/10 intensity but increases when he lays on it or when pressure is applied to 8/10 intensity. Pain decreases a few minutes after pressure is removed. Provider ordered gabapentin to treat pain.
Narrative: Patient was seen prior to administration of 2nd dose of Moderna COVID-19 vaccination. She reports having experienced mild b/l hand/foot paranesthesia after the initial vaccination. She notes that this started around 3-4 hours after and lasted for about 2-3x days before spontaneously resolving. She did not seek medical care or trial therapies. She denies other s/sx concerning for anaphylaxis. The issue was not associated with pain, she has no PMH of this issue and no focal neurological deficits were noted. Reviewed common side effects of COVID vaccination and discussed when to seek care, including s/sx that require emergent evaluation. Also reviewed specific advice regarding f/u related to the above issue if it is to reoccur and persist. Patient with no further questions/concerns and stated a desire to proceed with vaccination.